Роль глимепирида в комбинации с метформином в современной практике сахароснижающей терапии при сахарном диабете типа 2
Роль глимепирида в комбинации с метформином в современной практике сахароснижающей терапии при сахарном диабете типа 2
Жукова Л.А., Гуламов А.А., Кузнецов Е.В. Роль глимепирида в комбинации с метформином в современной практике сахароснижающей терапии при сахарном диабете типа 2. Consilium Medicum. 2015; 17 (4): 20–25.
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Zhukova L.A., Gulamov A.A., Kuznetsov E.V. The role of glimepiride in combination with metformin in modern practice of using antihyperglycemic therapy for type 2 diabetes mellitus. Consilium Medicum. 2015; 17 (4): 20–25.
Роль глимепирида в комбинации с метформином в современной практике сахароснижающей терапии при сахарном диабете типа 2
Жукова Л.А., Гуламов А.А., Кузнецов Е.В. Роль глимепирида в комбинации с метформином в современной практике сахароснижающей терапии при сахарном диабете типа 2. Consilium Medicum. 2015; 17 (4): 20–25.
________________________________________________
Zhukova L.A., Gulamov A.A., Kuznetsov E.V. The role of glimepiride in combination with metformin in modern practice of using antihyperglycemic therapy for type 2 diabetes mellitus. Consilium Medicum. 2015; 17 (4): 20–25.
В статье описано место препаратов сульфонилмочевины в современных рекомендациях по лечению пациентов с сахарным диабетом типа 2. Рассмотрены особенности механизма действия и фармакокинетики глимепирида и связанные с этим положительные отличия в эффективности терапии, частоте гипогликемических реакций, влиянии на массу, частоте побочных эффектов и осложнений лечения. Описаны результаты клинических исследований по изучению экстрапанкреатических эффектов глимепирида (влияние на синтез гликогена, показатели липидного обмена, ишемическое прекондиционирование, индекс инсулинорезистентности). Рассмотрена эффективность применения глимепирида (Амарила) в комбинации с метформином быстрого высвобождения и фиксированной комбинацией амарила с метформином (Амарил М).
The article describes the role of sulfonylurea medications in modern recommendations concerning the treatment of patients with diabetes mellitus type 2. We showed the characteristics of mechanism of action and pharmacokinetics of glimepiride associated with positive differences in the efficacy of treatment, the frequency of hypoglycemic reactions, effects on weight, the frequency of side effects and complications of the treatment. We described the results of clinical studies concerning extrapancreatic effects of glimepiride (effect on the synthesis of glycogen, lipid metabolism, ischemic preconditioning, insulin resistance index). We studied the efficacy of glimepiride (Amaryl) in combination with the rapid-release metformin fixed combination of Amaryl and metformin (Amaryl M).
1. World Health Organisation: “The World Health Report 1998. Life in 21st Century – a Vision for ALL” Geneva: World Health Organisation, 1998.
2. IDF Diabetes Atlas, 6th ed. International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas
3. Алгоритмы специализированной медицинской помощи больных сахарным диабетом. Под ред. И.И.Дедова, М.В.Шестаковой. 7-й выпуск. М., 2015. / Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nykh sakharnym diabetom. Pod red. I.I.Dedova, M.V.Shestakovoi. 7-i vypusk. M., 2015. [in Russian]
4. Жукова Л.А., Гуламов А.А., Кузнецов Е.В. Роль процесса обучения больных сахарным диабетом типа 2 принципам самоконтроля и профилактики патологии нижних конечностей. Consilium Medicum. 2014; 16 (10): 121–5. / Zhukova L.A., Gulamov A.A., Kuznetsov E.V. Rol' protsessa obucheniia bol'nykh sakharnym diabetom tipa 2 printsipam samokontrolia i profilaktiki patologii nizhnikh konechnostei. Consilium Medicum. 2014; 16 (10): 121–5. [in Russian]
5. Hsueh WA, Law RE. Cardiovascular risk continuum: Implications of insulin resistance and diabetes. Am J Med 1998; 105 (1A): 4S–14S.
6. Недосугова Л.В. Препараты сульфонилмочевины в современной стратегии лечения сахарного диабета 2 типа. Сахарный диабет. 2011; 2: 99–109. / Nedosugova L.V. Preparaty sul'fonilmocheviny v sovremennoi strategii lecheniia sakharnogo diabeta 2 tipa. Sakharnyi diabet. 2011; 2: 99–109. [in Russian]
7. Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events: a metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care 1999; 22 (2): 233–40.
8. Дедов И.И. и др. Консенсус совета экспертов Российской ассоциации эндокринологов по инициации и интенсификации сахароснижающей терапии у больных сахарным диабетом 2 типа. Сахарный диабет. 2011; 4: 6–17. / Dedov I.I. i dr. Konsensus soveta ekspertov Rossiiskoi assotsiatsii endokrinologov po initsiatsii i intensifikatsii sakharosnizhaiushchei terapii u bol'nykh sakharnym diabetom 2 tipa. Sakharnyi diabet. 2011; 4: 6–17. [in Russian]
9. Muller G et al. The Molecular Mechanism of the Insulin-mimetic/sensitizing Activity of the Antidiabetic Sulfonylurea Drug Amaryl. Mol Med 2000; 6 (11): 907–33.
10. Руяткина Л.А., Сорокин М.Ю. Глимепирид в современной гипогликемизирующей терапии: безопасность и эффективность. Сахарный диабет. 2012; 2: 89–97. /
Ruiatkina L.A., Sorokin M.Iu. Glimepirid v sovremennoi gipoglikemiziruiushchei terapii: bezopasnost' i effektivnost'. Sakharnyi diabet. 2012; 2: 89–97. [in Russian]
11. Смирнова О.М. Принципы терапии впервые выявленного сахарного диабета 2 типа. Место Амарила (глимепирида): свойства, эффективность, безопасность. Сахарный диабет. 2009; 1: 43–7. / Smirnova O.M. Printsipy terapii vpervye vyiavlennogo sakharnogo diabeta 2 tipa. Mesto Amarila (glimepirida): svoistva, effektivnost', bezopasnost'. Sakharnyi diabet. 2009; 1: 43–7. [in Russian]
12. Максимова Н.В., Романцова Т.И. Оптимизация таблетированной сахароснижающей терапии с использованием глимепирида при сахарном диабете 2 типа. Сахарный диабет. 2010; 1: 50–4. / Maksimova N.V., Romantsova T.I. Optimizatsiia tabletirovannoi sakharosnizhaiushchei terapii s ispol'zovaniem glimepirida pri sakharnom diabete 2 tipa. Sakharnyi diabet. 2010; 1: 50–4. [in Russian]
13. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837–53.
14. Holstein A, Plaschke A, Egberts EH. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev 2001; 17 (6): 467–73.
15. Schade DS, Jovanovic L, Schneider J. A placebo-controlled, randomized study of glimepiride in patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful. J Clin Pharmacol 1998; 38 (7): 636–41.
16. Goldberg RB, Holvey SM, Schneider J. A dose-response study of glimepiride in patients with NIDDM who have previously received sulfonylurea agents. The Glimepiride Protocol #201 Study Group. Diabetes Care 1996; 19 (8): 849–56.
17. Charpentier G, Fleury F, Kabir M et al. Improved glycaemic control by addition of glimepiride to metformin monotherapy in type 2 diabetic patients. Diabet Med 2001; 18 (10): 828–34.
18. Muller G et al. Extrapancreatic effects of sulfonylureas – a comparison between glimepiride and conventional sulfonylureas. Diabetes Res Clin Pract 1995; 28 (Suppl.): 115–37.
19. Overkamp D, Volk A, Maerker E et al. Acute effect of glimepiride on insulin-stimulated glucose metabolism in glucose-tolerant insulin-resistant offspring of patients with type 2 diabetes. Diabet Care 2002; 25 (11): 2065–73.
20. Xu DY, Zhao SP, Huang QX et al. Effects of Glimepiride on met-abolic parameters and cardiovascular risk factors in patients with newly diagnosed type 2 diabetes mellitus. Diabetes Res Clin Pract 2010; 88 (1): 71–5.
21. Davis SN. The role of glimepiride in the effective management of type 2 diabetes. J Diabetes Complications 2004; 18 (6): 367–76.
22. Leibel B. An analysis of the University Group Diabetes Study Program: data results and conslusions. Can Med Assoc J 1971; 105 (3): 292–4.
23. Campbell RK. Glimepiride: role of a new sulfonylurea in the treatment of type 2 diabetes mellitus. Ann Pharmacother 1998; 32 (10): 1044–52.
24. Dills DG, Schneider J. Clinical evaluation of glimepiride versus glyburide in NIDDM in a double-blind comparative study. Glimepiride/Glyburide Research Group. Horm Metab Res 1996; 28 (9): 426–9.
25. Nathan DM, Buse JB, Davidson MB et al. American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32 (1): 193–203.
26. Holstein P et al. Glimepiride less hypoglycemia than glyburide. Diabetologia 2000; 43: A40.
27. Bugos C, Austin M, Atherton T, Viereck C. Long-term treatment of type 2 diabetes mellitus with glimepiride is weight neutral: a meta-analysis. Diabetes Res Clin Pract 2000; 50 (Suppl. 1): S47.
28. Scholz G, Schneider K, Knirsch W, Becker G. Efficacy and tolerability of glimepiride in daily practice: a non-interventional observational cohort study. Clin Drug Invest 2001; 21 (9): 597–604.
29. Umpierrez G, Issa M, Vlajnic A. Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial. Curr Med Res Opin 2006; 22 (4): 751–9.
30. Muller G, Wied S, Straub J, Jung C. Coordinated regulation of esterification and lipolysis by palmitate, H2O2 and the antidiabetic sulfonylurea drug, glimepiride, in rat adipocytes. Eur J Pharmacol 2008; 597 (1–3): 6–18.
31. Shakuto S, Sato Y, Ohshima K, Yaguchi M. Atheroprotective effects of a new sulfonylurea of the third generation, glimepiride. Diabet Complications 2001; 15 (Suppl. 1): 68.
32. Draeger KE, Wernicke-Panten K, Lomp HJ et al. Long-term treatment of type 2 diabetic patients with the new oral antidiabetic agent glimepiride (Amaryl): a double-blind comparison with glibenclamide. Horm Metab Res 1996; 28 (9): 419–5.
33. Mocanu MM, Maddock HL, Baxter GF et al. Glimepiride, a novel sulfonylurea, does not abolish myocardial protection afforded by either ischemic preconditioning or diazoxide. Circulation 2001; 103 (25): 3111–6.
34. Caulfield M, O’Brien K. Cardiovascular safety of oral antidiabetic agents: the insulin secretagogues. Clin Diabetes 2002; 20 (2): 81–4.
35. Klepzig H et al. Sulfonylureas and ischemic preconditioning: a double-blind, placebo-controlled evaluation of glimepiride and glibenclamide. Eur Heart J 1999; 20: 439–46.
36. Tsunekawa T et al. Plasma adiponectin plays an important role in improving insulin resistance with glimepiride in elderly type 2 diabetic subjects. Diabetes Care 2003; 26: 285–9.
37. Kishida K, Funahashi T, Shimomura I. Molecular mechanisms of diabetes and atherosclerosis: Role of adiponectin. Endocr Metab Immune Disord Drug Targets 2012 Jan 11. [Epub ahead of print].
38. Kim BH, Shin KH, Kim J et al. Pharmacokinetic comparison of a new glimepiride 1-mg + metformin 500-mg combination tablet formulation and a glimepiride 2-mg + metformin 500-mg combination tablet formulation: a single-dose, randomized, open-label, two-period, two-way crossover study in healthy, fasting Korean male volunteers. Clin Ther 2009; 31 (11): 2755–64.
39. Gu N, Kim BH, Rhim H et al. Comparison of the bioa-vailability and tolerability of fixed-dose combination glimepiride/metformin 2/500-mg tablets versus separate tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Korean volunteers. Clin Ther 2010; 32 (7): 1408–18.
40. Shin KH, Kim SE, Yoon SH et al. Pharmacokinetic comparison of a new sustainedrelease formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther 2011; 33 (11): 1809–18.
41. Baik S et al. J Med Assoc Thai 2005; 88: S245.
42. Melikian C et al. Adherence to oral antidiabetic therapy in a managed care organization: a comparison of monotherapy, combination therapy, and fixed-dose combination therapy. Clin Ther 2002; 24: 460–7.
43. Blonde L et al. Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin. Diabetes Obes Metab 2003; 5: 424–31.
________________________________________________
1. World Health Organisation: “The World Health Report 1998. Life in 21st Century – a Vision for ALL” Geneva: World Health Organisation, 1998.
2. IDF Diabetes Atlas, 6th ed. International Diabetes Federation, 2013. http://www.idf.org/diabetesatlas
3. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nykh sakharnym diabetom. Pod red. I.I.Dedova, M.V.Shestakovoi. 7-i vypusk. M., 2015. [in Russian]
4. Zhukova L.A., Gulamov A.A., Kuznetsov E.V. Rol' protsessa obucheniia bol'nykh sakharnym diabetom tipa 2 printsipam samokontrolia i profilaktiki patologii nizhnikh konechnostei. Consilium Medicum. 2014; 16 (10): 121–5. [in Russian]
5. Hsueh WA, Law RE. Cardiovascular risk continuum: Implications of insulin resistance and diabetes. Am J Med 1998; 105 (1A): 4S–14S.
6. Nedosugova L.V. Preparaty sul'fonilmocheviny v sovremennoi strategii lecheniia sakharnogo diabeta 2 tipa. Sakharnyi diabet. 2011; 2: 99–109. [in Russian]
7. Coutinho M, Gerstein HC, Wang Y, Yusuf S. The relationship between glucose and incident cardiovascular events: a metaregression analysis of published data from 20 studies of 95,783 individuals followed for 12.4 years. Diabetes Care 1999; 22 (2): 233–40.
8. Dedov I.I. i dr. Konsensus soveta ekspertov Rossiiskoi assotsiatsii endokrinologov po initsiatsii i intensifikatsii sakharosnizhaiushchei terapii u bol'nykh sakharnym diabetom 2 tipa. Sakharnyi diabet. 2011; 4: 6–17. [in Russian]
9. Muller G et al. The Molecular Mechanism of the Insulin-mimetic/sensitizing Activity of the Antidiabetic Sulfonylurea Drug Amaryl. Mol Med 2000; 6 (11): 907–33.
10. Ruiatkina L.A., Sorokin M.Iu. Glimepirid v sovremennoi gipoglikemiziruiushchei terapii: bezopasnost' i effektivnost'. Sakharnyi diabet. 2012; 2: 89–97. [in Russian]
11. Smirnova O.M. Printsipy terapii vpervye vyiavlennogo sakharnogo diabeta 2 tipa. Mesto Amarila (glimepirida): svoistva, effektivnost', bezopasnost'. Sakharnyi diabet. 2009; 1: 43–7. [in Russian]
12. Maksimova N.V., Romantsova T.I. Optimizatsiia tabletirovannoi sakharosnizhaiushchei terapii s ispol'zovaniem glimepirida pri sakharnom diabete 2 tipa. Sakharnyi diabet. 2010; 1: 50–4. [in Russian]
13. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998; 352: 837–53.
14. Holstein A, Plaschke A, Egberts EH. Lower incidence of severe hypoglycaemia in patients with type 2 diabetes treated with glimepiride versus glibenclamide. Diabetes Metab Res Rev 2001; 17 (6): 467–73.
15. Schade DS, Jovanovic L, Schneider J. A placebo-controlled, randomized study of glimepiride in patients with type 2 diabetes mellitus for whom diet therapy is unsuccessful. J Clin Pharmacol 1998; 38 (7): 636–41.
16. Goldberg RB, Holvey SM, Schneider J. A dose-response study of glimepiride in patients with NIDDM who have previously received sulfonylurea agents. The Glimepiride Protocol #201 Study Group. Diabetes Care 1996; 19 (8): 849–56.
17. Charpentier G, Fleury F, Kabir M et al. Improved glycaemic control by addition of glimepiride to metformin monotherapy in type 2 diabetic patients. Diabet Med 2001; 18 (10): 828–34.
18. Muller G et al. Extrapancreatic effects of sulfonylureas – a comparison between glimepiride and conventional sulfonylureas. Diabetes Res Clin Pract 1995; 28 (Suppl.): 115–37.
19. Overkamp D, Volk A, Maerker E et al. Acute effect of glimepiride on insulin-stimulated glucose metabolism in glucose-tolerant insulin-resistant offspring of patients with type 2 diabetes. Diabet Care 2002; 25 (11): 2065–73.
20. Xu DY, Zhao SP, Huang QX et al. Effects of Glimepiride on met-abolic parameters and cardiovascular risk factors in patients with newly diagnosed type 2 diabetes mellitus. Diabetes Res Clin Pract 2010; 88 (1): 71–5.
21. Davis SN. The role of glimepiride in the effective management of type 2 diabetes. J Diabetes Complications 2004; 18 (6): 367–76.
22. Leibel B. An analysis of the University Group Diabetes Study Program: data results and conslusions. Can Med Assoc J 1971; 105 (3): 292–4.
23. Campbell RK. Glimepiride: role of a new sulfonylurea in the treatment of type 2 diabetes mellitus. Ann Pharmacother 1998; 32 (10): 1044–52.
24. Dills DG, Schneider J. Clinical evaluation of glimepiride versus glyburide in NIDDM in a double-blind comparative study. Glimepiride/Glyburide Research Group. Horm Metab Res 1996; 28 (9): 426–9.
25. Nathan DM, Buse JB, Davidson MB et al. American Diabetes Association; European Association for Study of Diabetes. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009; 32 (1): 193–203.
26. Holstein P et al. Glimepiride less hypoglycemia than glyburide. Diabetologia 2000; 43: A40.
27. Bugos C, Austin M, Atherton T, Viereck C. Long-term treatment of type 2 diabetes mellitus with glimepiride is weight neutral: a meta-analysis. Diabetes Res Clin Pract 2000; 50 (Suppl. 1): S47.
28. Scholz G, Schneider K, Knirsch W, Becker G. Efficacy and tolerability of glimepiride in daily practice: a non-interventional observational cohort study. Clin Drug Invest 2001; 21 (9): 597–604.
29. Umpierrez G, Issa M, Vlajnic A. Glimepiride versus pioglitazone combination therapy in subjects with type 2 diabetes inadequately controlled on metformin monotherapy: results of a randomized clinical trial. Curr Med Res Opin 2006; 22 (4): 751–9.
30. Muller G, Wied S, Straub J, Jung C. Coordinated regulation of esterification and lipolysis by palmitate, H2O2 and the antidiabetic sulfonylurea drug, glimepiride, in rat adipocytes. Eur J Pharmacol 2008; 597 (1–3): 6–18.
31. Shakuto S, Sato Y, Ohshima K, Yaguchi M. Atheroprotective effects of a new sulfonylurea of the third generation, glimepiride. Diabet Complications 2001; 15 (Suppl. 1): 68.
32. Draeger KE, Wernicke-Panten K, Lomp HJ et al. Long-term treatment of type 2 diabetic patients with the new oral antidiabetic agent glimepiride (Amaryl): a double-blind comparison with glibenclamide. Horm Metab Res 1996; 28 (9): 419–5.
33. Mocanu MM, Maddock HL, Baxter GF et al. Glimepiride, a novel sulfonylurea, does not abolish myocardial protection afforded by either ischemic preconditioning or diazoxide. Circulation 2001; 103 (25): 3111–6.
34. Caulfield M, O’Brien K. Cardiovascular safety of oral antidiabetic agents: the insulin secretagogues. Clin Diabetes 2002; 20 (2): 81–4.
35. Klepzig H et al. Sulfonylureas and ischemic preconditioning: a double-blind, placebo-controlled evaluation of glimepiride and glibenclamide. Eur Heart J 1999; 20: 439–46.
36. Tsunekawa T et al. Plasma adiponectin plays an important role in improving insulin resistance with glimepiride in elderly type 2 diabetic subjects. Diabetes Care 2003; 26: 285–9.
37. Kishida K, Funahashi T, Shimomura I. Molecular mechanisms of diabetes and atherosclerosis: Role of adiponectin. Endocr Metab Immune Disord Drug Targets 2012 Jan 11. [Epub ahead of print].
38. Kim BH, Shin KH, Kim J et al. Pharmacokinetic comparison of a new glimepiride 1-mg + metformin 500-mg combination tablet formulation and a glimepiride 2-mg + metformin 500-mg combination tablet formulation: a single-dose, randomized, open-label, two-period, two-way crossover study in healthy, fasting Korean male volunteers. Clin Ther 2009; 31 (11): 2755–64.
39. Gu N, Kim BH, Rhim H et al. Comparison of the bioa-vailability and tolerability of fixed-dose combination glimepiride/metformin 2/500-mg tablets versus separate tablets: A single-dose, randomized-sequence, open-label, two-period crossover study in healthy Korean volunteers. Clin Ther 2010; 32 (7): 1408–18.
40. Shin KH, Kim SE, Yoon SH et al. Pharmacokinetic comparison of a new sustainedrelease formulation of glimepiride/metformin 1/500 mg combination tablet and a sustained-release formulation of glimepiride/metformin 2/500 mg combination tablet in healthy Korean male volunteers: a randomized, 2-sequence, 2-period, 2-treatment crossover study. Clin Ther 2011; 33 (11): 1809–18.
41. Baik S et al. J Med Assoc Thai 2005; 88: S245.
42. Melikian C et al. Adherence to oral antidiabetic therapy in a managed care organization: a comparison of monotherapy, combination therapy, and fixed-dose combination therapy. Clin Ther 2002; 24: 460–7.
43. Blonde L et al. Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide co-administered with metformin. Diabetes Obes Metab 2003; 5: 424–31.
Авторы
Л.А.Жукова*, А.А.Гуламов, Е.В.Кузнецов
ГБОУ ВПО Курский государственный медицинский университет Минздрава России. 305041, Россия, Курск, ул. Карла Маркса, д. 3
*profzhukova@mail.ru
________________________________________________
L.A.Zhukova*, A.A.Gulamov, E.V.Kuznetsov
Kursk State Medical University of the Ministry of Health of the Russian Federation. 305041, Russian Federation, Kursk, ul. Karla Marksa, d. 3.
*profzhukova@mail.ru