Improving Niacin for Lipid Lowering

Robert W. Griffith, MD

Before the advent of statins, the B-vitamin drug Niacin® (nicotinic acid) was a standby in attempts to raise HDL-cholesterol levels and lower triglyceride levels. A serious drawback, however, was the skin flushing produced by the drug, even with normal doses. At higher doses more severe side effects can occur, but the flushing was a problem that led many patients to drop the drug.

At the recent European Society of Cardiology meeting there was a report of a large clinical study with a new combination drug: Niacin-plus- laropiprant, given the name Cordaptive®. Over 1,500 patients with abnormal lipid levels were randomly allocated to take a placebo, Niacin, or Cordaptive. The new combination had the required lipid effects - a 19% decrease in LDL-cholesterol (the bad cholesterol), a19% increase in HDL-cholesterol (the good cholesterol), and a 22% decrease in triglycerides. Importantly, however, when compared with Niacin alone, there was a reduction in moderate flushing by 60% and extreme flushing by 50%.

Dr Nissen of the Cleveland Clinic stated that the findings were, for him, a little disappointing - he had expected laropiprant to completely block the tissue receptors that trigger flushing. Dr Nissen is well-known for his skeptical opinion of pharmaceutical company-sponsored clinical research, and he was concerned that 8 of the 10 investigators in the study were Merck employees.

Cordaptive is now being reviewed for marketing by the FDA. It will be interesting to see if Dr Nissen's concerns are duplicated by the FDA reviewers, or if they will emerge again if-and-when the FDA's Advisory Committee considers the combination. In the meantime, we'll make do with statins, or Niacin-plus-flushing.

Source
HealthandAge Blog