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

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Sunwoo, S; Kim, Y S; Cho, B L; Cheon, K S; Seo, H G; Rho, M K; Cheong, Y S; Hong, M H; Kim, S W; Kim, D H
Issue Date
Nature Publishing Group
Int J Impot Res. 2005 Jan-Feb;17(1):71-5.
Age FactorsAgedBody Mass IndexErectile Dysfunction/*drug therapy/epidemiologyHumansKorea/epidemiologyMaleMiddle AgedPatient CompliancePhosphodiesterase Inhibitors/*adverse effects/*therapeutic usePiperazines/*adverse effects/*therapeutic useProduct Surveillance, PostmarketingPurinesSmokingSulfones
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.
0955-9930 (Print)
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College of Medicine/School of Medicine (의과대학/대학원)Family Medicine (가정의학전공)Journal Papers (저널논문_가정의학전공)
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