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Okada H1, Sato R1, Kobori Y1, Ashizawa Y1, Yagi H1, Soh S1, Arai G1 1. Department of Urology, Dokkyo Medical University Koshigaya Hospital LOW DOSE OF TADALAFIL CAN FURTHER IMPROVE SYMPTOMS OF LUTS/BPH PATIENTS
ALREADY TREATED WITH TAMSULOSIN.
Hypothesis / aims of study
Although 1 adrenoceptor blockers (-blocker) are the first line treatment in LUTS/BPH patients, they cannot relieve symptoms in
all cases. Recently phosphodiesterase type 5 inhibitors (PDE5I) sildenafil, vardenafil and tadalafil  were reported to be effective
in LUTS/BPH patients with or without erectile dysfunction (ED). We conducted an open-label clinical study to investigate the effect
of tadalafil in patients with LUTS/BPH who had already been treated with tamsulosin.
Study design, materials and methods
Men at least 50 years old with LUTS/BPH, who had been under treatment by tamsulosin for 12 weeks with little effect, were eligible
for this study. Inclusion criteria were a total International Prostate Symptom Score (IPSS) of 15 or greater, QoL score of 3 or
greater, a maximum urinary flow rate (Qmax) of 4 to15 mL/s, a prostate volume estimated by ultrasonography of 20mL or greater, a
postvoid residual urine volume (PVR) of < 100 m. Men were not required to have a history of ED and the frequency of sexual
intercourse was not discussed at the entry.
Patients were asked to take 5mg of tadalafil with tamsulosin everyday for 12 weeks. The primary endpoint was the change in IPSS
and IIFE-5 from baseline. Safety was assessed by adverse events, physical examination, vital signs and laboratory tests. Change
of Qmax and PVR were measured. The number of circulating angiogenic cells (CAC) was measured  before and after tadalafil
Fifteen patients completed study. The change in the total IPSS from baseline was -6.6 (p<0.05). The change in the storage
symptom was greater than that in voiding symptom (-3.7 v.s. -2.9, p<0.05). The change in IIEF-5 from baseline was +5.2 (p<0.05).
The change in QoL from baseline was -1.8 (P<0.05). These beneficial effects lasted for 12 months after treatment period. Qmax
and PVR did not change significantly. The number of CAC increased significantly. No drug-related adverse events were reported.
Interpretation of results
Low dose of tadalafil with tamsulosin significantly improved symptoms in LUTS/BPH patients who did not responded tamsulosin
alone. Increase in number of CAC may play a role to maintain the effect of treatment.
Low dose of tadalafil combined with -blocker can be a treatment option in those patients who showed unsatisfactory results with
1. J Urol. 180: 1228-1234, 2008
2. Atherosclerosis 196: 313-319, 2008 Specify source of funding or grant
Is this a clinical trial?
What were the subjects in the study?
Was this study approved by an ethics committee?
Specify Name of Ethics Committee
Ethical committee of Dokkyo Medical University Koshigaya
Was the Declaration of Helsinki followed?
Was informed consent obtained from the patients?
Description Product # Used in Research Packaging Product is packed in 12.5 kg box. Each box is identified with the Ingredient Lead Time Gamma-Irradiation Shelf Life Control Diets Used as a control diet for D12451and D12492Formulated by E. A. Ulman, Ph.D., Research Diets, Inc., 8/26/98and 3/11/99. *Typical analysis of cholesterol in lard = 0.95 mg/gram. Cholesterol (mg
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