AIM: To compare the clinical acceptability of two dose regimens of micronized purified @entity3096 fraction (MPFF): a single 1000 mg tablet once daily versus 500 mg twice daily in @entity1 suffering from @entity102 ( @entity102 ). METHODS: In an international, randomized, double-blind, parallel-group study, 174 @entity1 (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 were recorded in @entity1 -kept diaries (weeks 0, 2, 4, 8) and leg @entity158 was assessed using a visual analog scale (VAS). RESULTS: No serious adverse events 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 ( @entity1142 , @entity2210 , @entity56 ) 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 @entity158 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 @entity158 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 @entity158 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 @entity1 adherence.

Clinical acceptability study of once-daily versus twice-daily micronized purified XXXX fraction in @entity1 with symptomatic @entity102 : a randomized controlled trial.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient'] @entity3096 :: ('CHEBI:47916', 'Chemical') :: ['flavonoid'] @entity102 :: ('MESH:D002908', 'Disease') :: ['chronic venous disease', 'CVD'] @entity56 :: ('MESH:D004342', 'Disease') :: ['allergic dermatitis'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain'] @entity2210 :: ('MESH:D004415', 'Disease') :: ['dyspepsia'] @entity1142 :: ('MESH:D003248', 'Disease') :: ['constipation']
@entity3096 :: (CHEBI:47916,Chemical) :: ['flavonoid']
