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Related trials

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

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RENAAL, 2001 - losartan vs placebo

IDNT irbesartan, 2001 - Irbesartan vs placebo

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

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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, Dahl�f B, Lanke J, Linjer E, Scherst�n 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, Dahl�f B, Lanke J, Scherst�n 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, Dahl�f 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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