Trulicity ® (dulaglutide)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: Trulicity Summary of Product Characteristics (SmPC)

Trulicity® (dulaglutide): Use in Patients With Gallbladder Disease

The data from a cumulative review are not supportive of a causal relationship between dulaglutide and gallbladder disease.

Cumulative Safety Report

People with T2DM have higher rates of biliary disorders than the general population.1

Of note, investigations for GI related AEs during treatment with dulaglutide, including abdominal screens such as ultrasound and CT scans, may bias the detection of cholelithiasis.1

The risk of bile duct and gallbladder diseases with dulaglutide use was investigated in a cumulative safety report of

  • completed and ongoing clinical trials

  • postmarketing safety studies, and

  • spontaneously reported adverse events (AEs) from postmarketing experience.1

A cumulative query for biliary disorders was initiated from approval in September 2014 through August 04, 2017.1

The data from this cumulative safety report do not support a causal relationship between dulaglutide and biliary tract AEs. Events related to bile duct and gallbladder disease will continue to be assessed as part of routine pharmacovigilance activities.1

Postmarketing Use

Of the 46 postmarketing cases meeting the inclusion criteria of biliary disorders

  • 37 were serious cases

  • 9 were nonserious cases, and

  • no deaths were reported. 1

Since approval, more than 1 million patients are estimated to have been prescribed dulaglutide, and the rate of these biliary events was very rarely reported. Cholelithiasis and cholecystitis were the most commonly reported AEs accounting for 75% of the total cases.1

From the postmarketing data, no association between dulaglutide therapy and gallbladder disease could be confirmed.1

Clinical Trial Cases

In 17 completed phase 2 and phase 3 trials, the rates of AEs and serious AEs per 100 person-years were higher in the dulaglutide-treated patients compared with comparator or placebo treatment. There were no deaths.1

Cholelithiasis and cholecystitis were the most commonly reported AEs consisting of 80% of the total cases, or 59 of 74 AEs in dulaglutide-treated patients.

The frequency of occurrence was

  • 0.66% for cholelithiasis, and

  • 0.18% for cholecystitis.1

Additional Information From Cardiovascular Outcomes Trial

The REWIND trial is a CV outcomes trial of adults with T2DM and established CV disease or multiple CV risk factors followed for a median follow-up time of 5.4 years.2

After adjusting for prior cholecystectomy, cholelithiasis occurred at a rate of

  • 0.62/100 patient-years in dulaglutide-treated patients, and

  • 0.56/100 patient-years in placebo-treated patients.1

Serious events of acute cholecystitis were reported in 0.5% and 0.3% of patients on dulaglutide and placebo, respectively.1

References

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

2. Gerstein HC, Colhoun HM, Dagenais GR, et al. REWIND Trial Investigators. Design and baseline characteristics of participants in the Researching cardiovascular Events with a Weekly INcretin in Diabetes (REWIND) trial on the cardiovascular effects of dulaglutide. Diabetes Obes Metab. 2018;20(1):42-49. https://doi.org/10.1111/dom.13028

Glossary

AE = adverse event

CT = computed tomography

CV = cardiovascular

GI = gastrointestinal

REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes

T2DM = type 2 diabetes mellitus

Date of Last Review: September 04, 2020


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