(P-387) Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East

Background: There are growing numbers of patients with diabetes mellitus (DM) in Africa and the Middle East. The resultant increase in exposure to antidiabetic therapies necessitates an understanding of the adverse events (AE) experienced by patients in these regions. Evaluating AE reporting among patients with DM in these two regions and how the reporting compares across the regions as well as the countries within the regions provide valuable insights into regional AE reporting.

Objectives: To provide an AE reporting overview in patients using insulins in Africa and the Middle East by characterizing and comparing individual case safety report (ICSR) features.

Methods: Data from AE reports uploaded by subsidiaries of Novo Nordisk® in different countries from January to December 2018 were extracted from the global pharmacovigilance database. The data were analysed to describe and compare patient demographics, report sources, reporter types, case seriousness, suspect products, indication for insulin use and AE preferred terms stratified by country.

Results: Overall 7076 records were analysed, 63.6% from the Middle East vs. 36.4% from Africa. Countries that contributed the most reports overall were Iran (31.6%), Turkey (22.0%), Egypt (21.9%), South Africa (13.4%), and Israel (6.9%). Most ICSRs were non-serious (91.5%), from solicited sources (83.5%), and reported by consumers (70.7%). Compared to Africa, patients from the Middle East were younger (34.2 vs. 48.1 years old), reported insulin detemir as the suspect product (76.5% vs. 8.3%), and exposure during pregnancy as AE preferred term (89.1% vs. 15.9%). For Africa, human insulins were the frequently reported suspect products (51.6% vs. 1.6%), and blood glucose increase the most reported preferred term (23.1% vs. 1.8%). Type 2 diabetes mellitus as an indication was most prevalent in Africa (52.2% vs. 12.0%), whereas in the Middle East, it was gestational diabetes mellitus (64.3% vs. 6.1%). The frequency of indication for insulin use in the African ICSRs was T2DM ˃ T1DM ˃ GDM whereas in the Middle East the distribution was GDM ˃ T2DM ˃ T1DM. Few macrovascular and microvascular complications were reported. Associations between the region and patient age, gender, report sources, reporter types, indications for insulin use, suspect products, and AE preferred term were significant (p < 0.001).

Conclusions: ICSR features were region-specific and dependent on patient age, gender, report sources, reporter types, suspect products, and AE preferred terms. This study gives insight into and shows regional differences in AE reporting among insulin-treated patients in Africa and the Middle East.