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The HPS2-THRIVE study was a large multi-national, placebo-controlled, randomised trial of extended release niacin plus laropiprant 2g daily versus placebo added to effective background LDL-cholesterol lowering with simvastatin 40mg daily plus ezetimibe 10mg daily, if required.  Between 2007 and 2010, 25,673 patients at increased risk of vascular disease were randomised in 240 clinics in six countries: China, UK, Denmark, Finland, Norway, and Sweden. These patients were followed up for a median of four years in the study clinics while they continued on their randomised treatment and background LDL-lowering treatment.  Results were presented at the American College of Cardiology meeting in 2013 and published in the New England Journal of Medicine in 2014.

The HPS2-THRIVE study has shown that:

  • Allocation to ER niacin/laropiprant reduced LDL-cholesterol by 0.25 mmol/L and increased HDL-cholesterol by 0.16 mmol/L but did not significantly reduce the risk of major vascular events (MVEs i.e. heart attacks, strokes or coronary or non-coronary revascularisation) compared to placebo
  • Allocation to ER niacin/laropiprant significantly increased the risk of disturbances in diabetes  control and new onset  diabetes and serious adverse events associated with the gastrointestinal and musculoskeletal systems, skin and, unexpectedly, both infection and bleeding
  • ER Niacin increased the risk of simvastatin-induced myopathy by about 4-fold
  • Participants from China are at higher risk of statin-induced myopathy than those from Europe

The results of HPS2-THRIVE led to the withdrawal of ER niacin/laropiprant from the European market and Merck ceased development of the product.

The HPS2-THRIVE trial was funded by a grant to Oxford University from Merck who also provided the background simvastatin and ezetimibe and the packaged ER niacin/laropiprant and matching placebo.

Long-Term Follow-Up

In the UK, we will continue to collect information on health outcomes by obtaining routinely collected data via central data registries and NHS sources. See our Legacy Study Protocol for more information about this long-term follow-up, and our Privacy Notice for information on how we use participant data.

 

Our team

Funding

Unrestricted grant from Merck, Sharp and Dohme (see Unit's funding policy here)

Trial Registrations

ISRCTN: 29503772

ClinicalTrials.gov: NCT00461630

EU Clinical Trials Register: 2006-001885-17

Selected publications

documents

Main study protocol

340 KB, PDF document

Main data analysis plan

232 KB, PDF document

HPS2-THRIVE legacy study protocol

298 KB, PDF document

THRIVE Q&A about results 2013

55 KB, PDF document

Slide Set of results presented at the ACC - 2013

3 MB, PowerPoint presentation

Related research themes