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Comparison of efficay and safety for erectile dysfunction of mirodenalfil 50mg once daily and 100mg on-demand in patients with radical prostatectomy : Multicenter, Randomized trial.

Abstract: PD69-03
Sources of Funding: SK chemicals Korea

Introduction

To compare the improvement of erectile dysfunction (ED) as well as safety of mirodenalfil 50mg once daily and 100mg on-demand in patients with radical prostatectomy due to prostate cancer.

Methods

Prospective study was done with 166 patients who had ED after taken radical prostatectomy due to prostate cancer from June 2013 to October 2014. Out of 184 individuals, 171 met inclusion criteria and 153 finished the research. Patients were divided into two groups. Group 1 had mirodenafil 50mg daily and Group 2 had mirodenafil 100mg on-demand. The ?ve-item version of the International Index of Erectile Function (IIEF-5), SEP Q2, Q3 were assessed immediately before initiation of treatment (V1) and after two (V2), six (V3) and twelve months of treatment (V4). Also, to investigate the safety, blood pressure, pulse, and side effect were evaluated.

Results

Out of 171 individuals, 153 (89.4%) finished the research (group 1: n=74, 48.4%, group 2: n=79, 51.6%). Statistically, there were no difference of IIEF-5 at V1 between two groups. Both groups had meaningful improvement on IIEF-5 in V2,V3, V4 and group 1 had better improvement than group 2 (10.9±4.1 vs. 8.0±5.3, δ4.0±2.6, p=0.01) (Table1). Group 1 had larger improvements than Group 2 in SEP Q2 and Q3 significantly (V4-Q2: 60.1% vs. 50.7%, p=0.01, Q3: 58.4% vs.48.8%, p=0.01). There was no drop out patients due to cardiovascular problems and other side effects.

Conclusions

The administration of a 5 mg dose of mirodenafil daily to patients who had erectile dysfunction that had undergone a radical prostatectomy due to prostate cancer had batter effect on the recovery and maintenance of erectile function than 100mg dose of mirodenafil. The side effects were insignificant for both dosing schedules._x000D_ _x000D_

Funding

SK chemicals Korea

Authors
Kyu Shik Kim
Tae Hyo Kim
Joon Hwa Noh
Jae Hyun Bae
Cheol Young Oh
Jin Sun Cho
Ho Song Yu
Seung Hwan Lee
Sung Yong Cho
Hee Ju Cho
Jeong Man Cho
Jae Duck Choi
June Hyun Han
U-Syn Ha
Sung Hoo Hong
Yong Tae Kim
Hong Yong Choi
Seung Wook Lee
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