Getting LDL -- bad cholesterol -- in check is still in favor. Three cheers for Pfizer's (NYSE: PFE) Lipitor, AstraZeneca's (NYSE: AZN) Crestor, and generic drugmakers that sell knockoffs of Merck's (NYSE: MRK) Zocor and Bristol-Myers Squibb's (NYSE: BMY) Pravachol.

Raising HDL -- good cholesterol -- with niacin doesn't seem like it's all that helpful, though. In a government-run trial dubbed AIM-HIGH, patients taking Zocor and niacin saw their good cholesterol go up by 28% compared with those taking Zocor alone, but that didn't translate into a lower rate of heart attacks, strokes, and the like. The trial was ended early because it was clear that there was no point in finishing it. Based on the data at the interim look, Niacin wasn't going to help decrease heart-related problems by a statistically significant margin.

That's bad news for Abbott Labs (NYSE: ABT) -- which sells Niaspan, the niacin used in the trial -- and Merck, which is developing Cordaptive, a niacin drug that lessens one of niacin's side effects. The company tried to gain FDA approval of the drug a few years ago, but the FDA decided it wanted an outcomes study measuring heart-related problems rather than just cholesterol levels before it would sign off on the drug. The likelihood of that long and expensive trial coming up positive doesn't look as good after the AIM-HIGH results.

This is one of the major problems with developing heart drugs. Surrogate endpoints, like cholesterol levels, are no longer sufficient, and outcomes studies require a huge number of patients because, fortunately, heart attacks and strokes are fairly rare. In order to show a 15% improvement in outcomes, tens of thousands of patients have to be enrolled.

Large pharmaceutical companies can afford to take the financial risk given the potential Lipitor-sized rewards. But investors need to be cognizant that this isn't a place for smaller companies to be playing around. I thought Biogen Idec (Nasdaq: BIIB) recently dropping its cardiovascular program was a good move. And Amarin (Nasdaq: AMRN) needs to find a partner or acquirer in order to complete its outcome study. That shouldn't be too difficult given the positive data so far, but it's something for investors to watch out for nonetheless.

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