A study published April 18 in the Journal of the American College of Cardiology (JACC) titled, “Niacin and Statin Combination Therapy for Atherosclerosis Regression and Prevention of Cardiovascular Disease Events: Reconciling the AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) Trial With Previous Surrogate Endpoint Trials,” looked at the initial success of several small, randomized clinical trials of niacin plus statins. The study showed modest regression of carotid atherosclerosis is possible in individuals with cardiovascular disease, cardiovascular disease risk equivalents, or atherosclerosis. This is in the context of the failure of the AIM-HIGH trial which evaluated the impact of extended-release niacin versus placebo in patients with established atherosclerotic disease on statin therapy, with a background of low HDL-C and high triglyceride levels. The study didn’t demonstrate an incremental benefit of niacin among patients with atherosclerotic cardiovascular disease and on-treatment low-density lipoprotein cholesterol values _70 mg/dl.
The authors of the study said although low HDL-C remains a marker of residual risk even among statin-treated individuals treated to reach aggressive lipid goals (27), after AIM-HIGH, there likely will be less enthusiasm for starting niacin therapy in patients with low HDL-C who have well-controlled LDL-C. The authors noted that although the study does not mean that niacin plays no part in lipid-modifying therapy, there is no clear indication to withdraw niacin in patients receiving this therapy if further LDL-C reduction is needed.
Because there are larger ongoing clinical trials, such as the HPS2-THRIVE, Dal-OUTCOMES, REVEAL, and IMPROVE-IT, clinicians should wait for before making a final decision on whether the addition of lipid-modifying agents to background statin therapy is beneficial, the study authors recommended. They said only time will tell whether HDL-C– targeted therapeutics will live up to their hype.
In an accompanying editorial comment, “The AIM-HIGH (Atherothrombosis Intervention in Metabolic Syndrome With Low HDL/High Triglycerides: Impact on Global Health Outcomes) Trial: To Believe or Not to Believe?” the author noted how trials don’t always provide a clear answer to the question of what physicians should or should not do. Those who believe AIM-HIGH was a failure will use less niacin, and those who didn’t see the study as a failure will continue to use it, and will wait for the findings of future clinical trials to make their ultimate decision.
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