Ea. Belgrano et al., Prostanoids for chronic critical leg ischemia - A randomized, controlled, open-label trial with prostaglandin E-1, ANN INT MED, 130(5), 1999, pp. 412
Citations number
19
Categorie Soggetti
General & Internal Medicine","Medical Research General Topics
Background: No effective pharmacologic intervention is available for critic
al leg ischemia, a severe clinical condition associated with high morbidity
and mortality.
Objective: To assess the safety and efficacy of prostaglandin E-1 in improv
ing the prognosis and quality of life in patients with critical leg ischemi
a.
Design: Multicenter, centrally randomized, controlled, open-label trial.
Setting: 56 vascular surgery and angiology departments of the Italian Natio
nal Health Service.
Patients: 1560 patients with chronic critical leg ischemia.
Interventions: In addition to routine treatments practiced in each center,
patients were randomly assigned to receive either a daily intravenous infus
ion of 60 mu g of prostaglandin E-1 in the form of alprostadil-alpha-cyclod
extrine (n = 771) or no prostaglandin E-1 (n = 789) during their hospital s
tay. The treatment period lasted for up to 28 days.
Measurements: A combined end point consisting of death and peripheral and c
ardiocerebrovascular illness (major amputation or persistence of critical l
eg ischemia, acute myocardial infarction, or stroke) evaluated at hospital
discharge and during 6 months of follow-up.
Results: The incidence of the combined outcome measure was lower in the alp
rostadil group than in controls at hospital discharge (493 [63.9%] patients
compared with 581 [73.6%] patients; relative risk, 0.87 [95% CI, 0.81 to 0
.93]; P < 0.001) but differed only modestly at 6 months (348 of 661 [52.6%]
patients compared with 387 of 673 [57.5%] patients; relative risk, 0.92 [C
I, 0.83 to 1.01]; P = 0.074). Most of the observed benefit was due to recov
ery from critical leg ischemia.
Conclusions: Short-term treatment with alprostadil-alpha-cyclodextrine prov
ides patients with critical leg ischemia clinical benefit that is apparent
in the short term but decreases over time.