HPS2-THRIVE: Impact of cardiovascular and other adverse events on quality of life and hospital costs
|2012 - 2014
|Merck Sharp & Dohme Corp.
|Clinical Trials Service Unit (CTSU), University of Oxford
In HPS2-THRIVE 25,673 participants at increased risk of cardiovascular disease were randomised to an extended release niacin/laropiprant combination therapy or matching placebo and followed for an average of 4 years. The main study results, reported in March 2013, indicated that the extended release combination therapy did not reduce the rate of major vascular events (i.e. non-fatal heart attacks, coronary deaths, strokes and revascularisations) and caused a range of side-effects such as skin rashes, gastro-intestinal problems, complications with the management of pre-existing diabetes and increased risk of developing diabetes, infections and gastrointestinal/intracranial bleeding. For more details on HPS2-THRIVE please refer to the study website: http://www.thrivestudy.org/
HERC researchers are collaborating with CTSU to study the impact of cardiovascular and other serious adverse events on health-related quality of life and hospital resource use and costs, using data from this large study. As some of the side effects observed in HPS2-THRIVE occur with other preventative cardiovascular disease interventions (e.g. aspirin, COX-2 inhibitors and statins) the estimates derived using this study data could inform assessments of the net benefits of such interventions taking into account harms as well as benefits.
Kent S., Haynes R., Hopewell J.C., Parish S., Gray, A., Landray M.J., Collins R., Armitage, J., and 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