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Evidence-based GLP-1 & peptide discussion since 2023
ForumsClinical Trials & ResearchCan we talk about how SLOW the FDA is Page 2

Can we talk about how SLOW the FDA is

KarenAZ_mom Mon, Apr 20, 2026 at 10:27 AM 38 replies 1,036 viewsPage 2 of 8
kate.chem
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Apr 20, 2026 at 1:58 PM#6
DataDave said:
Read four things before the headline number.

Filing a mild objection. Mild because I might be wrong; an objection because nobody has addressed the case that does not fit. 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.

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FDA_TrackerJim
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Apr 20, 2026 at 3:22 PM#7
KarenAZ_mom said:
I keep finding that the number in the press summary and the number in the paper are not the same number, and the difference is always in the same…

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 18,000 GLP-1 users vs matched controls showed reduced stroke risk (HR 0.82) over 4 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.
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chris_chi24
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Apr 20, 2026 at 4:45 PM#8
kate.chem 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 0.83 (95% CI 0.66-0.83), I²=41%. This is a robust and consistent effect.

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carl_compliance
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Apr 20, 2026 at 6:08 PM#9

Following on from tampaLisa73 — and this may be the naive question:

Did your prescriber agree with that reading, and if not what was their objection?

Last edited: Apr 20, 2026 at 9:08 PM
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KarenAZ_mom
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Apr 21, 2026 at 12:47 AM#10

Closing the loop on my own question.

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

37 12HPLC_Greg, LibrarianMeg, bri_stats and 34 others
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