[Evaluation of the efficacy and tolerance of naftidrofuryl in patients presenting with exertional angina. Multicenter double-blind versus placebo study]. / Evaluation de l'efficacité et tolérance du naftidrofuryl chez des patients présentant un angor d'effort. Etude multicentrique double-aveugle versus placebo.

Due to its vascular and platelet 5-HT2 receptor antagonist properties and its metabolic properties, naftidrofuryl specifically counteracts local ischaemic phenomena. One of its major indications is the treatment of intermittent claudication, but it is well known that peripheral arterial disease is the sign of diffuse arterial disease, associated with particularly lethal coronary disease. Recent studies increasingly implicate serotonin (5-HT) in coronary ischaemic processes. In view of the similarities between these pathophysiological data and the characteristics of this molecule, we decide to evaluate the coronary protection afforded by naftidrofuryl and its safety. This multicentre double-blind placebo-controlled study was conducted in 51 patients over a period of one month. Inclusion criteria were stable angina with an electrically positive stress test, despite antianginal treatment either by beta-blocker or by calcium channel blocker. Follow-up comprised clinical assessment and a stress test on inclusion and at 1 month. The groups were comparable on inclusion. Overall, the results showed a greater improvement with naftidrofuryl than with reference treatment for all parameters studied. Significant differences were observed in favour of the verum group for time to onset of ST depression, the maximum level reached, the number of stress tests which became negative and the patient's global assessment. No problems of interaction with concomitant treatments, particularly beta-blockers, calcium channel blockers or antiarrhythmics was observed. This study shows that naftidrofuryl allows improvement of ergometric parameters and especially elevation of the ischaemic threshold on exertion.

The effect of naftidrofuryl on transcutaneous oxygen tension during a treadmill test in patients with peripheral arterial occlusive disease.

Tissue hypoxaemia can be evaluated by the noninvasive method of transcutaneous oxygen tension (tcpO2) measurement in patients with peripheral arterial occlusive disease (PAOD). The effects of naftidrofuryl (Praxilene) on exercise-induced tissue ischaemia was objectively assessed by continuously measuring the tcpO2 in 30 patients during three treadmill tests over a 3-month period in a randomized double-blind, placebo controlled, parallel group study. To be included in the study, the tcpO2 and total walking distance had to be stable during the washout period (D-15-D0). The area under the tcpO2 curves was scanned and automatically calculated after identification of baseline and the end of the treadmill test. The treadmill test on D30 and D90 was terminated at a similar walking distance to that obtained on D0. On D0 both groups were comparable (p = 0.22). The area under the curve (AUC) reduced significantly in the naftidrofuryl group between D0 and D30 (p < 0.001) and D0 and D90 (p < 0.001). However, no significant tcpO2 AUC reduction was found in the placebo group (D0-D30, p = 0.58; D0-D90, p = 0.50). This was confirmed by calculation of the percentage of patients whose percentage change in the AUC on D90 was higher than the upper limit of the 90% confidence interval, calculated from the percentage change over the washout period. Of the 15 patients receiving natfidrofuryl, 66.6% exceeded this upper limit, compared with only 7% of patients receiving placebo (p = 0.0017). This study shows that naftidrofuryl has a protective effect on exercise-induced tissue ischaemia as measured by the tcpO2 AUC in PAOD stage II patients.