Questions raised about cholesterol drugs | Timi Gustafson

A just released study on the benefits of HDL (the “good”) cholesterol-raising drugs has shown disappointing results. While lowering LDL (bad) cholesterol levels plays an important role in the treatment of heart disease, doctors have long believed that taking active measures to increase HDL levels as well would yield additional benefits.

As widely reported in the press, these expectations now seem unwarranted. The interim analysis of the study shows that a high dose of niacin, a B vitamin credited with the ability to increase high-density lipoprotein (HDL) in the bloodstream, taken in combination with statins does little if anything more to prevent heart attacks and strokes.

Sponsorship for the study, called AIM-HIGH trial, was shared by the U.S. government and Abbot Laboratories, a pharmaceutical company that makes Niaspan, a drug widely prescribed to heart disease patients as an HDL booster. During the trial that was originally scheduled to last 32 months, 3414 participants with heart- and vascular disease were treated with Zocor, a low-density lipoprotein (LDL) lowering statin.

While all participants were given the statin, one group received also Niaspan and another one a placebo. The study was concluded 18 month early when it became clear that Niaspan did not provide the significant advantages it was supposed to. Although the drug raised HDL levels as expected, the effects did not translate into measurable improvements of heart problems.

The effectiveness of Zocor was not called into question. The researchers emphasized that patients who were using Niaspan should not stop taking the drug without consulting with their physicians first.

Abbot Laboratories says it remains confident about the effectiveness of its product even after the study, insisting that “Based on its long history of clinical evidence, Niaspan remains an important agent for patients with blood lipid problems.”

The Food and Drug Administration (F.D.A.) has announced it will review the study but has not yet revised its former findings and recommendations.

Still, the new results will probably change the ways physicians treat their heart disease patients from hereon in. And not all patients are unhappy about being taken off the drug either. Niacin, the active ingredient in Niaspan, can cause a number of unpleasant side effects, including flushing and headaches. But because it was widely seen as a potentially life-saving medicine, the downsides were deemed acceptable.

In 2006, another pharmaceutical company, Pfizer, reportedly halted the development of its own HDL-raising drug “after studies showed that the medicine increased the risk of death.” (New York Times 5/27/2011)

The fact that HDL (“good”) cholesterol helps to “sweep up” LDL (“bad”) cholesterol in the bloodstream remains unchanged, of course. The importance of keeping both LDL levels down and HDL levels up is not in dispute.

Less known in the public arena is that niacin is not only present in HDL-raising drugs but also in many foods we all consume every day, including dairy products, lean meats, poultry, fish, nuts, eggs and enriched breads and cereals.

What this means is that diet- and lifestyle changes can significantly help increase HDL levels “naturally.” For instance, drinking three cups of orange juice a day can increase HDL by over 20 percent, according to one British study. Replacing saturated with monounsaturated fats and eliminating trans fats can not only reduce LDL but also boost HDL. So does drinking alcohol in moderation, especially red wine. Two to three servings per day of soluble fiber, found in oats, rice, dried beans and many fruits and vegetables can offer similar benefits. And, of course, regular physical exercise, in particular aerobics, not smoking and consistent weight management are among the best measures you can take to keep your cholesterol in check both ways.

Some foods containing niacin: