Corona G, Rastrelli G, Burri A, Serra E, Gianfrilli D, Mannucci E, Jannini E A, Maggi M
Endocrinology Unit, Medical Department, Maggiore-Bellaria Hospital, Azienda-Usl Bologna, Bologna, Italy.
Sexual Medicine and Andrology Unit, Department of Experimental, Clinical and Biomedical Sciences, University of Florence, Florence, Italy.
Andrology. 2016 Nov;4(6):1002-1009. doi: 10.1111/andr.12255. Epub 2016 Sep 16.
The discontinuation rate with phosphodiesterase type 5 inhibitors (PDE5i) remains very high. The aim of this study was to review and meta-analyze currently available data regarding dropout of the first-generation of PDE5i including sildenafil, vardenafil, and tadalafil. An extensive Medline Embase and Cochrane search was performed including the following words: 'PDE5i', 'discontinuation'. All observational studies reporting the dropout rate of PDE5i and its specific causes without any arbitrary restrictions were included. Out of 103 retrieved articles, 22 were included in the study. Retrieved trials included a total of 162,936 patients with a mean age of 58.8 ± 7.9 years. Prevalence of reported comorbid diabetes and hypertension were 27.7% and 36.9%, respectively. PDE5i were associated with a mean discontinuation rate of 4% per month (almost 50% after one year). This rate was higher in younger subjects and in those reporting a higher prevalence of associated morbidities. Six main reasons of PDE5i dropout were identified in the evaluated trials. Partner-related problems and lack of efficacy represented the most important reasons for PDE5i discontinuation, although no significant difference among factors was detected. In conclusion, despite their high efficacy and easy administration, the discontinuation rate and dissatisfaction with PDE5i are still very high. Our data showed that no single factor plays a major role in PDE5i dropout, suggesting that the discontinuation rate is usually because of a combination of both medical problems and psychosocial and relational factors.
5型磷酸二酯酶抑制剂（PDE5i）的停药率仍然很高。本研究的目的是回顾和荟萃分析目前关于第一代PDE5i（包括西地那非、伐地那非和他达拉非）停药情况的现有数据。我们在Medline、Embase和Cochrane数据库进行了广泛检索，检索词包括：“PDE5i”、“停药”。纳入所有报告PDE5i停药率及其具体原因且无任何任意限制的观察性研究。在检索到的103篇文章中，22篇被纳入本研究。纳入的试验共涉及162936例患者，平均年龄为58.8±7.9岁。报告的合并糖尿病和高血压患病率分别为27.7%和36.9%。PDE5i的平均每月停药率为4%（一年后接近50%）。该停药率在年轻受试者以及报告合并症患病率较高的受试者中更高。在评估的试验中确定了PDE5i停药的六个主要原因。伴侣相关问题和疗效不佳是PDE5i停药的最重要原因，尽管各因素之间未检测到显著差异。总之，尽管PDE5i疗效高且易于给药，但其停药率和患者不满率仍然很高。我们的数据表明，没有单一因素在PDE5i停药中起主要作用，这表明停药率通常是医疗问题与心理社会及人际关系因素共同作用的结果。
