Reply to FDA removed black box warning for HRT

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Reply to "FDA removed black box warning for HRT"

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[quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous][quote=Anonymous]Re heart disease, the most important study is proably Hodis & Mack 2022, because it pulls together data from previous randomized trials, meta-analyses, and observational studies. This paper shows that timing is everything. When initiated in women <60 or <10 years since menopause, HRT reduces coronary heart disease events and all-cause mortality by roughly 30–50%, with no increase in stroke in this age/timing group. When started later, though, HRT shows no benefit and may be associated with increased risks. https://pmc.ncbi.nlm.nih.gov/articles/PMC9178928

There are plenty of other papers on the topic, but Hodis & Mack incorporate and synthesize them.

As with type 2 diabetes, HRT does not have FDA approval for prevention of heart disease.

And, similar to type 2 diabetes, The NAMS 2022 statement does not recommend starting HRT primarily to prevent cardiovascular disease, but they acknowledge that randomized trials, meta-analyses, and observational data suggest fewer cardiovascular events in *appropriately selected* (i.e. younger women who initiate HRT near menopause), and that overall benefits outweigh risks for most healthy symptomatic women <60 or within 10 years of menopause.[/quote]

Thanks. part of my concern with this research is that it uses (I believe) standardized dosages, types and delivery methods of hormones. Whereas there is much more varied in how HRT is actually prescribed in real life. [/quote]

The variability issue definitely affects FDA approval (a preventive indication requires a specific therapy, in a single dose/range, in a well-defined population). And it's likely why NAMS is so cautious about their language, even as they acknowledge the preventive benefits of HRT. But to your specific question, the studies linked to here -- which are the current gold standard (I hope we get more!) -- have included a range of HRT therapies, doses, and populations. The results are consistent across this variability, which actually strengthens rather than diminishes the case for HRT impact on prevention of these conditions. [/quote]

Yeah I’m going to need to see more than that. [/quote]

What specifically? [/quote]

Basically every assertion you made there is unsupported [/quote]

They’re…supported by the studies that have been linked to?

This is getting weird. [/quote]

The women who are passionate about opposing HRT use have cited nothing. It’s just bizarre. Why not let other women use in peace.[/quote]

As long as you mischaracterize the discussion as “opposing HRT,” you have zero credibility. Pointing out the limits of what we know is not opposing HRT. I don’t think there is any argument that HRT is effective for reducing hot flashes. Beyond that the risk benefit calculation for most women is very very complex and far from clear. 
[/quote]

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