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ForumsCardiovascular OutcomesSOUL trial preliminary data — 6 month update

SOUL trial preliminary data — 6 month update

pete_RVA Mon, Oct 27, 2025 at 8:34 PM 9 replies 1,081 viewsPage 1 of 2
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pete_RVA
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Oct 27, 2025 at 8:34 PM#1

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 material.

So the question, as narrowly as I can put it: how to read a result like this without either dismissing it or over-reading it, since the summaries all read like press releases.

I would rather have one careful answer than five confident ones.

7 10mike_mod, SarahChen_PharmD, sarah.morrison and 4 others
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LarryQC_SD
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Oct 27, 2025 at 9:54 PM#2

Taking the question as asked, rather than the general version of it. Relative and absolute effects need reading together. A 20% relative reduction on a high baseline risk is a large absolute benefit; the same relative figure on a low baseline risk is a small one, and press summaries almost always quote the relative number because it is bigger.

Last edited: Oct 27, 2025 at 10:54 PM
8 11paul_denver, TinaHashiRN, robert_kc and 5 others
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DanielChem_CHI
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Oct 27, 2025 at 11:14 PM#3
LarryQC_SD said:
Relative and absolute effects need reading together.
LarryQC_SD 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 antihypertensives for stroke reduction. That's a strong clinical argument for this approach.

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oliver_london
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Oct 28, 2025 at 12:34 AM#4
pete_RVA 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…

This matches mine closely enough to be worth saying so. The gap between trial results and real-world results is consistent and it is not fraud. Trial participants get titration by protocol, scheduled contact, free drug and dietetic support; removing that infrastructure costs a few percentage points every time it has been measured. When your own curve sits below the published mean, that is the likeliest explanation before anything about you or your material.

Last edited: Oct 28, 2025 at 1:34 AM
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claudia_zurich
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Oct 28, 2025 at 8:17 AM#5

From the other side of the consultation, briefly.

Forest plot interpretation for the the trial evidence meta-analysis: when reading the pooled estimate, pay attention to:

  1. Point estimate (HR/RR/OR) — center of the diamond
  2. Confidence interval width — precision of the estimate
  3. I² statistic — heterogeneity across studies
  4. Individual study weights — are results driven by one large trial?
  5. Prediction interval — range of plausible true effects in future settings

The the trial evidence meta-analysis shows a pooled RR of 0.76 (95% CI 0.68-0.91), I²=49%. This is a robust and consistent effect.

Last edited: Oct 28, 2025 at 2:17 PM
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