title: Achieving glycemic goal with initial versus sequential combination therapy using metformin and pioglitazone in type 2 diabetes mellitus.
abstract: OBJECTIVE
  To compare glycemic goal achievement (HbA(1c) < 7%) in type 2 diabetes patients receiving initial metformin plus pioglitazone combination therapy and initial metformin monotherapy augmented with pioglitazone in a cohort follow-up study.
  
  
  METHODS
  Adult patients were identified from the Ingenix Impact database (01/01/99-03/31/07). Qualified patients had a baseline HbA(1c) ≥ 7%; a second laboratory value within 9 months; no other anti-diabetic prescriptions 6 months before or 30 days after treatment initiation; and continuous enrollment during baseline. The index date was the date on which the second medication was initiated. Goal achievement was compared independently at 6, 12 and 18 months using a chi-square test. Logistic regression was used to control for baseline differences. Last observation carried forward was used to impute missing HbA(1c) values. Sub-group analysis was conducted on patients with baseline HbA(1c) values between 7% and 9%, and >9%.
  
  
  METHODS
  The proportion of patients achieving glycemic goal at each specified time point.
  
  
  RESULTS
  A total of 179 patients received initial combination therapy and 347 patients received sequential therapy. A greater proportion of initial combination patients achieved the glycemic goal compared to sequential patients at months 6, 12 and 18 (66.5 vs. 49.6%; 65.9 vs. 48.1%; 65.9 vs. 48.4%, respectively; p < 0.001 for all). Logistic regression confirmed these findings (odds ratios [OR]: 3.18-3.31). Sub-group analysis showed a more pronounced advantage for aggressive initial combination treatment among patients with HbA(1c) > 9% (OR: 5.39-6.04) than among patients with HbA(1c) between 7% and 9% (OR: 2.28-2.79).
  
  
  CONCLUSIONS
  Initial combination therapy patients are more likely to achieve glycemic control than sequential therapy patients, especially for patients with baseline HbA(1c) > 9%. This study is limited by the relatively small sample size and the frequency of HbA(1c) reporting. Future research could examine goal achievement using a larger sample and more complete laboratory data to confirm these findings.
authors.affiliation: Global Health Economics and Outcomes Research, Takeda Pharmaceuticals International, Inc., 1 Takeda Parkway, Deerfield, IL 60015, USA. bpandya@tgrd.com
authors.forename: Bhavik J
authors.initials: BJ
authors.lastname: Pandya
authors.forename: Morgan
authors.initials: M
authors.lastname: Bron
authors.forename: Therese
authors.initials: T
authors.lastname: McCall
authors.forename: Andrew P
authors.initials: AP
authors.lastname: Yu
authors.forename: Kristina S
authors.initials: KS
authors.lastname: Chen
authors.forename: Miles E
authors.initials: ME
authors.lastname: Mattson
authors.forename: Eric Q
authors.initials: EQ
authors.lastname: Wu
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000187:drug effects* / Q000378:metabolism; D015331:Cohort Studies; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006442:Glycated Hemoglobin / Q000032:analysis / Q000187:drug effects; D006801:Humans; D008297:Male; D008687:Metformin / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D000077205:Pioglitazone; D012042:Registries; D012189:Retrospective Studies; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D008687:Metformin; D000077205:Pioglitazone; D045162:Thiazolidinediones; C517652:hemoglobin A1c protein, human