A new study has revealed that there is insufficient data from randomised trials to draw a conclusion as to whether statins are safe and effective in cases of acute ischemic stroke and transient ischemic attack (TIA).
The authors of this study (Squizzato et al) searched the Cochrane Stroke Group's Trials Register (November 2010); the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 4); MEDLINE (1950 to November 2010); and EMBASE (1980 to November 2010). They included all randomised controlled trials (RCTs) comparing statins (any type and dosage) versus placebo or no treatment, administered within two weeks of the onset of acute ischemic stroke or TIA. Two review authors independently selected studies for inclusion and extracted data.
The authors assessed methodological quality and, when necessary, contacted study authors for additional data. They based quantitative analysis of outcome on the intention–to–treat principle. The primary outcomes were mortality from ischemic stroke and mortality from adverse drug effects, bleedings and infections. The authors estimated the overall treatment effect by the pooled odds ratio (OR) with 95% confidence interval (CI) using a fixed–effect model (Mantel–Haenszel). Eight RCTs involving 625 participants were included in the study.
The results of this analysis were that only one study was judged as 'low risk' of bias. Furthermore, there were insufficient published data from the eight studies for all planned primary and secondary outcomes. No patients died from ischemic stroke or from adverse drug effects, bleeding or infections among the 444 participants in the six studies where these outcomes were reported. Statin treatment did not reduce all–cause mortality compared with placebo or no treatment (OR 1.51, 95% CI 0.60 to 3.81) in the 431 patients enrolled in seven studies.