Trial-Results center  
Clinical trial results database Feedback    Home


Related trials

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

ROADMAP, 2010 - olmesartan vs placebo

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

AVOID, 2008 - aliskiren vs placebo

ADVANCE, 2007 - perindopril and indapamide vs placebo

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

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

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

IPDM, 2001 - irbesartan vs placebo

IDNT amlodipine, 2001 - amlodipine vs placebo

RENAAL, 2001 - losartan vs placebo

IDNT irbesartan, 2001 - Irbesartan vs placebo

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

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

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

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

UKPDS 38, 1998 - captopril or atenolol vs control

UKPDS 39, 1998 - captopril vs atenolol



See also:

  • All diabetes clinical trials
  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of captopril or atenolol
  •  

    UKPDS 38 study, 1998

    Facebook    pdf : captopril or atenolol - anti hypertensive agent for hypertension

    Treatments

    Studied treatment tight control of blood pressure aiming at a BP <150/85 (with the use of captopril or atenolol as main treatment, other treatment were added if the control criteria were not met)
    Control treatment less tight control aiming at a blood pressure of <180/105 (avoiding treatment with ACE inhibitors or beta-blockers)

    Patients

    Patients hypertensive patients with type 2 diabetes
    Inclusion criteria fasting plasma glucose concentration > 6 mmol/l on two mornings; hyper� tension, defined in 727 untreated patients as a systolic blood pressure >160 mm Hg and/or a diastolic blood press� ure >90 mm Hg or in 421 patients receiving antihypertensive treatment as a systolic pressure of >150 mm Hg and/or a diastolic pressure >85 mm Hg
    Exclusion criteria clinical requirement for strict blood pressure control (previous stroke, accelerated hypertension, cardiac fail� ure, or renal failure) or � blockade (myocardial infarc� tion in the previous year or current angina); severe vascular disease (more than one major vascular episode); a severe concurrent illness or contraindica� tions to � blockers (asthma, intermittent claudication, foot ulcers, or amputations); pregnancy;
    Baseline characteristics
    Duration of diabetes 2.6 y (median) 
    Duration of hypertension NA 
    Glycosylated hemoglobin 6.9% 
    BP (systolic/diastolic) 159/94 
    Female (%) 44% 
    Age 56.5y 
    subgroup no 

    Method and design

    Randomized effectives 758 / 390 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 8.4y (median)
    Lost to follow-up ND
    Number of centre 20
    Geographic area UK
    Hypothesis Superiority
    Primary endpoint not unique (3)
    Remarks
    Withdrawals (T1/T0) ND /


    Results

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

    renal death

    2 / 758
    3 / 390
    classic 0,34 [0,06;2,04]

    retinopathy

    102 / 300
    78 / 152
    0,66 [0,53;0,83]

    vision loss

    18 / 758
    13 / 390
    0,71 [0,35;1,44]

    All cause death

    134 / 758
    83 / 390
    0,83 [0,65;1,06]

    stroke (fatal and non fatal)

    38 / 758
    34 / 390
    0,58 [0,37;0,90]

    myocardial infarction (fatal and non fatal)

    107 / 758
    69 / 390
    0,80 [0,60;1,05]

    microvascular events

    68 / 758
    54 / 390
    0,65 [0,46;0,91]

    Death related to diabetes

    82 / 758
    62 / 390
    0,68 [0,50;0,92]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    renal death 2 / 758 (0,3%) 3 / 390 (0,8%) 0,34 [0,06;2,04] death from renal failure  13220 
    retinopathy 102 / 300 (34,0%) 78 / 152 (51,3%) 0,66 [0,53;0,83] progression of retinopathy by >=2 steps  13220 
    vision loss 18 / 758 (2,4%) 13 / 390 (3,3%) 0,71 [0,35;1,44] blindness in one eye  13220 
    All cause death 134 / 758 (17,7%) 83 / 390 (21,3%) 0,83 [0,65;1,06]    
    stroke (fatal and non fatal) 38 / 758 (5,0%) 34 / 390 (8,7%) 0,58 [0,37;0,90]   13220 
    myocardial infarction (fatal and non fatal) 107 / 758 (14,1%) 69 / 390 (17,7%) 0,80 [0,60;1,05]    
    microvascular events 68 / 758 (9,0%) 54 / 390 (13,8%) 0,65 [0,46;0,91]   13220 
    Death related to diabetes 82 / 758 (10,8%) 62 / 390 (15,9%) 0,68 [0,50;0,92]    
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 13220: Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group.BMJ 1998;317:703-13

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    renal death 2,64‰ 7,69‰ -5,1‰
    retinopathy 34,00% 51,32% -173,2‰
    vision loss 2,37% 3,33% -9,6‰
    All cause death 17,68% 21,28% -36,0‰
    stroke (fatal and non fatal) 5,01% 8,72% -37,0‰
    myocardial infarction (fatal and non fatal) 14,12% 17,69% -35,8‰
    microvascular events 8,97% 13,85% -48,8‰
    Death related to diabetes 10,82% 15,90% -50,8‰

    Meta-analysis of all similar trials:

    angiotensin renin system blockade in diabetes for all type of patients

    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 # NA
    • . Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. UK Prospective Diabetes Study Group.. BMJ 1998;317:713-20
      Pubmed | Hubmed | Fulltext
    • . Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study Group.. BMJ 1998;317:703-13
      Pubmed | Hubmed | Fulltext

    (c) 2004-2011 TrialResults-center - All Rights Reserved

    Tweet this  |  notify a friend