Hatzichristou D, Haro J M, Martin-Morales A, von Keitz A, Riley A, Bertsch J, Belger M, Wolka A M, Beardsworth A
2nd Department of Urology, Papageorgiou General Hospital and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Int J Clin Pract. 2007 Nov;61(11):1850-62. doi: 10.1111/j.1742-1241.2007.01560.x. Epub 2007 Sep 10.
This report describes patterns of treatment changes with the phosphodiesterase type 5 (PDE5) inhibitors tadalafil, sildenafil and vardenafil, and variables associated with those treatment changes, during the 6-month, prospective, pan-European Erectile Dysfunction Observational Study (EDOS).
EDOS observed 8047 men > or = 18 years old with erectile dysfunction (ED), who began or changed ED therapy as part of their routine healthcare. Patients could change ED treatment at any time during EDOS. Data were collected at baseline and at 3 (+/- 1) and 6 (+/- 1) months. Analyses included ED treatment-naïve patients with complete follow-up who were prescribed a PDE5 inhibitor at baseline (n = 4026).
Most patients, regardless of what PDE5 inhibitor they were prescribed at baseline, continued on that same PDE5 inhibitor throughout the study. Continuation rates were approximately 89% in the tadalafil cohort, vs. 63-64% in the sildenafil and vardenafil cohorts. The variables most strongly associated with increased risk of switching were prescription of sildenafil or vardenafil, vs. tadalafil, at baseline (odds ratios 4.43 and 4.14 respectively; p < 0.0001). Of patients who switched from tadalafil to another treatment, nearly 25% had switched back to tadalafil by study end. In contrast, of patients who switched from sildenafil or vardenafil, < 10% from each cohort had switched back to their original treatment by study end.
The data suggest that tadalafil treatment in treatment-naïve ED patients may increase their likelihood of treatment continuation. These findings should be interpreted conservatively due to the observational nature of the study.
本报告描述了在为期6个月的泛欧洲勃起功能障碍观察性研究（EDOS）中，5型磷酸二酯酶（PDE5）抑制剂他达拉非、西地那非和伐地那非的治疗变化模式，以及与这些治疗变化相关的变量。
EDOS观察了8047名年龄≥18岁的勃起功能障碍（ED）男性，他们开始或改变ED治疗作为其常规医疗保健的一部分。患者在EDOS期间可随时改变ED治疗。在基线以及3（±1）个月和6（±1）个月时收集数据。分析包括在基线时接受PDE5抑制剂治疗且随访完整的初治ED患者（n = 4026）。
大多数患者，无论基线时服用何种PDE5抑制剂，在整个研究过程中都继续使用同一种PDE5抑制剂。他达拉非队列中的持续使用率约为89%，而西地那非和伐地那非队列中的持续使用率为63% - 64%。与换药风险增加最密切相关的变量是基线时服用西地那非或伐地那非而非他达拉非（优势比分别为4.43和4.14；p < 0.0001）。从他达拉非换用其他治疗的患者中，近25%在研究结束时又换回了他达拉非。相比之下，从西地那非或伐地那非换用其他治疗的患者中，每个队列中不到10%的患者在研究结束时又换回了原来的治疗。
数据表明，初治ED患者使用他达拉非治疗可能会增加其持续治疗的可能性。由于该研究的观察性性质，这些发现应谨慎解读。
