Brock Gerald, Chan John, Carrier Serge, Chan Melanie, Salgado Luis, Klein Alexander H, Lang Clement, Horner Richard, Gutkin Stephen, Dickson Ruth
Department of Surgery, University of Western Ontario, St. Joseph's Health Center, London, ON, Canada.
BJU Int. 2007 Feb;99(2):376-82. doi: 10.1111/j.1464-410X.2006.06586.x. Epub 2006 Nov 28.
To assess patient and partner preferences for, and satisfaction with, tadalafil or sildenafil (phosphodiesterase type 5 inhibitors) in routine clinical practice for treating erectile dysfunction (ED), as these are important outcomes that might influence treatment adherence.
In a multicentre, prospective observational trial in Canada, patients with ED were eligible if they planned to change treatment from tadalafil to sildenafil or vice versa. Data were collected at baseline and 4-12 weeks later (endpoint). Satisfaction was assessed using patient and partner versions of the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire. EDITS index scores range from 0 (extremely low treatment satisfaction) to 100 (extremely high treatment satisfaction).
Of 2425 patients, approximately 98% completed the study and 295 partners participated. When patients changed from sildenafil to tadalafil (1722 men) the mean EDITS index scores increased significantly for both patients (from 61.6 to 78.3) and partners (from 65.0 to 82.6; both P < 0.001). When patients changed from tadalafil to sildenafil (703 men), the mean EDITS index scores increased slightly but significantly for patients (from 68.8 to 70.2; P = 0.007) but not partners (from 76.8 to 68.9; P = 0.066). For the individual EDITS questions, mean scores increased significantly from baseline to endpoint on all questions for patients (all 11 questions; P < 0.001) and partners (all five questions; P < 0.001) in the sildenafil-to-tadalafil group, and in the tadalafil-to-sildenafil group, mean scores for patients decreased on nine of 11 questions (seven of nine significantly; P < 0.041) and mean scores for partners decreased on all five (two significantly; P < 0.049). For treatment preference, regardless of the change in treatment (i.e. sildenafil-tadalafil or tadalafil-sildenafil), a significantly higher percentage of patients and partners preferred tadalafil to sildenafil.
These data indicate that patients with ED (and their partners) who changed from sildenafil to tadalafil treatment or vice versa in a routine clinical practice setting had higher treatment satisfaction when taking tadalafil than sildenafil, as assessed by most measures of EDITS. The higher treatment satisfaction with tadalafil might help to explain the greater preference for tadalafil compared with sildenafil in both patients and partners in this observational study.
评估在治疗勃起功能障碍(ED)的常规临床实践中,患者及其伴侣对他达拉非或西地那非(5型磷酸二酯酶抑制剂)的偏好及满意度,因为这些是可能影响治疗依从性的重要结果。
在加拿大进行的一项多中心前瞻性观察性试验中,计划从他达拉非换用西地那非或反之的ED患者符合入选条件。在基线时及4 - 12周后(终点)收集数据。使用患者版和伴侣版的治疗满意度勃起功能障碍问卷(EDITS)评估满意度。EDITS指数评分范围为0(极低的治疗满意度)至100(极高的治疗满意度)。
2425例患者中,约98%完成了研究,295名伴侣参与。当患者从西地那非换用他达拉非时(1722名男性),患者(从61.6增至78.3)和伴侣(从65.0增至82.6;均P < 0.001)的平均EDITS指数评分均显著增加。当患者从他达拉非换用西地那非时(703名男性),患者的平均EDITS指数评分略有但显著增加(从68.8增至70.2;P = 0.007),而伴侣的评分未显著增加(从76.8降至68.9;P = 0.066)。对于EDITS的各个问题,在西地那非换他达拉非组中,患者(所有11个问题;P < 0.001)和伴侣(所有5个问题;P < 0.001)的所有问题平均评分从基线到终点均显著增加;在他达拉非换西地那非组中,患者11个问题中有9个问题的平均评分下降(9个问题中的7个显著下降;P < 0.041),伴侣5个问题的平均评分均下降(5个问题中的2个显著下降;P < 0.049)。对于治疗偏好,无论治疗如何变化(即西地那非 - 他达拉非或他达拉非 - 西地那非),患者和伴侣中更喜欢他达拉非而非西地那非的比例显著更高。
这些数据表明,在常规临床实践环境中从西地那非换用他达拉非治疗或反之的ED患者(及其伴侣),根据EDITS的大多数测量方法,服用他达拉非时的治疗满意度高于西地那非。他达拉非更高的治疗满意度可能有助于解释在这项观察性研究中患者和伴侣对他达拉非的偏好高于西地那非。