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Применение ингибиторов дипептидилпептидазы-4 в клинической практике
Моргунова Т.Б., Фадеев В.В. Применение ингибиторов дипептидилпептидазы-4 в клинической практике. Consilium Medicum. 2019; 21 (4): 40–44. DOI: 10.26442/20751753.2019.4.190349
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Morgunova T.B., Fadeyev V.V. Dipeptidyl peptidase-4 inhibitors use in clinical practice. Consilium Medicum. 2019; 21 (4): 40–44. DOI: 10.26442/20751753.2019.4.190349
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Аннотация
По современным представлениям лечение пациентов с сахарным диабетом направлено не только на достижение целевых значений гликемического контроля, а в целом на предупреждение развития и прогрессирования поздних осложнений сахарного диабета, повышение качества жизни и увеличение продолжительности жизни пациентов. Актуальность исследований по лечению сахарного диабета обусловлена растущей распространенностью заболевания, в том числе среди людей старшей возрастной группы. В последние годы в практике стали использоваться новые классы сахароснижающих препаратов: ингибиторы дипептидилпептидазы-4 (иДПП-4), агонисты рецепторов глюкагоноподобного пептида-1, ингибиторы натрий-глюкозного котранспортера-2. Достаточно длительный опыт применения ингибиторов (иДПП-4) позволяет сделать выводы не только об эффективности этого класса препаратов, но и их безопасности. Проведены исследования, в том числе в реальной клинической практике, по применению иДПП-4 у пациентов старшего возраста, с сопутствующими заболеваниями, нарушениями функции почек. На сегодняшний день опубликованы результаты исследований по кардиоваскулярной безопасности препаратов из класса иДПП-4 у пациентов с сахарным диабетом 2-го типа. В представленной статье обсуждаются вопросы выбора сахароснижающей терапии, место иДПП-4 в клинической практике.
Ключевые слова: сахарный диабет, лечение, ингибиторы дипептидилпептидазы 4-го типа, гликированный гемоглобин, эффективность терапии.
Ключевые слова: сахарный диабет, лечение, ингибиторы дипептидилпептидазы 4-го типа, гликированный гемоглобин, эффективность терапии.
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According to modern view treatment of patients with diabetes mellitus is aimed not only at reaching target glycemic control levels but also at preventing development and progressing of late diabetes mellitus complications, improvement of quality of life and increase of life expectancy of patients. The relevance of the diabetes treatment research is explained with growing disorder prevalence including its prevalence in older population. Over the last years new classes of antihyperglycemic medications came into use: dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 agonists, and sodium-glucose linked transporter-2 inhibitors. Long-term experience of DPP-4 inhibitors use allows to conclude not only of effectiveness of medications of this class but also of their safety. Several studies of DPP-4 inhibitors use in older patients with comorbid disorders and renal impairment have been conducted including studies in real clinical practice. Results of studies of cardiovascular safety of medications from DPP-4 inhibitors class in patients with diabetes mellitus type 2 have been published. The article discusses the issues of antihyperglycemic therapy choice and the place of DPP-4 inhibitors in clinical practice.
Key words: diabetes mellitus, treatment, dipeptidyl peptidase-4 inhibitors, glycated hemoglobin, therapy effectiveness.
Key words: diabetes mellitus, treatment, dipeptidyl peptidase-4 inhibitors, glycated hemoglobin, therapy effectiveness.
Полный текст
Список литературы
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[Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. Pod red. I.I.Dedova, M.V.Shestakovoi, A.Iu.Maiorova. 8-i vyp. Sakharnyi diabet. 2017; 20 (1S): 1–112. DOI: 10.14341/DM20171S8 (in Russian).]
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): 104–12. DOI: 10.14341/DM2004116-17
[Dedov I.I., Shestakova M.V., Galstian G.R. Rasprostranennost' sakharnogo diabeta 2 tipa u vzroslogo naseleniia Rossii (issledovanie NATION). Sakharnyi diabet. 2016; 19 (2): 104–12. DOI: 10.14341/DM2004116-17 (in Russian).]
3. Montvida O, Shaw J, Atherton JJ et al. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes Care 2018; 41 (1): 69–78. DOI: 10.2337/dc17-1414
4. Overbeek JA, Heintjes EM, Prieto-Alhambra D et al. Type 2 Diabetes Mellitus Treatment Patterns Across Europe: A Population-based Multi-database Study. Clin Ther 2017; 39 (4): 759–70. DOI: 10.1016/j.clinthera.2017.02.008
5. Wilkinson S, Douglas IJ, Williamson E et al. Factors associated with choice of intensification treatment for type 2 diabetes after metformin monotherapy: a cohort study in UK primary care. Clin Epidemiol 2018; 10: 1639–48. DOI: 10.2147/CLEP.S176142. eCollection 2018.
6. Davies MJ, D'Alessio DA, Fradkin J et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018; 41 (12): 2669–701. DOI: 10.2337/dci18-0033
7. Scheen AJ. The safety of gliptins: updated data in 2018. Exp Opin Drug Saf 2018; 17 (4): 387–405. DOI: 10.1080/14740338.2018.1444027
8. Mishriky BM, Cummings DM, Tanenberg RJ. The efficacy and safety of DPP4 inhibitors compared to sulfonylureas as add-on therapy to metformin in patients with Type 2 diabetes: A systematic review and meta-analysis. Diabetes Res Clin Pract 2015; 109 (2): 378–88. DOI: 10.1016/j.diabres.2015.05.025
9. Seck T, Nauck M, Sheng D et al. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract 2010; 64 (5): 562–76. DOI: 10.1111/j.1742-1241.2010.02353.x
10. Göke B, Gallwitz B, Eriksson JG et al. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract 2013; 67 (4): 307–16. DOI: 10.1111/ijcp.12119
11. Del Prato S, Camisasca R, Wilson C, Fleck P. Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study. Diabetes Obes Metab 2014; 16 (12): 1239–46. DOI: 10.1111/dom.12377
12. Gallwitz B, Rosenstock J, Rauch T et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet 2012; 380 (9840): 475–83. DOI: 10.1016/s0140-6736(12)60691-6
13. Matthews DR, Dejager S, Ahren B et al. Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. Diabetes Obes Metab 2010; 12 (9): 780–9. DOI: 10.1111/j.1463-1326.2010.01233.x.
14. Chon S, Gautier JF. An Update on the Effect of Incretin-Based Therapies on b-Cell Function and Mass. Diabetes Metab J 2016; 40 (2): 99–114. DOI: 10.4093/dmj.2016.40.2.99
15. Jurczyk A, Diiorio P, Brostowin D et al. Improved function and proliferation of adult human beta cells engrafted in diabetic immunodeficient NOD-scid IL2rγ(null) mice treated with alogliptin. Diabetes Metab Syndr Obes 2013; 6: 493–9. DOI: 10.2147/DMSO.S53154
16. Lynch CP, Gebregziabher M, Axon RN et al. Geographic and racial/ethnic variations in patterns of multimorbidity burden in patients with type 2 diabetes. J Gen Intern Med 2015; 30 (1): 25–32. DOI: 10.1007/s11606-014-2990-y
17. Pratley RE, McCall T, Fleck PR et al. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc 2009; 57 (11): 2011–9. DOI: 10.1111/j.1532-5415.2009.02484.x
18. 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): 906–14. DOI: 10.1111/dom.12102
19. Karyekar CS, Ravichandran S, Allen E et al. Tolerability and efficacy of glycemic control with saxagliptin in older patients (aged≥65 years) with inadequately controlled type 2 diabetes mellitus. Clin Interv Aging 2013; 8: 419–30. DOI: 10.2147/CIA.S41246
20. Umezawa S, Kubota A, Maeda H et al. Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: Post hoc analysis of the ASSET-K study. BMC Endocr Disord 2015; 15: 34. DOI: 10.1186/s12902-015-0033-2
21. White WB, Cannon CP, Heller SR et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013; 369: 1327–35. DOI: 10.1056/NEJMoa1305889
22. Mita T, Katakami N, Yoshii H et al. Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). Diabetes Care 2016; 39 (1): 139–48. DOI: 10.2337/dc15-0781
[Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. Pod red. I.I.Dedova, M.V.Shestakovoi, A.Iu.Maiorova. 8-i vyp. Sakharnyi diabet. 2017; 20 (1S): 1–112. DOI: 10.14341/DM20171S8 (in Russian).]
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): 104–12. DOI: 10.14341/DM2004116-17
[Dedov I.I., Shestakova M.V., Galstian G.R. Rasprostranennost' sakharnogo diabeta 2 tipa u vzroslogo naseleniia Rossii (issledovanie NATION). Sakharnyi diabet. 2016; 19 (2): 104–12. DOI: 10.14341/DM2004116-17 (in Russian).]
3. Montvida O, Shaw J, Atherton JJ et al. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes Care 2018; 41 (1): 69–78. DOI: 10.2337/dc17-1414
4. Overbeek JA, Heintjes EM, Prieto-Alhambra D et al. Type 2 Diabetes Mellitus Treatment Patterns Across Europe: A Population-based Multi-database Study. Clin Ther 2017; 39 (4): 759–70. DOI: 10.1016/j.clinthera.2017.02.008
5. Wilkinson S, Douglas IJ, Williamson E et al. Factors associated with choice of intensification treatment for type 2 diabetes after metformin monotherapy: a cohort study in UK primary care. Clin Epidemiol 2018; 10: 1639–48. DOI: 10.2147/CLEP.S176142. eCollection 2018.
6. Davies MJ, D'Alessio DA, Fradkin J et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018; 41 (12): 2669–701. DOI: 10.2337/dci18-0033
7. Scheen AJ. The safety of gliptins: updated data in 2018. Exp Opin Drug Saf 2018; 17 (4): 387–405. DOI: 10.1080/14740338.2018.1444027
8. Mishriky BM, Cummings DM, Tanenberg RJ. The efficacy and safety of DPP4 inhibitors compared to sulfonylureas as add-on therapy to metformin in patients with Type 2 diabetes: A systematic review and meta-analysis. Diabetes Res Clin Pract 2015; 109 (2): 378–88. DOI: 10.1016/j.diabres.2015.05.025
9. Seck T, Nauck M, Sheng D et al. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract 2010; 64 (5): 562–76. DOI: 10.1111/j.1742-1241.2010.02353.x
10. Göke B, Gallwitz B, Eriksson JG et al. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract 2013; 67 (4): 307–16. DOI: 10.1111/ijcp.12119
11. Del Prato S, Camisasca R, Wilson C, Fleck P. Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study. Diabetes Obes Metab 2014; 16 (12): 1239–46. DOI: 10.1111/dom.12377
12. Gallwitz B, Rosenstock J, Rauch T et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet 2012; 380 (9840): 475–83. DOI: 10.1016/s0140-6736(12)60691-6
13. Matthews DR, Dejager S, Ahren B et al. Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. Diabetes Obes Metab 2010; 12 (9): 780–9. DOI: 10.1111/j.1463-1326.2010.01233.x.
14. Chon S, Gautier JF. An Update on the Effect of Incretin-Based Therapies on b-Cell Function and Mass. Diabetes Metab J 2016; 40 (2): 99–114. DOI: 10.4093/dmj.2016.40.2.99
15. Jurczyk A, Diiorio P, Brostowin D et al. Improved function and proliferation of adult human beta cells engrafted in diabetic immunodeficient NOD-scid IL2rγ(null) mice treated with alogliptin. Diabetes Metab Syndr Obes 2013; 6: 493–9. DOI: 10.2147/DMSO.S53154
16. Lynch CP, Gebregziabher M, Axon RN et al. Geographic and racial/ethnic variations in patterns of multimorbidity burden in patients with type 2 diabetes. J Gen Intern Med 2015; 30 (1): 25–32. DOI: 10.1007/s11606-014-2990-y
17. Pratley RE, McCall T, Fleck PR et al. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc 2009; 57 (11): 2011–9. DOI: 10.1111/j.1532-5415.2009.02484.x
18. 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): 906–14. DOI: 10.1111/dom.12102
19. Karyekar CS, Ravichandran S, Allen E et al. Tolerability and efficacy of glycemic control with saxagliptin in older patients (aged≥65 years) with inadequately controlled type 2 diabetes mellitus. Clin Interv Aging 2013; 8: 419–30. DOI: 10.2147/CIA.S41246
20. Umezawa S, Kubota A, Maeda H et al. Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: Post hoc analysis of the ASSET-K study. BMC Endocr Disord 2015; 15: 34. DOI: 10.1186/s12902-015-0033-2
21. White WB, Cannon CP, Heller SR et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013; 369: 1327–35. DOI: 10.1056/NEJMoa1305889
22. Mita T, Katakami N, Yoshii H et al. Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). Diabetes Care 2016; 39 (1): 139–48. DOI: 10.2337/dc15-0781
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1. Algoritmy spetsializirovannoi meditsinskoi pomoshchi bol'nym sakharnym diabetom. Pod red. I.I.Dedova, M.V.Shestakovoi, A.Iu.Maiorova. 8-i vyp. Sakharnyi diabet. 2017; 20 (1S): 1–112. DOI: 10.14341/DM20171S8 (in Russian).
2. Dedov I.I., Shestakova M.V., Galstian G.R. Rasprostranennost' sakharnogo diabeta 2 tipa u vzroslogo naseleniia Rossii (issledovanie NATION). Sakharnyi diabet. 2016; 19 (2): 104–12. DOI: 10.14341/DM2004116-17 (in Russian).
3. Montvida O, Shaw J, Atherton JJ et al. Long-term Trends in Antidiabetes Drug Usage in the U.S.: Real-world Evidence in Patients Newly Diagnosed With Type 2 Diabetes. Diabetes Care 2018; 41 (1): 69–78. DOI: 10.2337/dc17-1414
4. Overbeek JA, Heintjes EM, Prieto-Alhambra D et al. Type 2 Diabetes Mellitus Treatment Patterns Across Europe: A Population-based Multi-database Study. Clin Ther 2017; 39 (4): 759–70. DOI: 10.1016/j.clinthera.2017.02.008
5. Wilkinson S, Douglas IJ, Williamson E et al. Factors associated with choice of intensification treatment for type 2 diabetes after metformin monotherapy: a cohort study in UK primary care. Clin Epidemiol 2018; 10: 1639–48. DOI: 10.2147/CLEP.S176142. eCollection 2018.
6. Davies MJ, D'Alessio DA, Fradkin J et al. Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care 2018; 41 (12): 2669–701. DOI: 10.2337/dci18-0033
7. Scheen AJ. The safety of gliptins: updated data in 2018. Exp Opin Drug Saf 2018; 17 (4): 387–405. DOI: 10.1080/14740338.2018.1444027
8. Mishriky BM, Cummings DM, Tanenberg RJ. The efficacy and safety of DPP4 inhibitors compared to sulfonylureas as add-on therapy to metformin in patients with Type 2 diabetes: A systematic review and meta-analysis. Diabetes Res Clin Pract 2015; 109 (2): 378–88. DOI: 10.1016/j.diabres.2015.05.025
9. Seck T, Nauck M, Sheng D et al. Safety and efficacy of treatment with sitagliptin or glipizide in patients with type 2 diabetes inadequately controlled on metformin: a 2-year study. Int J Clin Pract 2010; 64 (5): 562–76. DOI: 10.1111/j.1742-1241.2010.02353.x
10. Göke B, Gallwitz B, Eriksson JG et al. Saxagliptin vs. glipizide as add-on therapy in patients with type 2 diabetes mellitus inadequately controlled on metformin alone: long-term (52-week) extension of a 52-week randomised controlled trial. Int J Clin Pract 2013; 67 (4): 307–16. DOI: 10.1111/ijcp.12119
11. Del Prato S, Camisasca R, Wilson C, Fleck P. Durability of the efficacy and safety of alogliptin compared with glipizide in type 2 diabetes mellitus: a 2-year study. Diabetes Obes Metab 2014; 16 (12): 1239–46. DOI: 10.1111/dom.12377
12. Gallwitz B, Rosenstock J, Rauch T et al. 2-year efficacy and safety of linagliptin compared with glimepiride in patients with type 2 diabetes inadequately controlled on metformin: a randomised, double-blind, non-inferiority trial. Lancet 2012; 380 (9840): 475–83. DOI: 10.1016/s0140-6736(12)60691-6
13. Matthews DR, Dejager S, Ahren B et al. Vildagliptin add-on to metformin produces similar efficacy and reduced hypoglycaemic risk compared with glimepiride, with no weight gain: results from a 2-year study. Diabetes Obes Metab 2010; 12 (9): 780–9. DOI: 10.1111/j.1463-1326.2010.01233.x.
14. Chon S, Gautier JF. An Update on the Effect of Incretin-Based Therapies on b-Cell Function and Mass. Diabetes Metab J 2016; 40 (2): 99–114. DOI: 10.4093/dmj.2016.40.2.99
15. Jurczyk A, Diiorio P, Brostowin D et al. Improved function and proliferation of adult human beta cells engrafted in diabetic immunodeficient NOD-scid IL2rγ(null) mice treated with alogliptin. Diabetes Metab Syndr Obes 2013; 6: 493–9. DOI: 10.2147/DMSO.S53154
16. Lynch CP, Gebregziabher M, Axon RN et al. Geographic and racial/ethnic variations in patterns of multimorbidity burden in patients with type 2 diabetes. J Gen Intern Med 2015; 30 (1): 25–32. DOI: 10.1007/s11606-014-2990-y
17. Pratley RE, McCall T, Fleck PR et al. Alogliptin use in elderly people: a pooled analysis from phase 2 and 3 studies. J Am Geriatr Soc 2009; 57 (11): 2011–9. DOI: 10.1111/j.1532-5415.2009.02484.x
18. 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): 906–14. DOI: 10.1111/dom.12102
19. Karyekar CS, Ravichandran S, Allen E et al. Tolerability and efficacy of glycemic control with saxagliptin in older patients (aged≥65 years) with inadequately controlled type 2 diabetes mellitus. Clin Interv Aging 2013; 8: 419–30. DOI: 10.2147/CIA.S41246
20. Umezawa S, Kubota A, Maeda H et al. Two-year assessment of the efficacy and safety of sitagliptin in elderly patients with type 2 diabetes: Post hoc analysis of the ASSET-K study. BMC Endocr Disord 2015; 15: 34. DOI: 10.1186/s12902-015-0033-2
21. White WB, Cannon CP, Heller SR et al. Alogliptin after acute coronary syndrome in patients with type 2 diabetes. N Engl J Med 2013; 369: 1327–35. DOI: 10.1056/NEJMoa1305889
22. Mita T, Katakami N, Yoshii H et al. Alogliptin, a Dipeptidyl Peptidase 4 Inhibitor, Prevents the Progression of Carotid Atherosclerosis in Patients With Type 2 Diabetes: The Study of Preventive Effects of Alogliptin on Diabetic Atherosclerosis (SPEAD-A). Diabetes Care 2016; 39 (1): 139–48. DOI: 10.2337/dc15-0781
Авторы
Т.Б.Моргунова*, В.В.Фадеев
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М.Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*tanmorgun@mail
ФГАОУ ВО «Первый Московский государственный медицинский университет им. И.М.Сеченова» Минздрава России (Сеченовский Университет), Москва, Россия
*tanmorgun@mail
________________________________________________
Tatiana B. Morgunova*, Valentin V. Fadeyev
I.M.Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*tanmorgun@mail
I.M.Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia
*tanmorgun@mail
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