[Evaluation of the efficacy and tolerance of naftidrofuryl in patients presenting with exertional angina. Multicenter double-blind versus placebo study].
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.
Hirsch
J L
JL
Service de Cardiologie, Centre Hospitalier Général, 305, rue Raoul Follereau, 84000 Avignon.
Bensoussan
J J
JJ
Mosnier
M
M
Lehert
P
P
D000319:Adrenergic beta-Antagonists / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000787:Angina Pectoris / Q000175:diagnosis / Q000188:drug therapy*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D004311:Double-Blind Method; D004562:Electrocardiography; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009257:Nafronyl / Q000494:pharmacology / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000494:pharmacology / Q000627:therapeutic use*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000494:pharmacology / Q000627:therapeutic use*
D000319:Adrenergic beta-Antagonists; D000889:Anti-Arrhythmia Agents; D002121:Calcium Channel Blockers; D012702:Serotonin Antagonists; D014665:Vasodilator Agents; D009257:Nafronyl