Pfizer Inc said that patients taking its cholesterol-lowering medicine Lipitor (atorvastatin calcium) experienced 47 per cent fewer non-fatal heart attacks compared to patients receiving usual care, according to data presented at the annual American College of Cardiology meeting.
Patients taking Lipitor in the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events (ALLIANCE) trial also experienced a 17 per cent reduction in overall negative cardiovascular outcomes including cardiac death, heart attacks, strokes and hospitalizations compared to patients treated with usual care. Patients treated with usual care received cholesterol-lowering therapies prescribed by their physicians which included lifestyle changes such as modifications in diet, weight loss, exercise and drug treatment, if necessary.
"These results clearly show the important cardiovascular benefits of intensively lowering cholesterol with Lipitor and the additional benefits that it provides for patients already receiving usual care," said Dr. Donald Hunninghake, professor of medicine and pharmacology at the University of Minnesota the and principal investigator of the ALLIANCE study. "This study provides new insights for physicians in how to effectively manage patients who have high cholesterol-especially those who have not succeeded in reaching their recommended cholesterol goal levels with usual care."
The four-year study involved 2,442 patients with a history of coronary heart disease and was designed to determine whether intensive cholesterol-lowering with Lipitor across the full dose range of 10 mg to 80 mg would reduce cardiovascular events better than usual care. Patients enrolled in the study who were currently receiving cholesterol-lowering therapy had LDL cholesterol levels between 110 mg/dL and 200 mg/dL and patients who were not receiving any cholesterol-lowering therapy had LDL cholesterol levels between 130 mg/dL and 250 mg/dL.
Approximately 72 per cent of the patients who received Lipitor reached their recommended LDL cholesterol levels of less than 100 mg/dL compared to 40 per cent of patients treated with usual care.
"These results further support the efficacy and safety of Lipitor, across the full dose range in getting patients to goal levels, particularly those who are at a higher risk of developing heart disease," said Dr. Joseph Feczko, Pfizer's executive vice president of Global Research and Development and president of Worldwide Development. "Physicians can continue to not only feel confident in prescribing Lipitor, but also using Lipitor more intensively in their treatment regimen to get their patients to the recommended goal levels."
Current guidelines issued by the National Cholesterol Education Program (NCEP) encourage physicians to intensively treat patients with high cholesterol, particularly those with coronary heart disease or other major risk factors such as diabetes to levels under 100 mg/dL.
It is estimated that more than 105 million people in the United States have high cholesterol, which is a leading risk factor for heart disease-one of the leading causes of death in the United States. The most common risk factors for developing high cholesterol include age, family history, lack of exercise, obesity, smoking and ethnicity.
The REVERSAL (REVERSing Atherosclerosis with Aggressive Lipid-Lowering) trial, which was recently published in the Journal of the American Medical Association also provides insight into the benefits of intensive treatment. REVERSAL showed that patients intensively treated with Lipitor experienced a significant reduction in the progression of plaque build-up in the arteries. Ninety-seven percent of patients treated with Lipitor reached their recommended LDL-C cholesterol levels.
Since the introduction of Lipitor seven years ago, its safety and effectiveness have been supported through the Atorvastatin Landmark Program, an extensive clinical program with more than 400 ongoing and completed trials involving more than 80,000 patients. Lipitor is the leading cholesterol-lowering therapy in the world with more than 67 million patient years of experience.
Lipitor (atorvastatin calcium) is a prescription drug used with diet to lower cholesterol. Lipitor is not for everyone, including those with liver disease or possible liver problems, women who are nursing, pregnant, or may become pregnant. Lipitor is not indicated for the prevention of heart disease or heart attacks.
Patients who take Lipitor should tell their doctor about any unusual muscle pain or weakness. This could be a sign of serious side effects. Patients should also inform their doctor about any medications they are currently taking to avoid possible serious drug interactions. Prescribing physicians may do simple blood tests to monitor liver function before and during drug treatment. The most commonly reported side effects are gas, constipation, stomach pain and indigestion. They are usually mild and tend to go away.