Trulicity® (dulaglutide): Retinopathy

Detailed Information

During both clinical studies and standard postmarketing pharmacovigilance activities, retinopathy and retinopathy-related complications were collected as

• spontaneously reported medical history

• adverse events, or 

• a component of a secondary endpoint in a CV outcomes trial.¹

In 6 placebo- and active-controlled studies, retinopathy was reported in

• 5.2% of the population at baseline, and

• less than 1% of patients as a treatment-emergent adverse event.²

Diabetic retinopathy is a leading cause of vision loss globally.³

Among people with DM, the overall worldwide prevalence is approximately

• 35% for any diabetic retinopathy, and

• 7% for proliferative diabetic retinopathy.⁴

The risk of diabetic retinopathy increases with

• longer duration of DM

• higher HbA1c levels, and

• presence of hypertension.³

Severity of diabetic retinopathy can range from asymptomatic changes in nonproliferative retinopathy detectable only by ophthalmological exams to vision-threatening sequelae associated with proliferative retinopathy and diabetic macular edema.³

Retinopathy in the REWIND Study

In the REWIND CV outcomes trial, diabetic retinopathy events were collected as 

• an AE, and

• a prespecified secondary composite endpoint.¹

For the secondary composite endpoint, REWIND prospectively collected events of diabetic retinopathy requiring

• photocoagulation

• antivascular endothelial growth factor therapy, or

• vitrectomy¹

Although numerically more events occurred in patients treated with Trulicity 1.5 mg compared to the placebo group, the risk difference was not statistically significant between groups.¹

The incidence of the eye outcome was

• 0.37 per 100 person-years for those assigned to dulaglutide, and

• 0.30 per 100 person-years for placebo (HR, 1.24; 95% CI, 0.92-1.68 ).¹

Eli Lilly and Company continues to monitor retinopathy reports through routine pharmacovigilance.

References

1. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

3. Stitt AW, Curtis TM, Chen M, et al. The progress in understanding and treatment of diabetic retinopathy. Prog Retin Eye Res. 2016;51:156-186. http://dx.doi.org/10.1016/j.preteyeres.2015.08.001

4. Yau JW, Rogers SL, Kawasaki R, et al. Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35(3):556-564. http://dx.doi.org/10.2337/dc11-1909

Glossary

AE = adverse event

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

CV = cardiovascular

DM = diabetes mellitus

GLP-1 RA = glucagon-like peptide-1 receptor agonist

HbA1c = glycated hemoglobin

HR = hazard ratio

REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes