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Abstract
Objective
To assess the economic efficiency of adding troglitazone to sulfonylurea therapy to
improve glycemic control.
Background
Despite the high prevalence of type 2 diabetes, existing treatment strategies often
fail. New oral agents give a wider segment of the population with type 2 diabetes
hope of achieving near-normal blood-glucose levels. Troglitazone, a novel chemical
entity, is one promising new agent.
Methods
We conducted an economic analysis based on glycemic-control data from a randomized
clinical trial comparing troglitazone with placebo, each added to glyburide. A patient
simulation model was used to translate these data to long-term outcomes associated
with diabetes. Patients had poorly controlled type 2 diabetes mellitus despite glyburide
therapy. Risk functions of developing and progressing through nephropathy, retinopathy,
neuropathy, hypoglycemia, and macrovascular disease were developed from the Diabetes
Control and Complications Trial and large epidemiologic studies. Cost estimates were
based on data from 5 states, all payor databases, surveys, and literature. The main
outcomes of the model were cost-consequences, number of patients developing each type
of complication, mean time to development of the complication, cost per life-year
gained (LYG), and cost per quality-adjusted life-year.
Results
The model predicts that for every 1000 patients treated with troglitazone, the improved
glycemic control could mean that 95 to 140 fewer patients would experience one of
the most severe diabetic complications (eg, blindness, end-stage renal disease, amputation),
which may increase life expectancy by 2.0 years. These benefits are obtained at an
additional $2100 per LYG (undiscounted). The ratio remains <$50,000 per LYG for most
variations in input.
Conclusions
The clinical trial demonstrated that troglitazone + glyburide improves glycemic control
compared with glyburide alone. Based on these results, the model estimates fewer diabetic
complications at a cost well below accepted cost-effective thresholds.
Key words
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References
- Diabetes Statistics.in: NIH publication No. 96-3926. Natlonal Institutes of Health, Bethesda1997: 1-4
- The medical management of hyperglycemia over a 10-year period in people with diabetes.Diabetes Care. 1996; 19: 744-750
- Metabolic effects of new oral hypoglycemic agent CS-045 in NIDDM subjects.Diabetes Care. 1992; 15: 193-203
- Improvement in glucose tolerance and insulin resistance in obese subjects treated with troglitazone.N Engl J Med. 1994; 331: 1188-1193
- Troglitazone in combination with sulfonylurea restores glycemic control in patients with type 2 diabetes.Diabetes Care. 1998; 21: 1462-1469
- Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33).Lancet. 1998; 352: 837-853
- The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus.N Engl Med. 1993; 329: 977-986
- Long-term complications of diabetes mellitus.N Engl J Med. 1993; 328: 1676-1685
- Implications of the Diabetes Control and Complications Trial.Diabetes. 1993; 42: 1555-1558
- The applicability and implications of the DCCT to NIDDM.Diabetes Rev. 1994; 2: 413-427
- Direct medical costs of complications resulting from type 2 diabetes in the U.S..Diabetes Care. 1998; 21: 1122-1128
- Model of complications of NIDDM. I. Model construction and assumptions.Diabetes Care. 1997; 20: 725-734
- Model of complications of NIDDM. II. Analysis of the health benefits and cost-effectiveness of treating NIDDM with the goal of normoglycemia.Diabetes Care. 1997; 20: 735-744
- Microalbuminuria predicts clinical proteinuria and early mortality in maturity-onset diabetes.N Engl J Med. 1984; -310: 356-360
- Proteinuria predicts stroke and other atherosclerotic vascular disease events in nondiabetic and non-insulin-dependent diabetic subjects.Stroke. 1996; 27: 2033-2039
- A prospective population-based study of microalbuminuria as a predicfor of mortality in NIDDM.Diabetes Care. 1993; 16: 996-1003
- Albuminuria and poor glycemic control predict mortality in NIDDM.Diabetes. 1995; 44: 1303-1309
- Effect of proteinuria on mortality in NIDDM.Diabetes. 1988; 37: 1499-1504
- The association of microalbuminuria mortality in non-insulin-dependent diabetes mellitus. A systematic overview of the literature.Arch Intern Med. 1997; 157: 1413-1418
- Risk factors for diabetic retinopathy: A population-based study in Rochester, Minnesota.Diabetes Care. 1986; 9: 334-342
- The contribution of non-insulindependent diabetes to lower-extremity amputation in the community.Arch Intern Med. 1994; 154: 885-892
- The Wisconsin Epidemiologic Study of Diabetic Retinopathy. X. Four-year incidence and progression of diabetic retinopathy when age at diagnosis is 30 years or more.Arch Ophthalmol. 1989; 107: 244-249
- Troglitazone [package insert]. Parke-Davis, Ann Arbor, Mich1999
- The incidence of liver effects in Rezulin clinical trials and post-marketing surveillance.October 7, 1999 (Available at) (Accessed)
- United Kingdom Prospective Diabetes Study 17: A 9-year update of a randomized, controlled trial on the effect of improved metabolic control on complications in non-insulin-dependent diabetes mellitus.Ann Intern Med. 1996; 124: 136-145
- Glycemic control and cardiopulmonary function in patients with insulindependent diabetes mellitus.Am J Med. 1997; 103: 504-513
- Troglitazone plus sulfonylurea combination: Long term efficacy in patients with type 2 diabetes.Diabetes. 1998; 47 (Abstract): A85
- Nursing home residents: A multivariate analysis of their medical, behavioral, psychosocial, and service use characteristics.J Gerontol A Biol Sci Med Sci. 1995; 50: 242-251
- The Guide to the Nursing Home Industry, 1995. Health Care Investment Analyst Inc. and Arthur Andersen LLP, Baltimore1995
- Nursing Facilities in Massachusetts: 1994 Update. Massachusetts Rate Setting Commission, Boston1996
- Medical Economics. 7996.in: Drug Topics Redbook®. Medical Economics Company, Inc, Montvale, NJ1996
- Standards of medical care for patients with diabetes mellitus.Diabetes Care. 1996; 19: S8-S15
- A cost analysis of Alprostadil in liver transplantation.Pharmacoeconomics. 1996; 6: 517-524
- Effect of troglitazone in insulin-treated patients with type II diabetes mellitus. Troglitazone and Exogenous Insulin Study Group.N Engl J Med. 1998; 338: 861-866
- How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations.Can Med Assoc J. 1992; 146: 473-481
Article info
Publication history
Accepted:
November 3,
1999
Identification
Copyright
© 2000 Published by Elsevier Inc.
