Надежный выбор в терапии сахарного диабета 2-го типа: фокус на алоглиптин
Аннотация
В настоящей работе обсуждаются возможности и преимущества ранней комбинированной терапии и особенности применения фиксированной комбинации метформина и алоглиптина (Випдомет®) в лечении сахарного диабета 2-го типа (СД 2).
Ключевые слова
алоглиптин,
метформин,
ингибиторы ДПП-4,
комбинированная терапия,
Випдомет®,
фиксированная комбинация,
эффективность,
безопасность
Об авторах
Н. А. Петунина
Federal State Autonomous Educational Institution of Higher Education «Sechenov First Moscow State Medical University» of Ministry of Health of the Russian Federation (Sechenov University)
Россия
Россия
Петунина Нина Александровна – доктор медицинских наук, профессор, заведующая кафедрой эндокринологии лечебного факультета
119991, г. Москва, ул. Б. Пироговская, д. 6, стр. 1
А. Л. Терехова
Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский университет)
Россия
Россия
Терехова Анна Леонтьевна – кандидат медицинских наук, ассистент кафедры эндокринологии лечебного факультета
119991, г. Москва, ул. Б. Пироговская, д. 6, стр. 1
Список литературы
1. International Diabetes Federation. IDF Diabetes Atlas 7th ed., 2015. http://www.idf.org/diabetesatlas.
2. Дедов И.И., Шестакова М.В., Галстян Г.Р. Распространенность сахарного диабета 2 типа у взрослого населения России (исследование NATION). Сахарный диабет. 2016;19(2):104-112. doi: 10.14341/DM2004116-17.
3. Дедов И.И., Шестакова М.В., Викулова О.К. Государственный регистр сахарного диабета в Российской Федерации: статус 2014 г. и перспективы развития. Сахарный диабет. 2015;18(3):5-22. doi: 10.14341/DM201535-22.
4. Global health risks: mortality and burden of disease attributable to selected major risks. Geneva: World Health Organization; 2009. Available from: http://www.who.int/healthinfo/global_burden_disease/GlobalHealthRisks_report_full.pdf.
5. Ali M.K., Bullard K.M., Gregg E.W., Del Rio C. A cascade of care for diabetes in the United States: visualizing the gaps. Ann Intern Med. 2014;161:681–9.
6. Stark Casagrande S., Fradkin J.E., Saydah S.H., Rust K.F., Cowie C.C. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988-2010. Diabetes Care. 2013;36:2271–2279.
7. Дедов И.И., Калашникова М.Ф., Белоусов Д.Ю., Колбин A.C., Рафальский В.В., Чеберда А.Е., Кантемирова М.А., Закиев В.Д., Фадеев В.В. Анализ стоимости болезни сахарного диабета 2 типа в Российской Федерации: результаты российского многоцентрового наблюдательного фармакоэпидемиологического исследования ФОРСАЙТ-СД2. Сахарный диабет. 2017;20(6):403-419. doi: 10.14341/DM9278.
8. DeFronzo R.A. Banting Lecture. From the triumvirate to the ominous octet: a new paradigm for the treatment of type 2 diabetes mellitus. Diabetes. 2009;58(4):773–95. https://doi.org/10.2337/db09-9028.
9. Zonszein Joel, Groop Per-Henrik Strategies for Diabetes Management: Using Newer Oral Combination Therapies Early in the Disease. Diabetes Ther. 2016;7:621–639. doi: 10.1007/s13300-016-0208-5.
10. Дедов И.И., Шестакова М.В., Майоров А.Ю., и др. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Под редакцией И.И. Дедова, М.В. Шестаковой, А.Ю. Майорова. 8-й выпуск. Сахарный диабет. 2017;20(1S):1-121.
11. 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;38:140–149. doi: 10.2337/dc14-2441
12. Consensus statement by the American Association of Clinical Endocrinologists and American College of Endocrinology on the comprehensive type 2 diabetes management algorithm – 2018 Executive Summary. 2018 AACE/ACE T2D Managemen. Endocr Pract. 2018;24(1):91-120.
13. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes—2018. American Diabetes Association. Diabetes Care. 2018 Jan;41(Supplement 1):S73-S85. https://doi.org/10.2337/dc18-S008.
14. Дедов И.И., Шестакова М.В. Феномен «метаболической памяти» в прогнозировании риска развития сосудистых осложнений при сахарном диабете. Терапевтический архив. 2015;87(10):4-10.
15. Phung O.J., Sobieraj D.M., Engel S.S., Rajpathak S.N. Early combination therapy for the treatment of type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes Obes Metab. 2014;16:410–17.
16. Phillips L.S., Ratner R.E., Buse J.B., Kahn S.E. We can change the natural history of type 2 diabetes. Diabetes Care. 2014;37:2668–2676.
17. Lavernia F., Adkins SE., Shubrook JH. Use of oral combination therapy for type 2 diabetes in primary care: Meeting individualized patient goals. Postgraduate Medicine, 2015;127:8, 808- 817. doi: 10.1080/00325481.2015.1085293.
18. 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/GuidanceComplianceRegulatoryInformation/Guidances/UCM071627.pdf. Accessed February 9, 2014.
19. Karagiannis T., Paschos P., Paletas K., Matthews D.R., Tsapas A. Dipeptidyl peptidase-4 inhibitors for treatment of type 2 diabetes mellitus in the clinical setting: systematic review and metaanalysis. BMJ. 2012 Mar 12;344:e1369. doi: 10.1136/bmj.e1369.
20. Abdulrahman S. Alanazi Saudi. Systematic review and meta-analysis of efficacy and safety of combinational therapy with metformin and dipeptidyl peptidase-4 inhibitors. Pharmaceutical Journal. 2015;23:603–613. https://doi.org/10.1016/j.jsps.2013.12.018.
21. Deacon C.F., Mannucci E., Ahrén B. Glycaemic efficacy of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors as add-on therapy to metformin in subjects with type 2 diabetes – a review and meta analysis. Diabetes Obes Metab. 2012 Aug;14(8):762-7. doi: 10.1111/j.1463-1326.2012.01603.x.
22. Huang E.S., Karter A.J., Danielson K.K., Warton E.M., Ahmed A.T. The association between the number of prescription medications and incident falls in a multi-ethnic population of adult type-2 diabetes patients: the diabetes and aging study. J Gen Intern Med. 2010;25(2):141–6.
23. 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(7160):703–13.
24. Frye R.L., August P., Brooks M.M., et al. A randomized trial of therapies for type 2 diabetes and coronary artery disease. N Engl J Med. 2009;360(24):2503–15.
25. Ho P.M., Rumsfeld J.S., Masoudi F.A., et al. Effect of medication nonadherence on hospitalization and mortality among patients with diabetes mellitus. Arch Intern Med. 2006;166:1836–41.
26. McGovern A., Tippu Z., Hinton W., et al. Systematic review of adherence rates by medication class in type 2 diabetes: a study protocol. BMJ Open. 2016;6:e010469. doi:10.1136/bmjopen-2015-010469.
27. Luis-Emilio Garcı´a-Pe´rez, Marı´a A´ lvarez, Tatiana Dilla et al. Adherence to Therapies in Patients with Type 2 Diabetes. Diabetes Ther. 2013;4:175–194. Doi: 10.1007/s13300-013-0034-y.
28. Hutchins V., Zhang B., Fleurence R.L., Krishnarajah G., Graham J. A systematic review of adherence, treatment satisfaction and costs, in fixed-dose combination regimens in type 2 diabetes. Curr Med Res Opin. 2011;27:1157–68.
29. Cheong C., Barner J.C., Lawson K.A., Johnsrud M.T. Patient adherence and reimbursement amount for antidiabetic fixed-dose combination products compared with dual therapy among Texas Medicaid recipients. Clin Ther. 2008;30:1893–907.
30. Cramer J.A. A systematic review of adherence with medications for diabetes. Diabetes Care. 2004;27:1218–24.
31. Blonde L., San Juan Z.T., Bolton P. Fixed-dose combination therapy in type 2 diabetes mellitus. Endocr Pract. 2014;20(12):1322–32.
32. Blonde L., San Juan Z.T. Fixed-dose combinations for treatment of type 2 diabetes mellitus. Adv Ther. 2012;29(1):1–13.
33. Blonde L., Wogen J., Kreilick C., Seymour A.A. Greater reductions in A1C in type 2 diabetic patients new to therapy with glyburide/metformin tablets as compared to glyburide coadministered with metformin. Diabetes Obes Metab. 2003;5(6):424–31.
34. Han S., Iglay K., Davies M.J., Zhang Q., Radican L. Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: a meta-analysis. Curr Med Res Opin. 2012;28:969–77.
35. Liu Y., Hong T. Combination therapy of dipeptidyl peptidase-4 inhibitors and metformin in type 2 diabetes: rationale and evidence. Diabetes Obes Metab. 2014;16:111–17.
36. Harpreet S. Bajaj, Chenglin Ye, Esha Jain, Karri Venn, Eden Stein, Ronnie Aronson. Glycemic Improvement with a Fixed-dose combination of DPP-4 inhibitor + metformin in patients with Type 2 diabetes (GIFT study). Diabetes Obes Metab. 2017;1–5. doi: 10.1111/dom.13040.
37. Руяткина Л.А., Руяткин Д.С. Многоплановые эффекты метформина у пациентов с сахарным диабетом 2 типа. Сахарный диабет. 2017;20(3):210-219. doi: 10.14341/DM2003458-64.
38. Food and Drug Administration. FDA Drug Safety Communication: FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm493244.htm. Accessed June 16, 2016
39. Глюкофаж 500/850/1000 мг – официальная инструкция по применению, электронный ресурс https://medi.ru/instrukciya/glyukofazh-500-800-1000_9567/
40. Aguilar D., Chan W., Bozkurt B., et al. Metformin Use and Mortality in Ambulatory Patients with Diabetes and Heart Failure. Circ Heart Fail. 2011;4(1):53–58. doi: 10.1161/CIRCHEARTFAILURE.110.952556.
41. Papanas N., Maltezos E., Mikhailidis D.P. Metformin and heart failure: never say never again. Expert Opin Pharmacother. 2012;13(1):1-8. doi: 10.1517/14656566.2012.638283.
42. Crowley M.J., Diamantidis C.J., McDuffie J.R., et al. Clinical Outcomes of Metformin Use in Populations With Chronic Kidney Disease, Congestive Heart Failure, or Chronic Liver Disease: A Systematic Review. Ann Intern Med. 2017;166(3):191-200. doi: 10.7326/M16-1901.
43. 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):435–441.
44. Seino Y., Fujita T., Hiroi S., Hirayama M., Kaku K. 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):1781–1792.
45. DeFronzo R.A., Fleck P.R., Wilson C.A., 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, doubleblind, placebo-controlled study. Diabetes Care. 2008;31(12):2315–2317.
46. Rosenstock J., Inzucchi S.E., Seufert J., Fleck P.R., Wilson G.A., Mekki Q. Initial combination therapy with alogliptin and pioglitazone in drugnaïve patients with type 2 diabetes. Diabetes Care. 2010;33(11):2406–2408.
47. 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.
48. Nauck M.A., Ellis G.C., Fleck P.R., Wilson C.A., 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.
49. Kaku K., Itayasu T., Hiroi S., Hirayama M., Seino Y. Efficacy and safety of alogliptin added to pioglitazone in Japanese patients with type 2 diabetes: a randomized, double-blind, placebocontrolled trial with an open-label long-term extension study. Diabetes Obes Metab. 2011;13(11):1028–1035.
50. Pratley R.E., Reusch J.E., Fleck P.R., Wilson C.A., Mekki Q., 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):2361–2371.
51. Bosi E., Ellis G.C., Wilson C.A., Fleck P.R. 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):1088–1096.
52. Pratley R.E., Kipnes M.S., Fleck P.R., Wilson C., Mekki Q. 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):167–176.
53. Seino Y., Fujita T., Hiroi S., Hirayama M., Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, doubleblind, placebo-controlled trial with an openlabel, long-term extension. Curr Med Res Opin. 2011;27(Suppl 3):21–29.
54. Rosenstock J., Rendell M.S., Gross J.L., 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;11:1145–1152.
55. Asres Berhan and Yifru Berhan. 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.
56. 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.
57. Seino Y., Miyata Y., Hiroi S., Hirayama M., Kaku K. Efficacy and safety of alogliptin added to metformin in Japanese patients with type 2 diabetes: a randomized, double-blind, placebocontrolled trial with an open-label, long-term extension study. Diabetes Obes Metab. 2012;14(10):927–936.
58. 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.
59. 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.
60. White W.B., Bakris G.L., Bergenstal R.M., 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):620–626.
61. Hall C Alogliptin in patients with type 2 diabetes after acute coronary syndromes: heart failure utcomes and cardiovascular safety in heart failure patients. JACC. 2014 April 1; 63(12).
62. Fujita H., Tania H., Murayama H. et al. DPP-4 inhibition with alogliptin on top of angiotensin II type 1 receptor blockade ameliorates albuminuria via up-regulation of SDF-1α in type 2 diabetic patients ith incipient nephropathy. Endocrine Journal. 2014;61(2):159-166. doi: 10.1507/endocrj.EJ13-0305).
63. Pratley R.E., McCall T., Fleck P.R., Wilson C.A., Mekki Q. Alogliptin Use in Elderly People: A Pooled Analysis from Phase 2 and 3 Studies. J Am Geriatr Soc. 2009 Nov;57(11):2011-9. doi: 10.1111/j.1532-5415.2009.02484.x.
64. 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.
65. 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.
66. Jianying Fu, Jianhong Zhu, Yehua Hao, Chongchong Guo, and Zhikun Zhoua. Dipeptidyl peptidase-4 inhibitors and fracture risk: an updated meta-analysis of randomized clinical trials. Sci Rep. 2016;6: 29104. doi: 10.1038/srep29104. PMCID: PMC4935882.
67. Pratley R.E., Fleck P., Wilson C. Efficacy and safety of initial combination therapy with alogliptin plus metformin versus either as monotherapy in drug-naïve patients with type 2 diabetes: a randomized, double-blind, 6-month study. Diabetes Obes Metab. 2014 Jul;16(7):613-21. doi: 10.1111/dom.12258.
68. Alogliptin Plus Metformin (Kazano) for Type 2 Diabetes Mellitus. CDR submission: Kazano™ (alogliptin and metformin) 12.5 mg/500 mg, 12.5 mg/850 mg and 12.5 mg/1000 mg tablets. Company: Takeda Canada Inc. [CONFIDENTIAL manufacturer’s submission]. Oakville (ON): Takeda Canada Inc; Dec, 2013. электронный ресурс - https://www.ncbi.nlm.nih.gov/books/NBK349220/
69. Linong Ji, Ling Li, Jian Kuang, Tao Yang, DongJun Kim, Azidah A.Kadir, Chien-Ning Huang, Douglas Lee Efficacy and safety of fixed-dose combination therapy, alogliptin plus metformin, in Asian patients with type 2 diabetes: A phase 3 trial. Diabetes Obes Metab. 2017;19:754–758. Doi: 10.1111/dom.12875.
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