18 Jul Niacin-Laropiprant Reduced Quality of Life-Adjusted Survival and Increased Hospital Costs in HPS2-THRIVE

MedicalResearch.com Interview with:
Seamus Kent, MSc, Research Fellow and
Borislava Mihaylova, MSc DPhil, Associate Professor
Health Economics Research Centre,
Nuffield Department of Population Health
University of Oxford, UK

MedicalResearch.com: What is the background for this study?

Response: Niacin lowers the LDL cholesterol and increases the HDL cholesterol and it was hoped this would translate into reduced risks of vascular events. This hypothesis was assessed in the Heart Protection Study 2 – Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trial in which over 25,000 adults aged 50 to 80 years with prior cardiovascular disease were randomised to either niacin-laropiprant or placebo, in addition to effective LDL-cholesterol lowering therapy, and followed for about 4 years. Previously published results from the study demonstrated that niacin-laropiprant did not significantly reduce the risk of major vascular events but did significantly increase the risk of various adverse events including infections, bleeding, gastrointestinal, musculoskeletal, skin, and diabetes-related events.

MedicalResearch.com:  What are the main findings?

Response: In the current study, we estimate the impacts of a wide range of serious vascular and nonvascular adverse events on health-related quality of life and healthcare costs, and evaluate the net effects of allocation to niacin-laropiprant on quality-of-life-adjusted survival and healthcare costs over the 4 years in HPS2-THRIVE. We find that stroke, heart failure, musculoskeletal events, gastrointestinal events, and infections are associated with significant decreases in 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. We report that patients allocated niacin-laropirant in HPS2-THRIVE experienced worse health (ie, had fewer years of quality-adjusted survival) and accrued greater healthcare costs than those allocated placebo.

MedicalResearch.com: What should readers take away from your report?

Response: Our report adds to the evidence of serious adverse health effects with use of niacin and shows that the addition of extended release niacin-laropiprant to statin-based therapy reduces health and increases health care costs. Any continued use of niacin will need to be reconsidered. Although the reduction in LDL-cholesterol achieved with niacin in the absence of statin therapy (eg, in individuals who cannot tolerate statins or for whom LDL-cholesterol is not adequately controlled using these therapies) might be bigger and, consequently, the effect on vascular events might be larger, the net benefits are highly uncertain given the large range of serious adverse events caused by niacin. In HPS2-THRIVE we found that the use of niacin-laropiprant even among patients at the greatest cardiovascular disease risk resulted in net health harm and elevated hospital costs.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Given observed hazards, further reliable data is needed in support of any claims for net health benefits with use of niacin in specific groups of patients.

MedicalResearch.com: Is there anything else you would like to add?

Response: Reliable estimates of the impacts of categories of adverse events on health and healthcare costs are needed to evaluate the net effects of health interventions. The estimates of the quality of life and cost impacts of adverse events derived from HPS2-THRIVE data are now available for use in other analyses of effects of interventions in secondary cardiovascular disease populations.

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Citation:
Kent S., Haynes R., Hopewell J.C., Parish S., Gray, A., Landray M.J., Collins R., Armitage, J., Mihaylova B., on behalf of the HPS2-THRIVE Collaborative Group. The Effects of Vascular and Nonvascular Adverse Events and of Extended Release Niacin with Laropiprant on Health and Healthcare Costs, Circulation: Cardiovascular Quality and Outcome. 2016. DOI: 10.1161/CIRCOUTCOMES.115.002592.

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Last Updated on July 18, 2016 by Marie Benz MD FAAD