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TNT: New data on intensive lipid lowering in stable CHD patients

TNT: New data on intensive lipid lowering in stable CHD patients. Hypothesis: Lowering LDL-C levels to well below 100 mg/dL could yield an incremental clinical benefit Participants: 10,001 patients with stable CHD and LDL-C 130-250 mg/dL Treatments: Atorvastatin 10 mg and 80 mg

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TNT: New data on intensive lipid lowering in stable CHD patients

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  1. TNT: New data on intensive lipid lowering in stable CHD patients

  2. Hypothesis: Lowering LDL-C levels to well below 100 mg/dL could yield an incremental clinical benefit Participants: 10,001 patients with stable CHD and LDL-C 130-250 mg/dL Treatments: Atorvastatin 10 mg and 80 mg Median follow-up: 4.9 years Primary outcome: CHD death, MI, resuscitation after cardiac arrest, fatal/nonfatal stroke TNT: Treating to New Targets LaRosa JC et al. N Engl J Med. 2005;352.

  3. Benefit of intensive LDL-C lowering: Accumulating evidence 30 4S Statin Placebo 25 4S 20 Event(%) 15 LIPID LIPID CARE CARE 10 HPS HPS 5 0 70 90 110 130 150 170 190 210 0 LDL cholesterol (mg/dL) LaRosa JC et al. N Engl J Med. 2005;352.

  4. TNT: Design • Patient population • 250 centers in 14 countries(N = 10,001) • LDL 130–250 mg/dL • TG <600 mg/dL Atorvastatin 10 mg Atorvastatin 10 mg Atorvastatin 80 mg 8 weeks 4.9 years Waters DD et al. Am J Cardiol. 2004;93:154-8.

  5. TNT: Baseline characteristics Atorvastatin Atorvastatin Characteristics 10 mg (N = 5006) 80 mg (N = 4995) Age (yr) 60.9±8.8 61.2±8.8 Male sex (%) 80.8 81.2 White race (%) 94.1 94.1 Systolic BP (mm Hg) 131±17 131±17 Diastolic BP (mm Hg) 78±10 78±10 BMI (kg/m2) 28.6±4.7 28.4±4.5 LaRosa JC et al. N Engl J Med. 2005;352.

  6. % Atorvastatin % Atorvastatin 10 mg (N = 5006) 80 mg (N = 4995) Current smoker 13.4 13.4 Former smoker 63.3 63.2 Systemic hypertension 54.4 53.9 Diabetes mellitus 15.0 15.0 MI 57.7 59.0 Angina 81.2 81.8 Cerebrovascular event 5.3 5.1 PAD 11.4 12.1 CHF 8.1 7.6 Arrhythmia 18.5 18.2 Coronary revascularization Angioplasty 54.3 53.8 Bypass 46.7 46.4 TNT: CV history of participants LaRosa JC et al. N Engl J Med. 2005;352.

  7. TNT: Baseline lipids Atorvastatin Atorvastatin Lipids (mg/dL) 10 mg (N = 5006) 80 mg (N = 4995) LDL cholesterol 98±18 97±18 Total cholesterol 175±24 175±24 Triglycerides 151±72 151±72 HDL cholesterol 47±11 47±11 LaRosa JC et al. N Engl J Med. 2005;352.

  8. 160 TNT: Treatment effects on LDL-C 140 Atorvastatin 10 mg 120 100 LDL-C (mg/dL) 80 60 Atorvastatin 80 mg 40 20 0 Screening 0 3 12 24 36 48 60 Final Months LaRosa JC et al. N Engl J Med. 2005;352.

  9. TNT: Treatment effects on primary outcome 0.15 Atorvastatin 10 mg 22% risk reduction 0.10 Major CV events (%) 0.05 Atorvastatin 80 mg 0.00 0 1 2 3 4 5 6 Years HR = 0.78 (0.69–0.89) P < 0.001 LaRosa JC et al. N Engl J Med. 2005;352.

  10. TNT: Treatment effects on first major coronary event 0.10 Atorvastatin 10 mg 20% risk reduction Major CV events (%) 0.05 CHD death, MI, resuscitation after cardiac arrest Atorvastatin 80 mg 0.00 0 1 2 3 4 5 6 Years HR = 0.80 (0.69–0.92) P = 0.002 LaRosa JC et al. N Engl J Med. 2005;352.

  11. TNT: Treatment effects on CHD death, MI Atorvastatin 10 mg 0.10 22% risk reduction Major CV events (%) 0.05 Atorvastatin 80 mg 0.00 0 1 2 3 4 5 6 Years HR = 0.78 (0.68–0.91) P < 0.001 LaRosa JC et al. N Engl J Med. 2005;352.

  12. TNT: Treatment effects on stroke 0.04 Atorvastatin 10 mg 0.03 25% risk reduction Major CV events (%) 0.02 0.01 Atorvastatin 80 mg 0.00 0 1 2 3 4 5 6 Years HR = 0.75 (0. 59–0.96) P = 0.02 LaRosa JC et al. N Engl J Med. 2005;352.

  13. TNT: Non-CV mortality % Atorvastatin % Atorvastatin 10 mg 80 mg Hazard ratio (N = 5006) (N = 4995) (95% CI) P Cancer 1.5 1.7 1.13 (0.83, 1.55) 0.42 Other nontraumatic causes 0.9 1.2 1.35 (0.91, 2.00) 0.13 LaRosa JC et al. N Engl J Med. 2005;352.

  14. TNT: Tolerability of treatments % Atorvastatin % Atorvastatin 10 mg 80 mg (N = 5006) (N = 4995) P Adverse events 5.8 8.1 <0.001 Discontinuation 5.3 7.2 <0.001 Myalgia 4.7 4.8 0.72 ALT/AST >3x ULN 0.2 1.2 <0.001 LaRosa JC et al. N Engl J Med. 2005;352.

  15. 30 4S Statin Placebo 25 4S 20 15 LIPID LIPID CARE CARE 10 HPS HPS TNT (10 mg atorvastatin) 5 TNT (80 mg atorvastatin) 0 70 90 110 130 150 170 190 210 0 LDL cholesterol (mg/dL) TNT: Extending and confirming benefit of LDL-C lowering beyond current guidelines Event(%) LaRosa JC et al. N Engl J Med. 2005;352.

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