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Published on: September 22, 2020
Prostanoids for critical limb ischaemia
Antonio J Ruffolo1, Marina Romano, Agustín Ciapponi
1c/o Cochrane Peripheral Vascular Diseases Group, Public Health Sciences, The University of Edinburgh, Teviot Place, Edinburgh, UK, EH8 9AG.
Insights
Prostanoids may help with critical limb ischaemia (CLI) symptoms like pain and ulcers, and potentially reduce amputations. However, more high-quality research is needed to confirm their long-term effectiveness and safety.
Area of Science:
- Vascular Medicine
- Pharmacology
- Clinical Trials
Background:
- Peripheral arterial occlusive disease (PAOD) is a significant contributor to cardiovascular morbidity and mortality.
- Critical limb ischaemia (CLI) often necessitates amputation due to limited treatment options for patients unsuitable for intervention.
Purpose of the Study:
- To evaluate the efficacy and safety of prostanoids in managing critical limb ischaemia (CLI).
- To synthesize evidence from randomized controlled trials (RCTs) on prostanoid treatment for CLI.
Main Methods:
- Comprehensive literature search of multiple databases (Cochrane, MEDLINE, EMBASE, etc.) up to October 2009.
- Inclusion of 20 randomized controlled trials (RCTs) comparing prostanoids with placebo or other treatments for CLI.
- Independent data extraction and quality assessment by two authors.
Main Results:
- Prostanoids demonstrated efficacy in relieving rest pain (RR 1.32, 95% CI 1.10-1.57) and promoting ulcer healing (RR 1.54, 95% CI 1.22-1.96).
- Iloprost showed a trend towards reducing major amputations (RR 0.69, 95% CI 0.52-0.93).
- Common adverse events included headache, facial flushing, nausea, vomiting, and diarrhea.
Conclusions:
- Prostanoids show potential benefits for CLI symptoms, including pain relief, ulcer healing, and possibly reducing amputations.
- Current meta-analysis lacks conclusive evidence on the long-term effectiveness and safety of various prostanoids for CLI.
- Further high-quality, randomized, double-blinded trials are essential to establish definitive conclusions.
Background:
Peripheral 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.
Objectives:
To determine the effectiveness and safety of prostanoids in patients presenting with CLI.
Search Strategy:
The 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 Criteria:
Randomised 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 Analysis:
Two 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 Results:
We 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' Conclusions:
Despite 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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