Authors
Sever PS, Dahlöf B, Poulter NR, et al.
Title
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
References
Lancet. 2003 Apr 5;361(9364):1149-58
Background
The lowering of cholesterol concentrations in individuals at high risk of cardiovascular disease improves outcome. No study to this point had assessed benefits of cholesterol lowering in the primary prevention of coronary heart disease (CHD) in hypertensive patients who are not conventionally deemed dyslipidemic.
Purpose
To determine the cardiovascular effects of atorvastatin, with placebo among patients who have total cholesterol concentrations of 6·5 mmol/L or less.
Design
  • Randomized, double-blind, placebo-controlled trial
  • 10,305 patients, age 40-79 years with either untreated hypertension (SBP>160mmHg, DBP>100mg) or treated hypertension with (SBP>140mm Hg or DBP>90mmHg).
  • Total cholesterol >6.5mmol/L and not taking a statin or fibrate
  • Required 3 additions risk factors of (LVH, DM2, PVD, TIA, male, age>55yrs, smoking, proteinuria, FHx premature CAD, or total chol/HDL>4)
Exclusion Criteria
  • Preceding myocardial infarction
  • Currently treated angina
  • TIA with previous 3 months
  • Triglycerides>4.5mmol/L
  • Heart failure
  • Uncontrolled arrhythmias
  • Any clinically significant biochemical lab abnormality
Follow-Up
Planned 5 years (stopped early after mean 3.3 years follow up)
Treatment Regimen
  • Atorvastatin 10mg or placebo
Results

Primary Endpoints

Non-fatal myocardial infarction and fatal CHD:

  • Atorvastatin reduced primary endpoint by 36% (HR 0.64; 95% CI 0.50-0.83; p=0.0005).

Secondary Endpoint

Atorvastatin reduced total cardiovascular events and procedures by (21%; p=0.0005), fatal and not fatal stroke by (27%; p=0.0236) and total coronary events by (29%; p=0.0005).

Non-significant reduction in all cause mortality, cardiovascular death

Summary
Important and large relative reductions in cardiovascular events associated with the use of atorvastatin 10 mg among a population of hypertensive patients who on average were, despite other risk factors, at only moderate cardiovascular risk, and who would not conventionally have been deemed dyslipidemic