Most anti-diabetic treatments have to be adjusted according to patients' kidney function, in lines with relevant treatments guidelines. The aim of this study is to examine the extent to which such guidelines are followed by General Practitioners (GPs) for a certain group of anti-diabetic treatments. More specifically, this study aims to explore the extent to which diabetic patients start specific anti-diabetic treatments on a higher than the recommended dose for the level of their kidney function, and explore how this might differ amongst different geographical areas in the country. Another objective of the study is to explore whether GPs prescribe more appropriate therapies during follow up visits to their patients, taking into consideration their kidney function at the time of prescription. Finally, this study will aim to explore the extent to which patients with good renal function start their treatment at the lower available doses of certain anti-diabetic treatments. The findings of this study will aim to contribute to medical education and inform GP prescribing decisions.
DPP-4i drug class is indicated for the glycaemic control in patients with Type 2 Diabetes Mellitus (T2DM). According to the Summary of Product Characteristics (SmPC), Saxagiptin, Sitagliptin, Alogliptin and Vildagliptin require dose adjustments according to patients' renal function as expressed by different Creatinine Clearance thresholds. The proposed study aims to examine a number of objectives around compliance to SmPCs for DPP4-is in relation to renal function. Cross-sectional analyses will generate descriptive statistics to characterise the extent to which T2DM patients are initiating on a higher than the recommended dose of a DPP-4i according to SmPCs. Higher than the recommended prescription patterns will also be explored in regional level. Moreover, descriptive statistics will be generated to characterise the extent to which patients with good renal function are initiating on the lower doses of a DPP-4i. Additional outcomes will be explored in retrospective analyses; in particular, time to event analyses will be conducted to characterise the extent of dose adjustment and appropriate therapy switching among T2DM patients who initiate on a higher than the recommended DPP-4i dose. Separate retrospective analysis characterise the extent to which deterioration of renal function overtime is associated with therapy change or DPP4-i dose adjustment.
Counts and percentages of patients initiating on a higher than the recommended DPP-4i dose for level of renal function according to the SmPCs (Creatinine Clearance), on
country level and per CPRD defined region: Counts and percentages of patients initiating on a lower than the recommended DPP-4i dose according to the SmPCs.
Amongst patients who initiate on a higher than the recommended dose for renal function according to the SmPCs (Creatinine Clearance level): Counts and percentages of patients who have their dose adjusted or switched (time to event analysis).
Amongst patients who initiate on the high dose of a DPP-4 inhibitor in accordance with the level of renal function as per SmPCs: Counts and percentage of patients who have their therapy changed or switched when their renal function is reduced to a creatinine clearance level according to which therapy switch/dose adjustment is required.
Chris D Poole - Chief Investigator - Digital Health Labs Limited
Dionysios Spanopoulos - Corresponding Applicant - Eli Lilly & Co - UK
Brendan Barrett - Collaborator - Boehringer-Ingelheim - UK
Dionysios Spanopoulos - Collaborator - Eli Lilly & Co - UK
Michael Busse - Collaborator - Boehringer-Ingelheim - UK
Toni Roman - Collaborator - Eli Lilly & Co - UK