Pioglitazone and Rosiglitazone Have Different Effects on Serum Lipoprotein Particle Concentrations and Sizes in Patients with Type 2 Diabetes and Dyslipidemia

  1. Mark A. Deeg, MD1,
  2. John B. Buse, MD2,
  3. Ronald B. Goldberg, MD3,
  4. David M. Kendall, MD4,
  5. Anthony J. Zagar, MS5,
  6. Scott J. Jacober, DO5,
  7. Mehmood A. Khan, MD6,
  8. Alfonzo T. Perez, MD7 and
  9. Meng H. Tan, MD (tan_meng{at}lilly.com)5 on behalf of the GLAI Study Investigators
  1. 1Endocrinology and Metabolism, Veterans Affairs Hospital and Indiana University, Indianapolis, Indiana;
  2. 2Endocrinology and General Medicine, University of North Carolina, Chapel Hill, North Carolina;
  3. 3Endocrinology, Metabolism and Diabetes, University of Miami, Miami, Florida;
  4. 4International Diabetes Center, Park Nicollet Institute, Minneapolis, Minnesota;
  5. 5Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana;
  6. 6Takeda Pharmaceuticals North America, Lincolnshire, Illinois;
  7. 7Takeda Global Research and Development, Lincolnshire, Illinois

    Abstract

    Objective: Associated with insulin resistance in type 2 diabetes are increased serum triglycerides, decreased HDL-C, and a predominance of large VLDL, small LDL, and small HDL particles. The comparative effects of thiazolidinedione insulin sensitizers on serum lipoprotein particle concentrations and sizes in type 2 diabetes are not known. We studied the effects of pioglitazone (PIO) and rosiglitazone (ROSI) treatments on serum lipoprotein particle concentrations and sizes in type 2 diabetes patients with dyslipidemia.

    Research Design and Methods: This is a prospective, randomized, double-blind, multi-center, parallel-group study. After a 4-week placebo washout period, patients randomized to PIO (n=369) were treated with 30 mg qd for 12 weeks followed by 45 mg qd for another 12 weeks, while patients randomized to ROSI (n=366) were treated with 4 mg qd followed by 4 mg bid for the same intervals. Lipoprotein subclass particle concentrations and sizes were determined by proton nuclear magnetic resonance spectroscopy at baseline and endpoint (PIO [n=333] and ROSI [n=325] patients).

    Results: PIO-treatment increased total VLDL particle concentration less than ROSI-treatment and decreased VLDL particle size more than ROSI. PIO-treatment reduced total LDL particle concentration whereas ROSI-treatment increased it. Both treatments increased LDL particle size, with PIO-treatment having a greater effect. Whereas PIO-treatment increased total HDL particle concentration and size, ROSI-treatment decreased them; both increased HDL cholesterol levels.

    Conclusion: PIO and ROSI treatments have different effects on serum lipoprotein subclass particle concentrations and sizes in patients type 2 diabetes and dyslipidemia.

    Conclusion: Registered in clinicaltrials.gov as NCT00331487

    Footnotes

      • Received September 12, 2006.
      • Accepted June 18, 2007.