New drug eases chest pain or angina


The American Heart Association (AHA) estimates that approximately 6.6 million Americans are affected with chronic angina.


The Food & Drug Administration has approved ranolazine (Ranexa, CV Therapeutics) for the treatment of chronic angina. The first in a new class of angina medications called fatty acid oxidation (pFOX) inhibitors, it is indicated for use in combination with the traditional antianginal agents amlodipine, beta-blockers, or nitrates.

The most commonly reported adverse events associated with ranolazine were dizziness, headache, constipation, and nausea. About 6% of patients discontinued treatment with ranolazine in clinical trials due to an adverse event, compared with 3% receiving placebo.

The package labeling states that ranolazine is contraindicated in patients with preexisting QT prolongation, or in patients taking QT-prolonging drugs (i.e., quinidine, sotalol, or dofetilide). Ranolazine is also contraindicated in patients with hepatic impairment and in patients taking potent or moderately potent CYP3A inhibitors (i.e., ketoconazole, diltiazem, verapamil, or macrolide antibiotics).

"Pharmacists should be fully knowledgeable about these drug interactions and communicate this vital information to their patients in order to ensure safe use of Ranexa," said Claude Clermont, R.Ph., a staff pharmacist at Newark Beth Israel Medical Center.

According to its maker, ranolazine should be initiated at 500 mg twice daily and increased to 1000 mg twice daily, as needed, based on clinical symptoms. No dosage adjustment is needed in patients with congestive heart failure or diabetes. The manufacturer recommends that, in patients receiving ranolazine, both baseline and follow-up electrocardiograms should be obtained to evaluate the effects on QT interval.

The company expects to launch ranolazine by the end of March.

THE AUTHOR is a writer and hospital pharmacist in New Jersey.

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