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Long-Term Safety and Efficacy of Tadalafil 5 mg Dosed Once Daily in Men with Erectile Dysfunction
Abstract
Introduction: With once-daily administration of tadalafil, dosing and sexual activity would no longer need to be temporally linked for patients with erectile dysfunction (ED). Aim: To evaluate long-term safety and efficacy of tadalafil 5 mg dosed once daily for the treatment of ED. Methods: Patients ≥18 years of age with ED of any functional severity or etiology received tadalafil 5 mg once daily for 1 (N = 234) or 2 (N = 238) years during the open-label extensions of two previously reported studies. Patients who completed the 1-year open-label extension concluded with a 4-week ED treatment-free period. Baseline was defined as prior to receiving any study drug. Main Outcome Measures: Safety measures included adverse events, electrocardiograms, and clinical laboratory measures. Efficacy measures included the International Index of Erectile Function (IIEF)-Erectile Function (-EF), -Intercourse Satisfaction (-IS), and -Overall Satisfaction (-OS) domain scores, and the Global Assessment Questions (GAQ1: improved erections; GAQ2: improved ability to engage in sexual activity). Results: Overall, 208/234 (88.9%) and 139/238 (58.4%) patients completed the 1- and 2-year open-label extensions, respectively. No study drug-related serious adverse events were observed. Treatment-emergent adverse events observed in ≥5% of the patients during the first year of either open-label extension were dyspepsia, headache, back pain, and influenza. No clinically meaningful abnormalities associated with tadalafil were observed for electrocardiograms or clinical laboratory measures. Mean IIEF domain scores improved from baseline to the conclusions of the 1- and 2-year open-label extensions, respectively: -EF, +10.4 and +10.8; -IS, +4.0 and +3.7; and -OS, +3.0 and +3.2. At the conclusion of the 2-year open-label extension, 95.7% and 92.1% of the patients reported positive responses to GAQ1 and GAQ2, respectively. Conclusions: In these long-term, open-label, once-daily dosing studies, tadalafil 5 mg was well tolerated and effective, making it a viable alternative to the current on-demand dosing of tadalafil for men with ED.
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“The IIEF-EF score improved from baseline by 10.4 and 10.8 in the 1- and 2-year extensions, respectively.”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as Porst et al 2008
In the citing paper
“After 2 years, 95.7% of patients reported improved erections (Porst et al 2008).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as Porst et al 2008
In the citing paper
“There were 208 of 234 possible patients (88.9%) who completed the 1-year extension and 139 of 238 possible patients (58.4%) who completed the 2-year extension.”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as Porst et al 2008
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“In open-label extensions of the two randomized, placebo controlled trials of once-daily tadalafil described above, Porst and colleagues have evaluated the long-term safety and efficacy of once-daily tadalafil 5 mg over 1 and 2 years (Porst et al 2008).”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as Porst et al 2008
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“Although an impressively positive response, the 2-year GAQ data had a significant dropout rate and likely contained selection bias toward patients who had a positive response.”
From Tadalafil in the treatment of erectile dysfunction (2008) · cites this paper as Porst et al 2008
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Citations
Cites
Oral Sildenafil in the Treatment of Erectile Dysfunction
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Cited by
Shamloul, R., & Ghanem, H. (2013) · The Lancet · doi:10.1016/s0140-6736(12)60520-0 · Cited by 1,091
Tadalafil in the treatment of erectile dysfunction
Coward, R., & Carson, C. (2008) · Therapeutics and Clinical Risk Management · doi:10.2147/tcrm.s3336 · Cited by 138
Metadata
- Authors
- Porst, H., Rajfer, J., Casabé, A., Feldman, R., Ralph, D., Vieiralves, L. F., Esler, A., Wolka, A. M., & Klise, S. R.
- Affiliations
- Private practice of Urology and Andrology , Hamburg , Germany
- Harbor-UCLA Medical Center , Torrance , USA
- Instituto Médico Especializado , Buenos Aires , Argentina
- Connecticut Clinical Research Center/Urology Specialists , Middlebury , USA
- Institute of Urology , London , UK
- Hospital Naval Marcilio Dias , Rio de Janeiro , Brazil
- ICOS Corporation , Bothell , USA
- Eli Lilly and Company , Indianapolis , USA
- Venue
- The Journal of Sexual Medicine
- Publisher
- Oxford University Press (OUP)
- Published
- 2008-09-01
- Volume
- 5
- Issue
- 9
- Pages
- 2160-2169
- ISSN
- 1743-6109
- 1743-6095
- Cited by
- 72
- References
- 2
- Language
- en
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- Porst, H., Rajfer, J., Casabé, A., Feldman, R., Ralph, D., Vieiralves, L. F., Esler, A., Wolka, A. M., & Klise, S. R. (2008). Long-Term Safety and Efficacy of Tadalafil 5 mg Dosed Once Daily in Men with Erectile Dysfunction. The Journal of Sexual Medicine. https://doi.org/10.1111/j.1743-6109.2008.00935.x
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