L. Keith Lloyd, MD
Professor of Surgery
Department of Surgery, Division of Urology

Gerald McGwin, Jr., PhD
Associate Professor of Public Health
Department of Epidemiology

The University of Alabama at Birmingham
Birmingham, Alabama

In accordance with the Accreditation Council for Continuing Medical Education Standards for Commercial Support, Dr. Lloyd discloses research support from Celgene, Ortho-McNeil; consultant for Pfizer, GlaxoSmithKline, Lilly, ICOS, Novartis, Watson. Dr. McGwin has no conflicts of interest to disclose.

The University of Alabama School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The University of Alabama School of Medicine designates this educational activity for a maximum of 0.25 Category 1 credit toward the AMA Physician's Recognition Award. Physicians should only claim credit commensurate with the extent of their participation in the activity.

The boards of nursing in many states, including Alabama, recognize Category 1 continuing medical education courses as acceptable activities for the renewal of license to practice nursing.

Erectile dysfunction (ED) affects 15 to 30 million men in the United States, according to the American Urology Association (AUA). In May 2005, AUA released the first new ED clinical management guidelines since the 1998 US Food and Drug Administration (FDA) approval of phosphodiesterase type 5 (PDE5) inhibitors. The consensus-based guidelines for ED diagnosis and treatment reflect advances in clinical research and outcomes measurement.

Following careful analysis of data published from 1994 through 2004, a panel appointed by the AUA Practice Guidelines Committee concludes patients should be thoroughly informed about options and their risks and benefits; reaffirms current guidelines on diagnostic evaluation; acknowledges frequency of psychologic overlay in ED patients; and recognizes endocrine disorders as an important etiological consideration. (Available at: http://www.auanet.org. Accessed June 19, 2006.)

The guidelines acknowledge variation in management of atypical ED patients and identify the standard patient as “a man with no evidence of hypogonadism or hyperprolactinemia who develops, after a well-established period of normal erectile function, ED that is primarily organic in nature.”

Risk Factors, Patient Evaluation

ED often is associated with cardiovascular and other chronic conditions, including diabetes mellitus, obesity, and smoking, according to three studies published in the January 23, 2006 issue of Archives of Internal Medicine. Additional risk factors include alcoholism, depression, traumatic or surgical pelvic, perineal, or penile injury, neurologic disease, endocrinopathy, pelvic radiation therapy, Peyronie disease, and prescription or recreational drug use. Low testosterone level is a factor in <5% of cases.

UAB urologist and ED expert L. Keith Lloyd, MD, observes that most ED patients are referred to his practice following a general medical examination. “Initial evaluation of a patient complaining of ED should include sexual, medical, and psychosocial histories, as well as identification of all drugs the patient takes, and lab tests to identify conditions, such as hyperlipidemia, that may predispose to ED and contraindicate certain drug therapies,” says Lloyd. “A focused physical exam evaluates the abdomen, penis, testicles, secondary sexual characteristics, and lower extremity pulses. Because the condition can cause serious emotional and relationship problems, physicians should critically assess the partner’s needs and expectations,” he says. A complete history also may uncover related dysfunctions including premature ejaculation, age-related increases in latency, and psychosexual relationship issues.

Guidelines address ED in patients with cardiovascular disease, a condition that shares a common etiology with ED, as endothelial dysfunction and atherosclerosis affect both penile vasculature and coronary arteries. Updated guidelines also support recommendations of the Second Princeton Consensus Conference on Sexual Dysfunction and Cardiac Risk (Am J Cardiol. 2005;96:313-321), which emphasize risk factor evaluation and management. Men at high risk for cardiovascular disease should not receive ED treatment until their cardiac condition is stabilized, Lloyd says.

He also notes ED may be an early marker for systemic vascular disease and raises questions about the level of cardiovascular evaluation required. “Because blood vessels in the penis are so small, with such high demands for increased flow during sexual stimulation, they may be among the first arteries to show signs of atherosclerosis or changes related to hypertension, resulting in impaired function.”

Lloyd advises that asymptomatic patients with ED should have routine screening for diabetes, hyperlipidemia, and hypertension; those with any symptoms suggestive of cardiac disease should be referred to a cardiologist for appropriate testing. “Physicians should defer treatment in symptomatic patients until cardiac problems are treated, as vigorous sexual activity is a risk factor for a cardiac event,” he says.

Following identification of organic comorbidities and psychosexual dysfunction, currently available first-line therapies include oral PDE5 inhibitors (silden-afil [Viagra], vardenafil [Levitra], and tadalafil [Cialis]) or vacuum constriction devices. Nonresponders can be treated with intraurethral alprostadil suppositories or intracavernous vasoactive drug injection. Patients who fail or dislike these treatments may consider penile prosthesis implantation. Physicians should begin with the least invasive treatment, balancing risk against efficacy, according to the guidelines.

Surgical therapies, mechanical failure and replacement rates of implantable devices, and vascular surgery are reviewed, as are herbal therapies, for which there is limited data supporting usefulness. The guidelines panel made no new recommendations for use of vacuum constriction devices or intracavernous vasoactive drug injection. Although surgery to limit venous outflow of the penis is not recommended, arterial reconstructive surgery is offered as an option in healthy individuals with “recently acquired ED secondary to a focal arterial occlusion without evidence of generalized vascular disease.”

Therapy with oral PDE5 inhibitors should include appropriate monitoring for efficacy and changes in health status, unless contraindicated by comorbidities or concomitant use of organic nitrates.

“PDE5 inhibitors changed our whole approach to ED, and shifted the paradigm in terms of how we evaluate and treat patients,” says Lloyd. “Patients experiencing milder ED due to normal declines in sexual function usually respond best to these drugs.”

For patients who do not respond to PDE5 inhibitors, Lloyd recommends reevaluation and reeducation on correct drug use, while discussing benefits and risks of other therapies. Options include alternate PDE5 inhibitors; alprostadil intraurethral suppositories; intracavernous vasoactive drug injection (with alprostadil or papaverine, or combination therapy with bimix and trimix, with initial dose administered under health care provider supervision); vacuum constriction devices; and penile prostheses.

“Vasoactive drugs, approved as injectable agents 20 years ago, were the first agents that allowed us to treat ED to any significant degree,” says Lloyd, who participated in the multicenter trial that resulted in FDA approval of prostaglandin. He cautions prostaglandin has a 20% to 30% incidence of postinjection penile discomfort caused by sensory nerve stimulation.

“We know sexual function declines with age, and it is an understandable human response to want to revive it,” says Lloyd. “During my many years in practice, I have seen tremendous advances in the treatment of ED, which is today a highly treatable condition.”

A recent UAB study published in the British Journal of Ophthalmology (2006;90:154-157) concluded that for men with a history of myocardial infarction (MI) or hypertension, use of sildenafil or tadalafil — taken by an estimated 23 million American men — may increase risk of non-arteritic ischemic optic neuropathy (NAION). The condition is one of the most common causes of sudden vision loss in older Americans, with up to 6000 cases annually. Risk factors for NAION include diabetes and cardiovascular disease.

The retrospective study compared 38 men with NAION with 38 controls with no history of the condition, using self-reported information regarding past and current use of sildenafil or tadalafil or both. Overall, men with NAION were no more likely to report a history of sildenafil or tadalafil use compared with similarly aged controls. However, investigators observed a statistically significant association for those with a history of MI and a similar, although less significant, association with a history of hypertension.

“Our results do not suggest erectile dysfunction medications significantly increase risk for vision loss for men in good health,” says UAB epidemiologist Gerald McGwin, Jr, PhD, the study’s lead author. “However, patients with a history of vision loss, MI, or hypertension should be warned about potential risks of this serious and often irreversible eye condition.”

For more information:

Dr. L. Keith Lloyd
Dr. Gerald McGwin, Jr.
1-800-UAB-MIST
mist@uabmc.edu

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