Summary

Objective: To assess the effect of treatment with mesoglycan, a sulphatedpolysaccharide compound, on the walking capacity of patientswith stage II peripheral arterial disease. Methods: Non-diabetic outpatientswith intermittent claudication, duplex ultrasound evidence ofperipheral atherosclerosis, ankle/arm index <0.80, systolic ankle pressure>50 mmHg, and absolute walking distance (AWD) between 100and 300 m (standardised treadmill test) were eligible. After a 5-weekrun-in on single-blind placebo, patients were randomised to doubleblindtreatment with mesoglycan, 30 mg/day intramuscularly for3 weeks followed by 100 mg/day orally for 20 weeks, or matchingplacebo. All patients received low-dose aspirin and lifestyle instructions.Clinical response was defined as an AWD increase at Week 23>50% over baseline. Health-related quality of life and ischaemic eventswere assessed as secondary efficacy variables. Results: 242 patientswere randomised and 237 were assessed for clinical response. Patientsachieving clinical response were 59/118 with mesoglycan (50.0%) and31/119 with placebo (26.1%; p <0.001). Geometric mean AWD increasedfrom 192 to 298 m with mesoglycan, and from 192 to 238 m withplacebo (p <0.001). Pain-free walking distance showed a non-significantincrease with mesoglycan (p = 0.057). Changes in quality of lifescores were in favour of mesoglycan. The rate of ischaemic events was1/120 on mesoglycan and 6/122 on placebo (p = 0.053). The rate ofnon-ischaemic adverse events leading to treatment discontinuation was7/120 and 4/122, respectively. Conclusion: Treatment with mesoglycanimproves the walking capacity of patients with intermittent claudication,and might confer additional antithrombotic protection over that ofaspirin.