rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2010-6-6-876-881rpcardio-935Research ArticleCURRENT QUESTIONS OF CLINICAL PHARMACOLOGYАКТУАЛЬНЫЕ ВОПРОСЫ КЛИНИЧЕСКОЙ ФАРМАКОЛОГИИTHE CHOICE OF DRUG FROM THE STANDPOINT OF EVIDENCE-BASED MEDICINE: CASE STUDY OF BETA-BLOCKERSПРОБЛЕМА ВЫБОРА ЛЕКАРСТВЕННОГО ПРЕПАРАТА С ПОЗИЦИЙ ДОКАЗАТЕЛЬНОЙ МЕДИЦИНЫ НА ПРИМЕРЕ БЕТА-АДРЕНОБЛОКАТОРОВМарцевичС. Ю.MartsevichS. Yu.

д.м.н., профессор, руководитель отдела профилактической фармакотерапии

профессор кафедры доказательной медицины 

101990 Москва, Петроверигский переулок, 10

119991, Москва, ул. Трубецкая, д. 8, стр. 2

Petroverigsky per. 10, Moscow, 101990 

Trubetskaya ul. 8-2, Moscow, 119991 

smartsevich@gnicpm.ruКутишенкоН. П.KutishenkoN. P.

д.м.н., руководитель лаборатории того же отдела

101990 Москва, Петроверигский переулок, 10

Petroverigsky per. 10, Moscow, 101990

ЛукинаЮ. В.LukinaYu. V.

к.м.н., с.н.с. того же отдела, ассистент той же кафедры 

101990 Москва, Петроверигский переулок, 10

119991, Москва, ул. Трубецкая, д. 8, стр. 2

Petroverigsky per. 10, Moscow, 101990 

Trubetskaya ul. 8-2, Moscow, 119991 

Государственный научно-исследовательский центр профилактической медицины, Первый Московский медицинский университет им. И.М. СеченоваРоссияState Research Center for Preventive Medicine, I.M. Setchenov First Moscow State Medical UniversityRussian FederationГосударственный научно-исследовательский центр профилактической медициныРоссияState Research Center for Preventive MedicineRussian Federation20102101201666876881Copyright © Martsevich S.Y., Kutishenko N.P., Lukina Y.V., 20162016Марцевич С.Ю., Кутишенко Н.П., Лукина Ю.В.Martsevich S.Y., Kutishenko N.P., Lukina Y.V.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.rpcardio.online/jour/article/view/935

Basic principles of beta-blockers choice strategy are presented. Attention is focused on the facts concerning the evidence base for effects of various beta-blockers on the outcomes of cardiovascular diseases. Beta-blocker indications and safety of their long-term use are considered from this point of view. Convincing data about beta-blocker impact on the prognosis of cardiovascular disease should be the reason for any beta-blocker choice, as well as choice of their doses which were tested in large randomized trials.

Приводятся основные принципы, на которых строится стратегия выбора бета-адреноблокаторов (БАБ). Внимание сконцентрировано на фактах, касающихся вопросов доказательной базы различных БАБ в отношении влияния на исходы сердечно-сосудистых заболеваний. С этой точки зрения рассматриваются показания к назначению БАБ и безопасность их длительного приема. Наличие убедительных данных о влиянии на прогноз заболевания должны быть основой выбора любого БАБ, который должен назначаться в тех же дозах, в которых он применялся в крупных рандомизированных исследованиях.

проблема выбора лекарственного препаратариск сердечно-сосудистых осложненийбета-адреноблокаторыdrug choicecardiovascular riskbeta-blockersReferencesEMEA (The European Agency for the Evaluation of Medicinal Products). Bioequivalence Guidelines/Regulations. Available on: http://www.gcphelpdesk.com/index.php/bioequivalence-guidelinesregulations.EMEA (The European Agency for the Evaluation of Medicinal Products). Bioequivalence Guidelines/Regulations. Available on: http://www.gcphelpdesk.com/index.php/bioequivalence-guidelinesregulations.Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO Technical Report Series, No. 937, 2006. Available on: http://apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex7_eng.pdf.Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability. WHO Technical Report Series, No. 937, 2006. Available on: http://apps.who.int/prequal/info_general/documents/TRS937/WHO_TRS_937__annex7_eng.pdf.Poole-Wilson P.A., Swedberg K., Cleland J.G. et al. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heartfailure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet 2003;362(9377):7–13.Poole-Wilson P.A., Swedberg K., Cleland J.G. et al. Comparison of carvedilol and metoprolol on clinical outcomes in patients with chronic heartfailure in the Carvedilol Or Metoprolol European Trial (COMET): randomised controlled trial. Lancet 2003;362(9377):7–13.Drug facts and comparisons. Philadelphia: Lippincott Williams & Wilkins / Springhouse; 2009.Drug facts and comparisons. Philadelphia: Lippincott Williams & Wilkins / Springhouse; 2009.ESC GuidelinesDesk Reference2010:Compendium ofAbridged ESC Guidelines2010.1st Edition. Springer Healthcare Ltd.; 2010. p.336.ESC GuidelinesDesk Reference2010:Compendium ofAbridged ESC Guidelines2010.1st Edition. Springer Healthcare Ltd.; 2010. p.336.Olsson G., Tuomilehto J., Berglund G. et al. Primary prevention of sudden cardiovascular death in hypertensive patients. Mortality results from the MAPHY study. Am J Hypertens 1991;4(2 Pt 1): 151-8.Olsson G., Tuomilehto J., Berglund G. et al. Primary prevention of sudden cardiovascular death in hypertensive patients. Mortality results from the MAPHY study. Am J Hypertens 1991;4(2 Pt 1): 151-8.Lever A.F., Brennan P.J. MRC working party. MRC trial of treatment in elderly hypertensives. Clin Exp Hypertens 1993;15(6):941-2.Lever A.F., Brennan P.J. MRC working party. MRC trial of treatment in elderly hypertensives. Clin Exp Hypertens 1993;15(6):941-2.Wilhelmsen L., Berglund G., Elmfeldt D. et al. Beta-blockers versus diuretics in hypertensive men: main results from the HAPPHY trial. J Hypertens 1987;5(5):561-72.Wilhelmsen L., Berglund G., Elmfeldt D. et al. Beta-blockers versus diuretics in hypertensive men: main results from the HAPPHY trial. J Hypertens 1987;5(5):561-72.Dahlöf B., Lindholm L.H., Hansson L. et al. Morbidity and mortality in the Swedish Trial in Old Patients with Hypertension (STOP-Hypertension). Lancet 1991;338(8778):1281-5.Dahlöf B., Lindholm L.H., Hansson L. et al. Morbidity and mortality in the Swedish Trial in Old Patients with Hypertension (STOP-Hypertension). Lancet 1991;338(8778):1281-5.Chen Z.M., Pan H.C., Chen Y.P. et al. Commit (ClOpidogrel and Metoprolol in Miocardial Infarction Trial) collaborative group. Early intravenous than oral metoprolol in 45582 patients with acute myocardial infarction: randomized placebo-controlled trial. Lancet 2005; 366(9497):1622-32.Chen Z.M., Pan H.C., Chen Y.P. et al. Commit (ClOpidogrel and Metoprolol in Miocardial Infarction Trial) collaborative group. Early intravenous than oral metoprolol in 45582 patients with acute myocardial infarction: randomized placebo-controlled trial. Lancet 2005; 366(9497):1622-32.Dargie H.J. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001;357(9266):1385–90.Dargie H.J. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001;357(9266):1385–90.Packer M., Bristow M.R., Cohn J.N. et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. US Carvedilol Heart Failure Study Group. N Engl J Med 1996; 334(21): 1349 – 55.Packer M., Bristow M.R., Cohn J.N. et al. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. US Carvedilol Heart Failure Study Group. N Engl J Med 1996; 334(21): 1349 – 55.Hjalmarson Å., Goldstein S., Fagerberg B. et al. mortality, hospitalizations, and well-being in patients with heart failure. The Metoprolol CR/XL Randomized International Trial in congestive heart failure (MERIT-HF). JAMA 2000;283(10):1295–302.Hjalmarson Å., Goldstein S., Fagerberg B. et al. mortality, hospitalizations, and well-being in patients with heart failure. The Metoprolol CR/XL Randomized International Trial in congestive heart failure (MERIT-HF). JAMA 2000;283(10):1295–302.CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353(9146):9-13.CIBIS-II Investigators and Committees. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999;353(9146):9-13.Flather M.D., Shibata M.C., Coats A.J.S. et al. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). Eur Heart J 2005; 26(3): 215–225.Flather M.D., Shibata M.C., Coats A.J.S. et al. Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). Eur Heart J 2005; 26(3): 215–225.Packer M., Fowler M., Rouleau J. COPERNICUS (Carvedilol Prospective Randomized Cumulative Survival Trial). A multicenter randomized double-blind, placebo-controlled study to determine the effect of carvedilol on mortality in severe congestive heart failure (absract). Cardiovasc Drugs Ther 1999;13(1):24.Packer M., Fowler M., Rouleau J. COPERNICUS (Carvedilol Prospective Randomized Cumulative Survival Trial). A multicenter randomized double-blind, placebo-controlled study to determine the effect of carvedilol on mortality in severe congestive heart failure (absract). Cardiovasc Drugs Ther 1999;13(1):24.Bakris G.L., Fonseca V., Katholi R.E. et al. Metabolic Effects of Carvedilol vs Metoprolol in Patients With Type 2 Diabetes Mellitus and Hypertension. A Randomized Controlled Trial. JAMA 2004; 292(18): 2227—2236.Bakris G.L., Fonseca V., Katholi R.E. et al. Metabolic Effects of Carvedilol vs Metoprolol in Patients With Type 2 Diabetes Mellitus and Hypertension. A Randomized Controlled Trial. JAMA 2004; 292(18): 2227—2236.UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ 1998;317(7160):713- 20.UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ 1998;317(7160):713- 20.Helfand M., Peterson K., Christensen V. et al. Drug Class Review. Beta Adrenergic Blockers. Final Report, update 4. 2009 by Oregon Health & Science University Portland, Oregon. Available on: http://derp.ohsu.edu/final/BB_Final_Report_Update%204_09_JUL.pdf.Helfand M., Peterson K., Christensen V. et al. Drug Class Review. Beta Adrenergic Blockers. Final Report, update 4. 2009 by Oregon Health & Science University Portland, Oregon. Available on: http://derp.ohsu.edu/final/BB_Final_Report_Update%204_09_JUL.pdf.Metra M., Guibbini R., Nodari S. et al. Differential effects of beta-blockers in patients with heart failure: A prospective, randomized, double-blind comparison of the long-term effects of metoprolol versus carvedilol. Circulation 2000; 102(5): 546-551.Metra M., Guibbini R., Nodari S. et al. Differential effects of beta-blockers in patients with heart failure: A prospective, randomized, double-blind comparison of the long-term effects of metoprolol versus carvedilol. Circulation 2000; 102(5): 546-551.Bangalore S., Parkar S., Grossman E., Messerli F.N. A meta-analysis of 94,492 patients with hypertension treated with beta blockers to determine the risk of the new-onset diabetes mellitus. Am J Cardiol 2007; 100(8): 1254-1262.Bangalore S., Parkar S., Grossman E., Messerli F.N. A meta-analysis of 94,492 patients with hypertension treated with beta blockers to determine the risk of the new-onset diabetes mellitus. Am J Cardiol 2007; 100(8): 1254-1262.

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