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What does FLOW tell me about reflux at the 1 mg dose?

Asked 28 Aug 2025Modified 10 months agoViewed 11k times
18

The case in front of me: FLOW · reflux · 1 mg.

The figures are clear enough; the question is what they mean and what they do not.

I can supply the numbers if the specifics change the answer.

What can I legitimately conclude from this figure?

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askedwren_calloway23k3828 Aug 2025

2 Answers

Accepted answer first, then by votes
95

Accepted answer

Only what the 1 mg arm reported, and the denominator is that arm rather than the trial. Adverse-event tables are published per arm, so the 1 mg incidence of reflux has its own numerator and its own denominator, and pooling it with the other arms produces a figure that describes nobody. Two further deductions before you use it. Subtract the placebo arm — reflux occurs in people who received nothing, and the difference is the part attributable to the drug. And check whether FLOW counted events or counted participants: one participant with six episodes is one row in a participant count and six in an event count, and the two get quoted interchangeably. Nothing here is medical advice.

This is answerable from the published record, but only if you take the placebo arm seriously rather than reading the active arm alone.

Trial populations are selected. Exclusion criteria in this class routinely remove people with significant renal impairment, prior pancreatitis and unstable psychiatric illness, which is exactly the population the results are then quoted for.

Headline results, principal programmes

TrialAgentnDurationPrimary result
STEP 1Semaglutide 2.4 mg1,96168 wk−14.9 % vs −2.4 % weight
STEP 2Semaglutide 2.4 mg, T2DM1,21068 wk−9.6 % vs −3.4 % weight
SURMOUNT-1Tirzepatide 5/10/15 mg2,53972 wk−15 / −19 / −21 % weight
SURMOUNT-4Tirzepatide, withdrawal67088 wkContinued loss vs substantial regain
SELECTSemaglutide 2.4 mg17,604~40 moMACE HR 0.80 (0.72–0.90)
FLOWSemaglutide 1.0 mg, CKD3,533~3.4 yrRenal composite reduced; stopped early
SURMOUNT-OSATirzepatide, OSA46952 wkAHI reduced with and without PAP

Concretely, a composite endpoint is only as informative as its least serious component. Where a cardiovascular composite combines death, infarction and stroke, ask which component moved, because they are not interchangeable outcomes.

Where a result is quoted from a conference abstract rather than a peer-reviewed publication, the numbers routinely move between the two. It is worth checking which one you are reading.

The short version: check the endpoint, check the comparator, check who was excluded, then look at the number.

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answered · acceptedDr_Nadia_Farsi104k24724 Sept 2025
5This should be linked from the help pages. – charge_state_3 7 months ago
4Adding that the endpoint definition differs between the two trials being compared here. – Dr_Ilse_Vandenberg 5 months ago
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The short version: the effect is real, the magnitude depends on the population, and the population is usually the part that gets dropped when a result is quoted second-hand.

Duration decides what can be seen. A 68-week trial can measure weight and glycaemia; it cannot measure anything whose event rate is one per cent per year without enrolling tens of thousands.

Non-inferiority and superiority designs are not interchangeable. A non-inferiority result says the new agent is not meaningfully worse against a pre-specified margin — it does not say it is as good, and it certainly does not say it is better.

The cardiovascular outcome programme in this class runs to several large randomised trials — LEADER for liraglutide, SUSTAIN-6 and SELECT for semaglutide, REWIND for dulaglutide — and they are the reason the class is discussed as more than a weight intervention.

Quote the interval alongside the estimate and half the disagreements on this site would not start.

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answeredDr_Colm_Fitzhenry69k2476 Oct 2025
8The exclusion criteria are the most informative page in the supplement and nobody reads them. – harriet_lonsdale 12 days ago
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Ask PeptideStack is a static archive. Posting is closed, but the norms are worth stating: answer the question that was asked, show your working, cite the trial or the certificate, and say plainly where the evidence runs out.

Not medical advice. Research-use-only compounds are not approved for human use.