Abstract:
OBJECTIVES:To investigate potential determinants of severe hypoglycaemia, including baseline characteristics, in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial and the association of severe hypoglycaemia with levels of glycated haemoglobin (haemoglobin A(1C)) achieved during therapy. DESIGN:Post hoc epidemiological analysis of a double 2x2 factorial, randomised, controlled trial. SETTING:Diabetes clinics, research clinics, and primary care clinics. PARTICIPANTS:10 209 of the 10 251 participants enrolled in the ACCORD study with type 2 diabetes, a haemoglobin A(1C) concentration of 7.5% or more during screening, and aged 40-79 years with established cardiovascular disease or 55-79 years with evidence of significant atherosclerosis, albuminuria, left ventricular hypertrophy, or two or more additional risk factors for cardiovascular disease (dyslipidaemia, hypertension, current smoker, or obese). Interventions Intensive (haemoglobin A(1C) <6.0%) or standard (haemoglobin A(1C) 7.0-7.9%) glucose control. MAIN OUTCOME MEASURES:Severe hypoglycaemia was defined as episodes of "low blood glucose" requiring the assistance of another person and documentation of either a plasma glucose less than 2.8 mmol/l (<50 mg/dl) or symptoms that promptly resolved with oral carbohydrate, intravenous glucose, or glucagon. RESULTS:The annual incidence of hypoglycaemia was 3.14% in the intensive treatment group and 1.03% in the standard glycaemia group. We found significantly increased risks for hypoglycaemia among women (P=0.0300), African-Americans (P<0.0001 compared with non-Hispanic whites), those with less than a high school education (P<0.0500 compared with college graduates), aged participants (P<0.0001 per 1 year increase), and those who used insulin at trial entry (P<0.0001). For every 1% unit decline in the haemoglobin A(1C) concentration from baseline to 4 month visit, there was a 28% (95% CI 19% to 37%) and 14% (4% to 23%) reduced risk of hypoglycaemia requiring medical assistance in the standard and intensive groups, respectively. In both treatment groups, the risk of hypoglycaemia requiring medical assistance increased with each 1% unit increment in the average updated haemoglobin A(1C) concentration (standard arm: hazard ratio 1.76, 95% CI 1.50 to 2.06; intensive arm: hazard ratio 1.15, 95% CI 1.02 to 1.21). CONCLUSIONS:A greater drop in haemoglobin A(1C) concentration from baseline to the 4 month visit was not associated with an increased risk for hypoglycaemia. Patients with poorer glycaemic control had a greater risk of hypoglycaemia, irrespective of treatment group. Identification of baseline subgroups with increased risk for severe hypoglycaemia can provide guidance to clinicians attempting to modify patient therapy on the basis of individual risk. TRIAL REGISTRATION:ClinicalTrials.gov number NCT00000620.
journal_name
BMJjournal_title
BMJ (Clinical research ed.)authors
Miller ME,Bonds DE,Gerstein HC,Seaquist ER,Bergenstal RM,Calles-Escandon J,Childress RD,Craven TE,Cuddihy RM,Dailey G,Feinglos MN,Ismail-Beigi F,Largay JF,O'Connor PJ,Paul T,Savage PJ,Schubart UK,Sood A,Genuth S,ACCdoi
10.1136/bmj.b5444subject
Has Abstractpub_date
2010-01-08 00:00:00pages
b5444eissn
0959-8138issn
1756-1833journal_volume
340pub_type
杂志文章,多中心研究,随机对照试验abstract:OBJECTIVES:To provide insight into factors that contribute to the anxiety reported in a quantitative study of the psychological effect of screening for type 2 diabetes. To explore expectations of and reactions to the screening experience of patients with positive, negative, and intermediate results. DESIGN:Prospective...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1136/bmj.39308.392176.BE
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abstract:OBJECTIVE:To do an indirect comparison analysis of apixaban against dabigatran etexilate (2 doses) and rivaroxaban (1 dose), as well as of rivaroxaban against dabigatranetexilate (2 doses), for their relative efficacy and safety against each other, with particular focus on the secondary prevention population for stroke...
journal_title:BMJ (Clinical research ed.)
pub_type: 杂志文章
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abstract:OBJECTIVES:To identify the extent of HIV infection and injecting drug use among female streetworking prostitutes in Glasgow; to estimate the size of the female streetworking prostitute population in the city; and to estimate the number of HIV positive women working as prostitutes on the streets in Glasgow. DESIGN:Obse...
journal_title:BMJ (Clinical research ed.)
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更新日期:2005-05-07 00:00:00
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pub_type: 杂志文章
doi:10.1136/bmj.c2884
更新日期:2010-07-06 00:00:00
abstract::Accumulating data indicate that modifications in diet may reduce the risk of cancer by as much as one third and possibly by as much as two thirds. On the basis of the existing evidence, however, it is not possible to be certain which cancers are causally related to diet and what proportion of them are due to specific ...
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pub_type: 杂志文章,评审
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pub_type: 杂志文章,多中心研究,随机对照试验
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pub_type: 临床试验,杂志文章,随机对照试验
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pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1999-11-06 00:00:00
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doi:10.1136/bmj.304.6838.1339
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pub_type: 杂志文章,多中心研究
doi:10.1136/bmj.a752
更新日期:2008-07-31 00:00:00
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pub_type: 临床试验,杂志文章
doi:10.1136/bmj.301.6760.1074
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更新日期:2004-07-17 00:00:00
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更新日期:1993-08-21 00:00:00