Safety of picotamide, an antiplatelet agent, in an 18-month, double-blind, placebo-controlled, multicenter trial in 2304 patients with peripheral vascular disease

摘要: Abstract A double-blind, placebo-controlled, multicenter clinical trial was carried out in 2304 patients with peripheral vascular disease to assess the effectiveness and safety of picotamide, a new antiplatelet agent, 300 mg orally TID, comparison placebo for an 18-month period. The treatments assessed by comparing incidence cardiovascular events (ie, death, myocardial infarction, stroke, amputation, angina, transient ischemic attack [TIA]) during study. monitoring adverse reactions (ADRs) terms their severity, duration, relationship treatment, evolution, consequences. ADRs were classified according World Health Organization coding system. Blood pressure, electrocardiogram (ECG), routine laboratory tests also monitored throughout Eighty-four percent males, aged between 40 75 years. One hundred sixty-five 1150 receiving picotamide (14.3%) 156 1154 (13.5%) complained at least one ADR. total number reported case report forms 240 239 placebo. most frequent abdominal pain (8.3%), nausea (1.3%), headache (1.1%), pruritus (1.0%), vertigo (0.8%), similar Thirty-one required withdrawal from study (18 13 placebo), while 34 as severe even if they did not require withdrawal. Only 17 these 65 considered probably or possibly related treatment (nine eight placebo). No relevant changes found blood ECG, evaluations treatment. In present shown be effective well-tolerated drug, that lower than other drugs same class. This confirms profile based on toxicologic pharmacokinetic data.