Stable cv patients using niacin show no reduction in heart attack and stroke risks

Taken from the The New England Journal of Medicine (NEJM) by Bruce Sylvester – Among patients with a history of high cholesterol well-controlled by long-term statin therapy, adding high-dose, extended release niacin does not lower the risk of cardiovascular events, including heart attack and stroke. Researchers reported this finding from the Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health (AIM-HIGH) study on Nov. 15, 2011 in NEJM.In the study, 1,718 patients received a high-dose (1,500 to 2,000mg per day) of extended-release niacin, while 1,696 patients received a placebo.

After two years, HDL and triglyceride levels improved among the niacin subjects, with a 25% increase in good cholesterol, a 29% drop in triglycerides and a further decrease in bad cholesterol of about 12%. In the placebo group, there was a 10% increase in good cholesterol and an 8% lowering of  triglycerides.

But, the investigators reported, adding high-dose, extended-release niacin to statin treatment in  well-controlled patients with heart and cardiovascular disease, who had low HDL did not reduce any further the risk of cardiovascular events, including heart attacks and stroke.

Due to this lack of benefit, the (US) National Heart, Lung and Blood Institute ended the trial 18 months before its planned completion.

“If you are a patient with stable cardiovascular disease who has achieved and maintained very low levels of LDL cholesterol on a statin for a long time period, these research findings indicate the addition of high-dose niacin does not improve your risk for future events, and is not needed,” said investigator Dr. William Boden, Professor of Medicine and Preventive Medicine at the State University of New York at Buffalo Schools of Medicine and Public Health, in Buffalo New York.

Dr. Boden noted that the results do not apply to the majority of patients seen in routine clinical settings, where more than 80% are unable to lower their cholesterol levels to the degree seen in AIM-HIGH.

“The AIM-HIGH trial was designed to study extended-release niacin or Niaspan, in a specific, narrowly defined patient population,” said Dr. Boden. “That is why the results of AIM-HIGH cannot be extrapolated to apply to a broader patient population, especially higher-risk patients admitted for heart attack or acute coronary syndrome, for example, or those whose LDL, or non-HDL levels, are not as well-controlled as those in AIM-HIGH, where prior studies have shown benefit.

“The more relevant observation is that, in this modern era of statin therapy, we’ve made profound progress in controlling LDL,” Boden continues. “However, based on these results, physicians should not assume that boosting HDL levels with Niaspan is without merit,” he added.

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