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ForumsCardiovascular OutcomesSOUL trial preliminary data — what worked for you? Page 2

SOUL trial preliminary data — what worked for you?

Dr.KarenChen Thu, May 16, 2024 at 2:46 PM 13 replies 2,080 viewsPage 2 of 3
BethLabQueen
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May 17, 2024 at 1:31 AM#6
VendorMark said:
Read four things before the headline number.

This is where I part company with the consensus forming above. I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them. The results probably generalise, and "probably" should be stated as an assumption rather than dropped.

31 1maya_sedona, stefan_berlin, Dr.EM_Chicago and 28 others
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lucas_SP_BR
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May 17, 2024 at 5:46 AM#7
Dr.KarenChen said:
My own curve sits about four points below the published mean and I spent two months assuming that meant something was wrong with me or with my…

Propensity score matching studies and the trial evidence: when RCTs aren't available for a specific question, propensity score-matched observational studies can provide useful evidence.

A recent PSM study of 12,000 GLP-1 users vs matched controls showed reduced stroke risk (HR 0.82) over 3 years of follow-up[1].

These results complement the RCT data and suggest the benefits translate to real-world populations.

References:
[1] Registry-based cohort study, pre-print 2024.
30 0Dr.ObesityLA, NurseKim_ATL, paul_denver and 27 others
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TrialNerd_Beth
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May 17, 2024 at 10:01 AM#8
BethLabQueen said:
I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them.
BethLabQueen said:
...regarding the trial evidence...

I think this is an underappreciated point. To expand on it with some data:

A recent meta-analysis of 22 RCTs (n=18,900) found that the trial evidence was associated with a consistent effect size across diverse patient populations[1].

The NNT was 20, which is comparable to metformin for T2DM prevention. That's a strong clinical argument for this approach.

Last edited: May 17, 2024 at 2:01 PM
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PeptideSynthNJ
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May 17, 2024 at 2:16 PM#9

One thing that is still open after mike_mod’s answer:

How long did you give it before you decided it was working?

28 23MikeKY_noInsulin, Dr.RaviCardio, jennifer_SEA and 25 others
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Dr.KarenChen
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May 18, 2024 at 10:41 AM#10

OP back with an update, since a thread like this is useless without one.

Follow-up: I read the paper rather than the summary and the qualifier I was missing was in the second paragraph of the results.

10 8sarah_nash92, FitDadDave, RunnerRach and 7 others
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