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
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.