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Naftidrofuryl for acute stroke

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Abstract

Background

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.

Objectives

To assess the effects of naftidrofuryl in the acute phase of stroke.

Search methods

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 To identify further published, unpublished and ongoing studies we searched reference lists, handsearched conference proceedings and contacted pharmaceutical companies and authors of relevant articles.

Selection criteria

We included patients with acute ischaemic or haemorrhagic stroke clinically diagnosed by a medical practitioner with or without a computerised tomography (CT) scan.

Data collection and analysis

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.

Main results

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).

Authors' conclusions

There is not enough evidence to support the use of naftidrofuryl in the treatment of acute ischaemic or haemorrhagic stroke.

PICOs

Population
Intervention
Comparison
Outcome

The PICO model is widely used and taught in evidence-based health care as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses. PICO stands for four different potential components of a clinical question: Patient, Population or Problem; Intervention; Comparison; Outcome.

See more on using PICO in the Cochrane Handbook.

Plain language summary

Naftidrofuryl for acute stroke

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.