Stroke is the third most common cause of death and the commonest cause of disability in the western world. Stroke greatly adds to the burden on patients, carers, medical practitioners and health resources. The development of drugs to limit brain damage caused by stroke continues but no routine effective treatment has yet been identified. In previous years, naftidrofuryl has been considered as a potential treatment for acute stroke, but has been withdrawn from the market in the UK. This systematic review of six trials, involving 1274 participants, found there was not enough data to draw conclusions about the effectiveness of naftidrofuryl relating to survival or disability in the treatment of acute stroke.
There is not enough evidence to support the use of naftidrofuryl in the treatment of acute ischaemic or haemorrhagic stroke.
Stroke is the third most common cause of death and the most common cause of disability in the western world. The development of drugs to limit the effects of brain damage caused by stroke continues but no routine effective treatment has yet been identified. Naftidrofuryl has been reported to be beneficial in the treatment of acute stroke in some studies, but it is unclear whether all of the evidence supports these findings.
To assess the effects of naftidrofuryl in the acute phase of stroke.
We searched the Cochrane Stroke Group Trials Register (last searched November 2006); the Cochrane Central Register of Controlled Trials (CENTRAL), the Cochrane Database of Systematic Reviews, and the Database of Abstracts of Reviews of Effects (The Cochrane Library Issue 2, 2006); MEDLINE (1966 to July 2006); EMBASE (1980 to July 2006); Science Citation Index (1981 to July 2006); National Research Register (July 2006); LILACS Database (1982 to July 2006); metaRegister of Controlled Trials (mRCT) (July 2006); SUMsearch (July 2006). To identify further published, unpublished and ongoing studies we searched reference lists, handsearched conference proceedings and contacted pharmaceutical companies and authors of relevant articles.
We included patients with acute ischaemic or haemorrhagic stroke clinically diagnosed by a medical practitioner with or without a computerised tomography (CT) scan.
Two authors independently selected trials for inclusion, assessed trial quality, and extracted data using data extraction forms or, if available, re-analysed individual patient data.
Six trials involving 1274 participants were included. We found no significant benefits of naftidrofuryl compared with placebo in reducing the risks of mortality (pooled odds ratio (OR) 1.03, 95% confidence interval (CI) 0.78 to 1.36, six studies) or combined death or dependency/disability (pooled OR 0.94, 95% CI 0.70 to 1.16, three studies). Pooled results showed naftidrofuryl had no significant effect on systolic, diastolic or mean arterial blood pressure. No trials reported the effects of naftidrofuryl on the risk of early death or deterioration, quality of life, stroke recurrence, or discharge site. However, we found a trend towards an increase in risk of minor adverse events in patients taking naftidrofuryl (OR 1.99, 95% CI 0.96 to 4.11, P = 0.06).