Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia.
OBJECTIVE
To compare the efficacy and safety of silodosin and tamsulosin in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) by a randomized crossover method.


METHODS
BPH patients with the complaint of LUTS were included in this study, and were randomly divided into two groups: a silodosin-preceding group (4 weeks of twice-daily administration of silodosin at 4 mg, followed by 4 weeks of once-daily administration of tamsulosin at 0.2 mg) or a tamsulosin-preceding group (4 weeks' administration of tamsulosin, followed by 4 weeks' administration of silodosin). No drug withdrawal period was provided when switching the drug.


RESULTS
In the first treatment period, both drugs significantly improved the International Prostate Symptom Score total score, but the improvement by silodosin was significantly superior to that by tamsulosin. After crossover treatment, significant improvement was observed only with silodosin treatment. Moreover, intergroup comparison of changes revealed that silodosin showed significant improvement of straining and nocturia with first and crossover treatments, respectively, compared with tamsulosin. Silodosin also significantly improved quality of life (QOL) score in both treatment periods, while tamsulosin significantly improved QOL score only in the first treatment period. The most frequent adverse drug reaction was ejaculatory disorder with silodosin; however, the incidence of dizziness with silodosin was similar to that with tamsulosin.


CONCLUSIONS
In BPH/LUTS patients, silodosin exhibits excellent efficacy in improving subjective symptoms in both initial and crossover treatment, and it appears to improve the QOL of patients.
Miyakita
Hideshi
H
Department of Urology, Tokai University School of Medicine, Oiso, Kanagawa, Japan. miyakita@is.icc.u-tokai.ac.jp
Yokoyama
Eiji
E
Onodera
Yasutada
Y
Utsunomiya
Takuji
T
Tokunaga
Masatoshi
M
Tojo
Takanori
T
Fujii
Noriteru
N
Yanada
Shuichi
S
D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D018592:Cross-Over Studies; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*; D000077409:Tamsulosin; D016896:Treatment Outcome; D014551:Urinary Tract / Q000503:physiopathology*; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology
D000317:Adrenergic alpha-Antagonists; D007211:Indoles; D013449:Sulfonamides; C095285:silodosin; D000077409:Tamsulosin