Multicentre observational study of Phlebodia 600 in treatment of patients with CEAP class C0–C3 chronic venous diseases

Stoyko Yu.M.¹, Talibov O.B.², Yaskin M.N.¹, Kudykin M.N.³, Belentsov S.M.⁴, Katelnitskaya O.V.⁵, Suchkov I.A.⁶, Tolstikhin V.Yu.⁷, Kletskin A.E.⁸, Sevostyanova K.S.⁹

1) National Medical Surgical Centre named after N.I. Pirogov under the RF Ministry of Public Health,
2) Moscow State University of Medicine and Dentistry named after A.I. Evdokimov, Moscow,
3) Volga Region Federal Medical Research Centre of the RF Ministry of Public Health, Nizhny Novgorod,
4) Medical Centre "AngioLine", Ekaterinburg,
5) Rostov Scientific Research Institute of Oncology, Rostov-on-Don,
6) Ryazan State Medical University named after Academician I.P. Pavlov under the RF Ministry of Public Health, Ryazan,
7) Department of Surgical Diseases, Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky, Krasnoyarsk,
8) Chair of Surgery of the Department of Advanced Medical Training, Nizhny Novgorod State Medical Academy, Nizhny Novgorod,
9) Centre of New Medical Technologies, Institute of Chemical Biology and Fundamental Medicine under the Siberian Branch of the Russian Academy of Sciences, Novosibirsk, Russia

The purpose of the study was to evaluate efficacy of Diosmin (Phlebodia 600, Innothera, France) in treatment of patients presenting with class C0s–C3 chronic venous diseases (CVD) according to the CEAP classification.

Presented herein are the results of a prospective observational study aimed at assessing the outcomes of two-month administration of Phlebodia 600 (600 mg diosmin) in patients suffering from class C0s–C3 CVD according to the CEAP classification. The study comprised a total of 868 patients, including 175 (20.2%) men and 693 (79.8%) women. Of these, 866 patients completed the study according to the protocol.

Amongst the 868 followed-up patients, 851 (98.0%) subjects strictly adhered to the physician’s prescription and stopped taking the drug without violation of the regimen and dosing of diosmin. The main drug dosage regimen of diosmin was 1 tablet once a day in 851/868 (98.04%) patients. Satisfaction with treatment with diosmin was reported as "excellent" by 46.7 % of patients (95% CI: 43.3–50.0) and by 49.4% of physicians (95%: CI 46.1–52.7), being rated as "good" by 45.0% of patients (95 % CI: 41.7–48.4) patients and by 43.6% of physicians (95% CI: 40.3–47.0). The score for the quality of life of patients according to the CIVIQ-20 scale at the first follow-up visit amounted to 45.4±15.4 points (median 43.0 points). At the second follow-up visit, this parameter improved dramatically, dropping to the level of 35.6±11.5 points (median 33.0 points). By the third follow-up visit, the positive dynamics of the parameters preserved continued, averagely amounting to 28.9±8.7 points (median 26.0 points). A decrease in the circumference of the left and right crura (by 0.39±0.74 and by 0.36±0.75 cm, respectively) was observed at the second follow-up visit. The difference of the malleolar measurements between the first and third follow-up visits amounted to 7.2±9.4 mm and 6.6±9.7 mm for the right and left crus, respectively (p<0.001). The number of patients with a reported feeling of heaviness in the legs statistically significantly decreased from 97.6% at the stage of enrollment into the study to 73.0% after 2 months of therapy, that of those with painful sensations from 84.5 to 55.3%, those with complaints of swelling (oedemas) of the lower limbs from 83.9 to 56.8%, with complaints of convulsions from 71.2 to 35.7%, with complaints of sensation of tingling from 63.4 to 34.1%, respectively.

Hence, a statistically significant improvement of the patients’ condition was observed as early as 30 days after the beginning of treatment. By day 60, the positive effect of the carried out therapy continued to grow. Safety and good tolerance of the drug were noted, which was confirmed by low incidence of undesirable events and high adherence to treatment.

KEY WORDS: chronic venous disease, venotonic, diosmin, observational study.

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