Two New Imaging Studies Show Higher Dose Lipitor Stopped the Progression of Atherosclerosis

Business Wire, March 26, 2007

New Results Build on Previous Data that Lipitor is the Only Statin to Show an Impact in Head-To-Head Imaging Trials

Separate Analysis Shows Lipitor Cuts the Risk of Coronary Events by Half in Recurrent Stroke Patients

NEW ORLEANS -- Pfizer said today that results from two new imaging trials showed that higher dose Lipitor stopped the progression of atherosclerosis in patients with coronary heart disease or familial hypercholesterolemia (FH). The trials, which were designed to investigate the efficacy of the former investigational compound torcetrapib in combination with Lipitor compared to Lipitor alone, were presented today at the annual meeting of the American College of Cardiology.

In the Lipitor arm of the ILLUSTRATE and RADIANCE 1 trials, patients took an average Lipitor dose of 23 mg and 56 mg respectively and experienced halting of the progression of atherosclerosis. In the ILLUSTRATE trial, treatment with Lipitor resulted in plaque regression in the most diseased part of the coronary artery. In contrast in the Lipitor arm of RADIANCE 2 patients took a low average Lipitor dose of 13 mg and progression of atherosclerosis was observed.

"From a clinical perspective, what is remarkable in these studies is that Lipitor was able to stop the progression of disease, including the most difficult to treat FH patients studied in RADIANCE 1," said Professor John Kastelein, lead investigator for two of the trials, and professor of medicine and chairman of vascular medicine at the Academic Medical Center in Amsterdam. "These trials build on the effects seen with Lipitor in numerous imaging trials."

Lipitor is the only statin to have been studied in head-to-head imaging trials. In the ASAP and ARBITER trials, which measured changes in cIMT, high-risk patients who took Lipitor 80 mg experienced regression in atherosclerosis compared with patients who took other statins. In the REVERSAL trial, Lipitor patients experienced a halting of plaque progression compared with pravastatin, and Lipitor patients experienced a significant reduction in the plaque volume in the most diseased segments compared with pravastatin as measured by IVUS.

According to Dr Michael Berelowitz, Senior Vice President of Pfizer's global medical division, "These results support previous studies where higher doses of Lipitor have demonstrated impact on atherosclerosis. However, while imaging findings are scientifically interesting, we know that physicians make clinical decisions based on proven cardiovascular outcomes."

Lipitor Offers Remarkable Benefit for Stroke Patients

In a new separate analysis from a landmark clinical trial known as the Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL), patients without heart disease, who had suffered a recurrent stroke or mini-stroke during the trial and took Lipitor 80 mg had a significant 53 percent reduction in the risk of major coronary events (death from cardiac causes, heart attack, or resuscitation after cardiac arrest).

"This is the first time a statin has been shown to provide coronary benefit for patients with recent stroke or mini-stroke," said Professor Henrik Sillesen, chairman of the department of vascular surgery at the University of Copenhagen in Denmark. "What is impressive is the magnitude of benefit seen with Lipitor in these high risk patients. The results show that aggressive lipid lowering with Lipitor addresses an unmet medical need."

"This adds to the wealth of scientific evidence which has consistently shown improved cardiovascular outcomes in a broad range of patients. Lipitor is the only statin that offers a unique and robust body of evidence that includes proven reductions in heart attacks and stroke, impressive average LDL lowering of 39 to 60 percent, and an established safety profile across a broad range of patients," said Dr Berelowitz.

Summary of Imaging Trials Results for the Lipitor Arm

The three, two-year clinical trials, involving over 2,800 patients were designed to investigate the efficacy of torcetrapib in combination with Lipitor compared to Lipitor alone on the progression of atherosclerosis as measured by coronary intravascular ultrasound (IVUS) or carotid B-Mode ultrasound. IVUS is a relatively new, three-dimensional method of imaging to measure the total plaque volume in a cross-section of the coronary artery wall over the length of the vessel. Carotid ultrasound measures the thickness between the inner and middle layers of the carotid artery wall (IMT). All three trials had a run-in phase in which all patients were treated with Lipitor and patients' doses were titrated until individual LDL-C goals were reached. Patients were then randomized to either a combination of torcetrapib and Lipitor or Lipitor alone. Patients remained on the same dose of Lipitor for the duration of the two year study.

ILLUSTRATE

In patients with coronary heart disease randomized to Lipitor, progression of atherosclerosis was halted. Patients took an average dose of 23 mg of Lipitor (n=446). There was no significant change from baseline in percent atheroma volume (0.19%) and there was a significant regression of plaque build-up in the most diseased segment of the coronary artery (-3.3mm3).