The Serendipitous Story of Sildenafil: An Unexpected Oral Therapy for Erectile Dysfunction.

Introduction: The serendipitous discovery of sildenafil (Viagra [sildenafil citrate]) as a treatment for erectile dysfunction (ED) is one of the most fascinating drug development stories of our time. When sildenafil was approved by the U.S.

The pharmacist's role in improving the treatment of erectile dysfunction and its underlying causes.

Erectile dysfunction (ED), which worldwide is likely to affect in excess of 300 million men by 2025, is often either untreated or insufficiently treated. It can be a prelude to other serious illnesses and may be a cause or consequence of depression in affected individuals. Among men younger than 60 years of age, ED can be a robust early-stage indicator of vascular disease and type 2 diabetes.

Enriching the Interpretation of the Erectile Dysfunction Inventory of Treatment Satisfaction: Characterizing Success in Treatment Satisfaction.

Background: Patient-reported outcomes, such as the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index, are essential for successful evaluation and treatment of patients with erectile dysfunction.

Aim: To enrich interpretation of the EDITS index score and to complement the existing 0 to 100 scoring.

Methods: This supplemental analysis evaluated EDITS questionnaire data (11 items; index score range = 0-100; higher scores indicate more treatment satisfaction) after completion of an 8-week double-blinded trial of 279 men 18 to 65 years old with erectile dysfunction randomized to sildenafil 100 mg, sildenafil 50 mg, or placebo.

Real-world observational results from a database of 48 million men in the United States: Relationship of cardiovascular disease, diabetes mellitus and depression with age and erectile dysfunction.

Aims: To evaluate the relationship of comorbidities (cardiovascular disease [CVD], diabetes mellitus [DM] and depression) with erectile dysfunction (ED) and age using real-world claims data from 48 million men in the United States.

Methods: This was a cross-sectional, non-interventional study in men aged ≥18 years using data from the Truven Health MarketScan and Medicare Supplemental Research Databases from January 2010 to December 2015, with an observational period of January 2011 to December 2014 to allow for 12 months pre- and post-index. Comorbidity rate was compared between ED and non-ED groups by age using the χ (bivariate) test.

Clinically important difference on the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire in patients with erectile dysfunction.

Aim: To determine what constitutes a clinically important difference (CID) on the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), an 11-item validated questionnaire assessing treatment satisfaction used in clinical trials for patients with erectile dysfunction (ED).

Methods: Erectile Dysfunction Inventory of Treatment Satisfaction data were evaluated from a double-blind, fixed-dose trial of 279 men aged 18-65 years with ED who were treated with sildenafil 50 or 100 mg or placebo. The primary anchor measure was the erectile function (EF) domain of the International Index of Erectile Function (IIEF), which has a 4-point minimal CID.

Quality of erections by age group in men with erectile dysfunction.

Aims: The aim of this study was to assess erection quality with sildenafil vs placebo and adverse events (AEs) according to age (≤45, 46-55 and ≥56 years) in 997 men with erectile dysfunction (ED) using pooled data from four randomized, double-blind, placebo-controlled, flexible-dose trials.

Methods: The trials included 6- to 10-week treatment periods. The starting sildenafil dose was 50 mg, taken ~1 hour before sexual activity but not more than once daily, with subsequent adjustment to 100 or 25 mg based on efficacy and safety.

Ethnicity and age as factors in sildenafil treatment of erectile dysfunction.

Introduction: Sildenafil has been evaluated in >16 000 men with erectile dysfunction (ED) in double-blind, placebo-controlled trials.

Aim: To assess efficacy and safety of sildenafil in ED by ethnicity (white, black Asian) and age (≤45, 46-60, ≥61 years).

Methods: Data were pooled from 38 double-blind, placebo-controlled, flexible-dose trials.

Treatment response to sildenafil in men with erectile dysfunction relative to concomitant comorbidities and age.

Aim: To evaluate treatment response in men with erectile dysfunction (ED) and concomitant comorbidities.

Methods: Data were pooled from 42 placebo-controlled, flexible-dose sildenafil trials. In most trials, the sildenafil dose was 50 mg, taken ~1 hour before sexual activity but not more than once daily, with adjustment to 100 or 25 mg as needed.

Efficacy and Safety of Sildenafil in Men With Sexual Dysfunction and Spinal Cord Injury.

Introduction: Spinal cord injury (SCI) is estimated to affect approximately 276,000 individuals in the United States. Since 2010, the mean age of individuals at the time of the SCI has been 42 years, with nearly 80% of cases involving men. This means that individuals with SCI generally are young men who typically place a great deal of importance on normal sexual and reproductive function.

Relationship between age and erectile dysfunction diagnosis or treatment using real-world observational data in the USA.

Aims: With self-reporting of erectile dysfunction (ED) in population-based surveys, men with ED may not represent men who are bothered sufficiently to seek an ED diagnosis and treatment. We used real-world observational data to assess: 1) the prevalence of ED diagnosis or treatment by age subgroups; and 2) the relationship of age with ED diagnosis or treatment after controlling for ED-related comorbidities in the USA.

Methods: This cross-sectional study used de-identified claims data (MarketScan databases; primary analysis).

Quantifying Barriers to Improvement of Treatment Satisfaction in Men With Erectile Dysfunction: Use of Person-Item Maps.

Introduction: Patient-reported outcomes are a valuable tool used to gauge treatment satisfaction in different conditions, including erectile dysfunction (ED).

Aim: To use person-item maps to quantify barriers to improvement of treatment satisfaction in men with ED.

Methods: Men 18 to 65 years old with documented ED received sildenafil 50 mg, sildenafil 100 mg, or placebo for 8 weeks in a double-blinded manner.

Efficacy and Safety of Sildenafil by Age in Men With Erectile Dysfunction.

Introduction: Sildenafil, an oral phosphodiesterase type 5 inhibitor, has been extensively investigated for the treatment of erectile dysfunction in randomized controlled trials.

Aim: To assess the efficacy and safety of sildenafil vs placebo according to age subgroups (<65, 65-74, and ≥75 years) in 11,364 men with erectile dysfunction using pooled data from 48 randomized, double-blinded, placebo-controlled, parallel-group, flexible-dose trials.

Methods: Most trials had a 12-week treatment duration.

Simplified Interpretation of the Erectile Function Domain of the International Index of Erectile Function.

Introduction: This report describes a post hoc analysis of data from a randomized, double-blinded, placebo-controlled, flexible-dose, sildenafil trial in men with erectile dysfunction.

Aims: To simplify interpretation of erectile function (EF) domain scores of the International Index of Erectile Function (IIEF).

Methods: Men at least 18 years old with erectile dysfunction were randomized to receive sildenafil or placebo for 12 weeks.

Further Understanding of the International Index of Erectile Function at 15+ Years: Confirmatory Factor Analysis and Multidimensional Scaling.

The objective of this study was to describe confirmatory factor analysis (CFA) and multidimensional scaling (MDS) on the International Index of Erectile Function (IIEF) to confirm the structure and to enrich understanding of the IIEF, thereby heightening appreciation of the factors and responses underlying sexual functioning for men with erectile dysfunction. Baseline, end of double-blind, and end of open-label data sets were derived from all data from 2 previously published sildenafil trials. For the CFA model, an acceptable fit of the data was shown for each data set, as indicated by a Bentler comparative fit index >0.

Adulteration of purported herbal and natural sexual performance enhancement dietary supplements with synthetic phosphodiesterase type 5 inhibitors.

Introduction: Many products labeled "herbal" or "all natural" (herbal/natural) that claim to enhance sexual performance and imply use for the treatment of erectile dysfunction (ED) are marketed as over-the-counter (OTC) dietary supplements. However, adulteration with undeclared phosphodiesterase type 5 (PDE5) inhibitors appears widespread.

Aim: To assess the availability, cost, origin, categorical content, and adulteration with PDE5 inhibitors of purported herbal/natural OTC dietary supplements claiming to naturally enhance sexual performance.

Phosphodiesterase type 5 inhibitors improve endothelial function and may benefit cardiovascular conditions.

The effects of phosphodiesterase type 5 inhibitors on vasodilation mediated via nitric oxide-cyclic guanosine monophosphate are well described. Less is known about other mechanisms through which phosphodiesterase type 5 inhibitors benefit endothelial function, including normalization of serum biomarkers, increased levels of endothelial progenitor cells, ischemia-reperfusion protection mechanisms, and other actions specific to patients with diabetes. These various mechanisms are reviewed.

Multi-domain Longitudinal Modeling: An Application to the International Index of Erectile Function.

Individual domains of multi-domain, patient-reported outcome instruments are typically analyzed independently, without considering inherent interdependency. The authors assessed correlations across time (longitudinal) and across domains of a multi-domain instrument, simultaneously, in a single, unified, and cohesive integrated model. International Index of Erectile Function (IIEF) data from a trial of sildenafil in erectile dysfunction were used.

Erectile dysfunction diagnosis and treatment as a means to improve medication adherence and optimize comorbidity management.

Introduction: Optimal pharmacologic management of diseases comorbid with erectile dysfunction (ED), such as cardiovascular disease, depression, diabetes, dyslipidemia, hypertension, and benign prostatic hyperplasia/lower urinary tract symptoms (BPH/LUTS), is dependent upon long-term treatment compliance and may be complicated by poor adherence to medication use. ED may contribute to poor adherence to medication use because poor quality erectile function may be an unwanted adverse effect of antihypertensives, antidepressants, and 5-α reductase inhibitors for treatment of BPH/LUTS. Diminished erectile spontaneity, rigidity, and/or sustaining capability also negatively affects mood, self-esteem, and confidence, which compromise motivation to be compliant with medications that treat diseases comorbid with ED.

Internet-ordered viagra (sildenafil citrate) is rarely genuine.

Introduction: Counterfeit medication is a growing problem. This study assessed the requirement for prescription, cost, origin, and content of medications sold via the Internet and purporting to be the phosphodiesterase type 5 inhibitor Viagra (sildenafil citrate).

Methods: Pfizer monitored top search results for the query "buy Viagra" on the two leading Internet search engines in March 2011.

Cardiac uses of phosphodiesterase-5 inhibitors.

Phosphodiesterase-5 inhibitors (PDE5Is) improve erectile function by enhancing nitric oxide availability in the penis and its supplying vasculature, resulting in vasodilation and increased blood flow. PDE5Is might benefit cardiovascular diseases because phosphodiesterase-5 is also located elsewhere in the body, including the pulmonary and systemic vasculature and in hypertrophied myocardium. PDE5Is are approved for pulmonary arterial hypertension, given that they improved several hemodynamic and clinical parameters in large randomized trials.

Investigational noncardiovascular uses of phosphodiesterase-5 inhibitors.

Introduction: At the present time, inhibitors of phosphodiesterase type 5 (PDE5) have Food and Drug Administration approval only for the treatment of erectile dysfunction and pulmonary artery hypertension, for which their mechanism of action is vasodilation and augmentation of blood flow by impeding PDE5-mediated breakdown of cyclic guanosine monophosphate. However, these agents are also being investigated in a wide range of other potential medical and surgical applications for which current treatment options are limited and in which their mechanism of action may be the same as or different from their effects in the two approved indications. Even if only some of these potential applications prove useful, the effect on clinical practice could be far reaching.

Analysis of dyadic data: a guideline applied to erectile dysfunction.

Rationale: Research on relationships often does not refer to a single person but rather to two persons. Nonetheless, such data has been often analysed by examining individuals in isolation, which falls short of capturing their truly interpersonal and non-independent nature.

Aims And Objectives: This paper highlights and illustrates some analytic tools for such dyadic data that are essential for theories about dyadic relationships to be tested adequately.

Sildenafil citrate 100 mg starting dose in men with erectile dysfunction in an international, double-blind, placebo-controlled study: effect on the sexual experience and reducing feelings of anxiety about the next intercourse attempt.

Introduction: Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction (ED); however, most men are later titrated to sildenafil 100 mg for improved efficacy.

Aim: Assess the tolerability and efficacy of sildenafil initiated at the 100-mg dose in men with ED.

Methods: Men with ED (score < or =25 on the Erectile Function domain of the International Index of Erectile Function) who had received < or =6 total doses of a phosphodiesterase type 5 inhibitor and none within 4 weeks were randomized to 8 weeks of double-blind, placebo-controlled (DBPC), fixed-dose treatment (50 or 100 mg sildenafil or placebo) followed by 4 weeks of open-label flexible-dose sildenafil (50 or 100 mg).