Heart Protection Study results published in The Lancet show benefits for diabetics, women, and the elderly

In the largest clinical study ever conducted with a cholesterol-modifying medication, simvastatin, marketed as LIPEX^® (simvastatin, MSD) in New Zealand, saved lives and significantly reduced the risk of heart attack and stroke in a broad range of patients at high-risk of 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 LIPEX for several distinct, at-risk patient populations, including diabetics, stroke victims, women and the elderly. The results of the Heart Protection Study was published in the July 6 2002 issue of the prestigious international medical journal, The Lancet.

In April 2002 LIPEX was made available fully subsidised after an agreement reached between PHARMAC and pharmaceutical company Merck Sharp & Dohme. Approximately 80,000 New Zealanders are currently prescribed LIPEX. According to PHARMAC there are approximately 300,000 New Zealanders who qualify for the subsidised statin but only 140,000 of these patients are actually taking a statin.

David Woolner, Medical Director at Merck Sharp & Dohme NZ says: "The results from this independent study demonstrates the significant implications the Heart Protection Study trial has for the New Zealand public. Coupled with the recent widening of access to statin treatment with the PHARMAC agreement we are definitely moving in the right direction to reduce the prevalence of heart disease in New Zealand."

The results of the 20,536 patient study, conducted by investigators at Oxford University, showed that LIPEX 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 percent and of death from coronary heart disease (CHD) by 18 percent. 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, LIPEX 40 mg, even if they did not have elevated cholesterol levels at baseline.

Lowers heart disease risk in Type I and Type II 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 I and Type II 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 LIPEX 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 LIPEX 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 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 percent 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 LIPEX 40 mg experience vascular disease risk reductions of at least one-third.

Excellent safety profile

The results from the Heart Protection Study offered additional, conclusive evidence of the excellent safety profile of LIPEX, 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 LIPEX 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 percent of more than 10,000 patients on LIPEX, and a slightly lower rate in the placebo group, had significantly elevated muscle enzyme levels. LIPEX 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 LIPEX 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 LIPEX 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.

About Merck, Sharp & Dohme

LIPEX is one of the many breakthrough medicines of Merck & Co., Inc., which operates in many countries as Merck Sharp & Dohme. LIPEX is used in addition to diet to modify cholesterol levels after diet and other non-drug measures have failed to achieve target levels.

Merck is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through joint ventures.

For more information on the Heart Protection Study go to www.hpsinfo.org

THINGS TO KNOW BEFORE USING LIPEX (simvastatin) 10, 20 & 40 mg tablets:
LIPEX is indicated for patients at high risk of coronary heart disease (CHD) or with existing CHD and as an adjunct (addition) to diet for patients with high cholesterol (hyperlipidemia).  LIPEX should not be taken by patients who have a hypersensitivity reaction, active liver disease, who are pregnant or nursing. Precaution should be taken when administering LIPEX to patients with muscle pain, increased creatine kinase, history of liver disease, raised liver function tests and children. Common side effects are: abdominal pain, constipation, flatulence. Rarely: muscle pain (myopathy), rhabdomyolysis and hepatitis. LIPEX is a fully subsidised, prescription only medicine, a prescription charge will apply. Consult your doctor to see if LIPEX is right for you, a normal doctors visit fee will usually apply. Use only as directed and if symptoms continue or you have side effects, see your doctor, pharmacist or health professional. Marketed by: Merck Sharp & Dohme (NZ) Limited, Newmarket, Auckland. For detailed prescribing information, consult the data sheet or consumer medicine information phone 0800 500 673) or refer to the Medsafe website www.medsafe.govt.nz . [MPI-ZCR-2]

® Registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.  Marketed in New Zealand by Merck Sharp & Dohme (New Zealand) Limited, 109 Carlton Gore Road, Newmarket, Auckland.  Tel: 0800 500 673.

For further information, contact:   Angela Hayes, Merck Sharp & Dohme (NZ) Ltd, Tel 09 523 6125 (DDI), mobile 021 621 211.

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