Objective: to study the efficacy and safety of indigenously developed tenecteplase injection in the management of Indian STEMI patients in clinical practice.
Methods: post-licensure, observational, prescription event monitoring study.
Results: 2100 patients received weight-adjusted tenecteplase injection. More than 90% patients received aspirin, clopidogrel, and enoxaparin/heparin. Clinically successful thrombolysis was reported in 86.71%, in-hospital mortality was 3.48%. The adverse events recorded were comparable with previously published data. Any bleeding (excluding intra-cranial hemorrhage) was seen in 4.62% patients which was reported in 0.90% patients of which 47.34% patients had also received GpIIb/IIIa inhibitors.
Conclusion: This study confirms the efficacy and safety of indigenous tenecteplase in Indian STEMI patients.