The THRIVE study, (also known as HPS2-THRIVE), was a multicenter clinical trial designed to test the hypothesis that the increase in HDL, (using ER niacin/laropiprant), could prevent vascular events in a high risk population already receiving statin standard therapy. Between April 2007 and July 2010 a total of 25,673 randomized patients in China, the UK and Scandinavia were studied. The primary endpoints were non-fatal myocardial infarction, cardiac death, stroke and revascularization, (surgical or percutaneous). The secondary endpoints included peripheral vascular disease, diabetes and overall mortality. All patients presented elevated cardiovascular risk with lipid levels well controlled before randomization, (average total cholesterol 128mg/dl, LDL 63 mg/dl and HDL 44 mg/dl).
The main adverse effects leading to the withdrawal of treatment were complications with blood glucose levels in diabetic patients (3.7%) and newly diagnosed diabetes (1.5%). Other side effects were gastrointestinal (4.8%) and musculoskeletal (3.7%). The drug reduced LDL cholesterol to 10mg/dl average, 33 mg/dl triglycerides and increased HDL cholesterol to 6mg/dl. This reduction, according to the literature, should reduce the risk of cardiovascular events by 10% to 15% in a trace to four years.
Results: Drugs ER niacin/laropiprant cause side effects in about 30 per 1000 persons (3%). There was no benefit in the primary outcome when the drug was added to the standard therapy with statins. There is no evidence on the efficacy or safety of medications in different populations. The role of ER niacin in preventing cardiovascular disease should be reconsidered.
Discussion of Panelists: Donna Arnett, Ph.D., AHA President said that patients had good control of lipids before and they did not have to show a significant reduction in risk. Other panelists commented that this study creates a paradigm of how to test new hypotheses on the reduction of lipids in the future.
jane_armitage_acc2013
Jane Armitage.
2013-03-09
Original title: HPS2-THRIVE: Randomized Comparison Of Extended-Release (ER) niacin/laropiprant 2g Daily Versus Placebo in 25,673 Patients At High Risk Of Occlusive Vascular Events.
