Acute Nonarteritic Anterior Ischemic Optic Neuropathy and Exposure to Phosphodiesterase Type 5 Inhibitors

Acute Nonarteritic Anterior Ischemic Optic Neuropathy and Exposure to Phosphodiesterase Type 5 Inhibitors
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DOI:
10.1111/jsm.12726
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发表时间:
2015-01-01
影响因子:
3.5
通讯作者:
Reynolds, Robert F.
Reynolds, Robert F.
中科院分区:
医学2区
文献类型:
--
作者:
Campbell, Ulka B.;Walker, Alexander M.;Reynolds, Robert F.

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IntroductionNonarteritic前部缺血性视神经病变(NAION),一种罕见的视觉障碍,已被报道在男性使用磷酸二酯酶5型抑制剂(PDE 5i)勃起功能障碍。AimWe研究是否间歇性使用PDE 5i与急性NAION发作在大约五个半衰期后drugingesthet.MethodsOne在美国和欧洲的眼科中心确定潜在的NAION病例。专家裁定委员会对近期使用PDE 5i的患者的记录进行了盲态审查,以将病例分类为明确、可能或非NAION。受试者通过电话访谈提供了关于PDEi使用的信息。在观察性病例交叉设计中,将每个NAION病例在发作前即刻的PDE 5i暴露与其最近的使用模式进行比较。在NAION发作前30天内间歇性暴露于PDE 5i的40例患者的样本量需要检测3.0的优势比(OR)和80%的功效。使用PDE 5i与其他天数的寿命通过条件Logistic回归获得的OR进行估计在前30天内,OR为2.15(95%置信区间[CI]:1.06,4.34)。当21个可能NAION的情况下,包括(n=64),OR为2.36(95%CI:1.33,4.19)。ConclusionsWe发现一个大约两倍的急性NAION的风险增加五个半衰期内的PDE 5i使用相比,在更早的时间段。暴露回忆不准确的偏倚不太可能对结果产生实质性影响。根据我们的研究结果,我们估计每周使用PDE 5i每年每10万名50岁及以上男性中增加3例NAION病例。坎贝尔UB、步行者AM、Gaffney M、Petronis KR、Creanga D、Quinn S、Klein BEK、Laties AM、刘易斯M、Sharlip ID、Kolitsopoulos F、Klee BJ、Mo J和Reynolds RF。急性非动脉炎性前部缺血性视神经病变与暴露于磷酸二酯酶5型抑制剂J Sex Med 2015;12:139-151.
IntroductionNonarteritic anterior ischemic optic neuropathy (NAION), a rare visual disorder, has been reported in men using phosphodiesterase type 5 inhibitors (PDE5i) for erectile dysfunction.AimWe examined whether intermittent use of PDE5i is associated with acute NAION onset within approximately five half-lives following drug ingestion.MethodsOne hundred two ophthalmology centers in the United States and Europe identified potential cases of NAION. An expert adjudication committee conducted a blind review of the records of those with recent PDE5i use to classify cases as Definite, Possible, or not NAION. Subjects provided information on PDEi use via telephone interview. Each NAION case's PDE5i exposure immediately prior to onset was compared against his recent patterns of use in an observational case-crossover design. A sample size of 40 cases with intermittent PDE5i exposure in the 30 days prior to NAION onset was needed to detect an odds ratio (OR) of 3.0 with 80% power.Main Outcome MeasuresThe daily relative risk for acute NAION on days within five half-lives of PDE5i use vs. other days was estimated via an OR obtained from conditional logistic regression.ResultsAmong 43 Definite NAION cases with PDE5i exposure in the prior 30 days, the OR was 2.15 (95% confidence interval [CI]: 1.06, 4.34). When 21 Possible NAION cases were included (n=64), the OR was 2.36 (95% CI: 1.33, 4.19).ConclusionsWe found an approximately twofold increased risk of acute NAION within five half-lives of PDE5i use compared with use in a more prior time period. Bias from inaccurate recall of exposure was unlikely to have substantially affected the results. Based on our results, we estimate that weekly use of PDE5i adds three NAION cases per 100,000 men 50 years and older annually. Campbell UB, Walker AM, Gaffney M, Petronis KR, Creanga D, Quinn S, Klein BEK, Laties AM, Lewis M, Sharlip ID, Kolitsopoulos F, Klee BJ, Mo J, and Reynolds RF. Acute nonarteritic anterior ischemic optic neuropathy and exposure to phosphodiesterase type 5 inhibitors. J Sex Med 2015;12:139-151.