NEW YORK – 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.”
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.”
