problendoПроблемы ЭндокринологииProblems of Endocrinology0375-96602308-1430Endocrinology Research Centre10.14341/probl200753651-54problendo-10986Research ArticleОбзорыReviewsНовый метаанализ по оценке кардиоваскулярного риска розиглитазона и его потенциальные последствияNew meta-analysis of the assessment of the cardiovascular risk of rosiglitazone and its potential sequelsУшкаловаЕ. А.UshkalovaE. A.probl@endojournals.ru<p>Российский университет дружбы народов</p>Россия<p>Peoples Friendship University of Russia</p>Russian Federation200715122007536ТОМ 53, №6 (2007)5154Copyright &#x00A9; Ушкалова Е.А., 20072007Ушкалова Е.А.Ushkalova E.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.probl-endojournals.ru/jour/article/view/10986

21 мая 2007 г. на сайте одного из самых авторитетных в мире медицинских журналов "New England Journal of Medicine" был размещен метаанализ, который привлек к себе пристальное внимание не только специалистов здравоохранения, но и широких слоев населения, и вызвал активное обсуждение на страницах ведущих клинических журналов и в средствах массовой информации. Целью данного метаанализа, включавшего 42 относительно непродолжительных (24—53 нед) клинических исследования, в том числе 2 крупных — DREAM (A Diabetes Outcome Prevention Trial) и ADOPT (Diabetes Reduction Assessment with Ramipiril and Posiglitazone) являлась оценка влияния розиглитазона на риск инфаркта миокарда и смерти от сердечно-сосудистых заболеваний. Участниками исследований были около 28 тыс. больных СД2, из которых 15 560 получали режимы терапии, содержащие розиг- литазон, а 12 283 (контрольная группа) — плацебо или режимы, содержащие другие антидиабетические препараты (метформин, производные сульфонилмочеви- ны, преимущественно глибенкламид, или инсулин). Согласно результатам метаанализа, применение розиглитазона ассоциировалось со значительно более высоким кардиоваскулярным риском, чем использование плацебо и других сахароснижаюших средств (см. таблицу). Риск развития инфаркта миокарда в группе терапии розиглитазоном превышал таковой в контрольной группе на 43%, риск смерти от сердечно-сосудистых причин — на 64%.

On May 21, 2007, a meta-analysis was posted on the website of one of the most respected medical journals in the world, New England Journal of Medicine, which attracted close attention of not only healthcare professionals, but also the general public, and caused an active discussion on leading clinical journals and in the media.

The purpose of this meta-analysis, which included 42 relatively short-term (24–53 weeks) clinical trials, including 2 large ones, DREAM (A Diabetes Outcome Prevention Trial) and ADOPT (Diabetes Reduction Assessment with Ramipiril and Posiglitazone), was to assess the effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular disease. The participants in the studies were about 28 thousand patients with T2DM, of which 15,560 received treatment regimens containing rosiglitazone, and 12,283 (control group) received placebo or regimens containing other antidiabetic drugs (metformin, sulfonylurea derivatives, mainly glibenclamide, or insulin).

According to the results of meta-analysis, the use of rosiglitazone was associated with a significantly higher cardiovascular risk than the use of placebo and other hypoglycemic agents (see table). The risk of developing myocardial infarction in the rosiglitazone therapy group exceeded that in the control group by 43%, and the risk of death from cardiovascular causes by 64%.

розиглитазонсахарный диабеткардио-васкулярный рискметаанализrosiglitazonediabetes mellituscardio-vascular riskmeta-analysisacute heart deathReferencesКарпов О. И. // Рус. мед. жури. - 2006. - № 26. - С. 3- 6.Карпов О. И. // Рус. мед. жури. - 2006. - № 26. - С. 3- 6.Avandia: Available at: http://www.emea.europa.eu/humandocs/Humans/EPAR/avandia/avandia.htmAvandia: Available at: http://www.emea.europa.eu/humandocs/Humans/EPAR/avandia/avandia.htmAvandia (rosiglitazone maleate) tablets: prescribing information. Research Triangle Park, NC: GlaxoSmithKline, 2007 (package insert), http://www.fda.gov/cder/foi/label/2007/021071s0231bl.pdf.Avandia (rosiglitazone maleate) tablets: prescribing information. Research Triangle Park, NC: GlaxoSmithKline, 2007 (package insert), http://www.fda.gov/cder/foi/label/2007/021071s0231bl.pdf.Chiquette E., Ramirez G., Defronzo R. // Arch. Intern. Med. - 2004. - Vol. 164, N 19. - P. 2097-2104.Chiquette E., Ramirez G., Defronzo R. // Arch. Intern. Med. - 2004. - Vol. 164, N 19. - P. 2097-2104.Dormandy J. A., Charbonnel В., Eckland D. J. et al. // Lancet. - 2005. - Vol. 366. - P. 1279-1289.Dormandy J. A., Charbonnel В., Eckland D. J. et al. // Lancet. - 2005. - Vol. 366. - P. 1279-1289.The DREAM Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial // Lancet. - 2006. - Vol. 368. - P. 1096-1105.The DREAM Trial Investigators. Effect of rosiglitazone on the frequency of diabetes in patients with impaired glucose tolerance or impaired fasting glucose: a randomized controlled trial // Lancet. - 2006. - Vol. 368. - P. 1096-1105.EMEA Statement On Recent Publication On Cardiac Safety Of Rosiglitazone (Avandia, Avandamet, Avaglim), Europe. Available at: http://www.emea.europa.eu/pdfs/general/direct/pr/23005707en.pdf.EMEA Statement On Recent Publication On Cardiac Safety Of Rosiglitazone (Avandia, Avandamet, Avaglim), Europe. Available at: http://www.emea.europa.eu/pdfs/general/direct/pr/23005707en.pdf.FDA Issues Safety Alert on Avandia. FDA News. Available at: http://www.fda.gov/bbs/topics/NEVS/2007/NEW0I636.html.FDA Issues Safety Alert on Avandia. FDA News. Available at: http://www.fda.gov/bbs/topics/NEVS/2007/NEW0I636.html.Fredenrich A., Grimaldi P. А. Ц Diabetes Metab. - 2005. - Vol 31, N 1.-P. 23-27.Fredenrich A., Grimaldi P. А. Ц Diabetes Metab. - 2005. - Vol 31, N 1.-P. 23-27.Grey A., Holland M., Gamble G. et al. // J. Clin. Endocrinol. Metab. - 2007. - Vol. 92, N 4. - P. 1305-1310.Grey A., Holland M., Gamble G. et al. // J. Clin. Endocrinol. Metab. - 2007. - Vol. 92, N 4. - P. 1305-1310.Hoberbosch W. // Here. - 2007. - Bd 32, N 1. - S. 51-57.Hoberbosch W. // Here. - 2007. - Bd 32, N 1. - S. 51-57.Home P. D., Pocock S. J., Beck-Nielsen H. et al. // Diabetologia. - 2005. - Vol. 48. - P. 1726-1735.Home P. D., Pocock S. J., Beck-Nielsen H. et al. // Diabetologia. - 2005. - Vol. 48. - P. 1726-1735.Home P. D., Pocock S. J., Beck-Nielsen H. et al. Rosiglitazone evaluated for cardiovascular outcomesan interim analysis. N. Engl. J. Med. 2007; DOI: 0.1056/NEJMoa073394. Available at: &lt;http://www.nejm.org&gt;.Home P. D., Pocock S. J., Beck-Nielsen H. et al. Rosiglitazone evaluated for cardiovascular outcomesan interim analysis. N. Engl. J. Med. 2007; DOI: 0.1056/NEJMoa073394. Available at: &lt;http://www.nejm.org&gt;.Hughes S. The Rosiglitazone Aftermath: Legitimate Concerns or Hype? Heartwire 2007. Available at: http://www.med-scape.com/viewarticle/557198.Hughes S. The Rosiglitazone Aftermath: Legitimate Concerns or Hype? Heartwire 2007. Available at: http://www.med-scape.com/viewarticle/557198.Kahn S. E, Haffner S. M., Heise M. A. et al. // N. Engl. J. Med. - 2006. - Vol. 355. - P. 2427-2443.Kahn S. E, Haffner S. M., Heise M. A. et al. // N. Engl. J. Med. - 2006. - Vol. 355. - P. 2427-2443.Kannel W. В., McGee D. L. // Circulation. - 1979. - Vol 59. - P. 8-13.Kannel W. В., McGee D. L. // Circulation. - 1979. - Vol 59. - P. 8-13.Krentz A. J. // Expert. Opin. Drug Saf. - 2006. - Vol. 5. N 6. - P. 827-834.Krentz A. J. // Expert. Opin. Drug Saf. - 2006. - Vol. 5. N 6. - P. 827-834.Nainggolan L. Rosiglitazone Meta-Analysis Continues to Drive Controversy in Second Week. May 30, 2007. Available at: http://www.medscape.com/viewarticle/557511Nainggolan L. Rosiglitazone Meta-Analysis Continues to Drive Controversy in Second Week. May 30, 2007. Available at: http://www.medscape.com/viewarticle/557511Nathan D. M., Base J. В., Davidson M. B. et al. // Diabetes Care. - 2006. - Vol. 29, N 8. - P. 1963-1972.Nathan D. M., Base J. В., Davidson M. B. et al. // Diabetes Care. - 2006. - Vol. 29, N 8. - P. 1963-1972.Nesto R. W., Bell D., Bonow R. O. et al. Circulation. - 2003. -Vol. 108.-P. 2941-2948.Nesto R. W., Bell D., Bonow R. O. et al. Circulation. - 2003. -Vol. 108.-P. 2941-2948.Nissen S. E, Wolski K., Topol E. J. // J. A. M. A. - 2005. -Vol. 294. - P. 2581-2586.Nissen S. E, Wolski K., Topol E. J. // J. A. M. A. - 2005. -Vol. 294. - P. 2581-2586.Nissen S. E., Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, www.nejm.org May 21, 2007 (10.1056/NEJMoa072761).Nissen S. E., Wolski K. Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes, www.nejm.org May 21, 2007 (10.1056/NEJMoa072761).Psaty В., Furberg C. Rosiglitazone and cardiovascular risk. N. Engl. J. Med. 2007; DOI:l0.1056/NEJMe078099. Available at: http://www.nejm.org.Psaty В., Furberg C. Rosiglitazone and cardiovascular risk. N. Engl. J. Med. 2007; DOI:l0.1056/NEJMe078099. Available at: http://www.nejm.org.Ramsdell J. W, Braunstein S. N., Stephens J. M. et al. // Pharmacoeconomics. - 2003. - Vol. 21, N 11. - P. 819-837.Ramsdell J. W, Braunstein S. N., Stephens J. M. et al. // Pharmacoeconomics. - 2003. - Vol. 21, N 11. - P. 819-837.Rubenstrunk A., Hanf R., Hum D. W. et al. // Biochim. Biophys. Acta. - 2007. - Feb. 24; [Epub ahead of print].Rubenstrunk A., Hanf R., Hum D. W. et al. // Biochim. Biophys. Acta. - 2007. - Feb. 24; [Epub ahead of print].Saul S. Test of drug for diabetes in jeopardy. New York Times, May 26, 2007. Available at: http://www.nyiimes.com.Saul S. Test of drug for diabetes in jeopardy. New York Times, May 26, 2007. Available at: http://www.nyiimes.com.Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, 'Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes*. http://diabetes.org/diabetesnewsarticle.jsp7storyld = I5ll5339@filename = 2007052 l/T.xml.Statement from the American College of Cardiology, American Diabetes Association and American Heart Association Related to NEJM article, 'Effect of Rosiglitazone on the Risk of Myocardial Infarction and Death from Cardiovascular Causes*. http://diabetes.org/diabetesnewsarticle.jsp7storyld = I5ll5339@filename = 2007052 l/T.xml.Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). // Lancet. - 1998. -Vol. 352. - P. 837-853.Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). // Lancet. - 1998. -Vol. 352. - P. 837-853.Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) // Lancet. - 1998. - Vol. 352. - P. 854-865.Prospective Diabetes Study (UKPDS) Group. Effect of intensive blood-glucose control with metformin on complications in overweight patients with type 2 diabetes (UKPDS 34) // Lancet. - 1998. - Vol. 352. - P. 854-865.Yaturu S., Bryant В., Jain S. K. // Diabetes Care. - 2007. - Vol. 30. - P. 1574-1576.Yaturu S., Bryant В., Jain S. K. // Diabetes Care. - 2007. - Vol. 30. - P. 1574-1576.

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