Treatment of severe intermittent claudication with PGE1 a short-term vs a long-term infusion plan a 20-week, european randomized trial analysis of efficacy and costs.
The efficacy, safety, and cost of prostaglandin E1 (PGE1) in the treatment of severe intermittent claudication was studied by comparing a long-term treatment protocol (LTP) with a short-term treatment protocol (STP) in a randomized 20-week study.
The study included 109 patients (96 completed the study) with an average total walking distance of 65.5 ±8 m (range 20-109).
Phase 1 was a 2-week run-in phase (no treatment) for both protocols.
In LTP, phase 2 was the main treatment phase.
In the LTP, treatment was performed with 2-hour infusions (60 mug PGE1,5 days each week for 4 weeks).
In phase 3 (4-week interval period) PGE1 was administered twice a week (same dosage).
In phase 4 (monitoring lasting 3 months, from week 9 to 20) no drugs were used.
In STP, phase 2 treatment was performed in 2 days by a 2-hour infusion (1st day : morning 20 mug, afternoon 40 mug ; 2nd day morning and afternoon 60 mug).
The reduced dosage was used only at the first cycle (week 0) to evaluate reduced tolerability or side effects.
Full dosage (60 mug bid) was used for all other cycles.
The same cycle was repeated at the beginning of weeks 4,8, and 12.
The observation period was between weeks 12 and 20.
A treadmill test was performed at inclusion, at the beginning of each phase, and at the end of the 20th week.
A similar progressive physical training plan (based on walking) and a reduction in risk factors levels plan was used in both groups. (...)
Mots-clés Pascal : Claudication, Intermittent, Membre, Prostaglandine E1, Voie intraveineuse, Périmètre marche, Analyse coût, Economie santé, Europe, Essai thérapeutique contrôlé, Chimiothérapie, Traitement, Efficacité traitement, Homme, Vasodilatateur, Appareil circulatoire pathologie, Vaisseau sanguin pathologie, Artère pathologie, Artériopathie oblitérante
Mots-clés Pascal anglais : Claudication, Intermittent, Limb, Prostaglandin E1, Intravenous administration, Walking distance, Cost analysis, Health economy, Europe, Controlled therapeutic trial, Chemotherapy, Treatment, Treatment efficiency, Human, Vasodilator agent, Cardiovascular disease, Vascular disease, Arterial disease, Occlusive arterial disease
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0012805
Code Inist : 002B02F04. Création : 31/05/1999.