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Trulicity ® (dulaglutide)
This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. For current prescribing information for all Lilly products, including Summaries of Product Characteristics, Patient Information Leaflets and Instructions for Use, please visit: www.medicines.org.uk (England, Scotland, Wales) or www.emcmedicines.com/en-GB/northernireland/ (Northern Ireland).
Does Trulicity® (dulaglutide) cause the formation of gallstones?
Cholelithiasis and cholecystitis have been reported in dulaglutide clinical trials. They have also been reported in the postmarketing setting.
Gallbladder disease in patients diagnosed with type 2 diabetes
People with type 2 diabetes have higher rates of biliary disorders than the general population.1
Investigations for gastrointestinal-related adverse events during treatment with dulaglutide may bias the detection of cholelithiasis (including abdominal imaging such as ultrasound and computed tomography scans).1
Clinical trial cases of bile duct and gallbladder disease
In 17 completed phase 2 and phase 3 trials, the rates of adverse events and serious adverse events related to the bile duct and gallbladder diseases per 100 person-years were higher in dulaglutide-treated patients compared with comparator or placebo treatment. There were no deaths.1
Among the adverse events related to the bile duct and gallbladder diseases, cholelithiasis and cholecystitis were the most common adverse events consisting of 80% of the total cases, or 59 of 74 adverse events in dulaglutide-treated patients.1
REWIND – occurrence of cholecystectomy and cholelithiasis
The REWIND study is a cardiovascular outcomes trial of adults with type 2 diabetes and established cardiovascular disease or multiple cardiovascular 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% of patients on dulaglutide, and
- 0.3% of patients on placebo.1
Spontaneous adverse event reports
Cholelithiasis and Cholecystitis
Based on the Lilly spontaneous adverse event database up to September 18, 2021, and based on the estimated patient exposure of 9,987,000,
- Cholelithiasis has been Very Rarely Reported (<0.01%), and
- Cholecystitis has been Very Rarely Reported (<0.01%) in patients treated with dulaglutide.1
Postmarketing data do not necessarily represent the rate of occurrence of an adverse event in a treated population, but they represent a reporting rate of a particular adverse event to the company. Spontaneous reporting of adverse events can be highly variable and is not appropriately controlled clinical information on which to base an assessment of whether a particular drug product is the causal agent of an adverse event.
Spontaneous reporting has limited use due to
- lack of control population
- under-reporting or reporting bias, and
- missing or incomplete information regarding patient's medical history or concomitant medications.1
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1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Gerstein 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
Date of Last Review: 13 August 2021