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Клиническая эквивалентность генериков и оригинальных препаратов, применяемых в кардиологии: что нам известно?
Клиническая эквивалентность генериков и оригинальных препаратов, применяемых в кардиологии: что нам известно?
Леонова М.В. Клиническая эквивалентность генериков и оригинальных препаратов, применяемых в кардиологии: что нам известно? Consilium Medicum. 2021;23(12):920–927.
DOI: 10.26442/20751753.2021.12.201290
DOI: 10.26442/20751753.2021.12.201290
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Аннотация
Проблема использования генериков в лечении пациентов с сердечно-сосудистыми заболеваниями актуальна не одно десятилетие. Обеспокоенность врачей, фармацевтов и пациентов не уменьшается в связи с постоянным ростом сердечно-сосудистой заболеваемости и смертности в мире. По данным систематического обзора 186 публикаций, врачи выявили озабоченность по поводу качества, надежности и возможности замены оригинальных лекарственных средств; фармацевты показали наивысшую степень одобрения генериков. Было выявлено недоверие пациентов к генерикам, вызванное недостатком информации, опасениями относительно упаковки, наличием негативного опыта замены оригинального препарата. В трех метаанализах проведено сравнение генерических и оригинальных препаратов кардиоваскулярных групп по эффективности и безопасности. В метаанализе 2008 г. (47 исследований, 9 классов кардиоваскулярных препаратов) оценено влияние на мягкие исходы, в метаанализе 2016 г. (74 исследования, 7 классов препаратов) оценены еще и побочные эффекты. Совокупный эффект выявил небольшую и недостоверную разницу, что указывало на отсутствие превосходства оригинальных препаратов над генериками; не было выявлено различий по частоте и выраженности побочных эффектов между генериками и оригинальными препаратами. В метаанализе 2020 г. (72 исследования, 9 классов препаратов) проведена оценка частоты обращения в стационары (включая консультации в отделении неотложной помощи, госпитализацию) и выявлено достоверное увеличение риска для генериков по любой причине (на 14%), но не по сердечно-сосудистым заболеваниям. Обзор 8 когортных исследований по оценке антигипертензивных препаратов по отдаленным сердечно-сосудистым исходам, длительности удержания на терапии и эффекту замены не выявил существенных различий между генериками и брендами. В систематическом обзоре исследований по сравнению варфарина и генериков не выявлено достоверных различий по показателю международного нормализованного отношения и частоте тромбоэмболических и геморрагических осложнений; однако в одном исследовании частота посещений больниц была на 10% выше для генериков. В систематическом обзоре исследований по сравнению клопидогрела и генериков показана сопоставимость препаратов для основных сердечно-сосудистых событий и смертности. Обзор 5 когортных исследований по оценке оригинальных статинов и генериков показал сопоставимость по частоте общей смертности и главных сердечно-сосудистых событий, кроме одного исследования с противоположными результатами. Метаанализы и крупные наблюдательные исследования свидетельствуют, что генерики имеют не худшую эффективность, иногда даже превосходят таковую оригинальных препаратов и могут оправданно применяться в клинической практике.
Ключевые слова: кардиоваскулярные препараты, генерики, метаанализы, когортные исследования, эквивалентность, мягкие исходы, отдаленные исходы
A 2008 meta-analysis (47 studies, 9 classes of cardiovascular drugs) assessed the effect on mild outcomes, a 2016 meta-analysis (74 studies, 7 classes of drugs) also assessed side effects. The cumulative effect revealed a small and nonsignificant difference, which indicated that there was no superiority of original drugs over generics; there were no differences in the frequency and severity of side effects between generics and original drugs. A 2020 meta-analysis (72 studies, 9 drug classes) assessed the frequency of hospital admissions (including emergency department consultations, hospitalizations) and found a significant increase in the risk for generics for any reason (14%), but not for cardiac vascular diseases. A review of 8 cohort studies evaluating antihypertensive drugs for long-term cardiovascular outcomes, duration of retention, and substitution effect did not find significant differences between generics and brands. In a systematic review of studies comparing warfarin and generics, there were no significant differences in international normalized ratio and the incidence of thromboembolic and hemorrhagic complications; however, in one study, the frequency of hospital visits was 10% higher for generics. A systematic review of studies comparing clopidogrel versus generics shows drug comparability for major cardiovascular events and mortality. A review of 5 cohort studies evaluating originator statins and generics showed comparable rates of all-cause mortality and major cardiovascular events, except for one study with conflicting results. Meta-analyzes and large observational studies indicate that generics are not the worst efficacy, sometimes even surpass that of original drugs and can be justifiably used in clinical practice.
Keywords: cardiovascular drugs, generics, meta-analyzes, cohort studies, equivalence, mild outcomes, long-term outcomes
Ключевые слова: кардиоваскулярные препараты, генерики, метаанализы, когортные исследования, эквивалентность, мягкие исходы, отдаленные исходы
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A 2008 meta-analysis (47 studies, 9 classes of cardiovascular drugs) assessed the effect on mild outcomes, a 2016 meta-analysis (74 studies, 7 classes of drugs) also assessed side effects. The cumulative effect revealed a small and nonsignificant difference, which indicated that there was no superiority of original drugs over generics; there were no differences in the frequency and severity of side effects between generics and original drugs. A 2020 meta-analysis (72 studies, 9 drug classes) assessed the frequency of hospital admissions (including emergency department consultations, hospitalizations) and found a significant increase in the risk for generics for any reason (14%), but not for cardiac vascular diseases. A review of 8 cohort studies evaluating antihypertensive drugs for long-term cardiovascular outcomes, duration of retention, and substitution effect did not find significant differences between generics and brands. In a systematic review of studies comparing warfarin and generics, there were no significant differences in international normalized ratio and the incidence of thromboembolic and hemorrhagic complications; however, in one study, the frequency of hospital visits was 10% higher for generics. A systematic review of studies comparing clopidogrel versus generics shows drug comparability for major cardiovascular events and mortality. A review of 5 cohort studies evaluating originator statins and generics showed comparable rates of all-cause mortality and major cardiovascular events, except for one study with conflicting results. Meta-analyzes and large observational studies indicate that generics are not the worst efficacy, sometimes even surpass that of original drugs and can be justifiably used in clinical practice.
Keywords: cardiovascular drugs, generics, meta-analyzes, cohort studies, equivalence, mild outcomes, long-term outcomes
Полный текст
Список литературы
1. World Health Organization (WHO). Generic drugs. Geneva: WHO, 2015.
2. US Food and Drug Administration (FDA). Generic drugs. Silver Spring, MD: FDA, 2008. Approval of generic drugs.
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8. Dunne SS. What Do Users of Generic Medicines Think of Them? A systematic review of consumers’ and patients’ perceptions of, and experiences with, generic medicines. Patient. 2016;9(6):499-510. DOI:10.1007/s40271-016-0176-x
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11. Manzoli L, Flacco ME, Boccia S, et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol. 2016;31(4):351-68. DOI:10.1007/s10654-015-0104-8
12. Leclerc J, Thibault M, Gonella JM, et al. Are generic drugs used in cardiology as effective and safe as their brand-name counterparts? A systematic review and meta-analysis. Drugs. 2020;80(7):697-710. DOI:10.1007/s40265-020-01296-x
13. Corrao G, Soranna D, Merlino L, Mancia G. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study. Eur J Clin Invest. 2014;44(10):933-9. DOI:10.1111/eci.12326
14. Corrao G, Soranna D, La Vecchia C, et al. Medication persistence and the use of generic and brand-name blood pressure-lowering agents. J Hypertens. 2014;32(5):1146-53; discussion 1153. DOI:10.1097/HJH.0000000000000130
15. Desai RJ, Sarpatwari A, Dejene S, et al. Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019;16(3):e1002763. DOI:10.1371/journal.pmed.1002763
16. Zhang SY, Tao LY, Yang YY, et al. Evaluation of blood pressure lowering effect by generic and brand-name antihypertensive drugs treatment: a multicenter prospective study in China. Chin Med J (Engl). 2021;134(3):292-301. DOI:10.1097/CM9.0000000000001360
17. Leclerc J, Blais C, Rochette L, et al. Impact of the Commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec, Canada: a population-based time series analysis. Circ Cardiovasc Qual Outcomes. 2017;10(10):e003891. DOI:10.1161/CIRCOUTCOMES.117.003891
18. Leclerc J, Blais C, Rochette L, et al. Public health outcomes may differ after switching from brand-name to generic angiotensin II receptor blockers. Drugs R D. 2020;20(2):135-45. DOI:10.1007/s40268-020-00307-2
19. Tian Y, Reichardt B, Dunkler D, et al. Comparative effectiveness of branded vs. generic versions of antihypertensive, lipid-lowering and hypoglycemic substances: a population-wide cohort study. Sci Rep. 2020;10(1):5964. DOI:10.1038/s41598-020-62318-y
20. Hansen RA, Qian J, Berg R, et al. Comparison of generic-to-brand switchback rates between generic and authorized generic drugs. Pharmacotherapy. 2017;37(4):429-37. DOI:10.1002/phar.1908
21. Desai RJ, Sarpatwari A, Dejene S, et al. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018;361:k1180. DOI:10.1136/bmj.k1180
22. Dentali F, Donadini MP, Clark N, et al. Brand name versus generic warfarin: a systematic review of the literature. Pharmacotherapy. 2011;31(4):386-93. DOI:10.1592/phco.31.4.386
23. Leclerc J, Blais C, Rochette L, et al. Trends in hospital visits for generic and brand-name warfarin users in Québec, Canada; a population-based time series analysis. Am J Cardiovasc Drugs. 2019;19(3):287-97. DOI:10.1007/s40256-018-0309-9
24. Caldeira D, Fernandes RM, Costa J, et al. Branded versus generic clopidogrel in cardiovascular diseases: a systematic review. J Cardiovasc Pharmacol. 2013;61(4):277-82. DOI:10.1097/FJC.0b013e31827e5c60
25. Ko DT, Krumholz HM, Tu JV, et al. Clinical outcomes of Plavix and generic clopidogrel for patients hospitalized with an acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2018;11(3):e004194. DOI:10.1161/CIRCOUTCOMES.117.004194
26. Corrao G, Soranna D, Arfè A, et al. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base. Eur J Intern Med. 2014;25(8):745-50. DOI:10.1016/j.ejim.2014.08.002
27. Jackevicius CA, Tu JV, Krumholz HM, et al. Comparative effectiveness of generic Atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome. J Am Heart Assoc. 2016;5(4):e003350. DOI:10.1161/JAHA.116.003350
28. Sicras-Mainar A, Sánchez-Álvarez L, Navarro-Artieda R, Darbà J. Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis. Lipids Health Dis. 2018;17(1):277. DOI:10.1186/s12944-018-0918-y
29. Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-7. DOI:10.7326/M13-2942
30. Roth GA, Mensah GA, Johnson CO, et al.; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global burden of cardiovascular diseases and risk factors, 1990–2019: Update from the GBD 2019 Study. JACC. 2020;76(25):2982-3021. DOI:10.1016/j.jacc.2020.11.010
31. Aitken M, Kleinrock M. Global medicines use in 2020: outlook and implications. USA: Parsippany, New Jersey, 2015.
2. US Food and Drug Administration (FDA). Generic drugs. Silver Spring, MD: FDA, 2008. Approval of generic drugs.
3. European Medicines Agency (EMA). Questions and answers on generic medicines. Canary Wharf: EMA, 2011.
4. World Health Organization (WHO). WHO drug information. Vol. 28, No. 1. Geneva: WHO, 2014. Available at: https://www.who.int/medicines/publications/druginformation/DI_28-1_web.pdf?ua=1. Accessed: 21.06.2015.
5. Cameron A, Mantel-Teeuwisse AK, Leufkens HGM, Laing RO. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health. 2012;15(5):664-73. DOI:10.1016/j.jval.2012.04.004
6. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14:1. DOI:10.1186/2050-6511-14-1
7. Dunne SS, Dunne CP. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Med. 2015;13:173. DOI:10.1186/s12916-015-0415-3
8. Dunne SS. What Do Users of Generic Medicines Think of Them? A systematic review of consumers’ and patients’ perceptions of, and experiences with, generic medicines. Patient. 2016;9(6):499-510. DOI:10.1007/s40271-016-0176-x
9. Colgan S, Faasse K, Martin LR, et al. Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. BMJ Open. 2015;5(12):e008915. DOI:10.1136/bmjopen-2015-008915
10. Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21):2514-26. DOI:10.1001/jama.2008.758
11. Manzoli L, Flacco ME, Boccia S, et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol. 2016;31(4):351-68. DOI:10.1007/s10654-015-0104-8
12. Leclerc J, Thibault M, Gonella JM, et al. Are generic drugs used in cardiology as effective and safe as their brand-name counterparts? A systematic review and meta-analysis. Drugs. 2020;80(7):697-710. DOI:10.1007/s40265-020-01296-x
13. Corrao G, Soranna D, Merlino L, Mancia G. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study. Eur J Clin Invest. 2014;44(10):933-9. DOI:10.1111/eci.12326
14. Corrao G, Soranna D, La Vecchia C, et al. Medication persistence and the use of generic and brand-name blood pressure-lowering agents. J Hypertens. 2014;32(5):1146-53; discussion 1153. DOI:10.1097/HJH.0000000000000130
15. Desai RJ, Sarpatwari A, Dejene S, et al. Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019;16(3):e1002763. DOI:10.1371/journal.pmed.1002763
16. Zhang SY, Tao LY, Yang YY, et al. Evaluation of blood pressure lowering effect by generic and brand-name antihypertensive drugs treatment: a multicenter prospective study in China. Chin Med J (Engl). 2021;134(3):292-301. DOI:10.1097/CM9.0000000000001360
17. Leclerc J, Blais C, Rochette L, et al. Impact of the Commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec, Canada: a population-based time series analysis. Circ Cardiovasc Qual Outcomes. 2017;10(10):e003891. DOI:10.1161/CIRCOUTCOMES.117.003891
18. Leclerc J, Blais C, Rochette L, et al. Public health outcomes may differ after switching from brand-name to generic angiotensin II receptor blockers. Drugs R D. 2020;20(2):135-45. DOI:10.1007/s40268-020-00307-2
19. Tian Y, Reichardt B, Dunkler D, et al. Comparative effectiveness of branded vs. generic versions of antihypertensive, lipid-lowering and hypoglycemic substances: a population-wide cohort study. Sci Rep. 2020;10(1):5964. DOI:10.1038/s41598-020-62318-y
20. Hansen RA, Qian J, Berg R, et al. Comparison of generic-to-brand switchback rates between generic and authorized generic drugs. Pharmacotherapy. 2017;37(4):429-37. DOI:10.1002/phar.1908
21. Desai RJ, Sarpatwari A, Dejene S, et al. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018;361:k1180. DOI:10.1136/bmj.k1180
22. Dentali F, Donadini MP, Clark N, et al. Brand name versus generic warfarin: a systematic review of the literature. Pharmacotherapy. 2011;31(4):386-93. DOI:10.1592/phco.31.4.386
23. Leclerc J, Blais C, Rochette L, et al. Trends in hospital visits for generic and brand-name warfarin users in Québec, Canada; a population-based time series analysis. Am J Cardiovasc Drugs. 2019;19(3):287-97. DOI:10.1007/s40256-018-0309-9
24. Caldeira D, Fernandes RM, Costa J, et al. Branded versus generic clopidogrel in cardiovascular diseases: a systematic review. J Cardiovasc Pharmacol. 2013;61(4):277-82. DOI:10.1097/FJC.0b013e31827e5c60
25. Ko DT, Krumholz HM, Tu JV, et al. Clinical outcomes of Plavix and generic clopidogrel for patients hospitalized with an acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2018;11(3):e004194. DOI:10.1161/CIRCOUTCOMES.117.004194
26. Corrao G, Soranna D, Arfè A, et al. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base. Eur J Intern Med. 2014;25(8):745-50. DOI:10.1016/j.ejim.2014.08.002
27. Jackevicius CA, Tu JV, Krumholz HM, et al. Comparative effectiveness of generic Atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome. J Am Heart Assoc. 2016;5(4):e003350. DOI:10.1161/JAHA.116.003350
28. Sicras-Mainar A, Sánchez-Álvarez L, Navarro-Artieda R, Darbà J. Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis. Lipids Health Dis. 2018;17(1):277. DOI:10.1186/s12944-018-0918-y
29. Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-7. DOI:10.7326/M13-2942
30. Roth GA, Mensah GA, Johnson CO, et al.; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global burden of cardiovascular diseases and risk factors, 1990–2019: Update from the GBD 2019 Study. JACC. 2020;76(25):2982-3021. DOI:10.1016/j.jacc.2020.11.010
31. Aitken M, Kleinrock M. Global medicines use in 2020: outlook and implications. USA: Parsippany, New Jersey, 2015.
2. US Food and Drug Administration (FDA). Generic drugs. Silver Spring, MD: FDA, 2008. Approval of generic drugs.
3. European Medicines Agency (EMA). Questions and answers on generic medicines. Canary Wharf: EMA, 2011.
4. World Health Organization (WHO). WHO drug information. Vol. 28, No. 1. Geneva: WHO, 2014. Available at: https://www.who.int/medicines/publications/druginformation/DI_28-1_web.pdf?ua=1. Accessed: 21.06.2015.
5. Cameron A, Mantel-Teeuwisse AK, Leufkens HGM, Laing RO. Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health. 2012;15(5):664-73. DOI:10.1016/j.jval.2012.04.004
6. Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14:1. DOI:10.1186/2050-6511-14-1
7. Dunne SS, Dunne CP. What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs. BMC Med. 2015;13:173. DOI:10.1186/s12916-015-0415-3
8. Dunne SS. What Do Users of Generic Medicines Think of Them? A systematic review of consumers’ and patients’ perceptions of, and experiences with, generic medicines. Patient. 2016;9(6):499-510. DOI:10.1007/s40271-016-0176-x
9. Colgan S, Faasse K, Martin LR, et al. Perceptions of generic medication in the general population, doctors and pharmacists: a systematic review. BMJ Open. 2015;5(12):e008915. DOI:10.1136/bmjopen-2015-008915
10. Kesselheim AS, Misono AS, Lee JL, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21):2514-26. DOI:10.1001/jama.2008.758
11. Manzoli L, Flacco ME, Boccia S, et al. Generic versus brand-name drugs used in cardiovascular diseases. Eur J Epidemiol. 2016;31(4):351-68. DOI:10.1007/s10654-015-0104-8
12. Leclerc J, Thibault M, Gonella JM, et al. Are generic drugs used in cardiology as effective and safe as their brand-name counterparts? A systematic review and meta-analysis. Drugs. 2020;80(7):697-710. DOI:10.1007/s40265-020-01296-x
13. Corrao G, Soranna D, Merlino L, Mancia G. Similarity between generic and brand-name antihypertensive drugs for primary prevention of cardiovascular disease: evidence from a large population-based study. Eur J Clin Invest. 2014;44(10):933-9. DOI:10.1111/eci.12326
14. Corrao G, Soranna D, La Vecchia C, et al. Medication persistence and the use of generic and brand-name blood pressure-lowering agents. J Hypertens. 2014;32(5):1146-53; discussion 1153. DOI:10.1097/HJH.0000000000000130
15. Desai RJ, Sarpatwari A, Dejene S, et al. Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims. PLoS Med. 2019;16(3):e1002763. DOI:10.1371/journal.pmed.1002763
16. Zhang SY, Tao LY, Yang YY, et al. Evaluation of blood pressure lowering effect by generic and brand-name antihypertensive drugs treatment: a multicenter prospective study in China. Chin Med J (Engl). 2021;134(3):292-301. DOI:10.1097/CM9.0000000000001360
17. Leclerc J, Blais C, Rochette L, et al. Impact of the Commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec, Canada: a population-based time series analysis. Circ Cardiovasc Qual Outcomes. 2017;10(10):e003891. DOI:10.1161/CIRCOUTCOMES.117.003891
18. Leclerc J, Blais C, Rochette L, et al. Public health outcomes may differ after switching from brand-name to generic angiotensin II receptor blockers. Drugs R D. 2020;20(2):135-45. DOI:10.1007/s40268-020-00307-2
19. Tian Y, Reichardt B, Dunkler D, et al. Comparative effectiveness of branded vs. generic versions of antihypertensive, lipid-lowering and hypoglycemic substances: a population-wide cohort study. Sci Rep. 2020;10(1):5964. DOI:10.1038/s41598-020-62318-y
20. Hansen RA, Qian J, Berg R, et al. Comparison of generic-to-brand switchback rates between generic and authorized generic drugs. Pharmacotherapy. 2017;37(4):429-37. DOI:10.1002/phar.1908
21. Desai RJ, Sarpatwari A, Dejene S, et al. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018;361:k1180. DOI:10.1136/bmj.k1180
22. Dentali F, Donadini MP, Clark N, et al. Brand name versus generic warfarin: a systematic review of the literature. Pharmacotherapy. 2011;31(4):386-93. DOI:10.1592/phco.31.4.386
23. Leclerc J, Blais C, Rochette L, et al. Trends in hospital visits for generic and brand-name warfarin users in Québec, Canada; a population-based time series analysis. Am J Cardiovasc Drugs. 2019;19(3):287-97. DOI:10.1007/s40256-018-0309-9
24. Caldeira D, Fernandes RM, Costa J, et al. Branded versus generic clopidogrel in cardiovascular diseases: a systematic review. J Cardiovasc Pharmacol. 2013;61(4):277-82. DOI:10.1097/FJC.0b013e31827e5c60
25. Ko DT, Krumholz HM, Tu JV, et al. Clinical outcomes of Plavix and generic clopidogrel for patients hospitalized with an acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2018;11(3):e004194. DOI:10.1161/CIRCOUTCOMES.117.004194
26. Corrao G, Soranna D, Arfè A, et al. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base. Eur J Intern Med. 2014;25(8):745-50. DOI:10.1016/j.ejim.2014.08.002
27. Jackevicius CA, Tu JV, Krumholz HM, et al. Comparative effectiveness of generic Atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome. J Am Heart Assoc. 2016;5(4):e003350. DOI:10.1161/JAHA.116.003350
28. Sicras-Mainar A, Sánchez-Álvarez L, Navarro-Artieda R, Darbà J. Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis. Lipids Health Dis. 2018;17(1):277. DOI:10.1186/s12944-018-0918-y
29. Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-7. DOI:10.7326/M13-2942
30. Roth GA, Mensah GA, Johnson CO, et al.; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global burden of cardiovascular diseases and risk factors, 1990–2019: Update from the GBD 2019 Study. JACC. 2020;76(25):2982-3021. DOI:10.1016/j.jacc.2020.11.010
31. Aitken M, Kleinrock M. Global medicines use in 2020: outlook and implications. USA: Parsippany, New Jersey, 2015.
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17. Leclerc J, Blais C, Rochette L, et al. Impact of the Commercialization of three generic angiotensin II receptor blockers on adverse events in Quebec, Canada: a population-based time series analysis. Circ Cardiovasc Qual Outcomes. 2017;10(10):e003891. DOI:10.1161/CIRCOUTCOMES.117.003891
18. Leclerc J, Blais C, Rochette L, et al. Public health outcomes may differ after switching from brand-name to generic angiotensin II receptor blockers. Drugs R D. 2020;20(2):135-45. DOI:10.1007/s40268-020-00307-2
19. Tian Y, Reichardt B, Dunkler D, et al. Comparative effectiveness of branded vs. generic versions of antihypertensive, lipid-lowering and hypoglycemic substances: a population-wide cohort study. Sci Rep. 2020;10(1):5964. DOI:10.1038/s41598-020-62318-y
20. Hansen RA, Qian J, Berg R, et al. Comparison of generic-to-brand switchback rates between generic and authorized generic drugs. Pharmacotherapy. 2017;37(4):429-37. DOI:10.1002/phar.1908
21. Desai RJ, Sarpatwari A, Dejene S, et al. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018;361:k1180. DOI:10.1136/bmj.k1180
22. Dentali F, Donadini MP, Clark N, et al. Brand name versus generic warfarin: a systematic review of the literature. Pharmacotherapy. 2011;31(4):386-93. DOI:10.1592/phco.31.4.386
23. Leclerc J, Blais C, Rochette L, et al. Trends in hospital visits for generic and brand-name warfarin users in Québec, Canada; a population-based time series analysis. Am J Cardiovasc Drugs. 2019;19(3):287-97. DOI:10.1007/s40256-018-0309-9
24. Caldeira D, Fernandes RM, Costa J, et al. Branded versus generic clopidogrel in cardiovascular diseases: a systematic review. J Cardiovasc Pharmacol. 2013;61(4):277-82. DOI:10.1097/FJC.0b013e31827e5c60
25. Ko DT, Krumholz HM, Tu JV, et al. Clinical outcomes of Plavix and generic clopidogrel for patients hospitalized with an acute coronary syndrome. Circ Cardiovasc Qual Outcomes. 2018;11(3):e004194. DOI:10.1161/CIRCOUTCOMES.117.004194
26. Corrao G, Soranna D, Arfè A, et al. Are generic and brand-name statins clinically equivalent? Evidence from a real data-base. Eur J Intern Med. 2014;25(8):745-50. DOI:10.1016/j.ejim.2014.08.002
27. Jackevicius CA, Tu JV, Krumholz HM, et al. Comparative effectiveness of generic Atorvastatin and Lipitor® in patients hospitalized with an acute coronary syndrome. J Am Heart Assoc. 2016;5(4):e003350. DOI:10.1161/JAHA.116.003350
28. Sicras-Mainar A, Sánchez-Álvarez L, Navarro-Artieda R, Darbà J. Treatment persistence and adherence and their consequences on patient outcomes of generic versus brand-name statins routinely used to treat high cholesterol levels in Spain: a retrospective cost-consequences analysis. Lipids Health Dis. 2018;17(1):277. DOI:10.1186/s12944-018-0918-y
29. Gagne JJ, Choudhry NK, Kesselheim AS, et al. Comparative effectiveness of generic and brand-name statins on patient outcomes: a cohort study. Ann Intern Med. 2014;161(6):400-7. DOI:10.7326/M13-2942
30. Roth GA, Mensah GA, Johnson CO, et al.; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global burden of cardiovascular diseases and risk factors, 1990–2019: Update from the GBD 2019 Study. JACC. 2020;76(25):2982-3021. DOI:10.1016/j.jacc.2020.11.010
31. Aitken M, Kleinrock M. Global medicines use in 2020: outlook and implications. USA: Parsippany, New Jersey, 2015.
Авторы
М.В. Леонова*
Межрегиональная общественная организация «Ассоциация клинических фармакологов», Москва, Россия
*anti23@mail.ru
Interregional Public Organization “Association of Clinical Pharmacologists”, Moscow, Russia
*anti23@mail.ru
Межрегиональная общественная организация «Ассоциация клинических фармакологов», Москва, Россия
*anti23@mail.ru
________________________________________________
Interregional Public Organization “Association of Clinical Pharmacologists”, Moscow, Russia
*anti23@mail.ru
Цель портала OmniDoctor – предоставление профессиональной информации врачам, провизорам и фармацевтам.