The online version of this article (doi:10.1186/s12894-015-0107-5) contains supplementary material, which is available to authorized users.
The study was funded by Eli Lilly and Company, Indianapolis, IN, USA. D. Hatzichristou has received research grants for this study from Eli Lilly and speaker honoraria from Menarini, and reports activities as Advisory Board member for Eli Lilly, Menarini, Medispec and Dornier. H. Porst reports activities as speaker, investigator, and consultant for Eli Lilly and the Menarini/Berlin Chemie group. J. Buvat reports no conflicts of interest. G. d’Anzeo, C. Henneges, A. Rossi, K. Hamidi, and H. Büttner are employees of Eli Lilly and Company, H. Büttner also owns Lilly stock.
HB and CH designed the study, the manuscript outline, and provided data interpretation. CH was responsible for the statistical analyses. DH, HP, and JB were study investigators. AR contributed to data interpretation and manuscript outline. HB and CH drafted the manuscript with medical writing support provided by Trilogy Writing and Consulting GmbH. AR, DH, GdA, HP, JB, and KH provided substantial feedback on the draft manuscript. All authors read and approved the final manuscript.
To explore the impact of patient-characteristics and relevant comorbidities on treatment continuation rates, effectiveness, and satisfaction in patients with erectile dysfunction (ED) who started or switched to tadalafil 5 mg once daily (TAD-OaD) at baseline.
In the EDATE observational study, phosphodiesterase-type-5 (PDE5)-inhibitor pretreated or naïve ED patients who started or switched to TAD-OaD were prospectively followed for 6 months. Time to discontinuation of TAD-OaD was estimated using the Kaplan-Meier product-limit method at Months 2, 4, and 6 in subgroups stratified by age (18 − 65 years and >65 years), PDE5-inhibitor pretreatment, ED-severity (mild, moderate, severe), and presence or absence of relevant comorbidities (BPH, diabetes, CVD, hypertension, dyslipidemia). LSmean change from baseline in International Index of Erectile Function (IIEF) and Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) scores and associated 95 % CIs were assessed using a mixed-model for repeated measures. Visit, ED etiology, and subgroups were included as fixed-effects.
Overall, 778 patients received prescriptions for initiating or switching to TAD-OaD at baseline. At Month 2, >90 % of patients remained on TAD-OaD, except those aged >65 years (86.7 %) and patients with severe ED (89.0 %). More than 80 % of patients in all subgroups, except those aged >65 years (75.0 %), continued TAD-OaD at Month 6. There was a significant LSmean negative effect on IIEF- EF domain-score improvement for BPH (LSmean effect [95 % CI]: −2.77 [−4.98, −0.55], p = 0.014), previous PDE5-inhibitor treatment (−2.13 [−3.33,-0.94], p < 0.001), and mild vs moderate ED (-2.00 [−3.54,-0.46], p = 0.011); the latter possibly linked with a bigger treatment-effect in those with more severe ED at baseline. The LSmean effect on change in IIEF-EF was significantly positive for diabetes (2.28 [0.64,3.92], p = 0.007), most likely because those with diabetes had more severe ED at baseline. For all other parameters, no statistically significant LSmean effects in IIEF-EF changes were observed. No comorbidity or baseline-characteristic except age (18 − 65 years vs >65 years: 11.25 [2.96,19.54], p = 0.008) affected changes in EDITS.
Under routine clinical conditions, treatment continuation rate or satisfaction does not seem to be significantly affected by the presence of comorbidities in men who choose ED-treatment with TAD-OaD. The magnitude of treatment effectiveness was affected by certain baseline characteristics and comorbid conditions.
The study (H6D-EW-LVIU) is registered in the German VfA Registry of Non-Interventional Studies (Verband Forschender Arzneimittelhersteller) since 06 December 2011; available at: http://www.vfa.de/de/arzneimittel-forschung/datenbanken-zu-arzneimitteln/nisdb/nis-details/_741.
Additional file 1: List of ethical review boards. (PDF 17 kb)12894_2015_107_MOESM1_ESM.pdf
Additional file 2: IIEF domain scores at baseline in PDE5 inhibitor-naïve and PDE5 inhibitor pretreated patients (N = 778). (PDF 24 kb)12894_2015_107_MOESM2_ESM.pdf
Additional file 3: Kaplan-Meier estimation in different age groups for time to discontinuation of tadalafil OaD treatment. (PDF 109 kb)12894_2015_107_MOESM3_ESM.pdf
Additional file 4: Kaplan-Meier estimation in patients stratified according to severity of erectile dysfunction for time to discontinuation of tadalafil OaD treatment. (PDF 118 kb)12894_2015_107_MOESM4_ESM.pdf
Additional file 5: Change of IIEF and EDITS total scores from baseline to Month 6 during treatment with tadalafil OaD - subgroup analysis (N = 778; unadjusted data). (PDF 74 kb)12894_2015_107_MOESM5_ESM.pdf
Additional file 6: Kaplan-Meier estimation for time to discontinuation of tadalafil OaD treatment. (PDF 102 kb)12894_2015_107_MOESM6_ESM.pdf
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- Tadalafil 5 mg once daily for the treatment of erectile dysfunction during a 6-month observational study (EDATE): impact of patient characteristics and comorbidities
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