Matina Kouvari, Demosthenes B Panagiotakos, NG Patsourakos, A Kotidis, S Chantanis, K Kalantzi, M Tsoumani, A Kartalis, N Smyrnioudis, S Fousas, AD Tselepis
Aim: To evaluate the 6-month recurrent major adverse cardiac events (MACE) in acute coronary syndrome (ACS) patients, in relation to region and clopidogrel treatment separately for men and women. Material and Methods: During 2016, n=1,194 consecutive ACS patients hospitalized in various Cardiology Clinics in Aegean islands and Attica region, were enrolled. Clopidogrel treatment was recorded either as original product clopidogrel hydrogen sulphate (Plavix®/Iscover®) (branded) or clopidogrel besylate formulation (generic). Six-month follow-up evaluation was performed and recurrent MACE incidence and hemorrhage event were recorded. Results: The 6-month MACE incidence was 3.9% (4.6% in Aegean islands and 3.5% in Attica area, p>0.05). The respective incidence in men was 4.0% and in women 3.8% (p>0.05). Overall generic and branded clopidogrel use was 87% and 13%, respectively. No significant differences were observed between branded and generic clopidogrel use and 6-month MACE incidence, subgroup analysis with gender as strata, did not reveal any significant outcomes as well. Hemorrhage incidence did not exceed the 1% in the total sample. Conclusions: The low incidence of recurrent MACE in ACS patients along with the low rate of bleeding events, irrespective of type of clopidogrel used, support the clinical and safety equivalence of generic and branded clopidogrel in the cardiac rehabilitation of ACS men and women patients.
Keywords: clopidogrel besylate, acute coronary syndrome, cardiovascular disease, generic clopidogrel, gender, secondary prevention