This website will provide you with all the information you need about the HPS2-THRIVE trial and its results. You can view or download a copy of our Results Press Release, and we have prepared a series of Questions and Answers on the results. You can also download a Slide Set of the results that were presented at the American College of Cardiology meeting on 9 March 2013.
HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) concluded that adding ER niacin/laropiprant to current standard treatment did not produce worthwhile reductions in the risk of heart attacks, strokes and operations to open blocked arteries. The study also found that using ER niacin/laropiprant did cause side-effects.
HPS2-THRIVE involved over 25,000 volunteers aged between 50 and 80 with a history of heart disease, stroke or other circulatory disease recruited from almost 250 hospitals in 6 countries (China, Denmark, Finland, Norway, Sweden and the United Kingdom). All volunteers took simvastatin (with or without ezetimibe) to lower “bad” LDL cholesterol. In addition to this, volunteers were randomly allocated to take either ER niacin/laropiprant or matching dummy “placebo” tablets for an average of 5 years. Niacin has been used as a treatment for over 50 years because of its potentially beneficial effects on cholesterol. It increases “good” HDL cholesterol and also reduces “bad” LDL cholesterol which is why doctors have thought it would be a useful treatment.
The study was sponsored by the University of Oxford and funded by Merck, Sharp & Dohme Co. Inc.
Professor Jane Armitage:
“This is a clear result that is very important for patients. For many years doctors had believed that niacin would reduce the risk of heart attacks and strokes because of its effects on cholesterol. However, this trial showed that adding ER niacin/laropiprant on top of statins was not helpful for people with circulatory problems. All treatments have good and bad effects. This time the unwanted side-effects outweighed the benefits. This is important information for all the people who have been using this or similar medicines for many years.”
Dr Martin Landray:
“The HPS2-THRIVE study has shown that ER niacin/laropiprant does cause side-effects. It has long been known that niacin treatment causes skin irritation and gastrointestinal disturbances (and other side effects). However, HPS2-THRIVE has shown that ER niacin/laropiprant also increases the risk of other side effects including bleeding and infections which were not known about before the study. We are very grateful to the participants who have helped answer this important clinical question.”
The following pdf documents describe the Data Analysis Plan for the THRIVE study.
You can download a copy of the study Protocol from the Document Download page.
Protocol pre-specified, interim safety and tolerability analyses from the 25,000 patient HPS2-THRIVE study
of ER niacin/laropiprant 2g daily were presented at the European Society of Cardiology meeting in Munich
in August 2012 and have been published in the
European Heart Journal.
In addition, results of preliminary investigations into environmental and genetic risk factors for myopathy in Chinese participants in HPS2-THRIVE were presented as a poster. You can download the presented Chinese myopathy abstract and this can also be viewed from the European Heart Journal website, reference: Eur Heart J (2012) 33(suppl 1): 339-653 doi:10.1093/eurheartj/ehs282.
This website was last updated on 2nd May 2013