Trulicity ® (dulaglutid) injektion

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TRULICITY® (dulaglutid): Användning hos patienter med gallblåsesjukdom

Uppgifter från kumulativ granskning stödjer inte ett orsakssamband mellan dulaglutid och gallblåsesjukdom.

Detailed Information

Cumulative Safety Report

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

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


People with type 2 diabetes mellitus have higher rates of biliary disorders than the general population. While some studies suggest a link between incretin-based therapies and gallbladder diseases 2,3, the rates of these events in the completed dulaglutide clinical trials are within the range that would be expected for the general diabetic population.1

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


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

2. Pizzimenti V, Giandalia A, Cucinotta D, et al. Incretin-based therapy and acute cholecystitis: a review of case reports and EudraVigilance spontaneous adverse drug reaction reporting database. J Clin Pharm Ther. 2016;41(2):116-118.

3. Faillie JL, Yu OH, Yin H, et al. Association of bile duct and gallbladder diseases with the use of incretin-based drugs in patients with type 2 diabetes mellitus. JAMA Intern Med. 2016;176(10):1474-1481.

Datum fӧr senaste ӧversyn 2018 M01 02

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