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Systematic review and meta-analysis

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

cardiovascular prevention - cholesterol lowering intervention - all chronical situations

heart failure - cholesterol lowering intervention - all type of patients


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JUPITER, 2008 - rosuvastatin vs placebo

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See also:

  • All cardiovascular prevention clinical trials
  • All heart failure clinical trials
  • All clinical trials of cholesterol lowering intervention
  • All clinical trials of rosuvastatin
  •  
     GISSI-HF rosuvastatine study, 2008 TRC7346 
    [NCT00336336] download pdf: rosuvastatin | cholesterol lowering intervention for cardiovascular prevention

    Treatments

    Studied treatment low-dose rosuvastatin 10 mg daily
    Control treatment placebo
    Concomittant treatment factorial design

    Patients

    Patients Patients with NYHA classes II to IV heart failure, whatever the cause and the LVEF and already receiving optimized recommended therapy with no clear indication or contraindication to cholesterollowering therapy
    Inclusion criteria men and women; aged 18 years or older; symptomatic heart failure NYHA II–IV, treated according to European Society of Cardiology (ESC) guidelines (for patients with LVEF >40%, at least one hospital admission for congestive heart failure in the preceding year)
    Exclusion criteria any noncardiac comorbidity incompatible with a sufficiently long follow-up; acute coronary syndrome or a revascularisation procedure within 1 month before; planned cardiac surgery, expected to be done within 3 months after randomisation; significant liver disease; serum creatinine concentration greater than 221 µmol/L; alanine and aspartate transaminase > 1·5x UNL; creatine phosphokinase >UNL; hypersensitivity to study treatment;
    Baseline characteristics
    Age (year) 68 
    Women (%) 22 
    NYHA II 62 
    NYHA III 34.5 
    NYHA IV
    LVEF (%) 33 
    Previous MI 32 
    Diabetes (%) 26 
    Previous stroke
    Ischaemic cause (%) 39.5 
    Dilatative cause (%) 34 
    Hypertensive cause 17.5 
    ACE inhibitors 77 
    ARBs 18 
    â blockers 62 
    Spironolactone 40 
    Diuretic drugs 90 
    Digitalis 40 
    Oral anticoagulant drugs 29.5 
    Nitrates 32 

    Method and design

    Randomized effectives 2314 / 2317 (studied vs. control)
    Design Parallel groups
    Blinding double blind
    Follow-up duration 3.9y median (IQR 3-4.4)
    Lost to follow-up n=4
    Number of centre 326
    Geographic area Italy
    Hypothesis Superiority
    Primary endpoint death and death+hospitalization


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    Patients who died of cardiovascular reasons 478 / 2314 (20,7%) 488 / 2317 (21,1%) 0,98 [0,88;1,10]
    Patients who had an SCD 220 / 2314 (9,5%) 196 / 2317 (8,5%) 1,12 [0,94;1,35]
    Patients admitted 1278 / 2314 (55,2%) 1286 / 2317 (55,5%) 1,00 [0,94;1,05]
    Patients admitted for a cardiovascular reason 1033 / 2314 (44,6%) 1060 / 2317 (45,7%) 0,98 [0,92;1,04]
    Patients admitted for heart failure 629 / 2314 (27,2%) 634 / 2317 (27,4%) 0,99 [0,90;1,09]
    Patients who died of a cardiovascular cause or were admitted for any reason 1417 / 2314 (61,2%) 1385 / 2317 (59,8%) 1,02 [0,98;1,07]
    Patients with fatal and non-fatal MI 61 / 2314 (2,6%) 70 / 2317 (3,0%) 0,87 [0,62;1,22]
    Patients with fatal and non-fatal stroke 82 / 2314 (3,5%) 66 / 2317 (2,8%) 1,24 [0,90;1,71]
    Total mortality 657 / 2314 (28,4%) 644 / 2317 (27,8%) 1,02 [0,93;1,12]
    death by Acute myocardial infarction 10 / 2314 (0,4%) 15 / 2317 (0,6%) 0,67 [0,30;1,48]
    death by Worsening of heart failure 203 / 2314 (8,8%) 231 / 2317 (10,0%) 0,88 [0,74;1,05]
    death by Presumed arrhythmic 198 / 2314 (8,6%) 182 / 2317 (7,9%) 1,09 [0,90;1,32]
    fatal Stroke 38 / 2314 (1,6%) 29 / 2317 (1,3%) 1,31 [0,81;2,12]
    Other cardiovascular death 29 / 2314 (1,3%) 31 / 2317 (1,3%) 0,94 [0,57;1,55]
    death by Neoplasia 81 / 2314 (3,5%) 75 / 2317 (3,2%) 1,08 [0,79;1,47]
    Other non-cardiovascular death 75 / 2314 (3,2%) 55 / 2317 (2,4%) 1,37 [0,97;1,92]
    Not known cause of death 23 / 2314 (1,0%) 26 / 2317 (1,1%) 0,89 [0,51;1,55]

    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]

    new-onset diabetes

    225 / 1660
    215 / 1718
    1,08 [0,91;1,29]

    All cause death

    657 / 2314
    644 / 2317
    1,02 [0,93;1,12]

    Non vascular death

    156 / 2314
    130 / 2317
    1,20 [0,96;1,51]

    Cardiovascular death

    478 / 2314
    488 / 2317
    0,98 [0,88;1,10]

    Fatal MI

    10 / 2314
    15 / 2317
    0,67 [0,30;1,48]

    stroke (fatal and non fatal)

    82 / 2314
    66 / 2317
    1,24 [0,90;1,71]

    cardiovascular events

    1033 / 2314
    1060 / 2317
    0,98 [0,92;1,04]

    Fatal stroke

    38 / 2314
    29 / 2317
    classic 1,31 [0,81;2,12]

    myocardial infarction (fatal and non fatal)

    61 / 2314
    70 / 2317
    0,87 [0,62;1,22]

    Coronary event

    61 / 2314
    70 / 2317
    0,87 [0,62;1,22]
    0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial
    Ref
    Studied treat. Control treat.
    new-onset diabetes 225 / 1660 (13,6%) 215 / 1718 (12,5%) 1,08 [0,91;1,29] sub group 
    stroke (fatal and non fatal) 82 / 2314 (3,5%) 66 / 2317 (2,8%) 1,24 [0,90;1,71]   0
    Fatal stroke 38 / 2314 (1,6%) 29 / 2317 (1,3%) 1,31 [0,81;2,12] fatal Stroke 
    myocardial infarction (fatal and non fatal) 61 / 2314 (2,6%) 70 / 2317 (3,0%) 0,87 [0,62;1,22]   0
    Cardiovascular death 478 / 2314 (20,7%) 488 / 2317 (21,1%) 0,98 [0,88;1,10] Patients who died of cardiovascular reasons 
    Coronary event 61 / 2314 (2,6%) 70 / 2317 (3,0%) 0,87 [0,62;1,22] Patients with fatal and non-fatal MI 
    Non vascular death 156 / 2314 (6,7%) 130 / 2317 (5,6%) 1,20 [0,96;1,51]  
    cardiovascular events 1033 / 2314 (44,6%) 1060 / 2317 (45,7%) 0,98 [0,92;1,04] Patients admitted for a cardiovascular reason  18152
    All cause death 657 / 2314 (28,4%) 644 / 2317 (27,8%) 1,02 [0,93;1,12] Total mortality 
    Fatal MI 10 / 2314 (0,4%) 15 / 2317 (0,6%) 0,67 [0,30;1,48] death by Acute myocardial infarction 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 18152: Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni GEffect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.Lancet 2008;372:1231-9
  • 0:

  • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction (for a follow-up of 3.9y median (IQR 3-4.4))
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    new-onset diabetes 13,55% 12,51% 1,0%
    stroke (fatal and non fatal) 3,54% 2,85% 0,70%
    Fatal stroke 1,64% 1,25% 0,39%
    myocardial infarction (fatal and non fatal) 2,64% 3,02% -0,39%
    Cardiovascular death 20,66% 21,06% -0,40%
    Coronary event 2,64% 3,02% -0,39%
    Non vascular death 6,74% 5,61% 1,1%
    cardiovascular events 44,64% 45,75% -1,11%
    All cause death 28,39% 27,79% 0,60%
    Fatal MI 4,32‰ 6,47‰ -0,22%

    Meta-analysis of all similar trials:

    cholesterol lowering intervention in cardiovascular prevention for all chronical situations

    cholesterol lowering intervention in heart failure for all type of patients



    Reference(s)

    TrialResults-center ID TRC7346
    Trials register # NCT00336336
    • Tavazzi L, Tognoni G, Franzosi MG, Latini R, Maggioni AP, Marchioli R, Nicolosi GL, Porcu M. Rationale and design of the GISSI heart failure trial: a large trial to assess the effects of n-3 polyunsaturated fatty acids and rosuvastatin in symptomatic congestive heart failure.. Eur J Heart Fail 2004 Aug;6:635-41
      Pubmed | Hubmed | Fulltext
    • Tavazzi L, Maggioni AP, Marchioli R, Barlera S, Franzosi MG, Latini R, Lucci D, Nicolosi GL, Porcu M, Tognoni G. Effect of rosuvastatin in patients with chronic heart failure (the GISSI-HF trial): a randomised, double-blind, placebo-controlled trial.. Lancet 2008;372:1231-9
      Pubmed | Hubmed | Fulltext

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