Testmiljö
Observera att detta är en testmiljö för utveckling som inte ska användas som underlag för klinisk bedömning. Besök Janusmed här: https://janusmed.se

4/8/2025

Janusmed kön och genus

Janusmed kön och genus – Sitagliptin/Metformin Medical Valley

Janusmed kön och genus är ett kunskapsstöd som tillhandahåller information om köns- och genusaspekter på läkemedelsbehandling. Kunskapsstödet är avsedd främst för hälso- och sjukvårdspersonal. Texterna är generella och ska inte ses som behandlingsriktlinjer. Det är alltid behandlande läkare som ansvarar för patientens medicinering.

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Metformin Testmiljö

Metformin

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Competact, Eucreas, Glucophage, Glucophage SR, Janumet, Jentadueto, Me......

Competact, Eucreas, Glucophage, Glucophage SR, Janumet, Jentadueto, Metformin Accord, Metformin Actavis, Metformin Aristo, Metformin Aurobindo, Metformin Bluefish, Metformin EQL, Metformin EQL Pharma, Metformin Ebb, Metformin Hexal, Metformin Hydrochloride, Metformin Meda, Metformin Medical Valley, Metformin Mylan, Metformin Orifarm, Metformin STADA, Metformin Sandoz, Metformin Teva, Metformin Vitabalans, Metformin Zentiva, Mitforgen, Sitagliptin/Metformin Glenmark, Sitagliptin/Metformin Grindeks, Sitagliptin/Metformin Krka, Sitagliptin/Metformin Medical Valley, Sitagliptin/Metformin STADA, Sitagliptin/Metformin Sandoz, Sitagliptin/Metformin Zentiva, Sitagliptin/Metformin hydrochloride Mylan, Synjardy, Velmetia, Vildagliptin/Metformin Krka, Vildagliptin/Metformin STADA, Vildagliptin/Metformin hydrochloride Accord, Xigduo
ATC-koder

A10BA02, A10BD05, A10BD07, A10BD08, A10BD11, A10BD15, A10BD20

A10BA02, A10BD05, A10BD07, A10BD08, A10BD11, A10BD15, A10BD20
Substanser

metformin, metforminhydroklorid

metformin, metforminhydroklorid
Sammanfattning

Den blodsockersänkande effekten av metformin vid typ 2-diabetes är likvärdig hos kvinnor och män i kontrollerade kliniska studier. En av dessa studier indikerar att kvinnor har högre risk att få hypoglykemi vid antidiabetikabehandling än män.  I en observationell studie fick männen som behandlades med metformin en större HbA1c-minskning jämfört med kvinnorna. Däremot sågs en större viktreduktion hos kvinnor som behandlades med metformin jämfört med männen.

Det har diskuterats ifall metforminbehandlade kvinnor har större risk för laktacidos, men evidensläget är oklart.

Den blodsockersänkande effekten av metformin vid typ 2-diabetes är likvärdig hos kvinnor och män i kontrollerade kliniska studier. En av dessa studier indikerar att kvinnor har högre risk att få hypoglykemi vid antidiabetikabehandling än män.  I en observationell studie fick männen som behandlades med metformin en större HbA1c-minskning jämfört med kvinnorna. Däremot sågs en större viktreduktion hos kvinnor som behandlades med metformin jämfört med männen. Det har diskuterats ifall metforminbehandlade kvinnor har större risk för laktacidos, men evidensläget är oklart.
Background

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2].

Pharmacokinetics and dosing
The bioavailability of fixed-dose combination tablets of pioglitazone and metformin was examined in young healthy subjects (61 men, 63 women). For either pioglitazone or metformin, exposure differences in AUC between men and women did not exceed 20% and there was considerable overlap in AUC values. When AUC was normalized for 70-kg body weight, sex differences in mean AUC values were less than 10% [3]. According to the drug label information, there are no sex differences in metformin pharmacokinetics in normal subjects (19 men, 16 women) and no sex differentiation has been recommended by the pharmaceutical company [4].

Effects
In the UK Prospective Diabetes Study (UKPDS) that reported long-term metabolic effects of metformin and reduced cardiovascular ri......

Visa hela bakgrundstexten

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2]. # Pharmacokinetics and dosing The bioavailability of fixed-dose combination tablets of pioglitazone and metformin was examined in young healthy subjects (61 men, 63 women). For either pioglitazone or metformin, exposure differences in AUC between men and women did not exceed 20% and there was considerable overlap in AUC values. When AUC was normalized for 70-kg body weight, sex differences in mean AUC values were less than 10% [3]. According to the drug label information, there are no sex differences in metformin pharmacokinetics in normal subjects (19 men, 16 women) and no sex differentiation has been recommended by the pharmaceutical company [4]. # Effects In the UK Prospective Diabetes Study (UKPDS) that reported long-term metabolic effects of metformin and reduced cardiovascular risk with use, included both men and women (in total 1704 patients, 342 with metformin), although the results were not presented separately for men and women [5]. Controlled clinical studies in patients with type 2 diabetes show comparable antihyperglycemic effect of metformin in men and women [4]. A clinical trial (36 men, 42 women) evaluated the sex-related differences in the cardiac metabolic response to diabetes treatment. Patients received metformin alone, metformin plus rosiglitazone, or metformin plus Lovaza/Omacor (Omega-3 fish oil). In metformin treated men, but not in women, whole body fatty acid clearance decreased, which was linked to increased plasma fatty acid levels, myocardial fatty acid utilization and oxidation, and lower myocardial glucose utilization. Myocardial glucose metabolism was unchanged in women [6]. In an observational German study in patients with diabetes, effects of treatment with lifestyle, metformin or sulfonylurea on glycemic control and body weight were investigated. Data for subgroups of men and women adjusted for age, diabetes duration, baseline HbA1c and observational treatment period were analyzed. Men had higher HbA1c-reductions after treatment with lifestyle and metformin, respectively, than women. In contrast, women had a higher reduction of body weight after lifestyle intervention (2909 men, 2878 women), metformin (1098 men, 1082 women) or sulfonylurea (493 men, 450 women) monotherapies than men. Highest weight reductions were seen in women treated with metformin (women -1.8±0.2 vs. men -1.2±0.2kg; p<0.05)  [7]. Similarly, in a RCT evaluating the patterns of weight change in patients with type 2 diabetes (623 men, 461 women), women treated with metformin had lost more weight than men at six months (-0.8 kg vs. -2.1 kg, respectively). However, this sex difference did not persist to the end of follow-up period (50 months) [8]. In contrast, another study (935 men, 1986 women) reported no significant differences between races/ethnicities or men and women in weight loss in response to metformin [9]. A RCT investigated the effect of metformin for obesity in Spanish prepubertal and pubertal children (72 boys, 68 girls) with BMI z score (age and sex standardized body mass index) reduction as primary outcome. For one of the secondary outcome measures, boys had an increased ALR (adiponectin-leptin ratio) after metformin treatment versus placebo, but girls only showed a trend [10]. # Adverse effects The ACCORD study (Action to Control Cardiovascular Risk in Diabetes) was a randomized, controlled trial designed to test the effect of intensive glucose control compared with standard control on cardiovascular outcomes in patients with type 2 diabetes. The study showed that women had a higher risk of hypoglycemia than men regardless of treatment in general [11]. In a nested case-control study (109 120 men, 48 805 women), using Taiwan’s National Health Insurance Research Database from 2001 to 2014, interaction between patient’s sex and use of oral antidiabetic drugs was explored among patients with myocardial infarction in the US Food and Drug Administration Adverse Event Reporting System from 2004 to 2014. Men had a higher risk of metformin- and sulfonylureas-associated myocardial infarction than women (OR men 1.37 vs OR women 1.15) [12]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information In a Chinese study (199 men, 89 women), metformin was found to increase plasma lactic acid levels in type 2 diabetes patients. Women on metformin had higher lactic acid levels than men. Lactic acid concentrations increased with higher estradiol levels but decreased with increased levels of testosterone. The levels of testosterone and estradiol in women were significantly lower than those in men. This sex difference leads to different plasma lactate levels. The authors of this study suggest that lactate concentrations should be monitored frequently in diabetes patients during metformin administration, especially in women with high estrogen levels, to avoid potential lactic acidosis [13]. In an Iranian randomized, clinical trial (38 men, 61 women) of newly diagnosed, medication-naïve type 2 diabetes patients, the effects of metformin on serum concentrations of vaspin and adiponectin were studied. After 3 months of metformin therapy, vaspin dropped significantly only in women. Metformin therapy did not change adiponectin concentrations in neither women nor men. Higher adiponectin concentrations are believed to confer protection against development of type 2 diabetes in healthy subjects. This study showed that metformin exerts little benefit on adiponectin levels in diabetes patients [14]. In a RCT with patients newly diagnosed with diabetes, the effects of metformin (22 men, 19 women) and pioglitazone (19 men, 31 women) on omentin and leptin concentrations were investigated. After three months, metformin decreased both omentin and leptin concentrations in women, and leptin concentrations only in men [15]. In a study on diabetes type 2 patients treated with either metformin or lifestyle (446 men, 329 women), metformin was associated with higher fasting active and total GLP-1 levels but without any correlation to a patient’s sex [16]. A Taiwanese study (18 239 men, 16 099 women) examining the possible metformin effect on cancer, found a benefit of metformin in colorectal cancer in women but not in men [17]. In patients (163 men, 105 women) with normal or mildly impaired renal function (glomerular filtration rate of > 60 mL/min/1.73 m2), the impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy was examined. The ejection fraction and contrast volume were found to be independent predictors of contrast-induced nephropathy, while patient’s sex was not [18].
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Fler män än kvinnor hämtade ut tabletter innehållande metformin (ATC-kod A10BA02) på recept i Sverige år 2020, totalt 219 821 män och 153 862 kvinnor. Det motsvarar 42 respektive 30 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70-79 år hos män och i åldersgruppen 75-84 år hos kvinnor. I genomsnitt var tabletter innehållande metformin 1,5 gånger vanligare hos män [19].
Referenser

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  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.

  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.

  3. Karim A, Slater M, Bradford D, Schwartz L, Zhao Z, Cao C et al. Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin Effect of body weight, gender, and race on systemic exposures of each drug. J Clin Pharmacol. 2007;47:37-47.

  4. Glucophage (metformin). DailyMed [www]. U.S. National Library of Medicine. [updated 2018-05-31, cited 2021-01-26].

  5. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352(9131):854-65.

  6. Lyons MR, Peterson LR, McGill JB, Herrero P, Coggan AR, Saeed IM et al. Impact of sex on the heart's metabolic and functional responses to diabetic therapies. Am J Physiol Heart Circ Physiol. 2013;305:H1584-91.

  7. Schütt M, Zimmermann A, Hood R, Hummel M, Seufert J, Siegel E, Tytko A, Holl RW; DPV initiative; German BMBF Competence Network Diabetes Mellitus. Gender-specific Effects of Treatment with Lifestyle, Metformin or Sulfonylurea on Glycemic Control and Body Weight: A German Multicenter Analysis on 9 108 Patients. Exp Clin Endocrinol Diabetes. 2015;123(10):622-6.

  8. Tuthill A, McKenna MJ, O'Shea D, McKenna TJ. Weight changes in type 2 diabetes and the impact of gender. Diabetes Obes Metab. 2008;10:726-32.

  9. West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008;16:1413-20.

  10. Pastor-Villaescusa B, Cañete MD, Caballero-Villarraso J, Hoyos R, Latorre M, Vázquez-Cobela R et al. Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. Pediatrics. 2017;140(1).

  11. Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010;340:b5444.

  12. Wang SH, Chen WJ, Hsu LY, Chien KL, Wu CS. Use of Spontaneous Reporting Systems to Detect Host-Medication Interactions: Sex Differences in Oral Anti-Diabetic Drug-Associated Myocardial Infarction. J Am Heart Assoc. 2018;7(22):e008959.

  13. Shen Y, Liu F, Li Q, Tang J, Zheng T, Lu F et al. The gonadal hormone regulates the plasma lactate levels in type 2 diabetes treated with and without metformin. Diabetes Technol Ther. 2012;14:469-74.

  14. Esteghamati A, Mousavizadeh M, Noshad S, Zandieh A, Zarei H, Nakhjavani M. Gender-dependent effects of metformin on vaspin and adiponectin in type 2 diabetes patients: a randomized clinical trial. Horm Metab Res. 2013;45:319-25.

  15. Esteghamati A, Noshad S, Rabizadeh S, Ghavami M, Zandieh A, Nakhjavani M. Comparative effects of metformin and pioglitazone on omentin and leptin concentrations in patients with newly diagnosed diabetes: a randomized clinical trial. Regul Pept. 2013;182:1-6.

  16. Lee MS, Hsu CC, Wahlqvist ML, Tsai HN, Chang YH, Huang YC. Type 2 diabetes increases and metformin reduces total, colorectal, liver and pancreatic cancer incidences in Taiwanese: a representative population prospective cohort study of 800,000 individuals. BMC Cancer. 2011;11:20.

  17. Oktay V, Calpar Çıralı İ, Sinan ÜY, Yıldız A, Ersanlı MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017;18(5):334-339.

  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.
  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.
  3. Karim A, Slater M, Bradford D, Schwartz L, Zhao Z, Cao C et al. Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin Effect of body weight, gender, and race on systemic exposures of each drug. J Clin Pharmacol. 2007;47:37-47.
  4. Glucophage (metformin). DailyMed [www]. U.S. National Library of Medicine. [updated 2018-05-31, cited 2021-01-26].
  5. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352(9131):854-65.
  6. Lyons MR, Peterson LR, McGill JB, Herrero P, Coggan AR, Saeed IM et al. Impact of sex on the heart's metabolic and functional responses to diabetic therapies. Am J Physiol Heart Circ Physiol. 2013;305:H1584-91.
  7. Schütt M, Zimmermann A, Hood R, Hummel M, Seufert J, Siegel E, Tytko A, Holl RW; DPV initiative; German BMBF Competence Network Diabetes Mellitus. Gender-specific Effects of Treatment with Lifestyle, Metformin or Sulfonylurea on Glycemic Control and Body Weight: A German Multicenter Analysis on 9 108 Patients. Exp Clin Endocrinol Diabetes. 2015;123(10):622-6.
  8. Tuthill A, McKenna MJ, O'Shea D, McKenna TJ. Weight changes in type 2 diabetes and the impact of gender. Diabetes Obes Metab. 2008;10:726-32.
  9. West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008;16:1413-20.
  10. Pastor-Villaescusa B, Cañete MD, Caballero-Villarraso J, Hoyos R, Latorre M, Vázquez-Cobela R et al. Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. Pediatrics. 2017;140(1).
  11. Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010;340:b5444.
  12. Wang SH, Chen WJ, Hsu LY, Chien KL, Wu CS. Use of Spontaneous Reporting Systems to Detect Host-Medication Interactions: Sex Differences in Oral Anti-Diabetic Drug-Associated Myocardial Infarction. J Am Heart Assoc. 2018;7(22):e008959.
  13. Shen Y, Liu F, Li Q, Tang J, Zheng T, Lu F et al. The gonadal hormone regulates the plasma lactate levels in type 2 diabetes treated with and without metformin. Diabetes Technol Ther. 2012;14:469-74.
  14. Esteghamati A, Mousavizadeh M, Noshad S, Zandieh A, Zarei H, Nakhjavani M. Gender-dependent effects of metformin on vaspin and adiponectin in type 2 diabetes patients: a randomized clinical trial. Horm Metab Res. 2013;45:319-25.
  15. Esteghamati A, Noshad S, Rabizadeh S, Ghavami M, Zandieh A, Nakhjavani M. Comparative effects of metformin and pioglitazone on omentin and leptin concentrations in patients with newly diagnosed diabetes: a randomized clinical trial. Regul Pept. 2013;182:1-6.
  16. Lee MS, Hsu CC, Wahlqvist ML, Tsai HN, Chang YH, Huang YC. Type 2 diabetes increases and metformin reduces total, colorectal, liver and pancreatic cancer incidences in Taiwanese: a representative population prospective cohort study of 800,000 individuals. BMC Cancer. 2011;11:20.
  17. Oktay V, Calpar Çıralı İ, Sinan ÜY, Yıldız A, Ersanlı MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017;18(5):334-339.
  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
Uppdaterat

Litteratursökningsdatum: 1/26/2021

Litteratursökningsdatum: 1/26/2021
Fasstexter

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A A
A A

Metformin Testmiljö

Metformin

Klass : A

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Produkter

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Competact, Eucreas, Glucophage, Glucophage SR, Janumet, Jentadueto, Me......

Competact, Eucreas, Glucophage, Glucophage SR, Janumet, Jentadueto, Metformin Accord, Metformin Actavis, Metformin Aristo, Metformin Aurobindo, Metformin Bluefish, Metformin EQL, Metformin EQL Pharma, Metformin Ebb, Metformin Hexal, Metformin Hydrochloride, Metformin Meda, Metformin Medical Valley, Metformin Mylan, Metformin Orifarm, Metformin STADA, Metformin Sandoz, Metformin Teva, Metformin Vitabalans, Metformin Zentiva, Mitforgen, Sitagliptin/Metformin Glenmark, Sitagliptin/Metformin Grindeks, Sitagliptin/Metformin Krka, Sitagliptin/Metformin Medical Valley, Sitagliptin/Metformin STADA, Sitagliptin/Metformin Sandoz, Sitagliptin/Metformin Zentiva, Sitagliptin/Metformin hydrochloride Mylan, Synjardy, Velmetia, Vildagliptin/Metformin Krka, Vildagliptin/Metformin STADA, Vildagliptin/Metformin hydrochloride Accord, Xigduo
ATC-koder

A10BA02, A10BD05, A10BD07, A10BD08, A10BD11, A10BD15, A10BD20

A10BA02, A10BD05, A10BD07, A10BD08, A10BD11, A10BD15, A10BD20
Substanser

metformin, metforminhydroklorid

metformin, metforminhydroklorid
Sammanfattning

Den blodsockersänkande effekten av metformin vid typ 2-diabetes är likvärdig hos kvinnor och män i kontrollerade kliniska studier. En av dessa studier indikerar att kvinnor har högre risk att få hypoglykemi vid antidiabetikabehandling än män.  I en observationell studie fick männen som behandlades med metformin en större HbA1c-minskning jämfört med kvinnorna. Däremot sågs en större viktreduktion hos kvinnor som behandlades med metformin jämfört med männen.

Det har diskuterats ifall metforminbehandlade kvinnor har större risk för laktacidos, men evidensläget är oklart.

Den blodsockersänkande effekten av metformin vid typ 2-diabetes är likvärdig hos kvinnor och män i kontrollerade kliniska studier. En av dessa studier indikerar att kvinnor har högre risk att få hypoglykemi vid antidiabetikabehandling än män.  I en observationell studie fick männen som behandlades med metformin en större HbA1c-minskning jämfört med kvinnorna. Däremot sågs en större viktreduktion hos kvinnor som behandlades med metformin jämfört med männen. Det har diskuterats ifall metforminbehandlade kvinnor har större risk för laktacidos, men evidensläget är oklart.
Background

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2].

Pharmacokinetics and dosing
The bioavailability of fixed-dose combination tablets of pioglitazone and metformin was examined in young healthy subjects (61 men, 63 women). For either pioglitazone or metformin, exposure differences in AUC between men and women did not exceed 20% and there was considerable overlap in AUC values. When AUC was normalized for 70-kg body weight, sex differences in mean AUC values were less than 10% [3]. According to the drug label information, there are no sex differences in metformin pharmacokinetics in normal subjects (19 men, 16 women) and no sex differentiation has been recommended by the pharmaceutical company [4].

Effects
In the UK Prospective Diabetes Study (UKPDS) that reported long-term metabolic effects of metformin and reduced cardiovascular ri......

Visa hela bakgrundstexten

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2]. # Pharmacokinetics and dosing The bioavailability of fixed-dose combination tablets of pioglitazone and metformin was examined in young healthy subjects (61 men, 63 women). For either pioglitazone or metformin, exposure differences in AUC between men and women did not exceed 20% and there was considerable overlap in AUC values. When AUC was normalized for 70-kg body weight, sex differences in mean AUC values were less than 10% [3]. According to the drug label information, there are no sex differences in metformin pharmacokinetics in normal subjects (19 men, 16 women) and no sex differentiation has been recommended by the pharmaceutical company [4]. # Effects In the UK Prospective Diabetes Study (UKPDS) that reported long-term metabolic effects of metformin and reduced cardiovascular risk with use, included both men and women (in total 1704 patients, 342 with metformin), although the results were not presented separately for men and women [5]. Controlled clinical studies in patients with type 2 diabetes show comparable antihyperglycemic effect of metformin in men and women [4]. A clinical trial (36 men, 42 women) evaluated the sex-related differences in the cardiac metabolic response to diabetes treatment. Patients received metformin alone, metformin plus rosiglitazone, or metformin plus Lovaza/Omacor (Omega-3 fish oil). In metformin treated men, but not in women, whole body fatty acid clearance decreased, which was linked to increased plasma fatty acid levels, myocardial fatty acid utilization and oxidation, and lower myocardial glucose utilization. Myocardial glucose metabolism was unchanged in women [6]. In an observational German study in patients with diabetes, effects of treatment with lifestyle, metformin or sulfonylurea on glycemic control and body weight were investigated. Data for subgroups of men and women adjusted for age, diabetes duration, baseline HbA1c and observational treatment period were analyzed. Men had higher HbA1c-reductions after treatment with lifestyle and metformin, respectively, than women. In contrast, women had a higher reduction of body weight after lifestyle intervention (2909 men, 2878 women), metformin (1098 men, 1082 women) or sulfonylurea (493 men, 450 women) monotherapies than men. Highest weight reductions were seen in women treated with metformin (women -1.8±0.2 vs. men -1.2±0.2kg; p<0.05)  [7]. Similarly, in a RCT evaluating the patterns of weight change in patients with type 2 diabetes (623 men, 461 women), women treated with metformin had lost more weight than men at six months (-0.8 kg vs. -2.1 kg, respectively). However, this sex difference did not persist to the end of follow-up period (50 months) [8]. In contrast, another study (935 men, 1986 women) reported no significant differences between races/ethnicities or men and women in weight loss in response to metformin [9]. A RCT investigated the effect of metformin for obesity in Spanish prepubertal and pubertal children (72 boys, 68 girls) with BMI z score (age and sex standardized body mass index) reduction as primary outcome. For one of the secondary outcome measures, boys had an increased ALR (adiponectin-leptin ratio) after metformin treatment versus placebo, but girls only showed a trend [10]. # Adverse effects The ACCORD study (Action to Control Cardiovascular Risk in Diabetes) was a randomized, controlled trial designed to test the effect of intensive glucose control compared with standard control on cardiovascular outcomes in patients with type 2 diabetes. The study showed that women had a higher risk of hypoglycemia than men regardless of treatment in general [11]. In a nested case-control study (109 120 men, 48 805 women), using Taiwan’s National Health Insurance Research Database from 2001 to 2014, interaction between patient’s sex and use of oral antidiabetic drugs was explored among patients with myocardial infarction in the US Food and Drug Administration Adverse Event Reporting System from 2004 to 2014. Men had a higher risk of metformin- and sulfonylureas-associated myocardial infarction than women (OR men 1.37 vs OR women 1.15) [12]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information In a Chinese study (199 men, 89 women), metformin was found to increase plasma lactic acid levels in type 2 diabetes patients. Women on metformin had higher lactic acid levels than men. Lactic acid concentrations increased with higher estradiol levels but decreased with increased levels of testosterone. The levels of testosterone and estradiol in women were significantly lower than those in men. This sex difference leads to different plasma lactate levels. The authors of this study suggest that lactate concentrations should be monitored frequently in diabetes patients during metformin administration, especially in women with high estrogen levels, to avoid potential lactic acidosis [13]. In an Iranian randomized, clinical trial (38 men, 61 women) of newly diagnosed, medication-naïve type 2 diabetes patients, the effects of metformin on serum concentrations of vaspin and adiponectin were studied. After 3 months of metformin therapy, vaspin dropped significantly only in women. Metformin therapy did not change adiponectin concentrations in neither women nor men. Higher adiponectin concentrations are believed to confer protection against development of type 2 diabetes in healthy subjects. This study showed that metformin exerts little benefit on adiponectin levels in diabetes patients [14]. In a RCT with patients newly diagnosed with diabetes, the effects of metformin (22 men, 19 women) and pioglitazone (19 men, 31 women) on omentin and leptin concentrations were investigated. After three months, metformin decreased both omentin and leptin concentrations in women, and leptin concentrations only in men [15]. In a study on diabetes type 2 patients treated with either metformin or lifestyle (446 men, 329 women), metformin was associated with higher fasting active and total GLP-1 levels but without any correlation to a patient’s sex [16]. A Taiwanese study (18 239 men, 16 099 women) examining the possible metformin effect on cancer, found a benefit of metformin in colorectal cancer in women but not in men [17]. In patients (163 men, 105 women) with normal or mildly impaired renal function (glomerular filtration rate of > 60 mL/min/1.73 m2), the impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy was examined. The ejection fraction and contrast volume were found to be independent predictors of contrast-induced nephropathy, while patient’s sex was not [18].
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Fler män än kvinnor hämtade ut tabletter innehållande metformin (ATC-kod A10BA02) på recept i Sverige år 2020, totalt 219 821 män och 153 862 kvinnor. Det motsvarar 42 respektive 30 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 70-79 år hos män och i åldersgruppen 75-84 år hos kvinnor. I genomsnitt var tabletter innehållande metformin 1,5 gånger vanligare hos män [19].
Referenser

Visa referenser

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.

  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.

  3. Karim A, Slater M, Bradford D, Schwartz L, Zhao Z, Cao C et al. Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin Effect of body weight, gender, and race on systemic exposures of each drug. J Clin Pharmacol. 2007;47:37-47.

  4. Glucophage (metformin). DailyMed [www]. U.S. National Library of Medicine. [updated 2018-05-31, cited 2021-01-26].

  5. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352(9131):854-65.

  6. Lyons MR, Peterson LR, McGill JB, Herrero P, Coggan AR, Saeed IM et al. Impact of sex on the heart's metabolic and functional responses to diabetic therapies. Am J Physiol Heart Circ Physiol. 2013;305:H1584-91.

  7. Schütt M, Zimmermann A, Hood R, Hummel M, Seufert J, Siegel E, Tytko A, Holl RW; DPV initiative; German BMBF Competence Network Diabetes Mellitus. Gender-specific Effects of Treatment with Lifestyle, Metformin or Sulfonylurea on Glycemic Control and Body Weight: A German Multicenter Analysis on 9 108 Patients. Exp Clin Endocrinol Diabetes. 2015;123(10):622-6.

  8. Tuthill A, McKenna MJ, O'Shea D, McKenna TJ. Weight changes in type 2 diabetes and the impact of gender. Diabetes Obes Metab. 2008;10:726-32.

  9. West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008;16:1413-20.

  10. Pastor-Villaescusa B, Cañete MD, Caballero-Villarraso J, Hoyos R, Latorre M, Vázquez-Cobela R et al. Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. Pediatrics. 2017;140(1).

  11. Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010;340:b5444.

  12. Wang SH, Chen WJ, Hsu LY, Chien KL, Wu CS. Use of Spontaneous Reporting Systems to Detect Host-Medication Interactions: Sex Differences in Oral Anti-Diabetic Drug-Associated Myocardial Infarction. J Am Heart Assoc. 2018;7(22):e008959.

  13. Shen Y, Liu F, Li Q, Tang J, Zheng T, Lu F et al. The gonadal hormone regulates the plasma lactate levels in type 2 diabetes treated with and without metformin. Diabetes Technol Ther. 2012;14:469-74.

  14. Esteghamati A, Mousavizadeh M, Noshad S, Zandieh A, Zarei H, Nakhjavani M. Gender-dependent effects of metformin on vaspin and adiponectin in type 2 diabetes patients: a randomized clinical trial. Horm Metab Res. 2013;45:319-25.

  15. Esteghamati A, Noshad S, Rabizadeh S, Ghavami M, Zandieh A, Nakhjavani M. Comparative effects of metformin and pioglitazone on omentin and leptin concentrations in patients with newly diagnosed diabetes: a randomized clinical trial. Regul Pept. 2013;182:1-6.

  16. Lee MS, Hsu CC, Wahlqvist ML, Tsai HN, Chang YH, Huang YC. Type 2 diabetes increases and metformin reduces total, colorectal, liver and pancreatic cancer incidences in Taiwanese: a representative population prospective cohort study of 800,000 individuals. BMC Cancer. 2011;11:20.

  17. Oktay V, Calpar Çıralı İ, Sinan ÜY, Yıldız A, Ersanlı MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017;18(5):334-339.

  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.
  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.
  3. Karim A, Slater M, Bradford D, Schwartz L, Zhao Z, Cao C et al. Oral antidiabetic drugs: bioavailability assessment of fixed-dose combination tablets of pioglitazone and metformin Effect of body weight, gender, and race on systemic exposures of each drug. J Clin Pharmacol. 2007;47:37-47.
  4. Glucophage (metformin). DailyMed [www]. U.S. National Library of Medicine. [updated 2018-05-31, cited 2021-01-26].
  5. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998;352(9131):854-65.
  6. Lyons MR, Peterson LR, McGill JB, Herrero P, Coggan AR, Saeed IM et al. Impact of sex on the heart's metabolic and functional responses to diabetic therapies. Am J Physiol Heart Circ Physiol. 2013;305:H1584-91.
  7. Schütt M, Zimmermann A, Hood R, Hummel M, Seufert J, Siegel E, Tytko A, Holl RW; DPV initiative; German BMBF Competence Network Diabetes Mellitus. Gender-specific Effects of Treatment with Lifestyle, Metformin or Sulfonylurea on Glycemic Control and Body Weight: A German Multicenter Analysis on 9 108 Patients. Exp Clin Endocrinol Diabetes. 2015;123(10):622-6.
  8. Tuthill A, McKenna MJ, O'Shea D, McKenna TJ. Weight changes in type 2 diabetes and the impact of gender. Diabetes Obes Metab. 2008;10:726-32.
  9. West DS, Elaine Prewitt T, Bursac Z, Felix HC. Weight loss of black, white, and Hispanic men and women in the Diabetes Prevention Program. Obesity (Silver Spring). 2008;16:1413-20.
  10. Pastor-Villaescusa B, Cañete MD, Caballero-Villarraso J, Hoyos R, Latorre M, Vázquez-Cobela R et al. Metformin for Obesity in Prepubertal and Pubertal Children: A Randomized Controlled Trial. Pediatrics. 2017;140(1).
  11. Miller ME, Bonds DE, Gerstein HC, Seaquist ER, Bergenstal RM, Calles-Escandon J et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ. 2010;340:b5444.
  12. Wang SH, Chen WJ, Hsu LY, Chien KL, Wu CS. Use of Spontaneous Reporting Systems to Detect Host-Medication Interactions: Sex Differences in Oral Anti-Diabetic Drug-Associated Myocardial Infarction. J Am Heart Assoc. 2018;7(22):e008959.
  13. Shen Y, Liu F, Li Q, Tang J, Zheng T, Lu F et al. The gonadal hormone regulates the plasma lactate levels in type 2 diabetes treated with and without metformin. Diabetes Technol Ther. 2012;14:469-74.
  14. Esteghamati A, Mousavizadeh M, Noshad S, Zandieh A, Zarei H, Nakhjavani M. Gender-dependent effects of metformin on vaspin and adiponectin in type 2 diabetes patients: a randomized clinical trial. Horm Metab Res. 2013;45:319-25.
  15. Esteghamati A, Noshad S, Rabizadeh S, Ghavami M, Zandieh A, Nakhjavani M. Comparative effects of metformin and pioglitazone on omentin and leptin concentrations in patients with newly diagnosed diabetes: a randomized clinical trial. Regul Pept. 2013;182:1-6.
  16. Lee MS, Hsu CC, Wahlqvist ML, Tsai HN, Chang YH, Huang YC. Type 2 diabetes increases and metformin reduces total, colorectal, liver and pancreatic cancer incidences in Taiwanese: a representative population prospective cohort study of 800,000 individuals. BMC Cancer. 2011;11:20.
  17. Oktay V, Calpar Çıralı İ, Sinan ÜY, Yıldız A, Ersanlı MK. Impact of continuation of metformin prior to elective coronary angiography on acute contrast nephropathy in patients with normal or mildly impaired renal functions. Anatol J Cardiol. 2017;18(5):334-339.
  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
Uppdaterat

Litteratursökningsdatum: 1/26/2021

Litteratursökningsdatum: 1/26/2021
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Sitagliptin Testmiljö

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Janumet, Januvia, Sitagliptin Accord, Sitagliptin Glenmark, Sitaglipti......

Janumet, Januvia, Sitagliptin Accord, Sitagliptin Glenmark, Sitagliptin Grindeks, Sitagliptin Krka, Sitagliptin Orion, Sitagliptin STADA, Sitagliptin SUN, Sitagliptin Sandoz, Sitagliptin Teva, Sitagliptin Viatris, Sitagliptin Zentiva, Sitagliptin/Metformin Glenmark, Sitagliptin/Metformin Grindeks, Sitagliptin/Metformin Krka, Sitagliptin/Metformin Medical Valley, Sitagliptin/Metformin STADA, Sitagliptin/Metformin Sandoz, Sitagliptin/Metformin Zentiva, Sitagliptin/Metformin hydrochloride Mylan, Velmetia, Xelevia
ATC-koder

A10BD07, A10BH01

A10BD07, A10BH01
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sitagliptin, sitagliptinfosfat, sitagliptinfosfatmonohydrat, sitaglipt......

sitagliptin, sitagliptinfosfat, sitagliptinfosfatmonohydrat, sitagliptinfumarat, sitagliptinhydrokloridmonohydrat, sitagliptinmalat
Sammanfattning

En stor kohortstudie som undersökt effekten av behandling med sitagliptin på kardiovaskulära utfall visade att kvinnor hade en lägre risk att drabbas jämfört med män.

En klinisk studie har visat att fler kvinnor fick hypoglykemi än män vid sitagliptinbehandling.

En stor kohortstudie som undersökt effekten av behandling med sitagliptin på kardiovaskulära utfall visade att kvinnor hade en lägre risk att drabbas jämfört med män. En klinisk studie har visat att fler kvinnor fick hypoglykemi än män vid sitagliptinbehandling.
Background

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2].

Pharmacokinetics and dosing
Clinical studies have shown no pharmacokinetic differences between men and women of single- or multiple-dose sitagliptin [3, 4]. According to the original manufacturer, no clinically relevant pharmacokinetic sex differences have been shown [5].

In a Japanese retrospective cohort study (in total 87 678 patients), dose levels of sitagliptin were compared before and after the safety alert on the risk of serious hypoglycemic events with the combination sitagliptin and high-dose sulfonylureas. Women were prescribed lower mean daily doses of sitagliptin both before and after the safety alert (before; women : 59.6 ± 21.8 mg, men: 63.4 ± 24.4 mg, after; women: 57.2 ± 20.1 mg, men: 61.6 ± 23.7 mg) [6]. However, the original manufacturer does not recommend any dose......

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Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2]. # Pharmacokinetics and dosing Clinical studies have shown no pharmacokinetic differences between men and women of single- or multiple-dose sitagliptin [3, 4]. According to the original manufacturer, no clinically relevant pharmacokinetic sex differences have been shown [5]. In a Japanese retrospective cohort study (in total 87 678 patients), dose levels of sitagliptin were compared before and after the safety alert on the risk of serious hypoglycemic events with the combination sitagliptin and high-dose sulfonylureas. Women were prescribed lower mean daily doses of sitagliptin both before and after the safety alert (before; women : 59.6 ± 21.8 mg, men: 63.4 ± 24.4 mg, after; women: 57.2 ± 20.1 mg, men: 61.6 ± 23.7 mg) [6]. However, the original manufacturer does not recommend any dose adjustment based on patient’s sex [5]. # Effects  A placebo-controlled trial assessed the effect of sitagliptin treatment on cardiovascular (CV) outcomes in a prospective study in patients with type 2 diabetes and atherosclerotic vascular disease (10 374 men, 4297 women), the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) [7]. Sex differences in management and outcomes of the TECOS trial were analyzed [8]. The primary composite outcome of CV death, myocardial infarction, stroke, or hospitalization for unstable angina occurred in 418 women (9.7%) and 1272 men (12.3%; 3.48 vs 4.38 events/100 participant-years, adjusted HR 0.64, 95% CI 0.55-0.74). Women also had a significantly lower risk of secondary CV outcomes and all-cause death (1.58 vs 1.74 events/100 participant-years [adjusted HR 0.55, 95% CI 0.42-0.71) and all-cause death (2.18 vs 2.56 events/100 participant-years, adjusted HR 0.54, 95% CI 0.43-0.67) [8]. Differences in baseline characteristics of patients enrolled in the TECOS trial [7] was examined (10416 men, 4308 women). The prespecified clinical target goals in baseline characteristics were chosen to reflect those consistent with international guidelines at the time of the trial’s inception. The results showed that women were consistently less likely to reach the prespecified treatment target goals assessed at the time of study enrollment (SBP<140 mmHg, DBP<80 mmHg, LDL cholesterol <2.6 mmol/L, aspirin use, and statin use), with the exception of non-smoking status [9]. The effect on metabolic control and on CV risk evolution obtained by “add-on” persistent sitagliptin treatment (100 mg once daily) in a cohort of Italian participants with type 2 diabetes was assessed using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Analysis of sex differences in CV risk evolution evaluated by UKPDS RE (106 men, 64 women) showed a significantly lower CV risk in women (1.33 in men vs 1.12 in women in UKPDS after 48 months) [10]. A post-hoc analysis of pooled data from seven sitagliptin phase II and III clinical trials exploring the factors associated with the glucose-lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes (698 men, 370 women) showed no association between HbA1c changes and patient’s sex [11]. # Adverse effects A study evaluated the relative risk of hypoglycemic events in patients (691 men, 481 women) treated with sitagliptin or glipizide after adjusting for the most recently measured HbA1c value. The adjusted hazard ratio for women on either of the two studied drugs was 2.05, indicating that women had a twofold increase in risk of experiencing confirmed hypoglycemia relative to men. In multivariate analysis, female sex was one of the factors associated with a higher risk of hypoglycemia [12]. The risk of new-onset atrial fibrillation in patients with type 2 diabetes mellitus treated with sodium glucose cotransporter 2 (SGLT2) inhibitors versus dipeptidyl peptidase-4 (DPP-4) inhibitors was evaluated in an observational study from Taiwan. The subgroup analysis showed a lower risk of incident atrial fibrillation for SGLT2 inhibitors (9091 men, 6515 women) versus DPP-4 inhibitors (6911 men, 5472 women) in women compared to men with type 2 diabetes (HR men 0.51, HR women 0.70, p interaction =0.10) [13]. The fracture incidence among participants (10374 men, 4297 women) in the TECOS trial [7] was examined [14]. Although sitagliptin, compared with placebo, was not associated with a higher fracture risk (HR 1.03), adjusted analyses showed a significantly independently increased fracture risk in women (HR 1.95) [14]. A study with data on sitagliptin ever and never users (93858 men, 77860 women) derived from the Taiwan’s National Health Insurance evaluated the risk of heart failure hospitalization. Male sex was significantly associated with a higher risk of heart failure hospitalization in patients ever treated with sitagliptin (HR 1.033 men vs women) [15]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information (utelämna om inte tillämpligt) Data from the Italian Medicines Agency (AIFA) Monitoring Registry on drug utilization, safety and effectiveness of exenatide, sitagliptin, and vildagliptin showed that the risk of treatment discontinuation of sitagliptin was lower in men than women (20446 men, 18365 women). The authors discuss the relationship between discontinuation rates and adverse effects such as hypoglycemia [16]. An Italian multicenter, case-control, retrospective observational study investigated the effect of sitagliptin as an add-on treatment to standard care insulin administration in patients with type 2 diabetes who were hospitalized with COVID-19 (238 men, 100 women). A time to clinical endpoint subgroup analysis comparing men versus women in the sitagliptin-treated group as compared with those in the standard-of-care group did not show any difference in the clinical outcomes within the group of treatment (HR men 0.44, HR women 0.42) [17].
Försäljning på recept

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Fler män än kvinnor hämtade ut tabletter innehållande sitagliptin (ATC-kod A10BH01) på recept i Sverige år 2020, totalt 35 257 män och 25 422 kvinnor. Det motsvarar 6,8 respektive 5,0 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75-84 år hos båda könen. I genomsnitt var tabletter innehållande sitagliptin 1,5 gånger vanligare hos män [18]. Fler män än kvinnor hämtade ut tabletter innehållande kombination av metformin och sitagliptin (ATC-kod A10BD07) på recept i Sverige år 2020, totalt 5 673 män och 2 994 kvinnor. Det motsvarar 1,1 respektive 0,6 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 65-79 år hos båda könen. I genomsnitt var tabletter innehållande kombination av metformin och sitagliptin 2,1 gånger vanligare hos män [18].
Referenser

Visa referenser

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.

  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.

  3. Lyseng-Williamson KA. Sitagliptin. Drugs. 2007;67:587-97.

  4. Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51:501-14.

  5. Januvia (sitagliptin). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-02-23, cited 2021-05-26]

  6. Sato D, Sato Y, Masuda S, Kimura H. Impact of the sitagliptin alert on prescription of oral antihyperglycemic drugs in Japan. Int J Clin Pharm. 2012;34:917-24.

  7. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015;373(3):232-42.

  8. Alfredsson J, Green JB, Stevens SR, Reed SD, Armstrong PW, Angelyn Bethel M, Engel SS, McGuire DK, Van de Werf F, Hramiak I, White HD, Peterson ED, Holman RR; TECOS Study Group. Sex differences in management and outcomes of patients with type 2 diabetes and cardiovascular disease: A report from TECOS. Diabetes Obes Metab. 2018;20(10):2379-2388.

  9. Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM et al. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015;17(4):395-402.

  10. Buonaiuto G, De Mori V, Braus A, Balini A, Berzi D, Carpinteri R, Forloni F, Meregalli G, Ronco GL, Bossi AC. PERS&O (PERsistent Sitagliptin treatment & Outcomes): observational retrospective study on cardiovascular risk evolution in patients with type 2 diabetes on persistent sitagliptin treatment. BMJ Open Diabetes Care. 2016;4(1):0.

  11. Tajima N, Eiki JI, Okamoto T, Okuyama K, Kawashima M, Engel SS. Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials. J Diabetes Investig. 2020;11(3):640-646.

  12. Krobot KJ, Ferrante SA, Davies MJ, Seck T, Meininger GE, Williams-Herman D et al. Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value. Curr Med Res Opin. 2012;28:1281-7.

  13. Ling AW, Chan CC, Chen SW, Kao YW, Huang CY, Chan YH, Chu PH. The risk of new-onset atrial fibrillation in patients with type 2 diabetes mellitus treated with sodium glucose cotransporter 2 inhibitors versus dipeptidyl peptidase-4 inhibitors. Cardiovasc Diabetol. 2020;19(1):188.

  14. Josse RG, Majumdar SR, Zheng Y, Adler A, Bethel MA, Buse JB, Green JB, Kaufman KD, Rodbard HW, Tankova T, Westerhout CM, Peterson ED, Holman RR, Armstrong PW; TECOS Study Group. Sitagliptin and risk of fractures in type 2 diabetes: Results from the TECOS trial. Diabetes Obes Metab. 2017;19(1):78-86.

  15. Tseng CH. Sitagliptin and heart failure hospitalization in patients with type 2 diabetes. Oncotarget. 2016;7(38):62687-62696.

  16. Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C et al. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry. Nutr Metab Cardiovasc Dis. 2014;24(12):1346-53.

  17. Solerte SB, D'Addio F, Trevisan R, Lovati E, Rossi A, Pastore I, Dell'Acqua M, Ippolito E, Scaranna C, Bellante R, Galliani S, Dodesini AR, Lepore G, Geni F, Fiorina RM, Catena E, Corsico A, Colombo R, Mirani M, De Riva C, Oleandri SE, Abdi R, Bonventre JV, Rusconi S, Folli F, Di Sabatino A, Zuccotti G, Galli M, Fiorina P. Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study. Diabetes Care. 2020;43(12):2999-3006.

  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.
  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.
  3. Lyseng-Williamson KA. Sitagliptin. Drugs. 2007;67:587-97.
  4. Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51:501-14.
  5. Januvia (sitagliptin). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-02-23, cited 2021-05-26]
  6. Sato D, Sato Y, Masuda S, Kimura H. Impact of the sitagliptin alert on prescription of oral antihyperglycemic drugs in Japan. Int J Clin Pharm. 2012;34:917-24.
  7. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015;373(3):232-42.
  8. Alfredsson J, Green JB, Stevens SR, Reed SD, Armstrong PW, Angelyn Bethel M, Engel SS, McGuire DK, Van de Werf F, Hramiak I, White HD, Peterson ED, Holman RR; TECOS Study Group. Sex differences in management and outcomes of patients with type 2 diabetes and cardiovascular disease: A report from TECOS. Diabetes Obes Metab. 2018;20(10):2379-2388.
  9. Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM et al. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015;17(4):395-402.
  10. Buonaiuto G, De Mori V, Braus A, Balini A, Berzi D, Carpinteri R, Forloni F, Meregalli G, Ronco GL, Bossi AC. PERS&O (PERsistent Sitagliptin treatment & Outcomes): observational retrospective study on cardiovascular risk evolution in patients with type 2 diabetes on persistent sitagliptin treatment. BMJ Open Diabetes Care. 2016;4(1):0.
  11. Tajima N, Eiki JI, Okamoto T, Okuyama K, Kawashima M, Engel SS. Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials. J Diabetes Investig. 2020;11(3):640-646.
  12. Krobot KJ, Ferrante SA, Davies MJ, Seck T, Meininger GE, Williams-Herman D et al. Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value. Curr Med Res Opin. 2012;28:1281-7.
  13. Ling AW, Chan CC, Chen SW, Kao YW, Huang CY, Chan YH, Chu PH. The risk of new-onset atrial fibrillation in patients with type 2 diabetes mellitus treated with sodium glucose cotransporter 2 inhibitors versus dipeptidyl peptidase-4 inhibitors. Cardiovasc Diabetol. 2020;19(1):188.
  14. Josse RG, Majumdar SR, Zheng Y, Adler A, Bethel MA, Buse JB, Green JB, Kaufman KD, Rodbard HW, Tankova T, Westerhout CM, Peterson ED, Holman RR, Armstrong PW; TECOS Study Group. Sitagliptin and risk of fractures in type 2 diabetes: Results from the TECOS trial. Diabetes Obes Metab. 2017;19(1):78-86.
  15. Tseng CH. Sitagliptin and heart failure hospitalization in patients with type 2 diabetes. Oncotarget. 2016;7(38):62687-62696.
  16. Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C et al. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry. Nutr Metab Cardiovasc Dis. 2014;24(12):1346-53.
  17. Solerte SB, D'Addio F, Trevisan R, Lovati E, Rossi A, Pastore I, Dell'Acqua M, Ippolito E, Scaranna C, Bellante R, Galliani S, Dodesini AR, Lepore G, Geni F, Fiorina RM, Catena E, Corsico A, Colombo R, Mirani M, De Riva C, Oleandri SE, Abdi R, Bonventre JV, Rusconi S, Folli F, Di Sabatino A, Zuccotti G, Galli M, Fiorina P. Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study. Diabetes Care. 2020;43(12):2999-3006.
  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
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Litteratursökningsdatum: 5/26/2021

Litteratursökningsdatum: 5/26/2021
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Janumet, Januvia, Sitagliptin Accord, Sitagliptin Glenmark, Sitaglipti......

Janumet, Januvia, Sitagliptin Accord, Sitagliptin Glenmark, Sitagliptin Grindeks, Sitagliptin Krka, Sitagliptin Orion, Sitagliptin STADA, Sitagliptin SUN, Sitagliptin Sandoz, Sitagliptin Teva, Sitagliptin Viatris, Sitagliptin Zentiva, Sitagliptin/Metformin Glenmark, Sitagliptin/Metformin Grindeks, Sitagliptin/Metformin Krka, Sitagliptin/Metformin Medical Valley, Sitagliptin/Metformin STADA, Sitagliptin/Metformin Sandoz, Sitagliptin/Metformin Zentiva, Sitagliptin/Metformin hydrochloride Mylan, Velmetia, Xelevia
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A10BD07, A10BH01

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sitagliptin, sitagliptinfosfat, sitagliptinfosfatmonohydrat, sitaglipt......

sitagliptin, sitagliptinfosfat, sitagliptinfosfatmonohydrat, sitagliptinfumarat, sitagliptinhydrokloridmonohydrat, sitagliptinmalat
Sammanfattning

En stor kohortstudie som undersökt effekten av behandling med sitagliptin på kardiovaskulära utfall visade att kvinnor hade en lägre risk att drabbas jämfört med män.

En klinisk studie har visat att fler kvinnor fick hypoglykemi än män vid sitagliptinbehandling.

En stor kohortstudie som undersökt effekten av behandling med sitagliptin på kardiovaskulära utfall visade att kvinnor hade en lägre risk att drabbas jämfört med män. En klinisk studie har visat att fler kvinnor fick hypoglykemi än män vid sitagliptinbehandling.
Background

Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2].

Pharmacokinetics and dosing
Clinical studies have shown no pharmacokinetic differences between men and women of single- or multiple-dose sitagliptin [3, 4]. According to the original manufacturer, no clinically relevant pharmacokinetic sex differences have been shown [5].

In a Japanese retrospective cohort study (in total 87 678 patients), dose levels of sitagliptin were compared before and after the safety alert on the risk of serious hypoglycemic events with the combination sitagliptin and high-dose sulfonylureas. Women were prescribed lower mean daily doses of sitagliptin both before and after the safety alert (before; women : 59.6 ± 21.8 mg, men: 63.4 ± 24.4 mg, after; women: 57.2 ± 20.1 mg, men: 61.6 ± 23.7 mg) [6]. However, the original manufacturer does not recommend any dose......

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Studies indicate that men in the early middle age have a higher prevalence of type 2 diabetes mellitus compared with women in the same age group [1]. In Sweden, the age-standardized prevalence of pharmacologically and non-pharmacologically treated diabetes was 56% for men and 39% for women in 2012 [2]. # Pharmacokinetics and dosing Clinical studies have shown no pharmacokinetic differences between men and women of single- or multiple-dose sitagliptin [3, 4]. According to the original manufacturer, no clinically relevant pharmacokinetic sex differences have been shown [5]. In a Japanese retrospective cohort study (in total 87 678 patients), dose levels of sitagliptin were compared before and after the safety alert on the risk of serious hypoglycemic events with the combination sitagliptin and high-dose sulfonylureas. Women were prescribed lower mean daily doses of sitagliptin both before and after the safety alert (before; women : 59.6 ± 21.8 mg, men: 63.4 ± 24.4 mg, after; women: 57.2 ± 20.1 mg, men: 61.6 ± 23.7 mg) [6]. However, the original manufacturer does not recommend any dose adjustment based on patient’s sex [5]. # Effects  A placebo-controlled trial assessed the effect of sitagliptin treatment on cardiovascular (CV) outcomes in a prospective study in patients with type 2 diabetes and atherosclerotic vascular disease (10 374 men, 4297 women), the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) [7]. Sex differences in management and outcomes of the TECOS trial were analyzed [8]. The primary composite outcome of CV death, myocardial infarction, stroke, or hospitalization for unstable angina occurred in 418 women (9.7%) and 1272 men (12.3%; 3.48 vs 4.38 events/100 participant-years, adjusted HR 0.64, 95% CI 0.55-0.74). Women also had a significantly lower risk of secondary CV outcomes and all-cause death (1.58 vs 1.74 events/100 participant-years [adjusted HR 0.55, 95% CI 0.42-0.71) and all-cause death (2.18 vs 2.56 events/100 participant-years, adjusted HR 0.54, 95% CI 0.43-0.67) [8]. Differences in baseline characteristics of patients enrolled in the TECOS trial [7] was examined (10416 men, 4308 women). The prespecified clinical target goals in baseline characteristics were chosen to reflect those consistent with international guidelines at the time of the trial’s inception. The results showed that women were consistently less likely to reach the prespecified treatment target goals assessed at the time of study enrollment (SBP<140 mmHg, DBP<80 mmHg, LDL cholesterol <2.6 mmol/L, aspirin use, and statin use), with the exception of non-smoking status [9]. The effect on metabolic control and on CV risk evolution obtained by “add-on” persistent sitagliptin treatment (100 mg once daily) in a cohort of Italian participants with type 2 diabetes was assessed using the UK Prospective Diabetes Study (UKPDS) Risk Engine (RE). Analysis of sex differences in CV risk evolution evaluated by UKPDS RE (106 men, 64 women) showed a significantly lower CV risk in women (1.33 in men vs 1.12 in women in UKPDS after 48 months) [10]. A post-hoc analysis of pooled data from seven sitagliptin phase II and III clinical trials exploring the factors associated with the glucose-lowering efficacy of sitagliptin treatment in Japanese patients with type 2 diabetes (698 men, 370 women) showed no association between HbA1c changes and patient’s sex [11]. # Adverse effects A study evaluated the relative risk of hypoglycemic events in patients (691 men, 481 women) treated with sitagliptin or glipizide after adjusting for the most recently measured HbA1c value. The adjusted hazard ratio for women on either of the two studied drugs was 2.05, indicating that women had a twofold increase in risk of experiencing confirmed hypoglycemia relative to men. In multivariate analysis, female sex was one of the factors associated with a higher risk of hypoglycemia [12]. The risk of new-onset atrial fibrillation in patients with type 2 diabetes mellitus treated with sodium glucose cotransporter 2 (SGLT2) inhibitors versus dipeptidyl peptidase-4 (DPP-4) inhibitors was evaluated in an observational study from Taiwan. The subgroup analysis showed a lower risk of incident atrial fibrillation for SGLT2 inhibitors (9091 men, 6515 women) versus DPP-4 inhibitors (6911 men, 5472 women) in women compared to men with type 2 diabetes (HR men 0.51, HR women 0.70, p interaction =0.10) [13]. The fracture incidence among participants (10374 men, 4297 women) in the TECOS trial [7] was examined [14]. Although sitagliptin, compared with placebo, was not associated with a higher fracture risk (HR 1.03), adjusted analyses showed a significantly independently increased fracture risk in women (HR 1.95) [14]. A study with data on sitagliptin ever and never users (93858 men, 77860 women) derived from the Taiwan’s National Health Insurance evaluated the risk of heart failure hospitalization. Male sex was significantly associated with a higher risk of heart failure hospitalization in patients ever treated with sitagliptin (HR 1.033 men vs women) [15]. # Reproductive health issues Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan). # Other information (utelämna om inte tillämpligt) Data from the Italian Medicines Agency (AIFA) Monitoring Registry on drug utilization, safety and effectiveness of exenatide, sitagliptin, and vildagliptin showed that the risk of treatment discontinuation of sitagliptin was lower in men than women (20446 men, 18365 women). The authors discuss the relationship between discontinuation rates and adverse effects such as hypoglycemia [16]. An Italian multicenter, case-control, retrospective observational study investigated the effect of sitagliptin as an add-on treatment to standard care insulin administration in patients with type 2 diabetes who were hospitalized with COVID-19 (238 men, 100 women). A time to clinical endpoint subgroup analysis comparing men versus women in the sitagliptin-treated group as compared with those in the standard-of-care group did not show any difference in the clinical outcomes within the group of treatment (HR men 0.44, HR women 0.42) [17].
Försäljning på recept

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Fler män än kvinnor hämtade ut tabletter innehållande sitagliptin (ATC-kod A10BH01) på recept i Sverige år 2020, totalt 35 257 män och 25 422 kvinnor. Det motsvarar 6,8 respektive 5,0 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 75-84 år hos båda könen. I genomsnitt var tabletter innehållande sitagliptin 1,5 gånger vanligare hos män [18]. Fler män än kvinnor hämtade ut tabletter innehållande kombination av metformin och sitagliptin (ATC-kod A10BD07) på recept i Sverige år 2020, totalt 5 673 män och 2 994 kvinnor. Det motsvarar 1,1 respektive 0,6 personer per tusen invånare. Andelen som hämtat ut läkemedel var högst i åldersgruppen 65-79 år hos båda könen. I genomsnitt var tabletter innehållande kombination av metformin och sitagliptin 2,1 gånger vanligare hos män [18].
Referenser

Visa referenser

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.

  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.

  3. Lyseng-Williamson KA. Sitagliptin. Drugs. 2007;67:587-97.

  4. Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51:501-14.

  5. Januvia (sitagliptin). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-02-23, cited 2021-05-26]

  6. Sato D, Sato Y, Masuda S, Kimura H. Impact of the sitagliptin alert on prescription of oral antihyperglycemic drugs in Japan. Int J Clin Pharm. 2012;34:917-24.

  7. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015;373(3):232-42.

  8. Alfredsson J, Green JB, Stevens SR, Reed SD, Armstrong PW, Angelyn Bethel M, Engel SS, McGuire DK, Van de Werf F, Hramiak I, White HD, Peterson ED, Holman RR; TECOS Study Group. Sex differences in management and outcomes of patients with type 2 diabetes and cardiovascular disease: A report from TECOS. Diabetes Obes Metab. 2018;20(10):2379-2388.

  9. Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM et al. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015;17(4):395-402.

  10. Buonaiuto G, De Mori V, Braus A, Balini A, Berzi D, Carpinteri R, Forloni F, Meregalli G, Ronco GL, Bossi AC. PERS&O (PERsistent Sitagliptin treatment & Outcomes): observational retrospective study on cardiovascular risk evolution in patients with type 2 diabetes on persistent sitagliptin treatment. BMJ Open Diabetes Care. 2016;4(1):0.

  11. Tajima N, Eiki JI, Okamoto T, Okuyama K, Kawashima M, Engel SS. Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials. J Diabetes Investig. 2020;11(3):640-646.

  12. Krobot KJ, Ferrante SA, Davies MJ, Seck T, Meininger GE, Williams-Herman D et al. Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value. Curr Med Res Opin. 2012;28:1281-7.

  13. Ling AW, Chan CC, Chen SW, Kao YW, Huang CY, Chan YH, Chu PH. The risk of new-onset atrial fibrillation in patients with type 2 diabetes mellitus treated with sodium glucose cotransporter 2 inhibitors versus dipeptidyl peptidase-4 inhibitors. Cardiovasc Diabetol. 2020;19(1):188.

  14. Josse RG, Majumdar SR, Zheng Y, Adler A, Bethel MA, Buse JB, Green JB, Kaufman KD, Rodbard HW, Tankova T, Westerhout CM, Peterson ED, Holman RR, Armstrong PW; TECOS Study Group. Sitagliptin and risk of fractures in type 2 diabetes: Results from the TECOS trial. Diabetes Obes Metab. 2017;19(1):78-86.

  15. Tseng CH. Sitagliptin and heart failure hospitalization in patients with type 2 diabetes. Oncotarget. 2016;7(38):62687-62696.

  16. Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C et al. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry. Nutr Metab Cardiovasc Dis. 2014;24(12):1346-53.

  17. Solerte SB, D'Addio F, Trevisan R, Lovati E, Rossi A, Pastore I, Dell'Acqua M, Ippolito E, Scaranna C, Bellante R, Galliani S, Dodesini AR, Lepore G, Geni F, Fiorina RM, Catena E, Corsico A, Colombo R, Mirani M, De Riva C, Oleandri SE, Abdi R, Bonventre JV, Rusconi S, Folli F, Di Sabatino A, Zuccotti G, Galli M, Fiorina P. Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study. Diabetes Care. 2020;43(12):2999-3006.

  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]

  1. Gale EA, Gillespie KM. Diabetes and gender. Diabetologia. 2001;44(1):3-15.
  2. Jansson SP, Fall K, Brus O, Magnuson A, Wändell P, Östgren CJ et al. Prevalence and incidence of diabetes mellitus: a nationwide population-based pharmaco-epidemiological study in Sweden. Diabet Med. 2015;32(10):1319-28.
  3. Lyseng-Williamson KA. Sitagliptin. Drugs. 2007;67:587-97.
  4. Golightly LK, Drayna CC, McDermott MT. Comparative clinical pharmacokinetics of dipeptidyl peptidase-4 inhibitors. Clin Pharmacokinet. 2012;51:501-14.
  5. Januvia (sitagliptin). Summary of Product Characteristics. European Medicines Agency (EMA) [updated 2021-02-23, cited 2021-05-26]
  6. Sato D, Sato Y, Masuda S, Kimura H. Impact of the sitagliptin alert on prescription of oral antihyperglycemic drugs in Japan. Int J Clin Pharm. 2012;34:917-24.
  7. Green JB, Bethel MA, Armstrong PW, Buse JB, Engel SS, Garg J, Josse R, Kaufman KD, Koglin J, Korn S, Lachin JM, McGuire DK, Pencina MJ, Standl E, Stein PP, Suryawanshi S, Van de Werf F, Peterson ED, Holman RR; TECOS Study Group. Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2015;373(3):232-42.
  8. Alfredsson J, Green JB, Stevens SR, Reed SD, Armstrong PW, Angelyn Bethel M, Engel SS, McGuire DK, Van de Werf F, Hramiak I, White HD, Peterson ED, Holman RR; TECOS Study Group. Sex differences in management and outcomes of patients with type 2 diabetes and cardiovascular disease: A report from TECOS. Diabetes Obes Metab. 2018;20(10):2379-2388.
  9. Bethel MA, Green JB, Milton J, Tajar A, Engel SS, Califf RM et al. Regional, age and sex differences in baseline characteristics of patients enrolled in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS). Diabetes Obes Metab. 2015;17(4):395-402.
  10. Buonaiuto G, De Mori V, Braus A, Balini A, Berzi D, Carpinteri R, Forloni F, Meregalli G, Ronco GL, Bossi AC. PERS&O (PERsistent Sitagliptin treatment & Outcomes): observational retrospective study on cardiovascular risk evolution in patients with type 2 diabetes on persistent sitagliptin treatment. BMJ Open Diabetes Care. 2016;4(1):0.
  11. Tajima N, Eiki JI, Okamoto T, Okuyama K, Kawashima M, Engel SS. Factors associated with the glucose-lowering efficacy of sitagliptin in Japanese patients with type 2 diabetes mellitus: Pooled analysis of Japanese clinical trials. J Diabetes Investig. 2020;11(3):640-646.
  12. Krobot KJ, Ferrante SA, Davies MJ, Seck T, Meininger GE, Williams-Herman D et al. Lower risk of hypoglycemia with sitagliptin compared to glipizide when either is added to metformin therapy: a pre-specified analysis adjusting for the most recently measured HbA(1c) value. Curr Med Res Opin. 2012;28:1281-7.
  13. Ling AW, Chan CC, Chen SW, Kao YW, Huang CY, Chan YH, Chu PH. The risk of new-onset atrial fibrillation in patients with type 2 diabetes mellitus treated with sodium glucose cotransporter 2 inhibitors versus dipeptidyl peptidase-4 inhibitors. Cardiovasc Diabetol. 2020;19(1):188.
  14. Josse RG, Majumdar SR, Zheng Y, Adler A, Bethel MA, Buse JB, Green JB, Kaufman KD, Rodbard HW, Tankova T, Westerhout CM, Peterson ED, Holman RR, Armstrong PW; TECOS Study Group. Sitagliptin and risk of fractures in type 2 diabetes: Results from the TECOS trial. Diabetes Obes Metab. 2017;19(1):78-86.
  15. Tseng CH. Sitagliptin and heart failure hospitalization in patients with type 2 diabetes. Oncotarget. 2016;7(38):62687-62696.
  16. Montilla S, Marchesini G, Sammarco A, Trotta MP, Siviero PD, Tomino C et al. Drug utilization, safety, and effectiveness of exenatide, sitagliptin, and vildagliptin for type 2 diabetes in the real world: data from the Italian AIFA Anti-diabetics Monitoring Registry. Nutr Metab Cardiovasc Dis. 2014;24(12):1346-53.
  17. Solerte SB, D'Addio F, Trevisan R, Lovati E, Rossi A, Pastore I, Dell'Acqua M, Ippolito E, Scaranna C, Bellante R, Galliani S, Dodesini AR, Lepore G, Geni F, Fiorina RM, Catena E, Corsico A, Colombo R, Mirani M, De Riva C, Oleandri SE, Abdi R, Bonventre JV, Rusconi S, Folli F, Di Sabatino A, Zuccotti G, Galli M, Fiorina P. Sitagliptin Treatment at the Time of Hospitalization Was Associated With Reduced Mortality in Patients With Type 2 Diabetes and COVID-19: A Multicenter, Case-Control, Retrospective, Observational Study. Diabetes Care. 2020;43(12):2999-3006.
  18. Statistikdatabas för läkemedel. Stockholm: Socialstyrelsen. 2020 [cited 2021-03-10.]
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Litteratursökningsdatum: 5/26/2021

Litteratursökningsdatum: 5/26/2021
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