The incidence of recurrent cardiovascular events among acute coronary syndrome patients treated with generic or original clopidogrel in relation to their sociodemographic and clinical characteristics. The Aegean study.

INTRODUCTION: The use of generic drugs is continuously growing; however, there are limited epidemiological data regarding the therapeutic equivalence of each original drug formulation with its generic counterparts. We evaluated the 12-month composite endpoint of recurrent acute myocardial infarction, ischaemic stroke, cardiac deaths, or hospitalisation due to a major bleeding in acute coronary syndrome (ACS) patients treated with original clopidogrel or a generic clopidogrel formulation, in relation to sociodemographic and clinical characteristics. MATERIAL AND METHODS: Consecutive Greek ACS patients (n = 1194) hospitalised in the Aegean islands and the Attica region were enrolled. Clopidogrel treatment was recorded either as original clopidogrel hydrogen sulphate (Plavix®/Iscover®) or as a generic clopidogrel besylate formulation (Clovelen®). The composite endpoint was recorded at 12-month follow-up. RESULTS: The 12-month composite endpoint was 3.9% (4.6% in the Aegean islands and 3.5% in the Attica area, p > 0.05). The respective incidence in men was 4.0% and in women 3.8% (p > 0.05). Overall, generic and original clopidogrel use was 87% and 13% of patients, respectively. No significant differences were observed between original and generic clopidogrel use and 12-month composite endpoint incidence. Subgroup analysis with gender, region of residence, and clinical and lifestyle factors as strata did not reveal any significant outcomes. Haemorrhage incidence did not exceed 1% in the total sample. CONCLUSIONS: The use of a generic clopidogrel besylate formulation was quite high in both urban and insular areas of Greece and had similar efficacy and safety profile with the original clopidogrel salt, supporting the routine use of this low-cost generic clopidogrel in the management of cardiovascular disease patients.

Role of methylenetetrahydrofolate reductase 677C->T polymorphism in the development of premature myocardial infarction.

BACKGROUND: The pathogenetic mechanism of premature myocardial infarction (MI) remains unknown. We explored the association of homocysteine and its main genetic modulator methylenetetrahydrofolate reductase (MTHFR) 677C->T polymorphism with the development of MI T polymorphism. RESULTS: Patients with premature MI had higher homocysteine levels (13.9+/-8.6 vs. 11.8+/-4.9 mmol/l, p=0.02) and higher prevalence of TT homozygocity compared to controls (27.1% vs. 14.6%, p=0.02). Thirty-four patients (23.6%) had angiographically "normal" coronary arteries. Subgroup analysis according to angiographic findings ("normal" coronary arteries versus significant coronary heart disease) showed that only patients with MI and "normal" coronary arteries (MINCA) had higher homocysteine levels compared to controls (17.6+/-12.2 vs. 11.8+/-4.9 mmol/l, p<0.001). The prevalence of TT genotype was higher only in patients with MINCA compared to controls (44.1% vs. 14.6%, p=0.001) (odds ratio 4.6, 95% confidence interval (CI), 1.9-11, p=0.001). This association remained after adjusting for conventional risk factors (odds ratio 3.4, 95% CI, 1.1-10.4, p=0.03). The adjusted odds ratio for MINCA of young individuals with MTHFR TT genotype and folate levels in the lowest quartile (T mutation of MTHFR is independently associated with the development of premature MINCA.