Re: FDA approves "empagliflozin" for reducing risk of cardiovascular death, hospitalization among adult HFpEF patients

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dlee38

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Re: FDA approves "empagliflozin" for reducing risk of cardiovascular death, hospitalization among adult HFpEF patients

in response to

FDA approves "empagliflozin" for reducing risk of cardiovascular death, hospitalization among adult HFpEF patients

KOO-KOO2

posted on Apr 05, 2022 12:07PM

primary endpoitn was 'composite' so FDA granted approval based on primary composite endpoints.

FDA doesn't consider seriously secondary and/or exploratory outcomes if primary endpoint doesn't meet.

Empagliflozin is approved for pEF which doesn't really have treatments as opposed rEF which has many treatments. So, pEF is indeed a good population to go after (for RVX).

But, currently RVX is being tiraled in population with diabetes not heart failure. These are 2 diff. populations.

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