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Working the FLOW renal composite into ARR and NNT - am I doing this correctly?

Asked 22 Apr 2025Modified 14 months agoViewed 7.3k times
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FLOW tested semaglutide 1.0 mg in people with type 2 diabetes and chronic kidney disease, and reported a hazard ratio of 0.76 for its composite kidney endpoint. I want to convert that into something I can reason about, so I have attempted the absolute arithmetic myself and I would like it checked, because I suspect I am making at least one error of principle.

My working: I took the event counts as roughly 331 of 1767 on semaglutide and 410 of 1766 on placebo. That gives 18.7% versus 23.2%, so an absolute risk reduction of 4.5 percentage points and a number needed to treat of about 22. Median follow-up was around 3.4 years, so I would state it as "22 people treated for 3.4 years to prevent one composite kidney event".

Where I am unsure: the composite includes kidney failure, a 50% eGFR decline, and death from kidney or cardiovascular causes. Those are not equivalent outcomes to a patient, so a single NNT covering all of them feels like it is hiding something. I also do not know whether comparing crude proportions is legitimate when the paper reports rates per 100 patient-years, and whether the eGFR slope result is telling me something the composite does not.

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askedesther_vandeVelde49k3822 Apr 2025
8Your arithmetic is right; the question of whether a single NNT for a heterogeneous composite is meaningful is the better question. – Dr_Fatima_Belkacem 9 months ago
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3 Answers

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Accepted answer

Your arithmetic is correct. Your discomfort about the composite is also correct, and it is the more important of the two points.

Checking the numbers

  • Semaglutide: 331 / 1767 = 0.1873, so 18.73%.
  • Placebo: 410 / 1766 = 0.2321, so 23.21%.
  • ARR = 23.21 - 18.73 = 4.48 percentage points.
  • NNT = 1 / 0.0448 = 22.3, so 23 treated over the trial horizon to prevent one composite event.
  • RRR = 4.48 / 23.21 = 0.193, about 19%, against a reported hazard ratio of 0.76, 95% CI 0.66 to 0.88 [1].

Note that the crude RRR of 19% and the hazard-ratio-implied 24% do not match exactly. That is expected and it is not an error. The hazard ratio is an average instantaneous rate ratio over follow-up from a proportional-hazards model; the crude proportion ratio ignores when events happened and who was censored. When event rates are as high as 20% and follow-up is long, the two diverge noticeably. Neither is wrong; they answer slightly different questions. For an NNT you want the absolute risk difference, so your route is the right one - just do not then quote the hazard-ratio percentage as if it were the same quantity.

On rates per 100 patient-years: those exist because differential follow-up makes crude proportions misleading. In FLOW, follow-up was reasonably balanced, so the crude approach is defensible. As a habit, if the paper reports both proportions and rates and they tell the same story, use proportions for absolute arithmetic. If they disagree, that disagreement is itself information about censoring and you should stop and read the flow diagram.

The composite is the real problem

The FLOW composite bundles onset of kidney failure (sustained eGFR under 15, initiation of dialysis, or transplantation), a sustained 50% or greater reduction in eGFR from baseline, and death from kidney or cardiovascular causes. A patient does not regard a 50% eGFR decline and a cardiovascular death as the same event, so one NNT covering both is an average over things that should not be averaged.

What to do instead: report the composite NNT, then report the components separately and let the reader see the composition. In FLOW the reassuring feature is that the components moved in the same direction rather than one dominating - the kidney-specific components and the death components both favoured semaglutide, and cardiovascular death separately showed a hazard ratio around 0.71, 95% CI 0.56 to 0.89, with all-cause death around 0.80, 95% CI 0.67 to 0.95 [1]. A composite whose components agree is far more interpretable than SELECT's, where stroke went the other way.

The eGFR slope is a different kind of evidence

Yes, and it is worth more attention than it usually gets. FLOW reported a mean annual eGFR slope difference of roughly 1.16 mL/min/1.73 m² per year in favour of semaglutide, 95% CI about 0.86 to 1.47.

Why that is informative independently of the composite: the composite is driven by threshold-crossing events, which are noisy and depend on where the thresholds sit. Slope uses every measurement from every participant and is far more efficient statistically. If a drug slowed decline you would expect both a slope difference and fewer threshold crossings, and seeing both is much stronger than seeing either alone. A composite benefit with a flat slope would suggest the composite was being driven by something other than progressive kidney disease.

The standard caveat applies: GLP-1 receptor agonists cause an early haemodynamic dip in eGFR in some people, so slope analyses in this class are usually reported both from baseline and from a post-initiation timepoint. Check which one you are reading before comparing to another agent's slope.

One structural point

FLOW used semaglutide 1.0 mg, the glycaemic dose, not the 2.4 mg obesity dose. Mean weight loss in FLOW was accordingly modest. Anyone arguing that renal benefit in this class is simply a consequence of large weight loss has to account for a renal composite moving substantially at a dose that does not produce large weight loss.

edited 10 Jun 2025 by sample_id — updated for the 2026 guidance change

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answered · acceptedsample_id17k2714 May 2025
The point that a composite with concordant components is more interpretable than one with a discordant component is exactly right. – sian_llewellyn 2 months ago
2The early eGFR dip catches people out when they compare slopes across trials with different reference timepoints. – marcus_thorbjorn 4 months ago
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Worth putting the three semaglutide outcome trials side by side with the arithmetic done consistently, because the NNTs differ by a factor of nearly three and the reason is entirely baseline risk rather than drug potency.

TrialPopulationDoseEndpointEvent rate drug vs placeboARRNNTHorizon
SELECTObesity + established CVD, no diabetes2.4 mg s.c. weekly3-point MACE6.5% vs 8.0%1.5 pp67~3.3 y mean
SUSTAIN-6T2DM, high CV risk0.5 / 1.0 mg s.c. weekly3-point MACE6.6% vs 8.9%2.3 pp44104 wk
SOULT2DM + ASCVD and/or CKD14 mg oral daily3-point MACE12.0% vs 13.8%1.8 pp56~4.1 y median
FLOWT2DM + CKD1.0 mg s.c. weeklyKidney composite18.7% vs 23.2%4.5 pp23~3.4 y median

Sources: [1] [2] [3] [4].

The relative risk reductions across these trials sit in a fairly tight band, roughly 14% to 26%, and the intervals overlap heavily. The absolute risk reductions vary far more, from 1.5 to 4.5 percentage points. That is the whole lesson of absolute versus relative risk in one table: a similar relative effect applied to a population with triple the baseline event rate produces triple the absolute benefit and a third of the NNT.

Two comparability warnings. SUSTAIN-6's horizon was 104 weeks against roughly three to four years for the others, so its NNT of 44 is over a shorter period and is therefore the most favourable per unit time - do not compare NNTs across different horizons without annualising. And FLOW's endpoint is a kidney composite, not MACE, so its 23 is not competing with the others; it is answering a different question in a population selected for kidney disease.

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answeredplate_count_9k95k15825 May 2025
5Annualising before comparing NNTs would fix most of the bad comparisons I see in this literature. – e_dziedzic 5 months ago
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One methodological addition on why the FLOW composite includes cardiovascular death at all, since it looks like endpoint padding and is not.

In advanced kidney disease, death is a competing risk for kidney failure. A participant who dies of a cardiovascular cause can never go on to reach dialysis, so a trial that counts only kidney events will systematically undercount progression in whichever arm has more deaths. If a drug reduced kidney failure but increased mortality, a kidney-only endpoint would flatter it. Including death in the composite removes that particular way of being fooled.

The cost is exactly the interpretive muddle raised in the question: the composite no longer maps onto a single patient-relevant outcome. Nephrology outcome trials generally accept that trade, and the convention is to report the composite as primary and every component separately, so the reader can reconstruct whichever version they care about.

If you are building a comparison table, record the exact composite definition for each trial rather than the label. "Renal composite" means different things in different programmes - some use 40% eGFR decline rather than 50%, some include albuminuria progression, some exclude cardiovascular death - and those definitional choices move event rates far more than most drug effects do.

None of the above is clinical advice, and kidney-relevant decisions in particular need someone looking at your actual eGFR trajectory and albuminuria rather than a trial average.

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answeredp_mkhize41k1385 Jun 2025

Your answer

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.