Methods: TNT Study

1
Methods TNT Study

• Prospective, double blind, parallel group trial
• Completed at 256 sites in 14 countries
• Between April, 1998, and August, 2004
• Median follow-up was 4.9 years
• Enrolled 10,001 patients aged 3575 years with
  clinically evident CAD
• 5,584 patients had metabolic syndrome
• 2,820 patients were randomly assigned to receive
  atorvastatin 10 mg per day
• 2,764 patients were randomly assigned to receive
  atorvastatin 80 mg per day
• Primary outcome measure was time to first major
  cardiovascular event, defined as
• Death from coronary heart disease
• Non-fatal non-procedure-related myocardial
  infarction
• Resuscitated cardiac arrest
• Fatal or non-fatal stroke

Deedwania et al. Lancet 2006368919-928.
2
Patients with Major Cardiovascular Events by
Treatment TNT Study
All metabolic syndrome Atorvastatin 10 mg
(n2820)Atorvastatin 80 mg (n2764) HR (95
Cl)0.71 (0.610.84)plt0.0001
Metabolic syndrome, no diabetes Atorvastatin 10
mg (n2191)Atorvastatin 80 mg (n2162) HR (95
Cl)0.70 (0.5570.84)p0.0002
Patients with Major Cardiovascular Event ()
Time to First Major Cardiovascular Event (years)
Number at RiskAll Metabolic SyndromeAtv 10
mgAtv 80 mgMetabolic syndrome, no diabetesAtv
10 mgAtv 80 mg
2820276421912162
2728270721292118
2644263520662065
2554256120042018
2464248319451967
124912709941022
0000
Deedwania et al. Lancet 2006 368919-928.
3
Prevalence of Patients with Major Cardiovascular
Events in All TNT Patients
Metabolic syndrome diabetes (n1231) No
metabolic syndrome diabetes (n270) Metabolic
syndrome, no diabetes (n4353) No metabolic
syndrome,no diabetes (n4147)
HR (95Cl)2.24 (1.872.68)plt0.0001
Patients with Major Cardiovascular Event ()
HR (95Cl)1.35 (1.161.56) plt0.0001
Time to First Major Cardiovascular Event (years)
Hazard ratio for patients with metabolic
syndrome and diabetes versus patients without
metabolic syndrome or diabetes Hazard ratio for
patients with metabolic syndrome without diabetes
versus patients without metabolic syndrome or
diabetes
Deedwania et al. Lancet 2006 368919-928.
4
Patients with Major Cardiovascular Events by
Presence of Metabolic Syndrome Components in All
TNT Patients
Metabolic Syndrome
HR0.68 (0.480.96)
Atorvastatin 10 mg
Atorvastatin 80 mg
HR0.77 (0.601.00)
HR0.69 (0.540.89)
HR0.82 (0.571.19)
HR0.95 (0.721.24)
Patients with Major Cardiovascular Events ()
HR1.35 (0.632.90)
Number of Metabolic Syndrome Components
Deedwania et al. Lancet 2006 368919-928.
5
Results TNT Study

• Support the idea that LDL-C lowering greater than
  LDL-C lowering achieved with standard doses of
  statins is warranted in patients with CHD and the
  metabolic syndrome
• Also apply to non-diabetic subjects with the
  metabolic syndrome

Deedwania et al. Lancet 2006368919-928.