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Trulicity ® (dulaglutide)
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Has diabetic retinopathy been reported with the use of Trulicity® (dulaglutide)?
In 6 placebo- and active-controlled studies, retinopathy was reported in 4.1% of the dulaglutide patients at baseline and 0.4% of dulaglutide patients as a treatment-emergent AE.
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Retinopathy Reports
During both clinical studies and standard postmarketing pharmacovigilance activities, retinopathy and retinopathy-related complications were collected as
In pooled data from 6 placebo- and active-controlled studies of dulaglutide 0.75 mg and 1.5 mg in adults, diabetic retinopathy was reported in
- 4.1% of the dulaglutide-treated patients at baseline, and
- 0.4% of the dulaglutide-treated patients as a treatment-emergent AE.2
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Diabetic Retinopathy in the REWIND Study
REWIND was an event-driven, phase 3, randomized, double-blind trial of once-weekly dulaglutide 1.5 mg or placebo in adults with type 2 diabetes who had either a previous CV event or CV risk factors.1
In REWIND, 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
- vitrectomy.1
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 proportion of patients with diabetic retinopathy complications was larger among patients with a history of diabetic retinopathy at baseline (dulaglutide 8.5%, placebo 6.2%) than among patients without a known history of diabetic retinopathy (dulaglutide 1%, placebo 1%).2
The incidence of the eye outcome (ie, photocoagulation, antivascular endothelial growth factor therapy, or vitrectomy) was
- 0.37 per 100 person-years for those assigned to dulaglutide, and
- 0.30 per 100 person-years for placebo (hazard ratio [HR], 1.24; 95% CI, 0.92-1.68).1
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Diabetic Retinopathy in the AWARD-11 Trial
The AWARD-11 trial was a phase 3, randomized, double-blind, active-controlled, parallel-arm study that assessed the efficacy and safety of dulaglutide 3.0 mg and dulaglutide 4.5 mg compared to dulaglutide 1.5 mg in adults with inadequately controlled type 2 diabetes on concomitant metformin therapy.3,4
From baseline through week 36, diabetic retinopathy was reported as a treatment-emergent AE in
- 3 of 612 (0.5%) patients who received dulaglutide 1.5 mg
- 1 of 616 (0.2%) patient who received dulaglutide 3.0 mg
- 2 of 614 (0.3%) patients who received dulaglutide 4.5 mg.2
All safety findings for the AWARD-11 trial were similar across the elderly patient population, ≥65 years old, when compared to the general patient population.4
The effect of long-term glycemic control with dulaglutide on diabetic retinopathy complications has not been studied by Eli Lilly and Company (Lilly).
Eli Lilly and Company continues to monitor retinopathy reports through routine pharmacovigilance.
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Diabetic Retinopathy in Pediatric Patients in AWARD-PEDS
AWARD-PEDS was a phase 3, randomized, placebo-controlled study that assessed the efficacy and safety of dulaglutide 0.75 mg and 1.5 mg in pediatric patients, ages 10 to less than 18 years old, with inadequately controlled type 2 diabetes despite diet and exercise, with or without metformin and/or basal insulin.5
A total of 154 participants were randomized to receive once-weekly subcutaneous injections of dulaglutide 1.5 mg (n=52), dulaglutide 0.75 mg (n=51), or placebo (n=51).5
The study included a 26-week double-blinded period, followed by a 26-week open-label period.5
During the 26-week open-label period, patients previously randomized to placebo were initiated on dulaglutide 0.75 mg. Patients previously randomized to 0.75 mg and 1.5 mg remained on their assigned doses through 52 weeks (if tolerated).5
Retinopathy was not monitored in the AWARD-PEDS via fundoscopy or any other eye-related examinations.2
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Retinopathy and Type 2 Diabetes Mellitus
Diabetic retinopathy is a leading cause of vision loss globally.6
A systematic review of 59 population-based studies published up to March 2020 showed that among patients with diabetes, the global prevalence was
- 22.27% (95% CI, 19.73-25.03) for diabetic retinopathy
- 6.17% (95% CI, 5.43-6.98) for vision-threatening diabetic retinopathy, and
- 4.07% (95% CI, 3.42-4.82) for clinically significant macular edema.7
The risk of diabetic retinopathy increases with
- longer duration of diabetes
- higher glycated hemoglobin (HbA1c) levels, and
- presence of hypertension.6
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.6
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References
1Gerstein HC, Colhoun HM, Dagenais GR, et al; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Frias JP, Nevárez Ruiz L, Li YG, et al. Efficacy and safety of higher dulaglutide doses (3.0 mg and 4.5 mg) when added to metformin in patients with type 2 diabetes: a phase 3, randomized, double-blind, parallel arm study (AWARD-11). J Endocr Soc. 2020;4(suppl 1):A1036. Endocrine Society abstract OR26-08. https://doi.org/10.1210/jendso/bvaa046.2057
4Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg in metformin-treated patients with type 2 diabetes in a randomized controlled trial (AWARD-11). Diabetes Care. 2021;44(3):765-773. https://doi.org/10.2337/dc20-1473
5Arslanian SA, Hannon T, Zeitler P, et al; AWARD-PEDS Investigators. Once-weekly dulaglutide for the treatment of youths with type 2 diabetes. N Engl J Med. 2022;387(5):433-443. https://doi.org/10.1056/NEJMoa2204601
6Stitt 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
7Teo ZL, Tham YC, Yu M, et al. Global prevalence of diabetic retinopathy and projection of burden through 2045: systematic review and meta-analysis. Ophthalmology. 2021;128(11):1580-1591. https://doi.org/10.1016/j.ophtha.2021.04.027
Date of Last Review: 08 August 2023