The FDA has approved the marketing of extended release (ER) ranolazine (Ranexa - CV Therapeutics) for treatment of chronic angina in patients who have not achieved an adequate response with other antianginal drugs. It should be used in combination with a nitrate, a beta-blocker or the dihydropyridine calcium-channel blocker amlodipine (Norvasc), and appears to be more effective in men. The labeling for ranolazine specifies amlodipine as the calcium-channel blocker of choice because the use of other dihydropyridines with ranolazine has not been studied, and use with diltiazem (Cardizem, and...

The FDA has announced changes in the labeling of simvastatin to reduce the risk of myopathy. These changes include limiting the use of the 80-mg maximum dose to patients who have been taking it for 12 months or more without evidence of myopathy and new recommendations for use of simvastatin with other drugs. Simvastatin is available alone (Zocor, and others) and in combination with ezetimibe (Vytorin) and with niacin (Simcor).

The FDA has approved the subcutaneously injected PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor alirocumab (Praluent – Sanofi/Regeneron) as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C). It was not approved for general use in statin-intolerant patients. Alirocumab is the first PCSK9 inhibitor to be approved in the US. Evolocumab (Repatha – Amgen), another PCSK9 inhibitor, was...