Droupy Stéphane, Colson Marie Hélène
Urology and Andrology Department, Nimes University Hospital, Nimes, France.
Immuno-Hematology Clinic (CISIH), Sainte-Marguerite Hospital, Marseille, France.
Int J Reprod Med. 2022 Jun 2;2022:9122099. doi: 10.1155/2022/9122099. eCollection 2022.
Erectile dysfunction (ED) has a significant impact on the quality of life of patients. Xybilun® (IBSA Pharma SAS, France) is a new formulation of sildenafil in an orodispersible film (ODF). This study aims to assess the response rate (RR), satisfaction with, and safety of sildenafil-ODF in daily practice in France. Patients aged ≥18 years with ED were included in four groups: Group 1 mild, Group 2 moderate, Group 3 severe ED, according to the International Index for Erectile Function (IIEF)-6 subscore, never treated with phosphodiesterase inhibitors (PDE)5-I; Group 4, patients previously treated with another PDE5-I. Patients were evaluated at baseline (V1), one (V2), and three (V3) months. The RR and satisfaction were assessed using the IIEF-6 subscore questionnaire, a 5-point Likert scale, and a Global Assessment Question (GAQ). The primary endpoint for Groups 1 to 3 was the RR according to Rosen criteria at V3 compared to V1. For Group 4, the primary endpoint was the RR, defined as the satisfaction compared with previous treatment. Secondary endpoints were the RR at V2 compared to V1, the evolution of IIEF-6 and IIEF-15 scores, dose adjustment, satisfaction, convenience, and safety. One hundred and five patients were enrolled, 83 analysed. The RR at V3 was 100% (Group 1); 75% (Group 2); 65.2% (Group 3); and 84.2% (Group 4). The overall RR was 78.3%. Secondary parameters confirmed the satisfaction with sildenafil-ODF, with 81.6% of patients very satisfied at V3. No Serious Adverse Events (SAEs) were observed. In conclusion, sildenafil-ODF seems beneficial for patients irrespective of the severity of the ED. This study confirms in the context of daily clinical practice the satisfaction of patients with sildenafil-ODF. Data suggest that the availability of the intermediate dose of 75 mg could add greater flexibility to the therapy.
勃起功能障碍（ED）对患者的生活质量有重大影响。Xybilun®（法国IBSA制药公司）是西地那非的一种新剂型，制成了口腔崩解膜（ODF）。本研究旨在评估法国日常临床实践中，西地那非口腔崩解膜的有效率（RR）、患者满意度及安全性。年龄≥18岁的ED患者根据国际勃起功能指数（IIEF）-6评分被分为四组：1组为轻度，2组为中度，3组为重度ED，且均未接受过磷酸二酯酶抑制剂（PDE）5-I治疗；4组为曾接受过其他PDE5-I治疗的患者。在基线期（V1）、1个月（V2）和3个月（V3）对患者进行评估。使用IIEF-6评分问卷、5级李克特量表和整体评估问题（GAQ）评估有效率和满意度。1至3组的主要终点是V3时与V1相比，根据罗森标准得出的有效率。对于4组，主要终点是有效率，定义为与先前治疗相比的满意度。次要终点是V2时与V1相比的有效率、IIEF-6和IIEF-15评分的变化、剂量调整、满意度、便利性和安全性。共纳入105例患者，83例进行了分析。V3时的有效率分别为：第1组100%；第2组75%；第3组65.2%；第4组84.2%。总体有效率为78.3%。次要参数证实了患者对西地那非口腔崩解膜的满意度，V3时81.6%的患者非常满意。未观察到严重不良事件（SAE）。总之，无论ED的严重程度如何，西地那非口腔崩解膜似乎对患者有益。本研究在日常临床实践背景下证实了患者对西地那非口腔崩解膜的满意度。数据表明，75mg中间剂量的可用性可为治疗增加更大的灵活性。
