Non-arteritic anterior ischaemic optic neuropathy incidence in placebo-controlled clinical trials of liraglutide or semaglutide.
NAION incidence not increased with GLP-1RA use versus placebo in trials.
Non-arteritic anterior ischaemic optic neuropathy incidence in placebo-controlled clinical trials of liraglutide or semaglutide.
Risk of non-arteritic anterior ischaemic optic neuropathy (NAION) following exposure to glucagon-like peptide-1 receptor agonists (GLP-1RAs) in people with type 2 diabetes and/or obesity remains unclear.
The aim of this study was to investigate NAION incidence across randomised placebo-controlled trials evaluating the GLP-1RAs liraglutide and semaglutide.
Pooled safety evaluation of NAION incidence from completed phase II, III and IV randomised placebo-controlled trials that evaluated the six Novo Nordisk-manufactured GLP-1RA products (active ingredients: liraglutide and semaglutide) in people with type 2 diabetes and/or overweight/obesity.
This pooled analysis included 96 829 participants (GLP-1RA-treated: n=64 917; placebo-treated: n=31 912) with 205 777 participant-years of observation (participant-years of observation) (GLP-1RA-treated: 119 393 participant-years of observation; placebo-treated: 86 384 participant-years of observation).
Across all trials, three confirmed NAION cases were identified in three GLP-1RA-treated participants and five confirmed cases were identified in four placebo-treated participants.
All ophthalmologist-confirmed cases reported one or more associated risk factors (eg, age >50 years, obesity, smoking, dyslipidaemia, hypertension).
Data from randomised placebo-controlled trials with semaglutide and liraglutide do not show an increased incidence of NAION in participants receiving GLP-1RA treatment versus those receiving placebo and, thus, do not suggest a relationship between GLP-1RA use and NAION.