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See also:

  • All diabetes clinical trials
  • All hypertension clinical trials
  • All clinical trials of anti hypertensive agent
  • All clinical trials of losartan
  •  

    LIFE (diabetic subgroup) study, 2002

    Facebook    pdf : losartan - anti hypertensive agent for hypertension

    Treatments

    Studied treatment losartan 50mg daily at step 1
    Control treatment atenolol 50mg daily at step 1

    Patients

    Patients patients with diabetes (subgroup) , hypertension, and signs of left-ventricular hypertrophy on electrocardiograms
    Exclusion criteria secondary hypertension; myocardial infarction or stroke within the previous 6 months; angina pectoris requiring treatment with beta-blockers or calcium-antagonists; heart failure or left ventricular ejection fraction of 40% or less; or a disorder that, in the treating physician’s opinion, required treatment with losartan or another angiotensin–II type 1-receptor antagonist, atenolol or another beta-blocker, hydrochlorothiazide,or angiotensin-converting-enzyme inhibitors
    Remarks of all 9193 patients included in the trial, 1195 had diabetes
    Baseline characteristics
    BP (systolic/diastolic) 177/96 mmHg 
    Female (%) 53% 
    Age 67 y 
    subgroup yes 
    hypertension (%) 100% 

    Method and design

    Randomized effectives 586 / 609 (studied vs. control)
    Design Parallel groups
    Blinding double-blind
    Follow-up duration 4.7 years
    Number of centre 945
    Geographic area USA, UK, Nordic countries
    Hypothesis Superiority
    Primary endpoint CV events


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Primary composite (CV detah, stroke, MI) 103 / 586 (17,6%) 139 / 609 (22,8%) 0,77 [0,61;0,97]
    Cardiovascular mortality 38 / 586 (6,5%) 61 / 609 (10,0%) 0,65 [0,44;0,96]
    Stroke (all) 51 / 586 (8,7%) 65 / 609 (10,7%) 0,82 [0,58;1,16]
    Myocardial infarction (all) 41 / 586 (7,0%) 50 / 609 (8,2%) 0,85 [0,57;1,27]
    Total mortality 63 / 586 (10,8%) 104 / 609 (17,1%) 0,63 [0,47;0,84]
    Angina pectoris - Admitted to hospital for 30 / 586 (5,1%) 30 / 609 (4,9%) 1,04 [0,63;1,70]
    Heart failure - Admitted to hospital for 32 / 586 (5,5%) 55 / 609 (9,0%) 0,60 [0,40;0,92]
    Revascularisation 62 / 586 (10,6%) 70 / 609 (11,5%) 0,92 [0,67;1,27]

    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 / 586
    NA / 609
    0,76 [0,58;0,99]

    Cardiovascular death

    38 / 586
    61 / 609
    0,65 [0,44;0,96]

    All cause death

    NA / 586
    NA / 609
    0,61 [0,45;0,83]

    stroke (fatal and non fatal)

    51 / 586
    65 / 609
    0,82 [0,58;1,16]

    myocardial infarction (fatal and non fatal)

    41 / 586
    50 / 609
    0,85 [0,57;1,27]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    Cardiovascular death 38 / 586 (6,5%) 61 / 609 (10,0%) 0,65 [0,44;0,96]   12501 
    stroke (fatal and non fatal) 51 / 586 (8,7%) 65 / 609 (10,7%) 0,82 [0,58;1,16]   12501 
    myocardial infarction (fatal and non fatal) 41 / 586 (7,0%) 50 / 609 (8,2%) 0,85 [0,57;1,27]   12501 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12501: Lindholm LH, Ibsen H, Dahlöf B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristiansson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman J, Snapinn SCardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.Lancet 2002;359:1004-10

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    Cardiovascular death 6,48% 10,02% -35,3‰
    stroke (fatal and non fatal) 8,70% 10,67% -19,7‰
    myocardial infarction (fatal and non fatal) 7,00% 8,21% -12,1‰

    Meta-analysis of all similar trials:

    angiotensin renin system blockade in diabetes for all type of patients

    angiotensin-receptor blockers 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, Ibsen H, Dahlöf B, Devereux RB, Beevers G, de Faire U, Fyhrquist F, Julius S, Kjeldsen SE, Kristiansson K, Lederballe-Pedersen O, Nieminen MS, Omvik P, Oparil S, Wedel H, Aurup P, Edelman J, Snapinn S. Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.. Lancet 2002;359:1004-10 - 10.1016/S0140-6736(02)08090-X
      Pubmed | Hubmed | Fulltext
    • Dahlöf B, Devereux RB, Kjeldsen SE, Julius S, Beevers G, de Faire U, Fyhrquist F, Ibsen H, Kristiansson K, Lederballe-Pedersen O, Lindholm LH, Nieminen MS, Omvik P, Oparil S, Wedel H. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol.. Lancet 2002;359:995-1003 - 10.1016/S0140-6736(02)08089-3
      Pubmed | Hubmed | Fulltext

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