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The real-life safety and efficacy of vardenafil: An international post-marketing surveillance study of 2824 patients from the Middle East

Show simple item record Kamel A. Khaouli R. Sabha M. Al Mitwally K. Fouad W. Landen H.
dc.contributor.editor 2007 2017-10-05T16:07:21Z 2017-10-05T16:07:21Z 2007
dc.identifier 10.2165/00044011-200727050-00005
dc.identifier.issn 11732563
dc.description.abstract Objective: To assess the safety, efficacy and patient acceptability of vardenafil treatment under real-life conditions in patients with erectile dysfunction (ED). Methods: The present publication shows the results of a subgroup analysis of a multinational post-marketing surveillance study, including 2824 Middle East patients with ED whose attending physician chose vardenafil as the most appropriate therapy. Patients were assessed at an initial visit for demographic and baseline characteristics. At one or two follow-up visits, covering a period of approximately 2 months or eight vardenafil intakes, patients were interviewed about overall treatment success (general improvement of erection, number of tablets taken until improvement, patient's satisfaction with overall efficacy and tolerability, comparison with last ED treatment). All adverse events were recorded and assessed for a possible relationship to treatment, and for severity. Results: An overall improvement in erections was reported in 94.3percent of patients. Most patients achieved treatment success after the first (67.0percent) or second (83.6percent cumulative) tablet. Diabetic patients had a similar improvement rate (92.2percent) and 73.5percent of patients who had undergone radical prostatectomy reported an overall improvement. The rate of adverse drug reactions (ADRs) was low (9.1percent of patients). The most common ADRs were headache (5.8percent), flushing (1.6percent), nasal congestion (1.0percent), dyspepsia (0.6percent) and nausea (0.5percent). In total, 88.9percent of patients wanted to continue treatment with vardenafil. Conclusion: Vardenafil was effective, reliable and well tolerated in patients with ED treated under real-life conditions. © 2007 Adis Data Information BV. All rights reserved.
dc.format.extent Pages: (339-346)
dc.language English
dc.publisher AUCKLAND
dc.relation.ispartof Publication Name: Clinical Drug Investigation; Publication Year: 2007; Volume: 27; no. 5; Pages: (339-346);
dc.source Scopus
dc.title The real-life safety and efficacy of vardenafil: An international post-marketing surveillance study of 2824 patients from the Middle East
dc.type Article
dc.contributor.affiliation Kamel, A., German Polyclinic, Dubai, United Arab Emirates
dc.contributor.affiliation Khaouli, R., American University, Beirut Medical Center, Beirut, Lebanon
dc.contributor.affiliation Sabha, M., Khalidid Hospital, Jebal Amman, Jordan
dc.contributor.affiliation Al Mitwally, K., Dallah Hospital, El Riyadh, Saudi Arabia
dc.contributor.affiliation Fouad, W., Bayer HealthCare, Cairo, Egypt
dc.contributor.affiliation Landen, H., German Polyclinic, Dubai, United Arab Emirates, Bayer HealthCare, Leverkusen, Germany, Post-Marketing Surveillance Europe and Overseas, Bayer HealthCare, Bayer Vital GmbH, 51368 Leverkusen, Germany
dc.contributor.authorAddress Landen, H.; Post-Marketing Surveillance Europe and Overseas, Bayer HealthCare, Bayer Vital GmbH, 51368 Leverkusen, Germany; email:
dc.contributor.authorCorporate University: American University of Beirut Medical Center; Faculty: Faculty of Medicine; Department: Surgery;
dc.contributor.authorDepartment Surgery
dc.contributor.authorFaculty Faculty of Medicine
dc.contributor.authorInitials Kamel, A
dc.contributor.authorInitials Khaouli, R
dc.contributor.authorInitials Sabha, M
dc.contributor.authorInitials Al Mitwally, K
dc.contributor.authorInitials Fouad, W
dc.contributor.authorInitials Landen, H
dc.contributor.authorReprintAddress Landen, H (reprint author), Bayer Vital GmbH, Post Mkt Surveillance Europe and Overseas, Bayer HealthCare, Bldg D162, D-51368 Leverkusen, Germany.
dc.contributor.authorUniversity American University of Beirut Medical Center
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dc.description.citedCount 5
dc.description.citedTotWOSCount 5
dc.description.citedWOSCount 5
dc.format.extentCount 8
dc.identifier.coden CDINF
dc.identifier.pubmedID 17451282
dc.identifier.scopusID 34249004720
dc.relation.ispartOfISOAbbr Clin. Drug Invest.
dc.relation.ispartOfIssue 5
dc.relation.ispartofPubTitle Clinical Drug Investigation
dc.relation.ispartofPubTitleAbbr Clin. Drug Invest.
dc.relation.ispartOfVolume 27
dc.source.ID WOS:000246833800005
dc.type.publication Journal
dc.subject.otherChemCAS vardenafil, 224785-90-4, 224785-91-5, 224789-15-5
dc.subject.otherChemCAS 3',5'-Cyclic-GMP Phosphodiesterase, EC
dc.subject.otherChemCAS cyclic nucleotide phosphodiesterases, type 5, EC
dc.subject.otherChemCAS Imidazoles
dc.subject.otherChemCAS Phosphodiesterase Inhibitors
dc.subject.otherChemCAS Piperazines
dc.subject.otherChemCAS Sulfones
dc.subject.otherChemCAS Triazines
dc.subject.otherChemCAS vardenafil, 224785-90-4
dc.subject.otherIndex vardenafil
dc.subject.otherIndex adult
dc.subject.otherIndex article
dc.subject.otherIndex controlled study
dc.subject.otherIndex diabetes mellitus
dc.subject.otherIndex drug dose increase
dc.subject.otherIndex drug efficacy
dc.subject.otherIndex drug safety
dc.subject.otherIndex drug tolerability
dc.subject.otherIndex dyspepsia
dc.subject.otherIndex erectile dysfunction
dc.subject.otherIndex flushing
dc.subject.otherIndex follow up
dc.subject.otherIndex headache
dc.subject.otherIndex human
dc.subject.otherIndex interview
dc.subject.otherIndex major clinical study
dc.subject.otherIndex male
dc.subject.otherIndex Middle East
dc.subject.otherIndex nausea
dc.subject.otherIndex nose congestion
dc.subject.otherIndex patient attitude
dc.subject.otherIndex patient satisfaction
dc.subject.otherIndex physician
dc.subject.otherIndex postmarketing surveillance
dc.subject.otherIndex priority journal
dc.subject.otherIndex prostatectomy
dc.subject.otherIndex side effect
dc.subject.otherIndex 3',5'-Cyclic-GMP Phosphodiesterase
dc.subject.otherIndex Adult
dc.subject.otherIndex Aged
dc.subject.otherIndex Humans
dc.subject.otherIndex Imidazoles
dc.subject.otherIndex Impotence
dc.subject.otherIndex Male
dc.subject.otherIndex Middle Aged
dc.subject.otherIndex Middle East
dc.subject.otherIndex Phosphodiesterase Inhibitors
dc.subject.otherIndex Piperazines
dc.subject.otherIndex Product Surveillance, Postmarketing
dc.subject.otherIndex Sulfones
dc.subject.otherIndex Treatment Outcome
dc.subject.otherIndex Triazines
dc.subject.otherKeywordPlus MALE ERECTILE DYSFUNCTION
dc.subject.otherKeywordPlus DOUBLE-BLIND
dc.subject.otherKeywordPlus MEN
dc.subject.otherKeywordPlus MANAGEMENT
dc.subject.otherKeywordPlus UPDATE
dc.subject.otherKeywordPlus CONSEQUENCES
dc.subject.otherKeywordPlus MULTICENTER
dc.subject.otherKeywordPlus TRIAL
dc.subject.otherWOS Pharmacology and Pharmacy

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