title: Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care.
abstract: To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.
authors.affiliation: Department of Family Medicine, Catholic University College of Medicine, Uijeongbu, Korea.
authors.forename: C M
authors.initials: CM
authors.lastname: Kim
authors.forename: Y S
authors.initials: YS
authors.lastname: Kim
authors.forename: S
authors.initials: S
authors.lastname: Sunwoo
authors.forename: B
authors.initials: B
authors.lastname: Cho
authors.forename: M
authors.initials: M
authors.lastname: Rho
authors.forename: Y J
authors.initials: YJ
authors.lastname: Yang
authors.forename: C H
authors.initials: CH
authors.lastname: Kim
authors.forename: H C
authors.initials: HC
authors.lastname: Shin
authors.forename: S Y
authors.initials: SY
authors.lastname: Lee
authors.forename: D H
authors.initials: DH
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D003627:Data Interpretation, Statistical; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use*; D007723:Korea; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use*; D010879:Piperazines / Q000009:adverse effects* / Q000627:therapeutic use*; D011320:Primary Health Care; D011358:Product Surveillance, Postmarketing; D013450:Sulfones / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D014227:Triazines / Q000009:adverse effects / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
chemical_list: D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride