rpcardioRational Pharmacotherapy in CardiologyРациональная Фармакотерапия в Кардиологии1819-64462225-3653«SILICEA-POLIGRAF» LLC10.20996/1819-6446-2019-15-2-271-276rpcardio-1925Research ArticleCURRENT QUESTIONS OF CLINICAL PHARMACOLOGYАКТУАЛЬНЫЕ ВОПРОСЫ КЛИНИЧЕСКОЙ ФАРМАКОЛОГИИHow to solve the problem of drug choice within the same class from the standpoint of evidence-based medicine?Как решить проблему выбора препарата внутри одного класса с позиций доказательной медицины?МарцевичС. Ю.MartsevichS. Yu.

Марцевич Сергей Юрьевич - доктор медицинских наук, профессор, руководитель отдела профилактической фармакотерапии, НМИЦ ПМ.

101990, Москва, Петроверигский пер., 10

Sergey Yu. Martsevich - MD, PhD, Professor, Head of Preventive Pharmacotherapy Department.

Petroverigsky per. 1 0, Moscow, 101990

sergeymartsevich@mail.ruНациональный медицинский исследовательский центр профилактической медициныРоссияNational Medical Research Center for Preventive MedicineRussian Federation201905052019152271276Copyright © Martsevich S.Y., 20192019Марцевич С.Ю.Martsevich S.Y.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/1925

The question of the possibility of the most effective drug choosing within one class from the standpoint of evidence-based medicine is considered in the article. Drugs belonging to the same class may have both great similarities and significant differences. This is demonstrated by the example of different classes of drugs (beta-blockers, angiotensin-converting enzyme inhibitors, and new oral anticoagulants). The choice of the most effective (from the standpoint of evidence-based medicine) is impossible if there are no direct comparisons in randomized controlled studies between drugs of the same class that have demonstrated their effectiveness separately. Analysis of observational studies (large databases, registers) to identify the most effective drug in a class cannot be used to solve the problem of the superiority of a drug within a class.

В статье рассматривается вопрос о возможности выбора наиболее эффективного препарата внутри одного класса с позиций доказательной медицины. На примере разных классов препаратов (бета-адреноблокаторов, ингибиторов ангиотензинпревращающего фермента, новых оральных антикоагулянтов) демонстрируется, что препараты, относящиеся к одному и тому же классу, могут иметь как большое сходство, так и существенные различия. При отсутствии прямых сравнений в виде рандомизированных контролируемых исследований между препаратами - представителями одного класса, продемонстрировавших по отдельности свою эффективность, выбор наиболее эффективного с позиций доказательной медицины практически невозможен. Анализ наблюдательных исследований - крупных баз данных, регистров для выявления наиболее эффективного препарата в классе не может использоваться для решения проблемы первенства того или иного препарата внутри класса.

класс-эффект препаратоврандомизированные контролируемые исследованияпроблемы выбора препарата внутри классаclass effectrandomized controlled studiesproblems of drug choice within the same classБАЙЕР, АОBayer CompanyReferencesCollins R., MacMahon M. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet. 2001;357:373-80. doi:10.1016/S0140-6736(00)03651-5.Collins R., MacMahon M. Reliable assessment of the effects of treatment on mortality and major morbidity, I: clinical trials. Lancet. 2001;357:373-80. doi:10.1016/S0140-6736(00)03651-5.Рациональная фармакотерапия больных сердечно-сосудистыми заболеваниями. Российские рекомендации. Кардиоваскулярная Терапия и Профилактика. 2009;8(6) Приложение 4:1-56.Rational pharmacotherapy of patients with cardiovascular diseases. Russian guidelines. Cardiovascular Therapy and Prevention. 2009;8(6) suppl 4:1-56 (In Russ)Soares I., Carneiro A.V. Drug class effects: definitions and practical applications. Rev Port Cardiol. 2002;21:783-95.Soares I., Carneiro A.V. Drug class effects: definitions and practical applications. Rev Port Cardiol. 2002;21:783-95.Furberg C.D., Pitt B. Are All Angiotensin-Converting Enzyme Inhibitors Interchangeable? J Am Coll Cardiol. 2001;37:1 456-60. doi:10.1016/S0735-1097(01)01161-5.Furberg C.D., Pitt B. Are All Angiotensin-Converting Enzyme Inhibitors Interchangeable? J Am Coll Cardiol. 2001;37:1 456-60. doi:10.1016/S0735-1097(01)01161-5.Pocock S.J., Stone G.W. The Primary Outcome Fails - What Next? N Engl J Med. 2016;375:861-70. doi :10.1056/NEJMra1510064.Pocock S.J., Stone G.W. The Primary Outcome Fails - What Next? N Engl J Med. 2016;375:861 -70. doi :10.1056/NEJMra1510064.Марцевич С.Ю., Кутишенко Н.П., Толпыгина С.Н., и др. Эффектитвность и безопасность лекарственной терапии при первичной и вторичной профилактике сердечно-сосудистых заболеваний. Рекомендации ВНОК, 2011. Рациональная Фармакотерапия в Кардиологии. 2011 ;7(5) приложением -72. doi:10.20996/1819-64462011-7-5.Martsevich S.Yu., Kutishenko N.P., Tolpygina S.N., et al. Efficacy and safety of drug therapy in primary and secondary prevention of cardiovascular diseases. RSSC Guidelines, 2011. Rational Pharmacotherapy in Cardiology 2011 ;7(5) suppl:1 -72 (In Russ.) doi:10.20996/1819-64462011-7-5.O'Gara P.T., Kushner F.G., Ascheim D.D., et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61 (4):e78-140. doi:10.1016/j.jacc.2012.11.019.O'Gara P.T., Kushner F.G., Ascheim D.D., et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013;61 (4):e78-140. doi:10.1016/j.jacc.2012.11.019.Pedersen T.R., Faergeman O., Kastelein J.J., et al.; Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005;294(19):2437-45. doi:10.1001/jama.294.19.2437.Pedersen T.R., Faergeman O., Kastelein J.J., et al.; Incremental Decrease in End Points Through Aggressive Lipid Lowering (IDEAL) Study Group. High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction: the IDEAL study: a randomized controlled trial. JAMA. 2005;294(19):2437-45. doi:10.1001/jama.294.19.2437.Connolly S.J., Ezekowitz M.D., Yusuf S., et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(1 2):1 1 39-51. doi:10.1056/NEJMoa0905561.Connolly S.J., Ezekowitz M.D., Yusuf S., et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(1 2):1 1 39-51. doi:10.1056/NEJMoa0905561.Patel M.R., Mahaffey K.W., Garg J., et al. Riva roxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 ;365(10):883-891. doi:10.1056/NEJMoa1 009638.Patel M.R., Mahaffey K.W., Garg J., et al. Riva roxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 ;365(10):883-891. doi:10.1056/NEJMoa1009638.Granger C.B., Alexander J.H., McMurray J.J.V., et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011 ;365(1 1 ):981 -92. doi:10.1056/NEJMoa1107039.Granger C.B., Alexander J.H., McMurray J.J.V., et al. Apixaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med. 2011 ;365(1 1 ):981 -92. doi:10.1056/NEJMoa1107039.Марцевич С.Ю., Кутишенко Н.П. Рандомизированные клинические исследования и наблюдательные исследования: соотношение в иерархии доказательств эффективности терапии. Рациональная Фармакотерапия в Кардиологии. 2016;1 2(5):567-73. doi:10.20996/1819-6446-2016-12-5-567-573.Martsevich S.Y, Kutishenko N.P. Randomised Clinical Trials and Observational Studies: the Ratio in the Hierarchy of Evidence of the Efficacy of Drugs. Rational Pharmacotherapy in Cardiology 2016;1 2(5):567-73. (In Russ.) doi:10.20996/1819-6446-2016-12-5-567-573.. Camm J., Fox K., Peterson E. Challenges in comparing the non-vitamin K antagonist oral anticoagulants for atrial fibrillation-related stroke prevention. Europace. 2018;20(1 ):1-11.doi:10.1093/eu-ropace/eux086.. Camm J., Fox K., Peterson E. Challenges in comparing the non-vitamin K antagonist oral anticoagulants for atrial fibrillation-related stroke prevention. Europace. 2018;20(1 ):1-11. doi:10.1093/eu-ropace/eux086.Harris M., Taylor G., Jackson D. Clinical Evidence Made Easy: The Basics of Evidence-Based Medicine. Banbury, UK: Scion Publishing Limited; 2014.Harris M., Taylor G., Jackson D. Clinical Evidence Made Easy: The Basics of Evidence-Based Medicine. Banbury, UK: Scion Publishing Limited; 2014.Bakhai A., Patel S., Wang D. Blinding. In: Wang D., Bakhai A., eds. Clinical trials. A practical guide to design, analysis, and reporting. London, UK: Remedica; 2006: 75-87.Bakhai A., Patel S., Wang D. Blinding. In: Wang D., Bakhai A., eds. Clinical trials. A practical guide to design, analysis, and reporting. London, UK: Remedica; 2006: 75-87.Wang D., Bakhai A., eds. Clinical trials. A practical guide to design, analysis and reporting. London, UK: Remedica; 2006.Wang D., Bakhai A., eds. Clinical trials. A practical guide to design, analysis and reporting. London, UK: Remedica; 2006.Al-Lamee R., Thompson D., Dehbi H.M. et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391 (1 01 1 5):31 -40. doi:10.1016/S0140-6736(17)32714-9.Al-Lamee R., Thompson D., Dehbi H.M. et al. Percutaneous coronary intervention in stable angina (ORBITA): a double-blind, randomised controlled trial. Lancet. 2018;391 (1 01 1 5):31 -40. doi:10.1016/S0140-6736(17)32714-9.Acharjee S., Teo K.K., Jacobs A.K., et al. Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: A pre-specified subset analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial. Am Heart J. 2016;1 73:1 08-1 7. doi:10.1016/j.ahj.2015.07.020.Acharjee S., Teo K.K., Jacobs A.K., et al. Optimal medical therapy with or without percutaneous coronary intervention in women with stable coronary disease: A pre-specified subset analysis of the Clinical Outcomes Utilizing Revascularization and Aggressive druG Evaluation (COURAGE) trial. Am Heart J. 2016;1 73:108-17. doi:10.1016/j.ahj.2015.07.020.Марцевич С.Ю., Навасардян А.Р, Захарова Н.А., Лукьянов М.М. Новые оральные антикоагулянты: можно ли результаты международных контролируемых исследований с этими препаратами переносить на российских больных? Кардиоваскулярная Терапия и Профилактика. 2015;14:48-52. doi :10.15829/1728-8800-2015-5-48-52.Martsevich S.Yu., Navasardyan A.R., Zakharova N.A., Lukyanov M.M. New oral anticoagulants: can the results of international controlled studies with these drugs be transferred to Russian patients? Cardiovascular Therapy and Prevention. 2015;14:48-52 (In Russ.) doi :10.15829/1728-8800-2015-5-48-52.Andrade J.G., Krahn A.D., Skanes A.C., et al. Values and preferences of physicians and patients with nonvalvular atrial fibrillation who receive oral anticoagulation therapy for stroke prevention. Can J Cardiol. 2016;32(6):747-53. doi:10.1016/j.cjca.2015.09.023.Andrade J.G., Krahn A.D., Skanes A.C., et al. Values and preferences of physicians and patients with nonvalvular atrial fibrillation who receive oral anticoagulation therapy for stroke prevention. Can J Cardiol. 2016;32(6):747-53. doi:10.1016/j.cjca.2015.09.023.Camm A.J., Amarenco P., Hess S., et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016;37:1145-53. doi: 10.1093/eurheartj/ehv466.Camm A.J., Amarenco P., Hess S., et al. XANTUS: a real-world, prospective, observational study of patients treated with rivaroxaban for stroke prevention in atrial fibrillation. Eur Heart J. 2016;37:1 145-53. doi: 10.1093/eurheartj/ehv466.Larsen T.B., Skjoth F, Nielsen P.B., et al. Comparative effectiveness and safety of non-vitamin K antagonists oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted cohort study. BMJ. 2016;353:i3189.Larsen T.B., Skjoth F, Nielsen P.B., et al. Comparative effectiveness and safety of non-vitamin K antagonists oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted cohort study. BMJ. 2016;353:i3189.Collaborative meta-analysis or randomized trials of antiplatalet therapy for prevention of death, myocardial infarction, and stroke in high-risk patients. BMJ. 2002;324:71-86. doi:10.1136/bmj.324.7329.71.Collaborative meta-analysis or randomized trials of antiplatalet therapy for prevention of death, myocardial infarction, and stroke in high-risk patients. BMJ. 2002;324:71-86. doi:10.1136/bmj.324.7329.71.

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