The online version of this article (doi:10.1186/s12902-015-0064-8) contains supplementary material, which is available to authorized users.
WC and MFTR are employees of Janssen Scientific Affairs, LLC, a Johnson and Johnson company, and hold stocks and stock options in Johnson and Johnson. EKB and HJH are employees of Optum, a consulting firm retained by Janssen to conduct the study on which this manuscript is based.
EKB, WC, MFTR, and HJH conceived the study concept and participated in the design of the study. EKB and HJH performed the statistical analysis of the study. EKB, WC, MFTR, and HJH participated in the interpretation of the data, and helped in the development of the manuscript. All authors read and approved the final manuscript.
WC is Director of Health Economics & Outcomes Research, Metabolics at Janssen Scientific Affairs, LLC. MFTR is Senior Director of Health Economics & Outcomes Research, Analgesia and Metabolics at Janssen Scientific Affairs, LLC. EKB is Director of Health Economics & Outcomes Research, Endocrine and Metabolic Diseases at Optum. HJH is a Principal Consultant and Vice President of Research in Health Economics & Outcomes Research at Optum.
Canagliflozin, an oral agent that inhibits sodium glucose co-transporter 2, improves glycemic control, body weight, and blood pressure and is generally well tolerated in patients with type 2 diabetes mellitus (T2DM). This study extends the scope of previous analyses by evaluating outcomes associated with the use of canagliflozin over a 6-month period in a real-world setting.
This retrospective cohort study used data obtained from a large health plan database for patients (≥18 years) with a diagnosis of T2DM who filled at least one canagliflozin prescription between April 1, 2013 and October 30, 2013 (first 7 months canagliflozin was commercially available in the USA) and were continuously enrolled in the health plan for 6 months prior to (baseline) and 6 months following the first canagliflozin prescription claim (follow-up). Changes in glycemic control were evaluated, along with characteristics of enrolled patients and changes in treatment patterns.
4017 patients (mean age 56 years, 43 % female) met the study inclusion criteria. Of these, at the time of first canagliflozin claim, 21 % used canagliflozin concomitantly with three or more other antihyperglycemic agents (AHAs), 29 % with two other AHAs, 30 % with one other AHA, and 20 % without other AHAs. During follow-up, patients received 3.4 (average) canagliflozin prescription fills and a mean of 148 total days of supply; median adherence (interquartile range [IQR]) was 86 % (66–98 %) for patients with ≥2 fills. Among patients with available glycated hemoglobin (A1C) measurements at baseline and follow-up (n = 826, baseline A1C 8.59 %), mean A1C reduction was 0.81 % (P < 0.001). Mean A1C reduction during the follow-up period was greatest in patients with the highest baseline A1C levels. Of the patients who used canagliflozin concomitantly with other AHAs, 20 % were observed to discontinue one or more other AHAs during follow-up. The most commonly discontinued baseline AHAs were: glucagon-like peptide-1 receptor agonists (16 %), dipeptidyl peptidase-4 inhibitors (15 %), insulin (13 %), sulfonylureas (13 %), and metformin (11 %).
This real-world study on canagliflozin use in a range of patients with T2DM demonstrated significant improvements in mean A1C from baseline following the first canagliflozin prescription. In patients concomitantly using one or more additional AHAs at baseline, there appears to be a trend toward lower other AHA use after canagliflozin initiation.
Additional file 1: Figure S1. AHAs included in baseline regimen and with continued use in follow-up in patients with baseline and follow-up A1C measurements (N = 826). Medications included in the AHA regimen at the time of the canagliflozin fill were further assessed in the follow-up period for evidence of discontinuation. Treatment was considered discontinued if a ≥60 day gap in therapy was observed. DPP-4i, dipeptidyl peptidase-4 inhibitor; GLP-1, glucagon-like peptide-1. (PDF 82 kb)12902_2015_64_MOESM1_ESM.pdf
Additional file 2: Table S1. Baseline characteristics of patients with T2DM with baseline and follow-up A1C measurements treated with canagliflozin. A1C, glycated hemoglobin; DCSI, diabetes complication severity index; OB/GYM, obstetric/gynecology; SD, standard deviation. (DOC 36 kb)12902_2015_64_MOESM2_ESM.doc
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- Characteristics and outcomes of patients with type 2 diabetes mellitus treated with canagliflozin: a real-world analysis
Erin K. Buysman
Henry J. Henk
Marcia F. T. Rupnow
- BioMed Central
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