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 Alwine; Alan 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

doi:10.1111/j.1463-1326.2005.00541.x

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 journal › Article › peer-review

59 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 HbA_1c, 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 language	English (US)
Pages (from-to)	49-57
Number of pages	9
Journal	Diabetes, Obesity and Metabolism
Volume	8
Issue number	1
DOIs	https://doi.org/10.1111/j.1463-1326.2005.00541.x
State	Published - Jan 2006
Externally published	Yes

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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10.1111/j.1463-1326.2005.00541.x

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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

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. / Rosenstock, Julio; Goldstein, B. J.; Vinik, A. I. et al.
In: Diabetes, Obesity and Metabolism, Vol. 8, No. 1, 01.2006, p. 49-57.

Research output: Contribution to journal › Article › peer-review

Rosenstock, J, Goldstein, BJ, Vinik, AI, O'Neill, MC, Porter, LE, Heise, MA, Kravitz, B, Dirani, RG, Freed, MI, Aronson, R, Bailey, G, Boctor, M, Hardin, P, Joyce, C, Nadeau, A, Rodger, W, Tildesley, H, Woo, V, Yale, JF, Alwine, L, Braun, A, Burgess, G, Cathcart, HK, Chao, G, Dobs, A, Douglas, BC, Edgar, P, Eil, C, Evans, JG, Fallon, J, Gilbert, JG, Goldstein, B, Groch, G, Haag, B, Harris, M, Heatley, S, Hollander, P, Horst, E, Hurley, S, James, A, Katzeff, H, Kaye, W, Keiller, D, Knecht, T, Lorber, D, Lucas, KJ, Marks, J, Masharani, U, McClanahan, M, McKenney, J, Michlin, B, Miller, D, Neutel, J, Ovalle, F, Pi-Sunyer, X, Mezitis, N, Radbill, M, Rosenblatt, S, Rosenstock, J, Scott, G, Seibel, J, Smith, W, Synder, J, Steckel, A, Steinbrenner, R, Stotler, C, Sussman, A, Troupin, B, Vadakekalam, J, Vinik, A, Winkle, P, Yanez, J & 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, vol. 8, no. 1, pp. 49-57. https://doi.org/10.1111/j.1463-1326.2005.00541.x

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title = "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",

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.",

keywords = "Early combination treatment, Elderly subjects, Glycaemic control, Rosiglitazone, Type 2 diabetes",

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

year = "2006",

month = jan,

doi = "10.1111/j.1463-1326.2005.00541.x",

language = "English (US)",

volume = "8",

pages = "49--57",

journal = "Diabetes, Obesity and Metabolism",

issn = "1462-8902",

publisher = "Wiley-Blackwell",

number = "1",

}

TY - JOUR

T1 - Effect of early addition of rosiglitazone to sulphonylurea therapy in older type 2 diabetes patients (>60 years)

T2 - The Rosiglitazone Early vs. SULphonylurea Titration (RESULT) study

AU - Rosenstock, Julio

AU - Goldstein, B. J.

AU - Vinik, A. I.

AU - O'Neill, M. Colleen

AU - Porter, L. E.

AU - Heise, M. A.

AU - Kravitz, B.

AU - Dirani, R. G.

AU - Freed, M. I.

AU - Aronson, Ronnie

AU - Bailey, Gordon

AU - Boctor, Makram

AU - Hardin, Philip

AU - Joyce, Carol

AU - Nadeau, Andre

AU - Rodger, Wilson

AU - Tildesley, Hugh

AU - Woo, Vincent

AU - Yale, Jean Francois

AU - Alwine, Lawrence

AU - Braun, Alan

AU - Burgess, Geoffrey

AU - Cathcart, Harold Kennedy

AU - Chao, George

AU - Dobs, Andrian

AU - Douglas, Bruce Clayton

AU - Edgar, Paul

AU - Eil, Charles

AU - Evans, J. Gary

AU - Fallon, Joseph

AU - Gilbert, John Gilbert

AU - Goldstein, Barry

AU - Groch, George

AU - Haag, Burritt

AU - Harris, Michael

AU - Heatley, Scott

AU - Hollander, Priscilla

AU - Horst, Eric

AU - Hurley, Sean

AU - James, Andrian

AU - Katzeff, Harvey

AU - Kaye, William

AU - Keiller, Danny

AU - Knecht, Thomas

AU - Lorber, Daniel

AU - Lucas, Kathryn Jean

AU - Marks, Jennifer

AU - Masharani, Umesh

AU - McClanahan, Mark

AU - McKenney, James

AU - Michlin, Bernard

AU - Miller, David

AU - Neutel, Joel

AU - Ovalle, Fernando

AU - Pi-Sunyer, Xavier

AU - Mezitis, Nicholas

AU - Radbill, Mark

AU - Rosenblatt, Sid

AU - Rosenstock, Julio

AU - Scott, Graham

AU - Seibel, John

AU - Smith, William

AU - Synder, James

AU - Steckel, Alan

AU - Steinbrenner, Roger

AU - Stotler, Charles

AU - Sussman, Allen

AU - Troupin, Barbara

AU - Vadakekalam, Jacob

AU - Vinik, Aaron

AU - Winkle, Peter

AU - Yanez, Jose

AU - Zieve, Franklin

PY - 2006/1

Y1 - 2006/1

N2 - 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.

AB - 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.

KW - Early combination treatment

KW - Elderly subjects

KW - Glycaemic control

KW - Rosiglitazone

KW - Type 2 diabetes

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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

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