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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

diabetes - anti hypertensive agent - type1 and 2 diabetic patients with hypertension

hypertension - anti hypertensive agent - diabetic patients


Related trials

ACCOMPLISH (diabetic subgroup), 2010 - benazepril + amlodipine vs benazepril + hydrochlorothiazide

ACCORD blood pressure, 2010 - more intensive blood pressure lowering strategie vs less intensive blood pressure lowering strategie

AVOID, 2008 - aliskiren vs placebo

ABCD (N), 2002 - more intensive blood pressure lowering strategie vs less intensive blood pressure lowering strategie

ALLHAT (lisi vs chlor, diabetic subgroup), 2002 - lisinopril vs chlorthalidone

LIFE (diabetic subgroup), 2002 - losartan vs atenolol

ALLHAT (amlodipine vs chlor, diabetic subgroup), 2002 - amlodipine vs chlorthalidone

IPDM, 2001 - irbesartan vs placebo

IDNT amlodipine, 2001 - amlodipine vs placebo

RENAAL, 2001 - losartan vs placebo

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IDNT (irbesartan vs amlodipine), 2001 - Irbesartan vs amlodipine

STOP-2 CCB (diabetic subgroup), 2000 - calcium-channel blocker vs diuretic or beta-blocker

INSIGHT (diabetic subgroup), 2000 - Nifedipine vs coamilozide

ABCD (H), 2000 - more intensive blood pressure lowering strategie vs less intensive blood pressure lowering strategie

NORDIL (diabetic subgroup), 2000 - Diltiazem vs diuretic or beta-blocker

STOP-2 (ACEI vs CCB) (diabetic subgroup), 2000 - ACE inhibitor vs CCB

HOPE (diabetic subgroup), 2000 - ACE inhibitor vs placebo

STOP-2 ACEI (diabetic subgroup), 2000 - ACE inhibitor vs diuretic or beta-blocker

CAPP (diabetic subgroup), 1999 - captopril vs diuretic or beta-blocker

Syst-Eur (diabetic subgroup), 1999 - nitrendipine vs placebo

ABCD, 1998 - nisoldipine vs enalapril

UKPDS 38, 1998 - captopril or atenolol vs control

UKPDS 39, 1998 - captopril vs atenolol

FACET, 1997 - amlodipine vs fosinopril



See also:

  • All diabetes clinical trials
  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of more intensive blood pressure lowering strategie
  •  

    ACCORD blood pressure study, 2010

    [NCT00000620] Facebook    pdf : more intensive blood pressure lowering strategie - anti hypertensive agent for hypertension

    Treatments

    Studied treatment intensive blood-pressure control, targeting a systolic pressure of less than 120 mm Hg
    target systolic BP goal of <120 mm Hg
    Control treatment standard blood-pressure control
    target systolic BP goal of <140 mm Hg
    Remarks factorial design, patients were also randomized between intensive and standrd glycemic control

    Patients

    Patients high-risk patients with type 2 diabetes, high HbA1c concentrations (>7.5%), and cardiovascular disease (or >=2 cardiovascular risk factors)
    Inclusion criteria 1) Diagnosed with type 2 diabetes mellitus, as determined by the new American Diabetes Association guidelines, which include a fasting plasma glucose level greater than 126 mg/dl (7.0 mmol/l), or a 2-hour postload value in the oral glucose tolerance test of greater than 200 mg/dl, with confirmation by a retest; 2) For participants aged 40 years or older, history of CVD (heart attack, stroke, history of coronary revascularization, history of peripheral or carotid revascularization, or demonstrated angina); 3) For participants aged 55 years or older, a history of CVD is not required, but participant must be considered to be at high risk for experiencing a CVD event due to existing CVD, subclinical disease, or 2+ CVD risk factors; 4) HbA1c 7.5%-9% (if on more drugs) or 7.5%-11% (if on fewer drugs); patients with a systolic blood pressure between 130 and 180 mm Hg who were taking three or fewer antihypertensive medications and who had the equivalent of a 24-hour protein excretion rate of less than 1.0 g were also eligible
    Exclusion criteria body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 45, a serum creatinine level of more than 1.5 mg per deciliter (132.6 ìmol per liter), and other serious illness.
    Remarks Recruitment occurred during two noncontiguous periods: 491 participants in the blood-pressure trial were recruited from January 2001 through early June 2001 during a “vanguard” phase, and the remaining 4242 participants were recruited from January 2003 through October 2005 during the main trial phase.
    Baseline characteristics
    Duration of diabetes 10 yr 
    Glycosylated hemoglobin 8.3% 
    BP (systolic/diastolic) 139.2/76 mmHg 
    Female (%) 47.7% 
    Age 62.2 y 
    subgroup no 

    Method and design

    Randomized effectives 2363 / 2371 (studied vs. control)
    Design Factorial plan
    Blinding open
    Follow-up duration 4.7 y
    Number of centre 77
    Geographic area United States, Canada
    Primary endpoint CV events
    Studied endpoints First occurence of a major CVD event, specifically nonfatal heart attack, nonfatal stroke, or cardiovascular death (measured throughout the study), total mortality,


    Results



    Endpoints and data reported in the trial's publication(s)

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    CV death, MI, stroke 208 / 2363 (8,8%) 237 / 2371 (10,0%) 0,88 [0,74;1,05]
    Nonfatal myocardial infarction 126 / 2363 (5,3%) 146 / 2371 (6,2%) 0,87 [0,69;1,09]
    Any stroke 36 / 2363 (1,5%) 62 / 2371 (2,6%) 0,58 [0,39;0,88]
    Nonfatal stroke 34 / 2363 (1,4%) 55 / 2371 (2,3%) 0,62 [0,41;0,95]
    Death From any cause 150 / 2363 (6,3%) 144 / 2371 (6,1%) 1,05 [0,84;1,30]
    Death From cardiovascular cause 60 / 2363 (2,5%) 58 / 2371 (2,4%) 1,04 [0,73;1,48]
    Primary outcome plus revasculariza-tion or nonfatal heart failure 521 / 2363 (22,0%) 551 / 2371 (23,2%) 0,95 [0,85;1,05]
    Major coronary disease event 253 / 2363 (10,7%) 270 / 2371 (11,4%) 0,94 [0,80;1,11]
    Fatal or nonfatal heart failure 83 / 2363 (3,5%) 90 / 2371 (3,8%) 0,93 [0,69;1,24]

    Endpoints used by the meta-analysis and data retained for this trial

    Endpoint Studied treat.
    n/N
    Control treat.
    n/N
    Graph RR [95% CI]

    vision loss

    145 / 749
    113 / 713
    1,22 [0,98;1,53]

    renal death

    59 / 2363
    58 / 2371
    1,02 [0,71;1,46]

    retinopathy

    67 / 647
    54 / 616
    1,18 [0,84;1,66]

    cardiovascular event (fatal and non fatal)

    208 / 2363
    237 / 2371
    0,88 [0,74;1,05]

    Cardiovascular death

    60 / 2363
    58 / 2371
    1,04 [0,73;1,48]

    All cause death

    150 / 2363
    144 / 2371
    1,05 [0,84;1,30]

    stroke (fatal and non fatal)

    36 / 2363
    62 / 2371
    0,58 [0,39;0,88]

    myocardial infarction (fatal and non fatal)

    253 / 2363
    270 / 2371
    0,94 [0,80;1,11]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    vision loss 145 / 749 (19,4%) 113 / 713 (15,8%) 1,22 [0,98;1,53] sub group (Eye study)  13093 
    renal death 59 / 2363 (2,5%) 58 / 2371 (2,4%) 1,02 [0,71;1,46] End-stage renal disease or need for dialysis  13100 
    retinopathy 67 / 647 (10,4%) 54 / 616 (8,8%) 1,18 [0,84;1,66] sub group (Eye study)  13093 
    cardiovascular event (fatal and non fatal) 208 / 2363 (8,8%) 237 / 2371 (10,0%) 0,88 [0,74;1,05] CV death, MI, stroke   
    Cardiovascular death 60 / 2363 (2,5%) 58 / 2371 (2,4%) 1,04 [0,73;1,48]    
    All cause death 150 / 2363 (6,3%) 144 / 2371 (6,1%) 1,05 [0,84;1,30]    
    stroke (fatal and non fatal) 36 / 2363 (1,5%) 62 / 2371 (2,6%) 0,58 [0,39;0,88]    
    myocardial infarction (fatal and non fatal) 253 / 2363 (10,7%) 270 / 2371 (11,4%) 0,94 [0,80;1,11] MI, unstable angina  13100 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 13100: Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi FEffects of intensive blood-pressure control in type 2 diabetes mellitus.N Engl J Med 2010;362:1575-85
  • 13093: Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes.N Engl J Med 2010 Jun 29;:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    vision loss 19,36% 15,85% 3,5%
    renal death 2,50% 2,45% 0,5‰
    retinopathy 10,36% 8,77% 1,6%
    cardiovascular event (fatal and non fatal) 8,80% 10,00% -11,9‰
    Cardiovascular death 2,54% 2,45% 0,9‰
    All cause death 6,35% 6,07% 2,7‰
    stroke (fatal and non fatal) 1,52% 2,61% -10,9‰
    myocardial infarction (fatal and non fatal) 10,71% 11,39% -6,8‰

    Meta-analysis of all similar trials:

    anti hypertensive agent in diabetes for type1 and 2 diabetic patients with hypertension

    anti hypertensive agent in hypertension for diabetic patients



    Reference(s)

    Trials register # NCT00000620
    Study web site link http://www.theheart.org/coverage/acc-2010.do
    • . Effects of Medical Therapies on Retinopathy Progression in Type 2 Diabetes.. N Engl J Med 2010 Jun 29;: - 10.1056/NEJMoa1001288
      Pubmed | Hubmed | Fulltext
    • Ismail-Beigi F, Craven T, Banerji MA, Basile J, Calles J, Cohen RM, Cuddihy R, Cushman WC, Genuth S, Grimm RH Jr, Hamilton BP, Hoogwerf B, Karl D, Katz L, Krikorian A, O'Connor P, Pop-Busui R, Schubart U, Simmons D, Taylor H, Thomas A, Weiss D, Hramiak I. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial.. Lancet 2010 Jun 29;: - 10.1016/S0140-6736(10)60576-4
      Pubmed | Hubmed | Fulltext
    • Chew EY, Ambrosius WT, Howard LT, Greven CM, Johnson S, Danis RP, Davis MD, Genuth S, Domanski M. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE).. Am J Cardiol 2007;99:103i-111i - 10.1016/j.amjcard.2007.03.028
      Pubmed | Hubmed | Fulltext
    • 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 - 10.1056/NEJMoa0802743
      Pubmed | Hubmed | Fulltext
    • Cushman WC, Evans GW, Byington RP, Goff DC Jr, Grimm RH Jr, Cutler JA, Simons-Morton DG, Basile JN, Corson MA, Probstfield JL, Katz L, Peterson KA, Friedewald WT, Buse JB, Bigger JT, Gerstein HC, Ismail-Beigi F. Effects of intensive blood-pressure control in type 2 diabetes mellitus.. N Engl J Med 2010;362:1575-85 - 10.1056/NEJMoa1001286
      Pubmed | Hubmed | Fulltext

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