Cholesterol is one of the major risk factor for coronary heart disease. Attempts have been made to find out an agent that can increase HDL- the good cholesterol and lower LDL. Stopping the AIM-HIGH trial of extended-release niacin aimed at elevating HDL created lot of stir in the medical world. The main point of debate is, does niacin provide incremental benefits over usual standard of care?

Team@CMHF.

First major HDL-raising drug to be tested in a large trial—Pfizer’s torcetrapib—spectacularly failed a few years ago. This was attributed by many to an off-target effect of torcetrapib on raising blood pressure, and the focus therefore shifted to other HDL-raising drugs, of which niacin is one. This agent has been around for a long time and is known to effectively raise HDL and lower LDL and triglycerides. But it is hard to tolerate, with the main side effect of flushing causing many patients to discontinue treatment. Niaspan is an extended-release formulation of niacin claimed to reduce the flushing side effects of the drug.

Although it is believed that raising HDL will be beneficial, no large outcome trial has actually shown a reduction in clinical events with this approach, and the While the stopping of AIM-HIGH for futility was one reason, unexpected signal of ischemic stroke with niacin (not seen in any earlier studies) likely also contributed to the [National Institutes of Health’s] NIH’s decision to stop the trial. This will inevitably make doctors think more carefully about prescribing niacin.

All experts questioned said, “They would not be using niacin so much now in patients with low LDL.” Expert’s opinion was, ‘if you get LDL and total cholesterol low enough, whether HDL matters any more. Always try to maximize the statin and lifestyle intervention before adding in other agents.

However, niacin may still be of benefit if patients are not able to achieve goals for LDL, non-HDL-cholesterol, or [apolipoprotein B] apoB. Until more detailed data become available, we are telling our patients that if they are doing well on niacin not to stop taking it. But we are not starting new patients on it at the moment, especially if their LDL is well-controlled.’

Everyone agreed that any definite decisions about the place of niacin must wait for the results of the much larger HPS2-THRIVE study, currently under way. This study has 25 000 patients and so is much more likely to be able to show a real result. The trial has completed enrollment, with results expected in 2013.

Reference : http://www.theheart.org/article/1248191.do