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Related trials

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

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ADVANCE, 2007 - perindopril and indapamide 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

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IDNT amlodipine, 2001 - amlodipine vs placebo

RENAAL, 2001 - losartan vs placebo

IDNT irbesartan, 2001 - Irbesartan vs placebo

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

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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



See also:

  • All diabetes clinical trials
  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of ACE inhibitor
  •  

    STOP-2 ACEI (diabetic subgroup) study, 2000

    Facebook    pdf : ACE inhibitor - anti hypertensive agent for hypertension

    Treatments

    Studied treatment ACE inhibitor
    enalapril 10 mg or lisinopril 10 mg daily. if the target blood pressure (<160/95 mm Hg) had not been reached at the 2-month visit or later, patients were given hydrochlorothiazide 12·5–25·0 mg
    Control treatment conventional treatment (diuretic or beta-blocker)
    atenolol 50 mg, metoprolol 100 mg, pindolol 5 mg, or fixed-ratio hydrochlorothiazide 25 mg plus amiloride 2·5 mg daily. Patients on beta-blockers were given hydrochlorothiazide 25 mg plus amiloride 2·5 mg as additional treatment if the target blood pressure (<160/95 mm Hg) had not been reached at the 2-month visit or later. Patients who had started on diuretic treatment were given any of the b-blockers in the doses listed

    Patients

    Patients diabetic (subgroup) elderly patients aged 70-84 years with hypertension
    Inclusion criteria hypertension (blood pressure >=180 mm Hg systolic, >=105 mmHg diastolic, or both); aged 70–84 years; isolated systolic hypertension could be included
    Remarks Of all 6614 patients included in the trial, 719 had diabetes
    Baseline characteristics
    Glycosylated hemoglobin 7.6% 
    BP (systolic/diastolic) 195/96 mmHg 
    Female (%) 60% 
    Age 75.8 y 
    subgroup yes 
    hypertension (%) 100% 

    Method and design

    Randomized effectives 235 / 253 (studied vs. control)
    Design Parallel groups
    Blinding open with blind assessment
    Follow-up duration 5.03y
    Number of centre 312
    Geographic area Sweden
    Primary endpoint cardiovascular mortality


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Cardiovascular mortality 39 / 235 (16,6%) 45 / 253 (17,8%) 0,93 [0,63;1,38]
    Fatal myocardial infarction 4 / 235 (1,7%) 9 / 253 (3,6%) 0,48 [0,15;1,53]
    Fatal stroke 5 / 235 (2,1%) 9 / 253 (3,6%) 0,60 [0,20;1,76]
    Sudden death 11 / 235 (4,7%) 12 / 253 (4,7%) 0,99 [0,44;2,19]
    Other cardiovascular mortality 19 / 235 (8,1%) 15 / 253 (5,9%) 1,36 [0,71;2,62]
    All myocardial infarction 17 / 235 (7,2%) 26 / 253 (10,3%) 0,70 [0,39;1,26]
    All stroke 34 / 235 (14,5%) 39 / 253 (15,4%) 0,94 [0,61;1,43]
    All major cardiovascular events 67 / 235 (28,5%) 82 / 253 (32,4%) 0,88 [0,67;1,15]
    Total mortality 56 / 235 (23,8%) 67 / 253 (26,5%) 0,90 [0,66;1,22]
    Atrial fibrillation 18 / 235 (7,7%) 26 / 253 (10,3%) 0,75 [0,42;1,32]
    Congestive heart failure 22 / 235 (9,4%) 29 / 253 (11,5%) 0,82 [0,48;1,38]

    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]

    cardiovascular event (fatal and non fatal)

    NA / 719
    NA / 0
    0,85 [0,62;1,17]

    Cardiovascular death

    NA / 719
    NA / 0
    0,91 [0,59;1,40]

    All cause death

    NA / 719
    NA / 0
    0,88 [0,62;1,25]

    stroke (fatal and non fatal)

    NA / 719
    NA / 0
    0,88 [0,56;1,39]

    myocardial infarction (fatal and non fatal)

    NA / 719
    NA / 0
    0,68 [0,37;1,25]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:

    Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.

    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
    • Lindholm LH, Hansson L, Ekbom T, Dahlöf B, Lanke J, Linjer E, Scherstén B, Wester PO, Hedner T, de Faire U. Comparison of antihypertensive treatments in preventing cardiovascular events in elderly diabetic patients: results from the Swedish Trial in Old Patients with Hypertension-2. STOP Hypertension-2 Study Group.. J Hypertens 2000;18:1671-5
      Pubmed | Hubmed | Fulltext
    • Hansson L, Lindholm LH, Ekbom T, Dahlöf B, Lanke J, Scherstén B, Wester PO, Hedner T, de Faire U. Randomised trial of old and new antihypertensive drugs in elderly patients: cardiovascular mortality and morbidity the Swedish Trial in Old Patients with Hypertension-2 study.. Lancet 1999;354:1751-6
      Pubmed | Hubmed | Fulltext
    • Hansson L, Hedner T, Dahlöf B. Prospective randomized open blinded end-point (PROBE) study. A novel design for intervention trials. Prospective Randomized Open Blinded End-Point.. Blood Press 1992;1:113-9
      Pubmed | Hubmed | Fulltext

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