4C-06 - Evolution of Drug Initiation Patterns and Clinical Characteristics of New Users of Dapagliflozin in the United States up to 10 Years After Approval to Treat Type 2 Diabetes

Background: A multidatabase postauthorization safety study of dapagliflozin, a sodium-glucose cotransporter 2 inhibitor initially approved for type 2 diabetes (T2D) in the United States (US) in January 2014, identified cohorts of patients initiating dapagliflozin during the 8- to 10-year post-approval period (PAP) using 2 US-based administrative insurance claims databases: the Healthcare Integrated Research Database (HIRD) and Medicare.

Objectives: Describe changes in treatment initiation patterns and clinical characteristics among dapagliflozin initiators over the 8-10y PAP in the US.

Methods: Dapagliflozin initiators were identified in the HIRD (aged 40-64y; study period 2014-2023) and in the Medicare fee-for-service research database (aged ≥65y; study period 2014-2021). Clinical and treatment characteristics at dapagliflozin initiation were described for initiators in the early PAP (2014-2017; i.e., “early initiators”) and for initiators over the entire PAP (i.e., HIRD, 10y PAP; Medicare, 8y PAP, due to data lag).

Results: In the HIRD, a total of 15,664 early dapagliflozin initiators were identified, increasing to 77,324 by the end of the 10y PAP. In Medicare, a total of 19,831 early dapagliflozin initiators were identified, increasing to 83,887 by the end of the 8yr PAP. Compared with initiators over the entire PAP, lower proportions of early initiators used dapagliflozin as monotherapy with no other antidiabetic drug (AD) dispensing in the previous 3 months (HIRD, 12% vs. 16%; Medicare, 9% vs. 18%); higher proportions of early initiators were treated with ≥1 other AD class in the previous year (HIRD, 90% vs. 81%; Medicare, 95% vs. 86%); and early initiators had a lower prevalence of T2D severity indicators—notably retinopathy (HIRD, 19% vs. 33%; Medicare, 39% vs. 52%), peripheral vascular disease (HIRD, 18% vs. 33%; Medicare, 39% vs. 54%), and coronary heart disease (HIRD, 10% vs. 18%; Medicare, 33% vs. 43%). In the HIRD, a higher proportion of early initiators had ≥1 hospitalization in the last 6 months (14% vs. 9%) compared with initiators over the 10y PAP; conversely, in Medicare, a lower proportion of early initiators had ≥1 hospitalization in the last 6 months (6% vs. 11%) compared with initiators over the 8y PAP. Similar proportions of early initiators and those over the entire PAP had concomitant insulin use (HIRD, 15% vs. 14%; Medicare, 19% vs. 18%).

Conclusions: Since its approval in the US in 2014, the pattern of dapagliflozin initiation has evolved from combination therapy with other ADs to increasing use as monotherapy, aligning with changes in T2D treatment guidelines over the study period. Also, the health profile of patients treated with dapagliflozin has shifted to those with higher prevalences of T2D severity indicators.