The results of the Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol 6–HDL and LDL Treatment Strategies (ARBITER 6-HALTS) trial that were recently released showed that adding extended-release niacin (Nicotinic Acid; Vitamin B3) to statin therapy led to a decrease in carotid intima–media thickness (IMT), indicating regression of atherosclerosis, but adding ezetimibe (Zetia) to statin therapy did not result in reduced IMT. However, the section of Preventive Cardiology at Cleveland Clinic is still recommending that patients continue to take ezetimibe, as it is a safe medication that effectively lowers low-density lipoprotein (LDL) cholesterol (“bad” cholesterol).
The study included 208 patients who were evaluated for 14 months. Patients were split into two groups; one group took ezetimibe and a statin. Patients in the other group took extended-release niacin and a statin. All patients had LDL levels under 100 mg/dL and coronary artery disease or coronary artery disease risk equivalents, including diabetes, a 10-year Framingham risk score of 20% or more or a coronary calcium score above 200 for women or 400 for men.
Extended-release niacin positively affects high-density lipoprotein (HDL) cholesterol (“good” cholesterol), while ezetimibe has a neutral effect on HDL. Ezetimibe remains a reasonable option for patients who are currently taking high-dose statin therapy but have not reached their LDL goal. Ezetimibe is also a reasonable option for patients who cannot tolerate statins or can only tolerate a low-dose statin. Approximately 70 percent of patients who take extended-release niacin experience side effects like skin flushing, burning and itching, which can cause some people to stop therapy.
Two ongoing clinical trials, IMProved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT) and AIM-HIGH: Niacin Plus Statin to Prevent Vascular Events (AIM-HIGH), will provide more clinical information about the benefits of these therapies. IMPROVE-IT is an ongoing clinical trial from 2005 until 2012 in which patients are taking the statin simvastatin (Zocor) alone or in combination with ezetimibe. AIM-HIGH is an ongoing clinical trial of 3,300 patients who are taking either a statin alone or Niaspan plus simvastatin and will be completed in 2010.
Taylor AJ, Villines TC, Stanek EJ, et al. Extended-Release Niacin or Ezetimibe and Carotid Intima-Media Thickness. N Engl J Med. 2009;361:2113-2122.