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European Heart Journal 2004 25(20):1845-1852; doi:10.1016/j.ehj.2004.07.013
Copyright © 2004 by the European Society of Cardiology.
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Clinical research

Picotamide, a combined inhibitor of thromboxane A2 synthase and receptor, reduces 2-year mortality in diabetics with peripheral arterial disease: the DAVID study

Gian Gastone Neri Serneria, Sergio Coccherib,*, Ettore Marubinic and Francesco Violid for the Committees and the Investigators of the Drug Evaluation in Atherosclerotic Vascular Disease in Diabetics (DAVID) Study Group

a University of Florence, Italy
b University of Bologna, Italy: Hospital St. Orsola, Paol. 24 40138, Bologna
c University of Milan, Italy
d University "La Sapienza", Rome, Italy

Received February 19, 2004; revised June 10, 2004; accepted July 1, 2004 * Corresponding author. Tel./fax: +39 51 6364668 (E-mail: trombosi{at}orsola-malpighi.med.unibo.it).

See page 1769 for the editorial comment on this article (doi:10.1016/j.ehj.2004.08.008)

Aims Patients with diabetes are at excessive risk of mortality and cardiovascular morbidity. Previous studies suggest that aspirin may be less effective in diabetic patients. In this multi-centre, randomized, double blind trial picotamide, a dual inhibitor of thromboxane A2 synthase and receptor, was compared with aspirin for the prevention of mortality and major cardiovascular events in diabetics with peripheral arterial disease (PAD).

Methods and results A total of 1209 adults aged 40–75 years with type 2 diabetes and PAD were randomized to receive picotamide (600 mg bid) or aspirin (320 mg od) for 24 months. The cumulative incidence of the 2 years overall mortality was significantly lower amongst patients who received picotamide (3.0%) than in those who received aspirin (5.5%) with a relative risk ratio for picotamide versus aspirin of 0.55 (95% CI: 0.31–0.98%). Events were reported in 43 patients (7.1%) on picotamide and 53 (8.7%) on aspirin. The combined endpoint of mortality and morbidity had a slightly lower incidence in the picotamide group but this difference did not reach statistical significance.

Conclusion Picotamide is significantly more effective than aspirin in reducing overall mortality in type 2 diabetic patients with associated PAD.


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