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(Circulation. 1997;95:2335.)
© 1997 American Heart Association, Inc.

Articles

Cardiovascular and Renal Advisory Panel of the US Food and Drug Administration Considers Four Drugs

Dan M. Roden, MD

Vanderbilt University School of Medicine, Nashville, Tenn

	Introduction

 
As part of the US Food and Drug Administration's (FDA's) drug evaluation process, the agency turns to advisory panels for opinions on specific questions related to issues such as approval of new drug entities or changes in labeling. On February 27 and 28, 1997, the Cardiovascular and Renal Advisory Panel considered four drugs.

1. A fixed combination of hydralazine and isosorbide dinitrate (H-ISDN) as adjunctive therapy to digitalis and diuretics in congestive heart failure. V-HeFT (Veterans Administration Heart Failure Trial), an initial evaluation of vasodilator therapy in congestive heart failure, reported no effect of prasozin but did indicate a beneficial effect of H-ISDN versus placebo in patients with congestive heart failure. However, the mortality benefit was not statistically significant when protocol-defined methods of analysis were used. A follow up trial, V-HeFT II, compared enalapril with H-ISDN (without placebo) and found that the survival rate was significantly improved with enalapril. Given the superiority of enalapril versus H-ISDN in V-HeFT II, the clinical situations in which H-ISDN would be used were discussed. Patients intolerant of ACE inhibitors, with NYHA class IV heart failure, or already receiving ACE inhibitors were all considered; however, no data were available to evaluate the effects of the combination in these situations. Moreover, the usual standard is two positive trials, and V-HeFT II was not thought to provide confirmation of a benefit of H-ISDN. In addition, combination products generally require a demonstration of efficacy for both components; efficacy was lacking for H-ISDN. The application was not recommended for . . . [Full Text of this Article]

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