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Acute Pain | Chronic Pain | General

Pentoxifylline for intermittent claudication

Clinical bottom line:

Although pentoxifylline is associated with significant benefit in pain-free and maximum walking distances, based on small numbers of patients, this is unlikely to be of clinical relevance.


Intermittent claudication - pain, tension and weakness on walking which intensifies until walking becomes impossible, but disappears on resting - is estimated to affect 2% of people over 65 years. Treatments for intermittent claudication include administration of pentoxifylline (oxpentifylline), exercise programmes and smoking cessation.

Systematic review

Radack, K.; Wyderski, R. J. Conservative management of intermittent claudication. Ann Intern Med. 1990 Jul 15; 113(2): 135-46.

Inclusion criteria were randomised, double-blind trials of pentoxifylline for intermittent claudication; English language.

Reviewers calculated effect sizes with 95% confidence intervals, from means and standard deviations or standard errors. Effect sizes were regarded as showing a significant difference when the confidence intervals did not cross one. An improvement of at least 100% was regarded as a clinically relevant outcome measure. A change of at least 25% from baseline was regarded as an acceptable alternative where it was not possible to extract precise data.

Reviewers also assessed the relationship between trial quality and outcome.

Findings

Twelve trials were included in 529 patients. Ten were placebo-controlled, and two compared pentoxifylline with either flunarizine or nylidrin. Trials varied in terms of inclusion criteria, baseline measures, etc. Doses ranged from 600 mg/day to 1200 mg/day, and treatment duration ranged from eight to one year.

Effectiveness of pentoxifylline varied considerably across trials, as did placebo response rates, and reviewers did not feel that data pooling was therefore appropriate. Of the ten placebo-controlled trials, five trials had significant effect sizes, suggesting that pentoxifylline was significantly better than placebo. Efficacy did not seem to be a reflection of dose or treatment duration. Of the active trials, one showed pentoxifylline 1200 mg/day to be significantly better than nylidrin 6 mg/day, and the other showed no difference between pentoxifylline 1200 mg/day and flunarizine 15 mg/day. There was no relationship between trial outcome and quality.

To answer the question of clinical relevance, numbers of patients experiencing at least 25% improvement and 100% improvement on walking were calculated, based on five trials where these data were extractable.

At least 25% improvement from baseline: The pooled benefit for at least 25% improvement in pain-free walking distance in 141 patients was 0.16 (0.01 to 0.31, 95% confidence interval) when compared with placebo. This suggests a very small gain attributable to pentoxifylline, and that this is of no clinical significance.

At least 100% improvement from baseline: The pooled benefit for at least 100% improvement in pain-free walking distance in 137 patients was 0.16 (0.03 to 0.29, 95% confidence interval) when compared with placebo. The pooled benefit for at least 100% improvement in maximum walking distance in 153 patients was 0.27 (0.13 to 0.41, 95% confidence interval) when compared with placebo. These findings suggest that only a modest gain is attributable to pentoxifylline, and that this is of limited clinical significance.

This review also covered exercise therapy and smoking cessation. However, more recent reviews update this work, and it is covered in separate summaries (listed below).

Adverse effects

Adverse effects were not covered in this review.

Further Reference

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