Klinikum Osnabrück, Osnabrück, Germany.
J Sex Med. 2010 Sep;7(9):3161-9. doi: 10.1111/j.1743-6109.2010.01921.x.
The Real-Life Safety and Efficacy of vardenafil study is an international, open-label, prospective, noncomparative, noninterventional study in men with erectile dysfunction (ED).
To determine the safety and efficacy of vardenafil in a large international pool of men with ED (aged ≥ 18 years) and associated underlying conditions (N=73,946), in a real-life setting.
Patients attended an initial physician visit and one to two follow-up visits. Data were acquired by physician interviews and patient diaries and recorded in case report forms (CRFs). Data were pooled from 47 countries in Europe, Asia-Pacific, Latin America, and the rest of the world (excluding the United States and Japan for methodological reasons). Results were stratified by baseline ED severity, body mass index (BMI), and the presence of hypertension, diabetes, lipid metabolism disorder, or cardiovascular disease (CVD).
CRFs and patient questionnaires containing questions on overall improvement of erection, satisfaction with efficacy, and desire to continue vardenafil use.
Many participants had hypertension (32.0%), diabetes (22.1%), lipid metabolism disorder (14.6%), or CVD (42.2%). High percentages of patients reported improvements in erectile function, irrespective of baseline ED severity (mild, 97.0%; moderate, 96.2%; severe, 85.5%), BMI (<25, 94.1%; ≥ 25 and <30, 94.6%; ≥ 30, 92.9%), or the presence of hypertension (93.6%), diabetes (92.6%), lipid metabolism disorder (94.7%), or CVD (93.3%). Over 90% of patients, including those with underlying conditions, reported being "satisfied" or "very satisfied" with vardenafil efficacy, and stated their intention to continue vardenafil use after the end of the study period. The incidence of adverse events was low, and 97.0% of patients were either "satisfied" or "very satisfied" with vardenafil tolerability.
These data from a worldwide population of men with ED and associated underlying conditions show that vardenafil is effective and well-tolerated for the treatment of ED in a real-life setting, supporting its use as a first-line ED therapy.
真实世界中伐地那非的安全性和疗效研究是一项国际性、开放性、前瞻性、非对照、非干预性研究，入组人群为患有勃起功能障碍（ED）的成年男性（年龄≥18 岁）和相关基础疾病患者（N=73946）。
评估伐地那非在真实世界环境中治疗 ED（包括年龄≥18 岁）和相关基础疾病（包括但不限于高血压、糖尿病、血脂代谢紊乱、心血管疾病等）成年男性患者的安全性和疗效。
患者接受了初始访视和 1 到 2 次随访。数据由医生访谈和患者日记获得，并记录在病例报告表（CRF）中。数据来自欧洲、亚太、拉丁美洲和世界其他地区（出于方法学原因，不包括美国和日本）的 47 个国家。结果根据基线 ED 严重程度、体重指数（BMI）和高血压、糖尿病、血脂代谢紊乱或心血管疾病（CVD）的存在情况进行分层。
CRF 和患者问卷，内容包括勃起功能总体改善、对疗效的满意度以及继续使用伐地那非的意愿。
许多患者患有高血压（32.0%）、糖尿病（22.1%）、血脂代谢紊乱（14.6%）或 CVD（42.2%）。无论基线 ED 严重程度（轻度：97.0%；中度：96.2%；重度：85.5%）、BMI（<25：94.1%；≥25 且<30：94.6%；≥30：92.9%）或高血压（93.6%）、糖尿病（92.6%）、血脂代谢紊乱（94.7%）或 CVD（93.3%）的存在情况如何，均有较高比例的患者报告勃起功能得到改善。超过 90%的患者，包括有基础疾病的患者，对伐地那非的疗效表示“满意”或“非常满意”，并表示愿意在研究结束后继续使用伐地那非。不良事件的发生率较低，97.0%的患者对伐地那非的耐受性表示“满意”或“非常满意”。
来自患有 ED 和相关基础疾病的全球男性人群的数据表明，伐地那非在真实世界环境中治疗 ED 安全有效，可作为一线 ED 治疗药物。
