Eberhard Rabe1, Stefania Ballarini2 and Lorenz Lehr2, on behalf of the Doxium EDX09/01 Study Group
1Department of Dermatology, Rheinische Friedrich-Wilhelms University, Bonn, Germany 2Vifor Pharma, Meyrin, Switzerland
Abstract
Objective
To show the superiority of 500 mg calcium dobesilate vs. placebo in reduction of edema of the lower limbs
in patients with chronic venous insufficiency, Clinical, Etiological, Anatomical and Pathophysiological classes C3/C4.
Methods: A total of 351 patients were randomized (n=174 calcium dobesilate, n=177 placebo). Active treatment was
500 mg calcium dobesilate, three times daily for 12 weeks, with a 12-week follow-up.
Results
At the end of treatment, the relative volume change in the most pathological leg was -0.6±4.8% with calcium dobesilate compared to -0.3±3.3% with placebo (p=0.09). At the end of follow-up, this was -1.01±5.4% for calcium
dobesilate vs. -0.08±3.5% for placebo (p=0.002).
Conclusions
Calcium dobesilate treatment resulted in no significant volume change in the most pathological leg between baseline and end of treatment. However, the calcium dobesilate group showed a significantly greater volume decrease in the most pathological leg at the end of follow-up. Calcium dobesilate was well-tolerated, with a safety profile consistent with previously published data.
(Reference link : http://journals.sagepub.com/doi/pdf/10.1177/0268355515586097)
Phlebology, 2011; 26:162–168
Calcium dobesilate in patients suffering from chronic venous insufficiency: a double-blind,
placebo-controlled, clinical trial
E Rabe1, K A Jaeger2, M Bulitta3 and F Pannier4
1Department of Dermatology, University of Bonn, Sigmund-Freud-Str. 25, D-53105 Bonn, Germany; 2Department of Angiology, University Hospital Basel, Petersgraben 4, CH- 4031 Basel, Switzerland; 3CRM Biometrics GmbH, Marie-Curie-Str. 2, D-53359 Rheinbach, Germany; 4Department of Dermatology, University of Cologne, Kerpener Str 62, 50937 Koln, Germany
Abstract
Objective
To test the efficacy of calcium dobesilate (CaD) in chronic venous insufficiency (CVI).
Method
Double-blind, parallel groups, placebo-controlled, multicentre trial in adult patients with symptomatic CVI and pitting oedema. Wearing of compression stockings Class II was admitted. During treatment period of eight weeks, the patients received CaD 3 × 500 mg/day or placebo. The leg volume calculation was based on a truncated cone
model.
Results
A total of 256 patients was randomized to treatment (dobesilate: n =132, placebo: n =124); the demographic and anamnestic data at admission were comparable in the two therapeutic groups. The volume of the lower calf diminished in the dobesilate group at the end of the active treatment period by -64.72 ± 111.93 cm3 (mean ± SD), independent of the concomitant usage of compression stockings versus placebo +0.8 ± 152.98 cm3 (P = 0.0002). The symptoms of pain, discomfort, heavy legs, tired legs, tingling, itching and cramps, as well as the global assessments by investigators and patients, also improved significantly (P < 0.05) better in the dobesilate group at the end of the treatment. The observed adverse events correspond to the known profile. Conclusion: Dobesilate reduces leg oedema and improves the symptoms of objectively diagnosed CVI, independent of the concomitant usage of compression stockings.
(Reference link : https://www.ncbi.nlm.nih.gov/pubmed/21478142)
Angiology , Volume 55, Number 2, 2004
Calcium Dobesilate for Chronic Venous Insufficiency: A Systematic Review
Agustín Ciapponi, MD,1 Enrique Laffaire, MD, 2and Marta Roqué, BSc, 3Buenos Aires, Argentina and Barcelona, Spain
From the 1Family and Preventive Medicine Division, Hospital Italiano de Buenos Aires; the 2Programa de Efectividad Clínica, Hospital Italiano de Buenos Aires, Universidad de Buenos Aires, Argentina; and the 3Department of Clinic Epidemiology and Public Health, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
Chronic venous insufficiency (CVI) causes much discomfort and sick leave. Many randomized clinical trials (RCTs) have shown a beneficial effect of calcium dobesilate, but consensus is lacking about efficacy and safety. The authors report a meta-analysis of the effectiveness and safety of calcium dobesilate in CVI. Ten RCTs (778 patients) in which calcium dobesilate for CVI was compared with placebo met the inclusion criteria. Only 3 trials (608 patients) were of
good methodological quality. Calcium dobesilate significantly improved night cramps and discomfort nearly twice as well as placebo, with the number needed to treat (NNT) being 8 (95% Cl 4-50) and 4 (95% CI 3-7), respectively. Frequency of adverse events was not significantly different from placebo. Subgroup analysis found a differential response with respect to disease severity, with greater improvements in pain, heaviness, and malleolar swelling being seen in the severe group than in the mild group. Calcium dobesilate improved paresthesias significantly more than placebo in the severe but not in the mild group and the effect on leg volume was also significantly better in the severe group (-7.2% vs -1.6%). No difference in effect was found for different doses of calcium dobesilate (1,000 or 1,500 mg/day). Sensitivity analyses did not affect the results. Current evidence suggests that calcium dobesilate is more effective than placebo in improving some CVI symptoms, that there is higher efficacy in more severe disease, and that a dose of 1,000 mg/day is as effective and safe as 1,500 mg/day. Further adequately powered trials are needed to further evaluate these hypotheses.
(Reference link : https://www.ncbi.nlm.nih.gov/pubmed/15026869)
