Post-marketing surveillance study of the safety and efficacy of sildenafil prescribed in primary care to erectile dysfunction patients

Abstract

In order to investigate the safety and efficacy of sildenafil prescribed in primary care, a post-marketing surveillance study was undertaken. A total of 651 men with erectile dysfunction (ED) were enrolled from 31 family physicians in Korea from December 1999 to July 2002. Patients were regularly followed up to ascertain the safety and efficacy of sildenafil. Of the 651 patients enrolled, 572 (87.9%) returned for safety evaluation and efficacy assessment. In all, 458 (80.1%) of 572 patients reported improved erectile function with sildenafil. Hypertension, diabetes and low-dose sildenafil were associated with poor efficacy. A total of 71 adverse events were reported among 56 patients (8.6%), with the most frequent being hot flushes (5.6%), followed by headache (2.6%), palpitation (1.0%), anxiety (0.5%) and elevated ALT (0.5%). Only six patients (1.0%) discontinued sildenafil as a direct result of adverse events. These results suggest that sildenafil prescribed by primary care physicians was well tolerated and improved erectile function in patients with ED.

Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care

“…10 Our outcome was also similar to that of a clinical trial in Europe, 11 in which 80-86% of men reported overall improvements following vardenafil administration, and to the results of a community practice study, which showed improvements in 92% of men. 12 Our result was also similar to those of sildenafil 8 and tadalafil. 13 The percentages of patients reporting improvements increased relative to the dose of vardenafil, being 60.0, 75.0 and 85.0% in men prescribed 5, 10 and 20 mg/ day vardenafil, respectively.…”

“…10,11,18 In these earlier studies, facial flushing and headache were the most commonly reported adverse events, with each having an incidence of 10-22%. 10,11,19 In contrast, we found that only 3.2 and 1.2% of patients experienced flushing and headache, respectively, similar to the results of an earlier trial of vardenafil (1.6 and 3.1%, respectively) 20 and slightly lower than those of sildenafil (5.6-9.2 and 2.6-9.5%, respectively) 8,21 and tadalafil (4.0-4.6 and 7.2-14.0%, respectively). 13,22 The differences in adverse event reporting rates among these trials is largely due to the different methods used for their monitoring.…”

“…[15][16][17] The adverse event profile observed in this study reflected the known pharmacologic properties of vardenafil as a selective PDE5 inhibitor and were consistent with previous studies of PDE5 inhibitors. 8,12,13 Our patients reported a lower incidence of adverse events (5.2%) than in other clinical trials of vardenafil in other countries (24-45%). 10,11,18 In these earlier studies, facial flushing and headache were the most commonly reported adverse events, with each having an incidence of 10-22%.…”

“…7 Several phosphodiesterase type 5 (PDE5) inhibitors, including vardenafil, have been developed to treat ED, and most have been prescribed in primary care settings. 8 However, there have been very few studies on the efficacy and safety of vardenafil in the primary care setting. In this post-marketing surveillance study, we investigated the efficacy and safety of vardenafil, and patient satisfaction with its use, using a global assessment questionnaire (GAQ) and the Korean version of the IIEF-5.…”

Effectiveness of Sildenafil in Treating Erectile Dysfunction in PTSD Patients

“…In a recently published postmarketing survey (on 651 men) 22 on sildenafil, hot flushes (5.6%), headaches (2.6%), and palpitations (1.0%) were reported to be the most common adverse effects. In our much smaller sample, we did not find any difference between sildenafil and placebo on these 3 parameters, or any other adverse effects.…”