WEDNESDAY, March 22 (HealthDay News) -- Pactimibe is ineffective for reducing atherosclerosis and may even be harmful for some patients, according to the results of a phase 3 trial published in the March 23 issue of the New England Journal of Medicine.
Steven E. Nissen, M.D., from the Cleveland Clinic Foundation in Ohio, and the ACAT Intravascular Atherosclerosis Treatment Evaluation (ACTIVATE) Investigators performed intravascular ultrasonography in 408 patients with angiographically documented coronary disease, before and after treatment with pactimibe or placebo for 18 months. Pactimibe is an ACAT (acyl-coenzyme A:cholesterol acyltransferase) inhibitor.
Pactimibe had no effect on atheroma growth compared with placebo, and there was even a trend towards worsening atherosclerosis. Furthermore, the vascular segment with the most severe disease regressed in patients taking placebo but stayed about the same in those taking pactimibe. There were no differences in adverse cardiovascular outcomes, probably due to the short duration of the study.
"A bold conclusion can be drawn from the study by Nissen et al.: nonselective ACAT inhibition is an ineffective anti-atherosclerosis therapy and is probably harmful," write Sergio Fazio, M.D., Ph.D., and MacRae Linton, M.D., in an accompanying editorial. They add that "ACAT inhibition may have catastrophic effects in patients with hypercholesterolemia."
The study was funded by Sankyo Pharma, Tokyo.
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