Abstract
Objective: Clinical trials and real-world studies reported that canagliflozin (CANA) improved HbA1c, blood pressure (BP), and weight in patients with type 2 diabetes mellitus (T2DM). This study examines if previous results hold regionally and within specific patient sub-groups.
Methods: Adults with T2DM and ≥12 months of clinical activity before the first CANA prescription (index) were identified in electronic medical records (January 1, 2012–February 15, 2017) from a network of hospitals in Florida. Quality measures were described at baseline and 3, 6, 9, and 12 months post-index. Selected thresholds were HbA1c < 7%, BP < 140/90 mmHg, and weight loss ≥5%. Sub-groups included patients ≥65 years old, with African American race, with CANA dose increase, initiating CANA in an endocrinology setting, and initiating CANA in a primary care setting.
Results: Overall, 1,259 patients (mean age = 56.7 years; 51.2% female, 70.4% White) were identified. Among patients with a baseline HbA1c ≥ 7%, 16.1% had an HbA1c < 7% 3 months following CANA initiation, and the mean HbA1c decreased from 8.8% to 8.1%. Among patients with a baseline systolic BP ≥140 mmHg or diastolic BP ≥ 90 mmHg, 59.3% attained a systolic BP < 140 mmHg and 77.3% a diastolic BP < 90 mmHg after 3 months. HbA1c and BP responses were sustained through 12 months. The proportion of patients with a weight loss from baseline ≥5% increased from 17.0% at 3 months to 31.1% at 12 months. Consistent trends were observed for all sub-groups.
Conclusions: In CANA-treated patients and patient sub-groups from a network of Florida hospitals, improvements in quality measures and response durability were similar to clinical trials and other real-world studies.
Transparency
Declaration of funding
This study was supported by Janssen Scientific Affairs.
Declaration of financial/other relationships
M.S.D., M.H.L., P.L., D.P., B.E., and M.Z. are employees of Analysis Group, a consulting company that received research grants from Janssen Scientific Affairs. R.A.B. and D.I. are employees of Janssen Scientific Affairs. D.T. is an employee of Florida Hospital, and received consulting fees from Janssen Scientific Affairs. A peer reviewer on this manuscript declares consultancy for Janssen Scientific Affairs, the maker of canagliflozin, as well as with multiple other pharmaceutical companies; however, all honoraria and fees from these activities are directed to a non-profit, and the peer reviewer declares receiving no compensation. Peer reviewers on this manuscript have received an honorarium from CMRO for their review work, but have no other relevant financial relationships to disclose.
Acknowledgments
None.