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Lipitor® - Preuve de réduction du risque de CV

Significant CV risk reductions across the spectrum of Cardio-Vascular Disease

Diabetes

  • CARDS: Atorvastatin 10 mg provided a significant reduction in CV events in patients with type 2 diabetes and ≥1 risk factor compared with placebo.1

 

Incidence of major CV events*

 

Coronary Heart Disease & Diabetes

  • TNT (diabetes): Atorvastatin 80 mg reduced the risk of major CV events by 25% (p=0.026) compared with Atorvastatin 10 mg in a post hoc analysis of patients with stable CHD and type 2 diabetes.2

 

Incidence of major CV events##

 

Patients with CV risk factors5

  • ASCOT-LLA trial:In patients with hypertension and ≥3 additional risk factors LIPITOR® 10 mg reduced the risk of non-fatal MI and fatal CHD by 36% compared to placebo.5^

 

Coronary Heart Disease

  • TNTð trial: In patients with CHD, Lipitor® 80mg reduced the risk of First Major Cardio Vascular Event by 22% (compared with LIPITOR® 10 mg): 8

 

Acute Coronary Syndrome

  • PROVE-IT ß : Atorvastatin 80 mg reduced the risk of death or a major CV eventΩ by 16% (p=0.005) compared with pravastatin 40 mg in patients with acute coronary syndrome.9

 

 

Incidence of death or major CV events Ω

 

Coronary Heart Disease

  • The ALLIANCE Study: Clinical Outcomes in Managed-Care Patients With Coronary Heart Disease Treated Aggressively in Lipid-Lowering Disease Management Clinics.7

 

Abbreviations:

* Primary endpoint=time to first occurrence of a major CV event, (MI including silent MI, unstable angina, acute fatal CHD, resuscilated cardiac arrest, coronary revascularization, or stroke)

** ARR: Absolute Risk Reduction

# RRR: Relative Risk Reduction

## CHD death, non-fatal non procedure-related Ml, resuscitated cardiac arrest, fatal or non-fatal stroke

^ Anglo-Scandinavian Cardiac Outcomes Trial – Lipid Lowering Arm (ASCOT-LLA): Double-blind, placebo-controlled study including 10,305

hypertensive patients treated with antihypertensive therapy and without a previous MI with TC ≤250 mg/dL (6.4 mmol/L) randomised to LIPITOR®

10 mg (n=5,168) or placebo (n=5,137). Patients also had ≥3 of the following additional CV risk factors: left ventricular hypertrophy, other specified abnormalities on ECG, type 2 diabetes, peripheral arterial disease, previous stroke or transient ischaemic attack, male sex, age ≥55 years, microalbuminuria or proteinuria, smoking, plasma TC:HDL-C ratio ≥6 or family history of premature CHD. Primary endpoint: non-fatal MI and fatal CHD. Mean baseline LDL-C and HDL-C were 132 and 50 mg/dL (3.4 and 1.3 mmol/L). The ASCOT-LLA study was stopped after 3.3 years of a planned five-year follow-up due to a significant reduction in cardiovascular outcomes among hypertensive patients with normal cholesterol levels who were on Lipitor® treatment.

ð TNT: Treating to New Targets Investigators

ß Pravastatin or Atorvastatin Evaluation and Infection Therapy

Ω Major CV events: MI, unstable angina requiring hospitalization, revascularization, and stroke

‡ ALLIANCE (Aggressive Lipid-Lowering Initiation Abates New Cardiac Events): Prospective, “real-world” study in which 2,442 patients with known CHD and hyperlipidaemia (LDL-C 110-200 mg/dL [2.8-5.2 mmol/L] for lipid-treated patients, 130-250 mg/dL [3.4-6.5 mmol/L] for untreated patients) were randomised to aggressive treatment with LIPITOR® (n=1,217) or usual care (n=1,225) and followed for a mean of 51.5 months. LIPITOR®- treated patients were titrated to LDL-C goals of <80 mg/dL (2.1 mmol/L) or a maximum dose of 80 mg/day. Mean dose of LIPITOR® was 40.5mg/day. Usual-care patients received any treatment deemed appropriate by their physicians, including lipid-lowering treatment. The primary efficacy endpoint was the time from randomisation to the first occurrence of a primary cardiovascular event (cardiac death, non-fatal MI, resuscitated cardiac arrest, cardiac revascularization or unstable angina requiring hospitalisation).

† Primary CV events: cardiac death, non-fatal MI, resuscitated cardiac arrest, cardiac revascularization and unstable angina requiring hospitalisation.

References: 
  1. Colhoun HM et al. Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre, randomized, placebo-controlled trial. Lancet 2004;364:685-96.
  2. Shepherd J et al. Effect of lowering LDL cholesterol substantially below currently recommended levels in patients with coronary heart disease and diabetes: the Treating to New Targets (TNT) study. Diabetes Care 2006; 29:1220-26.
  3. Hitman GA et al. Stroke prediction and stroke prevention with atorvastatin in the Collaborative Atorvastatin Diabetes Study (CARDS). Diabet Med 2007; 24:1313-21.
  4. Lipitor® SmPC Jan 2014.
  5. Sever PS et al. for the ASCOT investigators. Prevention of coronary and stroke events with atorvastatin in hypertensive patients who have average or lower-than-average cholesterol concentrations, in the Anglo-Scandinavian Cardiac Outcomes Trial – Lipid Lowering Arm (ASCOT-LLA): a multicentre, randomized, controlled trial. Lancet 2003; 361:1149-58.
  6. Sever, P.S., et al. Different Time Course for Prevention of Coronary and Stroke Events by Atorvastatin in the Anglo-Scandinavian Cardiac Outcomes Trial–Lipid-Lowering Arm (ASCOT-LLA). Am J Cardiol 2005, 96; pp.39F–44F.
  7. Koren MJ, Hunninghake DB, on behalf of the ALLIANCE Investigators. Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the ALLIANCE study. J Am Coll Cardiol 2004; 44:1772-79.
  8. LaRosa JC et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med 2005; 352:1425-35.
  9. Cannon, C.P., et al. Intensive versus Moderate Lipid Lowering with Statins after Acute Coronary Syndromes. N Engl J Med 2004, 350; pp.1495-1504.