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

Marcio Steinbruch; Carlos Nunes; Romualdo Gama; Renato Kaufman; Gustavo Gama; Mendel Suchmacher Neto; Rafael Nigri; Natasha Cytrynbaum; Lisa Brauer Oliveira; Isabelle Bertaina; François Verrière; Mauro Geller

doi:10.1155/2020/4237204

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

Int J Vasc Med. 2020 Mar 7:2020:4237204. doi: 10.1155/2020/4237204. eCollection 2020.

Authors

Affiliations

¹ Hospital Albert Einstein (São Paulo-Brasil), R. Mauricio F Klabin 357/17, Vila Mariana, SP, Brazil 04120-020.
² Instituto de Pós-Graduação Médica Carlos Chagas-Fundação Educacional Serra dos Órgãos-UNIFESO (Rio de Janeiro/Teresópolis-Brasil), Av. Alberto Torres 111, Teresópolis, RJ, Brazil 25964-004.
³ Fundação Educacional Serra dos Órgãos-UNIFESO (Teresópolis-Brasil), Av. Alberto Torres 111, Teresópolis, RJ, Brazil 25964-004.
⁴ Faculdade de Ciências Médicas, Universidade Estadual do Rio de Janeiro (UERJ) (Rio de Janeiro-Brazil), Av. N. Sra. De Copacapana, 664/206, Rio de Janeiro, RJ, Brazil 22050-903.
⁵ Fundação Educacional Serra dos Órgãos-UNIFESO (Teresópolis-Brasil), Rua Prefeito Sebastião Teixeira 400/504-1, Rio de Janeiro, RJ, Brazil 25953-200.
⁶ Instituto de Pós-Graduação Médica Carlos Chagas (Rio de Janeiro-Brazil), R. General Canabarro 68/902, Rio de Janeiro, RJ, Brazil 20271-200.
⁷ Department of Medicine, Rutgers New Jersey Medical School-USA, 185 S Orange Ave., Newark, NJ 07103, USA.
⁸ Hospital Universitário Pedro Ernesto, Universidade Estadual do Rio de Janeiro (UERJ) (Rio de Janeiro-Brazil), R. Hilário de Gouveia, 87/801, Rio de Janeiro, RJ, Brazil 22040-020.
⁹ Universidade Federal do Rio de Janeiro (UFRJ) (Rio de Janeiro-Brazil), Av. das Americas, 411/1613-2, Rio de Janeiro, RJ, Brazil 22631-000.
¹⁰ Laboratoire Innotech International, 22 Avenue Aristide Briand, 94110 Arcueil, France.

Abstract

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, n = 57; D/H-group, n = 57; D/H-group, p < 0.0001) in the D-group and -22.8 mm (p < 0.0001) in the D-group and -22.8 mm (p < 0.0001) in the D-group and -22.8 mm (.

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.