Efficacy and safety of mirodenafil for patients with erectile dysfunction: a meta-analysis of three multicenter, randomized, double-blind, placebo-controlled clinical trials

Figures & data

Figure 1. Flow chart for selecting randomized controlled trials for analysis (RCTs = randomized controlled trials).

Table 1. Baseline characteristics of the included studies.

Study, Year	Intervention (n)	Mean age (yr)	Etiology of ED	Prior PDE5-I users (%)	Follow-up (wk)	Outcome measures
Paick et al., 2008 [10]	Placebo (75)	54.6	Alcohol, tobacco, diabetes mellitus, hypertension	49.3	12	The IIEF erectile function domain score, SEP Q2 and Q3, the response to GAQ, LSC, adverse events
	Mirodenafil 100 mg (74)	53.6		52.1
Paick et al., 2010 [16]	Placebo (53)	57.04	Hypertension	58.82	12	The IIEF erectile function domain score, SEP Q2 and Q3, the response to GAQ, LSC, adverse events
	Mirodenafil 100 mg (54)	58.02		71.7
Park et al., 2010 [17]	Placebo (53)	57.3	Diabetes mellitus	41.5	12	The IIEF erectile function domain score, SEP Q2 and Q3, the response to GAQ, LSC, adverse events
	Mirodenafil 100 mg (55)	55.5		40

ED = erectile dysfunction; PDE5-I = phosphodiesterase type 5 inhibitors; SEP = sexual encounter profile; Q = question; GAQ = Global Assessment Question; IIEF = International Index of Erectile Function.

Table 2. The methodological quality of the included studies.

Entry	Adequate sequence generation	Allocation concealment	Blinding	Incomplete outcome data	Selective outcome reporting	Other sources of bias
Jae-Seung, 2008 [10]	Unclear	Unclear	Double blind	Yes	Unclear	Unclear
Jae-Seung, 2010 [16]	Unclear	Unclear	Double blind	Yes	Unclear	Unclear
Hyun, 2010 [17]	Unclear	Unclear	Double blind	Yes	Unclear	Unclear

Table 3. Compared to placebo, the pooled results of meta-analysis on the efficacy and safety of mirodenafil for erectile dysfunction.

Parameters	n	Sample size (I/C)	Heterogeneity	Pooled MD or RR (95% CI)	Z test
The IIEF EFD scores	3	183/181	χ^2= 0.64, p = 0.73, I^2= 0%	8.13 (6.64, 9.61)	Z = 10.73, p < 0.00001
The IIEF EFD scores (changes)	2	109/106	χ^2= 0.46, p = 0.50, I^2= 0%	7.32 (5.56, 9.07)	Z = 8.19, p < 0.00001
Orgasmic function (changes)	3	183/181	χ^2= 1.88, p = 0.39, I^2= 0%	2.62 (2.09, 3.15)	Z = 9.69, p < 0.00001
Sexual desire (changes)	3	183/181	χ^2= 2.54, p = 0.28, I^2= 21%	1.70 (1.28, 2.12)	Z = 7.93, p < 0.00001
Intercourse satisfaction (changes)	3	183/181	χ^2= 2.15, p = 0.34, I^2= 7%	3.53 (2.92, 4.14)	Z = 11.34, p < 0.00001
Overall satisfaction (changes)	3	183/181	χ^2= 1.83, p = 0.40, I^2= 0%	2.44 (1.97, 2.90)	Z = 10.34, p < 0.00001
IIEF Q3 scores (changes)	3	183/181	χ^2= 0.88, p = 0.65, I^2= 0%	1.11 (0.80, 1.43)	Z = 6.94, p < 0.00001
IIEF Q4 scores (changes)	3	183/181	χ^2= 2.25, p = 0.33, I^2= 11%	1.52 (1.22, 1.81)	Z = 10.14, p < 0.00001
SEPQ2 (changes)	3	183/181	χ^2= 0.17, p = 0.92, I^2= 0%	24.73 (16.66, 32.80)	Z = 6.00, p < 0.00001
SEPQ3 (changes)	3	183/181	χ^2= 0.74, p = 0.69, I^2= 0%	43.78 (36.03, 51.53)	Z = 11.07, p < 0.00001
GAQ (changes)	3	183/181	χ^2= 1.26, p = 0.53, I^2= 0%	3.18 (2.48, 4.08)	Z = 9.08, p < 0.00001
LSC (changes)	3	183/181	χ^2= 18.17, p = 0.0001, I^2= 89%	0.70 (−0.01, 1.41)	Z = 1.92, p = 0.05
Adverse events
Flushing	3	184/186	χ^2= 0.29, p = 0.86, I^2= 0%	4.90 (2.09, 11.49)	Z = 3.65, p = 0.0003
Headache	3	184/186	χ^2= 0.32, p = 0.85, I^2= 0%	7.10 (1.92, 26.21)	Z = 2.94, p = 0.003
Dyspepsia	3	184/186	χ^2= 0.62, p = 0.73, I^2= 0%	2.23 (0.51, 9.78)	Z = 1.06, p = 0.29
Dizziness	3	185/185	χ^2= 0.28, p = 0.87, I^2= 0%	1.80 (0.39, 8.35)	Z = 0.75, p = 0.45

I = intervention; C = control; MD = mean difference; RR = risk ratio; SEP = sexual encounter profile; Q = question; GAQ = Global Assessment Question; IIEF EFD = International Index of Erectile Function erectile function domain.

Paick JS, Ahn TY, Choi HK, et al. Efficacy and safety of mirodenafil, a new oral phosphodiesterase type 5 inhibitor, for treatment of erectile dysfunction. J Sex Med 2008;5:2672–80

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Paick JS, Kim JJ, Kim SC, et al. Efficacy and safety of mirodenafil in men taking antihypertensive medications. J Sex Med 2010;7:3143–52

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Park HJ, Choi HK, Ahn TY, et al. 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. J Sex Med 2010;7:2842–50

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