| Disease | A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTI-CENTER STUDY. PATIENTS - MALE AND FEMALE OUTPATIENTS AGED 25 TO 75 YEARS WITH STAGE I TO STAGE II CHRONIC VENOUS INSUFFICIENCY(CVI), NOT HAVING ANY OTHER SIGNIFICANT
MEDICAL CONDITIONS AND NOT TREATED WITH COMPRESSION STOCKINGS, DIURETICS OR OTHER DRUGS AFFECTING FLUID BALANCE. PATIENTS WERE RANDOMLY ASSIGNED TO A DOUBLE-BLIND TREATMENT WITH PLACEBO, 360 MG AS 195 OR 720 MG AS 195 ONCE DAILY FOR 12 WEEKS,
PRECEDED AND FOLLOWED BY A SINGLE-BLIND 2-WEEK PLACEBO TRTMNT FOR BASELINE RUN-IN AND END-0F-TRIAL WASHOUT, RESPECTIVELY. STUDY CRITERIA WERE EVALUATED AT BASELINE, AFTER 6 AND 12 WEEKS OF TREATMENT AND 2 WEEKS AFTER DISCONT. OF TREATMENT.
ONCE-DAILY DOSES OF 360 AND 720 MG AS 195 WERE CONFIRMED TO BE SAFE AND EFFECTIVE IN THE TREATMENT OF MILD CVI, REDUCING SIGNIFICANTLY LOWER LEG EDEMA AND CIRCUMFERENCE WHILST IMPROVING KEY CVI-RELATED SYMPTOMS TO A CLINICALLY RELEVANT EXTENT.
THE EDEMA REDUCTION IS AT LEAST EQUIVALENT TO THAT REPORTED FOR COMPRESSION STOCKINGS AND/OR OTHER EDEMA-REDUCING AGENTS. THE HIGHER DOSE WAS AS WELL TOLERATED AS THE LOWER DOSE BUT RESULTED IN A SLIGHTLY GREATER AND MORE SUSTAINED IMPROVEMENT. |