The higher rates of serious A.Es in the placebo patients shows...

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Duke2

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29/09/24

21:27

Post #: 75895280
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Originally posted by Mozzarc: ↑

Thanks Duke2, appreciate the reply, yes you are right but there is some questioning of the safety profile...

Here is what I'm finding:

Safety Events:

Serious adverse events occurred in 1436 patients (47.9%) in the empagliflozin group and in 1543 patients (51.6%) in the placebo group. Adverse events leading to discontinuation of treatment occurred in 571 patients (19.1%) in the empagliflozin group and in 551 patients (18.4%) in the placebo group.

and this...

Post hoc analyses of a large-scale trial of dapagliflozin in type 2 diabetes indicated that SGLT2 inhibition might not reduce the incidence of serious adverse heart failure outcomes in patients with heart failure and a preserved ejection fraction.⁷In contrast, benefits in such patients were reported in a trial with sotagliflozin, but the number of events was too small to allow for a reliable estimate of a treatment effect.

So I would think it's better than nothing, I think there is a patient subset it will work better for perhaps. I don't like the number of AE's, specially the serious ones! It will certainly take some time for us to address this indication, but eventually we should have better results at lower cost, well lower costs in terms of unwanted effects. Our safety profile is indeed, second to none.

Reference:

1) https://www.nejm.org/doi/full/10.1056/NEJMoa2107038

2) https://www.ultromics.com/articles/emerging-therapy-for-hfpef-the-role-of-sglt2-inhibitors#:~:text=SGLT2%20inhibitors%20were%20very%20recently,HF%20in%20patients%20with%20HFpEF.

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The higher rates of serious A.Es in the placebo patients shows the story there. EMPEROR-preserve enrolled patients already with NYHA II-IV symptoms, so naturally adverse event rate is high in both treatment and placebo groups. That second quote is why they did a dedicated trial to show SGLT2 effectiveness, it's the same quote in emperor trial itself.

But nonetheless, a massive area of need. Just like HFrEF was and is, each new treatment is added to the regime rather than replace the patients current drug. e.g. all HFrEF patients should be on all of ACE/ARNI, BB, Spiro, SGLT2 together if tolerated.

Here's hoping the story is the same for HFpEF... SLGT2... + iPPS! Fingers crossed.

PAR Price at posting: 19.0¢ Sentiment: Hold Disclosure: Held
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