Document Detail


Glucose control and vascular complications in veterans with type 2 diabetes.
MedLine Citation:
PMID:  19092145     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: The effects of intensive glucose control on cardiovascular events in patients with long-standing type 2 diabetes mellitus remain uncertain. METHODS: We randomly assigned 1791 military veterans (mean age, 60.4 years) who had a suboptimal response to therapy for type 2 diabetes to receive either intensive or standard glucose control. Other cardiovascular risk factors were treated uniformly. The mean number of years since the diagnosis of diabetes was 11.5, and 40% of the patients had already had a cardiovascular event. The goal in the intensive-therapy group was an absolute reduction of 1.5 percentage points in the glycated hemoglobin level, as compared with the standard-therapy group. The primary outcome was the time from randomization to the first occurrence of a major cardiovascular event, a composite of myocardial infarction, stroke, death from cardiovascular causes, congestive heart failure, surgery for vascular disease, inoperable coronary disease, and amputation for ischemic gangrene. RESULTS: The median follow-up was 5.6 years. Median glycated hemoglobin levels were 8.4% in the standard-therapy group and 6.9% in the intensive-therapy group. The primary outcome occurred in 264 patients in the standard-therapy group and 235 patients in the intensive-therapy group (hazard ratio in the intensive-therapy group, 0.88; 95% confidence interval [CI], 0.74 to 1.05; P=0.14). There was no significant difference between the two groups in any component of the primary outcome or in the rate of death from any cause (hazard ratio, 1.07; 95% CI, 0.81 to 1.42; P=0.62). No differences between the two groups were observed for microvascular complications. The rates of adverse events, predominantly hypoglycemia, were 17.6% in the standard-therapy group and 24.1% in the intensive-therapy group. CONCLUSIONS: Intensive glucose control in patients with poorly controlled type 2 diabetes had no significant effect on the rates of major cardiovascular events, death, or microvascular complications with the exception of progression of albuminuria (P = 0.01) [added]. (ClinicalTrials.gov number, NCT00032487.)
Authors:
William Duckworth; Carlos Abraira; Thomas Moritz; Domenic Reda; Nicholas Emanuele; Peter D Reaven; Franklin J Zieve; Jennifer Marks; Stephen N Davis; Rodney Hayward; Stuart R Warren; Steven Goldman; Madeline McCarren; Mary Ellen Vitek; William G Henderson; Grant D Huang;
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.     Date:  2008-12-17
Journal Detail:
Title:  The New England journal of medicine     Volume:  360     ISSN:  1533-4406     ISO Abbreviation:  N. Engl. J. Med.     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2009-01-08     Completed Date:  2009-01-13     Revised Date:  2009-10-30    
Medline Journal Info:
Nlm Unique ID:  0255562     Medline TA:  N Engl J Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  129-39     Citation Subset:  AIM; IM    
Copyright Information:
2009 Massachusetts Medical Society
Affiliation:
Phoenix Veterans Affairs Health Care Center, Phoenix, AZ 85012, USA. william.duckworth@va.gov
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00032487
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MeSH Terms
Descriptor/Qualifier:
Blood Glucose / metabolism*
Cardiovascular Diseases / epidemiology,  mortality,  prevention & control*
Diabetes Mellitus, Type 2 / blood*,  drug therapy
Diabetic Angiopathies / epidemiology,  prevention & control*
Diabetic Neuropathies / epidemiology
Drug Therapy, Combination
Female
Follow-Up Studies
Hemoglobin A, Glycosylated / analysis
Humans
Hypoglycemic Agents / administration & dosage*
Insulin / administration & dosage
Kaplan-Meiers Estimate
Male
Metformin / administration & dosage
Middle Aged
Sulfonylurea Compounds / administration & dosage
Thiazolidinediones / administration & dosage
United States
Veterans
Chemical
Reg. No./Substance:
0/Blood Glucose; 0/Hemoglobin A, Glycosylated; 0/Hypoglycemic Agents; 0/Sulfonylurea Compounds; 0/Thiazolidinediones; 11061-68-0/Insulin; 122320-73-4/rosiglitazone; 657-24-9/Metformin; 93479-97-1/glimepiride
Investigator
Investigator/Affiliation:
C Abraira / ; W C Duckworth / ; C Paul / ; D Arca / ; L Cason / ; R Martinez Zolotor / ; L Williams / ; S L Collier / ; N Ahmed / ; A Boyd / ; D Reda / ; T Moritz / ; R Anderson / ; M E Vitek / ; T Paine / ; L Thottapurathu / ; P Luo / ; K Bukowski / ; D Motyka / ; V Barillas / ; R Brown / ; B Christine / ; L Anfinsen / ; M Biondic / ; R Havlicek / ; J Kubal / ; M McAuliffe / ; M McCarren / ; M Rachelle / ; L Rose / ; J Sacks / ; T Sindowski / ; J Thomas / ; C Zahora / ; M R Sather / ; S Warren / ; J Day / ; J Haroldson / ; C Abraira / ; W Duckworth / ; S N Davis / ; N Emanuele / ; S Goldman / ; R Hayward / ; J Marks / ; T Moritz / ; P Reaven / ; D Reda / ; S Warren / ; F Zieve / ; W Wendell / ; J Haroldson / ; P Harper / ; W G Henderson / ; R R Henry / ; M S Kirkman / ; M McCarren / ; J Sacks / ; J Gavin / ; E Chew / ; B Howard / ; T Karrison / ; I V Pacold / ; D Seigel / ; F Vinicor / ; B Massie / ; S Goldman / ; S Rapcsak / ; G Sethi / ; M Sharon / ; H Thai / ; K Zadina / ; J Christensen / ; D Morrison / ; P Spooner / ; A Westerband / ; B Materson / ; E Brinton / ; R Klein / ; J A Colwell / ; E J Schaefer / ; C S Gass / ; D A Ehrmann / ; P Rue / ; E J Schaefer / ; J R McNamara / ; M Brophy / ; D Humphries / ; D Govan / ; L McDonnell / ; L Carlton / ; Y Weng / ; R A Hayward / ; S Krein / ; S Goldman / ; K Zadina / ; M Davis / ; K Glander / ; J Soule / ; S Caulder / ; C Pittman / ; O Alston / ; R K Mayfield / ; G Moffitt / ; J Sagel / ; F Sanacor / ; E Ganaway / ; J Marks / ; L Okur / ; L Jones / ; H Florez / ; D Pfeifer / ; L Samos / ; A L Taylor / ; M B Zimering / ; A Sama / ; F Rosenberg / ; H Garcia / ; N Ertel / ; L Pogach / ; J J Shin / ; F Caldarella / ; C Carseli / ; M Shah / ; P Ginier / ; G Arakel / ; Y Fu / ; D Tayloe / ; J E Allen / ; E Fox / ; P G Hensley / ; N Emanuele / ; K Kahsen / ; P Linnerud / ; L Agrawal / ; N Azad / ; M Marcelli / ; G R Cunningham / ; N M Nichols / ; E Cordero / ; R Hijazi / ; F Roman / ; P Datta / ; M Garcia Touza / ; A Lteif / ; K L Moore / ; C Lazar-Robinson / ; S Gupta / ; M S Kirkman / ; M Mendez / ; Z Haider / ; L Risley / ; D Karounos / ; L Barber / ; J Hibbard / ; J W Anderson / ; L R Reynolds / ; J Carlsen / ; R W Collins / ; A Ehtisham / ; M L Kashyap / ; B Matheus / ; T Rahbarnia / ; A N Vo / ; N Downey / ; L Fox / ; R M Gonzales / ; C D Meyers / ; S Tavintharan / ; F Q Nuttall / ; L Cupersmith / ; K Dardick / ; L Kollman / ; A Georgopoulos / ; C Niewoehner / ; S N Davis / ; P Harper / ; D Davis / ; J Devin / ; A Marney / ; J Passyn-Dunn / ; J Perkins / ; J Stafford / ; A Powers / ; L Balch / ; P Harris / ; R J Anderson / ; D Dunning / ; S Ludwig / ; M Vogel / ; C DeSouza / ; R Ecklund / ; S Doran / ; C Korolchuk / ; M McElmeel / ; S Wagstaff / ; P Reaven / ; B Solie / ; J Matchette / ; C Meyer / ; S Vela / ; N Aslam / ; E Brinton / ; J Clark / ; A Domb / ; L McDonald / ; L Shurtz / ; R H Rao / ; J N Beattie / ; C Franko / ; F R DeRubertis / ; D Kelly / ; M Maser / ; J Paul / ; F Zieve / ; S J Clark / ; A Grimsdale / ; S Fredrickson / ; J Levy / ; D Schroeder / ; A Iranmanesh / ; B Dunn / ; D Arsura / ; C Kovesdy / ; S Hanna / ; A Iranmanesh / ; C Florow / ; F Remandaban / ; E Smith / ; R R Henry / ; M Keller / ; V Aroda / ; C Choe / ; S Edelman / ; A Gasper / ; D MaFong / ; S Mudaliar / ; D Oh / ; R Bandukwala / ; A Chang / ; S Chaudhary / ; S Chinnapongse / ; L Christiansen / ; N Chu / ; D Kim / ; M Lupo / ; C Manju / ; R Plodkowski / ; R Sathyaprakash / ; J Wilson / ; J Yu / ; G Macaraeg / ; S Tornes / ; R DeFronzo / ; L Johnson / ; K Cusi / ; D Tripathy / ; M Bajaj / ; J Blodgett / ; S Kayshup / ; M H Vasquez / ; B Walz / ; T Weaver / ; J Benabe / ; Z Mercado / ; B Padilla / ; J Serrano-Rodriguez / ; C Rosado / ; E Mejias / ; T Tejera / ; C Geldrez / ; E Gonzalez-Melendez / ; M Natal / ; M Rios Jimenez / ; J H Shah / ; W S Wendel / ; L Scott / ; L A Gurnsey / ; F A Kwiecinski / ; T Boyden / ; M G Goldschmid / ; V Easton /
Comments/Corrections
Comment In:
Praxis (Bern 1994). 2009 Oct 7;98(20):1171-2   [PMID:  19809983 ]
N Engl J Med. 2009 May 7;360(19):2031; author reply 2032   [PMID:  19420376 ]
N Engl J Med. 2009 May 7;360(19):2031-2; author reply 2032   [PMID:  19425194 ]
Evid Based Med. 2009 Jun;14(3):73   [PMID:  19483022 ]
Ann Intern Med. 2009 Mar 17;150(6):JC3-8   [PMID:  19306490 ]
N Engl J Med. 2009 Sep 3;361(10):1024-5   [PMID:  19726779 ]
Erratum In:
N Engl J Med. 2009 Sep 3;361(10):1028
N Engl J Med. 2009 Sep 3;361(10):1024-5   [PMID:  19726779 ]

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