Trulicity® (dulaglutid): Retinopati med höga doser

Label information

Dulaglutide is indicated for the treatment of adults with insufficiently controlled T2DM as an adjunct to diet and exercise

• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, and

• in addition to other medicinal products for the treatment of diabetes.¹

The recommended dose of dulaglutide is 0.75 mg once weekly as monotherapy.¹

The recommended dose of dulaglutide is 1.5 mg once weekly as add-on therapy.¹

For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.¹

For additional glycaemic control,

• the 1.5 mg dose may be increased after at least 4 weeks to 3 mg once weekly

• the 3 mg dose may be increased after at least 4 weeks to 4.5 mg once weekly.

The maximum dose is 4.5 mg once weekly¹

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 patients with inadequately controlled T2DM on concomitant metformin therapy.²

There was no difference in the number of patients reporting retinopathy-related or other eye disorders between the dulaglutide 1.5 mg, dulaglutide 3.0 mg, and dulaglutide 4.5 mg treatment groups.³

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.³

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

Background 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.⁴

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.³

Diabetic retinopathy is a leading cause of vision loss globally.⁵

Among people with DM, the overall worldwide prevalence is approximately

• 35% for any diabetic retinopathy, and

• 7% for proliferative diabetic retinopathy.⁶

The risk of diabetic retinopathy increases with

• longer duration of DM

• higher HbA1c levels, and

• presence of hypertension.⁵

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.⁵

References

1. Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Frias 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

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

4. Gerstein 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

5. 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

6. 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

AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes

CV = cardiovascular

DM = diabetes mellitus

HbA1c = glycated hemoglobin

T2DM = type 2 diabetes mellitus