Ruffolo AJ, Romano M, Ciapponi A, et al.
The Cochrane database of systematic reviews. Date of publication 2010 Jan 20;volume (1):CD006544.
1. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD006544. doi:
10.1002/14651858.CD006544.pub2.
Prostanoids for critical limb ischaemia.
Ruffolo AJ(1), Romano M, Ciapponi A.
Author information:
(1)c/o Cochrane Peripheral Vascular Diseases Group, Public Health Sciences, The
University of Edinburgh, Teviot Place, Edinburgh, UK, EH8 9AG.
Update in
Cochrane Database Syst Rev. 2018 Jan 10;1:CD006544.
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unpublished data and trials still underway.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.
DOI: 10.1002/14651858.CD006544.pub2
PMID: 20091595 [Indexed for MEDLINE]
