Robert Filice, M.D. - Dr. Bob's Newsletter

Cholesterol and Niacin
Here’s a recent study you probably didn’t hear about on TV! Both groups of patients were taking statin drugs, while only the group treated with time release niacin showed a dramatic reduction in adverse cardiovascular events, and lack of progression of atherosclerotic thickening of the carotid artery measured by intima-media thickness over the study period of one year.

Only 3 adverse events occurred among the 87 study subjects (3.8%), while 7 (9.6%) occurred in the 80 member “placebo”, i.e., statin, group.

This study is remarkable for it’s lack of media impact and for the fact that niacin outperformed statins over two critical variables.

The other thing I find really interesting is why the authors called the statin only group the “placebo” group, and why they didn’t include a true placebo group of patients with known coronary artery disease who were not taking statins or niacin. My guess is they were afraid the true placebo group might outperform or equal the results of the statin only group. That result has been found  in other non-biased studies of the statin drugs.

Below is the study abstract/summary:

“Arterial Biology for the Investigation of the Treatment Effects of Reducing Cholesterol (ARBITER) 2: A Double-blind, Placebo-Controlled Study of Extended-Release Niacin on Atherosclerosis Progression in Secondary Prevention Patients Treated With Statins,” Taylor AJ, Sullenberger LE, et al, Circulation, December 7, 2004;110:3512-3517.

In a study of 167 subjects with known coronary heart disease and low levels of HDL cholesterol (<45 mg/dl), 74 male and 6 female subjects (mean age 68 years) received placebo, while 78 male and 9 female subjects (mean age 67 years) received 500 mg/day of Niaspan, which is an extended-release niacin, for 30 days, which was then increased to 1,000 mg/day for the next 11 months in conjunction with the subject’s daily aspirin. Subjects were strongly encouraged not to take vitamin C or vitamin E. Baseline carotid intima-media thickness at 0.884 mm, LDL cholesterol at 89 mg/dl, and HDL cholesterol at 40 mg/dl were comparable in the placebo and niacin groups at baseline. There was a more than 90% compliance with the niacin group, and 89.2% of the total subjects completed this study. In the niacin group, the HDL cholesterol increased 21% from 39 to 47 mg/dl; and mean carotid intima-media thickness increased significantly in the placebo group at 0.044 mm, while it was unchanged in the niacin group at 0.014 mm. Cardiovascular events occurred in 3 patients treated with the niacin at 3.8% and 7 patients treated with placebo at 9.6%. All of the subjects were taking statin drugs.

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