Can we talk about how SLOW the FDA is

Dr.NateNeph 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.

If somebody has the primary source to hand I would rather cite it than paraphrase it.

KarenAZ_mom 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…

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 0.73 (95% CI 0.68-0.83), I²=31%. This is a robust and consistent effect.

LabKate said:

I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them.

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 all-cause mortality (HR 0.81) over 4 years of follow-up[1].

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

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

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

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.