Clinical Retrospective and Prospective Evaluation of Efficacy and Safety of Reteplase in STEMI Patients.

ABSTRACT

Reteplase is a third-generation recombinant form of t- PA (tissue plasminogen activator). A phase–III prospective, multi-centric trial and retrospective, post-marketing surveillance (PMS) of reteplase have been conducted to evaluate the efficacy and safety of reteplase in patients with ST segment Elevation Myocardial Infarction (STEMI). Phase-III trial was a prospective, multi-centric, open-label study conducted across 15 centers in India. 80 patients out of 83 screened were enrolled in the study. Patients with STEMI admitted to an intensive care unit in a hospital within 6 hours of onset of symptoms and meeting all eligibility criteria were enrolled in the study. Each patient received a total dose of 20 units of reteplase. The dose was given as two 10 unit intravenous injections each over two minutes, no more than 30 minutes apart. The primary objective of the study was to evaluate the all cause mortality rate at 30 days post-dosing in patients with STEMI following treatment with reteplase. Safety assessment was based on treatment emergent adverse events, physical examinations, vital signs, ECGs, echocardiography and safety laboratory tests. A Post Marketing Surveillance (PMS) following the marketing approval in India was undertaken to assess the safety profile of reteplase in patients with STEMI and/or recent left bundle branch block. Reteplase was administered as two bolus injections of 10 units each. Each bolus was administered as a slow intravenous injection over 2 minutes. Total 204 patients’ data has been considered for the analysis in present post-marketing study. The results of both these studies are discussed. In both these studies, reteplase efficacy and safety were well established in treatment of patients with ST segment elevation Myocardial Infarction (STEMI).