Empa PASS on Urinary Tract Malignancies

Post-authorisation Safety Study to Assess the Risk of Urinary Tract Malignancies in Relation to Empagliflozin Exposure in Patients With Type 2 Diabetes: a Multi-database European Study

The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor.

Inclusion Criteria:

• Diagnosis of type 2 diabetes
• Age over 18 years at index date
• At least 1 year of membership in the medication database prior to index date

Exclusion Criteria:

• Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
• Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
• Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
• Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
• Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)