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This trial is included in the following systematic reviews and meta-analyses:
Related trials
See also:
ACCORD blood pressure study, 2008 |
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| [NCT00000620] | |
Treatments
| Studied treatment |
intensive therapy, targeting a systolic pressure of less than 120 mm Hg
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| Control treatment |
standard therapy, targeting a systolic pressure of less than 140 mm Hg
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| Treatments description |
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Patients
| Patients | patients with a median glycated hemoglobin level of 8.1% at high risk for cardiovascular events | ||||||||
| Inclusion criteria | 40 years of age or older with cardiovascular disease or 55 years of age or older with anatomical evidence of a substantial amount of atherosclerosis, albuminuria, left ventricular hypertrophy, or at least two additional risk factors for cardiovascular disease (dyslipidemia, hypertension, smoking, or obesity) | ||||||||
| Exclusion criteria | body-mass index of more than 45, serum creatinine level of more than 1.5 mg per deciliter; other serious illness | ||||||||
| Baseline characteristics |
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Method and design
| Randomized effectives | 2362 / 2371 (studied vs. control) |
| Design | Factorial plan |
| Blinding | open |
| Follow-up duration | 4.7y |
| Number of centre | 77 |
| Geographic area | USA, Canada |
| Hypothesis | Superiority |
| Primary endpoint | cardiovascular events |
Results
n/N
n/N
Cardiovascular death
Serious adverse event
Heart failure
All cause death
myocardial infarction (fatal and non fatal)
stroke (fatal and non fatal)
Major cardiovascular events
| Relative risks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Endpoint | Events (%) | Relative Risk | 95% CI | Endpoint definition in the trial |
Ref | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Studied treat. | Control treat. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cardiovascular death | 60 / 2362 (2,5%) | 58 / 2371 (2,4%) | 1,04 | [0,73;1,48] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| myocardial infarction (fatal and non fatal) | 126 / 2362 (5,3%) | 146 / 2371 (6,2%) | 0,87 | [0,69;1,09] | non fatal MI | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| stroke (fatal and non fatal) | 36 / 2362 (1,5%) | 62 / 2371 (2,6%) | 0,58 | [0,39;0,88] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Major cardiovascular events | 208 / 2362 (8,8%) | 237 / 2371 (10,0%) | 0,88 | [0,74;1,05] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| All cause death | 150 / 2362 (6,4%) | 144 / 2371 (6,1%) | 1,05 | [0,84;1,30] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Serious adverse event | 77 / 2362 (3,3%) | 30 / 2371 (1,3%) | 2,58 | [1,70;3,91] | attributed to blood-pressure medications | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Heart failure | 83 / 2362 (3,5%) | 90 / 2371 (3,8%) | 0,93 | [0,69;1,24] | fatal and nonfatal heart failure | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| The primary endpoint (if exists) appears in blod characters | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Reference(s) used for data extraction: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Absolute risk reduction | ||||
| Endpoint | Events rate | Absolute risk reduction (ARR) |
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|---|---|---|---|---|
| Studied treat. | Control treat. | |||
| Cardiovascular death | 2,54% | 2,45% | 0,9‰ | |
| myocardial infarction (fatal and non fatal) | 5,33% | 6,16% | -8,2‰ | |
| stroke (fatal and non fatal) | 1,52% | 2,61% | -10,9‰ | |
| Major cardiovascular events | 8,81% | 10,00% | -11,9‰ | |
| All cause death | 6,35% | 6,07% | 2,8‰ | |
| Serious adverse event | 3,26% | 1,27% | 2,0% | |
| Heart failure | 3,51% | 3,80% | -2,8‰ | |
Reference(s)
| Trials register # | NCT00000620 |
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Gerstein HC, Miller ME, Byington RP, Goff DC Jr, Bigger JT, Buse JB, Cushman WC, Genuth S, Ismail-Beigi F, Grimm RH Jr, Probstfield JL, Simons-Morton DG, Friedewald WT.
Effects of intensive glucose lowering in type 2 diabetes..
N Engl J Med 2008;358:2545-59
Pubmed
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Hubmed
| Fulltext
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Cushman WC, Grimm RH Jr, Cutler JA, Evans GW, Capes S, Corson MA, Sadler LS, Alderman MH, Peterson K, Bertoni A, Basile JN.
Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial..
Am J Cardiol 2007;99:44i-55i
Pubmed
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Hubmed
| Fulltext
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.
Effects of Intensive Blood-Pressure Control in Type 2 Diabetes Mellitus..
N Engl J Med 2010 Mar 14;:
Pubmed
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Hubmed
| Fulltext
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