ONCE AGAIN ABOUT THE HIERARCHY OF EVIDENCES IN MEDICINE OR WHETHER IT IS POSSIBLE TO CHOOSE THE MOST EFFECTIVE AND SAFE DRUG WITH THE HELP OF OBSERVATIONAL STUDIES
https://doi.org/10.20996/1819-6446-2017-13-2-270-274
Abstract
The role of randomized controlled trials (RCTs) and observational studies in evaluation of the efficacy and safety of drugs in cardiology is discussed. The possibility of using the results of non-interventional studies in accepting the decision to choose the most effective and safe drug is presented in more detail.
About the Authors
S. Y. Martsevich
State Research Center for Preventive Medicine
Russian Federation
Russian Federation
Sergey Y. Martsevich - MD, PhD, Professor, Head of Department of Preventive Pharmacotherapy
Petroverigsky per. 10, Moscow, 101990
Yu. V. Lukina
State Research Center for Preventive Medicine
Russian Federation
Russian Federation
Yulia V. Lukina - MD, PhD, Senior Researcher, Laboratory for Pharmacoepidemiological Studies, Department of Preventive Pharmacotherapy
Petroverigsky per. 10, Moscow, 101990
N. P. Kutishenko
State Research Center for Preventive Medicine
Russian Federation
Russian Federation
Natalia P. Kutishenko - MD, PhD, Head of Laboratory for Pharmacoepidemiological Studies, Department of Preventive Pharmacotherapy
Petroverigsky per. 10, Moscow, 101990
References
1. DiCenso A., Guyatt G., Ciliska D. Evidence-based nursing: a guide to clinical practice. Sydney: Elsevier Mosby; 2005.
2. Directive 2001/20/EC of the European Parlament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of c. 2001. Available at: http://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf. Checked by April 21, 2017.
3. On the circulation of medicines. Federal Law of the Russian Federation of 12.04.2010 N 61-FZ (edition of 02.06.2016). (In Russ.) [Об обращении лекарственных средств. Федеральный закон РФ от 12.04.2010 N 61-ФЗ (ред. от 02.06.2016)].
4. Gitt A.K., Bueno H., Danchin N., et al. The role of cardiac registries in evidence-based medicine. Eur Heart J. 2010;31(5):525-9.
5. Martsevich S.Yu., Kutishenko N.P. Randomized clinical trials and observational studies: the ratio in the hierarchy demonstrates the effectiveness of therapy. Rational Pharmacotherapy in Cardiology. 2016;12(5):567-73. (In Russ.) [Марцевич С.Ю., Кутишенко Н.П. Рандомизированные клинические исследования и наблюдательные исследования: соотношение в иерархии доказательствт эффективности терапии. Рациональная Фармакотерапия в Кардиологии. 2016;12(5):567-73].
6. Connolly S.J., Ezekowitz M.D., Yusuf S., et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361(12):1139-51.
7. Patel M.R., Mahaffey K.W., Garg J., et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365(10):883-91.
8. 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(11):981-92.
9. Tendera M., SyzdЧłM., Parma Z. ARISTOTLE RE-LYs on the ROCKET. What’s new in stroke prevention in patients with atrial fibrillation? Cardiol J. 2012;19(1):4-10.
10. Larsen T.B., Skjњth F., Nielsen P.B., et al. Comparative effectiveness and safety of non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2016;353:i3189.
11. Nielsen P.B., Skjњth F., Sњgaard M., et al. Effectiveness and safety of reduced dose non-vitamin K antagonist oral anticoagulants and warfarin in patients with atrial fibrillation: propensity weighted nationwide cohort study. BMJ. 2017;356:j510.
12. Oganesyan N.S., Dmitrieva N.A., Kochetkov A.M., Martsevich S.Yu. Features of diagnosis and secondary prevention of arterial hypertension according to the results of a survey of doctors. Rational Pharmacotherapy in Cardiology. 2006; (2): 37-43. (In Russ.) [Оганесян Н.С., Дмитриева Н.А., Кочетков А.М., Марцевич С.Ю. Особенности диагностики и вторичной профилактики артериальной гипертонии по результатам опроса врачей. Рациональная Фармакотерапия в Кардиологии. 2006;(2):37-43].
13. Ipsos Health care: Medical representatives have become leaders among the main sources of information about medicines for doctors. Farmatsevticheskiy Vestnik. 2017;(19.01.2017). Available at http://www.pharmvestnik.ru/publs/lenta/obzory/ipsos-healthcare-medpredstaviteli-vyshli-v-liderysredi-osnovnyx-istochnikov-informatsii.html. Checked by April 21, 2017 (In Russ.) [Ipsos Health care: медпредставители вышли в лидеры среди основных источников информации о лекарствах для врачей. Фармацевтический Вестник. 2017;(19.01.2017). Доступно на: http://www.pharmvestnik.ru/publs/lenta/obzory/ipsos-healthcare-medpredstaviteli-vyshli-v-liderysredi-osnovnyx-istochnikov-informatsii.html. Проверено 21.04.2017].
14. Wazana A. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA. 2000;283(3): 373-80.
15. Granger C.B., Gersh B.J. Clinical trials and registries in cardiovascular disease: competitive or complementary? Eur Heart J. 2010;31(5):520-1.
16. Graham D.J., Reichman M.E., Wernecke M., et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131(2):157-64.
17. Lindell-Osuagwu L., Korhonen M.J., Saano S., et al. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther. 2009;34(3): 277-287.
18. Breckenridge A., Aronson J.K., Blaschke T.F., et al. Poor medication adherence in clinical trials: consequences and solutions. Nat Rev Drug Discov. 2017;16(3):149-50.
19. Warren S.R., Raisch D.W., Campbell H.M., et al. Medication adherence assessment in a clinical trial with centralized follow-up and direct-to-patient drug shipments. Clin Trials. 2013;10(3):441-8.
20. Vrijens B., Urquhart J. Methods for Measuring, Enhancing, and Accounting for Medication Adherence in Clinical Trials. Clin Pharmacol Ther. 2014;95(6):617-26.
21. Volskaya E.A. Patient compliance. Review of trends in research. Remedium. 2013;(11):6-15. (In Russ.) [Вольская Е.А. Пациентский комплаенс. Обзор тенденций в исследованиях. Ремедиум. 2013;(11):6-15].
22. Ellis S., Shumaker S., Sieber W., Rand C. Adherence to pharmacological interventions. Current trends and future directions. The Pharmacological Intervention Working Group. Control Clin Trials. 2000;21(5 Suppl):218S-25S.
23. Urquhart J. How much compliance is enough? Pharm Res. 1996;13(1):10-1.
24. Wu J.R., Moser D.K., De Jong M.J., et al. Defining an evidence-based cutpoint for medication adherence in heart failure. Am Heart J. 2009;157(2):285-91.
25. Rodriguez R.A., Carrier M., Wells P.S. Non-adherence to new oral anticoagulants: a reason for concern during long-term anticoagulation? J Thromb Haemost. 2013;11(2):390-4.
26. German pharmacies - figures, data, facts 2016. ABDA - Fed Union Ger Assoc Pharm. 2016. Available at: https://www.abda.de/fileadmin/assets/ZDF/ZDF_2016/ABDA_ZDF_2016_Brosch_english.pdf. Checked by April 21, 2017.
27. Talks with pharmacists improve the patient’s therapy. ABDA - Fed Union Ger Assoc Pharm. 2016. Available at: https://www.abda.de/pressemitteilung/artikel/gespraeche-mit-apothekern-verbesserntherapietreueder-patienten/. Checked by April 21, 2017.
28. Aznar-Lou I., FernЗndez A., Gil-Girbau M., et al. Initial medication non-adherence: prevalence and predictive factors in a cohort of 1.6 million primary care patients. Br J Clin Pharmacol. 2017 Feb 23. doi: 10.1111/bcp.13215. [Epub ahead of print]
29. Fischer M.A., Stedman M.R, Lii J., et al. Primary medication non-adherence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010;25(4):284-90.
30. Hemkens L.G., Contopoulos-Ioannidis D.G., Ioannidis J.P.A. Routinely collected data and comparative effectiveness evidence: promises and limitations. CMAJ. 2016;188(8):E158-E164.
31. Bai Y., Deng H., Shantsila A., Lip G.Y.H. Rivaroxaban Versus Dabigatran or Warfarin in Real-World Studies of Stroke Prevention in Atrial Fibrillation. Stroke. 2017;48(4):970-6.
32. Shrier I., Boivin J.F., Steele R.J., et al. Should meta-analyses of interventions include observational studies in addition to randomized controlled trials? A critical examination of underlying principles. Am J Epidemiol. 2007;166(10):1203-9.
Review
For citations:
Martsevich S.Y., Lukina Yu.V., Kutishenko N.P. ONCE AGAIN ABOUT THE HIERARCHY OF EVIDENCES IN MEDICINE OR WHETHER IT IS POSSIBLE TO CHOOSE THE MOST EFFECTIVE AND SAFE DRUG WITH THE HELP OF OBSERVATIONAL STUDIES. Rational Pharmacotherapy in Cardiology. 2017;13(2):270-274. (In Russ.) https://doi.org/10.20996/1819-6446-2017-13-2-270-274
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