El Khiat Yasser, Ghazi Sherif, Allam Ahmed, Khawaja Maqsood, Belger Mark, Tamer Mohammed, Kopernicky Vladimir
Cairo University Medical School, Cairo, Egypt.
Curr Med Res Opin. 2008 Jul;24(7):1965-73. doi: 10.1185/03007990802190641. Epub 2008 Jun 10.
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.
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.
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).
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.
这项在沙特阿拉伯、科威特和阿拉伯联合酋长国开展的观察性比较研究，对20毫克按需服用他达拉非在20周内对初治勃起功能障碍（ED）男性与曾接受过除他达拉非以外的ED治疗的男性的心理社会及疗效结果进行了评估。
使用心理和人际关系量表简表（SF-PAIRS）评估心理社会结果（时间关注、自发性和性自信）。采用国际勃起功能指数（IIEF）勃起功能（EF）领域得分相对于基线的变化评估疗效，并通过总体评估问题（GAQ）来确定勃起改善情况。
在分析的1080例患者中，557例（51.6%）为初治患者，523例（48.4%）为曾接受过治疗的患者。总计500例（89.8%）初治男性和473例（90.4%）曾接受过治疗的男性完成了研究。初治组和曾接受过治疗的组在基线特征方面存在一些统计学上的显著差异，包括ED病因、ED严重程度、ED持续时间以及合并心血管疾病、其他血管疾病和神经疾病的情况。与初治组相比，曾接受过治疗的组调整后的平均SF-PAIRS时间关注领域得分改善更为显著，而性自信领域得分改善则显著较少（均p<0.0001）。在自发性领域未观察到显著差异。初治组IIEF-ED领域得分的平均变化为13.26，而曾接受过治疗的组为9.28（p<0.0001）。在末次评估时，97.3%的初治男性和94.4%的曾接受过治疗的男性对GAQ给出了肯定回答（p<0.0263）。
这项在海湾地区开展的大型观察性研究表明，在自然环境中接受他达拉非治疗的ED患者，在心理社会结果和勃起功能方面均有改善，初治组和曾接受过治疗的组之间存在一些差异。本研究结果可能有助于医生调整他达拉非治疗方案并设定现实的治疗预期。
