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Efficacy and clinical tolerance of parenteral pentoxifylline in the treatment of critical lower limb ischemia. A placebo controlled multicenter study. Norwegian Pentoxifylline Multicenter Trial Group.
Int Angiol. 1996 Mar; 15(1):75-80.IA

Abstract

A total of 114 patients with critical lower limb ischemia from 11 hospitals were randomized to either Pentoxifylline 600 mg or placebo given intravenously twice a day. Rest pain was evaluated both by the investigator and the patient. Pain was evaluated with the patient in the supine as well as in the sitting position using a pain score scale, a pain relief scale and a visual analogue scale. All patients underwent a clinical 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 of the treatment was observed after one week, further medication was discontinued. Otherwise the treatment continued for two additional weeks. There was no statistically significant difference in pain-free or absolute walking distance between the two groups. Evaluating the patients with the most pronounced amelioration of rest pain in the supine position (divided by 4 to divided by 2 points), there was a beneficial effect of Pentoxifylline compared to placebo. Evaluation of the total material did not, however, show any statistical significances between the groups. From further subgroup analysis excluding patients who had only slight pain at the entrance of the study, there was a significant improvement in rest pain in favour of Pentoxifylline following seven days of treatment. In this group the pain evaluated according to this visual analogue scale had decreased 37 points (54%) compared to 14 points (25%) in the placebo group. More side effects, mainly gastrointestinal, were observed in the Pentoxifylline group. Most of these could be eliminated by increasing the infusion time. Further investigations are necessary to evaluated the place of Pentoxifylline in the treatment of patients with critical limb ischemia.

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8739541

Citation

"Efficacy and Clinical Tolerance of Parenteral Pentoxifylline in the Treatment of Critical Lower Limb Ischemia. a Placebo Controlled Multicenter Study. Norwegian Pentoxifylline Multicenter Trial Group." International Angiology : a Journal of the International Union of Angiology, vol. 15, no. 1, 1996, pp. 75-80.
Efficacy and clinical tolerance of parenteral pentoxifylline in the treatment of critical lower limb ischemia. A placebo controlled multicenter study. Norwegian Pentoxifylline Multicenter Trial Group. Int Angiol. 1996;15(1):75-80.
(1996). Efficacy and clinical tolerance of parenteral pentoxifylline in the treatment of critical lower limb ischemia. A placebo controlled multicenter study. Norwegian Pentoxifylline Multicenter Trial Group. International Angiology : a Journal of the International Union of Angiology, 15(1), 75-80.
Efficacy and Clinical Tolerance of Parenteral Pentoxifylline in the Treatment of Critical Lower Limb Ischemia. a Placebo Controlled Multicenter Study. Norwegian Pentoxifylline Multicenter Trial Group. Int Angiol. 1996;15(1):75-80. PubMed PMID: 8739541.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and clinical tolerance of parenteral pentoxifylline in the treatment of critical lower limb ischemia. A placebo controlled multicenter study. Norwegian Pentoxifylline Multicenter Trial Group. PY - 1996/3/1/pubmed PY - 1996/3/1/medline PY - 1996/3/1/entrez SP - 75 EP - 80 JF - International angiology : a journal of the International Union of Angiology JO - Int Angiol VL - 15 IS - 1 N2 - A total of 114 patients with critical lower limb ischemia from 11 hospitals were randomized to either Pentoxifylline 600 mg or placebo given intravenously twice a day. Rest pain was evaluated both by the investigator and the patient. Pain was evaluated with the patient in the supine as well as in the sitting position using a pain score scale, a pain relief scale and a visual analogue scale. All patients underwent a clinical 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 of the treatment was observed after one week, further medication was discontinued. Otherwise the treatment continued for two additional weeks. There was no statistically significant difference in pain-free or absolute walking distance between the two groups. Evaluating the patients with the most pronounced amelioration of rest pain in the supine position (divided by 4 to divided by 2 points), there was a beneficial effect of Pentoxifylline compared to placebo. Evaluation of the total material did not, however, show any statistical significances between the groups. From further subgroup analysis excluding patients who had only slight pain at the entrance of the study, there was a significant improvement in rest pain in favour of Pentoxifylline following seven days of treatment. In this group the pain evaluated according to this visual analogue scale had decreased 37 points (54%) compared to 14 points (25%) in the placebo group. More side effects, mainly gastrointestinal, were observed in the Pentoxifylline group. Most of these could be eliminated by increasing the infusion time. Further investigations are necessary to evaluated the place of Pentoxifylline in the treatment of patients with critical limb ischemia. SN - 0392-9590 UR - https://www.unboundmedicine.com/medline/citation/8739541/Efficacy_and_clinical_tolerance_of_parenteral_pentoxifylline_in_the_treatment_of_critical_lower_limb_ischemia__A_placebo_controlled_multicenter_study__Norwegian_Pentoxifylline_Multicenter_Trial_Group_ DB - PRIME DP - Unbound Medicine ER -