Background: The aim of the present interim analysis was to compare the
clinical efficacy and safety of the generic clopidogrel besylate (CB)
with the innovator clopidogrel hydrogen sulphate (CHS) salt in patient
groups eligible to receive clopidogrel.
Methods: A 2-arm, multicenter, open-label, phase IV clinical trial.
Consecutive patients (n=1,864) were screened and 1,800 were enrolled in
the trial and randomized to CHS (n=759) or CB (n=798). Primary efficacy
end point was the composite of myocardial infarction, stroke or death
from vascular causes. Primary safety end point was the rate of bleeding
events as defined by Bleeding Academic Research Consortium (BARC)
criteria.
Results: At 6-months follow-up no differences were observed between CB
and CHS in primary efficacy end point (OR, 0.80; 95% CI, 0.37 to 1.71;
p=0.57). Rates of BARC-1,-2,-3a and -5b bleeding were similar between
the two study groups whereas no bleeding events according to BARC-3b,
-3c, -4 and -5a were observed in either CHS or CB group.
Conclusion: The clinical efficacy and safety of the generic CB were
similar to those of the innovator CHS salt, thus this generic
clopidogrel formulation can be routinely used in the secondary
prevention of atherothrombotic events for a period of at least 6 months.
(Salts of Clopidogrel: Investigation to ENsure Clinical Equivalence,
SCIENCE study Clinical Trials.gov Identifier: NCT02126982)
