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Zocor (Simvastatin) Saves Lives In High-Risk Patients, Regardless Of Cholesterol Level, Study In Lancet Shows - Diabetics, Women, Elderly Benefit In Largest Cholesterol Study Ever

"Result With Massive Public Health Implications" - Primary Investigator

MONTREAL, QC -- July 5, 2002 -- In the largest clinical study ever conducted with a cholesterol-modifying medication, Zocor® (simvastatin) saved lives and significantly reduced the risk of heart attack and stroke in a broad range of patients at high-risk of coronary heart disease (CHD). These benefits were shown, even in patients with average or below-average cholesterol levels at study entry. In addition, the study demonstrated the life-saving benefits of simvastatin for several distinct, at-risk patient populations, including diabetics, stroke victims, women and the elderly. The results of the Heart Protection Study will be published in the July 6 issue of the prestigious international medical journal, The Lancet.

The results of the 20,536 patient study, conducted by investigators at Oxford University, showed that simvastatin given daily at 40 mg reduced the risk of heart attack and stroke by about one-fourth over the treatment period, which averaged 5.3 years. These results occurred regardless of the patient's sex, age or baseline cholesterol level. When adjusted for non-compliance (inadvertent or deliberate failure to take medication) in the trial, investigators estimate that the risk reduction among this broad population is
one-third.

The 69-hospital U.K. study demonstrated highly significant results at its primary endpoints by reducing the risk of death from all causes by 13 per cent and of death from coronary heart disease (CHD) by 18 per cent. During the study, all treatment groups received standard community-based medical care, which may have included cardiovascular medications such as aspirin, anticoagulants, nitrates, beta-blockers, calcium antagonists, and ACE inhibitors. The patient's personal physician could prescribe any of these treatments at any time and as the use of cholesterol modifying medication
became more and more accepted in the late 1990's such medication was also
allowed.

In a public statement issued by Oxford University, primary investigator Professor Rory Collins emphasized the importance of the trial. "The extent of the benefits of the Heart Protection Study, affected all population groups studied," he said. "In fact, it was a result with massive public health implications. Not only did we find that cholesterol-lowering treatment can protect a far wider range of people than was previously thought, but that the therapy we used in the study can prevent stroke as well as heart attack, in patients at risk of CHD even in people with already moderate or low cholesterol levels." The study demonstrated that patients at risk for heart disease benefited from the study's cholesterol-modifying therapy, simvastatin 40 mg, even if they did not have elevated cholesterol levels at baseline.

LOWERS HEART DISEASE RISK IN TYPE 1 AND TYPE 2 DIABETICS
With nearly 6,000 diabetes patients enrolled in the Heart Protection Study, it is the first trial designed to investigate the benefits of cholesterol-lowering therapy in Type 1 and Type 2 diabetics, with or without a prior history of heart disease or high cholesterol. The incidence of CHD events among the nearly 4,000 diabetic patients with no prior CHD was about a quarter lower in the patients allocated to receive simvastatin versus those in the placebo group. When adjusted for non-compliance, the Oxford investigators report that the incidence of coronary events in diabetics was approximately a third lower. In demographic terms, treatment with simvastatin 40 mg during a five-year period could be expected to prevent heart attacks, strokes or other major vascular events in 70 out of 1,000 patients with diabetes, aged 40 or older.

The study offers good news for the more than 2 million Canadians with diabetes, according to the Canadian Diabetes Association. "Heart disease is two to four times more common in people with diabetes, and also the most common complication of diabetes. The Heart Protection Study provides an important cardiovascular prevention opportunity for Canadians with diabetes," said Donna Lillie, Director, Research and Professional Education, Canadian Diabetes Association.

The World Health Organization estimates that, worldwide, there will be a two-fold increase in the number of diabetic patients to 300 million by 2025. "With diabetes reaching epidemic proportions, the Heart Protection Study reveals important new clinical insights for Physicians who treat patients with diabetes," said Dr. David Bilheimer, Merck Sharp & Dohme, vice president and medical director.

Benefits For Patients Without High Cholesterol
Patients with average or low cholesterol levels also achieved CHD risk reductions of about a quarter. When adjusted for non-compliance, Oxford researchers estimate that the risk of heart attack and stroke in this group would be reduced by one-third. Physician and lipid researcher, Roger Illingsworth, said "The Heart Protection Study amplifies and extends the benefits of simvastatin to more patients, particularly those with low cholesterol levels and the elderly. This study showed that simvastatin provided significant benefits for patients with high CHD risk factors. In particular, patients could live longer if they lower their LDL cholesterol levels with simvastatin 40 mg." For all patients in the Heart Protection Study, no matter what their cholesterol level, the risk of vascular events was reduced by a quarter, or by one-third with full treatment compliance.

Lower Heart Disease Risk In Women
The Heart Protection Study evaluated 5,082 women, or 25 per cent of the total patient population, making it the largest-ever statin trial involving women. While men achieved major vascular event risk reductions levels of about a quarter, for the first time researchers have shown a significant, comparable benefit in women when their cholesterol levels are reduced. In fact, when adjusted for non-compliance, the Heart Protection Study results show that women treated with simvastatin 40 mg experience vascular disease risk reductions of at least one-third.

Excellent Tolerability Profile
The results from the Heart Protection Study offered additional, conclusive evidence of the excellent tolerability profile of simvastatin which has been demonstrated in more than 15 years of clinical experience. Because many drugs are metabolized by the liver, elevated liver enzymes in treated patients are an indicator of drug-induced liver damage. The study showed no significant difference in liver enzymes elevations between the 10,269 patients taking simvastatin 40 mg and the 10,267 patients taking placebo. The incidence of significant muscle enzyme elevation, indicating possible muscle damage, was also extremely low in both groups. Only two-tenths of one per cent of more than 10,000 patients on simvastatin, and a slightly lower rate in the placebo group, had significantly elevated muscle enzyme levels. Simvastatin 40 mg was shown to be very well tolerated and to provide significant benefits in all high-risk populations, regardless of age, sex and cholesterol levels. According to Professor Rory Collins, "This trial confirms that at least 5 years of simvastatin 40 mg dosage is well tolerated."

Effects Of Vitamin Therapy Studied
The multi-center, double-blind, randomized, placebo controlled study was primarily designed to determine the cardiovascular and mortality effects of simvastatin 40 mg versus a placebo. In a separate component of the study, similar effects of antioxidant therapy (vitamins C and E and beta-carotene) in simvastatin versus placebo patients were evaluated. The results of the Heart Protection Study showed that this specific vitamin cocktail provided no evidence of cardiovascular or non-cardiovascular benefit or hazard in the groups studied. Other trials are ongoing to assess benefits of various vitamins in other patient groups.

Merck Frosst Canada & Co. is one of the country's leading research-based pharmaceutical companies. The Merck Frosst Centre for Therapeutic Research, one of the largest biomedical research facilities in Canada, has a mandate to discover new therapies for the treatment of respiratory, inflammatory and other diseases. In 2001, the company invested nearly $120 million in research and development in Canada. For its part, Merck Frosst Canada Ltd. markets an extensive line of cardiovascular products for high blood pressure, elevated cholesterol and heart failure as well as a broad range of vaccines.

Merck Frosst is a recognized leader in the treatment of arthritis, asthma, osteoporosis, HIV/AIDS, glaucoma, prostate disease, migraines and infectious diseases. Based in Montréal, Québec, Merck Frosst employs approximately 1,900 people including 300 of the world's leading scientific personnel. It is also firmly committed to science education and sponsors a number of programs designed to spark young people's interest in science. Merck Frosst Canada & Co. and Merck Frosst Canada Ltd. are affiliated companies of Merck & Co., Inc. of Whitehouse Station, New Jersey. Merck & Co., Inc. is a publicly traded company on the New York Stock Exchange under the symbol MRK.

(R) Registered Trademark Merck & Co., Inc., used under licence




SOURCE: , Merck Frosst Canada Ltd.,

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