Patrick Carpentier1, Bonno van Bellen2, Debora Karetova3, Harunarashid Hanafiah4, Elizabeth Enriquez-Vega5, Alexander Kirienko6, Andrej Dzupina7, Miso Sabovic8, Lourdes Reina Gutierrez9, Somboom Subwongcharoen10, Hasan Tüzün11, Arnaud Maggioli12. 1. Grenoble University Hospital, Grenoble, France - pcarpentier@chu-grenoble.fr. 2. Service of Vascular Surgery and Angiology, Real e Benemérita Associação Portuguesa de Beneficência, São Paulo, Brazil. 3. Department for Cardiology and Angiology, General Faculty Hospital. 4. st Faculty of Medicine, Charles University, Prague, Czech Republic. 5. National University of Malaysia, Kuala Lumpur, Malaysia. 6. National Autonomous University of Mexico, Mexico City, Mexico. 7. Department of Surgery, Faculty of Medicine, Pirogov Russian National Research Medical University, Moscow, Russia. 8. Angiologická Ambulancia Alian, Bardejov, Slovakia. 9. Department of Vascular Diseases, University Clinical Center of Ljubljana, Ljubljana, Slovenia. 10. Department of Angiology and Vascular Surgery, Hospital de la Cruz Roja, Madrid, Spain. 11. Rajavithi Hospital, Bangkok, Thailand. 12. Cerrahpaşa Faculty of Medicine, Istanbul University, Istanbul, Turkey.
Abstract
BACKGROUND:Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks. Lower limb symptoms (discomfort, pain and heaviness) were assessed using Visual Analog Scales (VAS), and quality of life (QoL) was measured with the CIVIQ-20 Questionnaire. RESULTS:A total of 1139 patients were included in the study. Both MPFF treatment regimens were well tolerated and associated with a significant reduction in lower limb symptoms. A non-inferiority of MPFF 1000-mg oral suspension once daily compared to MPFF 500-mg tablet twice daily (P<0.0001) was found for lower limb discomfort (-3.33 cm for MPFF 1000 mg and -3.37 cm for MPFF 500 mg), leg pain (-3.27 cm for MPFF 1000 mg and -3.31 cm for MPFF 500 mg) and leg heaviness (-3.41 cm for MPFF 1000 mg and -3.46 cm for MPFF 500 mg). The patients' QoL was improved by about 20 points on the CIVIQ scale in both groups (19.33 points for MPFF 1000 mg and 20.28 points for MPFF 500 mg). CONCLUSIONS:MPFF 1000-mg oral suspension and MPFF 500-mg tablets treatments were associated with similar reductions in lower limb symptoms and QoL improvement. The new once daily MPFF1000-mg oral suspension has a similar safety profile to two tablets of MPFF 500 mg, with the advantage of one daily intake, potentially associated with improved patient adherence and easier CVD management.
RCT Entities:
BACKGROUND:Chronic venous disorders (CVD) is estimated to affect 30% to 50% of women and 10% to 30% of men. The most widely prescribed treatment for CVD worldwide is micronized purified flavonoid fraction 500 mg (MPFF). The aim of this clinical trial was to develop a new once daily 1000-mg oral suspension of MPFF. METHODS: In an international, randomized, double-blind, parallel-group study, symptomatic individuals classified CEAP C0s to C4s were randomized in either treatment arm and treated for 8 weeks. Lower limb symptoms (discomfort, pain and heaviness) were assessed using Visual Analog Scales (VAS), and quality of life (QoL) was measured with the CIVIQ-20 Questionnaire. RESULTS: A total of 1139 patients were included in the study. Both MPFF treatment regimens were well tolerated and associated with a significant reduction in lower limb symptoms. A non-inferiority of MPFF 1000-mg oral suspension once daily compared to MPFF 500-mg tablet twice daily (P<0.0001) was found for lower limb discomfort (-3.33 cm for MPFF 1000 mg and -3.37 cm for MPFF 500 mg), leg pain (-3.27 cm for MPFF 1000 mg and -3.31 cm for MPFF 500 mg) and leg heaviness (-3.41 cm for MPFF 1000 mg and -3.46 cm for MPFF 500 mg). The patients' QoL was improved by about 20 points on the CIVIQ scale in both groups (19.33 points for MPFF 1000 mg and 20.28 points for MPFF 500 mg). CONCLUSIONS:MPFF 1000-mg oral suspension and MPFF 500-mg tablets treatments were associated with similar reductions in lower limb symptoms and QoL improvement. The new once daily MPFF1000-mg oral suspension has a similar safety profile to two tablets of MPFF 500 mg, with the advantage of one daily intake, potentially associated with improved patient adherence and easier CVD management.