Another look at the pentoxifylline efficacy data for intermittent claudication.

Porter et al have reported that pentoxifylline shows statistically significant superiority over placebo in a seven-center, double-blind, parallel group, randomized trial of outpatients with intermittent claudication secondary to chronic occlusive arterial disease. The objective of this report is convey results of the intention-to-treat population, paying careful attention to relevant methodologic issues relating to the analysis of clinical trials. At the same time, a new measure of clinical efficacy, minimum distance walked, is proposed. The rationale for this measure is discussed and results are compared with those for walking distances at each visit. The reanalysis of the Porter et al data by "intention to treat" and by use of the minimum-distance-walked measure confirms the published findings of efficacy of pentoxifylline for treatment of intermittent claudication.