Sildenafil citrate efficacy 8 h postdose in men with mild to moderate erectile dysfunction

McCullough, Andrew; Steidle, Christopher P.; Kaufman, Joel M.; Goldfischer, Evan R.; Klee, Brian; Carlsson, Martin

doi:10.1038/ijir.2008.21

Cited by 6 publications

(3 citation statements)

References 22 publications

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“…The published literature on phosphodiesterase type 5 (PDE5) inhibitors , the first‐line therapy for ED, contains few prospective randomized controlled trials that selected participants according to baseline ED severity. Mild ED, as defined by an IIEF‐EF score of 22–25 out of 30 has never been specifically selected for in a randomized controlled trial, only as part of a larger ED subgroup; for example, IIEF‐EF scores from 11 to 25 (moderate, mild‐to‐moderate and mild ED) [9–12] or IIEF‐EF scores from 17 to 30 (mild‐to‐moderate, mild, and no ED) [13,14]. Furthermore, there do not appear to be any published epidemiological data on the prevalence or risk for diseases associated with ED in populations of men with mild ED, as defined by IIEF‐EF score; published data either stratified severity according to the Sexual Health Inventory for Men [15] or used the IIEF‐EF score but combined men with mild ED (score of 22–25) and men with mild‐to‐moderate ED (score of 17–21) [4,5,16–23].…”

Section: Introductionmentioning

confidence: 99%

Do men with mild erectile dysfunction have the same risk factors as the general erectile dysfunction clinical trial population?

et al. 2010

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versus 55 ± 11 (18-89) years, body mass index was 29 ± 5 (20-48) versus 28 ± 5 (11-64) kg/m 2 and ED duration was 3.5 ± 3.2 ( < 1-18) versus 4.6 ± 4.7 ( < 1-45) years.• The prevalence of comorbidities associated with ED was similar (hypertension 26.1% ( n = 46) vs 32.8%; diabetes mellitus 13.6% ( n = 24) vs 22.1%; dyslipidemias 12.5% ( n = 22) vs 11.7%; hypercholesterolemia 12.5% ( n = 22) vs 9.5%; gastro-esophageal reflux disease 10.8% ( n = 19) vs 6.0%; benign prostatic hyperplasia 9.7% ( n = 17) vs 9.9%; depression 6.3% ( n = 11) vs 5.6%; and anxiety 4.0% ( n = 7) vs 1.6%), as was the rate of use of medications for those comorbidities. CONCLUSIONS• Men with mild ED have similar risk factors to a general ED clinical trial population. Thus, mild ED is an important indicator of risk for underlying disease associated with ED.• Inquiry into ED should be part of routine clinical evaluation to facilitate rapid identification and early intervention.• Men complaining of mild ED should be evaluated adequately for underlying cardiovascular risk. KEYWORDS erectile dysfunction, epidemiology, demography, risk factors, comorbidityWhat's known on the subject? and What does the study add? Erectile dysfunction (ED) that is mild (score of 22-25 on the Erectile Function domain of the International Index of Erectile Function) is often overlooked in clinical practice because men do not seek treatment or because healthcare professionals consider complaints of mild ED to be irrelevant and fail to evaluate such patients. ED is associated with increased prevalence of diseases that accompany ageing, including cardiovascular disease and diabetes, but there do not appear to be any published epidemiological data on the prevalence or risk for such diseases in populations of men with mild ED. Greater understanding of this population's underlying risk for diseases associated with ED may highlight the importance of earlier diagnosis and treatment.In this study, the underlying risk for diseases associated with ED is compared between the first large population of men with mild ED for whom demographic and baseline data have been reported and a manufacturer's database of men (representing the general ED clinical trial population), which is the largest population of men with ED for whom demographic and baseline data have been reported. The findings show that men with mild ED may have substantial underlying risk for diseases associated with ED, including hypertension, diabetes, and lipid disorders.Study Type -Symptom prevalence (prospective cohort/RCT) Level of Evidence 1b OBJECTIVE• To compare the underlying risk for diseases associated with erectile dysfunction (ED; i.e. cardiovascular disease and diabetes) in a population of men with mild ED relative to a general ED clinical trial population. PATIENTS AND METHODS• Men enrolled in a randomized, doubleblind placebo-controlled (DBPC) trial of sildenafil for the treatment of mild ED were compared with a database of men enrolled in 67 of the manufacturer's other DBPC sildenafil trials.• The main outc...

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Section: Introductionmentioning

confidence: 99%

Do men with mild erectile dysfunction have the same risk factors as the general erectile dysfunction clinical trial population?

et al. 2010

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“…Using the IIEF-EF, ED is diagnosed as mild (score, 22-25 out of 30), mild-to-moderate (score [17][18][19][20][21], moderate (score [11][12][13][14][15][16], and severe (score 6-10) [4,5]. Men with mild ED often do not seek treatment [6].…”

Section: Introductionmentioning

confidence: 99%

“…The published literature on phosphodiesterase type 5 inhibitors contains few randomized controlled trials that selected participants according to baseline ED severity. Mild ED, as defined by an IIEF‐EF score of 22 to 25 out of 30, has never been specifically selected for in a randomized controlled trial, only as part of a larger ED subgroup (e.g., IIEF‐EF scores from 11 to 25 [moderate, mild‐to‐moderate, and mild ED][21–24] or IIEF‐EF scores from 17 to 30 [mild‐to‐moderate, mild, and no ED][25,26]).…”

Section: Introductionmentioning

confidence: 99%

Men with Mild Erectile Dysfunction Benefit from Sildenafil Treatment

Bénard

Carrier

Lee

et al. 2010

The Journal of Sexual Medicine

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Introduction Sildenafil treatment has not been evaluated in a double-blind, placebo-controlled (DBPC) trial specific to men with mild erectile dysfunction (ED), defined by a 22–25 score on the International Index of Erectile Function-erectile function domain (IIEF-EF). Aim To assess sildenafil efficacy in sexually dissatisfied men with mild ED. Main Outcome Measures Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), IIEF, Quality of Erection Questionnaire (QEQ), Erection Hardness Score (EHS 4 = completely hard/fully rigid), general efficacy questions (GEQs), event log questions (hardness sufficient for penetration, duration sufficient for successful intercourse, ejaculation/orgasm, and second erection within 24 hours), and analog scales (erection firmness, reliability, and maintenance, and general sexual performance). Methods Eight-week DBPC flexible-dose (25, 50, or 100 mg) trial with 6-week, open-label (OL) extension. Results One hundred and seventy-six men were randomized (mean ± standard deviation: age, 50 ± 12 year; ED duration, 3.5 ± 3.2 year). Most had organic or mixed ED. For sildenafil vs. placebo, 66% vs. 89% titrated to 100 mg and efficacy at DBPC end was better, including the EDITS Index score (least squares mean [standard error], 80.3 [2.3] vs. 62.1 [2.5]; P < 0.0001); treatment satisfaction (EDITS Index score >50 in 89% vs. 63%; P = 0.0001); no ED (IIEF-EF ≥26 in 58% vs. 39%; P < 0.05); GEQs (≥4.9-fold greater odds of improved erections and ability to have sexual intercourse); and EHS 4 (47.2% vs. 25.2% of occasions; P < 0.0001). At OL end, 93% of men were satisfied (EDITS Index score > 50), 77% had no ED, and ≥89% were GEQ responders; mean scores on IIEF domains, the QEQ, and analog scales were >80% of the maximum; 60% of occasions had EHS 4; and event log responses were positive on >80% of occasions, except for second erections (41.9%). Headache, nasal congestion, and flushing, mostly mild to moderate, were the most common adverse events. Conclusion Men with mild ED derive substantial benefit from sildenafil treatment.

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PDE5 Inhibitors for the Treatment of Erectile Dysfunction in Patients with Hypertension

Kokkinos

Tsimploulis

Faselis

2014

Erectile Dysfunction in Hypertension and Cardiovascular Disease

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Sildenafil citrate efficacy 8 h postdose in men with mild to moderate erectile dysfunction

Cited by 6 publications

References 22 publications

Do men with mild erectile dysfunction have the same risk factors as the general erectile dysfunction clinical trial population?

Do men with mild erectile dysfunction have the same risk factors as the general erectile dysfunction clinical trial population?

Men with Mild Erectile Dysfunction Benefit from Sildenafil Treatment

PDE5 Inhibitors for the Treatment of Erectile Dysfunction in Patients with Hypertension

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