Contact:
Joe Muehlenkamp
Phone: 314.977.8015
muehlenk@slu.edu

January 20, 2004

When taken properly, ranolazine increases exercise capacity in patients with severe chronic angina.

ST. LOUIS -- A new study out this week offers some welcome news for the 6.6 million Americans who suffer from angina, a chronic condition that causes chest pain and limits a patient's work and other activities.

Bernard R. Chaitman, M.D., of Saint Louis University School of Medicine was the primary author of the study, appearing in the January 21 issue of The Journal of the American Medical Association (JAMA).

Chaitman and colleagues conducted the study to determine whether ranolazine (currently under review by the U.S. Food and Drug Administration) improves the total exercise time of patients who have symptoms of chronic angina and who experience angina and ischemia at low workloads despite taking standard doses of the other antianginal drugs such as atenolol, amlodipine or diltiazem.

Researchers discovered that when taken with other antianginal medications, the drug ranolazine reduces the frequency of angina and increases exercise capacity in patients with severe chronic angina. The study, a randomized, double-blind, placebo controlled trial, included 823 adult patients with symptomatic chronic angina who were randomly assigned to receive placebo or one or two doses of ranolazine. Patients treated at the 118 participating out-patient practice settings in several countries were enrolled in the Combined Assessment of Ranolazine In Stable Angina (CARISA) trial from July 1999 to August 2001 and were followed up through Oct. 31, 2002.

The patients received twice daily placebo or 750 mg or 1000 mg of ranolazine. Treadmill exercise at 12 hours ("trough," or lowest levels of the drug in the bloodstream) and four hours (peak, highest levels of the drug in the bloodstream) after dosing was assessed after two, six, and twelve weeks of treatment.

"We report the first evidence that ranolazine can reduce both angina frequency and nitroglycerin consumption when added to a standard dose of one of three frequently prescribed antianginal drugs: atenolol, amlodipine or diltiazem," the authors write. "The decrease in angina attacks vs. placebo were slightly less than one per week for those in the 750-mg and somewhat more than one per week for those in the 1000-mg ranolazine groups. Exercise duration after 12 weeks of ranolazine therapy increased by 115.6 seconds at trough for those taking ranolazine compared with 91.7 seconds for taking placebo."

The researchers add that ranolazine was without major adverse long-term survival consequences over one to two years of therapy.

Chaitman said that patients with angina report limitation of their work and other activities two to three times more frequently than what is reported by the general population. Despite myocardial revascularization, done largely to prevent angina, and antianginal drugs, up to 26 percent of patients still experience angina attacks.

(JAMA. 2004;291:309-316. Available post-embargo at JAMA.com)

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(Editor's note: To interview Dr. Chaitman please call Joe Muehlenkamp in SLU media relations at 314-977-8015 or Matt Shaw at 314-977-8018)