Effects of pioglitazone and rosiglitazone on blood lipid levels and glycemic control in patients with type 2 diabetes mellitus: a retrospective review of randomly selected medical records.

BACKGROUND The antihyperglycemic effects of pioglitazone hydrochloride and rosiglitazone maleate are well documented. The results of clinical trials and observational studies have suggested, however, that there are individual differences in the effects of these drugs on blood lipid levels. OBJECTIVE The present study evaluated the effects of pioglitazone and rosiglitazone on blood lipid levels and glycemic control in patients with type 2 diabetes mellitus. METHODS This was a retrospective review of randomly selected medical records from 605 primary care practices in the United States in which adults with type 2 diabetes received pioglitazone or rosiglitazone between August 1, 1999, and August 31, 2000. The outcome measures were mean changes in serum concentrations of triglycerides (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and glycosylated hemoglobin (HbA1c) values. RESULTS Treatment with pioglitazone was associated with a reduction in mean TG of 55.17 mg/dL, a reduction in TC of 8.45 mg/dL, an increase in HDL-C of 2.65 mg/dL, and a reduction in LDL-C of 5.05 mg/dL. Treatment with rosiglitazone was associated with a reduction in mean TG of 13.34 mg/dL, an increase in TC of 4.81 mg/dL, a reduction in HDL-C of 0.12 mg/dL, and an increase in LDL-C of 3.56 mg/dL. With the exception of HDL-C, the differences in mean changes in lipid parameters between treatment groups were statistically significant (P < 0.001, pioglitazone vs rosiglitazone). Reductions in HbA1c were statistically equivalent between treatments (1.04% pioglitazone, 1.18% rosiglitazone). CONCLUSIONS Treatment with pioglitazone was associated with greater beneficial effects on blood lipid levels than treatment with rosiglitazone, whereas glycemic control was equivalent between the 2 treatments.

[1]  J. Hokanson,et al.  Hypertriglyceridemia as a cardiovascular risk factor. , 1998, The American journal of cardiology.

[2]  A. Hamsten,et al.  In Vivo Stimulation of Vascular Plasminogen Activator Inhibitor-1 Production by very Low-Density Lipoprotein Involves Transcription Factor Binding to a VLDL-Responsive Element , 2000, Thrombosis and Haemostasis.

[3]  D. Einhorn,et al.  Pioglitazone hydrochloride in combination with metformin in the treatment of type 2 diabetes mellitus: a randomized, placebo-controlled study. The Pioglitazone 027 Study Group. , 2000, Clinical therapeutics.

[4]  J. Mckenney,et al.  Executive Summary of The Third Report of The National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, And Treatment of High Blood Cholesterol In Adults (Adult Treatment Panel III). , 2001, JAMA.

[5]  M. Pendergrass,et al.  Nonhypoglycemic Effects of Thiazolidinediones , 2001, Annals of Internal Medicine.

[6]  A. von Eckardstein,et al.  The emergence of triglycerides as a significant independent risk factor in coronary artery disease. , 1998, European heart journal.

[7]  K. Saigenji,et al.  An Autopsy Case of Troglitazone-Induced Fulminant Hepatitis , 1998, Diabetes Care.

[8]  P. Watkins,et al.  Hepatic dysfunction associated with troglitazone. , 1998, The New England journal of medicine.

[9]  C. Gegick,et al.  Comparison of effects of thiazolidinediones on cardiovascular risk factors: observations from a clinical practice. , 2001, Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists.

[10]  J. Olefsky Treatment of insulin resistance with peroxisome proliferator–activated receptor γ agonists , 2000 .

[11]  K. Maeda Hepatocellular injury in a patient receiving pioglitazone. , 2001, Annals of internal medicine.

[12]  S. Aronoff,et al.  Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose-response study. The Pioglitazone 001 Study Group. , 2000, Diabetes care.

[13]  R. Holman,et al.  Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study , 2000, BMJ : British Medical Journal.

[14]  R. Holman,et al.  Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom prospective diabetes study (UKPDS: 23) , 1998, BMJ.

[15]  J. S. St. Peter,et al.  A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone. , 2002, Diabetes care.

[16]  L. Wilkins,et al.  National Cholesterol Education Program. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). , 1994, Circulation.

[17]  B. Miskin,et al.  The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus , 2001, Coronary artery disease.

[18]  Anthony Grieco,et al.  Oral Montelukast versus Inhaled Salmeterol To Prevent Exercise-Induced Bronchoconstriction , 2000, Annals of Internal Medicine.

[19]  M. Kipnes,et al.  Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: a randomized, placebo-controlled study. , 2001, The American journal of medicine.

[20]  M. Mittal,et al.  Hepatocellular Injury in a Patient Receiving Rosiglitazone: A Case Report , 2000, Annals of Internal Medicine.

[21]  B. Sobel,et al.  Increased plasminogen activator inhibitor type 1 in coronary artery atherectomy specimens from type 2 diabetic compared with nondiabetic patients: a potential factor predisposing to thrombosis and its persistence. , 1998, Circulation.

[22]  Kristina Schoonjans,et al.  Thiazolidinediones: an update , 2000, The Lancet.

[23]  A. Melander,et al.  Thiazolidinediones for type 2 diabetes , 2000, BMJ : British Medical Journal.

[24]  A. King A comparison in a clinical setting of the efficacy and side effects of three thiazolidinediones. , 2000, Diabetes care.

[25]  H. Lebovitz,et al.  The Journal of Clinical Endocrinology & Metabolism Printed in U.S.A. Copyright © 2001 by The Endocrine Society Rosiglitazone Monotherapy Is Effective in Patients with Type 2 Diabetes , 1999 .

[26]  J. H. Zar,et al.  Biostatistical Analysis, 3rd edn. , 1996 .

[27]  Glazer Nb,et al.  Thiazolidinediones for type 2 diabetes , 2001, BMJ : British Medical Journal.

[28]  D. Everitt,et al.  Rosiglitazone and Hepatic Failure , 2000, Annals of Internal Medicine.

[29]  L. Wilkins National Cholesterol Education Program. Second Report of the Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). , 1994 .

[30]  Ames,et al.  Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. , 1999, The New England journal of medicine.

[31]  T. Wilt,et al.  Gemfibrozil for the secondary prevention of coronary heart disease in men with low levels of high-density lipoprotein cholesterol. Veterans Affairs High-Density Lipoprotein Cholesterol Intervention Trial Study Group. , 1999, The New England journal of medicine.

[32]  H. Hein,et al.  Triglyceride concentration and ischemic heart disease: an eight-year follow-up in the Copenhagen Male Study. , 1998, Circulation.

[33]  J. Nolan,et al.  Rosiglitazone taken once daily provides effective glycaemic control in patients with Type 2 diabetes mellitus , 2000, Diabetic medicine : a journal of the British Diabetic Association.

[34]  Rosiglitazone Toxicity , 2000, Annals of Internal Medicine.

[35]  J. Concato,et al.  Randomized, controlled trials, observational studies, and the hierarchy of research designs. , 2000, The New England journal of medicine.

[36]  P. Raskin,et al.  Rosiglitazone short-term monotherapy lowers fasting and post-prandial glucose in patients with Type II diabetes , 2000, Diabetologia.

[37]  A. Hamsten,et al.  VLDL activation of plasminogen activator inhibitor-1 (PAI-1) expression: involvement of the VLDL receptor. , 1999, Journal of lipid research.

[38]  J. Rosenstock,et al.  Effect of metformin and rosiglitazone combination therapy in patients with type 2 diabetes mellitus: a randomized controlled trial. , 2000, JAMA.

[39]  R. Anderson,et al.  Rosiglitazone monotherapy improves glycaemic control in patients with type 2 diabetes: a twelve‐week, randomized, placebo‐controlled study , 1999, Diabetes, obesity & metabolism.

[40]  P. Raskin,et al.  A randomized trial of rosiglitazone therapy in patients with inadequately controlled insulin-treated type 2 diabetes. , 2001, Diabetes care.

[41]  A. Hartz,et al.  A comparison of observational studies and randomized, controlled trials , 2000, American journal of ophthalmology.

[42]  M. Matsuda,et al.  Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone. , 2001, Diabetes care.

[43]  D. Levy,et al.  Prediction of coronary heart disease using risk factor categories. , 1998, Circulation.

[44]  R. Nesto,et al.  Heart disease in diabetes mellitus. , 1996, Endocrinology and metabolism clinics of North America.

[45]  C. Spurr,et al.  Two Cases of Severe Clinical and Histologic Hepatotoxicity Associated with Troglitazone , 1998, Annals of Internal Medicine.

[46]  J. Vamecq,et al.  Medical significance of peroxisome proliferator-activated receptors , 1999, The Lancet.

[47]  G. Grunberger,et al.  Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. , 2001, Diabetes care.

[48]  B. Wolffenbuttel,et al.  Addition of low‐dose rosiglitazone to sulphonylurea therapy improves glycaemic control in Type 2 diabetic patients , 2000, Diabetic medicine : a journal of the British Diabetic Association.

[49]  L. Forman,et al.  Hepatic Failure in a Patient Taking Rosiglitazone , 2000, Annals of Internal Medicine.

[50]  A. Hamsten,et al.  Plasminogen Activator Inhibitor-1 Gene Implicated in the Impaired Fibrinolysis of Very-low-density Lipoprotein Response Element in the Promoter Region of the Human , 2022 .

[51]  T. Watanabe,et al.  Thiazolidinediones down-regulate plasminogen activator inhibitor type 1 expression in human vascular endothelial cells: A possible role for PPARgamma in endothelial function. , 1999, Biochemical and biophysical research communications.