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)

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.

UK_cFAQ_GLP026_GALLBLADDER_DISEASE
UK_cFAQ_GLP026_GALLBLADDER_DISEASE
en-GB

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, 2020, and based on the estimated patient exposure of 6,588,000

  • 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

References

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: August 13, 2021


Contact Lilly

Call or Email us

If you want to ask a Medical Information question or you want to report an adverse event or product complaint you can call us or email us at ukmedinfo@lilly.com

Available Mon - Fri, 10am - 4pm, excluding Bank Holidays

Or you can

Chat with Us

Click to Chat is Offline

If you have a question, you can chat online with a Lilly Medical Information professional.

Submit a request