作者: Ulka B. Campbell , Alexander M. Walker , Michael Gaffney , Kenneth R. Petronis , Dana Creanga
DOI: 10.1111/JSM.12726
关键词: Anterior ischemic optic neuropathy 、 Crossover study 、 Sample size determination 、 Pediatrics 、 Erectile dysfunction 、 Odds ratio 、 Relative risk 、 Sildenafil 、 Medicine 、 Anesthesia 、 Confidence interval
摘要: Abstract Introduction Nonarteritic anterior ischemic optic neuropathy (NAION), a rare visual disorder, has been reported in men using phosphodiesterase type 5 inhibitors (PDE5i) for erectile dysfunction. Aim We examined whether intermittent use of PDE5i is associated with acute NAION onset within approximately five half‐lives following drug ingestion. Methods One hundred two ophthalmology centers the United States and Europe identified potential cases NAION. An expert adjudication committee conducted blind review records those recent to classify as Definite, Possible, or not Subjects provided information on PDEi via telephone interview. Each case's exposure immediately prior was compared against his patterns an observational case–crossover design. A sample size 40 30 days needed detect odds ratio (OR) 3.0 80% power. Main Outcome Measures The daily relative risk vs. other estimated OR obtained from conditional logistic regression. Results Among 43 Definite days, 2.15 (95% confidence interval [CI]: 1.06, 4.34). When 21 Possible were included (n = 64), 2.36 CI: 1.33, 4.19). Conclusions found twofold increased more time period. Bias inaccurate recall unlikely have substantially affected results. Based our results, we estimate that weekly adds three per 100,000 50 years older annually. Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BEK, Laties Lewis Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, Reynolds RF. Acute nonarteritic inhibitors. J Sex Med 2015;12:139–151.