lunes, 30 de agosto de 2010

Phase 2 safety and tolerability data on elinogrel, a novel antiplatelet agent, in non-urgent PCI

Phase 2 trial results for elinogrel, a novel antiplatelet agent available in both intravenous and oral formulations, were presented here today.
The study, INNOVATE PCI, was a randomised dose-ranging trial that compared elinogrel, a P2Y12 inhibitor which in its IV form provides rapid, reversible platelet inhibition, with clopidogrel in 652 patients undergoing non-urgent PCI. Current P2Y12 antagonists are taken orally and require several hours to reach maximal platelet inhibition. The most widely used P2Y12 inhibitor is clopidogrel, which has significant variability in response (and indeed a lack of response in some patients).
According to the INNOVATE PCI trial, elinogrel provides a more potent antiplatelet effect in both the IV and oral forms; however, this immediate platelet inhibition has yet to be translated into a reduction in hard clinical endpoints.
Patients were initially assigned pre-PCI to clopidogrel 300 or 600 mg followed by 75 mg/day, or to elinogrel 80 mg IV bolus followed by 50, 100, or 150 mg oral elinogrel twice daily. The Data & Safety Monitoring Committee recommended discontinuation of enrolment into the 50 mg oral dose arm and increasing elinogrel IV dose to 120 mg; 590 patients were followed for 60 days, and 328 for 120 days.
While the study was not powered to determine efficacy, principal investigator Dr Sunil Rao from the Duke Clinical Research Institute, Durham, USA, said the results now provide a basis for further exploration of elinogrel in larger trials examining clinical endpoints. Rao explained that a pharmacodynamic sub-study provided two key findings as the basis for this further research: elinogrel appeared to be more potent than clopidogrel in platelet inhibition and inhibition appeared greater at higher doses.
“While clopidogrel is a well established and effective therapy," said Rao, "it doesn’t work for all patients, so it is important that we explore alternatives to improve efficacy help prevent serious complications.”