Préparation ESC Septembre 24/02/2019 HPS2-THRIVE Heart Protection Study 2 Treatment of HDL to Reduce the Incidence of Vascular Events

HPS2-THRIVE: Study design Préparation ESC Septembre 24/02/2019 HPS2-THRIVE: Study design NY-160626.038/020131YlsjoLS1 Randomised, placebo-controlled, double-blind trial in 20,000 high-risk patients (50-80 years) with history of MI, stroke or peripheral arterial disease AND Optimally managed LDL-C Low HDL-C Patients randomized to niacin/laropiprant (2 g/day) vs.placebo on top of optimal LDL-C lowering therapy (simvastatin 40 mg/day  ezetimibe) Primary Outcome:  Time to first major vascular event (non-fatal MI, CHD, stroke or revascularisation) at end of study HDL cholesterol has long been known to have a strong inverse correlation with CHD risk. But, randomized trial evidence for beneficial effects from raising HDL cholesterol is limited. One of the most effective HDL-raising agents is niacin but the tolerability of niacin has been severely limited by flushing and cutaneous side-effects, which appear to be mediated largely by prostaglandin D. Laropiprant is a selective prostaglandin D receptor antagonist that substantially reduces the frequency and intensity of niacin-induced flushing. HPS2-THRIVE aims to find out whether raising HDL cholesterol with the combination of niacin/ laropiprant in high-risk patients with optimally managed LDL cholesterol provides additional reduction in cardiovascular risk. www.ClinicalTrials.gov NCT00461630 Results expected 2012