| Disease | MEDIANS). ADVERSE EVENTS OCCURRED SLIGHTLY MORE FREQUENTLY IN THE TAMSULOSIN GROUP COMPARED TO THE PRO 160/120 GROUP.
(N=136; P=0.03, TEST FOR NON-INFERIORITY ACCORDING TO FARRINGTON-MANNING; EQUIVALENCE MARGIN: 10%) QUALITY OF LIFE OF THE PATIENTS IMPROVED BY 2 POINTS UNDER PRO 160/120 AND BY 1 POINT UNDER TAMSULOSIN (BASELINE VALUES: 3 POINTS VS. 4 POINTS;
HAVING STARTED WITH BASELINE VALUES OF 20 POINTS IN EACH GROUP (MEDIANS). AT THE END OF THE STUDY, 22 (32.4%) OF THE PATIENTS TREATED WITH PRO 160/120 AND 19(27.9%) OF THE PATIENTS TREATED WITH TAMSULOSIN SHOWED ONLY MILD SYMPTOMS (I.E.I-PSS<7)
50 YEARS. I-PSS>13. QOL>3 QMAX<12ML/S) WERE RANDOMISED AND-AFTER A PLACEBO-RUN-IN-PHASE OF 2 WEEKS-TREATED WITH 2X1 CAPSULE PRO 160/120 (N=71) OR 1X1 CAPSULE TAMSULOSIN (N=69). DURING THE 60 WEEKS OF TREATMENT, THE I-PSS IMPROVED BY 9 POINTS
A SECOND PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTRE TRIAL COMPARED THE EFFICACY AND TOLERABILITY OF PRO 160/120 VS. TAMSULOSIN IN PATIENTS WITH LUTS (SYMPTOMATIC BPH) (BONDARENKO ET AL. 2002). IN TOTAL, 140 PATIENTS (AGED >
TREATMENT A STATISTICALLY SIGNIFICANT GROUP DIFFERENCE IN THE DECREASE OF THE I-PSS COULD BE SHOWN (PRO 160/120:
PERIOD OF ANOTHER 48 WEEKS (ALL PATIENTS RECEIVING 2X1 CAPSULE PRO 160/120). AT BASELINE, THE 253 PATIENTS EVALUATED (PRO 160/120: 127; PLACEBO: 126) SHOWED A MEDIAN I-PSS OF 17 POINTS IN BOTH TREATMENT GROUPS. AFTER THE DOUBLE-BLIND
CONSISTED OF A 2-WEEK PLACEBO-RUN-IN-PHASE FOLLOWED BY A 24-WEEK DOUBLE-BLIND TREATMENT (2X1 CAPSULE PRO 160/120 VS. PLACEBO), AN OPEN 24-WEEK CONTROL PERIOD (DURING WHICH ALL PATIENTS RECEIVED 2X1 CAPSULE PRO 160/120) AND AN OPEN FOLLOW-UP
A PROSPECTIVE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, LONG-TERM MULTICENTRE TRIAL IN 257 PATIENTS WITH LUTS (BPH STAGE I-II ACC. TO ALKEN (1973), I-PSS >14, QUALITY OF LIFE (QOL)>4, AND MAXIMUM URINARY FLOW RATE (QMAX)<15 ML/S) WHICH |