Oxford University's Dr Martin Landray, one of the other lead investigators, said: "We are disappointed that we have not been able to find a drug that helps patients further. However, it is just as important to find out about the hazards of a treatment, particularly for a drug as widely used as niacin."
THRIVE also reported last month in the European Heart Journal that there was an increased risk of myopathy in Chinese participants, which was seen particularly in patients who took niacin as well as simvastatin.
Professor Armitage expressed her gratitude to all of the participants in the study. "Without their help we would not have been able to make this progress towards improving the care of people who have had, or are at risk of having, a heart attack or stroke," she said.
HPS2-THRIVE was funded by a grant to Oxford University from Merck & Co, who also provided the ER niacin/laropiprant and matching placebo tablets, as well as background simvastatin or ezetimibe/simvastatin combination. However, the study was designed, conducted, analysed and interpreted independently by the investigators at Oxford University and the independent members of the study Steering Committee.http://www.ctsu.ox.ac.uk/~thrive/ NOTES TO EDITORS
- Niacin is also known as vitamin B3. Both niacin and statins have beneficial effects on blood cholesterol levels, but this study found that taking niacin in addition to a statin led to a significant increase in side effects and no worthwhile benefit.
- The researchers were looking at doses of niacin tens of times higher than you'd expect in your diet, or from a dietary supplement. This study does not affect advice on diet. It is important to eat plenty of vitamin-rich foods, like fresh vegetables.
- A high level of LDL cholesterol is a known risk factor for heart disease and stroke. Standard treatment for at-risk patients includes dietary and lifestyle changes, as well as commonly prescribed medications such as statins, cholesterol absorption inhibitors, and resins. Still, heart disease and stroke continue to cause death and disability even in patients receiving these medications. There was hope that the addition of niacin to standard therapy would improve patient outcomes.
- The expected effects of ER niacin on lipids were seen although they were somewhat smaller than observed in short term studies because of people stopping their study treatments during the study.