New drug combination can significantly reduce risk of heart attack in about 90 days

Combining certain blood pressure lowering drugs with cholesterol reducing drugs in patients with moderate cardiac risk can reduce heart attacks by half - <em>News Release </em>

Issued by MediNews on behalf of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)

Under strict embargo for 08.01 GMT
Monday 4 December 2006

Combining certain blood pressure lowering drugs with cholesterol reducing drugs in patients with moderate cardiac risk can reduce heart attacks by half, according to new results from a large European study.

The study, published today in the European Heart Journal, shows that the risk of heart attack can be reduced by more than 50 percent by combining atorvastatin calcium, which reduces cholesterol, with amlodipine besylate, which lowers blood pressure. The benefits are evident as early as 90 days after the start of treatment.

The research was conducted as part of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), which involves over 19,000 patients in the UK, Ireland and the Nordic countries. This trial also showed that simultaneous initiation of atorvastatin and amlodipine is about three times more effective at preventing heart attacks than the usual treatment of adding atorvastatin, a statin, to one of the world's most widely used blood pressure-lowering drugs, a beta-blocker called atenolol.

The new drug combination reduced the risk of fatal and non-fatal cardiac events by 53%. Adding atorvastatin to atenolol only achieved a non-significant 16% reduction by the end of the study.

These results have major implications for physicians and their patients worldwide, according to a principal ASCOT investigator, Professor Peter Sever  of the International Centre for Circulatory Health at Imperial College London.

"ASCOT demonstrates that the risk of heart attacks can be more than halved in the many patients at moderate risk who doctors see every day. In addition, there is a reduction in strokes of more than 25 percent. This is achieved by combining two well known and widely-used drugs - amlodipine and atorvastatin," said Professor Sever.

"However, if we continue to use older blood pressure-lowering drugs, such as atenolol, and choose only to treat high blood pressure in isolation without giving a statin, we only confer a small part of this potential benefit. As a result, the risk of heart attacks and strokes remains unacceptably high in too many patients despite treatment to blood pressure targets," he added.

Results establish important hypothesis for future research

The differences in risk reduction between the two treatments may be explained by recent, ongoing laboratory studies. These suggest that amlodipine and atorvastatin may stabilize the fatty deposits in the walls of the arteries (atherosclerotic plaques) which can rupture to cause cardiovascular events such as heart attacks.

Professor Sever said: "The new data generate an important hypothesis that suggests a synergistic effect between atorvastatin calcium and amlodipine besylate, which goes beyond the effects of the individual drugs. This is an exciting possibility for future research, which we and other groups will be exploring."

The future of treatment

The ASCOT Study is resulting in a worldwide re-evaluation of the management of patients with a moderately increased risk of cardiac events. The importance of combining a contemporary blood pressure drug regimen based on a calcium channel blocker with a statin is gaining importance. Meanwhile, the use of beta blockers - except where they are specifically indicated - is being questioned.

"For the first time, these important data show that the selection of a blood pressure-lowering drug regimen combined with a statin may have significant clinical implications for preventing heart attacks. It is vital that we use the right combination from the start to maximise the reduction in cardiac risk," Professor Sever said.

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Note to editors

1. "Potential synergy between lipid-lowering and blood pressure-lowering in the Anglo-Scandinavian Cardiac Outcomes Trial Lipid-Lowering Arm" European Heart Journal 2006, Volume 27; 24: 2982-2988

2. About cardiovascular risk

   More that 330 million adults in Europe and North America suffer from high blood pressure, which also affects an additional 639 million men and women in the rest of the world. (The Lancet, January 2005)

   About 80% of people with high blood pressure have additional uncontrolled cardiovascular risks. (World Health Organisation).

3. About ASCOT

ASCOT is the largest European study of people with high blood pressure and more than three additional common cardiac risk factors, e.g. history of smoking, age over 55 years, diabetes, lipid abnormalities, etc. It included more than 19,000 men and women with high blood pressure who were at a moderate risk of strokes and heart attacks and without previous history of heart disease. To control their blood pressure, they received either the newer drug - a calcium channel blocker, amlodipine besylate - or a beta-blocker, atenolol. Where necessary, the ACE inhibitor perindopril or the diuretic bendroflumethiazide were added to control the blood pressure. Additionally, 10,000 patients also were treated with the cholesterol-lowering drug atorvastatin calcium or a placebo (dummy pill). This is the only major European study to date to combine these two treatment strategies.

The most commonly seen adverse events (AEs) in the amlodipine regimen were peripheral oedema and cough. The most commonly seen AEs in the atenolol regimen were dizziness and fatigue. No new, unexpected AEs were observed beyond those seen in previously published ASCOT results.

Further details can be found at the ASCOT Web site, www.ascotstudy.org