Efficacy of Abbott cholesterol drug in question

By Dr. Ananya Mandal, MDMay 29 2011

A latest study has found that using medication to raise good cholesterol while lowering the bad does NOT translate into fewer adverse cardiovascular events like heart attacks and strokes. The study was revealed Thursday by the National Institutes of Health and it found that high dosages of Abbott Laboratories' Niaspan failed to prevent heart attacks and boosted the likelihood of a stroke when combined with the popular generic cholesterol pill Simvastatin, also known under the brand name Zocor.

The NIH study of more than 3,400 patients was stopped prematurely after researchers uncovered an “unexplained increase in the rate of ischemic stroke” to patients to given Niaspan, which is used to raise HDL, or the so-called good cholesterol, along with the generic simvastatin, which is used to lower LDL, or the so-called bad cholesterol. For this study all participants were prescribed 40 milligrams of simvastatin (Zocor) per day then randomly given either Niaspan or a placebo, the institute said. Niaspan and Simvastatin combination was linked to strokes in 1.6 percent of patients, compared with 0.7 percent in the control group. The combination failed to reduce heart attacks, heart-related hospitalizations and the need for procedures to reduce chest pain and restore strong blood flow.

An estimated 1 in 7 Americans has high cholesterol, the NIH said, calling it a major risk factor for cardiovascular disease, a killer of 800,000 people in the U.S. each year. Cholesterol builds up and causes walls of arteries to therefore narrow.

The price of Abbott shares lost more than 2 percent of their value in trading on the New York Stock Exchange. Late this afternoon, Abbott stock had dipped $1.06 per share to $51.91. Niaspan that is generically called niacin, raised levels of HDL that did not lead to fewer heart deaths or heart attacks. The study, called Aim-High, was intended to look at patients in the U.S. and Canada with a history of heart disease.

“Although we did not see the expected clinical benefit, we have answered an important scientific question about treatment for cardiovascular disease,” Dr. Susan Shurin, acting director of the NIH’s National Heart, Lung, and Blood Institute said in a statement.

The U.S. Food and Drug Administration said it has made “no new conclusions or recommendations regarding the use of niacin alone or in combination with simvastatin or other statins.”  The FDA, however, said physicians should consider the “available clinical information on high-dose extended-release niacin and statin drugs when deciding what cholesterol-lowering medication to prescribe.”

Abbott in reply said there “are a number of unanswered questions that remain” and that more may be known this fall when a more comprehensive analysis of the data is available. Abbott chief executive officer Miles White placed a huge bet on the benefits of raising good cholesterol when he engineered Abbott's $3.7 billion acquisition of Kos Pharmaceuticals Inc., the developer of Niaspan, in 2006. Dr. Eugene Sun, Abbott’s director of global pharmaceutical development said, “Lipid disorders and cardiovascular disease are complex and varied…Based on its long history of clinical evidence, Niaspan remains an important agent for patients with mixed dyslipidemia and primary hyperlipidemia.”

Abbott sells a combination of Niaspan and simvastatin called Simcor. The company’s Trilipix and Tricor pills are also designed to raise good cholesterol. Outside advisers to the FDA recommended last week that Abbott conduct a new trial of Trilipix after a government study failed to show heart benefits.

The Aim-High findings show regulators need to demand long- term studies to prove medicines improve health, rather than clearing the treatments based on laboratory tests of markers like cholesterol, said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio. He said, “This was the group everybody thought had the best chance at a benefit…At this point, we have to take a deep breath and realize we’re not as smart as we thought we were.”