Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Safety study (incl. comparative)

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Retrospective study
Study drug and medical condition

Name of medicine

LYXUMIA

Study drug International non-proprietary name (INN) or common name

LIXISENATIDE

Anatomical Therapeutic Chemical (ATC) code

(A10BJ03) lixisenatide
lixisenatide

Medical condition to be studied

Pancreatitis
Pancreatic carcinoma
Medullary thyroid cancer
Population studied

Short description of the study population

The study focused on diabetic patients prescribed with lixisenatide identified from the patients registry in Denmark, Norway and Sweden.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Diabetic patients

Estimated number of subjects

550000
Study design details

Main study objective

The primary objectives of this study are to estimate:
1. Incidence rates of acute pancreatitis (ICD10 K85) among adult type 2 diabetes patients treated with GLP-1 receptor agonists (i.e. exenatide and liraglutide), as well as patients treated with other anti-diabetic drugs and to examine the risk of acute pancreatitis in users of GLP-1 receptor agonists compared to users of other anti-diabetic medications;
2. Incidence rates of pancreatic cancer (ICD10 C25) among adult type 2 diabetes patients treated with GLP-1 receptor agonists (i.e. exenatide and liraglutide), as well as patients treated with other anti-diabetic drugs and to examine the risk of pancreatic cancer in users of GLP-1 receptor agonists compared to users of other anti-diabetic medications;
3. Incidence rates of thyroid cancer (ICD10 C73) (especially medullary thyroid cancer) among adult type 2 diabetes patients treated with GLP-1 receptor agonists (i.e. exenatide and liraglutide), as well as patients treated with other anti-diabetic drugs and to examine the odds ratio of medullary thyroid cancer in users of GLP-1 receptor agonists compared to users of other anti-diabetic medications.
This study is designed to focus on the risk associated with use of GLP-1 agonists and will investigate the following primary hypotheses:
1. That adult patients prescribed GLP-1 RAs have an increased risk of acute pancreatitis when compared to patients prescribed other types of anti-diabetic drugs;
2. That adult patients prescribed GLP-1 RAs have an increased risk of pancreatic cancer when compared to patients prescribed other types of anti-diabetic drugs;
3. That adult patients prescribed GLP-1 RAs have an increased risk of medullary thyroid cancer when compared to patients prescribed other types of anti-diabetic drugs.

Outcomes

Acute pancreatitis, pancreatic cancer, medullary thyroid cancer.

Data analysis plan

The studies in Belgium and Lombardy Region are based on the same protocol using the same methods for subject selection, drug exposure assessment, and statistical analysis. In both settings a “new users design” is implemented.Subjects contribute in a time dependent manner to the different exposure groups.Crude and standardized incidence rates (per 100,000 person years) of the outcome event are calculated for each exposure group. The risk of outcome events is evaluated using Cox proportional hazard models including time-dependent variables, stratified on age and gender and adjusted for gallbladder disease and insulin therapy. Hazard ratios (HRs) from Belgium and Italy are pooled using fixed effects meta-analyses.
Documents
Study results

csr-lixisenatide-PASS-EMA

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