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Treatment with Lipitor Reduces LDL-C, Halving Mortality in Patients with Diabetes and Coronary Heart Disease

LONDON, ENGLAND -- November 14, 2003 -- New data reinforces the benefits of aggressive lipid lowering in patients with coronary heart disease (CHD) and diabetes (DM).

In an important new subgroup analysis, of the 313 diabetes patients enrolled in the GREACE study, 93% in the structured care group receiving Lipitor reached the American National Cholesterol Education Program (NCEP) LDL cholesterol targets of <2.6mmol/L compared to only 4% of the usual care group1. Investigators saw early benefits after just sixth months of treatment and a 59% reduction in fatal and non-fatal major vascular events was observed by the twelfth month and remained at this level until the end of the study.1

Furthermore, treatment with Lipitor demonstrated a significant reduction in all-cause and coronary mortality and coronary morbidity in comparison to "usual" care. All-cause mortality was reduced by 52% (p=0.049) and coronary mortality by 62% (p=0.042).1

Paul Durrington said, "Statins are a proven method of reducing cholesterol levels and lowering heart disease. The excellent results of the GREACE study reinforce the need for early and effective lipid lowering in patients with diabetes and existing CHD. It is important that UK physicians are made aware of the substantial benefits statin therapy affords to such high-risk patients."

Around 70% of patients with diabetes have raised cholesterol levels, which is a major cause of CHD and cardiovascular disease.2 The GREACE study highlighted that only 12.5% of patients with diabetes and CHD receiving structured care experienced a major vascular event or died, compared to 30.3% on "usual" medical care.1

In the GREACE study, patients in the structured care group receiving Lipitor compared to usual care experienced a 49% reduction in their LDL cholesterol levels to a mean level of 2.5mmol/L and a 39% reduction in total cholesterol from 7.0mmol/L to 4.3mmol/L,1 statistically significant reductions. Triglycerides, a reliable indicator of CHD risk in the presence of elevate total and LDL cholesterol,1 also showed a significant reduction from 2.5 mmol/L to 1.6 mmol/L,1 a 34% decrease while HDL cholesterol levels increased by 8% from 0.9 mmol/L to 1.1 mmol/L.1The effects observed in the usual care group were negligible with total cholesterol and triglyceride levels being reduced by 3%.1

In the GREACE study, treatment with Lipitor was found to be cost effective. It was estimated that the structured care group had significantly fewer hospitalizations for recurrent CHD events and revascularization procedures than those on usual care, which offset 91% of the drug cost.1

The lead study investigator Dr Vasilios G Athyros, MD, Atherosclerosis Unit and Diabetes Centre of North Greece concludes, "Structured active management of dyslipidemia can help CHD patients with DM to achieve NCEP treatment goals and provide health benefits in terms of morbidity and mortality. Long-term atorvastatin treatment was safe and cost-effective, and achieved the NCEP LDL-C target goal in 93% of patients. It contributed thus to an early, by the 3rd year of treatment, reduction in total mortality, coronary mortality, coronary morbidity and stroke in the structured care arm by more than 50% compared to usual care. Hence, major and urgent steps should be taken to convince all physicians about the benefits of cost-effective statin treatment in secondary CHD prevention in patients with DM."

Stroke
Treatment with Lipitor demonstrated a significant reduction in stroke (68% (p=0.046) which was observed within a three year period.1 Stroke is the third most common cause of death in the UK and single biggest cause of disability among adults.3

About the GREACE study
GREACE is a study of 1,600 patients under the age of 75 with established CHD and raised LDL cholesterol levels (>2.6 mmol/L) and triglycerides (TG) <4.5mmol/L. The GREACE diabetes subgroup followed the progress of 313 people with diabetes mellitus and established CHD in Greece for a mean three year period. Of these, 161 received structured care with Lipitor and 152 received usual medical care comprising a low-cholesterol diet, weight loss, exercise and drug treatment including lipid-lowering agents. Patients in the structured group received a mean dose of 23.7mg of Lipitor, with a range from 10-80mg that was titrated to reach the NCEP LDL cholesterol goal of <2.6 mmol/L.

The study was developed and conducted independently by the Aristotelian University in Greece.

About Lipitor
Lipitor was first launched in the UK in 1997. Clinical studies demonstrate that Lipitor reduces LDL-C between 41% to 61%4 and triglycerides between 21% to 45% across the 10 mg to 80 mg dose range5.

Across the Lipitor dosage range, 95% of patients reached a target of < 2.6 mmol/L in a structured care setting6. It is well tolerated in clinical trials, even at maximum doses7. It is initiated more than any other statin worldwide8, offering over 62 million patient-years of real-world experience.8

References:

1. Athyros VG et al. Early Benefit from Structured Care with Atorvastatin in Patients with Coronary Heart Disease and Diabetes Mellitus. A subgroup analysis of the GREek Atorvastatin and Coronary-heart-disease Evaluation (GREACE) Study.
2. Department of Health. National Service Framework for Diabetes: Standards. London: Department of Health.
3. Department of Health. National Service Framework for Older People. London: Department of Health (March 2001).
4. Lipitor SMPC www.medicines.org.uk
5. Laskey OR et al. Assessment of LDL-C and Triglycerides efficacy of Atorvastatin at different starting doses in patients with Type 2 Diabetes. Presented at the International Diabetes Federation August 2003 Poster 583
6. Athyros V et al. Treatment with atorvastatin to the National Cholesterol Educational Program Goal Versus "Usual" Care in Secondary Coronary Heart Disease Prevention. Current Medical Research and Opinion 2002; 18: 4: 220-228
7. Newman CB et al. 2003 AMJCARDIOL 92 ;670-676
8. Data on file at017, Lipitor Patient Years Pfizer Ltd.


SOURCE: Ketchum

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