Kos Drug Shows Promise in Artery Clogging Trial

A long-acting niacin drug that raises so-called good cholesterol showed promise in slowing the clogging of arteries when taken along with cholesterol-lowering statins compared to statin therapy alone, according to a small clinical study.

The trial, presented at the American Heart Association’s scientific meeting on Wednesday, demonstrated that raising levels of high density lipoprotein (HDL), or “good” cholesterol, with Kos Pharmaceuticals Inc’s Niaspan helped slow progression of dangerous plaque buildup in the carotid artery of patients already taking statin. The trial appeared to show a link between raising HDL levels and slowing of arterial disease, researchers said. It also could bolster the prospects for an experimental tablet Kos is developing that combines Niaspan with a statin. The study of 149 patients measured the change in thickness of the carotid artery after 12 months in those taking Niaspan versus those taking a placebo. Both groups took their usual statins — in most cases Merck’s Zocor. According to the data, thickness in the wall of the carotid artery increased significantly in the placebo group — 0.1 millimeters — and was unchanged in the niacin group. HDL levels increased 21 percent among those taking the Kos drug. The trial therefore met its primary goal of showing less disease progression — meaning plaque buildup — in those taking the Kos drug plus a statin. “This was an important first step in showing the incremental benefit of adding niacin to statins,” said Dr Allen Taylor, the trial’s lead investigator and director of cardiovascular research at Walter Reed Army Medical Center. Progression of carotid wall thickness has previously been a good predictor of adverse heart disease events, such as heart attack, sudden death and the need for artery-clearing angioplasty, Taylor explained. But doctors attending the presentation were not convinced. They said a much larger trial was needed, and one with a goal of showing that niacin helped prevent heart attacks and other adverse events, not just artery plaque build-up. “I wouldn’t change current therapy based on this trial,” said Dr Philip Greenland of Northwestern University’s school of medicine in Chicago. Nevertheless, Taylor said a two-pronged approach to cholesterol treatment may be in order. “It lends some support that we should be expanding our focus to not just LDL cholesterol levels but also to be increasingly focused on HDL cholesterol as a way to identify and reduce risk,” Taylor said. Statins have been shown to reduce heart attacks and strokes by about 30 percent in patients at risk. “Thirty percent is not good enough,” Taylor said. Most of the 80 patients in the Niaspan arm of the trial experienced flushing, a reddening of the skin which is common with niacin but not considered unsafe. Prescription niacin use reached its heyday among physicians in the 1970s and 1980s before statins were introduced. “Niacin is like coming back to an old familiar friend you sort of forgot about when statins pushed it to the lower shelf in the drug closet,” Taylor said. Wall Street expects Kos to win approval for a combination of Niaspan and Zocor once Zocor’s 2006 U.S. patent expires. But SG Cowen analyst Ian Sanderson said by then Pfizer Inc. may already have launched a more potent rival. The Pfizer drug, if approved, would combine its best-selling statin Lipitor with an experimental medicine that raises HDL by 60 percent or more, some two to three times as much as Niaspan. (Source: American Heart Association: Reuters Health: Bill Berkrot: November 2004.)