Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other Antihyperglycemic Drugs. (B015)

Study identification

• EU PAS number:
  EUPAS3614
• Study ID:
  20439
• Official title and acronym:
  Incidence of Pancreatic Malignancy and Thyroid Neoplasm in Type 2 Diabetes Mellitus Patients who Initiate Exenatide Compared to Other Antihyperglycemic Drugs. (B015)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The purpose of this study was to assess incident pancreatic and thyroid cancers among patients who initiated exenatide as compared to patients who initiated other second line use antidiabetes drugs. This was a large population-based retrospective cohort study using data from two large administrative databases in the United States from 2005 to 2010. Medical chart validated claims based algorithms were used to identify incident outcomes. Outcomes were assessed starting one-year post index drug exposure. Propensity score matching and multivariate modeling were used to adjust for cohort differences. After selection criteria, there were 18,932 initiators of exenatide and 27,691 matched initiators of other antihyperglycemic drugs across both databases, with a total of 10 and 11 pancreatic cancer cases and 16 and 16 thyroid cancer cases, respectively. For pancreatic cancer there was no significant difference between study cohorts in either database assessed (HR=1.4, 95%CI=0.4-4.2, HR=0.8, 95%CI=0.2-3.6). For thyroid cancer, results were also non-significant in both databases (HR=2.0, 95%CI=0.7-5.6, HR=1.3, 95%CI=0.5-3.4). Additional analyses were conducted stratifying by follow-up time, exposure duration, and cumulative dose. Given the small numbers in several fo these strata, no conclusions were made regarding this data. In conclusion, these analyses do not support nor refute the presence of an increased incidence of pancreatic or thyroid cancers amogn exenatide initiators when compared to other antihyperglycemic drugs initiators. There were differences in the direction and strength of point estimates between the two different databases. Determining the underlying reasons (e.g., chance, unmeasured confounding, detection bias, and/or protopathic bias) for variability is challenging given the small number of outcomes observed.
• Study status:
  Finalised

Research institutions and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 02/03/2011

Actual: 02/03/2011

Study start date

Planned: 01/05/2011

Actual: 01/05/2011

Date of final study report

Planned: 19/12/2012

Actual: 19/12/2012

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)