背景：Anamorelin于2021年在日本被批准用于治疗与非小细胞肺相关的癌症恶病质，胃,胰腺,或结直肠癌。正在进行上市后监测，以评估anamorelin的实际安全性和有效性。
方法：这种前瞻性，观察性监测登记了所有在2021年4月21日之后开始接受anamorelin治疗的患者.高血糖症,肝功能损害，传导障碍,与治疗相关的不良事件被定义为主要安全规范.体重(BW)和食欲被评估为有效性规格。
结果：此分析基于截至2023年1月21日的数据。安全性和有效性分析集包括6016和4511名患者，分别。≥1%患者的治疗相关不良事件为高血糖（3.9%）和恶心（2.6%）。高血糖的发生率，肝功能损害，传导障碍,与治疗相关的不良事件为4.8%，1.2%,1.1%，分别。从基线到第3、12、24和52周的平均BW变化（标准误差[SE]）为0.64（0.05）kg，1.19(0.12)kg,1.40(0.21)kg,和1.42（0.39）千克，分别。从基线到第3、12、24和52周，厌食症/恶病质治疗功能评估5项厌食症症状量表总分的平均变化（SE）为3.2（0.09），4.8（0.18），5.2(0.30),和5.3（0.47），分别,超过临床意义的改善评分（2.0分）。
结论：阿纳瑞林的整体安全性没有引起新的安全性问题，尽管高血糖和恶心可能需要持续谨慎。在真实世界的临床环境中也观察到BW和食欲的改善。
BACKGROUND: Anamorelin was approved in Japan in 2021 to treat cancer cachexia associated with non-small cell lung, gastric, pancreatic, or colorectal cancers. Post-marketing surveillance is being conducted to evaluate the real-world safety and effectiveness of anamorelin.
METHODS: This prospective, observational surveillance registered all patients who started treatment with anamorelin after April 21, 2021. Hyperglycemia, hepatic impairment, conduction disorders, and their associated adverse events related to treatment were defined as main safety specifications. Body weight (BW) and appetite were assessed as effectiveness specifications.
RESULTS: This analysis was based on data as of January 21, 2023. The safety and effectiveness analysis sets included 6016 and 4511 patients, respectively. Treatment-related adverse events in ≥1% of patients were hyperglycemia (3.9%) and nausea (2.6%). The incidences of hyperglycemia, hepatic impairment, conduction disorders, and their associated adverse events related to treatment were 4.8%, 1.2%, and 1.1%, respectively. The mean changes (standard error [SE]) in BW from baseline to weeks 3, 12, 24, and 52 were 0.64 (0.05) kg, 1.19 (0.12) kg, 1.40 (0.21) kg, and 1.42 (0.39) kg, respectively. The mean changes (SE) in Functional Assessment of Anorexia/Cachexia Treatment 5-item Anorexia Symptom Scale total scores from baseline to weeks 3, 12, 24, and 52 were 3.2 (0.09), 4.8 (0.18), 5.2 (0.30), and 5.3 (0.47), respectively, exceeding the clinically meaningful improvement score (2.0 points).
CONCLUSIONS: The overall safety of anamorelin raised no new safety concerns, although continued caution may be required for hyperglycemia and nausea. Improvements in BW and appetite were also observed in real-world clinical settings.
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