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 heartâs 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.
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.