FDA_TrackerJim said:The gap between trial results and real-world results is consistent and it is not fraud.
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.
Correct me if the detail matters more than I have assumed.
SteveThurs 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 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.
[1] Registry-based cohort study, pre-print 2024.
DanielChem_CHI said:I would add the less popular caveat: these trial populations under-represented several groups, older adults and the highest BMI categories among them.
DanielChem_CHI said:...regarding the trial evidence...
I think this is an underappreciated point. To expand on it with some data:
A recent meta-analysis of 15 RCTs (n=12,300) found that the trial evidence was associated with a clinically meaningful effect size across diverse patient populations[1].
The NNT was 12, which is comparable to metformin for T2DM prevention. That's a strong clinical argument for this approach.
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View ResultsFollowing on from Dr.RaviCardio — and this may be the naive question:
Did your prescriber agree with that reading, and if not what was their objection?
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.