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Impact of Atorvastatin on Cardiovascular Events on Older Patients Similar to Benefit in Younger Patients: Presented at ISC

By Cameron Johnston

KISSIMMEE, FL -- February 21, 2006 -- A large 2003 study showed that the use of atorvastatin significantly reduced the risk of non-fatal myocardial infarction (MI) and fatal coronary heart disease (CHD) by as much as 36% among patients who were hypertensive but did not have high cholesterol or a history of prior cardiovascular events.

A previous trial of statin therapy (PROSPER) failed to show significant benefit of pravastatin in preventing stokes in older patients, and it has been suggested that this implies a lack of efficacy of statins in this population.

However, a new analysis of the data from the Anglo Scandinavian Cardiac Outcome Trial (ASCOT) seems to suggest that the benefit among patients over the age of 65 years is similar to that seen in younger patients.

The updated information was presented in a poster session here on February 16^th at the International Stroke Conference (ISC).

In the large study, 10,305 patients with CHD were randomized to receive either atorvastatin 10 mg/day or placebo. They were supposed to be followed for 5 years, but the study was truncated at 3.3 years because the treatment benefit of atorvastatin was so profound.

In the sub-analysis, outcomes in 4445 patients 65 years and older was compared with the effect in 5680 patients younger than 65 years.. These patients were hypertensive and had at least two other cardiovascular risk factors, including type 2 diabetes, history of smoking, history of cardiovascular disease, peripheral artery disease, abnormalities on electrocardiogram, and normal to moderately elevated cholesterol.

In both sub-groups, the primary endpoint of non-fatal myocardial infarction (MI) and fatal coronary heart disease (CHD) as well as total cardiovascular events was significantly reduced among patients receiving atorvastatin compared with placebo.

These benefits occurred early and appeared to continue throughout the study, according to the study authors, headed by Neil R. Poulter MD, Professor of Preventive Cardiovascular Medicine, Imperial College School of Medicine, and President, the British Hypertension Society, London, United Kingdom.

The actual benefits realized were a 37% decrease in the rate of non-fatal MI and fatal CHD (hazard ratio [HR] 0.63), a 21% decrease in the total number of cardiovascular events or procedures (HR = 0.79) and a 30% decrease in total coronary events (HR = 0.70). All of these findings were statistically significant and similar to the benefit in the younger age group.

In the study cohort as a whole there was a reduction in stroke of 27 % (P =.0236). There were 63 first strokes in older patients taking atorvastatin and 81 in those taking placebo (2.9% vs. 3.6%). This 20% reduction in stroke in the older patients did not reach statistical significance, but because of the small numbers of strokes in these patients, this subgroup analysis had very little power to confirm stroke prevention in this older group.

The outcome in both the younger and older groups were not significantly different from those in the whole ASCOT group (test for heterogeneity P =.43), so the benefit is likely to apply to all the patients.

None of the stand-alone trials has seen enough stroke-events to answer the question of whether cholesterol lowering prevents stroke in the elderly.

The authors reported that the data from ASCOT had since been incorporated into a larger meta-analysis which included more than 90,000 patients (the Cholesterol Treatment Trialists Collaboration). That meta-analysis demonstrated a 17% reduction in the incidence of stroke for every 1 mmol reduction in total cholesterol (37.8 mg/dL). And while levels of low-density lipoprotein (LDL)-cholesterol achieved were good predictors of stroke risk in the entire cohort of the meta-analysis, the benefit was not altered by patient age. The actual incidence of stroke in the meta-analysis was 3.0% among statin users versus 3.7% in groups assigned to placebo.

According to the Dr. Poulter, because stroke is more common in older patients, the actual number of strokes prevented in elderly patients through lipid lowering is likely to be greater, rather than less.

The authors concluded that although there is much concern about prescribing too many medications for elderly patients, the addition of lipid-lowering agents to the existing regimens in these studies did not lead to any additional complications from polypharmacy.

The drugs were tolerated as well in older patients as they were in younger patients and the benefit in terms of reduced non-fatal MI and fatal CHD (and stroke if you allow the data from the CTT meta-analysis) may outweigh the risks of taking these additional drugs, they said.


[Presentation title: Impact of Atorvastatin on Cardiovascular Events in 4445 Men and Women Aged 65 Years and Above: Evidence from the Anglo-Scandinavian Cardiac Outcomes Trial-Lipid Lowering Arm (ASCOT-LLA). Poster 244]

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