Calcium dobesilate in patients suffering from chronic venous insufficiency: a double-blind, placebo-controlled, clinical trial

2011 ◽  
Vol 26 (4) ◽  
pp. 162-168 ◽  
Author(s):  
E Rabe ◽  
K A Jaeger ◽  
M Bulitta ◽  
F Pannier
Keyword(s):  
Treatment Period ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Multicentre Trial ◽  
Controlled Clinical Trial ◽  
Calcium Dobesilate ◽  
Compression Stockings ◽  
Double Blind ◽  
Volume Calculation ◽  
Cone Model

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.

Effectiveness and safety of calcium dobesilate in treating chronic venous insufficiency: randomized, double-blind, placebo-controlled trial

2004 ◽  
Vol 19 (3) ◽  
pp. 123-130 ◽  
Author(s):  
K-H Labs ◽  
S Degischer ◽  
G Gamba ◽  
K A Jaeger
Keyword(s):  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Controlled Trial ◽  
Primary Outcome Measure ◽  
Calcium Dobesilate ◽  
Double Blind ◽  
Volume Calculation ◽  
Double Blind Placebo ◽  
Cone Model ◽  
The Difference

Objective: To determine whether calcium dobesilate is effective in reducing chronic venous insufficiency-related peripheral oedema. Methods: Randomized, double-blind, placebo-controlled, multicentre, parallel-group study in 253 consecutive outpatients with chronic venous insufficiency (CEAP C3-C4). The patients were treated for four weeks with either calcium dobesilate (CaD) 500 mg three times a day or matching placebo. The primary outcome measure was the reduction in lower leg volume. The leg volume calculation was based on a truncated cone model Results: Active drug treatment resulted in a median reduction of the leg volume of 25.5 ± 33.6 ml/l tissue. The difference in the median change of the leg volume between the treatment groups at week 4 was -12.2 ml/l tissue (95 % CI -21.6 to -2.8; P =0.01). In contrast with the placebo, the effects of CaD were independent of the duration of CVI and most pronounced in more severely diseased patients. Safety variables did not differ significantly between groups. Conclusions: Calcium dobesilate is an effective and well tolerated treatment for chronic venous insufficiency.

A randomized, double-blind, placebo-controlled, clinical study on the efficacy and safety of calcium dobesilate in the treatment of chronic venous insufficiency

2015 ◽  
Vol 31 (4) ◽  
pp. 264-274 ◽  
Author(s):  
Eberhard Rabe ◽  
Stefania Ballarini ◽  
Lorenz Lehr
Keyword(s):  
Volume Change ◽  
Chronic Venous Insufficiency ◽  
Venous Insufficiency ◽  
Relative Volume ◽  
Lower Limbs ◽  
Published Data ◽  
Calcium Dobesilate ◽  
Double Blind ◽  
End Of Treatment

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.

Association between heel-rise test performance and clinical severity of chronic venous insufficiency

2020 ◽  
Vol 35 (8) ◽  
pp. 631-636
Author(s):  
Danielle Aparecida Gomes Pereira ◽  
Sheyla Rossana Cavalcanti Furtado ◽  
Gisele Pereira de Oliveira Amâncio ◽  
Priscila Penasso Zuba ◽  
Cristiane Cenachi Coelho ◽  
...  
Keyword(s):  
Physical Activity ◽  
Chronic Venous Insufficiency ◽  
Test Performance ◽  
Repetition Rate ◽  
Venous Insufficiency ◽  
Clinical Severity ◽  
Inverse Association ◽  
Compression Stockings ◽  
Pump Performance ◽  
Muscular Pump

Background Peripheral pump dysfunction is important in identifying manifestations of chronic venous insufficiency. The association with disease severity may define better treatment strategies. Objective To evaluate the association between peripheral muscular pump performance by heel-rise test, age, physical activity, use of compression stockings, and chronic venous insufficiency clinical severity. Methods Subjects with chronic venous insufficiency were enrolled in the study ( n = 172) and evaluated by clinical–etiology–anatomy–pathophysiology severity and heel-rise test. Results In model 1 of logistic regression, number of heel-rise test repetitions, age, and physical activity explained 47% of clinical–etiology–anatomy–pathophysiology severity ( p = 0.0001), physical activity contributed the most. In model 2, heel-rise test repetition rate, age, and physical activity explained 46.4% of clinical–etiology–anatomy–pathophysiology severity ( p = 0.0001), repetition rate contributed the most. Conclusion: There was an inverse association between muscular pump performance and physical activity with clinical–etiology–anatomy–pathophysiology severity, muscular pump repetition rate contributed to a less severe outcome.

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