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ABSTRACT
Objective: This observational, comparative study, conducted in Saudi Arabia, Kuwait, and the United Arab Emirates, assessed psychosocial and efficacy outcomes of tadalafil 20 mg on demand, over a period of 20 weeks, in men with erectile dysfunction (ED) who were treatment-naïve versus pretreated with an ED treatment other than tadalafil.
Methods: The short form of the Psychological and Interpersonal Relationship Scales (SF-PAIRS) was used to assess psychosocial outcomes (Time Concerns, Spontaneity, and Sexual Self-Confidence). Change from baseline in the International Index of Erectile Function (IIEF) erectile function (EF) domain score was used to assess effectiveness, and Global Assessment Question (GAQ) was asked to determine improvement in erections.
Results: Of 1080 patients analyzed, 557 (51.6%) were treatment-naïve and 523 (48.4%) were pretreated. In all, 500 (89.8%) treatment-naïve men and 473 (90.4%) pretreated men completed the study. Some statistically significant differences were observed in baseline characteristics between treatment-naïve and pretreated groups, including ED etiology, ED severity, duration of ED, and the presence of cormorbid cardiovascular disease, other vascular disease, and neurological disease. Adjusted mean SF-PAIRS Time Concerns domain score was significantly more improved, while the Sexual Self-Confidence domain score was significantly less improved, for the pretreated group compared with the treatment-naive group (both p < 0.0001). No significant difference was observed for the Spontaneity domain. The mean change in IIEF-ED domain score for the treatment-naïve group was 13.26 compared with 9.28 for the pretreated group (p < 0.0001). Positive responses to GAQ at the last assessment were observed in 97.3% of treatment-naïve men and 94.4% of pretreated men (p < 0.0263).
Conclusion: This large, observational study in the Gulf region demonstrates that ED patients treated with tadalafil in a naturalistic setting, report improvements in both psychosocial outcomes and erectile function, with some differences between the treatment-naïve and pretreated groups. The results of this study may assist physicians in tailoring tadalafil therapy and setting realistic treatment expectations.
Acknowledgements
Declaration of interest: This research was sponsored by Eli Lilly and Company, Indianapolis, IN, USA. Authors MB, MT and VK are employees of Eli Lilly and Company. No other authors have a conflict of interest to disclose.
The authors gratefully acknowledge the contribution of Gabrielle Gallagher (of Intercontinental Information Sciences [ICIS], Eli Lilly Australia) for assistance with the submission process, and of Christine Kuepfer for editorial assistance in the preparation of the article.