Johannes C, Beachler D, Ziemiecki R, Yin R, McGrath L, Jemison J, Lanes S, Gilsenan A. Characteristics of new users of dapagliflozin and other antidiabetic drugs: United States and United Kingdom. Poster presented at the 33rd ICPE International Conference on Pharmacoepidemiology & Therapeutic Risk Management; August 28, 2017. Montreal, Canada. [abstract] Pharmacoepidemiol Drug Saf. 2017 Aug; 26(Suppl 2):129. doi: 10.1002/pds

BACKGROUND: Dapagliflozin (dapa) is a sodium-glucose cotransporter 2 (SGLT2) inhibitor medication for treatment of type 2 diabetes mellitus (T2DM), approved in the UK in 2012 and the US in 2014. A multidatabase, multiyear, retrospective cohort study is exploring the risk of hospitalization for acute outcomes (kidney injury, liver injury and severe complications of urinary tract infection) in patients with T2DM treated with dapa relative to other antidiabetic drugs (ADs) in routine clinical practice.

OBJECTIVES: To compare baseline characteristics of new users of dapa and other ADs (not including SGLT2 inhibitors or monotherapy with insulin, metformin or sulfonylurea).

METHODS: Adult new users of dapa or other ADs were identified in the Clinical Practice Research Datalink (CPRD), November 2012 through March 2015, and the HealthCore Integrated Research Database (HIRD), January 2014 through September 2015. Descriptive analyses were conducted using a common protocol in each database for each outcome. Index episodes of comparator patients were matched to index episodes of dapa patients (4:1) by age, sex, index year and geographic region.

RESULTS: At the first data cut, there were 3,601 (CPRD) and 4,937 (HIRD) dapa patients and 11,530 (CPRD) and 19,743 (HIRD) comparator patients. Dapa was most commonly initiated as add-on therapy (37% CPRD; 72% HIRD). Index insulin use was more common with dapa than comparators (17% vs 5% CPRD; 18% vs 10% HIRD), as was use of ≥3 antidiabetic drug classes in the year before the index date (47% vs 15% CPRD; 26% vs 8% HIRD). Diabetic retinopathy was more prevalent in dapa patients than comparators (35% vs 26% CPRD; 7% vs 4% HIRD). Most other baseline medical comorbidities were more common in insulin than noninsulin users, but were similar between dapa and comparator patients. In the CPRD, obesity, longer duration of diabetes, and higher HbA1c was more common in dapa patients than comparators.

CONCLUSIONS: Dapa patients were largely similar to comparator patients on non-first-line therapy, except they had more severe, longstanding diabetes at initiation. These results will inform multivariable adjustment in future comparative analysies.