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Triple Therapy in Type 2 Diabetes: Insulin Glargine or Rosiglitazone Added to Combination Therapy of Sulfonylurea Plus Metformin in Insulin-Naïve Patients

Response to Hamid and Simmons

From the Dallas Diabetes and Endocrine Center, Dallas, Texas

Address correspondence to Julio Rosenstock, MD, Dallas Diabetes and Endocrine Center at Medical City, 7777 Forest Ln., C-618, Dallas, Texas 75230. E-mail: juliorosenstock{at}dallasdiabetes.com

Drs. Hamid and Simmons (1) comment on two positive aspects that favor the use of insulin glargine over rosiglitazone as add-on therapy in type 2 diabetic patients who are inadequately controlled on sulfonylurea plus metformin therapy. The first is whether the beneficial lipid effects found with insulin glargine versus rosiglitazone translate to better clinical outcomes. The second is in regard to the assessment of the cost profile associated with glargine.

The neutral effect on LDL levels of 1.4% with insulin glargine when compared with a 13.1% increase with rosiglitazone in type 2 diabetic patients provided significant differences between both interventions. Also, the reduction in triglyceride levels of 19% with insulin glargine is compared with a 4.6% increase with rosiglitazone. Although the relative cardiovascular impact of such modest LDL changes is not clear, the overall goal is to achieve the lowest LDL possible. Hamid and Simmons suggest that the increase in LDL levels with rosiglitazone may not be clinically detrimental since this may reflect an increase in larger, less atherogenic LDL particles that have been reported with thiazolidinediones. This may turn out to be true. However, recent National Cholesterol Education Program guidelines consider diabetes a coronary heart disease risk equivalent and indicate a treatment goal of LDL <100 mg/dl without qualifying particle size (2). Furthermore, LDL decreases have been linked to better cardiovascular outcomes in type 2 diabetic patients, and independent implications of changes in LDL particle size in this patient population are not clear (3,4).

A large (n = 12,612) ongoing cardiovascular outcomes trial (ORIGIN [Outcome Reduction With Initial Glargine Intervention]) (5,6) will assess whether insulin glargine can reduce cardiovascular risk in people with early dysglycemia; lipid levels will be assessed in conjunction with the primary end point of cardiovascular outcomes.

With regard to cost, the $70 price cited by Hamid and Simmons represents average retail cost, which is higher than the more uniform average wholesale price that is commonly used for comparative cost analysis. In our analysis (7), costs of both rosiglitazone and insulin glargine were based on actual study medication usage by all patients during the trial; average wholesale price for insulin glargine was $46.99 (8) at the time of the study analysis, resulting in actual cost of $216.00 per patient, as reported.

References

1. Hamid Z, Simmons DL: Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylureas plus metformin in insulin-naïve patients (Letter). Diabetes Care 29:2331, 2006[Free Full Text]
   
2. Grundy SM, Cleeman JI, Merz CN, Brewer HB Jr, Clark LT, Hunninghake DB, Pasternak RC, Smith SC Jr, the Coordinating Committee on the National Cholesterol Education Program: Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines. Circulation 110:227–239, 2004[Abstract/Free Full Text]
   
3. Sever PS, Poulter NR, Dahlof B, Wedel H, Collins R, Beevers G, Caulfield M, Kieldsen SE, Kristinsson A, McInnes GT, Mehlsen J, Nieminen M, O’Brien E, Ostergren J: Reduction in cardiovascular events with atorvastatin in 2,532 patients with type 2 diabetes: Anglo-Scandinavian Cardiac Outcomes Trial–Lipid-Lowering Arm (ASCOT-LLA). Diabetes Care 28:1151–1157, 2005[Abstract/Free Full Text]
   
4. Collins R, Armitage J, Parish S, Sleigh P, Peto R, the Heart Protection Study Collaborative Group: MRC/BHF Heart Protection Study of cholesterol-lowering with simvastatin in 5,963 people with diabetes: a randomized placebo-controlled trial. Lancet 361:2005–2016, 2003[Medline]
   
5. ORIGIN Trial Investigators: Design and key features of the ORIGIN trial: outcome reduction with an initial glargine (Abstract). Diabetes 55(Suppl. 1):A523, 2006
   
6. Gerstein HC, Rosenstock J: Insulin therapy in people who have dysglycemia and type 2 diabetes mellitus: can it offer both cardiovascular protection and beta-cell preservation? Endocrinol Metab Clin N Am 34:137–154, 2005[Medline]
   
7. Rosenstock J, Sugimoto D, Strange P, Stewart J, Soltes-Rak E, Dailey G: Triple therapy in type 2 diabetes: insulin glargine or rosiglitazone added to combination therapy of sulfonylurea plus metformin in insulin-naïve patients. Diabetes Care 29:554–559, 2006[Abstract/Free Full Text]
   
8. Medical Economics Staff: 2001 Drug Topics Red Book. 105th ed. Montvale, NJ, Medical Economics Company, 2001
   

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