CLINICAL MONITORING OF VENOPHARMACEUTICAL EFFECT OF CYCLO 3 FORT (SEVEC) IN PATIENTS WITH VENOUS INSUFFICIENCY
Thrombotic Centre, General University Hospital and Charles University, 1st Faculty of Medicine, Prague
Objective: A six-month, open, clinical monitoring of venopharmaceutical effect of Cyclo 3 Fort (SEVEC) was conducted at the Thrombotic Center in Prague. It evaluated the complex effectiveness of Cyclo 3 Fort (Pierre Fabre Medicament, France) in view of changes in laboratory haemocoagulation and proinflammatory parameters and clinical manifestations in patients with chronic venous insufficiency (CVI).
Methods: A total of 125 CVI patients, with CEAP max. C3 clinical signs and symptoms, were evaluated in clinical trials. The primary objectives were to evaluate changes in CVI clinical picture according to CEAP classification, changes in the circuits of the individual legs of the lower limbs, and changes in the patients’ quality of life (according to CIVIQ questionnaire). The secondary goal was to monitor changes in haemocoagulation and “inflammatory” parameters.
Results: During the follow-up period, Cyclo 3 Fort significantly decreased oedema in each leg of the leg. The calf swelling decreased by 1.1 cm (p < 0.001) after a six-month treatment. Similarly, the circumference of the thighs was reduced by 1.4 cm (p < 0.001). The severity of all significant CVI symptoms observed (pain, swelling, tension, feeling of heavy and restless legs) decreased significantly after only 3 months of treatment. In terms of changes in inflammatory parameters, fibrinogen (Fbg) levels decreased: 3.49 vs. 3.31 g/l (p < 0.001); CRP 3,14 vs. 3.01 mg/l (p = 0.005) and FVIII levels 149.5 vs. 140.12% (p = 0.005), other laboratory parameters were not significantly affected.
Conclusion: Objectively, therapy with Cyclo 3 Fort significantly reduces the swelling of the lower extremities in individual levels. Subjectively, it brings patients relief from unpleasant CVI symptoms and levels of proinflammatory parameters (Fbg, CRP and FVIII) are reduced during therapy. This finding objectifies the efficacy of Cyclo 3 Fort therapy in CVI patients.
The work was supported by the project of the Ministry of Health, CZE, 64165.