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参与替尔泊肽临床试验的接受替尔泊肽受试者的恶性肿瘤发病率较低，与对照组受试者的恶性肿瘤发病率相当。

SURPASS 研究期间的恶性肿瘤发病率

在 SURPASS 研究中，未观察到平均降钙素水平的临床相关变化，也未报告甲状腺髓样增生或癌症病例。^1-7

在 T2D 患者中开展的关于替尔泊肽 2 期和 3 期临床研究期间发生恶性肿瘤的患者百分比在替尔泊肽组与对照组中相似。至少 1 种治疗期间出现恶性肿瘤的发病率报告如下

• 使用替尔泊肽的患者（55 名患者）为 1.02%
• 使用安慰剂的患者（5 名患者）为 1.60%
• 使用司美格鲁肽的患者（3 名患者）为 0.64%
• 使用德谷胰岛素的患者（1 名患者）为 0.28%
• 使用甘精胰岛素的患者（19 名患者）为 1.90%，以及
• 使用度拉糖肽的患者（4 名患者）为 1.88%。⁸

在所有研究中，仅有 1 或 2 名患者报告了大部分类型的恶性肿瘤。超过 2 名患者报告了基底细胞癌、鳞状细胞癌、结肠腺癌、肾细胞癌、肾脏肿瘤、前列腺癌。替尔泊肽治疗的患者未报告甲状腺恶性肿瘤或 C 细胞增生。礼来公司将继续在正在进行的研究中仔细评估恶性肿瘤，并将继续通过上市后病例评估风险。⁸

上次审阅日期：2024年5月6日

参考文献

1. Rosenstock J, Wysham C, Frías JP, et al. Efficacy and safety of a novel dual GIP and GLP-1 receptor agonist tirzepatide in patients with type 2 diabetes (SURPASS-1): a double-blind, randomised, phase 3 trial. Lancet. 2021;398(10295):143-155. https://doi.org/10.1016/S0140-6736%2821%2901324-6

2. Frías JP, Davies MJ, Rosenstock J, et al; SURPASS-2 Investigators. Tirzepatide versus semaglutide once weekly in patients with type 2 diabetes. N Engl J Med. 2021;385(6):503-515. https://doi.org/10.1056/NEJMoa2107519

3. Ludvik B, Giorgino F, Jódar E, et al. Once-weekly tirzepatide versus once-daily insulin degludec as add-on to metformin with or without SGLT2 inhibitors in patients with type 2 diabetes (SURPASS-3): a randomised, open-label, parallel-group, phase 3 trial. Lancet. 2021;398(10300):583-598. https://doi.org/10.1016/S0140-6736(21)01443-4

4. Del Prato S, Kahn SE, Pavo I, et al; SURPASS-4 Investigators. Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Lancet. 2021;398(10313):1811-1824. https://doi.org/10.1016/S0140-6736(21)02188-7

5. Dahl D, Onishi Y, Norwood P, et al. Effect of subcutaneous tirzepatide vs placebo added to titrated insulin glargine on glycemic control in patients with type 2 diabetes: the SURPASS-5 randomized clinical trial. JAMA. 2022;327(6):534-545. https://doi.org/10.1001/jama.2022.0078

6. Inagaki N, Takeuchi M, Oura T, et al. Efficacy and safety of tirzepatide monotherapy compared with dulaglutide in Japanese patients with type 2 diabetes (SURPASS J-mono): a double-blind, multicentre, randomised, phase 3 trial. Lancet. 2022;10(9):623-633. https://doi.org/10.1016/S2213-8587(22)00188-7

7. Kadowaki T, Chin R, Ozeki A, et al. Safety and efficacy of tirzepatide as an add-on to single oral antihyperglycaemic medication in patients with type 2 diabetes in Japan (SURPASS J-combo): a multicentre, randomised, open-label, parallel-group, phase 3 trial. Lancet. 2022;10(9):634-644. https://doi.org/10.1016/S2213-8587(22)00187-5

8. Data on file, Eli Lilly and Company and/or one of its subsidiaries.