Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy
- PMID: 17145742
- DOI: 10.1056/NEJMoa066224
Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy
Erratum in
- N Engl J Med. 2007 Mar 29;356(13):1387-8
Abstract
Background: The efficacy of thiazolidinediones, as compared with other oral glucose-lowering medications, in maintaining long-term glycemic control in type 2 diabetes is not known.
Methods: We evaluated rosiglitazone, metformin, and glyburide as initial treatment for recently diagnosed type 2 diabetes in a double-blind, randomized, controlled clinical trial involving 4360 patients. The patients were treated for a median of 4.0 years. The primary outcome was the time to monotherapy failure, which was defined as a confirmed level of fasting plasma glucose of more than 180 mg per deciliter (10.0 mmol per liter), for rosiglitazone, as compared with metformin or glyburide. Prespecified secondary outcomes were levels of fasting plasma glucose and glycated hemoglobin, insulin sensitivity, and beta-cell function.
Results: Kaplan-Meier analysis showed a cumulative incidence of monotherapy failure at 5 years of 15% with rosiglitazone, 21% with metformin, and 34% with glyburide. This represents a risk reduction of 32% for rosiglitazone, as compared with metformin, and 63%, as compared with glyburide (P<0.001 for both comparisons). The difference in the durability of the treatment effect was greater between rosiglitazone and glyburide than between rosiglitazone and metformin. Glyburide was associated with a lower risk of cardiovascular events (including congestive heart failure) than was rosiglitazone (P<0.05), and the risk associated with metformin was similar to that with rosiglitazone. Rosiglitazone was associated with more weight gain and edema than either metformin or glyburide but with fewer gastrointestinal events than metformin and with less hypoglycemia than glyburide (P<0.001 for all comparisons).
Conclusions: The potential risks and benefits, the profile of adverse events, and the costs of these three drugs should all be considered to help inform the choice of pharmacotherapy for patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00279045 [ClinicalTrials.gov].).
Copyright 2006 Massachusetts Medical Society.
Comment in
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Thiazolidinediones for initial treatment of type 2 diabetes?N Engl J Med. 2006 Dec 7;355(23):2477-80. doi: 10.1056/NEJMe068264. Epub 2006 Dec 4. N Engl J Med. 2006. PMID: 17145743 No abstract available.
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Glycemic durability of monotherapy for diabetes.N Engl J Med. 2007 Mar 29;356(13):1378-9; author reply 1380. doi: 10.1056/NEJMc063760. N Engl J Med. 2007. PMID: 17392313 No abstract available.
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Glycemic durability of monotherapy for diabetes.N Engl J Med. 2007 Mar 29;356(13):1379-80; author reply 1380. N Engl J Med. 2007. PMID: 17402163 No abstract available.
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Glycemic durability of monotherapy for diabetes.N Engl J Med. 2007 Mar 29;356(13):1379; author reply 1380. N Engl J Med. 2007. PMID: 17402164 No abstract available.
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Glycemic durability of monotherapy for diabetes.N Engl J Med. 2007 Mar 29;356(13):1379; author reply 1380. N Engl J Med. 2007. PMID: 17402165 No abstract available.
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Rosiglitazone monotherapy for type 2 diabetes mellitus-too soon to ADOPT?Nat Clin Pract Endocrinol Metab. 2007 Jun;3(6):456-7. doi: 10.1038/ncpendmet0503. Epub 2007 Apr 10. Nat Clin Pract Endocrinol Metab. 2007. PMID: 17426715 No abstract available.
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ADOPT: lessons from comparison of glycemic durability of rosiglitazone, metformin, or glyburide monotherapy.Curr Diab Rep. 2007 Jun;7(3):173-4. doi: 10.1007/s11892-007-0028-0. Curr Diab Rep. 2007. PMID: 17547833 No abstract available.
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The rosiglitazone controversy: meta-analysis and the RECORD study.Prev Cardiol. 2007 Fall;10(4):235-7. doi: 10.1111/j.1520-037x.2007.06099.x. Prev Cardiol. 2007. PMID: 17917522 No abstract available.
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