A randomized, double-blind, placebo-controlled, clinical trial of the effects of pioglitazone on glycemic control and dyslipidemia in oral antihyperglycemic medication-naive patients with type 2 diabetes mellitus

Clinical Therapeutics - Tập 25 Số 4 - Trang 1074-1095 - 2003
Matthias Herz1, Don Johns1, Jesús Reviriego1, Loren D. Grossman1, Chantal Godin2, Santiago Durán3, Federico Hawkins4, Heather Lochnan5, Fernando López Rodríguez6, Philip A Hardin7, Christopher S. Konkoy1, Meng H. Tan1
1Lilly Research Laboratories, Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA
2Centre de Recherche d'Endocrinologie, Sherbooke, Quebec, Canada
3Hospital Universitario Nuestra Senora de Valme, Sevilla, Canada
4Hospital 12 de Octubre, Madrid, Spain
5Ottawa Civic Hospital, Ottawa, Ontario, Canada
6Hospital Clínico Universitario San Cecilio, Granada, Spain
7West Edmonton Diabetes Center, Edmonton, Alberta, Canada

Tóm tắt

Từ khóa


Tài liệu tham khảo

1998, Lancet, 352, 837, 10.1016/S0140-6736(98)07019-6

Ohkubo, 1995, Intensive insulin therapy prevents the progression of diabetic microvascular complications in Japanese patients with non-insulin-dependent diabetes mellitus: A randomized prospective 6-year study, Diabetes Res Clin Pract, 28, 103, 10.1016/0168-8227(95)01064-K

Tan, 1999, Diabetes and coronary artery disease, Diabetes Spectrum, 12, 81

Haffner, 1999, Management of dyslipidemia in adults with diabetes, Diabetes Care, 22, S56

Fontbonne, 1991, Hyperinsulinaemia as a predictor of coronary heart disease mortality in a healthy population: The Propective Study, Diabetologia, 34, 356, 10.1007/BF00405009

Reaven, 2000, Insulin resistance and its consequences: Type 2 diabetes mellitus and coronary heart disease, 604

Vosper, 2002, Peroxisome proliferator-activated receptor agonists, hyperlipidaemia, and atherosclerosis, Pharmacol Ther, 95, 47, 10.1016/S0163-7258(02)00232-2

Kipnes, 2001, Pioglitazone hydrochloride in combination with sulfonylurea therapy improves glycemic control in patients with type 2 diabetes mellitus: A randomized, placebo-controlled study, Am J Med, 111, 10, 10.1016/S0002-9343(01)00713-6

Miyazaki, 2001, Improved glycemic control and enhanced insulin sensitivity in type 2 diabetic subjects treated with pioglitazone, Diabetes Care, 24, 710, 10.2337/diacare.24.4.710

Rosenstock, 2002, Efficacy and safety of pioglitazone in type 2 diabetes: A randomised, placebo-controlled study in patients receiving stable insulin therapy, Int J Clin Pract, 56, 251, 10.1111/j.1742-1241.2002.tb11251.x

Dobiasova, 2001, The plasma parameter log (TG/HDL-C) as an atherogenic index: Correlation with lipoprotein particle size and esterification rate in apoB-lipoprotein-depleted plasma (FER(HDL)), Clin Biochem, 34, 583, 10.1016/S0009-9120(01)00263-6

Tan, 2001, Pioglitazone reduces atherogenic index of plasma, an indirect indicator of LDL particle size, Diabetes, 50, A133

American Diabetes Association, 2002, Standards of medical care for patients with diabetes mellitus, Diabetes Care, 25, 213, 10.2337/diacare.25.1.213

Aronoff, 2000, 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, Diabetes Care, 23, 1605, 10.2337/diacare.23.11.1605

Rosenblatt, 2001, The impact of pioglitazone on glycemic control and atherogenic dyslipidemia in patients with type 2 diabetes mellitus, Coron Artery Dis, 12, 413, 10.1097/00019501-200108000-00011

1993, N Engl J Med, 329, 977, 10.1056/NEJM199309303291401

Levy, 1998, Correct homeostasis model assessment (HOMA) evaluation uses the computer program, Diabetes Care, 21, 2191, 10.2337/diacare.21.12.2191

Hochberg, 1988, A sharper Bonferroni procedure for multiple significance testing, Biometrika, 75, 800, 10.1093/biomet/75.4.800

Miyazaki, 2002, Dose-response effect of pioglitazone on insulin sensitivity and insulin secretion in type 2 diabetes, Diabetes Care, 25, 517, 10.2337/diacare.25.3.517

Radziuk, 2000, Insulin sensitivity and its measurement: Structural commonalities among the methods, J Clin Endocrinol Metab, 85, 4426

Bonora, 2000, Homeostasis model assessment closely mirrors the glucose clamp technique in the assessment of insulin sensitivity: Studies in subjects with various degress of glucose tolerance and insulin sensitivity, Diabetes Care, 23, 57, 10.2337/diacare.23.1.57

Matthews, 1985, Homeostasis model assessment: Insulin resistance and beta-cell function from fasting plasma glucose and insulin concentrations in man, Diabetologia, 28, 412, 10.1007/BF00280883

Huang, 2001, The effect of interventions to prevent cardiovascular disease in patients with type 2 diabetes mellitus, Am J Med, 111, 633, 10.1016/S0002-9343(01)00978-0

Gu, 1998, Mortality in adults with and without diabetes in a national cohort of the U.S. population, 1971–1993, Diabetes Care, 21, 1138, 10.2337/diacare.21.7.1138

Kannel, 1985, Lipids, diabetes, and coronary heart disease: Insights from the Framingham Study, Am Heart J, 110, 1100, 10.1016/0002-8703(85)90224-8

1988, UK Prospective Diabetes Study. IV. Characteristics of newly presenting type 2 diabetic patients: Male preponderance and obesity at different ages. Multi-center Study, Diabet Med, 5, 154, 10.1111/j.1464-5491.1988.tb00963.x

Grundy, 1999, Diabetes and cardiovascular disease: A statement for healthcare professionals from the American Heart Association, Circulation, 100, 1134, 10.1161/01.CIR.100.10.1134

Turner, 1998, Risk factors for coronary artery disease in non-insulin dependent diabetes mellitus: United Kingdom Prospective Diabetes Study (UKPDS: 23), BMJ, 316, 823, 10.1136/bmj.316.7134.823

Walldius, 2001, High apolipoprotein B, low apolipoprotein A-I, and improvement in the prediction of fatal myocardial infarction (AMORIS study): A prospective study, Lancet, 358, 2026, 10.1016/S0140-6736(01)07098-2

Lamarche, 1996, Apolipoprotein A-I and B levels and the risk of ischemic heart disease during a five-year follow-up of men in the Quebec cardiovascular study, Circulation, 94, 273, 10.1161/01.CIR.94.3.273

Austin, 1990, Atherogenic lipoprotein phenotype. A proposed genetic marker for coronary heart disease risk, Circulation, 82, 495, 10.1161/01.CIR.82.2.495

Coresh, 1993, Association of plasma triglyceride concentration and LDL particle diameter, density, and chemical composition with premature coronary artery disease in men and women, J Lipid Res, 34, 1687, 10.1016/S0022-2275(20)35731-X

Khan, 2002, A prospective, randomized comparison of the metabolic effects of pioglitazone or rosiglitazone in patients with type 2 diabetes who were previously treated with troglitazone, Diabetes Care, 25, 708, 10.2337/diacare.25.4.708

Boyle, 2002, 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, Clin Ther, 24, 378, 10.1016/S0149-2918(02)85040-8

Gegick, 2001, Comparison of effects of thiazolidinediones on cardiovascular risk factors: Observations from a clinical practice, Endocr Pract, 7, 162, 10.4158/EP.7.3.162

Mori, 1999, Effect of troglitazone on body fat distribution in type 2 diabetic patients, Diabetes Care, 22, 908, 10.2337/diacare.22.6.908

Nakamura, 2001, Thiazolidinedione derivative improves fat distribution and multiple risk factors in subjects with visceral fat accumulation—double-blind placebo-controlled trial, Diabetes Res Clin Pract, 54, 181, 10.1016/S0168-8227(01)00319-9

Miyazaki, 2002, Effect of pioglitazone on abdominal fat distribution and insulin sensitivity in type 2 diabetic patients, J Clin Endocrinol Metab, 87, 2784, 10.1210/jcem.87.6.8567

Tolman, 2000, Thiazolidinedione hepatotoxicity: A class effect?, Int J Clin Pract Suppl, 113, 29

Jick, 1999, Frequency of liver disease in type 2 diabetic patients treated with oral antidiabetic agents, Diabetes Care, 22, 2067, 10.2337/diacare.22.12.2067

Luyckx, 2000, Non-alcoholic steatohepatitis: Association with obesity and insulin resistance, and influence of weight loss, Diabetes Metab, 26, 98

Yu, 2002, Nonalcoholic fatty liver disease, Rev Gastroenterol Disord, 2, 11