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Indexed/Abstracted in: BIOSIS Previews, EMBASE, Scopus, Emerging Sources Citation Index
Online ISSN 1827-1812
Iannuzzi A. 1, Covetti G. 1, Bresciani A. 1, Cavallaro R. 1, Capasso F. 2, Caruso D. 2, Saponati G. 3
1 Geriatric Unit, Department of Internal Medicine, A. Cardarelli General Hospital, Naples, Italy;
2 Vascular Unit, Department of Internal Medicine, A. Cardarelli General Hospital, Naples, Italy;
3 Ispharm s.r.l., Lucca, Italy
Aim: Chronic venous insufficiency (CVI) is characterized by a spectrum of symptoms and signs as the result of the venous hypertension caused by structural or functional abnormalities of veins, and the associated inflammation. This study was carried out to compare the efficacy and tolerability of heparan sulphate slow-release 120 mg tablets (Clarema®, Farmaceutici Damor S.p.A.) or defibrotide 400 mg capsules (Noravid®, Gentium S.p.A.), both given once daily for 12 weeks, in the treatment of subjective symptoms and clinical signs of CVI.
Methods: Two hundreds patients with ultrasonography-confirmed CVI, score 2-5 in the clinical components of the CEAP and at least two subjective symptoms and two signs of CVI of at least moderate degree (i.e. score ≥ 2) at baseline, were treated with heparan sulphate (140 patients, 70.0%) or defibrotide (60 patients, 30.0%). CVI signs and symptoms (measured using a 0-3 point rating scale ranging from none to severe), and coagulation parameters (prothrombin time, fibrinogen circulating levels, aPTT and D-dimer) were evaluated at baseline and after 6 and 12 weeks of treatment.
Results: Treatment with both study drugs was associated with significant improvements of sum of score of subjective symptoms and of objective signs of CVI, as well as of overall score. Heparan sulfate was significantly more effective than defibrotide in the relief of the primary variable (sum of score of subjective symptoms of CVI : mean decreases in score from baseline to endpoint -4.5 in the heparan sulfate group and -2.6 in the defibrotide group). The improvements from baseline were also significantly more marked in the heparan sulfate group than in the defibrotide group in both the intention to treat (ITT) and the per-protocol (PP) population (or at least in one sample) for overall sum of scores, sum of score of objective signs of CVI, most of subjective symptoms (burning, pain, lower limb restless, cramps and tiredness) and oedema. Mean D-dimer levels decreased more markedly in the heparan sulphate group than in the defibrotide group, whereas there were no substantial changes from baseline in the other coagulation parameters in both groups. Both study drugs were well tolerated in terms of adverse events (no adverse events were reported with either drug), laboratory parameters and vital signs (blood pressure and heart rate).
Conclusion: Both heparan sulphate slow-release 120 mg tablets and defibrotide 400 mg capsules given once daily for 12 weeks were effective in reducing signs and symptoms of CVI. Patients treated with heparan sulphate experienced more marked benefits than those treated with defibrotide.