29 May 2008
Database assessment of the effectiveness of brand versus generic rosiglitazone in patients with type 2 diabetes mellitus
Ronen LoebsteinACDEF, Itzhak KatzirADF, Janet Vasterman-LandesBCD, Hillel HalkinACDEF, Yossef LomnickyACDFMed Sci Monit 2008; 14(6): CR323-326 :: ID: 859036
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 and Method
Comparison of HbA1C reduction in patients starting treatment with either BRM (n=740) or GRH (n=306) 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 distribution, 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 r2=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% (-3.8% 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.
Keywords: Thiazolidinediones - therapeutic use, Hypoglycemic Agents - therapeutic use, Hemoglobin A, Glycosylated - metabolism, Dose-Response Relationship, Drug, Diabetes Mellitus, Type 2 - drug therapy, Databases as Topic
Editorial
01 April 2024 : Editorial
Editorial: Forty Years of Waiting for Prevention and Cure of HIV Infection – Ongoing Challenges and Hopes for Vaccine Development and Overcoming Antiretroviral Drug ResistanceDOI: 10.12659/MSM.944600
Med Sci Monit 2024; 30:e944600
In Press
15 Apr 2024 : Laboratory Research
The Role of Copper-Induced M2 Macrophage Polarization in Protecting Cartilage Matrix in OsteoarthritisMed Sci Monit In Press; DOI: 10.12659/MSM.943738
07 Mar 2024 : Clinical Research
Knowledge of and Attitudes Toward Clinical Trials: A Questionnaire-Based Study of 179 Male Third- and Fourt...Med Sci Monit In Press; DOI: 10.12659/MSM.943468
08 Mar 2024 : Animal Research
Modification of Experimental Model of Necrotizing Enterocolitis (NEC) in Rat Pups by Single Exposure to Hyp...Med Sci Monit In Press; DOI: 10.12659/MSM.943443
18 Apr 2024 : Clinical Research
Comparative Analysis of Open and Closed Sphincterotomy for the Treatment of Chronic Anal Fissure: Safety an...Med Sci Monit In Press; DOI: 10.12659/MSM.944127
Most Viewed Current Articles
17 Jan 2024 : Review article
Vaccination Guidelines for Pregnant Women: Addressing COVID-19 and the Omicron VariantDOI :10.12659/MSM.942799
Med Sci Monit 2024; 30:e942799
14 Dec 2022 : Clinical Research
Prevalence and Variability of Allergen-Specific Immunoglobulin E in Patients with Elevated Tryptase LevelsDOI :10.12659/MSM.937990
Med Sci Monit 2022; 28:e937990
16 May 2023 : Clinical Research
Electrophysiological Testing for an Auditory Processing Disorder and Reading Performance in 54 School Stude...DOI :10.12659/MSM.940387
Med Sci Monit 2023; 29:e940387
01 Jan 2022 : Editorial
Editorial: Current Status of Oral Antiviral Drug Treatments for SARS-CoV-2 Infection in Non-Hospitalized Pa...DOI :10.12659/MSM.935952
Med Sci Monit 2022; 28:e935952