Serious Gastrointestinal Adverse Events Research Articles

ADVERSE EVENTS ASSOCIATED WITH GLP1–RECEPTOR AGONISTS TREATMENT IN DIABETIC PATIENTS WITH HIGH CARDIOVASCULAR RISK: A META–ANALYSIS

Abstract Background GLP1–receptor agonists (GLP1–RA) have been associated with a reduction of cardiovascular (CV) outcomes in diabetic patients with high cardiovascular risk. However, these drugs have some adverse effects. The aim of this study was to assess the relative risk (RR) of adverse effects in patients with a high risk of developing CV disease treated with GLP1–agonists. Methods we considered randomized controlled trials (RCTs) aimed to assess the cardiovascular effects of GLP1–RA in diabetic patients with high CV risk. The following outcomes were explored: pancreatitis, severe hypoglycemia, renal and urinary serious adverse events (SAE), gastrointestinal SAE and AE, pancreatic cancer, and neoplasms. Results 8 RCTs, enrolling 60008 patients, were included in the analysis. There was no difference between GLP1–RA and placebo in the risk of pancreatitis (RR 0.99; 95% CI 0.73–1.35; p=0.972), severe hypoglycemia (0.93; 95% CI 0.76–1.15; p=0.501), renal and urinary SAE (0.94; 95% CI 0.82–1.07; p=0.339), pancreatic cancer (RR 0.98; 95% CI 0.56–1.70; p=0.936) and neoplasms (RR 1.02; 95% CI 0.95–1.09; p=0.547) (Fig 1 A e B). Conversely, GLP1–agonist treatment was associated with an increased risk of gastrointestinal AE (RR 1.95; 95% CI 1.23–3.06; p=0.004) (Fig 2). However, when gastrointestinal SAE were considered, GLP1–agonists demonstrated similar risk compared to placebo (RR 1.09; 95% CI 0.92–1.28; p= 0.318) (Fig 2). Conclusion in diabetic patients with high cardiovascular risk, the treatment with GLP1–RA has been associated with an increased risk of gastrointestinal AE. No difference in severe gastrointestinal AE has been associated with GLP1–RA.