[Heparan sulphate in association with indobufen in the treatment of chronic peripheral obliterative arteriopathy of the lower extremities. Controlled clinical trial].
BACKGROUND
The aim of this study has been to assess the efficacy and the safety of heparansulphate administered with indobufen in the treatment of occlusive arterial disease.


METHODS
In a controlled open study, nineteen out-patients with Fontaine's stage II occlusive arterial disease since one year were randomly assigned to treatment with indobufen 200 mg/day or indobufen 200 mg/day and heparansulphate 200 mg/day for 6 months. Efficacy assessments were based on functional evaluations (pain-free sub-maximal exercise ergometric test, ankle-arm pressure ratio at rest and after induced ischemia), on hemocoagulative parameters and on physical signs and subjective symptoms assessed monthly over the whole period of treatment. All patients but one who was lost to follow-up completed the study treatment period as foreseen by the experimental protocol.


RESULTS
The results of the study show an improvement of 10.89% (day 30), 15.92% (day 60), 21.04% (day 90), 24.19% (day 120), 25.18 (day 150) 28.84% (day 180) end of study in ergometric test pain-free interval obtained by patients treated with heparansulphate and indobufen with respect to patients receiving indobufen alone. Also hemocoagulative parameters and signs and patients' subjective symptoms were positively influenced by the association heparansulphate and indobufen.


CONCLUSIONS
On the whole, the results of the study indicate that heparansulphate in association with antiplatelet therapy with indobufen has a beneficial effect in the treatment of peripheral occlusive arterial disease.
Rossini
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Clinica Casa del Sole, Formia, Latina. dr.arosini@fabernet.com
Tascino
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C
Costa
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F
D000328:Adult; D000368:Aged; D001157:Arterial Occlusive Diseases / Q000150:complications / Q000188:drug therapy*; D005260:Female; D006497:Heparan Sulfate / Q000627:therapeutic use*; D006801:Humans; D007383:Intermittent Claudication / Q000188:drug therapy / Q000209:etiology; D054833:Isoindoles; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010654:Phenylbutyrates / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use*
D006497:Heparan Sulfate; D054833:Isoindoles; D010654:Phenylbutyrates; D010975:Platelet Aggregation Inhibitors; C020371:indobufen