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Trulicity ® (dulaglutide)
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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.
Content overview
Gallbladder disease in patients diagnosed with type 2 diabetes
People with type 2 diabetes are at high risk for gallbladder disease, including cholelithiasis.1
Clinical trial cases of bile duct and gallbladder disease
In 22 completed phase 2, 3, and 4 trials evaluating glycemic control, the rate of treatment-emergent adverse events (TEAEs) for gallbladder-related disorders per 1000 patient-years was higher in dulaglutide-treated patients compared with comparator or placebo treatment. Gallbladder-related TEAEs were experienced by patients at an incidence of less than 1%.2
The higher incidence of gallbladder-related TEAEs in dulaglutide-treated patients was mainly driven by adverse events of cholelithiasis and cholecystitis.2
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.3
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.2
Serious events of acute cholecystitis were reported in
- 0.5% of patients on dulaglutide, and
- 0.3% of patients on placebo.2
If cholelithiasis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.2
Spontaneous adverse event reports
Cholelithiasis and Cholecystitis
Through September 18, 2021, the MedDRA preferred term of cholecystitis has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2
Through September 18, 2021, the MedDRA preferred term of cholestasis has been Very Rarely Reported in the Lilly spontaneous adverse event database, based on the estimated exposure of 9,987,000 patients. Very Rarely Reported is defined as an adverse event that has been reported at an estimated rate of <0.01% according to the reporting system information.2
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.2
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.2
The Eli Lilly and Company (Lilly) spontaneous adverse event database may also include reports of adverse events for products that may be available from Lilly and from other manufacturers. Although verification of product manufacturer is sought, this verification is not always obtainable. The default for these cases is to include them in the database.2
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References
1Chen L, Peng YT, Chen FL, Tung TH. Epidemiology, management, and economic evaluation of screening of gallstone disease among type 2 diabetics: a systematic review. World J Clin Cases. 2015;3(7):599-606. https://doi.org/10.12998/wjcc.v3.i7.599.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Gerstein 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 July 2022