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Clinical acceptability study of once-daily versus twice-daily micronized purified flavonoid fraction in patients with symptomatic chronic venous disease: a randomized controlled trial.

BACKGROUND
The aim of this study was to compare the clinical acceptability of two dose regimens of micronized purified flavonoid fraction (MPFF): a single 1000 mg tablet once daily versus 500 mg twice daily in patients suffering from chronic venous disease (CVD).


METHODS
In an international, randomized, double-blind, parallel-group study, 174 patients (Clinical Etiological Anatomic Pathophysiologic [CEAP] class C0s to C4) were randomized to MPFF 1000 mg once daily or MPFF 500 mg twice daily for 8 weeks. Adverse events (AEs) were recorded in patient-kept diaries (weeks 0, 2, 4, 8) and leg pain was assessed using a Visual Analog Scale (VAS).


RESULTS
No serious AEs occurred. A total of 30 treatment-emergent adverse events (EAE) were reported (15 in each group). Three treatment-EAE in the MPFF 1000 mg group (constipation, dyspepsia, allergic dermatitis) were considered by the investigator to be related to treatment. All were of mild intensity and resolved when treatment finished. Both MPFF regimens were associated with a significant reduction in leg pain score with a reduction of 4.21 cm for MPFF 1000 mg once daily (P<0.001) and 4.01 cm for MPFF 500 mg twice daily (P<0.001). The reduction in pain was noted after 2 weeks of treatment and continuously throughout the treatment.


CONCLUSIONS
Both treatment regimens were well tolerated and associated with similar reductions in leg pain after 8 weeks of treatment. The new MPFF 1000 mg dose regimen has a similar safety profile to two MPFF 500 mg tablets with the advantage of one tablet per day and potential improved patient adherence.