%0 Journal Article
%T Is Nonmicronized Diosmin 600£¿mg as Effective as Micronized Diosmin 900£¿mg plus Hesperidin 100£¿mg on Chronic Venous Disease Symptoms? Results of a Noninferiority Study
%A Bertaina
%A Isabelle
%A Brauer Oliveira
%A Lisa
%A Cytrynbaum
%A Natasha
%A Gama
%A Gustavo
%A Gama
%A Romualdo
%A Geller
%A Mauro
%A Kaufman
%A Renato
%A Nigri
%A Rafael
%A Nunes
%A Carlos
%A Steinbruch
%A Marcio
%A Suchmacher Neto
%A Mendel
%A Verri¨¨re
%A Fran£¿ois
%J -
%D 2020
%R https://doi.org/10.1155/2020/4237204
%X Background. Phlebotonics have beneficial effects on some symptoms related to chronic venous disease (CVD) of the lower limbs. The most commonly used one is diosmin, available in a pure semisynthetic form or as a micronized purified flavonoid fraction. Patients and Methods. The primary objective of this single-blind, randomized, parallel-group, prospective study was to assess the clinical noninferiority of nonmicronized diosmin 600£¿mg once daily (D-group) compared to micronized diosmin 900£¿mg plus hesperidin 100£¿mg once daily (D/H-group) over a 6-month treatment period. Adult patients with a symptomatic CVD of the lower limbs (C0-C3 grade; 20-60£¿mm on a 100£¿mm visual analog scale (VAS)) were included. The primary endpoint was the change (from baseline to last postbaseline value) of the intensity of the lower-limb symptoms on VAS. Results. 114 patients (mean age, 44.4 years; women, 90.4%) were randomized in the per-protocol analysis (D-group, ; D/H-group, ). Symptoms significantly improved in both groups with adjusted mean VAS changes of -24.9£¿mm ( ) in the D-group and -22.8£¿mm ( ) in the D/H-group, corresponding to approximately 50% reduction in basal symptom intensity. The difference between groups was -2.1£¿mm with an upper limit of one-sided 90% confidence interval equal to 1.0£¿mm for a noninferiority margin set at 20£¿mm (noninferiority demonstrated). Intent-to-treat analysis confirmed per-protocol analysis. Difficulty in swallowing the tablets (VAS) was significantly lower in the D-group compared to the D/H-group (9.4£¿mm and 54.7£¿mm at 6 months, respectively; ). The overall safety of both study drugs was good. Conclusion. Nonmicronized diosmin 600£¿mg was proven to have a noninferior efficacy compared to micronized diosmin 900£¿mg plus hesperidin 100£¿mg, associated with greater ease in swallowing the tablet
%U https://www.hindawi.com/journals/ijvm/2020/4237204/