Effect of early addition of rosiglitazone to sulphonylurea therapy in older type 2 diabetes patients (>60 years): The Rosiglitazone Early vs. SULphonylurea Titration (RESULT) study

Julio Rosenstock, B. J. Goldstein, A. I. Vinik, M. Colleen O'Neill, L. E. Porter, M. A. Heise, B. Kravitz, R. G. Dirani, M. I. Freed, Ronnie Aronson, Gordon Bailey, Makram Boctor, Philip Hardin, Carol Joyce, Andre Nadeau, Wilson Rodger, Hugh Tildesley, Vincent Woo, Jean Francois Yale, Lawrence AlwineAlan Braun, Geoffrey Burgess, Harold Kennedy Cathcart, George Chao, Andrian Dobs, Bruce Clayton Douglas, Paul Edgar, Charles Eil, J. Gary Evans, Joseph Fallon, John Gilbert Gilbert, Barry Goldstein, George Groch, Burritt Haag, Michael Harris, Scott Heatley, Priscilla Hollander, Eric Horst, Sean Hurley, Andrian James, Harvey Katzeff, William Kaye, Danny Keiller, Thomas Knecht, Daniel Lorber, Kathryn Jean Lucas, Jennifer Marks, Umesh Masharani, Mark McClanahan, James McKenney, Bernard Michlin, David Miller, Joel Neutel, Fernando Ovalle, Xavier Pi-Sunyer, Nicholas Mezitis, Mark Radbill, Sid Rosenblatt, Julio Rosenstock, Graham Scott, John Seibel, William Smith, James Synder, Alan Steckel, Roger Steinbrenner, Charles Stotler, Allen Sussman, Barbara Troupin, Jacob Vadakekalam, Aaron Vinik, Peter Winkle, Jose Yanez, Franklin Zieve

Research output: Contribution to journalArticle

56 Scopus citations

Abstract

Aim: To compare the efficacy, safety and tolerability of adding rosiglitazone (RSG) vs. sulphonylurea (SU) dose escalation in older type 2 diabetes mellitus (T2DM) patients inadequately controlled on SU therapy. Methods: A total of 227 T2DM patients from 48 centres in the USA and Canada, aged ≥60 years, were randomized to receive RSG (4 mg) or placebo once daily in combination with glipizide 10 mg twice daily for 2 years in a double-blind, parallel-group study. Previous SU monotherapy was 1/4 to 1/2 maximum recommended dose for ≥2 months prior to screening with fasting plasma glucose (FPG) ≥7.0 and ≤13.9 mmol/l. Treatment options were individualized, and escalation of study medication was specifically defined. Results: Disease progression (time to reach confirmed FPG ≥10 mmol/l while on maximum doses of both glipizide and study medication or placebo) was reported in 28.7% of patients uptitrating SU plus placebo compared with only 2.0% taking RSG and SU combination (p <0.0001). RSG + SU significantly decreased HbA1c, FPG insulin resistance, plasma free fatty acids and medical care utilization and improved treatment satisfaction compared with uptitrated SU. Conclusions: Addition of RSG to SU in older T2DM patients significantly improved glycaemic control and reduced disease progression compared with uptitrated SU alone but without increasing hypoglycaemia. These benefits were associated with increased patient treatment satisfaction and reduced medical care utilization with regards to emergency room visits and length of hospitalization. Early addition of RSG is an effective treatment option for older T2DM patients inadequately controlled on submaximal SU monotherapy.

Original languageEnglish (US)
Pages (from-to)49-57
Number of pages9
JournalDiabetes, Obesity and Metabolism
Volume8
Issue number1
DOIs
StatePublished - Jan 2006

Keywords

  • Early combination treatment
  • Elderly subjects
  • Glycaemic control
  • Rosiglitazone
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

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    Rosenstock, J., Goldstein, B. J., Vinik, A. I., O'Neill, M. C., Porter, L. E., Heise, M. A., Kravitz, B., Dirani, R. G., Freed, M. I., Aronson, R., Bailey, G., Boctor, M., Hardin, P., Joyce, C., Nadeau, A., Rodger, W., Tildesley, H., Woo, V., Yale, J. F., ... Zieve, F. (2006). Effect of early addition of rosiglitazone to sulphonylurea therapy in older type 2 diabetes patients (>60 years): The Rosiglitazone Early vs. SULphonylurea Titration (RESULT) study. Diabetes, Obesity and Metabolism, 8(1), 49-57. https://doi.org/10.1111/j.1463-1326.2005.00541.x