A double-blind trial of suloctidil v. Placebo in intermittent claudication

Abstract

In a recent double-blind trial lasting over 6 months, 40 patients suffering from intermittent claudication were randomly allocated to receive 300 mg of suloctidil per day or exactly matching placebo capsules. In addition to treadmill walking distance, other objective criteria including ankle blood pressure response and muscle blood flow measured by 133Xe clearance were used to assess the effectiveness of therapy. Nine patients (4 in the suloctidil group and 5 controls) did not complete the trial according to the protocol. Of the remaining 31 patients, 17 were in the control group and 14 received suloctidil. A significant improvement in the absolute walking distance, the level of beta-thromboglobulin (beta TG) compared to pre-therapy value and the time for the ankle pressure index to return to the pre-exercise value was observed in patients receiving suloctidil.

Systematic review of antiplatelet therapy for the prevention of myocardial infarction, stroke or vascular death in patients with peripheral vascular disease

“…This represented 5 per cent of the ADEP patients but there was no difference in percentage of patients lost to follow-up in the antiplatelet or placebo groups. In eight studies 27,32,44,48,50,51,56,59 patients lost to follow-up accounted for 5 per cent or less of the respective study populations. In four trials 24,39,46,64 patients lost to follow-up accounted for more than 10 per cent of the respective study populations.…”

“…Five trials of one antiplatelet treatment (aspirin) against another antiplatelet regimen (aspirin Mortality data were available either from the published study or through contact with the authors. In 12 studies there were no deaths in either the antiplatelet or placebo groups 23,31,33,34,46,48,51,53,60,61,63,64 .…”

Stimulation of prostacyclin production in blood vessels by the antithrombotic drug suloctidil

“…The antithrombotic action of suloctidil has been demon strated in a variety of animal models of thrombosis: it decreases the incidence of occlusive thrombi in the fémoral artery of dogs, foUowing a localized removal of the endothelium, and reduces the incidence and severity of expérimental hepatic thrombophlebitis in rats [3]. This antithrombotic activity can be explained, at least partially, by an inhibitory effect on platelet aggregation, which has been demon strated in vivo in animais and man: oral suloctidil reduces the spontaneous formation of circulating platelet aggregates in aged breeder rats [4], nor malizes the reduced platelet survival time in patients bearing prosthetic heart valves [5,6] and reduces the plasma level of )Sthromboglobulin in patients with intermittent claudication [7]. It has been very difficult to reproduce in vitro the antiplatelet effect of suloc tidil observed in vivo: whereas the ex vivo aggre gation, induced by threshold concentrations of col lagen in plateletrich plasma samples from volunteers, was inhibited after suloctidil ingestion, very large concentrations (>10 fiM) of suloctidil pro duced only a slight inhibition of platelet aggregation in vitro [8].…”

Antithrombotic Drugs in the Primary Medical Management of Intermittent Claudication: A Meta-analysis

“…Total walking distance was assessed with aspirin (22), ticlopidine (17,30), suloctidil (34)(35)(36), indobufen (41), and defibrotide (58-60), and results were similar to those observed for pain-free walking distance, but did not reach statistical significance, except for indobufen and defibrotide, which increased total walking distance for a (common) difference of the means equal to 98.3 m (95% C.I., 49.2-147), and to 88.8 m (95% C.I., 45-132.6), respectively (41,(58)(59)(60). In one study (43), triflusal increased total walking distance of 53.2 m compared to placebo (p = 0.05).…”