Diabetes is a condition that causes a person's blood sugar level to become too high. There are two main types of diabetes, type 1 is a lifelong condition requiring treatment with insulin, type 2 is more common, predominantly develops in adults and does not always require insulin. Dapagliflozin is a drug mainly used to treat type 2 diabetes, although it has been previously used in the treatment of type 1 diabetes. When used in treatment of type 1 diabetes additional warnings were required about the risk of a specific adverse event occurring more frequently in these patients. In 2021 the product license was changed and dapagliflozin could no longer be used in type 1 diabetes. Risk communication to healthcare professionals advised that dapagliflozin should be reviewed and discontinued in patients with type 1 diabetes. This change in the license was not due to any new safety concerns but was a commercial decision by the manufacturer.
This study’s purpose is to look at prescribing of dapagliflozin in type 1 diabetes both before and after the communication of the change to assess if a change in prescribing followed the advice. This will be done by calculating the proportion of dapagliflozin prescriptions that are given to patients with type 1 diabetes for each month over the study period (January 2019 to June 2023).
The rationale for the study is to find if there continues to be use of dapagliflozin in type 1 diabetes despite the previously required additional warnings no longer being available.
Dapagliflozin is a sodium glucose co-transporter 2 (SGLT2) inhibitor which is predominantly used in the treatment of type 2 diabetes mellitus (T2DM). It previously had an indication for use in type 1 diabetes mellitus (T1DM), but this was removed by the marketing authorisation holder (MAH) in 2021, this change was communicated via a Drug Safety Update (DSU). This DSU advised that dapagliflozin should be reviewed and discontinued in patients with T1DM. This change in the license was not due to any new safety concerns but due to commercial reasons influenced by additional risk minimisation measures required for use in T1DM.
This descriptive study will look to explore the impact of the DSU by quantifying the use of dapagliflozin for the indication of T1DM both before and after the DSU was published. This will be done by calculating the proportion of dapagliflozin prescriptions that are given to patients with T1DM (as opposed to other indications) for each month over the study period. The study population will comprise all acceptable patients, in CPRD AURUM with at least one prescription for dapagliflozin issued between January 2019 and June 2023.
The rationale for this study is to explore if there continues to be off-label use of dapagliflozin in patients with T1DM. If so this will be without the additional risk minimisation measures that were previously in place and could represent a potential risk to patients.
Proportion of dapagliflozin prescribed for T1DM of all dapagliflozin prescriptions.
Sophie Scanlon - Chief Investigator - MHRA
Sophie Scanlon - Corresponding Applicant - MHRA
Katherine Donegan - Collaborator - MHRA