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ForumsCardiovascular OutcomesSOUL trial preliminary data — 6 month update Page 2

SOUL trial preliminary data — 6 month update

pete_RVA Mon, Oct 27, 2025 at 8:34 PM 9 replies 1,081 viewsPage 2 of 2
KevinCompounds
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Oct 28, 2025 at 4:00 PM#6
anders_CPH said:
Read four things before the headline number.

I read this differently from anders_CPH, on substance rather than tone. 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.

12 15jennifer_SEA, tyler_CSCS, VanRx_Mike and 9 others
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wendy_avl
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Oct 28, 2025 at 11:43 PM#7
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…
pete_RVA said:
...regarding the trial evidence...

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

A recent meta-analysis of 18 RCTs (n=15,600) found that the trial evidence was associated with a robust effect size across diverse patient populations[1].

The NNT was 15, which is comparable to statins for secondary prevention. That's a strong clinical argument for this approach.

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Dr.GastroMayo
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Oct 29, 2025 at 7:26 AM#8
KevinCompounds said:
I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them.

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 0.77 (95% CI 0.70-0.87), I²=35%. This is a robust and consistent effect.

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rick_sfbay
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Oct 29, 2025 at 3:09 PM#9

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

What did you change at the same time, and can you separate the two now?

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pete_RVA
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Oct 31, 2025 at 4:14 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.

47 22Dr.LeslieOBGYN, MikeNYC_runner and 44 others
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