Controlled clinical trial on the efficacy and safety of oral sulodexide in patients with peripheral occlusive arterial disease

Abstract

One hundred and seven adult outpatients with Leriche stage II peripheral occlusive arterial disease took part in this open, controlled trial. Patients were randomly treated over a six-month period either with sulodexide capsules containing 250 lipoproteinlipase releasing units (LRU, two capsules twice daily for 176 days on average: 56 patients), or with pentoxifylline 400 mg tablets (one tablet three times a day for 180 days on average: 51 patients). The incidences of diabetes, hyperlipoproteinaemias, smoking habit and other risk factors were the same in the two groups. The drugs' efficacies were evaluated by monitoring, at the start of treatment and every month during it, the Winsor Index and the walking distance, both prior to (initial claudication distance-IDC) and after (absolute claudication distance-ACD) the symptom's onset. Compliance with treatment and occurrence of adverse events were constantly monitored; systemic tolerability was evaluated through the use of routine haematological and haematochemical tests. Both treatments brought about a progressive increase in the claudication-free walking distance, statistically significant versus baseline from the second month (ACD, sulodexide group) and third month (ACD and ICD, pentoxifilline and sulodexide groups). At the end of treatment, the absolute increase of ACD was significantly greater in sulodexide-treated patients (p < 0.01) with respect to the pentoxifylline-treated group. In both groups the Doppler test evidenced a good improvement in local arterial haemodynamics. In the sulodexide group, 3.6% of patients developed nausea, dyspepsia and other minor gastrointestinal phenomena. In the pentoxifylline group 17.6% of patients complained of gastroenteric disorders (nausea, vomiting, dyspepsia), or of headache and dizziness. In one patient of this latter group insomnia was also present. Systemic tolerance of both drugs was consistently good.