title: 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.
authors.affiliation: Asan Medical Center, University of Ulsan College of Medicine, Songpa-gu, Seoul, Republic of Korea.
authors.forename: S
authors.initials: S
authors.lastname: Sunwoo
authors.forename: Y S
authors.initials: YS
authors.lastname: Kim
authors.forename: B L
authors.initials: BL
authors.lastname: Cho
authors.forename: K S
authors.initials: KS
authors.lastname: Cheon
authors.forename: H G
authors.initials: HG
authors.lastname: Seo
authors.forename: M K
authors.initials: MK
authors.lastname: Rho
authors.forename: Y S
authors.initials: YS
authors.lastname: Cheong
authors.forename: M H
authors.initials: MH
authors.lastname: Hong
authors.forename: S W
authors.initials: SW
authors.lastname: Kim
authors.forename: D H
authors.initials: DH
authors.lastname: Kim
mesh_terms: D000367:Age Factors; D000368:Aged; D015992:Body Mass Index; D007172:Erectile Dysfunction / Q000188:drug therapy* / Q000453:epidemiology; D006801:Humans; D007723:Korea / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D011358:Product Surveillance, Postmarketing; D011687:Purines; D000068677:Sildenafil Citrate; D012907:Smoking; D013450:Sulfones
chemical_list: D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D000068677:Sildenafil Citrate