Trulicity ® (dulaglutid) injektion

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Trulicity® (dulaglutid): Pankreascancer

Resultat från fas 2- och 3 kliniska studier tyder inte på en ökad incidens av malignitet inklusive cancer i bukspottskörteln med dulaglutid.

Detailed Information

No patients who received placebo or any active comparator reported pancreatic cancers.1

Two cases of pancreatic carcinoma were reported in patients receiving dulaglutide in the completed phase 2 and phase 3 studies. These 2 patients both

  • had a shorter duration of diabetes that was ≤3 years, and

  • a baseline BMI less than 25 kg/m2.1

The first patient was diagnosed with a large, nonresectable tumor 1 week after their first and only dose of dulaglutide 0.75 mg. It was Lilly’s assessment that this tumor preceded initiation of dulaglutide.1

After approximately 5 months of exposure to dulaglutide, the second patient was found to have a large tumor that consumed most of the body and tail of their pancreas. Given the patient’s short exposure to dulaglutide and the large tumor size, Lilly believes that this tumor was preexisting.1

Results from phase 2 and phase 3 clinical studies do not suggest an increased incidence of malignancy in general or any specific malignancy type with dulaglutide treatment. However, for a rare disease with a long latency period like pancreatic cancer, malignancies in ongoing studies will continue to be carefully assessed in addition to risk assessment through postmarketing cases and exposure.1

Pancreatic carcinoma and metastatic pancreatic carcinoma have been very rarely reported in Lilly postmarketing reports through September 18, 2018 (<0.01%).1

Spontaneous reporting of AEs can be highly variable and is not controlled clinical information on which to assess the causality of a drug to an AE.1 

Spontaneous reporting has limitations due to bias in reporting, including incomplete information concerning the patient. These data do not represent the rate of occurrence of an AE; they merely represent the rate of reporting of a particular AE to the company.1

Pancreatic Cancer in the REWIND Study

The REWIND study was an event-driven, randomized, double-blind, phase 3 study evaluating once-weekly dulaglutide 1.5 mg treatment compared with placebo when added to standard of care on a composite endpoint of MACE-3 in adults with T2DM and established CV disease and/or risk factors.2

Dulaglutide 1.5 mg significantly reduced MACE-3 when compared to placebo: (HR=0.88 [95% CI 0.79, 0.99]; p=.026), demonstrating a decrease in CV events and showing safety in a population that included a majority of participants without established CV disease.2

Of the 4949 patients receiving dulaglutide, 19 patients experienced pancreatic cancer. A total of 4952 patients received placebo, 12 of which reported having pancreatic cancer. The frequency of a prespecified AE, such as pancreatic cancer, did not differ significantly between the dulaglutide and placebo treated groups.2

References

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

2. Gerstein HC, Colhoun HM, Dagenais GR, et al. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3

Glossary

AE = adverse event

BMI = body mass index

CV = cardiovascular

HR = hazard ratio

MACE-3 = major adverse cardiovascular events (death due to cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke)

REWIND = Researching cardiovascular Events with a Weekly INcretin in Diabetes

T2DM = type 2 diabetes mellitus

Datum fӧr senaste ӧversyn 2019 M11 03


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