"One of these analyses suggests that even with the availability of low cost generics, intensive Lipitor therapy is a good economic value," said Dr. Peter Lindgren, managing director of European Health Economics in Stockholm, Sweden, and lead investigator of the economic evaluation of the Incremental Decrease in Endpoints through Aggressive Lipid Lowering (IDEAL) trial. "The economic impact of heart attacks and strokes in the U.S. alone totals more than $400 billion in medical care and lost productivity annually."
New IDEAL Health Economic Analysis
In a new post-hoc analysis of a subset of patients (n=999) in the IDEAL study that had acute coronary syndrome (i.e. had a heart attack less than two months prior to entering the study):
-- Hospitalization costs during the five-year trial were 21 percent lower for Lipitor 80 mg ($6,427 per patient) than for simvastatin 20 mg--40 mg ($8,179 per patient).
-- This finding was due to the significant 21 percent reduction in the risk of any cardiovascular event for these patients.
Even in a low cost generic market, treatment of acute coronary syndrome patients with Lipitor 80 mg is predicted to reduce cardiovascular events at an acceptable incremental cost over simvastatin 20 mg-40 mg.
On average in the U.S., coronary heart disease, including heart attacks, costs $ 96,467 in direct costs per patient, a stroke costs $59,429 and certain types of heart surgery cost $122,122.
"As physicians, payers and employers come under increasing pressure to reduce medical h ealthcare costs, this analysis provides them with additional support for offering intensive Lipitor therapy to help achieve improved and cost-effective cardiovascular outcomes for their patients," said Dr. Michael Berelowitz, senior vice president of Pfizer's global medical division.
This new analysis of patients with acute coronary syndrome is consistent with the health economic findings of the overall IDEAL trial of 8,888 patients.
Additionally, in a separate analysis of a large U.S. managed care database that was recently presented, Lipitor patients achieved a significant additional 14 percent reduction in the risk of cardiovascular events compared with patients taking simvastatin, even after adjustments for expected differences of LDL lowering based on dose.
"Together these analyses provide additional evidence for physicians who may be considering prescribing statins interchangeably using dose adjustments," said Dr Berelowitz.
About the Overall IDEAL Trial
IDEAL was an open-label trial of 8,888 patients who had had a previous heart attack comparing Lipitor 80 mg with simvastatin 20 mg-40 mg. There was an 11 percent reduction in the primary endpoint, major coronary events, in Lipitor patients compared to simvastatin patients, but this difference did not reach statistical significance. Based on a secondary endpoint, Lipitor reduced the risk of non-fatal heart attack by a significant 17 percent and the risk of any cardiovascular events by 16 percent compared with patients taking simvastatin 20 mg--40 mg.
In a subset of these patients (n=999) who had had a heart attack less than two months prior to entering the study, Lipitor 80 mg reduced the risk of heart attacks by 46 percent, major coronary events by 34 percent, and any cardiovascular event by 21 percent compared with simvastatin 20 mg--40 mg.
New Analysis of the Treating to New Targets (TNT) Trial
In a pre-specified analysis of more than 5,300 U.S. patient s with stable coronary heart disease from the TNT trial:
-- Lipitor 80 mg provided significantly better clinical outcomes at almost no additional cost over five years compared with Lipitor 10 mg (the five-year cost of the 80 mg dose was $181 more).
-- This finding resulted from a significant 15 percent reduction in both cardiovascular hospitalizations and a significant 27 percent reduction in revascularizations.
About the overall TNT Trial
The five-year TNT study involved 10,000 patients with both heart disease and elevated LDL levels. In this study, patients taking Lipitor 80 mg had a significant 22 percent reduction in the risk of major cardiovascular events over and above patients taking Lipitor 10 mg. In addition, patients treated with Lipitor 80 mg had a significant 26 percent reduction in the risk of hospitalization for heart failure.
Lipitor is the only statin proven to provide a combination of significant and proven cardiovascular event reductions, impressive average LDL lowering of 39 percent to 60 percent, and a well-established safety profile across a broad range of patients.
It is the most prescribed cholesterol-lowering therapy in the world, with nearly 133 million patient-years of experience. Lipitor is supported by an extensive clinical trial program involving more than 400 ongoing and completed trials with more than 80,000 patients.
Important US Prescribing Information
Lipitor is a prescription medication. It is used in patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of a heart attack and stroke, certain kinds of heart surgery and chest pain.
Lipitor is also used in patients with type 2 diabetes and at least one other risk factor for heart disease such as high blood pressure, smoking or complications of diabetes, including eye disease and protein in urine , to reduce the risk of heart attack and stroke.
Lipitor is used in patients with existing coronary heart disease to reduce the risk of heart attack, stroke, certain kinds of heart surgery, hospitalization for heart failure, and chest pain.
When diet and exercise alone are not enough, Lipitor is used along with a low-fat diet and exercise to lower cholesterol.
Lipitor is not for everyone. It is not for those with liver problems. And it is not for women who are nursing, pregnant or may become pregnant.
Patients taking Lipitor should tell their doctors if they feel any new muscle pain or weakness. This could be a sign of rare but serious muscle side effects. Patients should tell their doctors about all medications they take. This may help avoid serious drug interactions. Doctors should do blood tests to check liver function before and during treatment and may adjust the dose. The most common side effects are gas, constipation, stomach pain and heartburn. They tend to be mild and often go away.
For additional product information, visit www.Lipitor.com.
Vanessa Aristide, 212-733-3784
Rebecca Hamm, 212-733-8811