A randomised, double-blind study comparing the efficacy and tolerability of controlled-release doxazosin and tamsulosin in the treatment of benign prostatic hyperplasia in Brazil.
Brazilian patients with benign prostatic hyperplasia were randomised in a 12-week, double-blind, double-dummy study to receive doxazosin gastrointestinal therapeutic system (GITS) 4 mg q.i.d. (n = 82) or tamsulosin 0.4 q.i.d. (n = 83). Primary endpoints were the absolute and percentage change from baseline in symptoms measured by International Prostate Symptom Score (IPSS). Secondary endpoints included IPSS, quality-of-life (QOL) question from the IPSS, and questions 6 and 7 of the Sexual Function Abbreviated Questionnaire (SFAQ) at weeks 4 and 12. Doxazosin GITS and tamsulosin improved IPSS with no significant differences between groups at week 12. During weeks 4-8, tamsulosin-treated patients demonstrated a slower improvement (p < 0.001) in IPSS than doxazosin GITS-treated patients. The proportion of satisfied patients was observed earlier with doxazosin GITS (p = 0.006) vs. tamsulosin. At week 12, the proportion of patients with little or no difficulty at ejaculation (Q6 of SFAQ) was higher in the doxazosin GITS group (p = 0.019). Both treatments were well tolerated.
Pompeo
A C L
AC
IMEG, São Paulo, Brazil. pompeuro@uol.com.br
Rosenblatt
C
C
Bertero
E
E
DA Ros
C T
CT
Cairoli
C E D
CE
Damião
R
R
Wroclawski
E R
ER
Koff
W J
WJ
Mesquita
F
F
Pinheiro
G E
GE
D000317:Adrenergic alpha-Antagonists / Q000627:therapeutic use*; D000368:Aged; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D017292:Doxazosin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D013449:Sulfonamides / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome
D000317:Adrenergic alpha-Antagonists; D003692:Delayed-Action Preparations; D013449:Sulfonamides; D000077409:Tamsulosin; D017292:Doxazosin