Περίληψη:
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).
Συγγραφείς:
Ntalas, Ioannis V.
Kalantzi, Kalliroi I.
Tsoumani, Maria E. and
Vakalis, John N.
Vasilakopoulos, Vasileios
Vardakis,
Konstantinos
Vemmos, Konstantinos N.
Voukelatou, Maria and
Giannakoulas, Georgios
Giatrakos, Ioannis
Giogiakas, Vasileios
and Goumas, Georgios
Dimoulis, Nikos
Draganigos, Antonios and
Efthimiadis, Ioannis
Thoma, Maria
Kazakos, Evangelos and
Kipouridis, Nikolaos
Konstantinou, Spiros
Milionis, Haralampos
and Bourdakis, Adamantios
Nikolopoulos, Dimitrios
Peltekis,
Leonidas
Prokopakis, Nikos
Sinteles, Ioannis
Stroumbis,
Christos S.
Terzoudi, Kyriafina
Tsilias, Karmelos
Xaraktsis,
Ioannis
Charmpas, Christos
Hatziathanasiou, Georgios and
Christogiannis, Zacharias
Panagiotakos, Demosthenes B. and
Goudevenos, John A.
Tselepis, Alexandros D.
