Efficacy and safety of tenecteplase in Indian patients with st-segment elevation myocardial infarction.

ABSTRACT

OBJECTIVE: To assess the efficacy and safety of tenecteplase in Indian patients with ST-segment elevation MI (STEMI). METHODS: Cardiologists/physicians who had used tenecteplase for management of STEMI, recorded safety and efficacy parameters from consecutively treated patients. Tenecteplase was administered as per the prescribing information. Adjunctive therapy which included clopidogrel and UFH/LMWH was administered as routinely practiced and indicated by guidelines. RESULTS: Five hundred and seven patients (male = 415, females = 92; mean age = 58.28 +/- 12.23 yrs; weight (kg) = 70.12 +/- 11.06) with STEMI were treated with weight-adjusted tenecteplase within median chest pain to drug interval of 120 minutes. Resolution of chest pain within median interval of 45 minutes occurred in 436 patients with median duration required for > or = 50% resolution of ST segment of 75 minutes. Clinically successful thrombolysis was reported in 80.67% patients. Five patients suffered intra-cranial hemorrhage (ICH), of which 3 patients had received Gp IIb/IIIa inhibitors. Incidence of intra-cranial hemorrhage attributable to tenecteplase was 0.39% (2 out of 507 patients). Incidence of myocardial re-infarction was 2.96% (15 out of 507 patients). There were 12 deaths (2.36%). CONCLUSION , This data shows that tenecteplase is safe and effective in Indian patients with STEMI and conforms to the international ASSENT-2 trial data.