...Background: No effective pharmacologic intervention is available for critical leg ischemia, a severe clinical condition associated with high morbidity and mortality. Objective: To assess the safety and efficacy of prostaglandin E1 in improving the prognosis and quality of life in patients with critical leg ischemia. Design: Multicenter, centrally randomized, controlled, open-label trial. Setting: 56 vascular surgery and angiology departments of the Italian National 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 infusion of 60 μg of prostaglandin E1 in the form of alprostadil-α-cyclodextrine (n = 771) or no prostaglandin E1 (n = 789) during their hospital stay. The treatment period lasted for up to 28 days. Measurements: A combined end point consisting of death and peripheral and cardiocerebrovascular illness (major amputation or persistence of critical leg 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 alprostadil 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 [CI, 0.83 to 1.01]; P = 0.074). Most of the observed benefit was due to recovery from critical leg ischemia. Conclusions: Short-term treatment with alprostadil-αcyclodextrine provides patients with critical leg ischemia clinical benefit that is apparent in the short term but decreases over time.

Prostanoids for chronic critical leg ischaemia. A randomized, controlled, open label trial with prostaglandin E1 / Bertele, V. - In: ANNALS OF INTERNAL MEDICINE. - ISSN 0003-4819. - STAMPA. - 130:(1999), pp. 412-421.

Prostanoids for chronic critical leg ischaemia. A randomized, controlled, open label trial with prostaglandin E1.

1999

Abstract

...Background: No effective pharmacologic intervention is available for critical leg ischemia, a severe clinical condition associated with high morbidity and mortality. Objective: To assess the safety and efficacy of prostaglandin E1 in improving the prognosis and quality of life in patients with critical leg ischemia. Design: Multicenter, centrally randomized, controlled, open-label trial. Setting: 56 vascular surgery and angiology departments of the Italian National 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 infusion of 60 μg of prostaglandin E1 in the form of alprostadil-α-cyclodextrine (n = 771) or no prostaglandin E1 (n = 789) during their hospital stay. The treatment period lasted for up to 28 days. Measurements: A combined end point consisting of death and peripheral and cardiocerebrovascular illness (major amputation or persistence of critical leg 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 alprostadil 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 [CI, 0.83 to 1.01]; P = 0.074). Most of the observed benefit was due to recovery from critical leg ischemia. Conclusions: Short-term treatment with alprostadil-αcyclodextrine provides patients with critical leg ischemia clinical benefit that is apparent in the short term but decreases over time.
1999
130
412
421
Prostanoids for chronic critical leg ischaemia. A randomized, controlled, open label trial with prostaglandin E1 / Bertele, V. - In: ANNALS OF INTERNAL MEDICINE. - ISSN 0003-4819. - STAMPA. - 130:(1999), pp. 412-421.
Bertele, V
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