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Evidence summaries

Buflomedil for Intermittent Claudication

Buflomedil may improve pain free and maximum walking distance in intermittent claudication, but causes severe adverse effects at overdoses and has a narrow therapeutic range. Level of evidence: "C"

The quality of evidence is downgraded by study quality (unclear allocation concealment) and by potential publication bias.

Buflomedil is not recommended for intermittent claudication.

The balance between benefit and risk for buflomedil in the symptomatic treatment of intermittent claudication is unfavourable.

Summary

A Cochrane review [Abstract] 1 included 2 studies with a total of 127 subjects. Both studies showed moderate improvements in pain-free walking distance for patients on buflomedil. This improvement was statistically significant for both trials (WMD 75.1 m, 95% CI 20.6 to 129.6; WMD 80.6 m, 95% CI 3.0 to 158.2), the latter being a wholly diabetic population. For both studies, maximum walking distance gains were statistically significant with wide confidence intervals (WMD 80.7 m, 95% CI 9.4 to 152; WMD 171.4 m, 95% CI 51.3 to 291.5), respectively. Recent safety concerns have been raised about buflomedil because of lethal and non-lethal neurologic and cardiovascular adverse events in cases of accidental and voluntary overdoses2 3. The authors conclude that buflomedil's benefit is small in relation to safety issues and its narrow therapeutic range.

Note

European Medicines Agency recommended suspension of all buflomedil-containing medicines in November 2011 (see http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/11/news_detail_001388.jsp&mid=WC0b01ac058004d5c1).

Primary/Secondary Keywords