Orally disintegrating vardenafil tablets for the treatment of erectile dysfunction: efficacy, safety, and patient acceptability

Figures & data

Table 1 Common classes of drugs associated with erectile dysfunction

Drug class	Examples of specific drugs
Antihypertensives	Alpha-adrenergic agonists
	Beta blockers (nonselective)
	Calcium-channel blockers
Diuretics	Aldosterone antagonists
	Thiazide diuretics
Psychiatric agents	Benzodiazepines
	Butyrophenones
	Selective serotonin reuptake inhibitors
	Tricyclic antidepressants
Cardiac glycosides	Digitalis preparations
Steroid agents
Neoplastic agents	Leuprolide

Note: Data from Hatzichristou DG, Pescatori ES. Current treatments and emerging therapeutic approaches in male erectile dysfunction. BJU Int. 2001; Suppl 3:11–17.⁴

Table 2 Demographic data findings from POTENT I and POTENT II

Variable	POTENT I^Citation13		POTENT II^Citation14		Total
Age	<65 yrs	≥65 yrs	<65 yrs	≥65 yrs	<65 yrs	≥65 yrs
Subjects (n)	168	190	170	167	338	357
Race	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
White	108 (64.3)	132 (69.5)	107 (62.9)	125 (74.9)	240 (71)	232 (65)
Black	5 (3)	9 (4.7)	14 (8.2)	3 (1.8)	14 (4.1)	17 (4.8)
Asian	8 (4.8)	5 (2.6)	8 (4.7)	5 (3)	13 (3.8)	13 (3.6)
Missing	47 (28)	44 (23.2)	41 (24.1)	34 (20.4)	91 (26.9)	75 (21)
ED type	n (%)	n (%)	n (%)	n (%)	n (%)	n (%)
Organic	77 (48.5)	110 (57.9)	98 (57.6)	121 (72.5)	187 (55.3)	219 (61.3)
Psychogenic	30 (17.9)	11 (5.8)	25 (14.7)	4 (2.4)	41 (12.1)	29 (8.1)
Mixed	60 (35.7)	68 (35.8)	41 (24.1)	38 (22.8)	128 (37.9)	79 (22.1)
Missing	1 (0.6)	1 (0.5)	6 (3.5)	4 (2)	2 (0.6)	10 (2.8)

Table 3 POTENT I and POTENT II efficacy findings at 12 weeks by mean scores

Efficacy	POTENT I^Citation13		POTENT II^Citation14
	Placebo	Vardenafil ODT	Placebo	Vardenafil ODT
IIEF-EF	14.4	21.5*	15.0	22.9*
SEP # 2	46.7	73.7*	48.8	76.1*
SEP # 3	26.7	64.9*	30.7	69.6*

Note:

* Difference in mean scores statistically significant (P < 0.0001).

Abbreviations: IIEF-EF, International Index of Erectile Function; SEP, Sexual Encounter Profile.

Table 4 Leading adverse events^a from POTENT I and POTENT II

Adverse event	POTENT I^Citation13		POTENT II^Citation14
	Placebo	Vardenafil ODT	Placebo	Vardenafil ODT
Headache	2	30	4	21
Flushing	0	14	2	13
Nasal congestion	0	3	1	8
Dyspepsia	0	7	0	3

Note:

a In patients reporting more than 1% adverse events.

Table 5 Significant drug:drug interactions with PDE-5 agents

Drug class^Citation15	Potential serious adverse effects
Alpha blockers	Hypotension
Nitrates	Hypotension, myocardial infarction, shock
Antihypertensives	Additive effects; may see 0–10 mmHg reduction
CYP3A4 inhibitors	Increases vardenafil levels

HatzichristouDGPescatoriESCurrent treatments and emerging therapeutic approaches in male erectile dysfunctionBJU Int2001Suppl 3111711578273

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SperlingHDebruyneFBoermansABenekeMUlbrichEEwaldSThe POTENT I randomized trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunctionJ Sex Med201074 Pt 11497150720233275

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GittelmanMMcMahonCGRodriguez-RiveraJABenekeMUlbrichEEwaldSThe POTENT II randomised trial: efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunctionInt J Clin Pract201064559460320456213

 PubMed Web of Science ®Google Scholar

DouglassMALinJCErectile dysfunction and premature ejaculation: underlying causes and available treatmentFormulary2010451727

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