Exenatide is a new medicine to treat type 2 diabetes in adults. Exenatide is available as a twice-daily (Byetta®), and once-weekly (Bydureon®) injectable product. Pancreatic cancer and thyroid neoplasm are considered as a potential risk associated with the use of exenatide, based on the independent investigation and review of clinical safety data by both U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). A potential safety study is being planned to further address these concerns among patients who used exenatide as compared with those who used other glucose lowering drugs. Pancreatic cancer and thyroid neoplasms are in general rare events. Pancreatic cancer affects approximately 15 and thyroid neoplasms 5 in 100.000 individuals yearly in the UK. The possible safety indications related to thyroid neoplasms originates from observations in animal studies and have yet to be reproduced in human data. The aim of this feasibility assessment is to evaluate the number of patients using exenatide and other relevant diabetes medications for whom information is available in the Clinical Practice Research Datalink (CPRD). Evaluating number of available patients in the CPRD will inform us on whether it would be possible to conduct the potential safety study in the UK.
Diabetes is currently one of the major public diseases worldwide and the number of new individuals that are diagnosed is increasing rapidly. Exenatide is a novel treatment for type 2 diabetes mellitus (T2DM) among adults, used as a combination treatment together with other glucose lowering drugs when desirable effects have not been achieved on previous regimens. During the preclinical and clinical development of exenatide some concerns were raised regarding potential pancreatic and thyroid toxicity. This feasibility assessment aims to evaluate whether the Clinical Practice Research Datalink (CPRD) has an adequate population size for conducting a future safety study on the possible association between exenatide use and malignant neoplasm of pancreas, malignant neoplasm of thyroid gland and benign neoplasm of thyroid gland. In this feasibility assessment, the number of exenatide users and comparator drug users will be assessed from the CPRD, and information for estimating the length of exposure to exenatide. The assessed number of users and estimated length of exposure will be used for estimating power for conducting the future safety study in the CPRD. The incidence of the outcome neoplasms will be estimated from national cancer statistics. Similar assessments are being conducted in other selected European databases.
Primary outcomes: Pancreatic cancer; Thyroid neoplasm.
Fabian Hoti - Chief Investigator - IQVIA Finland Oy
Anna Lundin - Corresponding Applicant - EPID Research Oy (Finland)
Anna Lundin - Collaborator - EPID Research Oy (Finland)
Jessie Oyinlola - Collaborator - CPRD
Katja Hakkarainen - Collaborator - IQVIA - USA (Headquarters)