Efficacy and safety of oral mirodenafil in the treatment of erectile dysfunction in diabetic men in Korea: a multicenter, randomized, double-blind, placebo-controlled clinical trial.
BACKGROUND
Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).


OBJECTIVE
To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes.


METHODS
A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks.


METHODS
Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC).


RESULTS
After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (≥ 26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously.


CONCLUSIONS
Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.
Park
Hyun Jun
HJ
Department of Urology, Pusan National University School of Medicine, Buan, Korea. joon501@pusan.ac.kr
Choi
Hyung Ki
HK
Ahn
Tai Young
TY
Park
Jong Kwan
JK
Chung
Woo Sik
WS
Lee
Sung Won
SW
Kim
Sae Woong
SW
Hyun
Jae Seog
JS
Park
Nam Cheol
NC
D000284:Administration, Oral; D000368:Aged; D003431:Cross-Cultural Comparison; D003925:Diabetic Angiopathies / Q000188:drug therapy* / Q000208:ethnology; D004311:Double-Blind Method; D006801:Humans; D018783:Impotence, Vasculogenic / Q000188:drug therapy* / Q000208:ethnology*; D008297:Male; D008875:Middle Aged; D010410:Penile Erection / Q000187:drug effects; D058986:Phosphodiesterase 5 Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011744:Pyrimidinones / Q000009:adverse effects / Q000627:therapeutic use*; D056910:Republic of Korea; D013449:Sulfonamides / Q000009:adverse effects / Q000627:therapeutic use*
D058986:Phosphodiesterase 5 Inhibitors; D011744:Pyrimidinones; D013449:Sulfonamides; C528396:mirodenafil