Lixisenatide (Adlyxin)

Safety Summary

Nausea is the most common adverse event (25% in clinical trials), with vomiting at 10%, headache at 9%, diarrhea at 8%, and dizziness at 7% PMID 28556176. In GetGoal-L-Asia, nausea and vomiting were 39.6% and 18.2% versus 4.5% and 1.9% with placebo PMID 22564709. GI side effects are generally transient, mostly mild-to-moderate, and most frequent during the initial 2-week titration period PMID 29923298. The 2-step dose increase regimen (10 mcg x14 days, then 20 mcg) reduces nausea rates compared to a 1-step approach (36.4% vs 50.0% at 24 weeks in Japanese patients) PMID 26342556. When combined with insulin glargine as iGlarLixi, GI side effects are substantially lower than with lixisenatide alone due to gradual titration (9.6% nausea vs 24.0% with lixisenatide alone) PMID 29923298. Symptomatic hypoglycemia ranged from 0.8% to 42.9% depending largely on background sulfonylurea or insulin use, with severe hypoglycemia below 1.5% PMID 28556176. The FDA Soliqua label lists hypoglycemia, nausea, diarrhea, and headache among the most common adverse reactions and warns about pancreatitis, kidney injury from volume depletion, and rare anaphylaxis. Anti-drug antibodies developed in 70% of lixisenatide-treated patients at Week 24; in the 2.4% with highest antibody concentrations (>100 nmol/L), an attenuated glycemic response was observed. In the LixiPark Parkinson's disease trial, nausea was reported in 46% and vomiting in 13% of lixisenatide-treated participants PMID 38598572. Lixisenatide produces a smaller increase in heart rate compared to liraglutide (+3 bpm vs +9 bpm) PMID 25887358.