A meta‐analysis of randomized, double‐blind, placebo‐controlled studies of the effect of buflomedil on intermittent claudication

Abstract

A meta-analysis was performed on the results of clinical trials of buflomedil in intermittent claudication. The analysis used results from 744 patients enrolled in ten studies, conducted at 42 centers in seven countries. All studies were randomized, double-blind, placebo-controlled trials which measured improvement in "pain-free" walking distance by treadmill ergometry as the primary measure of efficacy. The meta-analysis results were based on "effect size", a standardized difference in mean response between buflomedil and placebo. Results demonstrated a statistically superior response to buflomedil compared with placebo, indicating that the average buflomedil treated patient was likely to have a greater improvement in walking distance than at least 60% of the placebo treated patients. Results were corroborated using various weighting schemes proportional to study quality ratings and sample sizes.

Randomized double-blind placebo-controlled crossover study of caffeine in patients with intermittent claudication

“…The 20·0 per cent increase in PWD and 26·6 per cent increase in MWD seen after treatment with caffeine matched the results obtained following the administration of lipid‐lowering agents3. However, the results of the present study exceeded those obtained in similar trials that compared vasoactive agents (buflomedil, naftidrofuryl and pentoxifylline) with placebo1, 2, 4, 19, except for an increase in PWD by 37 per cent after treatment with naftidrofuryl, which was based on individual data2. The level of daily activity is usually limited by the onset of pain (PWD) and not by the maximally tolerated discomfort.…”

Prise en compte des cas d’intoxication aiguë notifiés aux centres antipoison et de toxicovigilance dans l’évaluation du bénéfice/risque du buflomédil

“…Les bénéfices attendus pour le patient traité sont moins évidents : peu d'études cliniques ont démontré un effet thérapeutique [7,8]. Pourtant, le libellé de l'autorisation de mise sur le marché (AMM) mentionne, en 1977, pour la forme orale, une indication pour le traitement symptomatique de « l'insuffisance circulatoire artérielle des membres et des troubles vasomoteurs des extrémités (syndrome de Raynaud) » (Vidal 1977).…”

Safety profile assessment of buflomedil: an overview of adverse reactions between 1975 and 2011

“…7 Buflomedil is principally indicated for use in the symptomatic treatment of peripheral arterial occlusive disease (PAD, Fontaine Stage II, intermittent claudication), in addition to other adequate medical treatment, including anti-platelet therapy. 8,9 Buflomedil has also been indicated for other aspects of peripheral vascular disease (PVD) than intermittent claudication, including more severe PVD, for example arterial circulatory insufficiency in limbs, Raynaud's syndrome and disease, Buerger's disease, erythrocyanosis. Additionally, over its time on the market and in various territories, buflomedil has been indicated for manifestations of cerebrovascular disease and insufficiency, for example: vertigo, tinnitus, mental deterioration, personality disorders, lability of memory and of capacity to concentrate, spatiotemporal disorientation, sequelae of cerebral apoplexy and of neurosurgical interventions.…”