Estimates from the National Health and Nutrition Examination Survey (NHANES) suggests that the cost of treatment of ED in the U.S. could reach $15 billion if all men sought care.

Analyses by the Erectile Dysfunction subgroup for the Urologic Diseases in America Project identified that almost 1.5 percent of privately insured males between the ages of 18 and 64 had at least 1 claim related to ED in 2002; shifting forms of health care were demonstrated, as the use of diagnostic tests for underlying causes of ED markedly decreased and utilization of pharmacological therapy especially with oral PDE-5 inhibitors, increased.

National pharmacy claims data indicated an increased prevalence of sildenafil use from 1.5 percent in 1998 to 2.9 percent in 2002, with its use increasing with age. For example, in 2002, 6 percent of men aged 55 or older had one or more claims for sildenafil.

Furthermore, the Department of Veteran Affairs (VA) indicated a nine-fold increase in treatment for ED between 1999 and 2003, with 9.3 percent of men 55-64 years of age reporting filling a prescription for oral agents in 2003. The overall use of pharmacological treatment for ED increased from 17,458/100,000 in 1999 to 56,716/100,000 in 2003. This is reflected by data from the VA Pharmacy Benefits Management Group, as prescriptions for specific ED drugs increased from 681/100,000 to 6,120/100,000 during this period. According to national sales, in 2005, the pharmaceutical costs of sildenafil, tadalafil, and vardenafil were $1.6 billion, $747 million, and $327 million, respectively.

Harms Observed in Clinical Trials Headache, flushing, rhinitis, and dyspepsia are the most commonly observed adverse events related to treatment with PDE–5 drugs. There also have been concerns regarding the excess incidence of cardiovascular events and visual disturbances occurring in patients receiving PDE–5 drugs; however, the current evidence does not indicate any marked trends for increased rates of these events in ED patients taking PDE–5 drugs compared with those in the general population

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