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


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.


CONCLUSIONS
Picotamide is significantly more effective than aspirin in reducing overall mortality in type 2 diabetic patients with associated PAD.
University of Florence, Italy.
Gian Gastone
GG
Neri Serneri
Sergio
S
Coccheri
Ettore
E
Marubini
Francesco
F
Violi
D000328:Adult; D000368:Aged; D001241:Aspirin / Q000627:therapeutic use; D003925:Diabetic Angiopathies / Q000188:drug therapy* / Q000401:mortality; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000188:drug therapy* / Q000401:mortality; D010795:Phthalic Acids / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*; D012307:Risk Factors; D016019:Survival Analysis; D013928:Thromboxane A2 / Q000037:antagonists & inhibitors*
D010795:Phthalic Acids; D010975:Platelet Aggregation Inhibitors; D013928:Thromboxane A2; C011581:picotamide; D001241:Aspirin