Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study

Gómez, F.; Dávila, H.; Costa, André Carvalho; Acuna, Antonio; Wadskier, Luis Alfredo; Plúa, Pilarcita Alvarez

doi:10.1038/sj.ijir.3900897

Cited by 15 publications

(6 citation statements)

References 17 publications

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“…There is clear evidence that sildenafil is efficacious in the treatment of the broad population of men with erectile dysfunction when taken on demand at a doses of 25, 50, and 100 mg. There are multiple level 1 studies with consistent outcomes [20–43]. The overall grade of recommendation is grade A.…”

Section: Drugs Which Are Effective When Administered Systemicallymentioning

confidence: 99%

“…Although side effects do occur with sildenafil (most notably headache, flushing, indigestion, nasal congestion, and occasional visual changes), providing that the drug is used in line with the labeling recommendations, there is no convincing evidence in the literature of any significant safety issue, including cardiovascular, visual, and aural safety [20–74] (Consistent level 1 studies, Overall grade of recommendation is grade A).…”

Section: Drugs Which Are Effective When Administered Systemicallymentioning

confidence: 99%

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Pharmacotherapy for Erectile Dysfunction

Eardley

Donatucci

Corbin

et al. 2010

The Journal of Sexual Medicine

175

150

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Introduction Pharmacotherapy is the usual initial therapy for most men with erectile dysfunction. Aim To review the current data relating to the efficacy, tolerability and safety of drugs used in the treatment of men with erectile dysfunction. Methods A critical review of the literature relating to the use of pharmacotherapeutic agents was undertaken by a committee of eight experts from five countries, building on prior reviews. Main Outcome Measures Expert opinion and recommendations were based on grading of evidence-based literature, internal committee dialogue, open presentation, and debate. Results Almost all currently available evidence relates to sildenafil, tadalafil, and vardenafil. Phosphodiesterase type 5 (PDE5) inhibitors are first-line therapy for most men with erectile dysfunction who do not have a specific contraindication to their use. There is no evidence of significant differences in efficacy, safety, and tolerability between the PDE5 inhibitors and apomorphine. Intracavernosal injection therapy with alprostadil should be offered to patients as second line therapy for erectile dysfunction. Intraurethral alprostadil is a less effective treatment than intracavernosal alprostadil for the treatment of men with erectile dysfunction. Conclusions PDE5 inhibitors are effective, safe, and well-tolerated therapies for the treatment of men with erectile dysfunction. Apomorphine, intracavernosal injection therapy with alprostadil, and intraurethral alprostadil are all effective and well-tolerated treatments for men with erectile dysfunction. We recommend some standardization of the assessment of psychosocial outcomes within clinical trials in the field of erectile dysfunction.

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Section: Drugs Which Are Effective When Administered Systemicallymentioning

confidence: 99%

Section: Drugs Which Are Effective When Administered Systemicallymentioning

confidence: 99%

Pharmacotherapy for Erectile Dysfunction

Eardley

Donatucci

Corbin

et al. 2010

The Journal of Sexual Medicine

175

150

View full text Add to dashboard Cite

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“…Sildenafil citrate (VIAGRA ® , Pfizer Limited, Sandwich, Kent, UK), approved by the United States Food and Drug Administration in March 1998 and by the European Medicines Agency in September 1998 for the on‐demand treatment of erectile dysfunction (ED), was the first phosphodiesterase type 5 (PDE5) inhibitor licensed for this indication. Initial clinical trials of sildenafil were conducted in the United Kingdom (1), Europe (2) and the United States (3) and were followed by trials performed in Central and South America (4–6), Africa (7,8), Asia (9,10) and Australia (11). The effectiveness and safety of sildenafil for treating ED have been established in over 120 manufacturer‐sponsored clinical trials with a cumulative exposure of more than 14,000 patient‐years and in other independent studies (12,13).…”

Section: Introductionmentioning

confidence: 99%

Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database

Giuliano

Jackson

Montorsi

et al. 2009

International Journal of Clinical Practice

142

101

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Summary Aim: To review special safety topics associated with sildenafil and to document the tolerability of 50‐ and 100‐mg doses, overall and by age, in men with erectile dysfunction (ED). Methods: Data were collated from 67 double‐blind placebo‐controlled (DBPC) trials (> 14,000 men) conducted by the manufacturer and from the manufacturer’s postmarketing safety database (39,277 patients). The DBPC data were stratified by dose, starting dose and age (≥ 65 and ≥ 75 years). Special safety topics included cardiovascular risk, priapism, non‐arteritic anterior ischaemic optic neuropathy (NAION), impaired renal and hepatic function, drug interactions (i.e. nitrates, cytochrome P3A4 inhibitors, other ED therapies and α‐blockers) and incorrect use. Results: Sildenafil was well tolerated at a dose of 50 or 100 mg in men with ED, overall, in those aged ≥ 65 years, and in those aged ≥ 75 years. Analyses of the databases did not reveal any causal link between sildenafil and cardiovascular events, or any new safety risks relating to cardiovascular events, priapism, NAION, hearing loss or drug interactions. In the small number of men with moderate impairment of renal function or hepatic function who were treated with sildenafil in DBPC trials, the safety profile was similar to that in men with no impairment of renal or hepatic function. Overdose with sildenafil was rare in the ED population. No new safety issues, emerging trends or adverse reactions were identified in conjunction with overdose, dependence, abuse or misuse. Conclusion: This collated review confirms generally the good tolerability and established safety profile of sildenafil 50 and 100 mg in men with ED and reveals no new safety issues.

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“…Of them, a total of 13 trials fulfilled all inclusion criteria and were included in the meta-regression analysis. [23][24][25][26][27][28][29][30][31][32][33][34][35] Characteristics of the included trials are presented in Table 1.…”

Section: Included Trialsmentioning

confidence: 99%

A meta-regression analysis of treatment effect modifiers in trials with flexible-dose oral sildenafil for erectile dysfunction in broad-spectrum populations

2006

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Several trials and reviews provide evidence for the efficacy of phosphodiesterase-5 inhibitors in the treatment of erectile dysfunction (ED). However, little is known about the impact of treatment effect modifiers other than concomitant diseases. Our objective was to identify patient and trial characteristics as well as methodological and publication-related issues that are associated with the treatment effect measured in flexible-dose randomized controlled trials of oral sildenafil for ED. The MEDLINE and the Cochrane Central databases were searched for efficacy trials of sildenafil. Thirteen trials fulfilled all inclusion criteria. A series of meta-regression and graphical analyses were performed to test the impact of possible effect modifiers. Treatment effect was influenced by mean baseline disease severity and mean duration of the disease. These associations were at least partly mediated by placebo response. Trial duration, age of patients and etiology of ED in patients did not have any significant influence on the treatment effect. The year of publication of primary trials was also related to trial findings. Our analysis adds important data to enable the control of confounding variables in future trials and meta-analyses. It might also help the individual to assess the unbiased efficacy and true innovative potential of available and forthcoming pharmacological agents.

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Efficacy and safety of oral sildenafil citrate (Viagra®) in the treatment of male erectile dysfunction in Colombia, Ecuador, and Venezuela: a double-blind, multicenter, placebo-controlled study

Cited by 15 publications

References 17 publications

Pharmacotherapy for Erectile Dysfunction

Pharmacotherapy for Erectile Dysfunction

Safety of sildenafil citrate: review of 67 double-blind placebo-controlled trials and the postmarketing safety database

A meta-regression analysis of treatment effect modifiers in trials with flexible-dose oral sildenafil for erectile dysfunction in broad-spectrum populations

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