TUESDAY, March 17 (HealthDay News) -- Pactimibe treatment does not improve atherosclerosis and leads to an increase in the incidence of major cardiovascular events in patients with hereditary high cholesterol compared with placebo, according to a study in the March 18 issue of the Journal of the American Medical Association.
Marijn C. Meuwese, M.D., from Academic Medical Center in Amsterdam, the Netherlands, and colleagues randomly assigned 892 patients heterozygous for familial hypercholesterolemia to 100 mg/day of pactimibe or placebo in addition to standard lipid-lowering therapy. The drug inhibits acyl coenzyme A:cholesterol acyltransferase (ACAT), which is involved in cholesterol accumulation, they note.
The researchers found that after six months, low-density lipoprotein cholesterol significantly increased in patients treated with pactimibe versus placebo (7.3 versus 1.4 percent). In the 716 patients who had ultrasound carotid intima-media thickness (CIMT) measurements taken at least 40 weeks apart, maximum CIMT was similar in the two groups, but mean CIMT increased by a significant 0.004 mm in patients receiving pactimibe compared with placebo. Significantly more patients in the pactimibe group experienced major cardiovascular events (cardiovascular death, myocardial infarction, and stroke, 2.3 versus 0.2 percent). The trial was terminated prematurely after a follow-up of 15 months due to lack of efficacy of pactimibe, according to the study.
"In patients with familial hypercholesterolemia, pactimibe had no effect on atherosclerosis as assessed by changes in maximum CIMT compared with placebo but was associated with an increase in mean CIMT as well as increased incidence of major cardiovascular events," Meuwese and colleagues conclude.
The study was sponsored by Daiichi Sankyo Pharma Development (formerly Sankyo Pharma Development). Several study authors reported financial ties to it and other pharmaceutical companies.
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