Comparison of effectiveness of branded and generic clopidogrel in patients with ST-elevation acute coronary syndrome on electrocardiogram

Abstract

INTRODUCTION: Assessment of the effect of generic antiplatelet drugs on the outcomes of the acute coronary syndrome (ACS) still remains an unresolved issue, especially in terms of modern therapy of the disease.

AIM: To assess therapeutic equivalence of the original and generic clopidogrel drug in patients with ST-elevation ACS (STE-ACS) during a three-year follow-up period.

MATERIALS AND METHODS: The pilot single-center open-label retrospective-prospective observational study between 2016 and 2018 included patients with STE-ASC (n = 94; mean age 59.98 ± 7.42 years; 68.3% of men). Inclusion criteria: signed informed consent, age from 25 to 70 years; confirmed STE-ACS with performed coronary angiography and coronary angioplasty; intake of clopidogrel (branded or generic). During hospitalization for STE-ACS, all patients received branded clopidogrel at a dose of 75 mg/day, after discharge, the patients were divided into two groups: the branded clopidogrel group (Plavix®; n = 63) and the generic clopidogrel group (Zilt®, Clopidogrel®; n = 31). For 1 year, patients took clopidogrel together with acetylsalicylic acid, then continued intake of acetylsalicylic acid as monotherapy. The median follow-up was 35.5 ± 3.4 months, the study response was 100%.

RESULTS: There were no statistically significant differences between the compared groups in all-cause mortality rate (overall mortality) and incidence of recurrent infarctions. At the same time, the frequency of recurrent ACS was lower in patients taking generic clopidogrel than in those taking branded clopidogrel (6.45% versus 26.98%, р < 0.05). The branded clopidogrel and generic drugs were well tolerated: no cases of bleeding or adverse events associated with intake of the antiplatelet drug, were recorded.

CONCLUSION: Generic clopidogrel preparations are not inferior to the branded drug in terms of efficacy and safety in patients with STE-ACS.

Keywords

clopidogrel / ST segment elevation acute coronary syndrome / ACS / STE-ACS / branded drug / generic drug

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Andreyeva AV, Filippov EV