FRIDAY, Feb. 20 (HealthDay News) -- The investigational drug A-002 may be an effective anti-atherosclerotic agent because it reduces levels of secretory phospholipase A2 (sPLA2) enzymes, plasma lipoproteins, and inflammatory biomarkers, according to a study published in the Feb. 21 issue of The Lancet.
Robert S. Rosenson, M.D., of the University of Michigan in Ann Arbor, and colleagues randomly assigned 393 patients with stable coronary heart disease to receive either placebo or one of four doses of A-002 (50 mg, 100 mg, 250 mg or 500 mg) twice a day for eight weeks.
Overall, the researchers found that A-002 was associated with significant reductions in mean sPLA2-IIA concentrations compared to placebo (86.7 percent versus 4.8 percent). They found that the reductions ranged from 69.2 percent in the 50 mg group to 95.8 percent in the 500 mg group, and were associated with lower levels of plasma lipoproteins and inflammatory biomarkers. Although they observed one serious adverse event in the 500 mg group, a similar proportion of the treatment and placebo groups reported adverse effects. In the treatment group, the most common side effects included headache, nausea, and diarrhea.
"The reduction in low-density lipoprotein cholesterol, C-reactive protein, arachidonic acid, and oxidized low-density lipoprotein cholesterol resulting from A-002 treatment over a background of statin therapy is potentially clinically relevant," the authors write. "Furthermore, combined use of A-002 with a statin may have complementary benefits."
The study was funded by Anthera Pharmaceuticals, and several co-authors have financial ties to Anthera.
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