EFFICACY AND CLINICAL TOLERANCE OF PARENTERAL PENTOXIFYLLINE IN THE TREATMENT OF CRITICAL LOWER-LIMB ISCHEMIA - A PLACEBO-CONTROLLED MULTICENTER STUDY

A total of 114 patients with critical lower limb ischemia from 11 hosp itals were randomized to either Pentoxifylline 600 mg or placebo given intravenously twice a day. Rest pain was evaluated both by the invest igator and the patient. Pain was evaluated with the patient in the sup ine as well as in the sitting position using a pain score scale, a pai n relief scale and a visual analogue scale. All patients underwent a c linical examination, measurement of ankle systolic blood pressure and arteriography. These arteriograms were evaluated by a radiologist who did not know which treatment had been given. If no beneficial effect o f the treatment was observed after one week, further medication was di scontinued. Otherwise the treatment continued for two additional weeks . There was no statistically significant difference in pain-free or ab solute walking distance between the two groups. Evaluating the patient s with the most pronounced amelioration of rest pain in the supine pos ition (divided by 4 to divided by 2 points), there was a beneficial ef fect of Pentoxifylline compared to placebo. Evaluation of the total ma terial did not, however, show any statistical significances between th e groups. From further subgroup analysis excluding patients who had on ly slight pain at the entrance of the study, there was a significant i mprovement in rest pain in favour of Pentoxifylline following seven da ys of treatment. In this group the pain evaluated according to the vis ual analogue scale had decreased 37 points (54%) compared to 14 points (25%) in the placebo group. More side effects, mainly gastrointestina l, were observed in the Pentoxifylline group. Most of these could be e liminated by increasing the infusion time. Further investigations are necessary to evaluate the place of Pentoxifylline in the treatment of patients with critical limb ischemia.