XYMOGEN's Stance on Niacin
Once again, the major media outlets are making a major splash with the negative news about niacin based on the HPS2-THRIVE study – first announced in March of 2013, and now again with the full publication of the study in the New England Journal of Medicine.
What is it that journalists and medical correspondents are getting wrong? Let’s begin with the assertion that niacin does not provide any benefit. HPS2-THRIVE was a study of an investigational drug from Merck, containing BOTH extended release niacin and laropiprant, a drug which partially blocks the flushing response to niacin. This niacin combination was given to subjects already very well controlled on statin therapy. At baseline, average cholesterol levels were 63mg/dl for LDL-C, 84mg/dl for non-HDL-C, and triglycerides were 125mg/dl. According to the National Lipid Association (NLA) in their March, 2013 response to the media, HPS2-THRIVE investigators tested a drug in patients who, on average, had no indication to take it! In addition to early data from the Coronary Drug Project, which showed significant reductions in cardiovascular events when niacin was used alone in individuals with documented heart disease, the NLA response makes it clear many other trials have documented a benefit of additive therapy on top of statins when LDL-C or triglyceride remain elevated.
Second, the assertion that this study showed that niacin caused greater harm than the statin arm of the study is very misleading. This study, unlike other studies using statins and niacin in combination, did show increases in serious adverse events (3.7% excess) including myalgia (muscle pains), diabetic complications, new onset diabetes, gastrointestinal complications, infections and bleeding. While the media associates these increases with niacin, it is in fact the investigational drug laropiprant that has documented mechanisms of harm just like the cox-2 inhibitors and non-steroidal anti-inflammatory drugs that it is related to. A very thorough review of the literature on laropiprant was published by Amy Doneen and Bradley Bale in March of 2013 specifically addressing the mechanisms leading to harm. Knowing this, Merck pulled this drug from the 22 countries where it had been approved and marketed as Cordaptive/Tredaptive immediately in March of 2013. Niaspan, the prescription extended-release niacin marketed by Abbott, was never considered for removal from the market and is still being prescribed in the United States and throughout the world.
The main points to keep in mind regarding niacin and this latest study are that: 1) niacin has a long history (50+ years) of safe use; 2) the addition of laropiprant caused harm in the treatment arm, and the conclusions relating to both safety and efficacy cannot be attributed to niacin alone; and 3) the available evidence strongly suggests that individuals who are not adequately treated on a statin medication alone can benefit from niacin’s additive effect on LDL reduction, particle number reduction, and triglyceride reduction.