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Thromb Haemost 2001; 86(05): 1181-1187
DOI: 10.1055/s-0037-1616048
Review Article
Schattauer GmbH

Treatment of Intermittent Claudication with Mesoglycan – A Placebo-controlled, Double-blind Study

Giuseppe G. Nenci
1   Institute of Internal and Cardiovascular Medicine, University of Perugia, Milan, Italy
,
Paolo Gresele
1   Institute of Internal and Cardiovascular Medicine, University of Perugia, Milan, Italy
,
Gianni Ferrari
2   Medical Department, Mediolanum Farmaceutici, Milan, Italy
,
Luigi Santoro
2   Medical Department, Mediolanum Farmaceutici, Milan, Italy
,
Francesco Gianese
2   Medical Department, Mediolanum Farmaceutici, Milan, Italy
,
for the Mesoglycan Intermittent Claudication Group › Author AffiliationsStudy monitoring was performed by R. Salemi and O. Baiardo. The study was supported in part by a grant from Mediolanum Farmaceutici, Milan, Italy.
Further Information

Publication History

Received 13 March 2001

Accepted after revision 31 July 2001

Publication Date:
13 December 2017 (online)

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Summary

Objective: To assess the effect of treatment with mesoglycan, a sulphated polysaccharide compound, on the walking capacity of patients with stage II peripheral arterial disease. Methods: Non-diabetic out-patients with intermittent claudication, duplex ultrasound evidence of peripheral atherosclerosis, ankle/arm index <0.80, systolic ankle pressure >50 mmHg, and absolute walking distance (AWD) between 100 and 300 m (standardised treadmill test) were eligible. After a 5-week run-in on single-blind placebo, patients were randomised to double-blind treatment with mesoglycan, 30 mg/day intramuscularly for 3 weeks followed by 100 mg/day orally for 20 weeks, or matching placebo. 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 events were assessed as secondary efficacy variables. Results: 242 patients were randomised and 237 were assessed for clinical response. Patients achieving clinical response were 59/118 with mesoglycan (50.0%) and 31/119 with placebo (26.1%; p <0.001). Geometric mean AWD increased from 192 to 298 m with mesoglycan, and from 192 to 238 m with placebo (p <0.001). Pain-free walking distance showed a non-significant increase with mesoglycan (p = 0.057). Changes in quality of life scores were in favour of mesoglycan. The rate of ischaemic events was 1/120 on mesoglycan and 6/122 on placebo (p = 0.053). The rate of non-ischaemic adverse events leading to treatment discontinuation was 7/120 and 4/122, respectively. Conclusion: Treatment with mesoglycan improves the walking capacity of patients with intermittent claudication, and might confer additional antithrombotic protection over that of aspirin.

Keywords

Peripheral arterial disease - intermittent claudication - treadmill test - mesoglycan - randomised clinical trial
 

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