ometendoОжирение и метаболизмObesity and metabolism2071-87132306-5524Endocrinology Research Centre10.14341/omet2014425-31ometendo-6818Research ArticleОбзор литературыReviewАлоглиптин – новый представитель класса ингибиторов ДПП-4Alogliptin – the new member of DPP-4 inhibitors classПетунинаНина АлександровнаPetuninaNina Aleksandrovna

д.м.н, профессор, зав. кафедры эндокринологии

napetunina@mail.ruТереховаАнна ЛеонтьевнаTerekhovaAnna Leont'evna

старший лаборант кафедры эндокринологии

svkh@mail.ruГОУ ВПО Первый Московский государственный медицинский университет им. И.М. Сеченова Минзрава РоссииРоссияI.M. Sechenov First Moscow State Medical UniversityRussian FederationГОУ ВПО Первый Московский государственный медицинский университет им. И.М. Сеченова Минздрава РоссииРоссияI.M. Sechenov First Moscow State Medical UniversityRussian Federation2014141220141142531Copyright © Петунина Н.А., Терехова А.Л., 20142014Петунина Н.А., Терехова А.Л.Petunina N.A., Terekhova A.L.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.omet-endojournals.ru/jour/article/view/6818

В настоящем обзоре представлены данные клинических исследований по эффективности и  безопасности применения нового представителя класса иДПП-4, алоглиптина, у взрослых больных сахарным диабетом 2 типа (СД 2) в качестве монотерапии или в комбинации с метформином, пиоглитазоном, глибенкламидом и инсулином.

This review presents data on the efficacy and safety of alogliptin, a new representative of the DPP-4 inhibitors, in adult patients with type2 diabetes mellitus (DM type 2) as monotherapy or in combination with metformin, pioglitazone, glibenclamide and insulin.

алоглиптинингибиторы ДПП-4эффективностьбезопасностьсердечно-сосудистый рискгипогликемияalogliptinDPP-4 inhibitorsefficacysafetycardiovascular riskhypoglycemiaReferencesInternational Diabetes Federation. IDF Diabetes Atlas, Sixth edition. www.idf.org/diabetesatlas; 2013.International Diabetes Federation. IDF Diabetes Atlas, Sixth edition. www.idf.org/diabetesatlas; 2013.Сунцов Ю.И., Дедов И.И., Кудрякова С.В. Государственный регистр сахарного диабета: эпидемиологическая характеристика инсулиннезависимого сахарного диабета. Сахарный диабет. 1998; № 1: С. 41–43 [Suntsov YI, Dedov II, Kudryakova SV. Gosudarstvennyy registr sakharnogo diabeta: epidemiologicheskaya kharakteristika insulinnezavisimogo sakharnogo diabeta. Diabetes mellitus 1998; (1):41–43. doi: 10.14341/2072-0351-6215.]Сунцов Ю.И., Дедов И.И., Кудрякова С.В. Государственный регистр сахарного диабета: эпидемиологическая характеристика инсулиннезависимого сахарного диабета. Сахарный диабет. 1998; № 1: С. 41–43 [Suntsov YI, Dedov II, Kudryakova SV. Gosudarstvennyy registr sakharnogo diabeta: epidemiologicheskaya kharakteristika insulinnezavisimogo sakharnogo diabeta. Diabetes mellitus 1998; (1):41–43. doi: 10.14341/2072-0351-6215.]Drucker DJ. Incretine-based therapies. A clinical need filled by unique metabolic effects. The Diabetes Educator 2006;32(2):65–71. doi: 10.1177/0145721706287651.Drucker DJ. Incretine-based therapies. A clinical need filled by unique metabolic effects. The Diabetes Educator 2006;32(2):65–71. doi: 10.1177/0145721706287651.Andukuri R, Drincic A, Rendell M. Alogliptin: a new addition to the class of DPP-4 inhibitors. Diabetes Metab Syndr Obes 2009;2:117–126. PMID: 21437125.Andukuri R, Drincic A, Rendell M. Alogliptin: a new addition to the class of DPP-4 inhibitors. Diabetes Metab Syndr Obes 2009;2:117–126. PMID: 21437125.Covington P, Christopher R, Davenport M, Fleck P, Mekki QA, Wann ER, et al. Pharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes. Clin Ther 2008;30(3):499–512. PMID: 18405788. doi: 10.1016/j.clinthera.2008.03.004.Covington P, Christopher R, Davenport M, Fleck P, Mekki QA, Wann ER, et al. Pharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes. Clin Ther 2008;30(3):499–512. PMID: 18405788. doi: 10.1016/j.clinthera.2008.03.004.Scheen AJ. Pharmacokinetics of dipeptidylpeptidase-4 inhibitors. Diabetes, Obesity and Metabolism 2010;12(8):648–658. PMID: 20590741. doi: 10.1111/j.1463-1326.2010.01212.x.Scheen AJ. Pharmacokinetics of dipeptidylpeptidase-4 inhibitors. Diabetes, Obesity and Metabolism 2010;12(8):648–658. PMID: 20590741. doi: 10.1111/j.1463-1326.2010.01212.x.Golightly LK, Drayna CC, McDermott MT. Comparative Clinical Pharmacokinetics of Dipeptidyl Peptidase-4 Inhibitors. Clin Pharmacokinet 2012;51(8):501–514. PMID: 22686547. doi: 10.1007/BF03261927.Golightly LK, Drayna CC, McDermott MT. Comparative Clinical Pharmacokinetics of Dipeptidyl Peptidase-4 Inhibitors. Clin Pharmacokinet 2012;51(8):501–514. PMID: 22686547. doi: 10.1007/BF03261927.Scott LJ. Alogliptin: a review of its use in the management of type 2 diabetes mellitus. Drugs 2010;70(15):2051–2072. PMID: 20883057. doi: 10.2165/11205080-000000000-00000.Scott LJ. Alogliptin: a review of its use in the management of type 2 diabetes mellitus. Drugs 2010;70(15):2051–2072. PMID: 20883057. doi: 10.2165/11205080-000000000-00000.Christopher R, Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of Type 2 diabetes. Expert Review of Clinical Pharmacology 2009;2(6):589–600. PMID: 22112254. doi: 10.1586/ecp.09.45.Christopher R, Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of Type 2 diabetes. Expert Review of Clinical Pharmacology 2009;2(6):589–600. PMID: 22112254. doi: 10.1586/ecp.09.45.Nesina, (alogliptin), prescribing information. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; Jun 2013.Nesina, (alogliptin), prescribing information. Deerfield, IL: Takeda Pharmaceuticals America, Inc.; Jun 2013.Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. Diabetes, Obesity and Metabolism 2009;11(12):1145–1152. PMID: 19758359. doi: 10.1111/j.1463-1326.2009.01124.x.Rosenstock J, Rendell MS, Gross JL, Fleck PR, Wilson CA, Mekki Q. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. Diabetes, Obesity and Metabolism 2009;11(12):1145–1152. PMID: 19758359. doi: 10.1111/j.1463-1326.2009.01124.x.DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. 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):2315–2317. doi: 10.2337/dc08-1035.DeFronzo RA, Fleck PR, Wilson CA, Mekki Q. 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):2315–2317. doi: 10.2337/dc08-1035.Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. 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. International Journal of Clinical Practice 2009;63(1):46–55. PMID: 19125992. doi: 10.1111/j.1742-1241.2008.01933.x.Nauck MA, Ellis GC, Fleck PR, Wilson CA, Mekki Q. 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. International Journal of Clinical Practice 2009;63(1):46–55. PMID: 19125992. doi: 10.1111/j.1742-1241.2008.01933.x.Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes, Obesity and Metabolism 2009;11(2):167–176. doi: 10.1111/j.1463-1326.2008.01016.x.Pratley RE, Kipnes MS, Fleck PR, Wilson C, Mekki Q. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes, Obesity and Metabolism 2009;11(2):167–176. doi: 10.1111/j.1463-1326.2008.01016.x.Pratley RE, Reusch JEB, Fleck PR, Wilson CA, Mekki Q. 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):2361–2371. PMID: 19650752. doi: 10.1185/03007990903156111.Pratley RE, Reusch JEB, Fleck PR, Wilson CA, Mekki Q. 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):2361–2371. PMID: 19650752. doi: 10.1185/03007990903156111.Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial Combination Therapy With Alogliptin and Pioglitazone in Drug-Naive Patients With Type 2 Diabetes. Diabetes Care 2010;33(11):2406–2408. PMID: 20724648. doi: 10.2337/dc10-0159.Rosenstock J, Inzucchi SE, Seufert J, Fleck PR, Wilson CA, Mekki Q. Initial Combination Therapy With Alogliptin and Pioglitazone in Drug-Naive Patients With Type 2 Diabetes. Diabetes Care 2010;33(11):2406–2408. PMID: 20724648. doi: 10.2337/dc10-0159.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: 2012.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: 2012.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, double-blind, active-controlled, parallel-group study. Diabetes, Obesity and Metabolism 2011;13(12):1088–1096. PMID: 21733058. doi: 10.1111/j.1463-1326.2011.01463.x.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, double-blind, active-controlled, parallel-group study. Diabetes, Obesity and Metabolism 2011;13(12):1088–1096. PMID: 21733058. doi: 10.1111/j.1463-1326.2011.01463.x.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.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.Sayeed MA, Mahtab H, Khanam PA, Latif ZA, Ali SMK, Banu A, et al. Diabetes and Impaired Fasting Glycemia in a Rural Population of Bangladesh. Diabetes Care 2003;26(4):1034–1039. doi: 10.2337/diacare.26.4.1034.Sayeed MA, Mahtab H, Khanam PA, Latif ZA, Ali SMK, Banu A, et al. Diabetes and Impaired Fasting Glycemia in a Rural Population of Bangladesh. Diabetes Care 2003;26(4):1034–1039. doi: 10.2337/diacare.26.4.1034.Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab 2013;15(10):906–914. PMID: 23531118. doi: 10.1111/dom.12102.Rosenstock J, Wilson C, Fleck P. Alogliptin versus glipizide monotherapy in elderly type 2 diabetes mellitus patients with mild hyperglycaemia: a prospective, double-blind, randomized, 1-year study. Diabetes Obes Metab 2013;15(10):906–914. PMID: 23531118. doi: 10.1111/dom.12102.Warram J, Kopczynski J, Janka H, Krolewski A. Epidemiology of non-insulin-dependent diabetes mellitus and its macrovascular complications: a basis for the Development of Cost-Effective Programs. Endocrinol. Metabol. Clin 1997;26:165–188.Warram J, Kopczynski J, Janka H, Krolewski A. Epidemiology of non-insulin-dependent diabetes mellitus and its macrovascular complications: a basis for the Development of Cost-Effective Programs. Endocrinol. Metabol. Clin 1997;26:165–188.Diabetes Mellitus: A Major Risk Factor for Cardiovascular Disease : A Joint Editorial Statement by the American Diabetes Association; the National Heart, Lung, and Blood Institute; the Juvenile Diabetes Foundation International; the National Institute of Diabetes and Digestive and Kidney Diseases; and the American Heart Association. Circulation 1999;100(10):1132–1133. doi: 10.1161/01.CIR.100.10.1132.Diabetes Mellitus: A Major Risk Factor for Cardiovascular Disease : A Joint Editorial Statement by the American Diabetes Association; the National Heart, Lung, and Blood Institute; the Juvenile Diabetes Foundation International; the National Institute of Diabetes and Digestive and Kidney Diseases; and the American Heart Association. Circulation 1999;100(10):1132–1133. doi: 10.1161/01.CIR.100.10.1132.Food and Drug Administration, f.D.E.a.R.G.f.i. (Center), diabetes, m.c.r.i.n.a.t.t.t.t. (diabetes). for Drug Evaluation and Research Guidance for industry: diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type-2 diabetes. 2008.Food and Drug Administration, f.D.E.a.R.G.f.i. (Center), diabetes, m.c.r.i.n.a.t.t.t.t. (diabetes). for Drug Evaluation and Research Guidance for industry: diabetes mellitus—evaluating cardiovascular risk in new antidiabetic therapies to treat type-2 diabetes. 2008.Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes. ADVANCE. N Engl J Med 2008;358(24):2560–2572. doi: 10.1056/NEJMoa0802987.Intensive Blood Glucose Control and Vascular Outcomes in Patients with Type 2 Diabetes. ADVANCE. N Engl J Med 2008;358(24):2560–2572. doi: 10.1056/NEJMoa0802987.Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes. ACCORD. N Engl J Med 2010;363(3):233–244. doi: 10.1056/NEJMoa1001288.Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes. ACCORD. N Engl J Med 2010;363(3):233–244. doi: 10.1056/NEJMoa1001288.Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, et al. Heart Failure, Saxagliptin, and Diabetes Mellitus: Observations from the SAVOR-TIMI 53 Randomized Trial. Circulation 2014;130(18):1579–1588. PMID: 25189213. doi: 10.1161/CIRCULATIONAHA.114.010389.Scirica BM, Braunwald E, Raz I, Cavender MA, Morrow DA, Jarolim P, et al. Heart Failure, Saxagliptin, and Diabetes Mellitus: Observations from the SAVOR-TIMI 53 Randomized Trial. Circulation 2014;130(18):1579–1588. PMID: 25189213. doi: 10.1161/CIRCULATIONAHA.114.010389.White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, et al. Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. N Engl J Med 2013;369(14):1327–1335. PMID: 23992602. doi: 10.1056/NEJMoa1305889.White WB, Cannon CP, Heller SR, Nissen SE, Bergenstal RM, Bakris GL, et al. Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. N Engl J Med 2013;369(14):1327–1335. PMID: 23992602. doi: 10.1056/NEJMoa1305889.TECOS (NCT00790205). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control. 2014.TECOS (NCT00790205). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control. 2014.CAROLINA (NCT01243424). A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. 2014. Available from: https://www.clinicaltrials.gov/ct2/show/NCT01243424;CAROLINA (NCT01243424). A Multicentre, International, Randomised, Parallel Group, Double Blind Study to Evaluate Cardiovascular Safety of Linagliptin Versus Glimepiride in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk. 2014. Available from: https://www.clinicaltrials.gov/ct2/show/NCT01243424;CARMELINA (NCT01897532). A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk. 2014.CARMELINA (NCT01897532). A Multicenter, International, Randomized, Parallel Group, Double-blind, Placebo-controlled, Cardiovascular Safety and Renal Microvascular Outcome Study With Linagliptin, 5 mg Once Daily in Patients With Type 2 Diabetes Mellitus at High Vascular Risk. 2014.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).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).

The authors declare that there are no conflicts of interest present.