Pioglitazone in the treatment of type 2 diabetes mellitus: U.S. clinical experience

Summary:

This paper reviews US clinical experience with pioglitazone, a recently released thiazolidinedione for the treatment of type 2 diabetes mellitus. In placebo controlled clinical studies, pioglitazone effectively improved glycaemic control, as evidenced by significant reductions in HbA_1c and fasting blood glucose, for patients with type 2 diabetes. Pioglitazone also exhibited a positive impact on the abnormal lipid profile common in patients with type 2 diabetes (increased triglycerides and low HDL-cholesterol). Compared to placebo, pioglitazone, as monotherapy or in combination with sulphonylureas, metformin or insulin, significantly reduced serum triglyceride concentrations and increased HDL-cholesterol with no change in LDL or total cholesterol. Adverse event profiles were similar across the placebo and pioglitazone treated groups in the US clinical trial program. With respect to liver function tests, no differences from placebo were noted.

Key words:

Pioglitazone - HbA_1c - fasting plasma glucose - triglycerides - cholesterol

References

• 1 Brockley M R, Schneider R L. The onset of blood glucose response in patients with type 2 diabetes treated with pioglitazone.  Diabetes 49 ((Suppl 1)) A99 Abstract 400-P 2000; 
• 2 Egan J, Rubin C, Mathisen A. Pioglitazone 027 Study Group . Adding pioglitazone to metformin therapy improves the lipid profile in patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A106-A107 Abstract 459 1999; 
• 3 Egan J, Rubin C, Mathisen A. Pioglitazone 027 Study Group . Combination therapy with pioglitazone and metformin in patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A117 Abstract 504 1999; 
• 4 Egan J W, Mathisen A L. Pioglitazone 012 Study Group . The effect of pioglitazone on glucose control and lipid profile in patients with type 2 diabetes.  Diabetes 49 ((Suppl 1)) A105-A425-P 2000; 
• 5 IMS Health .Data on File. Eli Lilly and Company Indianapolis, IN, USA June 2000
• 6 King A. A comparison in a clinical setting of the efficacy and side effects of three thiazolidinediones.  Diabetes Care. 23 557 2000; 
• 7 Mathisen A, Egan J, Schneider R. Pioglitazone 010 Study Group . The effect of combination therapy with pioglitazone and sulphonylurea on the lipid profile in patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A106 Abstract 457 1999a; 
• 8 Mathisen A, Geerlof J, Houser V. Pioglitazone 026 Study Group . The effect of pioglitazone on glucose control and lipid profile in patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A102-A103 Abstract 441 1999b; 
• 9 Mathisen A, Rubin C. Study Group - Pioglitazone 011 . The long-term effect of pioglitazone on glucose control and lipid profile in patients with type 2 diabetes.  Diabetes 49 ((Suppl 1)) A361 Abstract 1518-PO 2000; 
• 10 Mathisen A L, Schneider R, Rubin C, Houser V. Pioglitazone 026 Study Group . The effect of pioglitazone on glucose control and lipid profile in patients with type 2 diabetes.  Diabetologia 42 ((Suppl 1)) A227 Abstract 853 1999; 
• 11 National Institute of Diabetes, and Digestive and Kidney Diseases. Diabetes Statistics .(NIH Publication No. 99-3892, March 1999). National Institutes of Health, U.S. Department of Health and Human Services Bethesda, Maryland 1999
• 12 Prescription Card Systems (PCS) .Data on File. Eli Lilly and Company Indianapolis, IN, USA June 2000
• 13 Roper Starch .Data on File. Eli Lilly and Company Indianapolis, IN, USA 1999
• 14 Rubin C, Egan J, Schneider R. Pioglitazone 014 Study Group . Combination therapy with pioglitazone and insulin in patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A110 Abstract 474 1999; 
• 15 Schneider R, Egan J, Houser V. Pioglitazone 010 Study Group . Combination therapy with pioglitazone and sulphonylurea in patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A106 Abstract 458 1999; 
• 16 Schneider R, Lessem J, Lekich R. Pioglitazone 001 Study Group . Pioglitazone is effective in the treatment of patients with type 2 diabetes.  Diabetes 48 ((Suppl 1)) A109 Abstract 469 1999; 
• 17 Schneider R L, Mathisen A L. Pioglitazone 001 Study Group . The evaluation of baseline blood glucose levels on glycemic control in pioglitazone-treated patients with type 2 diabetes.  Diabetes 49 ((Suppl 1)) A124 Abstract 505-P 2000; 
• 18 Takeda Pharmaceuticals America, Inc .28.May.1999 Package Insert for ACTOS™ Full Prescribing Information. 
• 19 Takeda Pharmaceuticals America, Inc. .Eli Lilly and Company ACTOS Confronting the Challenges and Concerns of Type 2 Diabetes. A Product Monograph. 1999
• 20 World Health Organization .The World Health Report. Geneva, Switzerland 1998
• 21 World Health Organization .The World Health Bulletin,. Geneva, Switzerland June/1997
• 22 Yu S. Effect of pioglitazone on blood glucose following an oral glucose challenge.  Diabetes 49 ((Suppl 1)) A352 Abstract 1476-PO, 2000;