Diabetes complications

Early worsening of diabetic retinopathy in individuals with type 2 diabetes treated with tirzepatide: a real-world cohort study

DiabetologiaPublished Retrospective cohort study

Main finding · New-onset proliferative DR (PDR) (grade R3M0, R3M1)Result — go to the resultOdds ratio 2.15 95% CI 1.24–3.74

Authors' conclusion

Tirzepatide therapy resulted in significantly increased odds of incident PDR, particularly in individuals with mild NPDR with maculopathy (grade R1M1), or moderate-to-severe NPDR with or without maculopathy (grade R2M0, R2M1). The increase in odds of progression would justify specialist ophthalmologist referral by Early Treatment Diabetic Retinopathy Study (ETDRS) criteria.

Study context

Population
Individuals with T2D, matched for sex, diabetes duration, retinopathy status, HbA1c, number of retinal screening episodes and glucose-lowering medications; mean HbA1c 56.1 ± 15.8 mmol/molmatched cohort
Participants
3,435 vs 3,434
Exposure
Tirzepatide-exposed vs tirzepatide-unexposed
  • Tirzepatide-exposedn = 3,435
  • Tirzepatide-unexposedn = 3,434reference
Outcome
New-onset proliferative DR (proliferative diabetic retinopathy (PDR)) (grade R3M0, R3M1)
Methodological detailsreal-world clinical data, matched 1:1, conditional logistic regression
  • Real-world clinical data
  • Matched 1:1
  • Conditional logistic regression

Main finding

As reported in the abstract

Odds ratio

2.15

95% CI 1.24–3.74

P < 0.01

Events by group

Tirzepatide-exposedvs Tirzepatide-unexposed
OR 2.15 (95% CI 1.24–3.74); P < 0.01

Observational data: associations, not effects.

Further findings

New-onset retinopathy in those without DR (R0M0) at initiation

Tirzepatide associated with reduced odds of new-onset retinopathy, OR
0.73 (0.62, 0.86), p<0.001 (95% CI)
  • Multivariate analysis

Retinopathy progression in mild non-proliferative diabetic retinopathy (NPDR) (R1M0 or R1M1)

Tirzepatide not significantly associated with retinopathy progression

Original publication

Early worsening of diabetic retinopathy in individuals with type 2 diabetes treated with tirzepatide: a real-world cohort study. Diabetologia. Published 10 July 2025. doi:10.1007/s00125-025-06466-8

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