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Sildenafil For Ed

Sildenafil For Ed

Abstract

Erectile dysfunction (ED) is a highly prevalent disease associated with aging as well as with several risk factors including hypertension, heart disease, obesity, dyslipidemia, diabetes, hypogonadism, drugs-related, and pelvic surgery. Many of these factors are components of the metabolic syndrome, a multiplex risk factor for cardiovascular disease (CVD). ED shares common risk factors with CVD. Endothelial dysfunction seems to be the early underlying pathophysiology across both conditions. The efficacy, tolerability and cardiovascular safety of sildenafil has been evaluated in numerous large, randomized, double-blind, placebo-controlled clinical studies in the broad population of men with ED including men with several co-morbid conditions.
Sildenafil is effective in several specific patient populations including the difficult-to-treat subpopulations such as diabetes mellitus and after radical prostatectomy. It is associated with rapid onset of action – within 14 minutes for some men – and an extended duration of action for up to 12 hours. Sildenafil improves quality of life and satisfaction for treated men and is well tolerated with a favorable safety profile.
New data suggest that sildenafil has beneficial effects in several chronic conditions. It has been approved for the treatment of idiopathic pulmonary hypertension. Numerous articles have suggested that it improves endothelial function and a possible role on premature ejaculation or treatment of lower urinary tract symptoms has been suggested.

Introduction

Erectile dysfunction (ED) is a highly prevalent disease, as well as a major sexual concern for men (Braun et al 2000 Martin-Morales et al 2001 Papaharitou et al 2006 The prevalence of ED is increasing with age. The Massachusetts Male Aging Study (MMAS) demonstrated a 40% prevalence of ED in men aged 40 years that increased to almost 70% in men aged 70 years (Feldman et al 1994)
As the proportion of older people in the population increases, it has been estimated that the worldwide prevalence of ED will double from 152 million men in 1995 to 322 million men in 2025 (Aytac et al 1999).
ED is also associated with other conditions such as age, smoking, hypertension, heart disease, diabetes, and as a consequence of radical prostatectomy. Cardiovascular disease (CVD) and ED share common risk factors and reflect endothelial dysfunction (Kostis et al 2005). There is an increasing body of evidence that ED is the first sign of CVD in men with free medical history and may present well before CVD with a mean time-interval of even 3 years (Montorsi et al 2003).

Efficacy in broad populations of men with ED

The first data on efficacy of sildenafil were published by Goldstein and colleagues (1998) Sexual intercourse was successful in 69% of all attempts for the men receiving sildenafil, as compared with 22% for those receiving placebo (p<0.001). The mean numbers of successful attempts per month were 5.9 for men receiving sildenafil and 1.5 for those receiving placebo (p<0.001).
 Efficacy parameters for sildenafil in 11 double-blind, placebo controlled, pre-marketing studies included the International Index of Erectile Function (IIEF) erectile function domain score and especially the questions 3 and 4 (ability to attain and ability to maintain an erection sufficient for intercourse respectively) as well as the general efficacy question (GEQ).

In 6 of the 11 trials, patients maintained an event log of sexual activity. Patients were stratified in subgroups in terms of age, race, body mass index (BMI), duration of ED, ED etiology, smoking status, and concomitant conditions/medications (Figure ​(Figure2).2 ) All subgroups were well balanced between placebo and sildenafil. After 12 weeks of treatment, 46.5% to 87% of patients in the subgroups receiving sildenafil indicated that treatment had improved their erections compared with 11.3% to 41.3% of patients in subgroups receiving placebo.
In the 6 trials in which sexual event log data were collected, significantly greater percentages of successful attempts at intercourse were reported by patient subgroups receiving sildenafil (52.6% to 80.1%) compared with patient subgroups receiving placebo (14.0% to 34.5%). All differences were statistically significant (Carson et al 2002).

Efficacy in subpopulations of men with ED

The efficacy of sildenafil in almost every subgroup of patients with ED is more than established. Response rates in elderly men (≥65 years) are comparable with general population regardless of age (Wagner et al 2001). No differences in response rates were demonstrated in ethnic groups (Young et al 2002).
In type 1 diabetic patients, 66.6% reported improved erections (GAQ) and 63% reported successful intercourse attempts compared with 28.6% and 33% by those taking placebo, respectively (Stuckey et al 2003). In another multicenter, randomized, double-blind, placebo-controlled, flexible dose-escalation study in diabetic patients, 56% of patients reported improved erections and 61% reported at least 1 successful intercourse attempt compared with 10% and 22% in the placebo group, respectively (Rendell et al 1999).
Diabetic patients are one of the most difficult to treat subgroups (Behrend et al 2005). In patients after bilateral nerve-sparing radical prostatectomy, 76% responded to sildenafil (defined as successful vaginal intercourse) (Raina et al 2004).
A favorable response to sildenafil in patients with ischemic heart disease (GEQ and IIEF Q3 and Q4) who were receiving b-blockers and/or angiotensin-converting enzyme inhibitors and/or calcium channel blockers has been observed (Olsson and Persson 2001).
Similar results presented in patients with hypertension (taking different or multiple antihypertensive drugs). High efficacy rates presented in patients on chronic dialysis for renal failure (lower doses and longer intervals between treatments are usually required) (Chen et al 2001; Mahon et al 2005), after renal transplantation (Prieto Castro et al 2001; 
Sharma et al 2006), in spinal cord injuries (Derry et al 2002; Deforge et al 2006) and patients with depression (treated with selective serotonin reuptake inhibitors [SSRIs] or not) (Seidman et al 2001; Nurnberg et al 2002) or patients treated with antipsychotic agents (Gopalakrishnan et al 2006).

 

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