Udenafil for the treatment of erectile dysfunction

Figures & data

Figure 1 Structural formula of udenafil.

Table 1 Patient characteristics and outcome measures of six randomized, placebo-controlled trials

Study population	ED type	Study duration	Group	No of patients	ED etiology (%) (organic/psychogenic/mixed)	ED severity (%) (mild/mild-to-moderate/moderate/severe)	Prior users of other PDE5Is (%)	Primary efficacy	Secondary efficacy
Paick et al^Citation27	General	12 weeks	Placebo	54	38.9/9.3/51.8	0/18.5/53.7/27.8	74.1	IIEF-EF	IIEF-3, −4
			100 mg udenafil	57	40.4/10.5/49.1	3.5/31.6/47.4/17.5	75.4		SEP2
			200 mg udenafil	56	42.9/5.4/51.7	3.6/26.8/51.8/17.8	82.1		SEP3 GAQ
Paick et al^Citation32	Hypertension	12 weeks	Placebo	55	56.4/0.0/43.6	9.1/47.3/25.5/18.2	50.9	IIEF-EF	IIEF-3, −4
			100 mg udenafil	53	60.4/0.0/39.6	1.9/34.0/41.5/22.6	54.7		SEP2, 3
			200 mg udenafil	57	57.9/0.0/42.1	1.8/28.1/54.4/15.8	57.9		GAQ % shift to normal EF
Park et al^Citation28	General	4 weeks	Placebo	51	8.24/3.9/13.7	2.0/51.0/41.2/5.8	58.8	SEP3	SEP2
			100 mg udenafil	53	84.9/0.0/15.1	3.8/41.5/43.4/11.3	71.7		IIEF-EF
Moon et al^Citation29	DM	12 weeks	Placebo	57	73.7/0.0/26.3	1.8/15.8/54.4/28.1	57.9	IIEF-EF	IIEF-3, −4
			100 mg udenafil	58	74.1/0.0/25.9	1.7/29.3/37.9/31.0	56.9		SEP2, 3
			200 mg udenafil	59	72.9/0.0/27.1	6.8/20.3/45.8/27.1	59.3		GAQ % shift to normal EF
Zhao et al^Citation31	General	12 weeks	Placebo	60	51.7/6.7/41/7	6.7/40.0/41.7/11.7	71.7	IIEF-EF	SEP2, 3
			25 mg udenafil	59	61.0/0.0/39.0	8.5/32.2/33.9/25.4	78.0		GAQ
			50 mg udenafil	60	53.3/1.7/45.0	15.0/31.7/36.7/16.7	81.7		% shift to normal EF
			75 mg udenafil	60	50.0/0.0/50.0	5.0/23.3/63.3/8.3	88.3
Ortac et al^Citation33	General	8 weeks	Placebo	59	13.6/62.7/23.7	NA	52.5	IIEF-EF	Other domains of IIEF
			100 mg udenafil	59	18.6/61.0/20.3	NA	52.5		SEP2, 3 GAQ

Abbreviations: DM, diabetes mellitus; ED, erectile dysfuction; EF, erectile function; GAQ, Global Assessment Question; IIEF, International Index of Erectile Dysfunction; IIEF-EF, EF domain of IIEF; NA, not available; PDE5I, phosphodiesterase type 5 inhibitor; SEP, Sexual Encounter Profile.

Table 2 Summary of efficacy of udenafil in six randomized, placebo-controlled trials

Study	Group	IIEF-EF			SEP2 (%)			SEP3 (%)			GAQ (%)	% shift to normal EF
		Baseline	End point	Change	Baseline	End point	Change	Baseline	End point	Change
Paick et al^Citation27	Placebo	12.93	13.13	0.2	57.40	53.38	−4.02	7.67	15.44	7.77	25.9	3.7
	100 mg	14.68	22.2	7.52	57.65	88.83	31.18	17.14	70.08	52.94	81.5	35.0
	200 mg	14.26	24.19	9.93	63.43	92.40	28.97	9.26	75.70	66.44	88.5	48.0
Paick et al^Citation32	Placebo	16.02	18.00	1.98	66.18	69.31	3.13	12.55	33.14	20.59	41.2	15.7
	100 mg	14.23	22.94	8.71	58.41	84.27	25.85	5.38	63.25	57.88	78.8	44.2
	200 mg	14.29	24.33	10.14	62.10	91.92	29.82	5.54	76.65	71.11	85.2	54.5
Park et al^Citation28	Placebo	16.38	15.80	−0.58	72.30	73.22	0.92	18.03	28.26	10.23	NA	6.0
	100 mg	15.36	19.77	4.41	75.00	82.27	7.27	19.03	54.66	35.63	NA	24.5
Moon et al^Citation29	Placebo	13.02	14.22	1.20	49.53	48.99	−0.54	7.50	22.60	7.50	30.9	3.6
	100 mg	13.31	20.31	7.00	53.04	76.88	23.84	7.16	53.13	45.97	65.5	38.2
	200 mg	13.98	22.19	8.21	55.60	86.67	31.07	7.44	63.00	55.56	83.9	44.8
Zhao et al^Citation31	Placebo	NA	NA	3.14	NA	NA	11.95	NA	NA	23.46	35.6	13.6
	25 mg	NA	NA	4.67	NA	NA	22.10	NA	NA	42.09	69.5	30.5
	50 mg	NA	NA	6.59	NA	NA	27.90	NA	NA	51.41	75.0	40.0
	75 mg	NA	NA	8.34	NA	NA	39.11	NA	NA	73.50	88.1	44.1
Ortac et al^Citation33	Placebo	15.4	19.1	3.7	NA	NA	46.0	NA	NA	42.0	49.1	NA
	100 mg	16.0	23.7	7.7	NA	NA	66.0	NA	NA	69.8	72.2	NA

Abbreviations: EF, erectile function; GAQ, Global Assessment Question; IIEF, International Index of Erectile Dysfunction; IIEF-EF, EF domain of IIEF; NA, not available; SEP, Sexual Encounter Profile.

Table 3 Summary of treatment-related adverse effects caused by udenafil

Study	Group	Flushing (%)	Headache (%)	Nasal congestion (%)	Conjunctival hyperemia (%)	Dyspepsia (%)	Visual disturbance (%)	Myalgia (%)	Back pain (%)	Others (%)	Total (%)
Paick et al^Citation27	Placebo	0.0	0.0	0.0	0.0		0.0	0.0			5.6
	100 mg	10.5	1.8	3.5	3.5		0.0	0.0			19.3
	200 mg	23.2	8.9	7.1	7.1		0.0	0.0			37.5
Paick et al^Citation32	Placebo	1.9	0.0		0.0	0.0	0.0
	100 mg	5.7	1.9		3.8	1.9	0.0
	200 mg	5.3	8.8		5.3	5.3	1.8
Park et al^Citation28	Placebo	0.0	4.0	0.0		0.0	0.0	0.0		0.0	4.0
	100 mg	1.9	1.9	1.9		3.8	0.0	0.0		1.9	11.3
Moon et al^Citation29	Placebo										3.6
	100 mg	10.0	5.0								15.8
	200 mg	10.0	5.0								22.4
Zhao et al^Citation31	Placebo	1.7	0.0	0.0	0.0	0.0	0.0	1.7			3.4
	25 mg	1.7	0.0	0.0	1.7	0.0	1.7	0.0			3.4
	50 mg	8.3	1.7	0.0	0.0	1.7	0.0	0.0			10.0
	75 mg	6.8	3.4	1.7	0.0	0.0	0.0	0.0			10.2
Ortac et al^Citation33	Placebo										13.6
	100 mg	3.4	5.1								16.9

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