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Prostanoids for intermittent claudication

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Abstract

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Background

Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity in the general population. While numerous studies have established the efficacy of prostanoids in PAOD stages III and IV the question of the role of prostanoids as an alternative or additive treatment in patients suffering from claudicatio intermittens (PAOD II) has not yet been clearly answered.

Objectives

The aim of this review was to evaluate effects of prostanoids in patients with intermittent claudication.

Search methods

Computerised searches of the Cochrane Peripheral Vascular Diseases Specialized Register (last searched July 2004), The Cochrane Central Register of Controlled Trials (CENTRAL) (last searched The Cochrane Library Issue 2, 2004), MEDLINE and EMBASE were undertaken. In addition relevant journals were hand‐searched.

Selection criteria

Randomized clinical trials describing the effects of prostanoids in the treatment of patients suffering from intermittent claudication have been considered for inclusion.

Data collection and analysis

All reviewers assessed the quality of studies and extracted data unblinded. Statistical analysis including tests for heterogeneity and overall effect were performed by using MetaView of Review Manager 4.2. All numeric values are expressed as mean +/‐ Standard deviation (SD).

Main results

Eighteen studies were included for analysis. A significant heterogeneity between the included studies was detected in most of the subgroup analysis. Five studies compared the effects of prostaglandin E1 (PGE1) versus placebo, and reported in their individual results significant increases in walking distances after the administration of PGE1. The attained increase in walking distances appears to be not merely a short‐term effect because several studies reported that walking capacity remained increased even after termination of treatment. On the other hand, oral or intravenous prostacyclin did not increase the walking distances significantly.

At least one adverse reaction was reported from 23.6% of the participants treated with prostacyclin (PGI2), and its analogues and from 13.7% of the participants treated with PGE1.

Authors' conclusions

Because of the heterogeneity between most of the included studies, we did not pool relevant parts of the data by meta‐analysis. Based on the individual results of the published literature, patients with intermittent claudication seem to benefit from administration (intravenous or intra‐arterial) of PGE1 by a significant improvement of their walking capacity. Further well‐conducted randomized, double blinded trials, with a sufficient number of participants to provide statistical powerful information, should be performed to confirm the results of this review.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

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Prostanoids for intermittent claudication

Intermittent claudication is a symptom of lower limb ischemia that results from peripheral arterial occlusive disease (PAOD). Prostaglandin E1 (PGE1) and prostacyclin (PGI2) are vasoactive drugs used in PAOD to reduce arterial insufficiency. This review identified eighteen randomized studies. Five studies compared the effects of parenteral PGE1 versus placebo and, based on the individual results, patients with PAOD stage II demonstrated significant increases in walking distances; several studies reported that walking capacity remained increased even after termination of treatment. Oral or intravenous prostacyclin and stable analogues did not increase walking distances. Side effects with PGE1 included local reaction at the injection site and facial flushing.