Background: Dapagliflozin (dapa) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor approved in 2012 (Europe) and 2014 (US) for treating type 2 diabetes mellitus (T2DM). A multidatabase, retrospective cohort study in routine clinical practice will assess the risk of bladder cancer and female breast cancer in patients with T2DM prescribed dapa relative to other antidiabetic drugs (ADs).
Objectives: Describe index dapa prescription and baseline characteristics of new users of dapa versus other ADs.
Methods: New users of dapa and other ADs aged 40+ years without prior diagnoses of invasive cancer were identified in the Clinical Practice Research Datalink (CPRD), UK; PHARMO Database Network (PHARMO), the Netherlands; and HealthCore Integrated Research Database (HIRD), US, from as early as November 2012 through September 2015. Descriptive analyses in each database followed a common protocol. Comparator patients were matched to dapa patients (4:1) by age, sex, index year, and geographic region.
Results: There were 2,711, CPRD; 402, PHARMO; and 4,335, HIRD, dapa patients and 9,906, CPRD; 1,545, PHARMO; and 17,352, HIRD, comparator patients. Dapa was most often initiated as add-on therapy (55% CPRD, 42% PHARMO, and 73% HIRD) at 10 mg daily (77% CPRD, 86% PHARMO, and 54% HIRD). Index insulin use was more common in dapa patients than comparators in CPRD and HIRD (20% vs 6% and 19% vs 11%, respectively), but not in PHARMO (7% vs 22%). Use of ≥3 antidiabetic drug classes in the year before the index date was more common in dapa patients than comparators (49% vs 16% CPRD; 22% vs 7% PHARMO; and 27% vs 8% HIRD). On average, dapa patients had a longer time since T2DM diagnosis than comparators. In CPRD and HIRD (but not PHARMO), diabetic retinopathy was more prevalent at initiation of dapa than other ADs (36% vs 28% and 7% vs 5%); comorbidities were more common in insulin than non-insulin users but similar between dapa and comparator patients.
Conclusions: Characteristics of dapa patients were similar to comparator patients except they had more severe, longstanding diabetes at initiation. These results will inform multivariable adjustment in future comparative analyses.
Article