Key result
Adding niacin-laropiprant to statins reduces QALYs by ~0.02 and increases hospital costs.
Why the study?
Extended-release niacin with laropiprant did not significantly reduce major vascular events and increased serious adverse events, but its net effects on health and healthcare costs were unknown.
Does extended-release niacin with laropiprant improve quality-adjusted life years and reduce hospital costs in patients with previous cardiovascular disease on statin therapy?
RCT (n=25,673)
Yes
Does extended-release niacin with laropiprant improve quality-adjusted life years and reduce hospital costs in patients with previous cardiovascular disease on statin therapy?
Mean Difference: -0.023
The addition of extended-release niacin-laropiprant to statin therapy in patients with cardiovascular disease reduces quality-adjusted survival and increases hospital costs.
Niacin-laropiprant reduced QALYs while raising costs; leaves open whether any formulation merits further cost analyses in statin-treated patients.
BACKGROUND: Extended-release niacin with laropiprant did not significantly reduce the risk of major vascular events and increased the risk of serious adverse events in Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE), but its net effects on health and healthcare costs are unknown. METHODS AND RESULTS: 25 673 participants aged 50 to 80 years with previous cardiovascular disease were randomized to 2 g of extended-release niacin with 40 mg of laropiprant daily versus matching placebo, in addition to effective statin-based low-density lipoprotein cholesterol-lowering treatment. The net effects of niacin-laropiprant on quality-adjusted life years and hospital care costs (2012 UK £; converted into US $ using purchasing power parity index) during 4 years in HPS2-THRIVE were evaluated using estimates of the impact of serious adverse events on health-related quality of life and hospital care costs. During the study, participants assigned niacin-laropiprant experienced marginally but not statistically significantly lower survival (0.012 fewer years [standard error (SE) 0.007]), fewer quality-adjusted life years (0.023 [SE 0.007] fewer using UK EQ-5D scores; 0.020 [SE 0.006] fewer using US EQ-5D scores) and accrued greater hospital costs (UK £101 [SE £37]; US $145 [SE $53]). Stroke, heart failure, musculoskeletal events, gastrointestinal events, and infections were associated with significant decreases in health-related quality of life in both the year of the event and in subsequent years. All serious vascular and nonvascular events were associated with substantial increases in hospital care costs. CONCLUSIONS: In HPS2-THRIVE, the addition of extended-release niacin-laropiprant to statin-based therapy reduced quality of life-adjusted survival and increased hospital costs. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00461630.
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Kent et al. (2016) conducted an RCT in previous cardiovascular disease (n=25,673). Extended-release niacin with laropiprant vs. matching placebo was evaluated on quality-adjusted life years (MD -0.023). Adding extended-release niacin-laropiprant to statin therapy in patients with cardiovascular disease reduced quality-adjusted life years (0.023 fewer QALYs) and increased hospital costs.
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