[Press Release] new phase 3 numbers, no publication yet, calm down
new phase 3 numbers, no publication yet, calm down. It is the sort of thing everyone half-believes and nobody writes down.
A confidence interval is the range of effects compatible with the data. Two trials with overlapping intervals have not disagreed, whatever their point estimates look like next to each other.
Cardiovascular outcome trials are powered for events, not for weight, and are typically run in a different population with different inclusion criteria. Reading a weight number out of one is reading a secondary endpoint.
Open-label extensions lose their randomisation. Anybody still enrolled at week 104 is a selected group and the numbers describe that group.
I will update this if the picture changes rather than quietly leaving it up.
best — the order this archive was captured in
Intention-to-treat analyses everybody randomised regardless of what they did afterwards. Completer analyses only those who finished. The second is systematically more flattering and both are legitimate if labelled.
The discontinuation numbers were the most useful thing in the paper for me and they were in a supplementary table.
Push back: an open-label extension tells you about the people who stayed. That is a different question.
a mean is not a promise
Read a press release and the publication three months apart. The hedging in the second one was substantial.
Went looking for the registered protocol to see whether the endpoint had changed. It had not, which was reassuring and worth checking.
Careful with that mean. The distribution around it was wide enough that it describes very few individual participants.
Discontinuation rates are a tolerability result. A trial with a strong efficacy number and heavy discontinuation is telling you two things and people only quote one.
Relative risk reduction without the baseline rate is uninterpretable. A large relative reduction on a small absolute risk is a small absolute benefit.
Not convinced. Cross-trial comparison between two programmes with different populations and designs is not a comparison.
Spent an evening with the appendix tables and found the subgroup detail that the entire thread had been speculating about.
check who the comparator was before you compare anything
Do you have the publication or the press release?
Correction: SURMOUNT is the obesity programme and SURPASS is the diabetes one. The figure you quoted belongs to the other one.
That is a relative risk reduction. Quoting it without the absolute numbers overstates the case considerably.
That is a relative risk reduction.
Agreed. And the interval, not the point estimate, is what the trial actually established.
The registered protocol is public. Comparing the registered primary endpoint with the reported one is a two-minute check and it is how outcome switching gets caught.
Small fix — that was the cardiovascular outcomes trial, so weight was a secondary endpoint and the population was different.
The press release said that; the publication says something more hedged. Worth reading both.
That is the 68-week readout, not the 72-week one. Different trial, different duration.
Absolute or relative risk reduction?
Compared myself to a trial mean for about six months before realising the trial arm had dietitian contact every fortnight.
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