Abstract
Objective: To evaluate the impact of a 0.2% reduction in glycated hemoglobin (HbA1c) on treatment intensification, poor HbA1c control and HbA1c goal attainment in patients with type 2 diabetes mellitus (T2DM) initiated on a sodium glucose co-transporter 2 (SGLT2) inhibitor (SGLT2i).
Methods: IQVIATM Health Plan Claims Data – US and IQVIATM Ambulatory EMR Data – US databases (29 October 2012–31 March 2016) were used to identify adults with T2DM initiated on an SGLT2i (index date) who had HbA1c measurements pre- and post-index, and ≥6 months of eligibility pre-index (baseline). HbA1c change was defined as the difference between the first post-index and the last pre-index measurements. Cox regression models were used to assess treatment intensification, poor HbA1c control (i.e. HbA1c > 9%, among patients <9% at baseline) and goal attainment (HbA1c < 7%, <8%; among patients with HbA1c above goal at baseline) adjusting for HbA1c change and baseline characteristics. Patients were observed up to one year after the first HbA1c measurement or end of eligibility. Hazard ratios (HRs) and 95% confidence intervals (CIs) were reported.
Results: A total of 938 patients (mean age 54.9, 42.5% female, mean HbA1c 8.5%) were selected. Following SGLT2i initiation, each 0.2% reduction in HbA1c levels was associated with a decreased risk of treatment intensification (HR [95% CI] = 0.90 [0.86–0.92]), a decreased likelihood of reaching HbA1c > 9% (HR [95% CI] = 0.85 [0.79–0.88]) and higher likelihoods of achieving a treatment goal of HbA1c < 7% (HR [95% CI] = 1.17 [1.12–1.21]) and HbA1c < 8% (HR [95% CI] = 1.08 [1.04–1.10]).
Conclusions: In T2DM patients, each HbA1c reduction of 0.2% following the initiation of an SGLT2i was associated with a significant positive impact on treatment intensification and HbA1c goal attainment.
Transparency
Declaration of funding
This research was funded by Janssen Scientific Affairs LLC.
Author contributions
All authors were involved in the conception and design, or analysis and interpretation of the data; the drafting of the paper or revising it critically for intellectual content; and the final approval of the version to be published. All authors agree to be accountable for all aspects of the work.
Declaration of financial/other relationships
S.B. has disclosed that he received consulting honoraria from Janssen Scientific Affairs LLC. B.K.B. has disclosed that he is an employee of Janssen Scientific Affairs LLC and a stockholder of Johnson & Johnson. R.K. has disclosed that at the time this study was conducted she was an employee of Analysis Group Inc. H.M.R. has disclosed that at the time this study was conducted she was an employee of Janssen Scientific Affairs LLC. D.P., M.H.L., W.W. and P.L. have disclosed that they are employees of Analysis Group Inc., a consulting company that has provided paid consulting services to Janssen Scientific Affairs LLC, which funded the development and conduct of this study and manuscript. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Acknowledgements
Writing assistance was provided by Samuel Rochette from Analysis Group Inc., a consultancy company that has provided paid consulting services to Janssen Scientific Affairs LLC, which funded the development and conduct of this study and manuscript. The statements, findings, conclusions, views, and opinions contained and expressed in this study are based in part on data obtained under license from IQVIATM. Source: IQVIATM Health Plan Claims Data and IQVIATM Ambulatory EMR Data (10/29/2012 - 3/31/2016. All Rights Reserved. The statements, findings, conclusions, views, and opinions contained and expressed herein are not necessarily those of IQVIATM or any of its affiliated or subsidiary entities.
Previous presentation
Part of the material in this manuscript was presented at the American Diabetes Association (ADA) 78th Annual Scientific Sessions; 2018 Jun 22–26; Orlando, FL.