Veterans Affairs Cooperative Studies Program, Clinical Research Pharmacy Coordinating Center, Albuquerque, NM 87106, USA.
Pharmacotherapy. 2010 Jan;30(1):112. doi: 10.1592/phco.30.1.112.
The phosphodiesterase type 5 (PDE-5) inhibitors-sildenafil, vardenafil, and tadalafil-are used primarily in erectile dysfunction, but sildenafil is also indicated for pulmonary hypertension. Common adverse effects of vardenafil include headache, flushing, nasal congestion, dyspepsia, and nausea. Recently, PDE-5 inhibitors have been associated with adverse vision effects, and emerging evidence now indicates that they may also be responsible for hearing changes and hearing loss. We describe a patient who developed unilateral sudden sensorineural hearing loss possibly related to the use of vardenafil for erectile dysfunction. To our knowledge, only one other case of hearing loss related to this drug class has been published. Our patient was a 57-year-old man who came to the emergency department with right-sided mild-to-moderate hearing loss in the 500-3000-Hz range, confirmed by audiogram, that occurred after ingestion of vardenafil. The patient was hospitalized 2 days later for administration of intravenous dexamethasone, followed by oral prednisone. He reported that his hearing had improved on the fourth hospital day and was discharged 3 days later, continuing to taper the prednisone on an outpatient basis. A repeat audiogram after 10 days of corticosteroid therapy confirmed that his hearing in the 500-3000-Hz range was within normal limits. Use of the Naranjo adverse drug reaction probability scale indicated a possible (score of 3) adverse reaction of sudden sensorineural hearing loss associated with vardenafil consumption. We also performed an analysis of hearing loss cases related to PDE-5 inhibitors in the United States Food and Drug Administration's Adverse Event Reporting System database to compare the characteristics of our patient with those of other reported adverse event cases. Based on the temporal relation of the sudden sensorineural hearing loss to this patient's drug consumption, we propose that the vardenafil is a likely cause of the hearing loss. This case provides further evidence that PDE-5 inhibitor consumption should be considered as a possible cause in patients presenting with sudden sensorineural hearing loss.
磷酸二酯酶 5（PDE-5）抑制剂-西地那非、伐地那非和他达拉非-主要用于治疗勃起功能障碍，但西地那非也用于治疗肺动脉高压。伐地那非的常见不良反应包括头痛、潮红、鼻塞、消化不良和恶心。最近，PDE-5 抑制剂与不良视力影响有关，新出现的证据表明，它们也可能导致听力变化和听力损失。我们描述了一位患者，他因勃起功能障碍使用伐地那非后出现单侧突发性感觉神经性听力损失。据我们所知，只有另一例与该药物类别相关的听力损失病例已发表。我们的患者是一名 57 岁男性，因右耳 500-3000Hz 范围内轻度至中度听力损失到急诊科就诊，听力图证实，听力损失发生在服用伐地那非后。2 天后，患者因静脉注射地塞米松住院，随后口服泼尼松。他报告说，他的听力在住院第 4 天有所改善，并在 3 天后出院，继续在门诊逐渐减少泼尼松的剂量。皮质类固醇治疗 10 天后重复听力图证实，他在 500-3000Hz 范围内的听力正常。使用 Naranjo 药物不良反应概率量表表明，与伐地那非消费相关的突发性感觉神经性听力损失的不良反应可能性为中等（得分为 3）。我们还对美国食品和药物管理局不良事件报告系统数据库中与 PDE-5 抑制剂相关的听力损失病例进行了分析，以比较我们患者的特征与其他报告的不良事件病例的特征。基于突发性感觉神经性听力损失与该患者药物使用的时间关系，我们提出伐地那非可能是听力损失的原因。该病例进一步证明，PDE-5 抑制剂的使用应被视为突发性感觉神经性听力损失患者的可能原因之一。
