title: An observational study of glycemic control in canagliflozin treated patients.
abstract: OBJECTIVE
  To evaluate changes in glycemic control following the initial canagliflozin pharmacy claim in a real-world population.
  
  
  METHODS
  A retrospective cohort analysis of adult patients with type 2 diabetes mellitus (T2DM) was conducted using 2013 medical, pharmacy and laboratory claims from the Inovalon MORE 2 Registry. Patients with T2DM aged ≥18 years with ≥60 days of canagliflozin supply and HbA1c test results within 120 days before and ≥60 days after initial canagliflozin claim (defined as index date) were included. The differences between HbA1c levels pre- and post-index were assessed. Changes pre- and post-index in Healthcare Effectiveness Data and Information Set (HEDIS) glycemic control criteria of HbA1c <7% and <8% and poor control of HbA1c >9% were evaluated. Subgroup analyses of patients with HbA1c >7% at baseline and patients aged ≥65 were also conducted.
  
  
  RESULTS
  Among the 268 patients meeting the study criteria, mean HbA1c pre-index was 8.3% and post-index was 7.6%; the mean reduction in HbA1c pre-post index was 0.7% (95% CI: 0.6%, 0.9%). The proportions of patients meeting the HEDIS glycemic control measures (HbA1c <7%, <8% and poor control of >9%) improved and was significantly different pre- and post-index (all p < 0.001). Of the patients with an HbA1c >7% prior to index (81% of the cohort; mean pre-index HbA1c = 8.8%), HbA1c was reduced by 0.9% (95% CI: 0.8%, 1.1%). The aged ≥65 subgroup consisted of 15% of the cohort, with a pre-index HbA1c of 8.3%. The mean reduction in HbA1c test results pre- and post-canagliflozin index was 0.6% (95% CI: 0.4%, 0.9%). This analysis did not adjust for changes in antihyperglycemic agents during the study period.
  
  
  CONCLUSIONS
  Patients with T2DM were observed to have improved glycemic control following initial canagliflozin pharmacy claim as measured by HbA1c change and attainment of specific glycemic control criteria.
authors.affiliation: a a Trinity Partners LLC , Waltham , MA , USA.
authors.forename: L M
authors.initials: LM
authors.lastname: Meckley
authors.forename: G
authors.initials: G
authors.lastname: Miyasato
authors.forename: F
authors.initials: F
authors.lastname: Kokkotos
authors.forename: J
authors.initials: J
authors.lastname: Bumbaugh
authors.forename: R A
authors.initials: RA
authors.lastname: Bailey
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D000068896:Canagliflozin / Q000627:therapeutic use*; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies
chemical_list: D001786:Blood Glucose; D000068896:Canagliflozin; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human
keywords: Aged; Diabetes mellitus, type 2; Quality indicators, health care; Sodium–glucose co-transporter 2 inhibitor