Клиническая характеристика и практические аспекты применения нового базального аналога инсулина гларгин 300 ЕД/мл Туджео СолоСтар®


Цитировать

Полный текст

Открытый доступ Открытый доступ
Доступ закрыт Доступ предоставлен
Доступ закрыт Доступ платный или только для подписчиков

Аннотация

Обзор посвящен анализу результатов клинических исследований, проведенных с целью оценки терапевтической сопоставимости инсулина гларгин 100 и 300 ЕД/мл. Отмечено, что по сравнению с инсулином гларгин 100 ЕД/мл инсулин гларгин 300 ЕД/мл обеспечивает более продолжительное и плавное всасывание и длительность действия (до 36 часов независимо от дозы). Приведены результаты, доказавшие возможность гибкого графика введения гларгина 300 ЕД/мл, при котором изменение показателей HbA1c, глюкозы плазмы натощак, а также частота развития гипогликемии ночью и в любое время суток не отличались от таковых при фиксированном применении. Сделан вывод, согласно которому применение нового базального инсулина 300 ЕД/мл открывает широкие возможности для современного адекватного лечения пациентов с сахарным диабетом.

Полный текст

Доступ закрыт

Об авторах

М. Б Анциферов

ГБУЗ «Эндокринологический диспансер» Департамента здравоохранения г. Москвы

д.м.н., проф., главный врач

Список литературы

  1. Алгоритмы специализированной медицинской помощи больным сахарным диабетом. Изд. 7-е. / Под ред. И.И. Дедова, М.В. Шестаковой. Сахарный диабет. 2015;18(1S):1-112.
  2. Standards of Medical Care in Diabetes-2015 Abridged for Primary Care Providers. Clin. Diabetes. 2015;33:97-111.
  3. Inzucchi S.E., Bergenstal R.M., Buse J.B., et al. 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;38:140-49.
  4. Stratton I.M., Adler A.I., Neil H.A. Matthews D.R., Manley S.E., Cull C.A., Hadden D., Turner R.C., Holman R.R. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000;321:405-12.
  5. DCCT. Lifetime benefits and costs of intensive therapy as practiced in the Diabetes Control and Complications Trial. JAMA. 1996;276:1409-415.
  6. Turner R.C., Cull C.A., Frighi V., Holman R.R. Glycemic control with diet, sulfonylurea, metformin, or insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS 49). UK Prospective Diabetes Study (UKPDS) Group. JAMA. 1999;281:2005-12.
  7. Holman R.R., Paul S.K., Bethel M.A., Matthews D.R., Neil H.A. 10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes. N. Engl. J. Med. 2008;359:1577-89.
  8. Riddle M.C., Rosenstock J., Gerich J. The treat-to-target trial randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003;26:3080-86.
  9. Porcellati F., Rossetti P., Busciantella N.R., Marzotti S., Lucidi P., Luzio S., Owens D.R., Bolli G.B., Fanelli C.G. Comparison of pharmacokinetics and dynamics of the long-acting insulin analogs Glargine and Detemir at steady state in Type 1 Diabetes a double-blind, randomized, crossover study. Diabetes Care. 2007;30:2447-52.
  10. Abah S., Turan S., Atay Z., Güran T., Haliloğlu B., Bereket A. Higher insulin detemir doses are required for the similar glycemic control: comparison of insulin detemir and glargine in children with type 1 diabetes mellitus. Pediatr. Diabetes. 2015;16:361-66.
  11. Bryant G.A., McDanel D.L., Horner K.E., et al. Evaluation of dosing and clinical outcomes in patients undergoing conversion of insulin glargine to insulin detemir. Pharmacother. J. Hum. Pharmacol. Drug Ther. 2013;33:56-62.
  12. Инструкция по применению лекарственного препарата для медицинского применения Туджео СолоСтар®.
  13. Steinstraesser A., Schmidt R., Bergmann K., Dahmen R., Becker R.H. Investigational new insulin glargine 300 U/ml has the same metabolism as insulin glargine 100 U/ml. Diabetes Obes. Metab. 2014;16:873-76.
  14. Shiramoto M., Eto T., Irie S., Fukuzaki A., Teichert L., Tillner J., Takahashi Y., Koyama M., Dahmen R., Heise T., Becker R.H. Single-dose new insulin glargine 300 U/ml provides prolonged, stable glycaemic control in Japanese and European people with type 1 diabetes. Diabetes Obes. Metab. 2015;17:254-60.
  15. Becker R.H., Dahmen R., Bergmann K., Lehmann A., Jax T., Heise T. New insulin glargine 300 units• mL- 1 provides a more even activity profile and prolonged glycemic control at steady state compared with insulin glargine 100 units• mL- 1. Diabetes Care. 2015;38:637-43.
  16. Becker R.H.A., Nowotny I., Teichert L., Bergmann K., Kapitza C. Low within-and between-day variability in exposure to new insulin glargine 300 U/ml. Diabetes Obes. Metab. 2015;17:261-67.
  17. Bergenstal R.M., et al. Poster presentation at EASD 2014; Abstract 949 Available at: http://www.easdvirtualmeeting.org/ resources/18574 Accessed April 2016.
  18. Home P.D., Bergenstal R.M., Bolli G.B., Ziemen M., Rojeski M., Espinasse M., Riddle M.C. New insulin glargine 300 units/ml versus glargine 100 units/mL in people with type 1 diabetes: a randomized, phase 3a, open-label clinical trial (EDITION 4). Diabetes Care. 2015;38: 2217-25.
  19. Riddle M.C., Yki-Järvinen H., Bolli G.B., et al. One-year sustained glycaemic control and less hypoglycaemia with new insulin glargine 300 U/ml compared with 100 U/ml in people with type 2 diabetes using basal plus meal-time insulin: the EDITION 1 12-month randomized trial, including 6-month extension. Diabetes Obes. Metab. 2015;17:835-42.
  20. Bolli G.B., Riddle M.C., Bergenstal R.M., Ziemen M., Sestakauskas K., Goyeau H., Home P.D. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3). Diabetes Obes. Metab. 2015;17:386-94.
  21. Ritzel R., Roussel R., Bolli G.B., Vinet L., Brulle-Wohlhueter C., Glezer S., Yki-Järvinen H. Patient-level meta-analysis of the EDITION 1, 2 and 3 studies: glycaemic control and hypoglycaemia with new insulin glargine 300 U/ml versus glargine 100 U/ml in people with type 2 diabetes. Diabetes Obes. Metab. 2015; 17:859-67.
  22. Yki-Järvinen H., Bergenstal R., Ziemen M., Wardecki M., Muehlen-Bartmer I., Boelle E., Riddle M.C. New insulin glargine 300 units/ mL versus glargine 100 units/mL in people with type 2 diabetes using oral agents and basal insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 2). Diabetes Care. 2014;37:3235-43.
  23. Riddle M.C., Bolli G.B., Home P.D., Bergenstal R.M., Ziemen M., Muehlen-Bartmer I., Wardecki M., Vinet L., Jeandidier N., Yki-J rvinen H. Efficacy and safety of flexible versus fixed dosing intervals of insulin glargine 300 U/ mL in people with Type 2 Diabetes. Diabetes Technology & Therapeutics. 2016;18(4):252-57.
  24. Riddle M.C., Bolli G.B., Ziemen M., Muehlen-Bartmer I., Bizet F., Home P.D. New insulin glargine 300 units/mL versus glargine 100 units/mL in people with type 2 diabetes using basal and mealtime insulin: glucose control and hypoglycemia in a 6-month randomized controlled trial (EDITION 1). Diabetes Care. 2014;37:2755-62.
  25. Frier B.M. How hypoglycaemia can affect the life of a person with diabetes. Diabetes Metab. Res. Rev. 2008;24:87-92.
  26. Twigg S.M., et al. Age, BMI, and diabetes duration: effect on glycemic control and hypoglycemia with insulin glargine 300U/ml in type 2 diabetes. Poster presented at ADA 2015. 1017-P
  27. Pathak R., Schroeder E., Seaquist E., Zeng C., Lafata J.E., Thomas A., Desai J., Waitzfelder B., Nichols G.A., Lawrence J.M., Karter A.J., Steiner J.F., Segal J., O'Connor P.J. Severe Hypoglycemia Requiring Medical Intervention in a Large Cohort of Adults With Diabetes Receiving Care in U.S. Integrated Health Care Delivery Systems: 2005-2011. Diabetes Care. 2016;39:363-70.
  28. Moen M., Zhan M., Hsu V.D., Walker L.D., Einhorn L.M., Seliger S.L., Fink J.C. Frequency of hypoglycemia and its significance in chronic kidney disease. Clin. J. Am. Soc. Nephrol. 2009;4:1121-27.
  29. Escalada J., Halimi S., Senior P., et al. Glycemic control and hypoglycemia benefits with insulin glargine 300 U/mL (Gla-300) extend to people with type 2 diabetes (T2DM) and mild-to-moderate renal impairment. ADA 76th Scientific Sessions (Abstract 69-OR).
  30. Stella P., et al. Abstract at EASD 2015. ePoster, abstract 977. Available from http://www. easdvirtualmeeting.org/resources/older-people-with-type-2-diabetes-glycaemic-control-and-hypoglycaemia-risk-with-new-insulin-glargine-300-u-ml-gla-300--2. Date accessed May 31 2016.
  31. The ORIGIN trial investigators, Gilbert R.E., Mann J.F., Hanefeld M., Spinas G., Bosch J., Yusuf S., Gerstein H.C. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial. Diabetologia. 2014;57(7):1325-31.
  32. Lonn E.M., Bosch J., Diaz R., Lopez-Jaramillo P., Ramachandran A., Hâncu N., Hanefeld M., Krum H., Ryden L., Smith S., McQueen M.J., Dyal L., Yusuf S., Gerstein H.C. Effect of Insulin Glargine and n-3FA on Carotid Intima-Media Thickness in People With Dysglycemia at High Risk for Cardiovascular Events: The Glucose Reduction and Atherosclerosis Continuing Evaluation Study (ORIGIN-GRACE). Diabetes Care. 2013;36:2466-74.

Дополнительные файлы

Доп. файлы
Действие
1. JATS XML
Скачать

© ООО «Бионика Медиа», 2016