Niacin...it's deja vu all over again.

Implications: 1. Pfizer Inc, the pharmaceutical giant, halted late-stage trials of the HDL increasing drug torcetrapib after investigators discovered that it increased heart problems and increased death rates in the treated population.
2. Niacin, a B vitamin that increases HDL (the good cholesterol) up to 35%, has largely been ignored by physicians treating hypercholesterolemia and coronary heart disease because it is difficult to prescribe related to the common nuisance, but non-serious side effect of flushing.
3. Statins typically decrease LDL (the bad cholesterol) by 30-50% and cardiovascular events by about 30-40% but one analysis suggests that by decreasing LDL by 40% and increasing HDL by 30%, cardiovascular events could be decreased by 70%.
4. A large trial is underway to test this hypothesis comparing statin therapy alone with combination statin plus niacin therapy.

Analysis: There are several small trials already in existence that suggest that combination statin plus niacin therapy is superior to statin therapy alone. These trials, however, used surrogate endpoints such as plaque reduction instead of the more heralded cardiovascular event reduction that is the hallmark of large trials. Most physicians, however, including most cardiologists, don't prescribe a lot of niacin because it is a difficult drug to use related to the nuisance, but non-serious side effect of flushing. There are a few of us, however, that are already aggressive prescribers of combination therapy because we are impressed with the small trials. If Merck's large trial confirms that combination therapy virtually doubles cardiovascular event reduction, it will likely mean a big boost to the use of niacin (in particular, the Kos/Abbott drugs Niaspan and Advicor and Merck's statin/niacin combination tablet under development).