Coronary Heart Disease Patients Benefit From Intensive Lipid Lowering

Main Category: Heart Disease
Also Included In: Cholesterol
Article Date: 09 Mar 2005 - 10:00 PST

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Treating patients with established coronary heart disease (CHD) to below the current US NCEP LDL cholesterol target significantly reduces deaths from heart attacks and stroke according to a new study announced at the American College of Cardiology today.1

In the Treating to New Targets (TNT) study, 10,000 patients with marginally elevated LDL cholesterol levels (3.4mmol/L or below) were treated with either 10mg atorvastatin (to the current NCEP target of LDL cholesterol 2.6mmol/L) or 80mg atorvastatin (to a LDL cholesterol target of 1.9 mmol/L).1

After five years of treatment, patients on atorvastatin 80mg had 22% fewer major cardiovascular events (the primary endpoint) than those on the 10mg dose (P<0.001). The patients on higher dose also benefited from a 25% reduction in stroke (P=0.02).1

"The findings from TNT have important implications for the management of heart disease and support the need for more aggressive treatment in people with this condition," commented Professor James Shepherd, Honorary Consultant in Pathological Biochemistry, University of Glasgow and one of the study investigators.

TNT involved patients with existing CHD from 14 countries including the UK. After an 8-week run with all patients on 10mg atorvastatin, those with LDL cholesterol levels below 3.4 mmol/L (10,000) were randomised to receive atorvastatin 10mg or 80mg and followed up for a median of 4.9 years. The primary endpoint was the occurrence of a first major cardiovascular event, defined as death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest or fatal/nonfatal stroke.

During the trial, patients on 80mg atorvastatin had an average LDL cholesterol level of 2.0mmol/L and those on 10mg atorvastatin had an average of LDL cholesterol of 2.6 mmol/L.

Atorvastatin was well tolerated at both doses. The study also confirmed that the musculoskeletal safety profile of Lipitor 80mg is comparable to the 10mg dose. The incidence of liver enzyme elevations in both groups was within the existing product labelling. TNT is the longest and largest study to date of Lipitor 80mg efficacy and safety.

Notes to editors

Lipitor is currently licensed for the reduction of cholesterol in hypercholesterolaemic patients.

In TNT, both doses of atorvastatin were well tolerated with the adverse event profiles consistent with previous large-scale trials of the treatment.2,3

As expected from previous studies, more patients on 80mg atorvastatin experienced side effects than those on 10mg atorvastatin (8.1% vs. 5.8% P<0.001). For example, persistent elevations in amino transferase levels occurred in 1.2% of patients on the higher dose compared to 0.2% in those on the lower dose (P<0.001). The adverse event profile was in line with the current datasheet for atorvastatin.

During the study, there were no elevations of creatinine kinase and five cases of rhabdomyolysis were reported by study investigators, none of which met the ACC criteria for rhabdomyolysis. Of the rhabdomyolysis cases, three occurred the 10mg atorvastatin arm and two in the 80mg atorvastatin arm.

There was no significant difference in death from noncardiovascular causes between the two groups P=0.06. Cancer accounted for more than half the noncardiovascular deaths, with 75 deaths in patients on 10mg atorvastatin and 85 in patients on 80mg atorvastatin (the difference was not significant P=0.42).

The study was not powered to detect changes in the risk of death from any cause.

For further information, please contact:

Di Burrows
Ketchum
Tel: 020 7611 3520
dianne.burrows@ketchum.com

Gareth Field
Ketchum
Tel: 020 7611 3668
gareth.field@ketchum.com

References

1 LaRosa JC, Grundy SM, Waters DD, et al. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Eng J Med 2005;352 (online version).

2 Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet 2002;360:7-22.

3 Cannon CP, Braunwald E, McCabe CH, et al. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Eng J Med 2004;350:1495-504. No significant increase in adverse events of any type was identified among patients who had very low levels of cholesterol (less than 1.8 mmol/L) compared to those with higher levels.

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