The study, called HDL and LDL Treatment Strategies, or HALTs, was ended early in June. Clinical trials are generally ended early if a safety issue arises, but in this case the less common reason was used: when a measure of success is achieved.
It was discovered in the trial that LDL-cholesterol-lowering Zetia was less effective than extended-release niacin (Niaspan), which alternatively raises HDL, or "good," cholesterol levels, in reducing plaque build-up in arteries. The study compared niacin with a statin vs. Zetia with a statin. The niacin combo reduced carotid arterial wall thickness in the neck, which is used as a gauge of atherosclerosis, by an average of 014 of a millimeter. In contrast, the Zetia group showed no significant changes.
However, in both cases LDL was reduced. In the case of Zetia, it was reduced by 18 mg per dl, nearly double that of niacin (10 mg per dl).
The study, TS, involved 363 men and women, and was shut down after only 208 study participants had completed the full treatment timeline of 14 months. Notably, the study was funded by pharmaceutical company Abbott Laboratories, which makes Niaspan. Merck makes Zetia.
While the Zetia / niacin trial results were released Sunday, a press release on Monday criticized the decision to terminate the Zetia / niacin study early. That press release came from Johns Hopkins.
The press release noted that an editorial will be published alongside the Zetia / niacin study in The New England Journal of Medicine online Nov. 16 and presented jointly at a news conference at the American Heart Association's (AHA) annual Scientific Sessions in Orlando. Besides criticizing the early termination of the study, with 40% of participants omitted, the editorial's author, Hopkins cardiologist Roger Blumenthal, M.D. noted that he is not convinced.
"Although study results are provocative, I am not convinced. These early results offer no conclusive evidence that niacin along with a statin will actually lower the number of deaths and incidents of heart attack from coronary artery disease down the road."
Meanwhile, the study's author, Dr. Allen Taylor, director of Advanced Cardiovascular Imaging and the Lipid/Prevention Clinic at Washington Hospital Center in Washington, D.C., said at a Sunday afternoon news conference that:
"This trial provides a clear and undeniable statement on the superior clinical effectiveness of niacin over ezetimibe."
Taylor was careful to caution against using OTC niacin vs. Niaspan. Niaspan is extended-release, and prescription-grade, vs. OTC niacin which Taylor warned "is not considered a useful alternative to prescription niacin. Its safety and efficacy are unknown."
Written by Michael Santo
Posted November 16th, 2009 by Michael Santo
