THE EFFECT OF NIMESULIDE VERSUS PLACEBO ON HEMOSTASIS IN HEALTHY-VOLUNTEERS

Objective: The primary objective was to evaluate the effect of 7 days treatment with nimesulide on bleeding time. Blood coagulation, von Wil lebrand factor and platelet aggregation ex vivo were investigated as a secondary objective. Method: A randomised, double-blind, placebo-cont rolled, parallel group, single centre study performed on 20 healthy ma le volunteers who received either placebo or nimesulide 100 mg twice d aily for 7 days. Bleeding time, platelet count and platelet aggregatio n, thromboplastin time (prothrombin time), activated partial thrombopl astin time, fibrinogen, Factor VIII:C, vWF:Ag, vWF:RCof and platelet-r ich plasma aggregation following stimulation with adenosine 5'-diphosp hate, collagen, arachidonic acid, ristocetin, thrombin and thrombin re ceptor-activating peptide were measured at baseline (day 0), and then 3 h after the first (day 1) and last (day 7) treatment. Results: The b leeding times for all subjects remained within the normal range throug hout the study period, with no significant differences between the two treatment groups. There were no significant changes from baseline in platelet aggregation studies or in any of the other haemostasis tests, with no significant differences between the two groups. No clinically significant adverse events were reported or observed. Conclusions: Da ily administration of 200 mg nimesulide for 7 days neither prolongs bl eeding time nor modifies any of the other haemostasis variables measur ed. The lack of interactions with important haemostatic mechanisms sug gests that nimesulide may also be used in patients with bleeding probl ems. This expectation has still to be confirmed by clinical experience .