Atorvastatin for high risk patients and normal cholesterol (ASCOT-LLA)

The Headline

Lipitor prevents cardiovascular events in people with normal cholesterol

The Facts

The Big Idea: Major cardiovascular events can be reduced with atorvastatin in patients who are not dyslipidemic

Study Design: Multicenter, randomized, placebo-controlled trial

Outcomes Nonfatal MI and fatal CHD

Number of Patients 19342 randomized, 10,305 in lipid-lowering arm, 5168 atorvaststin, 5137 placebo

Type of Patients 40-79 yo with hypertension and total cholesterol less than 250. At least 3 of following risk factors: LVH, abnormalities on ECG,Diabetes, Peripheral Artery Disease, previous stroke or TIA, male, 55 or older, microalbuminuria or proteinuria, smoking, ratio of TC to HDL of >6, family history of premature CHD

Important ExclusionsCoronary artery disease, recent stroke, TG >400 gm/dl, heart failure, uncontrolled arrhythmias Interventions 10mg atorvastatin or placebo once daily

Duration 3.3 years

Statistics Kaplan-Meier & Cox’s proportional hazard

The Results

Outcomes in 3.3 years

Note that mortality difference is not statistically sigificant

For The Cynic

Funding Funded by Pfizer. The absolute risks in our fact box are not as impressive as the 36% reduction reported in the abstract. Note that you have to be very high risk to get the benefits listed. Even in this high risk group, you have a 97% chance of not having the primary outcome in 3 years. This improves to a 98.1% chance if you take atorvastatin. This is a real improvement however.

Atorvastatin 10mg/day reduces cardiovascular risk in high risk patients with normal cholesterol.

Reference

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 randomised controlled trial. The Lancet, Volume 361, Issue 9364, Pages 1149 – 1158, 5 April 2003