Sildenafil Citrate

(Revatio) for Early-Stage Pulmonary Arterial Hypertension.

On June 3, the FDA approved sildenafil citrate 20-mg tablets (Revatio, made by Pfizer, Inc.) to improve exercise ability in patients with early-stage pulmonary arterial hypertension. The approval was based on a priority review of data from a three-month, randomized double-blind trial in 277 patients with PAH, showing that 20, 40, or 80 mg of sildenafil given three times daily significantly increased exercise ability from baseline, compared with placebo. The effect was apparent after one month of therapy and was maintained at two and three months, as evaluated by six-minute walk distance (placebo-corrected mean increase of 45 to 50 m).

Patients receiving all doses of sildenafil also achieved significant improvements in mean pulmonary arterial pressure and other measures of cardiac function. As the dosage strengths were similarly effective, the approved regimen was limited to 20 mg three times daily.

Most patients (259 [93.5%] 277) continued into a long-term, uncontrolled sildenafil extension study. At one year, 94% of patients were still alive and demonstrated stability in walk distance and functional class. The FDA notes that without a control group, these data must be interpreted cautiously.

Sildenafil was well tolerated; headache, dyspepsia, flushing, epistaxis, and insomnia were the most commonly reported adverse events related to its use.

Sildenafil citrate (Viagra 25-, 50-, and 100-mg tablets, made by Pfizer, Inc.) was approved in March 1998 for the treatment of erectile dysfunction. The Revatio pill is white and round and easily distinguished from the blue diamond-shaped Viagra tablet.

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DID YOU KNOW:
INCIDENCE OF END-STAGE KIDNEY DISEASE IN DIABETES DROPPING
Because diabetes is the leading cause of end-stage renal disease (ESRD) in the U.S., this is especially good news. CDC researchers found that even though the number of people with ESRD and diabetes has grown dramatically over the last decade, it has not grown as much as the number of people with diabetes (#821). Thus, between 1990-2002, the incidence of ESRD has declined. Actually, the decline really began after an increase that peaked in 1996 at 344.4 per 100,000 population and dropped to 234.6 in 2002. Why? Probably due to a reduction in the prevalence of kidney disease risk factors (hypertension, high blood glucose levels), people getting better diabetes care and taking better care of themselves, yielding a healthier diabetic population. BUT, there’s a downside. The researchers caution that we are seeing a growing prevalence in CVD mortality, which tends to occur much earlier in diabetes than kidney disease, perhaps even before clinical diabetes onset. So this "competing mortality" may account for part of the reduced incidence.

ADA 65th Annual Scientific Sessions: Oral Presentation #821 Presented June 11, 2005.