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Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote

 
• By Bridget Silverman

A new indication for the generic diuretic in heart failure with preserved ejection fraction gets an 8-4 vote, with one abstention, despite troubles an analysis that tries to revive the TOPCAT trial with an analysis excluding Eastern European sites – or about half the participants.

top cat (shutterstock_160615241)
Advisory committee members found the secondary bowtie was more impressive than the top hat. • Source: Shutterstock

The US FDA’s Cardiovascular and Renal Drugs Advisory Committee voted in favor of an expanded heart failure indication for the generic diuretic spironolactone based on the TOPCAT trial, but the panelists were more persuaded by the effect on a secondary endpoint of hospitalization for heart failure than by the regional analysis presented at the 16 December 2020 meeting.

The case before the committee was difficult: should the FDA approve a new indication on the basis of a post-hoc analyses of a trial that missed its primary endpoint

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