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

Abstract

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.