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

Outcome	Atorvastatin	Placebo
Fatal and NonFatal MI	1.9%	3%
Coronary Events	3.4%	4.8%
Death	3.6%	4.1%

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