Assessment of the Tolerance of Dobenox Forte® in Patients with Chronic Venous Disease
Abstract
:1. Introduction
2. Materials and Methods
2.1. Assessment of Dobenox Forte® Tolerance
2.2. Assessment of Dobenox Forte® Effectiveness
2.3. Data Analysis
2.4. Statistical Analysis
3. Results
3.1. Study Group Characteristics
3.2. Dobenox Forte® Tolerance
3.3. Dobenox Forte®‘s Effectiveness
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References and Notes
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Whole Group (N = 1795) | Included in the Analysis of Efficacy (N = 1705) | |
---|---|---|
Age (years) | 57.4 ± 14.0 | 58.2 ± 13.9 |
Women (N; %) | 1309; 72.9 | 1240; 72.7 |
Nutritional status: | ||
Overweight—BMI 25–29.9 kg/m2 (N; %) | 849; 47.3 | 803; 47.1 |
Obesity—BMI ≥ 30 kg/m2 (N; %) | 533; 29.7 | 501; 29.4 |
Visceral obesity: | ||
Women (waist circumference ≥ 80 cm) (N; %) | 1300; 72.4 | 1240; 72.7 |
Men (waist circumference ≥ 94 cm) (N; %) | 862; 48.0 | 826; 48.5 |
CVD symptoms | ||
Varicose veins of the lower limbs (N; %) | 984; 55.1 | 929; 54.5 |
Heaviness (N; %) | 1287; 71.7 | 1273; 74.7 |
Pain (N; %) | 1023; 57.0 | 1010; 59.2 |
Cramps (N; %) | 1063; 59.2 | 1028; 60.3 |
Burning sensation (N; %) | 874; 48.7 | 825; 48.4 |
Swelling (N; %) | 1023; 60.0 | 1013; 59.4 |
Duration of CVD: | ||
<1 year (N; %) | 294; 16.4 | 271; 15.9 |
1–5 years (N; %) | 880; 49.0 | 839; 49.2 |
>5 years (N; %) | 621; 34.6 | 595; 34.9 |
Co-morbidity (N; %) | 1046; 58.3 | 988; 57.9 |
Hypertension (N; %) | 878; 48.9 | 825; 48.4 |
Coronary heart disease (N; %) | 232; 12.9 | 216; 12.7 |
Past myocardial infarction (N; %) | 36; 2.0 | 34; 2.0 |
Heart arrhythmias (N; %) | 120; 6.7 | 113; 6.6 |
Heart failure (N; %) | 77; 4.3 | 76; 4.5 |
Stroke (N; %) | 29; 1.6 | 24; 1.4 |
Chronic kidney disease (N; %) | 23; 1.3 | 19; 1.1 |
Diabetes type 1 (N; %) | 9; 0.5 | 9; 0.5 |
Diabetes type 2 (N; %) | 113; 6.3 | 113; 6.6 |
Asthma/COPD (N; %) | 50; 2.8 | 48; 2.8 |
Dyslipidemia (N; %) | 133; 7.4 | 132; 7.7 |
Hypothyroidism (N; %) | 41; 2.3 | 41; 2.4 |
Degenerative changes in the spine (N; %) | 47; 2.6 | 43; 2.5 |
The prescribed dose of Dobenox Forte®: | ||
500 mg once a day (N; %) | 713; 39.7 | 688; 40.4 |
500 mg twice a day (N; %) | 1082; 60.3 | 1017; 59.6 |
Compression therapy (N; %) | 9; 0.5 | 0 |
Phlebothrophics used before Dobenox Forte® (N; %) | 470; 26.2 | 451; 26.4 |
Ruscus aculeatus extracts (N; %) | 61; 3.4 | 60; 3.5 |
Diosmin (N; %) | 359; 20.0 | 345; 20.2 |
Horse chestnut extracts (N; %) | 14; 0.8 | 13; 0.8 |
Calcium dobesilate (N; %) | 14; 0.8 | 0 |
Sulodexid [N, %] | 7; 0.4 | 7; 0.4 |
I Visit | II Visit | |
---|---|---|
Whole group | N = 1705 | N = 1673 |
Patients reporting swelling of the lower legs (N; %) | 1023; 60.0 | 1008; 60.3 |
Ankle circumference (cm) | 25.2 ± 5.7 | 24.4 ± 5.6 ** |
Δ of ankle circumference (mm) | - | −9.7 ± 10.7 |
Patients with reduced ankle circumference ≥ 10 mm (N; %) | - | 253; 24.9 |
Missing data (N) | 47 | 49 |
Calf circumference (cm) | 38.8 ± 7.8 | 37.6 ± 7.6 ** |
Δ of calf circumference (mm) | - | −13.1 ± 11.6 |
Patients with reduced calf circumference ≥ 10 mm (N; %) | - | 352; 34.9 |
Missing data (N) | 47 | 44 |
500 mg once daily | N = 677 | N = 664 |
Patients reporting swelling of the lower legs (N; %) | 390; 57.7 | 385; 57.9 |
Ankle circumference (cm) | 26.2 ± 4.9 | 25.5 ± 5.5 ^ |
Δ of ankle circumference (cm) | - | −9.3 ± 10.1 |
Patients with reduced ankle circumference ≥ 10 mm (N; %) | - | 86; 22.2 |
Missing data (N) | 10 | 20 |
Calf circumference (cm) | 39.1 ± 5.9 | 37.9 ± 6.6 * |
Δ of calf circumference (mm) | - | −13.2 ± 10.5 |
Patients with reduced calf circumference ≥ 10 mm (N; %) | - | 133; 34.5 |
Missing data (N) | 11 | 12 |
500 mg twice daily | N = 1028 | N = 1009 |
Patients reporting swelling of the lower legs (N; %) | 633; 61.5 | 623; 61.7 |
Ankle circumference (cm) | 24.5 ± 6.1 | 23.6 ± 5.5 * |
Δ of ankle circumference (mm) | - | −10.0 ± 11.2 |
Patients with reduced ankle circumference ≥ 10 mm (N; %) | - | 167; 26.8 |
Missing data (N) | 37 | 29 |
Calf circumference (cm) | 38.6 ± 8.9 | 37.4 ± 8.2 * |
Δ of calf circumference (mm) | - | −13.1 ± 12.3 |
Patients with reduced calf circumference ≥ 10 mm (N; %) | - | 219; 35.2 |
Missing data (N) | 36 | 32 |
I Visit | II Visit | χ2 for Trend p | |||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
No Signs | Mild | Moderate | Severe | Very Severe | No Signs | Mild | Moderate | Severe | Very Severe | ||
Whole group (N = 1705) | |||||||||||
Heaviness | 28.3 | 2.4 | 16.0 | 38.6 | 14.7 | 32.5 | 29.8 | 32.1 | 5.5 | 0.1 | <0.001 |
Pain | 42.2 | 6.2 | 17.5 | 26.5 | 7.6 | 46.7 | 30.0 | 19.6 | 3.6 | 0.1 | <0.001 |
Cramps | 39.9 | 5.4 | 19.3 | 26.3 | 9.1 | 45.6 | 32.1 | 19.8 | 2.3 | 0.2 | <0.001 |
Burning sensation | 51.3 | 10.2 | 19.3 | 13.7 | 5.5 | 54.6 | 30.1 | 13.3 | 1.7 | 0.3 | <0.001 |
Swelling | 39.9 | 8.3 | 23.2 | 21.3 | 7.3 | 44.0 | 34.3 | 17.9 | 3.5 | 0.3 | <0.001 |
500 mg once daily (N = 677) | |||||||||||
Heaviness | 23.6 | 1.9 | 19.6 | 37.5 | 17.4 | 28.7 | 31.7 | 32.8 | 6.8 | 0.0 | <0.001 |
Pain | 37.3 | 6.8 | 19.8 | 26.6 | 9.5 | 40.9 | 37.4 | 17.6 | 4.1 | 0.0 | <0.001 |
Cramps | 37.2 | 4.1 | 18.8 | 29.6 | 10.3 | 40.0 | 33.6 | 22.8 | 3.3 | 0.3 | <0.001 |
Burning sensation | 47.0 | 10.1 | 21.7 | 13.6 | 7.6 | 47.9 | 34.7 | 16.0 | 1.4 | 0.0 | <0.001 |
Swelling | 37.7 | 8.7 | 26.4 | 19.6 | 7.6 | 40.4 | 38.2 | 18.4 | 3.0 | 0.0 | <0.001 |
500 mg twice daily (N = 1028) | |||||||||||
Heaviness | 31.1 | 2.7 | 13.9 | 39.2 | 13.1 | 34.8 | 28.6 | 31.7 | 4.7 | 0.2 | <0.001 |
Pain | 45.1 | 5.9 | 16.1 | 26.4 | 6.5 | 50.2 | 25.5 | 20.8 | 3.3 | 0.2 | <0.001 |
Cramps | 41.4 | 6.2 | 19.6 | 24.4 | 8.4 | 48.8 | 31.2 | 18.0 | 1.8 | 0.2 | <0.001 |
Burning sensation | 53.7 | 10.3 | 17.9 | 13.8 | 4.3 | 58.6 | 27.3 | 11.6 | 2.0 | 0.5 | <0.001 |
Swelling | 41.1 | 8.1 | 21.4 | 22.3 | 7.1 | 46.2 | 31.9 | 17.6 | 3.8 | 0.5 | <0.001 |
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Chudek, J.; Almgren-Rachtan, A.; Pastuszka, A.; Ziaja, D. Assessment of the Tolerance of Dobenox Forte® in Patients with Chronic Venous Disease. Life 2024, 14, 437. https://doi.org/10.3390/life14040437
Chudek J, Almgren-Rachtan A, Pastuszka A, Ziaja D. Assessment of the Tolerance of Dobenox Forte® in Patients with Chronic Venous Disease. Life. 2024; 14(4):437. https://doi.org/10.3390/life14040437
Chicago/Turabian StyleChudek, Jerzy, Agnieszka Almgren-Rachtan, Agnieszka Pastuszka, and Damian Ziaja. 2024. "Assessment of the Tolerance of Dobenox Forte® in Patients with Chronic Venous Disease" Life 14, no. 4: 437. https://doi.org/10.3390/life14040437