Database assessment of the effectiveness of brand versus generic rosiglitazone in patients with type 2 diabetes mellitus

Ronen Loebstein, Itzhak Katzir, Janet Vasterman-Landes, Hillel Halkin, Yossef Lomnicky

Research output: Contribution to journalArticlepeer-review

Abstract

Background: To compare the effectiveness of brand rosiglitazone maleate (BRM) versus generic rosiglitazone HCl (GRH) in patients with type 2 diabetes mellitus, using computerized records of a healthcare organization. Retrospective, longitudinal database analysis. Material/Methods: Comparison of HbA1 C reduction in patients starting treatment with either BRM (n=740) or GRH (n=806) in the years 2004-2005. Results: BRM users were older (63.5±11 vs. 61.7±10 years p<0.001) and presented more cardiovascular disorders (38% vs. 25%, p<.0.001) with no differences in gender contribution, rates of hypertension or use of concomitant oral hypoglycemic drugs. Use of concomitant insulin was more frequent (17.7% vs. 6.2%, p<0.0001), rates of dispensed rosiglitazone doses >4 mg/d (65.3% vs. 48.5%, p<0.001) and treatment duration was longer (9.3±6.2 vs. 5.2±2.2 months, p<0.001) with the generic formulation. Baseline HbA1C levels were higher (9.0±1.5 vs. 8.6±1.2%, p<0.001) and the absolute decrease in HbA1C levels was greater in the GRH group (-1.2±1.6% vs. -0.5±1.7%, p<0.001). On multiple regression analysis, the decrease in HbA1C (dependent variable) was associated mainly with initial HbA1C level (partial r 2=0.30). Rosiglitazone formulation (partial r2=0.02), age, treatment duration and concomitant insulin (partial r2=0.006) were all significant but minor predictors, with no effect of rosiglitazone daily dose. Mean regression-predicted decreases in HbA1C (with 95% CL) were not significantly different between the two rosiglitazone formulations: -1.6% (-4.3% to +1.1%) for GRH and -1.1% (-3.0% to +1.6%) for BRM. Conclusions: In this retrospective database analysis, we found no evidence of different effectiveness of generic vs. brand rosiglitazone in lowering HbA1C levels.

Original languageEnglish
Pages (from-to)CR323-CR326
JournalMedical Science Monitor
Volume14
Issue number6
StatePublished - Jun 2008

Keywords

  • Bioequivalence
  • Database utilization
  • Generic substitution
  • Rosiglitazone

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