Are Generic Drugs Used in Cardiology as Effective and Safe as their Brand-name Counterparts? A Systematic Review and Meta-analysis

Leclerc, Jacinthe; Thibault, Magalie; Gonella, Jennifer Midiani; Beaudoin, Claudia; Sampalis, John S.

doi:10.1007/s40265-020-01296-x

Cited by 13 publications

(15 citation statements)

References 60 publications

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“…Several systematic reviews and meta-analyses have compared the clinical characteristics of generics and originator products used for cardiovascular diseases (CVD) and showed no superiority of the latter over the former. Nonetheless, heterogeneities remained between studies, and most studies included were bioequivalence trials ( Kesselheim et al, 2008 ; Manzoli et al, 2016 ; Leclerc et al, 2020 ). Although several observational studies have investigated the clinical equivalence of generics to originator products, they demonstrated ambiguous results ( Kesselheim et al, 2008 ; Manzoli et al, 2016 ; Desai et al, 2019 ; Leclerc et al, 2020 ).…”

Section: Introductionmentioning

confidence: 99%

“…Nonetheless, heterogeneities remained between studies, and most studies included were bioequivalence trials ( Kesselheim et al, 2008 ; Manzoli et al, 2016 ; Leclerc et al, 2020 ). Although several observational studies have investigated the clinical equivalence of generics to originator products, they demonstrated ambiguous results ( Kesselheim et al, 2008 ; Manzoli et al, 2016 ; Desai et al, 2019 ; Leclerc et al, 2020 ). Given a lack of real-world evidence, many patients still perceived generics as less clinically effective and safe with the belief that being cheap implied being inferior ( Babar et al, 2011 ; Ngo et al, 2013 ; Dunne and Dunne, 2015 ; Toverud et al, 2015 ).…”

Section: Introductionmentioning

confidence: 99%

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Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China

et al. 2022

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Background: The substitution of generic drugs can effectively alleviate the rapid growth of drug costs; however, the clinical effectiveness and medical costs of originator products and generics were barely studied in China.Objectives: To compare the effectiveness of antihypertensive drugs and hypertension-related medical costs between originator and generic initiators in Yinzhou, China.Methods: We conducted a population-based retrospective cohort study using the Chinese Electronic Health Records Research in Yinzhou (CHERRY), from July 1, 2011, to December 31, 2018. Hypertension patients initiating with originator products were compared with patients initiating with generic counterparts. We used 1:1 propensity score matching to pair the two groups based on sociodemographic, clinical, and health service utilization variables. Cox proportional regression was adopted to compare the rate of hospitalization for hypertension-related cardiovascular disease between matched originator and generic initiators. Wilcoxon matched-pairs signed-rank test was used to compare annual hypertension-related medical costs.Results: Matched pairs (10,535) of patients were included in the comparative study of originator products and generics, corresponding to seven antihypertensive drugs including amlodipine, felodipine, nifedipine, irbesartan, losartan, valsartan, and metoprolol. The average age of patients included in the analysis was around 60 years (originator vs. generics initiators: from 59.0 vs. 59.1 years in losartan to 62.9 vs. 63.6 years in nifedipine). Higher hospitalization rates among originator initiators were observed for three calcium channel blockers (hazard ratio[95% CI]: amlodipine, 3.18[1.43, 7.11]; felodipine, 3.60[1.63, 7.98]; and nifedipine, 3.86[1.26, 11.81]; respectively). The remaining four out of seven drugs of the clinical endpoint estimates showed comparable outcomes between originator products and generics (hazard ratio[95% CI]: irbesartan, 1.19[0.50, 2.84]; losartan, 1.84[0.84, 4.07]; valsartan, 2.04[0.72, 5.78]; and metoprolol, 1.25[0.56, 2.80]; respectively). Higher median annual hypertension-related medical costs were observed in originator initiators (all p < 0.001), except for metoprolol (p = 0.646).Conclusion: We observed comparable or even better clinical outcomes and less medical cost associated with the use of antihypertensive generics compared to originator counterparts. This could help increase patient and provider confidence in the efficacy of generic medicines to manage hypertension diseases.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China

et al. 2022

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“…Пациенты Величина эффекта (95% ДИ) 0,00 (-0,24-0,25) -0,03 (-0,28-0,22) 0,00 (-0,53-0,53) 0,21 (-0,19-0,61) -0,09 (-0,68-0,50) -0,25 (-0,62-0,12) 0,06 (-0,37-0,50) -0,09 (-0,33-0,15) Самый последний систематический обзор по сравнению эффективности и безопасности генериков и оригинальных кардиоваскулярных препаратов включал 72 исследования (за период с 1984 по 2018 г.) с участием более 1 млн пациен тов (средний возраст 65±10 лет), и его результаты несколь ко отличались от предшествующих [12]. Наиболее частыми фармакологическими классами в анализе были антиагре ганты (клопидогрел, 20 РКИ), антикоагулянты (варфарин, 13 РКИ), статины (аторвастатин, симвастатин и другие, 16 РКИ), βадреноблокаторы (метопролол, бисопролол, карведилол, 7 РКИ), ИАПФ (эналаприл, периндоприл, рамиприл, 6 РКИ), блокаторы рецепторов ангиотензи на II -БРА (лозартан, валсартан, кандесартан, 5 РКИ), бло каторы кальциевых каналов (амлодипин, нифедипин, вера памил, 4 РКИ), антиаритмики (амиодарон, 1 РКИ), тиазиды (1 РКИ).…”

Section: исследованияunclassified

“…Метаанализ, оценивающий эффективность по частоте обращений в стационар и клиническому эффекту генерических и оригинальных препаратов, используемых при сердечно-сосудистых заболеваниях (адаптировано из[12]). …”

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Clinical equivalence of generic and brand-name drugs used in cardiology: what do we know?

Леонова

2021

Consilium Medicum

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The problem of using generics in the treatment of patients with cardiovascular diseases remains relevant for more than a decade. The concern of doctors, pharmacists and patients is not diminishing with the constant rise in cardiovascular morbidity and mortality worldwide. Based on a systematic review of 186 publications, physicians identified concerns about the quality, reliability and replaceability of original drugs; pharmacists have shown the highest level of generic approval. Patients distrust of generics was revealed, caused by a lack of information, concerns about packaging, and negative experience of replacing the original drug. Three meta-analyzes compared generic and original drugs of cardiovascular groups in terms of efficacy and safety. 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.

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“…A treating physician or prescriber would predominantly be interested in therapeutic equivalence for their individual patient. This presumed therapeutic equivalence is often debated, for instance for cardiovascular drugs [16,17] and drugs for psychiatric illness [18]. Nonetheless, no substantial differences in clinical outcomes were observed between patients who started treatment with either generic or brand-name warfarin [19].…”

Section: Key Pointsmentioning

confidence: 99%

Pharmacokinetics and Generic Drug Switching: A Regulator’s View

et al. 2020

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There appears to be a mismatch between the assumed therapeutic equivalence of generic drugs, their interchangeability, and reported clinical discomfort following generic drug use and drug switches. In this article, we describe why we are of the opinion that the current regulatory approach to the evaluation of generic drugs based on average bioequivalence is sufficient to expect therapeutic equivalence in the clinical setting. This has often been debated, specifically as adverse drug reactions related to generic drug switches are regularly reported. We agree that clinical discomfort during a bioequivalent drug switch may indeed be caused by different exposures to the active substance. However, this difference in exposure is not a result of the characteristics or quality of generic drugs; it is caused by the pharmacokinetic within-subject variability of the active substance, i.e., the variability on the bioavailability of the active substance, when comparing two occasions of administration of the same drug product, to the same patient. Therefore, reported clinical discomfort following generic drug use and drug switches does not warrant a change in the regulatory approach to the evaluation of the bioequivalence of generic drugs. Switching from a brand-name drug to currently approved generic drugs, or between different generic drugs, will in principle result in comparable exposure, within boundaries determined by the within-subject variability of the pharmacokinetics of the active substance involved.

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Are Generic Drugs Used in Cardiology as Effective and Safe as their Brand-name Counterparts? A Systematic Review and Meta-analysis

Cited by 13 publications

References 60 publications

Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China

Clinical Outcome and Medical Cost of Originator and Generic Antihypertensive Drugs: A Population-Based Study in Yinzhou, China

Clinical equivalence of generic and brand-name drugs used in cardiology: what do we know?

Pharmacokinetics and Generic Drug Switching: A Regulator’s View

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