“Whitehouse Station, NJ – The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS-2 THRIVE) study has missed its primary end point and shown no clinical benefit for extended-release niacin .
After nearly four years of follow-up, the combination of niacin with the antiflushing agent laropiprant did not significantly reduce the risk of the combination of coronary deaths, nonfatal MI, strokes, or coronary revascularizations compared with statin therapy, according to Merck, the sponsor of the HPS-2 THRIVE trial. In a press release announcing the results, Merck said the combination significantly increased the risk of nonfatal but serious side effects.
Merck announced it will no longer be taking the drug before the US Food and Drug Administration to gain approval. The combination of extended-release niacin and laropiprant, known as Tredaptive or Cordaptive, was approved by European regulators in 2008, but Merck is advising doctors from starting any new patients on the drug.
This is the second major setback for physicians hoping that niacin, a drug that raises HDL-cholesterol levels, might be used clinically to reduce the risk of cardiovascular events. In May 2011, the National Heart, Lung, and Blood Institute (NHLBI)-sponsored Atherothrombosis Intervention in Metabolic Syndrome with Low HDL Cholesterol/High Triglyceride and Impact on Global Health Outcomes (AIM-HIGH) study, was halted early after showing no benefit of niacin when given in addition to statin therapy.”
What’s going on here — there’s a lot of effort in the supplement and natural foods corners for taking niacin in large doses, enough so it would make you have, trust me on this, I tried it, major red flushing and major itchy drive-you-nuts complications unless it’s timed-release — to raise your HDL and cut your risk of heart events.
What’s been found, twice now, is that while it’s possible to increase your HDL this way there’s no proof that it will help you reduce your risk of cardiovascular issues.
Pretty shocking, really. There was a lot of hope that surely this was one can’t miss evidence that taking a nutritional supplement was good for you. And again, as always, nope. If you do not have a deficiency of a nutrient, taking more of it has never been shown to be of benefit.
We’re back to where we were a hundred years ago. Eat. Eat good food. Eat in moderation and with an eye toward your health.