Treatment of intermittent claudication with mesoglycan--a placebo-controlled, double-blind study.
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 outpatients 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.


CONCLUSIONS
Treatment with mesoglycan improves the walking capacity of patients with intermittent claudication, and might confer additional antithrombotic protection over that of aspirin.
Nenci
G G
GG
Institute of Internal and Cardiovascular Medicine, University of Perugia, Italy. medvasc@unipg.it
Gresele
P
P
Ferrari
G
G
Santoro
L
L
Gianese
F
F
D000368:Aged; D000369:Aged, 80 and over; D001161:Arteriosclerosis / Q000150:complications; D004311:Double-Blind Method; D005260:Female; D006025:Glycosaminoglycans / Q000008:administration & dosage* / Q000633:toxicity; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy* / Q000209:etiology / Q000534:rehabilitation; D007511:Ischemia / Q000209:etiology / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D016491:Peripheral Vascular Diseases / Q000150:complications; D010919:Placebos; D011788:Quality of Life; D016896:Treatment Outcome; D016138:Walking / Q000592:standards
D006025:Glycosaminoglycans; D010919:Placebos; C040617:mesoglycan