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Алоглиптин – эффективный и безопасный выбор в терапии сахарного диабета типа 2
Алоглиптин – эффективный и безопасный выбор в терапии сахарного диабета типа 2
Петунина Н.А., Терехова А.Л. Алоглиптин – эффективный и безопасный выбор в терапии сахарного диабета типа 2. Consilium Medicum. 2015; 17 (4): 14–19.
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Аннотация
В настоящей работе с позиций клинического индивидуализированного подхода обсуждаются возможности и особенности применения алоглиптина (препарат Випидия) в терапии сахарного диабета типа 2.
Ключевые слова: алоглиптин, Випидия, ингибиторы дипептидилпептидазы-4, эффективность, безопасность, сердечно-сосудистый риск, гипогликемия.
Key words: alogliptin, Vipidia, dipeptidyl peptidase-4 inhibitors, efficacy, safety, cardiovascular risk, hypoglycemia.
Ключевые слова: алоглиптин, Випидия, ингибиторы дипептидилпептидазы-4, эффективность, безопасность, сердечно-сосудистый риск, гипогликемия.
________________________________________________
Key words: alogliptin, Vipidia, dipeptidyl peptidase-4 inhibitors, efficacy, safety, cardiovascular risk, hypoglycemia.
Полный текст
Список литературы
1. International Diabetes Federation, 2013. IDF Diabetes Atlas, Sixth edition. www.idf.org/diabetesatlas
2. American Diabetes Association, Standards of Medical Care in Diabetes – 2015. Diabetes Care 2015; 38 (Suppl. 1): 1–94.
3. Дедов И.И., Шестакова М.В. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. 6-е изд., 2013. / Dedov I.I., Shestakova M.V. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. 6-e izd., 2013. [in Russian]
4. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38: 140–9. Doi: 10.2337/dc14-2441.
5. Seino Y, Fukushima M, Yabe D. GIP and GLP-1, the two incretin hormones: similarities and differences. J Diabetes Investig 2010; 1: 8–23.
6. Cox ME, Rowell J, Corsino L, Green JB. Dipeptidyl peptidase-4 inhibitors in the management of type diabetes: safety, tolerability and efficacy. Drug Health Patient Saf 2010; 2: 7–19.
7. Kutoh E, Ukai Y. Alogliptin as an initial therapy in patients with newly diagnosed, drug naıve type 2 diabetes: a randomized, control trial. Endocrine 2012; 41 (3): 435–41.
8. Seino Y, Fujita T, Hiroi S et al. Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. Curr Med Res Opin 2011; 27 (9): 1781–92.
9. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 010 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008; 31 (12): 2315–7.
10. Rosenstock J, Inzucchi SE, Seufert J et al. Initial combination therapy with alogliptin and pioglitazone in drug-naïve patients with type 2 diabetes. Diabetes Care 2010; 33 (11): 2406–8.
11. Pratley R, Wilson C, Fleck P. Alogliptin plus metformin combination therapy vs. alogliptin or metformin monotherapy for type 2 DM (abstract). Presented at 48th Annual Meeting of the European Association for the Study of Diabetes; Berlin, Germany. October 2012.
12. Seino Y, Miyata Y, Hiroi S et al. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. Diabetes Obes Metab 2012; 14 (10): 927–36.
13. DeFronzo RA, Burant CF, Fleck P et al. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012; 97 (5): 1615–22.
14. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 008 Group Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009; 63 (1): 46–55.
15. Del Prato S, Camisasca R, Craig Wilson et al. Durability of the Efficacy and safety of Alogliptin Compared to Glipizide over 2 Years When Used in Combination with Metformin. Poster 66-LB presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA), Chicago, Illinois, June 21-25, 2013.
16. Kaku K, Itayasu T, Hiroi S et al. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. Diabetes Obes Metab 2011; 13 (11): 1028–35.
17. Pratley RE, Reusch JE, Fleck PR et al. Alogliptin Study 009 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009; 25 (10): 2361–71.
18. Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, doubleblind, active-controlled, parallel-group study. Diabetes Obes Metab 2011; 13 (12): 1088–96.
19. Pratley RE, Kipnes MS, Fleck PR et al. Alogliptin Study 007 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009; 11 (2): 167–76.
20. Seino Y, Fujita T, Hiroi S et al. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin 2011; 27 (Suppl. 3): 21–9.
21. Rosenstock J, Rendell MS, Gross JL et al. Alogliptin added to insulin therapy in patients with type-2 diabetes reduces HbA1c without causing weight gain or increased hypoglycemia. Diabetes Obes Metab 2009; 11: 1145–52.
22. Berhan A, Berhan Y. Efficacy of alogliptin in type 2 diabetes treatment: a meta-analysis of randomized double-blind controlled studies. BMC Endocrine Disorders 2013; 13: 9. http://www.biomedcentral.com/1472-6823/13/9
23. Capuano A, Sportiello L, Maiorino M, Rossi F et al. Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy – focus on alogliptin. Drug Des Devel Ther 2013; 7: 989–1001. Doi: 10.2147/DDDT.S37647.
24. Seino Y, Hiroi S, Hirayama K, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Invest 2012; 3: 517–25.
25. Gore MO, McGuire DK. The 10-year posttrial follow-up of the United Kingdom Prospective Diabetes Study (UKPDS): cardiovascular observations in context. Diab Vasc Dis Res 2009; 6: 53–5.
26. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977–86.
27. Desouza CV, Bolli GB, Fonseca V. Hypoglycemia, diabetes and cardiovascular events. Diabetes Care 2010; 33 (6): 1389–94.
28. Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type-2 diabetes mellitus patients with mild hyperglycemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab 2013. Doi: 10.1111/dom.12102.
29. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703–13.
30. Gregg EW, Li Y, Wang J, Burrows NR et al. Changes in diabetes-related complications in the United States, 1990–2010. N Engl J Med 2014; 370: 1514–23. Doi: 10.1056/NEJMoa1310799.
31. Food and Drug Administration, Center for Drug Evaluation and Research Guidance for industry: diabetes mellitus – evaluating cardiovascular risk in new antidiabetic therapies to treat type-2 diabetes. 2008 Dec; Available at: http://www.fda.gov /downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM071627.pdf
32. White WB, Bakris GL, Bergenstal RM et al. EXamination of CArdiovascular OutcoMes with AlogliptIN versus Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J 2011; 162 (4): 620–6.
33. Hall C. Alogliptin in patients with type 2 diabetes after acute coronary syndromes: heart failure outcomes and cardiovascular safety in heart failure patients. JACC 2014; 63 (12).
34. Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2013. Doi: 10.1111/dom.12176.
35. Vipidia: EPAR – Public assessment report. European Medicines Agency 2013. Available from: www.ema.europa.eu
36. Christopher R, Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of Type 2 diabetes. Expert Rev Clin Pharmacol 2009; 2: 589–600.
37. Nesina (alogliptin), prescribing information. Deerfield, IL: Takeda Pharmaceuticals America, Inc., 2013.
38. Инструкция по медицинскому применению препарата Випидия. / Instruktsiia po meditsinskomu primeneniiu preparata Vipidiia. [in Russian]
2. American Diabetes Association, Standards of Medical Care in Diabetes – 2015. Diabetes Care 2015; 38 (Suppl. 1): 1–94.
3. Dedov I.I., Shestakova M.V. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. 6-e izd., 2013. [in Russian]
4. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38: 140–9. Doi: 10.2337/dc14-2441.
5. Seino Y, Fukushima M, Yabe D. GIP and GLP-1, the two incretin hormones: similarities and differences. J Diabetes Investig 2010; 1: 8–23.
6. Cox ME, Rowell J, Corsino L, Green JB. Dipeptidyl peptidase-4 inhibitors in the management of type diabetes: safety, tolerability and efficacy. Drug Health Patient Saf 2010; 2: 7–19.
7. Kutoh E, Ukai Y. Alogliptin as an initial therapy in patients with newly diagnosed, drug naıve type 2 diabetes: a randomized, control trial. Endocrine 2012; 41 (3): 435–41.
8. Seino Y, Fujita T, Hiroi S et al. Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. Curr Med Res Opin 2011; 27 (9): 1781–92.
9. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 010 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008; 31 (12): 2315–7.
10. Rosenstock J, Inzucchi SE, Seufert J et al. Initial combination therapy with alogliptin and pioglitazone in drug-naïve patients with type 2 diabetes. Diabetes Care 2010; 33 (11): 2406–8.
11. Pratley R, Wilson C, Fleck P. Alogliptin plus metformin combination therapy vs. alogliptin or metformin monotherapy for type 2 DM (abstract). Presented at 48th Annual Meeting of the European Association for the Study of Diabetes; Berlin, Germany. October 2012.
12. Seino Y, Miyata Y, Hiroi S et al. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. Diabetes Obes Metab 2012; 14 (10): 927–36.
13. DeFronzo RA, Burant CF, Fleck P et al. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012; 97 (5): 1615–22.
14. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 008 Group Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009; 63 (1): 46–55.
15. Del Prato S, Camisasca R, Craig Wilson et al. Durability of the Efficacy and safety of Alogliptin Compared to Glipizide over 2 Years When Used in Combination with Metformin. Poster 66-LB presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA), Chicago, Illinois, June 21-25, 2013.
16. Kaku K, Itayasu T, Hiroi S et al. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. Diabetes Obes Metab 2011; 13 (11): 1028–35.
17. Pratley RE, Reusch JE, Fleck PR et al. Alogliptin Study 009 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009; 25 (10): 2361–71.
18. Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, doubleblind, active-controlled, parallel-group study. Diabetes Obes Metab 2011; 13 (12): 1088–96.
19. Pratley RE, Kipnes MS, Fleck PR et al. Alogliptin Study 007 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009; 11 (2): 167–76.
20. Seino Y, Fujita T, Hiroi S et al. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin 2011; 27 (Suppl. 3): 21–9.
21. Rosenstock J, Rendell MS, Gross JL et al. Alogliptin added to insulin therapy in patients with type-2 diabetes reduces HbA1c without causing weight gain or increased hypoglycemia. Diabetes Obes Metab 2009; 11: 1145–52.
22. Berhan A, Berhan Y. Efficacy of alogliptin in type 2 diabetes treatment: a meta-analysis of randomized double-blind controlled studies. BMC Endocrine Disorders 2013; 13: 9. http://www.biomedcentral.com/1472-6823/13/9
23. Capuano A, Sportiello L, Maiorino M, Rossi F et al. Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy – focus on alogliptin. Drug Des Devel Ther 2013; 7: 989–1001. Doi: 10.2147/DDDT.S37647.
24. Seino Y, Hiroi S, Hirayama K, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Invest 2012; 3: 517–25.
25. Gore MO, McGuire DK. The 10-year posttrial follow-up of the United Kingdom Prospective Diabetes Study (UKPDS): cardiovascular observations in context. Diab Vasc Dis Res 2009; 6: 53–5.
26. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977–86.
27. Desouza CV, Bolli GB, Fonseca V. Hypoglycemia, diabetes and cardiovascular events. Diabetes Care 2010; 33 (6): 1389–94.
28. Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type-2 diabetes mellitus patients with mild hyperglycemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab 2013. Doi: 10.1111/dom.12102.
29. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703–13.
30. Gregg EW, Li Y, Wang J, Burrows NR et al. Changes in diabetes-related complications in the United States, 1990–2010. N Engl J Med 2014; 370: 1514–23. Doi: 10.1056/NEJMoa1310799.
31. Food and Drug Administration, Center for Drug Evaluation and Research Guidance for industry: diabetes mellitus – evaluating cardiovascular risk in new antidiabetic therapies to treat type-2 diabetes. 2008 Dec; Available at: http://www.fda.gov /downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM071627.pdf
32. White WB, Bakris GL, Bergenstal RM et al. EXamination of CArdiovascular OutcoMes with AlogliptIN versus Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J 2011; 162 (4): 620–6.
33. Hall C. Alogliptin in patients with type 2 diabetes after acute coronary syndromes: heart failure outcomes and cardiovascular safety in heart failure patients. JACC 2014; 63 (12).
34. Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2013. Doi: 10.1111/dom.12176.
35. Vipidia: EPAR – Public assessment report. European Medicines Agency 2013. Available from: www.ema.europa.eu
36. Christopher R, Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of Type 2 diabetes. Expert Rev Clin Pharmacol 2009; 2: 589–600.
37. Nesina (alogliptin), prescribing information. Deerfield, IL: Takeda Pharmaceuticals America, Inc., 2013.
38. Instruktsiia po meditsinskomu primeneniiu preparata Vipidiia. [in Russian]
2. American Diabetes Association, Standards of Medical Care in Diabetes – 2015. Diabetes Care 2015; 38 (Suppl. 1): 1–94.
3. Дедов И.И., Шестакова М.В. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. 6-е изд., 2013. / Dedov I.I., Shestakova M.V. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. 6-e izd., 2013. [in Russian]
4. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38: 140–9. Doi: 10.2337/dc14-2441.
5. Seino Y, Fukushima M, Yabe D. GIP and GLP-1, the two incretin hormones: similarities and differences. J Diabetes Investig 2010; 1: 8–23.
6. Cox ME, Rowell J, Corsino L, Green JB. Dipeptidyl peptidase-4 inhibitors in the management of type diabetes: safety, tolerability and efficacy. Drug Health Patient Saf 2010; 2: 7–19.
7. Kutoh E, Ukai Y. Alogliptin as an initial therapy in patients with newly diagnosed, drug naıve type 2 diabetes: a randomized, control trial. Endocrine 2012; 41 (3): 435–41.
8. Seino Y, Fujita T, Hiroi S et al. Efficacy and safety of alogliptin in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, dose-ranging comparison with placebo, followed by a long-term extension study. Curr Med Res Opin 2011; 27 (9): 1781–92.
9. DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 010 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control: a randomized, double-blind, placebo-controlled study. Diabetes Care 2008; 31 (12): 2315–7.
10. Rosenstock J, Inzucchi SE, Seufert J et al. Initial combination therapy with alogliptin and pioglitazone in drug-naïve patients with type 2 diabetes. Diabetes Care 2010; 33 (11): 2406–8.
11. Pratley R, Wilson C, Fleck P. Alogliptin plus metformin combination therapy vs. alogliptin or metformin monotherapy for type 2 DM (abstract). Presented at 48th Annual Meeting of the European Association for the Study of Diabetes; Berlin, Germany. October 2012.
12. Seino Y, Miyata Y, Hiroi S et al. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. Diabetes Obes Metab 2012; 14 (10): 927–36.
13. DeFronzo RA, Burant CF, Fleck P et al. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin-treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012; 97 (5): 1615–22.
14. Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. Alogliptin Study 008 Group Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes inadequately controlled with metformin monotherapy: a multicentre, randomised, double-blind, placebo-controlled study. Int J Clin Pract 2009; 63 (1): 46–55.
15. Del Prato S, Camisasca R, Craig Wilson et al. Durability of the Efficacy and safety of Alogliptin Compared to Glipizide over 2 Years When Used in Combination with Metformin. Poster 66-LB presented at the 73rd Scientific Sessions of the American Diabetes Association (ADA), Chicago, Illinois, June 21-25, 2013.
16. Kaku K, Itayasu T, Hiroi S et al. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label long-term extension study. Diabetes Obes Metab 2011; 13 (11): 1028–35.
17. Pratley RE, Reusch JE, Fleck PR et al. Alogliptin Study 009 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled study. Curr Med Res Opin 2009; 25 (10): 2361–71.
18. Bosi E, Ellis GC, Wilson CA, Fleck PR. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52-week, randomized, doubleblind, active-controlled, parallel-group study. Diabetes Obes Metab 2011; 13 (12): 1088–96.
19. Pratley RE, Kipnes MS, Fleck PR et al. Alogliptin Study 007 Group Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes Obes Metab 2009; 11 (2): 167–76.
20. Seino Y, Fujita T, Hiroi S et al. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin 2011; 27 (Suppl. 3): 21–9.
21. Rosenstock J, Rendell MS, Gross JL et al. Alogliptin added to insulin therapy in patients with type-2 diabetes reduces HbA1c without causing weight gain or increased hypoglycemia. Diabetes Obes Metab 2009; 11: 1145–52.
22. Berhan A, Berhan Y. Efficacy of alogliptin in type 2 diabetes treatment: a meta-analysis of randomized double-blind controlled studies. BMC Endocrine Disorders 2013; 13: 9. http://www.biomedcentral.com/1472-6823/13/9
23. Capuano A, Sportiello L, Maiorino M, Rossi F et al. Dipeptidyl peptidase-4 inhibitors in type 2 diabetes therapy – focus on alogliptin. Drug Des Devel Ther 2013; 7: 989–1001. Doi: 10.2147/DDDT.S37647.
24. Seino Y, Hiroi S, Hirayama K, Kaku K. Efficacy and safety of alogliptin added to sulfonylurea in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension study. J Diabetes Invest 2012; 3: 517–25.
25. Gore MO, McGuire DK. The 10-year posttrial follow-up of the United Kingdom Prospective Diabetes Study (UKPDS): cardiovascular observations in context. Diab Vasc Dis Res 2009; 6: 53–5.
26. The Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 1993; 329: 977–86.
27. Desouza CV, Bolli GB, Fonseca V. Hypoglycemia, diabetes and cardiovascular events. Diabetes Care 2010; 33 (6): 1389–94.
28. Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type-2 diabetes mellitus patients with mild hyperglycemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab 2013. Doi: 10.1111/dom.12102.
29. UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998; 317: 703–13.
30. Gregg EW, Li Y, Wang J, Burrows NR et al. Changes in diabetes-related complications in the United States, 1990–2010. N Engl J Med 2014; 370: 1514–23. Doi: 10.1056/NEJMoa1310799.
31. Food and Drug Administration, Center for Drug Evaluation and Research Guidance for industry: diabetes mellitus – evaluating cardiovascular risk in new antidiabetic therapies to treat type-2 diabetes. 2008 Dec; Available at: http://www.fda.gov /downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/UCM071627.pdf
32. White WB, Bakris GL, Bergenstal RM et al. EXamination of CArdiovascular OutcoMes with AlogliptIN versus Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am Heart J 2011; 162 (4): 620–6.
33. Hall C. Alogliptin in patients with type 2 diabetes after acute coronary syndromes: heart failure outcomes and cardiovascular safety in heart failure patients. JACC 2014; 63 (12).
34. Monami M, Dicembrini I, Mannucci E. Dipeptidyl peptidase-4 inhibitors and pancreatitis risk: a meta-analysis of randomized clinical trials. Diabetes Obes Metab 2013. Doi: 10.1111/dom.12176.
35. Vipidia: EPAR – Public assessment report. European Medicines Agency 2013. Available from: www.ema.europa.eu
36. Christopher R, Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of Type 2 diabetes. Expert Rev Clin Pharmacol 2009; 2: 589–600.
37. Nesina (alogliptin), prescribing information. Deerfield, IL: Takeda Pharmaceuticals America, Inc., 2013.
38. Инструкция по медицинскому применению препарата Випидия. / Instruktsiia po meditsinskomu primeneniiu preparata Vipidiia. [in Russian]
________________________________________________
2. American Diabetes Association, Standards of Medical Care in Diabetes – 2015. Diabetes Care 2015; 38 (Suppl. 1): 1–94.
3. Dedov I.I., Shestakova M.V. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. 6-e izd., 2013. [in Russian]
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Авторы
Н.А.Петунина*, А.Л.Терехова
ГБОУ ВПО Первый Московский государственный медицинский университет им. И.М.Сеченова Минздрава России. 119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2
*napetunina@mail.ru
I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation. 119991, Russian Federation, Moscow, ul. Trubetskaia, d. 8, str. 2
*napetunina@mail.ru
ГБОУ ВПО Первый Московский государственный медицинский университет им. И.М.Сеченова Минздрава России. 119991, Россия, Москва, ул. Трубецкая, д. 8, стр. 2
*napetunina@mail.ru
________________________________________________
I.M.Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation. 119991, Russian Federation, Moscow, ul. Trubetskaia, d. 8, str. 2
*napetunina@mail.ru
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