A prospective, randomized, controlled, multicenter study of naftopidil for treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia: 75 mg once daily in the evening compared to 25 mg thrice daily.
BACKGROUND
We examined the tolerability of dosage methods of naftopidil in the treatment of male lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH/male LUTS).


METHODS
A total of 80 patients with BPH/male LUTS who had an International Prostate Symptom Score (IPSS) >or=8 and IPSS quality of life (QoL) >or=2 were enrolled and randomly administered naftopidil for 8 weeks at either 75 mg once daily (OD) in the evening (group O; n = 41) or 25 mg thrice daily (TID) in the morning, afternoon and evening (group T; n = 39).


RESULTS
IPSS total score, IPSS-QoL and BPH impact index (BII) were significantly improved for both groups at 8 weeks after starting treatment compared to baseline. IPSS total score and daytime and 24-hour voiding frequencies were significantly improved at 8 weeks after starting treatment for group O in comparison to group T. Group O showed a significantly better degree of change in BII in comparison to group T.


CONCLUSIONS
Naftopidil 75 mg OD in the evening was better tolerated than naftopidil 25 mg TID for the objective parameter and BII.
Department of Urology, Kurobe City Hospital, Kurobe, Japan. turi2202 @ yahoo.co.jp
Shinji
S
Tsuritani
Tetsuo
T
Nozaki
Akiou
A
Okumura
Hitomi
H
Kimura
Taizo
T
Kazama
D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage* / Q000009:adverse effects; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects
D058668:Adrenergic alpha-1 Receptor Antagonists; D009281:Naphthalenes; D010879:Piperazines; C064357:naftopidil