Most of our patients have by now gone off Niacin, but there are some folks out there who were prescribed it years ago and are still using it.
Here is the story of why niacin should be eliminated from most patients’ treatment.
AIM-HIGH
AIM-HIGH was a randomized study of 3,414 patients who were given Niaspan® (niacin) or placebo on top of LDL cholesterol lowering therapy with Zocor® (simvastatin).
The study was slated to run for 3 years, but it was stopped prematurely after 18 months because no benefit was found. At the time, many experts criticized AIM-HIGH for not having enough patients and not running long enough to have any possibility of showing a benefit for niacin. Most said that we should wait for the subsequent HPS2-THRIVE study before any conclusions were to be made about niacin.
HPS2-THRIVE
HPS2-THRIVE was a very large study of 25,673 patients. The study was investigating whether niacin adds any benefit on top of standard therapy with statins.
In addition to routine statin therapy, patients were given niacin with laropiprant (a drug meant to reduce the annoying skin flushing often seen as a side effect from niacin) or niacin with a placebo. All patients received Zocor™ (simvastatin), and if needed, Zetia™ (ezetimibe), to get their LDL cholesterol down.
The HPS2-THRIVE study appears to show that niacin does not add any benefit when added to standard therapy. Study highlights include:
- Patients receiving the niacin/laropiprant combination had just as many deaths, heart attacks, strokes, stents and bypasses as those who took placebo.
- The patients on niacin/laropiprant had more non-fatal but serious side effects. These included skin, muscle, gastrointestinal, bleeding, infection, and diabetes related problems.
- There was even a trend towards more deaths in the patients given the niacin/laropiprant combination.
- A sub-analysis of patients with very low HDL cholesterol, the ones where one would expect the greatest improvement from niacin, also showed no benefit.
HPS2-THRIVE is likely to be the best study we will ever get on the value of niacin on top of standard statin therapy, and in that test niacin has failed. Standard statin treatment has consistently been shown to reduce the risk of death, heart attack, stenting, bypass, and strokes. The benefit of the statin drugs has now been reproduced in dozens of randomized double blind trials. After more than 30 years of widespread use, the advantages of taking statins continue to greatly exceed any known risk.
The Bottom Line
Niacin appears to have reached a dead end in routine treatment of high cholesterol and vascular disease. There could be unusual instances where it may still be used in statin-intolerant patients, but for the vast majority of patients there seems to be no benefit to justify the significant risk of this drug.