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N Engl J Med. 2009 Jan 8;360(2):129-39. doi: 10.1056/NEJMoa0808431. Epub 2008 Dec 17.

Glucose control and vascular complications in veterans with type 2 diabetes.

Collaborators (282)

Abraira C, Duckworth WC, Paul C, Arca D, Cason L, Martinez Zolotor R, Williams L, Collier SL, Ahmed N, Boyd A, Reda D, Moritz T, Anderson R, Vitek ME, Paine T, Thottapurathu L, Luo P, Bukowski K, Motyka D, Barillas V, Brown R, Christine B, Anfinsen L, Biondic M, Havlicek R, Kubal J, McAuliffe M, McCarren M, Rachelle M, Rose L, Sacks J, Sindowski T, Thomas J, Zahora C, Sather MR, Warren S, Day J, Haroldson J, Abraira C, Duckworth W, Davis SN, Emanuele N, Goldman S, Hayward R, Marks J, Moritz T, Reaven P, Reda D, Warren S, Zieve F, Wendell W, Haroldson J, Harper P, Henderson WG, Henry RR, Kirkman MS, McCarren M, Sacks J, Gavin J, Chew E, Howard B, Karrison T, Pacold IV, Seigel D, Vinicor F, Massie B, Goldman S, Rapcsak S, Sethi G, Sharon M, Thai H, Zadina K, Christensen J, Morrison D, Spooner P, Westerband A, Materson B, Brinton E, Klein R, Colwell JA, Schaefer EJ, Gass CS, Ehrmann DA, Rue P, Schaefer EJ, McNamara JR, Brophy M, Humphries D, Govan D, McDonnell L, Carlton L, Weng Y, Hayward RA, Krein S, Goldman S, Zadina K, Davis M, Glander K, Soule J, Caulder S, Pittman C, Alston O, Mayfield RK, Moffitt G, Sagel J, Sanacor F, Ganaway E, Marks J, Okur L, Jones L, Florez H, Pfeifer D, Samos L, Taylor AL, Zimering MB, Sama A, Rosenberg F, Garcia H, Ertel N, Pogach L, Shin JJ, Caldarella F, Carseli C, Shah M, Ginier P, Arakel G, Fu Y, Tayloe D, Allen JE, Fox E, Hensley PG, Emanuele N, Kahsen K, Linnerud P, Agrawal L, Azad N, Marcelli M, Cunningham GR, Nichols NM, Cordero E, Hijazi R, Roman F, Datta P, Garcia Touza M, Lteif A, Moore KL, Lazar-Robinson C, Gupta S, Kirkman MS, Mendez M, Haider Z, Risley L, Karounos D, Barber L, Hibbard J, Anderson JW, Reynolds LR, Carlsen J, Collins RW, Ehtisham A, Kashyap ML, Matheus B, Rahbarnia T, Vo AN, Downey N, Fox L, Gonzales RM, Meyers CD, Tavintharan S, Nuttall FQ, Cupersmith L, Dardick K, Kollman L, Georgopoulos A, Niewoehner C, Davis SN, Harper P, Davis D, Devin J, Marney A, Passyn-Dunn J, Perkins J, Stafford J, Powers A, Balch L, Harris P, Anderson RJ, Dunning D, Ludwig S, Vogel M, DeSouza C, Ecklund R, Doran S, Korolchuk C, McElmeel M, Wagstaff S, Reaven P, Solie B, Matchette J, Meyer C, Vela S, Aslam N, Brinton E, Clark J, Domb A, McDonald L, Shurtz L, Rao RH, Beattie JN, Franko C, DeRubertis FR, Kelly D, Maser M, Paul J, Zieve F, Clark SJ, Grimsdale A, Fredrickson S, Levy J, Schroeder D, Iranmanesh A, Dunn B, Arsura D, Kovesdy C, Hanna S, Iranmanesh A, Florow C, Remandaban F, Smith E, Henry RR, Keller M, Aroda V, Choe C, Edelman S, Gasper A, MaFong D, Mudaliar S, Oh D, Bandukwala R, Chang A, Chaudhary S, Chinnapongse S, Christiansen L, Chu N, Kim D, Lupo M, Manju C, Plodkowski R, Sathyaprakash R, Wilson J, Yu J, Macaraeg G, Tornes S, DeFronzo R, Johnson L, Cusi K, Tripathy D, Bajaj M, Blodgett J, Kayshup S, Vasquez MH, Walz B, Weaver T, Benabe J, Mercado Z, Padilla B, Serrano-Rodriguez J, Rosado C, Mejias E, Tejera T, Geldrez C, Gonzalez-Melendez E, Natal M, Rios Jimenez M, Shah JH, Wendel WS, Scott L, Gurnsey LA, Kwiecinski FA, Boyden T, Goldschmid MG, Easton V.

Author information

1
Phoenix Veterans Affairs Health Care Center, Phoenix, AZ 85012, USA. william.duckworth@va.gov

Erratum in

Abstract

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.)

PMID:
19092145
DOI:
10.1056/NEJMoa0808431
[Indexed for MEDLINE]
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