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

被引:52
作者
Rosenstock, J
Goldstein, BJ
Vinik, AI
O'Neill, MC
Porter, LE
Heise, MA
Kravitz, B
Dirani, RG
Freed, MI
机构
[1] Dallas Diabet & Endocrine Ctr, Dallas, TX 75230 USA
[2] Thomas Jefferson Univ, Div Endocrinol Diabet & Metab Dis, Philadelphia, PA 19107 USA
[3] Eastern Virginia Med Sch, Strelitz Diabet Res Inst, Norfolk, VA 23501 USA
[4] GlaxoSmithKline Inc, King Of Prussia, PA USA
关键词
early combination treatment; elderly subjects; glycaemic control; rosiglitazone; type; 2; diabetes;
D O I
10.1111/j.1463-1326.2005.00541.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:49 / 57
页数:9
相关论文
共 21 条
[1]  
[Anonymous], 2003, SF 36 HLTH SURVEY MA
[2]   Role of fatty acids in the pathogenesis of insulin resistance and NIDDM [J].
Boden, G .
DIABETES, 1997, 46 (01) :3-10
[3]   MEASURES OF PSYCHOLOGICAL WELL-BEING AND TREATMENT SATISFACTION DEVELOPED FROM THE RESPONSES OF PEOPLE WITH TABLET-TREATED DIABETES [J].
BRADLEY, C ;
LEWIS, KS .
DIABETIC MEDICINE, 1990, 7 (05) :445-451
[4]  
Bradley C., 1994, HDB PSYCHOL DIABETES
[5]   Sensitivity effect of rosiglitazone on insulin and body composition in type 2 diabetic patients [J].
Carey, DG ;
Cowin, GJ ;
Galloway, GJ ;
Jones, NP ;
Richards, JC ;
Bisivas, N ;
Doddrell, DM .
OBESITY RESEARCH, 2002, 10 (10) :1008-1015
[6]   Using dose-response characteristics of therapeutic agents for treatment decisions in type 2 diabetes [J].
Garber, AJ .
DIABETES OBESITY & METABOLISM, 2000, 2 (03) :139-147
[7]  
Gavin JR, 1999, DIABETES CARE, V22, pS5
[8]   Redefining the clinical management of type 2 diabetes: matching therapy to pathophysiology [J].
Gerich, JE .
EUROPEAN JOURNAL OF CLINICAL INVESTIGATION, 2002, 32 :46-53
[9]   DEVELOPMENT OF A TYPE-2 DIABETES SYMPTOM CHECKLIST - A MEASURE OF SYMPTOM SEVERITY [J].
GROOTENHUIS, PA ;
SNOEK, FJ ;
HEINE, RJ ;
BOUTER, LM .
DIABETIC MEDICINE, 1994, 11 (03) :253-261
[10]  
Herman WH, 2005, AM J MANAG CARE, V11, P273