Lipitor Significantly Reduced the Risk of Serious Cardiovascular Events Compared With Simvastatin in an 80,000-Patient Analysis
March 02 2007 - 11:40AM
PR Newswire (US)
Real-World Implications for Patients, Providers and Healthcare
Systems Seeking Quality Care; Pfizer to Further Explore These
Benefits in Partnership with Others BUENA VISTA, Fla., March 2
/PRNewswire-FirstCall/ -- A retrospective analysis of a large U.S.
managed care database showed that patients who took Pfizer's
cholesterol-lowering medicine Lipitor(R) (atorvastatin calcium)
Tablets had a significant 14 percent reduction in the risk of
cardiovascular events, including heart attacks and strokes,
compared with patients who took simvastatin. Today, physicians and
healthcare plans are switching patients between what is believed to
be comparable LDL-lowering doses of statins and assuming that this
will result in similar cardiovascular benefits. To replicate
real-world physician and payor behavior, this study was rigorously
designed to adjust for expected differences of Lipitor and
simvastatin LDL lowering based on dose. Lipitor patients achieved a
significant additional 14 percent reduction in the risk of
cardiovascular events compared with patients taking simvastatin,
even after the dose adjustments. "This analysis is important for
physicians, employers and formulary directors at managed care
companies who are making real-world treatment decisions for
patients," said Dr. Robert Vogel, an author of the study and
professor of medicine at the University of Maryland. "This further
supports the cardiovascular benefits previously seen with Lipitor."
"This study is significant because it calls into question whether
statins should be prescribed interchangeably through simple dose
adjustments," said Dr. Michael Berelowitz, senior vice president of
Pfizer's global medical division. The analysis was presented at the
American Heart Association's 47th Annual Conference on
Cardiovascular Disease Epidemiology and Prevention. Confirms
Previous Study Netherlands analysis: In a previously published
real-world study of a general practice database with approximately
3,500 patients in the Netherlands, characteristics such as age and
cholesterol levels were measured and adjusted to account for
differences among statins. This analysis demonstrated a similar
finding to the analysis presented at the meeting. Patients taking
Lipitor had a significant 30 percent reduction in the risk of total
events compared with those taking other statins combined. Other
statins included simvastatin, pravastatin, fluvastatin, and
cerivastatin. Given the results of these two studies, Pfizer will
work with managed care organizations and other healthcare networks
to further understand the benefit of Lipitor compared to
simvastatin after adjustments to cholesterol levels. Further
Studies Planned "Based on these important findings, it would be
appropriate for health organizations responsible for lipid lowering
formulary and treatment decisions to evaluate their own data and
determine if they see similar findings," said Dr. Berelowitz. "We
expect that there will be upcoming publications and expanded
medical information that will continue to contribute to this
important discussion around the benefits of Lipitor." Key Points of
the Analysis Following are details of the analysis that showed the
14 percent event reduction: * Patients in the analysis (61,324
taking Lipitor and 19,585 taking simvastatin) had not used statins
in the previous six months. * The primary endpoint was defined as
hospitalization due to a heart attack, stroke, mini-stroke
(transient ischemic attack), chest pain (angina) or coronary artery
disease, vascular disease, or certain types of heart surgery. * The
primary endpoint was assessed after patients had been taking either
statin for at least three months. * The median observation time was
177 days. * To provide a rigorous comparison, the analysis adjusted
for differences in expected LDL lowering, prior cardiovascular
events and baseline characteristics between the treatment groups.
Additional Findings In a secondary analysis, which looked at event
reduction from day one of Lipitor therapy, patients achieved a
significant 26 percent cardiovascular risk reduction compared with
patients who took simvastatin. The differences in benefit for
patients who took Lipitor was apparent early within the first three
months and increased at a proportional rate during the observation
period compared with patients who took simvastatin. About Lipitor
Lipitor is the only statin with all the following criteria most
important for many physicians, patients and payers: significant and
proven cardiovascular event reductions, impressive average LDL
lowering of 39 percent to 60 percent, and a proven safety profile
across a broad range of patients. Lipitor is the most prescribed
cholesterol-lowering therapy in the world, with nearly 133 million
patient-years of experience. It is supported by an extensive
clinical trial program involving more than 400 ongoing and
completed trials with more than 80,000 patients. There have been
more than ten cardiovascular outcomes trials with more then 50,000
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 heart attack, stroke, certain kinds of heart surgery,
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 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 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 http://www.lipitor.com/.
DATASOURCE: Pfizer Inc CONTACT: Vanessa Aristide, +1-212-733-3784;
Rebecca Hamm, +1-212-733-8811 Web site: http://www.pfizer.com/
http://www.lipitor.com/ Company News On-Call: Pfizer's press
releases are available through PR Newswire's Company News On-Call
service on PRN's Web Site. Visit
http://www.prnewswire.com/comp/688250.html Company News On-Call:
http://www.prnewswire.com/comp/688250.html
Copyright