SAFETY AND EFFICACY OF VARDENAFIL 10 MG AND TAMSULOSIN 0,4 MG IN THE
TREATMENT OF MEN WITH LUTS DUE TO BPH: A RANDOMISED, PLACEBOCONTROLLED STUDY
M. Gacci, G. Vittori, G. Siena, M.A. Rossetti, N. Tosi, A. Lapini, S. Serni, M. Maggi, M. Carini
INTRODUCTION
Safety and efficacy of tamsulosin and vardenafil are well defined: however, there is no report
regarding the safety and efficacy of combined therapy of both types of agents for LUTS/BPH men.
The aim of our study was to compare the safety and efficacy of tamsulosin 0.4 mg/day vs.
tamsulosin 0.4 mg/day plus vardenafil 10 mg/day in men with LUTS/BPH, in a randomized trial
with 3 month follow up.
MATERIALS AND METHODS
Sixty men with persistent irritative urinary symptoms after 2 weeks run-in with tamsulosin 0.4 mg
were randomized in 2 groups: group VAR (30 P.ts) undergone a combination therapy with
tamsulosin 0,4 mg and vardenafil 10 mg (both one a day), while group PLA (30 P.ts) undergone a
combination therapy with tamsulosin 0,4 mg and placebo (both one a day). IPSS (International
Prostate Symptom Score), IPSS-B (International Prostate Symptom Score- Bother), IIEF-5
(International Index of Erectile Function, Version 5) and OAB-q (Over Active Bladder
questionaire) scores, uroflowmetry data and post-voiding residual urine (PVR) were recorded at
baseline (after run in), 2 weeks and 12 weeks after treatment. Differences between VAR and PLA at
different times were calculated with unpaired samples T test. Between-group differences in change
from baseline to 2 and 12 weeks were evaluated with ANOVA analysis.
RESULTS
One patient (from group PLA) discontinued the protocol for lack of efficacy at 2 weeks. No
differences between the groups in QOL questionnaire scores, uroflowmetry data or PVR were
recorded at baseline. All enrolled men did not report any grade  2 adverse event. At 12 weeks,
only 2 ( 6.9%) men in placebo groups and 3 (10%) in the vardenafil group reported persistent AEs.
We reported significant differences between PLA and VAR for IIEF (2 weeks: 16,2 vs 18.7, p =
0,053; 12 weeks: 15.9 vs 19.4, p= 0,022), IPSS (2 weeks: 18.0 vs 14.9, p = 0,042; 12 weeks: 16.7 vs
12.8 , p= 0,014), IPSS-B (12 weeks: 3.8 vs 3.1, p= 0,045) and OAB-q (2 weeks: 18.2 vs 14.7, p =
0,000; 12 weeks: 17.7 vs 13.6, p= 0,006), while no significant differences resulted for uroflowmetry
data and PVR. Furthermore, in VAR group after 12 weeks we observed a statistically significant
increase in both Qmax and Qave (+2.4 mL/sec, p=0,025 and +1.0 mL/sec, p=0.042 respectively):
this data was not present after 2 weeks of treatment.
ANOVA analysis did not showed significant difference in change between PLA and VAR group for
IPSS, IPSS-B and OAB-q, while it was found for IIEF (+0.33 vs +2.62, p=0,03), Qmax (+0.07 vs
+2.44, p=0.034) and Qave (placebo: -0.15, vardenafil: +1.02, p=0.031). Moreover, 12 weeks
treatment with vardenafil was associated with a significant change in mean irritative IPSS subscores
(-1.68 vs -3.24, p=0.039), with no significance for obstructive IPSS subscores.
CONCLUSION
Vardenafil 10 mg combined with Tamsulosin 0.4 mg shows an excellent tolerability profile both at
2 and 12 weeks, in patients with persistent irritative urinary symptoms.
As showed in the figure, this combination therapy allows to achieve significant improvement of
erectile function, general and irritative urinary symptoms and bother compared to tamsulosin alone
after 2 weeks of treatment. All These effects are further enhanced after 3 months of therapy. At 12
weeks a further improvement of both Qmax and Qave is obtained compared to tamsulosin alone.
IPSS
IIEF
25
24
23
22
*
20
*
21
19
Pla
18
Var
16
17
Pla
15
13
*
11
14
9
12
Var
*
7
10
5
baseline
2w eeks
12 w eeks
baseline
OAB-q
2w eeks
12 w eeks
IPSS-B
5
24
22
4,5
20
Pla
18
Var
16
4
Pla
Var
3,5
14
*
12
10
baseline
2w eeks
3
*
12 w eeks
*
2,5
baseline
2w eeks
12 w eeks