• Antonio J Ruffolo, Marina Romano, and Agustín Ciapponi.
• c/o Cochrane Peripheral Vascular Diseases Group, Public Health Sciences, The University of Edinburgh, Teviot Place, Edinburgh, UK, EH8 9AG.
• Cochrane Db Syst Rev. 2010 Jan 20 (1): CD006544.

BackgroundPeripheral arterial occlusive disease (PAOD) is a common cause of morbidity and mortality due to cardiovascular diseases in the general population. While numerous treatments have been adopted for different disease stages, there is no option other than amputation for patients presenting with critical limb ischaemia (CLI), unsuitable for rescue or reconstructive intervention.ObjectivesTo determine the effectiveness and safety of prostanoids in patients presenting with CLI.Search StrategyThe Cochrane Peripheral Vascular Diseases Group searched their trials register (last searched October 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (last searched 2009, Issue 4) for publications describing randomised controlled trials (RCTs) of prostanoids for CLI. We ran additional searches in MEDLINE, EMBASE, LILACS, and SciSearch, and we also contacted pharmaceutical companies and experts, in order to identify unpublished data and trials still underway.Selection CriteriaRandomised controlled trials describing efficacy and safety of prostanoids compared with placebo or other pharmacological control treatments, in patients presenting with CLI, without chance of rescue or reconstructive intervention.Data Collection And AnalysisTwo authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. Disagreements were resolved by consensus or by the third author.Main ResultsWe retrieved 532 citations which after the first screening resulted in 111 potential studies. Finally, after exclusion of studies of poor quality and a lack of sufficient information, 20 trials were included in the review.Prostanoids seem to have efficacy regarding rest-pain relief (risk ratio (RR) 1.32, 95% confidence interval (CI) 1.10 to 1.57; P = 0.003), and ulcer healing (RR 1.54, 95% CI 1.22 to 1.96). Iloprost also shows favourable results regarding major amputations (RR 0.69, 95% CI 0.52 to 0.93). The more frequently reported adverse events when using prostanoids were headache, facial flushing, nausea, vomiting and diarrhoea.Authors' ConclusionsDespite some positive results regarding rest-pain relief, ulcer healing and amputations, there is no conclusive evidence based on this meta-analysis of the long-term effectiveness and safety of different prostanoids in patients with CLI. Further well-conducted, high quality randomised double-blinded trials should be performed.

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