Gastrointestinal safety of semaglutide and tirzepatide vs. placebo in obese individuals without diabetes: a systematic review and meta analysis.

Annals of Saudi medicine Pub Date : 2025-03-01 Epub Date: 2025-04-03 DOI:10.5144/0256-4947.2025.129

Moaz Safwan, Mariam Safwan Bourgleh, Shahad Abdullah Alotaibi, Eman Alotaibi, Abdulsalam Al-Ruqi, Fathiya El Raeya

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Abstract

Introduction: Semaglutide and tirzepatide are newly approved glucagon-like peptide-1 receptor agonists for weight management in adults without diabetes. However, safety concerns regarding gastrointestinal (GI) adverse outcomes have been raised. This review comprehensively evaluates their GI safety profile in randomized controlled trials (RCTs).

Methods: Thirteen RCTs involving 26 894 obese participants without diabetes were analyzed. Pooled analysis assessed the risks for GI, biliary, hepatic, and pancreatic adverse events.

Results: Overall GI adverse events were 1.86 times higher with *both* agents (95% CI=1.56, 2.21), with tirzepatide showing a greater risk (RR 2.94, 95% CI=2.61, 3.32) than semaglutide (RR 1.68, 95% CI=1.46, 1.94). Semaglutide increased gallbladder-related disorders, particularly cholelithiasis, by over 2.6 times (95% CI=1.40, 4.82), while tirzepatide showed no significant biliary risk. Neither agent significantly increased hepatic or pancreatic adverse events.

Conclusion: Compared to placebo, both Semaglutide and tirzepatide are associated with increased GI adverse outcomes, with most cases being mild. Clinicians should carefully monitor patients for potential adverse outcomes.

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西马鲁肽和替西帕肽与安慰剂在非糖尿病肥胖患者的胃肠道安全性：一项系统评价和荟萃分析

简介：Semaglutide和tizepatide是新批准的胰高血糖素样肽-1受体激动剂，用于非糖尿病成人体重管理。然而，关于胃肠道（GI）不良后果的安全性问题已经提出。本综述在随机对照试验（RCTs）中全面评价了它们的GI安全性。方法：分析13项随机对照试验，涉及26894名无糖尿病的肥胖受试者。汇总分析评估了胃肠道、胆道、肝脏和胰腺不良事件的风险。结果：两种药物的总体胃肠道不良事件发生率为1.86倍（95% CI=1.56, 2.21），其中替西帕肽的风险（RR 2.94, 95% CI=2.61, 3.32）高于西马鲁肽（RR 1.68, 95% CI=1.46, 1.94）。Semaglutide使胆囊相关疾病，特别是胆石症增加2.6倍以上（95% CI=1.40, 4.82），而替西帕肽没有显著的胆道风险。两种药物均未显著增加肝脏或胰腺不良事件。结论：与安慰剂相比，西马鲁肽和替西帕肽均与胃肠道不良结局增加相关，且大多数病例为轻度。临床医生应仔细监测患者潜在的不良后果。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Annals of Saudi medicine

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