, 15:332
Date: 19 Apr 2013

When Clinical Trials Fail to Address Treatment Gaps: The Failure of Niacin-Laropiprant to Reduce Cardiovascular Events

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Introduction: The Heart Protection Study-2-THRIVE trial (official title: A Randomized Trial of the Long-term Clinical Effects of Raising HDL Cholesterol With Extended Release Niacin/Laropiprant) was designed to investigate the effect raising HDL cholesterol (HDL-C) with extended release niacin (ERN) 2 g plus laropiprant (LRPT) 40 mg daily versus placebo on the time to the first major vascular event (composite of nonfatal myocardial infarction [MI], coronary heart disease [CHD] death, stroke, or arterial revascularization) in patients with a history of occlusive arterial disease (MI, ischemic stroke or transient ischemic attack, peripheral arterial disease, or diabetes with other CHD) who were receiving simvastatin 40 mg daily as background therapy.

Methods: Prior to randomization, the trial incorporated a run-in phase in which 42,424 participants received open-label treatment with simvastatin 40 mg daily to achieve a total cholesterol level < 135 mg/dL (3.5 mmol/L) or simvastatin 40 mg/ ...

HPS2-Thrive Collaborative Group. HPS2-THRIVE randomized placebo-controlled trial in 25,673 high-risk patients of ER niacin/laropiprant: trial design, pre-specified muscle and liver outcomes, and reasons for stopping study treatment. Eur Heart J. 2013: Oct 24. [Epub ahead of print].
HPS2-Thrive Collaborative Group. HPS2-THRIVE: Randomized placebo-controlled trial of ER niacin and laropiprant in 25,673 patients with pre-existing cardiovascular disease. American College of Cardiology 2013 Scientific Sessions. March 9, 2013 presentation by Jane Armitage.