INTRAVENOUS PENTOXIFYLLINE FOR THE TREATMENT OF CHRONIC CRITICAL LIMBISCHEMIA

Citation
P. Vandenbrande et al., INTRAVENOUS PENTOXIFYLLINE FOR THE TREATMENT OF CHRONIC CRITICAL LIMBISCHEMIA, European journal of vascular and endovascular surgery, 9(4), 1995, pp. 426-436
Citations number
NO
Categorie Soggetti
Surgery,"Cardiac & Cardiovascular System","Peripheal Vascular Diseas
ISSN journal
10785884
Volume
9
Issue
4
Year of publication
1995
Pages
426 - 436
Database
ISI
SICI code
1078-5884(1995)9:4<426:IPFTTO>2.0.ZU;2-O
Abstract
Objectives: To investigate the safety and efficacy of intravenous pent oxifylline infusion therapy, 600 mg twice daily for up to 21 days, for the management of patients with chronic critical limb ischaemia (CLI) . Design: A prospective, randomised, double-blind, placebo-controlled, parallel-group, multicentre trial. Setting: County and university hos pitals in six European countries. Materials: A total of 314 patients s uffering from CLI were enrolled: 157 patients were allocated to each t reatment. Outcome measures: Patients were reviewed after 7 days of tre atment and continued in the study for up to a further 14 days if their condition had not deteriorated Rest pain (assessed by pain score and visual analogue scale), sleep disturbances and analgesic consumption w ere measured. Results: Both intention-to-treat and per protocol analys es showed significantly positive results in favour of pentoxifylline o ver placebo. Severity of rest pain was consistently and significantly lower as shown by tile results of the pre-infusion pain scores (p=0.00 7), pain visual analogue scales (p<0.001) and scores describing rest p ain-related sleep disturbances (p=0.003). Treatment response was not i nfluenced by the presence of diabetes mellitus or by eligibility for s urgery. Conclusion: These results justify the use of intravenous pento xifylline infusion therapy for the management of rest pain in patients with CLI.