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Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study

International Journal of Impotence Research volume 26, pages 223–229 (2014)Cite this article

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Abstract

Initiation of ED treatment with a particular PDE5I may influence treatment-adherence and other outcomes. In this multicenter, open-label study, men with ED, naïve to PDE5I, were randomized to tadalafil 5 mg once-a-day (OaD; N=257), 10 mg on demand (PRN; N=252) or sildenafil-citrate (sildenafil) 50 mg PRN (N=261) for 8 weeks (dose adjustments allowed), followed by 16 weeks of pragmatic treatment (switching between PDE5I allowed). Primary outcomes (treatment-adherence) were reported previously. Here, we report effects on: Psychological and Interpersonal Relationship Scales, Self-Esteem and Relationship (SEAR) questionnaire, ED Inventory of Treatment Satisfaction (EDITS), International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP) and Global Assessment Questions (GAQ). Mixed-model for repeated measures and analysis of covariance were used to analyze changes from baseline; GAQ-responses were evaluated by logistic regression. Analyses were adjusted for treatment, country, ED-severity, baseline and baseline-by-treatment interaction. Patients randomized to tadalafil OaD or PRN reported greater improvement (least-square mean (s.e.) change) in Sexual Self-Confidence (OaD +0.90 (0.048), PRN +0.93 (0.050), vs +0.73 (0.049); P=0.006 and P=0.001) and Spontaneity (OaD +0.11 (0.035), PRN +0.13 (0.035), vs +0.02 (0.035); P=0.044 and P=0.010) compared with sildenafil. Improvements in GAQ and SEP responses, IIEF-EF, orgasmic function, sexual desire, overall satisfaction domains, SEAR and EDITS scores did not differ significantly between treatment groups.

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Acknowledgements

We thank all patients who volunteered to participate in this trial and all study investigators for their contribution to data acquisition and patient care. We thank Beatriz Sanz, Eli Lilly and Company, Spain, and Krzysztof Jasek, Eli Lilly and Company, Poland, for supporting the conduct of the study. We thank Clare Barker, Lilly UK, Global Statistical Sciences, UK, and Bruce Basson, Lilly France, Global Statistical Sciences, Suresnes, France, for their contributions to the statistical analysis plan. We thank Karin Helsberg, PhD, and Michael Riley, PhD, Trilogy Writing and Consulting GmbH, Frankfurt, Germany, for providing medical writing services on behalf of Eli Lilly and Company. Statistical analyses were programmed by PSI CRO LTD, St Petersburg, Russia. The study was funded by Eli Lilly and Company, Indianapolis, USA.

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Authors and Affiliations

  1. 2nd Department of Urology, Aristotle University of Thessaloniki, Thessaloniki, Greece

    K Hatzimouratidis

  2. Centre d’Etude et de Traitement de la Pathologie de l’Appareil Reproducteur et de la Psychosomatique (CETPARP), Lille, France

    J Buvat

  3. Medical Department, Lilly Deutschland GmbH, Bad Homburg, Germany

    H Büttner & F G Boess

  4. Saúde Atlântica, Clínica do Dragão, Porto, Portugal

    P A S Vendeira

  5. Department of Urology, Hospital La Zarzuela, Madrid, Spain

    I Moncada

  6. Diabetological Practice, Warburg, Germany

    M Boehmer

  7. Lilly Deutschland GmbH, Global Statistical Sciences, Bad Homburg, Germany

    C Henneges

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  1. K Hatzimouratidis
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  6. M Boehmer
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Correspondence to H Büttner.

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Competing interests

KH has served as speaker for Eli Lilly. JB has received honorary as scientific advisor for Eli Lilly and has been clinical trial investigator for trials sponsored by Eli Lilly, Bayer-Schering, Boehringer Ingelheim and Janssen-Cilag. IM has served as scientific advisor and speaker for Janssen-Cilag, Eli Lilly and Co., Bayer-Schering; and has received research grants from Pfizer. IM, KH, MB and PASV have been clinical trial investigator for trials sponsored by Eli Lilly. HB, CH and FGB are employees of Eli Lilly and Company; HB and FGB also own Lilly stock.

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Hatzimouratidis, K., Buvat, J., Büttner, H. et al. Psychosocial outcomes after initial treatment of erectile dysfunction with tadalafil once daily, tadalafil on demand or sildenafil citrate on demand: results from a randomized, open-label study. Int J Impot Res 26, 223–229 (2014). https://doi.org/10.1038/ijir.2014.15

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