OBJECTIVE To assess risk of anaphylaxis among patients with type 2 diabetes mellitus who are initiating therapy with a glucagon-like peptide-1 receptor agonist (GLP-1 RA), with a focus on those starting lixisenatide therapy. RESEARCH DESIGN AND METHODS A cohort study was conducted in three large, U.S. claims databases (2017–2021). Adult (aged ≥18 years) new users of a GLP-1 RA who had type 2 diabetes mellitus and ≥6 months enrollment in the database before GLP-1 RA initiation (start of follow-up) were included. GLP-1 RAs evaluated were lixisenatide, an insulin glargine/lixisenatide fixed-ratio combination (FRC), exenatide, liraglutide or insulin degludec/liraglutide FRC, dulaglutide, and semaglutide (injectable and oral). The first anaphylaxis event during follow-up was identified using a validated algorithm. Incidence rates (IRs) and 95% CIs were calculated within each medication cohort. The unadjusted IR ratio (IRR) comparing anaphylaxis rates in the lixisenatide cohort with all other GLP-1 RAs combined was analyzed post hoc. RESULTS There were 696,089 new users with 456,612 person-years of exposure to GLP-1 RAs. Baseline demographics, comorbidities, and use of other prescription medications in the 6 months before the index date were similar across medication cohorts. IRs (95% CIs) per 10,000 person-years were 1.0 (0.0–5.6) for lixisenatide, 6.0 (3.6–9.4) for exenatide, 5.1 (3.7–7.0) for liraglutide, 3.9 (3.1–4.8) for dulaglutide, and 3.6 (2.6–4.9) for semaglutide. The IRR (95% CI) for the anaphylaxis rate for the lixisenatide cohort compared with the pooled other GLP-1 RA cohort was 0.24 (0.01–1.35). CONCLUSIONS Anaphylaxis is rare with GLP-1 RAs. Lixisenatide is unlikely to confer higher risk of anaphylaxis than other GLP-1 RAs.

中文翻译：

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GLP-1 受体激动剂新使用者的过敏反应风险：一项队列研究

目的 评估开始接受胰高血糖素样肽 1 受体激动剂 (GLP-1 RA) 治疗的 2 型糖尿病患者的过敏反应风险，重点关注开始利西拉来治疗的患者。研究设计和方法 在美国三个大型理赔数据库（2017-2021 年）中进行了一项队列研究。患有 2 型糖尿病且在 GLP-1 RA 启动（随访开始）前已在数据库中登记 6 个月以上的 GLP-1 RA 成人（年龄≥18 岁）新用户被纳入。评估的 GLP-1 RA 包括利西拉肽、甘精胰岛素/利拉鲁肽固定比例组合 (FRC)、艾塞那肽、利拉鲁肽或德谷胰岛素/利拉鲁肽 FRC、度拉鲁肽和索马鲁肽（注射剂和口服剂）。使用经过验证的算法确定了随访期间的首次过敏反应事件。计算每个药物队列内的发病率 (IR) 和 95% CI。事后分析了将利西拉来队列与所有其他 GLP-1 RA 组合的过敏反应率进行比较的未调整 IR 比率 (IRR)。结果 共有 696,089 名新用户接触过 GLP-1 RA，共计 456,612 人年。索引日期前 6 个月内的基线人口统计数据、合并症和其他处方药的使用情况在药物队列中相似。每10,000人年的IR（95% CI）为利西拉肽1.0（0.0-5.6）、艾塞那肽6.0（3.6-9.4）、利拉鲁肽5.1（3.7-7.0）、度拉鲁肽3.9（3.1-4.8）和3.6 (2.6–4.9) 索马鲁肽。与合并的其他 GLP-1 RA 队列相比，利西拉来队列的过敏反应发生率的 IRR (95% CI) 为 0.24 (0.01–1.35)。结论 GLP-1 RA 引起的过敏反应很少见。与其他 GLP-1 RA 相比，利西拉来不太可能带来更高的过敏反应风险。