Lipitor Provided an Unexpectedly Potent Heart Benefit

Pfizer Inc.Pfizer announced that Lipitor® (atorvastatin calcium) 80 mg showed unexpectedly potent reduction in myocardial ischemia (a condition defined by insufficient blood supply and oxygen to the heart) in patients with chronic stable angina (chest pain). These results were presented at the annual meeting of the American College of Cardiology.

Lipitor significantly reduced the average number of ischemic events by nearly 70 percent and total duration of events by more than 60 percent from baseline to week 18 of the study, and sustained these effects until the end of the trial at week 26. In 60 percent of the patients treated with Lipitor, all ischemic events were completely eliminated by the end of the study. This resulted in a substantial decrease in angina attacks and need for nitroglycerin treatment.

"Ischemia is a serious condition in which the collective effect of minor untreated events can lead to a weakening of the heart muscle and the death of heart cells," said Professor John Deanfield, British Heart Foundation Vandervell Chair of Congenital Heart Disease, professor of cardiology at University College London and lead investigator of the Double-Blind Atorvastatin Amlodipine (DUAAL) study. "These findings were a pleasant surprise because statins are not part of the current standard of care for the treatment of angina."

About the DUAAL Study
The DUAAL study was a randomized, double-blind, multi-country study comparing Lipitor (n=103), Norvasc® (amlodipine besylate) (n=104) and a combination of the two (n=104) in patients with coronary artery disease and chronic stable angina. Patients received intensive usual care therapy for their coronary artery disease including beta- blockers, long acting nitrates and aspirin.

Lipitor also caused a significant reduction in C-reactive protein, a marker of inflammation that helps in identifying and stratifying individuals at risk for cardiovascular disease. The anti-ischemic results demonstrated by Lipitor alone were remarkably similar to those in patients taking Norvasc alone. Norvasc, a high blood pressure and anti-angina medication in the calcium channel blocker class, is a part of the standard of care for this patient population, so it was expected to have benefit on the patients studied. Norvasc also significantly reduced the average number of ischemic events by approximately 70 percent and total duration of events by more than 60 percent. This was mirrored by a substantial decrease in angina attacks and need for nitroglycerin treatment.

The combination of Lipitor and Norvasc also offered a significant reduction in ischemic events, but there was not an incremental benefit with the combination versus either Lipitor or Norvasc alone. Given the patient characteristics in this study along with the magnitude of ischemic benefits demonstrated by Lipitor and Norvasc individually, no additional benefits were demonstrated in the combination arm. The number of angina attacks and the need for nitroglycerin use was reduced to a similar degree as the ischemic events.

"Previous studies have suggested an anti-ischemic effect with Lipitor, but the magnitude of the benefit seen in this study is notable," said Dr. Rochelle Chaiken, vice president of Pfizer global medical. "This study complements the cardiovascular benefits of Lipitor in a broad range of patients as demonstrated in more than 10 completed cardiovascular outcomes trials involving Lipitor."

About Ischemia and Angina
Symptomatic myocardial ischemia is characterized by angina and affects more than 9 million Americans. People with any cardiovascular risk factor are at risk for developing ischemia.

Standard of care for the treatment of symptomatic ischemia typically focuses on reducing the heart’s need for oxygen or improving the supply of oxygen to the heart. This may include taking medications that slow the heart rate, reduce blood pressure and relax the blood vessels. Medication classes for ischemia include beta blockers, calcium channel blockers and nitrates.

About Lipitor
Lipitor is the only statin proven to provide a combination of impressive average LDL ("bad" cholesterol) lowering of 39 percent to 60 percent, significant and proven cardiovascular event reductions, 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 144 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.

For additional product information, visit www.Lipitor.com.

NORVASC is indicated for high blood pressure and angina. In clinical trials, the most common side effects for NORVASC versus placebo were edema (8.3 percent vs. 2.4 percent), headache (7.3 percent vs. 7.8 percent), fatigue (4.5 percent vs. 2.8 percent), and dizziness (3.2 percent vs. 3.4 percent). For additional product information, visit www.norvasc.com.

Most Popular Now

AstraZeneca enters license agreement with KYM Bios…

AstraZeneca and KYM Biosciences Inc.* have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targetin...

Pill for skin disease also curbs excessive drinkin…

Researchers from Oregon Health & Science University and institutions across the country have identified a pill used to treat a common skin disease as an "incredibly promi...

Pfizer's elranatamab receives FDA and EMA filing a…

Pfizer Inc. (NYSE:PFE) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the company's Biologics License Application (BLA) ...

Pfizer receives positive FDA Advisory Committee vo…

Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that avail...

"Semantic similarity" leads to novel dru…

The words that researchers use to describe their results can be harnessed to discover potential new treatments for Parkinson's disease, according to a new study published...

US FDA Advisory Committee votes to support effecti…

GSK plc (LSE/NYSE: GSK) announced that the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the avail...

Tumour cells' response to chemotherapy is driven b…

Cancer cells have an innate randomness in their ability to respond to chemotherapy, which is another tool in their arsenal of resisting treatment, new research led by the...

Nanosatellite shows the way to RNA medicine of the…

The RNA molecule is commonly recognized as messenger between DNA and protein, but it can also be folded into intricate molecular machines. An example of a naturally occur...

Gene and cell therapies to combat pancreatic cance…

Pancreatic cancer is an incurable form of cancer, and gene therapies are currently in clinical testing to treat this deadly disease. A comprehensive review of the gene an...

First nasal monoclonal antibody treatment for COVI…

A pilot trial by investigators from Brigham and Women's Hospital, a founding member of the Mass General Brigham healthcare system, tested the nasal administration of the ...

Digital twin opens way to effective treatment of i…

Inflammatory diseases like rheumatoid arthritis have complex disease mechanisms that can differ from patient to patient with the same diagnosis. This means that currently...

AI conjures proteins that speed up chemical reacti…

For the first time, scientists have used machine learning to create brand-new enzymes, which are proteins that accelerate chemical reactions. This is an important step in...