Real world clinical outcomes and patient characteristics for canagliflozin treated patients in a specialty diabetes clinic

Abstract

Objective: To examine characteristics and outcomes of type 2 diabetes (T2DM) patients prescribed canagliflozin (CANA) and managed in the real-world setting of a diabetes clinic. Primary outcome was change in A1c, and secondary outcomes were change in weight and blood pressure.

Methods: Study was an electronic health record (EHR) review of CANA prescribed at the diabetes clinic from June 2013 to June 2015. Patients were included in the study if they were adults with T2DM, received routine follow-up diabetes care at the diabetes clinic, received an initial prescription for CANA from a diabetes clinic prescriber, and returned for at least one follow-up office visit (OV) after initial CANA prescribing. Paired t-tests were performed on the primary and secondary outcomes, and p < .05 was considered statistically significant. Descriptive statistics were used to characterize the population and other outcomes.

Results: A total of 462 patients met study inclusion criteria. Mean baseline values were: age 55.32 years, BMI 38.23 kg/m², A1c 8.84%, mean number of diabetes medications (including CANA) 3.58. Men comprised 60% of patients. At baseline, 54% of patients were prescribed insulin. A1c decreased by 1.06% and 1.09% (p < .0001), weight decreased by 2.01% and 1.83% (p < .001), systolic blood pressure (SBP) decreased by 3.2% and 2.4% (p < .0001), and diastolic blood pressure (DBP) decreased by 2.59% and 2.16% (p = .0002) from baseline to first and second follow-up OV, respectively. Study limitations included retrospective design, inability to control for confounding factors (e.g. changes in nutrition, exercise, medical care plan, medications), missing information in the EHR, potential lack of generalizability of results to those in a non-specialty diabetes clinic, inability to assess adherence, and inability to assess reliable adverse event data.

Conclusions: ANA was associated with a statistically and clinically significant reduction in A1c, weight, and blood pressure when added to multiple diabetes medication regimens by prescribers in a diabetes clinic.

Keywords:

• Blood pressure reduction
• canagliflozin
• effectiveness
• glycemic control
• type 2 diabetes
• weight loss

Transparency

Declaration of funding

This study was supported by Janssen Scientific Affairs LLC.

J.F.J. was responsible for protocol development, project management, dataset construction, manuscript development, and final report. R.P. was responsible for and completed independent analysis of the data. R.B. provided guidance on all aspects of the project.

All authors contributed to the editing of the manuscript and approved the final version of the manuscript submitted.

Declaration of financial/other relationships

J.F.J. has disclosed that she has received financial support for this project from Janssen Scientific Affairs LLC, and is not an employee of Janssen. R.P. has disclosed that he has received financial support for this project from Janssen Scientific Affairs LLC, and is not an employee of Janssen. R.B. has disclosed that he is an employee of Janssen Scientific Affairs LLC and stockholder of Johnson and Johnson.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

Thanks to the Janssen team for project guidance, manuscript review, and study funding, to Drake University Doctor of Pharmacy students for assistance in data collection, and to IDEC for access to information on patients through their EHR.