[Investigation of adverse events and the continuance rate of silodosin in all patients who received silodosin for lower urinary tract symptoms suggestive of benign prostatic hyperplasia].
OBJECTIVE
We retrospectively evaluated patients who received silodosin for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) in our hospital, to investigate its efficacy, adverse events and continuance rate.


METHODS
From the release of silodosin (July 2006) through October 2008, 256 patients received silodosin for BPH/LUTS in our hospital. Of these 256, we evaluated 195, as 61 were excluded due to conditions such as prostate cancer. We evaluated the International Prostate Symptom Score (IPSS), quality of life (QOL) index, uroflowmetry and postvoid residual urine volume before and after medication. We calculated the continuance rate of the drug by the Kaplan-Meier method.


RESULTS
The patients' mean age was 68.1 years and the mean medicated period was 3.1 months. Overall severity at baseline estimated by the criteria for severity of BPH was mild in 0%, moderate in 69%, and severe in 31%. Silodosin significantly improved the IPSS, QOL index, maximum urinary flow rate and postvoid residual urine volume in 90 patients whose data were available for analysis of the efficacy. Improvements were observed both in voiding symptoms and in storage symptoms. However, 45.6% of the overall efficacy was insufficient. Adverse events were observed in 56 of the 195 cases (28.7%). The most common adverse event was abnormal ejaculation (10.8%). The patients who reported adverse events were significantly younger in age and had lower IPSS and QOL index values after treatment than those without adverse events (mean age: 65.4 vs. 69.2 years old; mean IPSS: 7.7 vs. 13.1, mean QOL index: 2.9 vs. 3.6). The continuance rate for the drug was 12.0% at 1 year on the Kaplan-Meier curve. The development of adverse events was involved in the low continuance rate of silodosin.


CONCLUSIONS
Modification of treatment such as dose reduction is necessary to continue silodosin.
Urology Service, Furuya Hospital.
Ryoji
R
Furuya
Naoya
N
Masumori
Seiji
S
Furuya
Hiroshi
H
Ogura
Masatoshi
M
Mutoh
Ko
K
Kobayashi
Shin-ichi
S
Hisasue
Taiji
T
Tsukamoto
D000367:Age Factors; D000368:Aged; D004542:Ejaculation / Q000187:drug effects; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000150:complications*; D011788:Quality of Life; D012189:Retrospective Studies; D014555:Urination Disorders / Q000188:drug therapy* / Q000209:etiology* / Q000503:physiopathology; D014563:Urodynamics
D007211:Indoles; C095285:silodosin