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普瑞巴林诱发低血糖的风险:对日本药品不良事件报告数据库的分析

Risk of Pregabalin-Induced Hypoglycemia: Analysis of the Japanese Adverse Drug Event Report Database.

作者信息

Yamada Tomoyuki, Mitsuboshi Satoru, Makino Junko, Suzuki Kaoru, Nishihara Masami, Neo Masashi

机构信息

Department of Pharmacy, Osaka Medical and Pharmaceutical University Hospital, Takatsuki, Osaka, Japan.

Department of Pharmacy, Kaetsu Hospital, Niigata-shi, Niigata, Japan.

出版信息

J Clin Pharmacol. 2022 Jun;62(6):756-761. doi: 10.1002/jcph.2009. Epub 2022 Jan 5.

DOI:10.1002/jcph.2009
PMID:34817883
Abstract

Pregabalin is a first-line treatment option for neuropathic pain. Recently, some cases of pregabalin-induced hypoglycemia have been reported, which can complicate the treatment of neuropathic pain and worsen patient outcomes. Therefore, a better understanding of the clinical condition of patients with pregabalin-induced hypoglycemia is desirable. In this study, we evaluated the risk of hypoglycemia in patients administered pregabalin, using the Japanese Adverse Drug Event Report database. All patients on pregabalin not taking any antidiabetic agents were screened from April 2004 to July 2020, and data on adverse events related to hypoglycemia, sex, age, weight, and the presence of chronic kidney disease were collected. Gabapentin and duloxetine, which are usually indicated for neuropathic pain, were used for comparison. Among 242 275 patients, 4287 were administered pregabalin, which included 37 patients who reported hypoglycemic incidents. Disproportionality of hypoglycemia was observed in patients administered pregabalin (reporting odds ratio, 2.25; 95%CI, 1.16-3.13; P < .01), whereas this was not the case in patients taking gabapentin and duloxetine. Multivariate logistic regression showed that hypoglycemia in patients on pregabalin was associated with age ≥70 years (odds ratio, 2.76; 95%CI, 1.29-5.91; P < 0.01) and weight <40 kg (odds ratio, 2.97; 95%CI, 1.32-6.71; P < 0.01). These findings suggest that pregabalin may be associated with a higher risk of hypoglycemia, especially in elderly individuals with low body weight. Health care providers may need to be aware of pregabalin-induced hypoglycemia in patients with these risk factors during therapy.

摘要

普瑞巴林是治疗神经性疼痛的一线选择。最近,有一些关于普瑞巴林诱发低血糖的病例报道,这可能使神经性疼痛的治疗复杂化并使患者预后恶化。因此,更好地了解普瑞巴林诱发低血糖患者的临床情况很有必要。在本研究中,我们使用日本药品不良事件报告数据库评估了服用普瑞巴林患者的低血糖风险。筛选出2004年4月至2020年7月期间所有服用普瑞巴林且未服用任何抗糖尿病药物的患者,并收集了与低血糖相关的不良事件、性别、年龄、体重以及慢性肾脏病情况的数据。使用通常用于治疗神经性疼痛的加巴喷丁和度洛西汀作为对照。在242275例患者中,4287例服用了普瑞巴林,其中37例报告了低血糖事件。服用普瑞巴林的患者中观察到低血糖的不成比例情况(报告比值比,2.25;95%置信区间,1.16 - 3.13;P < 0.01),而服用加巴喷丁和度洛西汀的患者则未出现这种情况。多因素逻辑回归显示,服用普瑞巴林患者的低血糖与年龄≥70岁(比值比,2.76;95%置信区间,1.29 - 5.91;P < 0.01)和体重<40 kg(比值比,2.97;95%置信区间,1.32 - 6.71;P < 0.01)相关。这些发现表明,普瑞巴林可能与较高的低血糖风险相关,尤其是在体重低的老年人中。医疗保健提供者在治疗期间可能需要留意这些有风险因素的患者中普瑞巴林诱发的低血糖情况。

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