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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 amlodipine
    		•  

    FACET study, 1997

    Treatments

    Studied treatment amlodipine (long acting) 10 mg daily
    Control treatment fosinopril 20 mg daily
    Remarks if blood pressure was not controlled, the other study drug was added

    Patients

    Patients hypertensive patients with NIDDM
    Inclusion criteria diagnosis of NIDDM and hypertension (systolic blood pre ssure of 140 mmHg or diastolic blood pressure of 90 mmHg)
    Exclusion criteria history of coronary heart disease or stroke, serum creatinine >1.5 mg/dl, albuminuria >40 �g/min, and use of lipid-lowering drugs, aspirin, or antihypertensive agents other than beta-blockers or diuretics
    Baseline characteristics
    Glycosylated hemoglobin 7.0 %  
    BP (systolic/diastolic) 170/95 
    Female (%) 40% 
    Age 63 y 
    subgroup no 
    hypertension (%) 100% 

    Method and design

    Randomized effectives 191 / 189 (studied vs. control)
    Design Parallel groups
    Blinding open
    Follow-up duration 3.5 y
    Lost to follow-up ND
    Number of centre single center
    Geographic area Italy
    Hypothesis Superiority
    Primary endpoint not defined
    Withdrawals (T1/T0) ND /


    Results



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

    Endpoint Events (%) Relative Risk 95% CI
    Studied treat. Control treat.
    All-cause mortality 5 / 191 (2,6%) 4 / 189 (2,1%) 1,24 [0,34;4,54]
    Fatal or nonfatal stroke 10 / 191 (5,2%) 4 / 189 (2,1%) 2,47 [0,79;7,75]
    Fatal or nonfatal acute myocardial infarction 13 / 191 (6,8%) 10 / 189 (5,3%) 1,29 [0,58;2,86]
    Hospitalized angina 4 / 191 (2,1%) 0 / 189 (0,3%) 7,92 [0,42;148,71]
    Any major vascular event 27 / 191 (14,1%) 14 / 189 (7,4%) 1,91 [1,03;3,52]
    Coronary artery bypass 2 / 191 (1,0%) 3 / 189 (1,6%) 0,66 [0,11;3,90]
    Percutaneous transluminal coronary angioplasty 1 / 191 (0,5%) 0 / 189 (0,3%) 1,98 [0,07;58,64]
    Any major vascular event or procedure 27 / 191 (14,1%) 14 / 189 (7,4%) 1,91 [1,03;3,52]
    Other cardiovascular events or procedures 5 / 191 (2,6%) 4 / 189 (2,1%) 1,24 [0,34;4,54]
    Any death or any vascular event or any procedure 34 / 191 (17,8%) 20 / 189 (10,6%) 1,68 [1,01;2,81]
    Nonfatal cancer 9 / 191 (4,7%) 7 / 189 (3,7%) 1,27 [0,48;3,35]
    Fatal cancer 2 / 191 (1,0%) 1 / 189 (0,5%) 1,98 [0,18;21,64]
    Any cancer 11 / 191 (5,8%) 8 / 189 (4,2%) 1,36 [0,56;3,31]
    Any event listed above 42 / 191 (22,0%) 27 / 189 (14,3%) 1,54 [0,99;2,39]

    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)

    27 / 191
         14 / 189
         classic 1,91 [1,03;3,52]

    Cardiovascular death

    10 / 235
         5 / 235
         classic 2,00 [0,69;5,76]

    All cause death

    5 / 191
         4 / 189
         classic 1,24 [0,34;4,54]

    stroke (fatal and non fatal)

    10 / 191
         4 / 189
         classic 2,47 [0,79;7,75]

    myocardial infarction (fatal and non fatal)

    13 / 191
         10 / 189
         classic 1,29 [0,58;2,86]     0 2 1.0

    Relative risks
    Endpoint Events (%) Relative Risk 95% CI Endpoint definition
    in the trial    		 Ref
    Studied treat. Control treat.
    cardiovascular event (fatal and non fatal) 27 / 191 (14,1%) 14 / 189 (7,4%) 1,91 [1,03;3,52] Any major vascular event   
    Cardiovascular death 10 / 235 (4,3%) 5 / 235 (2,1%) 2,00 [0,69;5,76]    
    All cause death 5 / 191 (2,6%) 4 / 189 (2,1%) 1,24 [0,34;4,54] All-cause mortality   
    stroke (fatal and non fatal) 10 / 191 (5,2%) 4 / 189 (2,1%) 2,47 [0,79;7,75] Fatal or nonfatal stroke  12506 
    myocardial infarction (fatal and non fatal) 13 / 191 (6,8%) 10 / 189 (5,3%) 1,29 [0,58;2,86] Fatal or nonfatal acute myocardial infarction  12506 
    The primary endpoint (if exists) appears in blod characters
    Reference(s) used for data extraction:
  • 12506: Tatti P, Pahor M, Byington RP, Di Mauro P, Guarisco R, Strollo G, Strollo FOutcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM.Diabetes Care 1998 Apr;21:597-603

    • Endpoint studied treat. control treat. mean diff

    Absolute risk reduction
    Endpoint Events rate Absolute risk
    reduction (ARR)
    Studied treat. Control treat.
    cardiovascular event (fatal and non fatal) 14,14% 7,41% 6,7%
    Cardiovascular death 4,26% 2,13% 2,1%
    All cause death 2,62% 2,12% 5,0‰
    stroke (fatal and non fatal) 5,24% 2,12% 3,1%
    myocardial infarction (fatal and non fatal) 6,81% 5,29% 1,5%


    Reference(s)

    Trials register # NA
    • Tatti et al. . . Circulation 1997; 96:I-764 (abstr)
      Pubmed | Hubmed | Fulltext
    • Tatti P, Pahor M, Byington RP, Di Mauro P, Guarisco R, Strollo G, Strollo F. Outcome results of the Fosinopril Versus Amlodipine Cardiovascular Events Randomized Trial (FACET) in patients with hypertension and NIDDM.. Diabetes Care 1998 Apr;21:597-603
      Pubmed | Hubmed | Fulltext

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