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The novel england journal of medication

n engl j med 391;2 nejm.org July 11, 2024 109

established in 1812 July 11, 2024 vol. 391 no. 2

From the University of Unique South Wales, Sydney (V.P.); the Division of Nephrolo- gy, University of Washington Faculty of Medication, Seattle, and Providence Medi- cal Research Center, Providence Inland Northwest Health, Spokane — both in Washington (Okay.R.T.); Steno Diabetes Cen- ter Copenhagen, Herlev (P.R.), the De- partment of Clinical Medication, University of Copenhagen, Copenhagen (P.R.), and Novo Nordisk, Søborg (F.M.M.B., T.I., H.B.-T., N.L.L.) — all in Denmark; Stan- ford Center for Clinical Research, Leave- ment of Medication, Stanford Faculty of Medication, Palo Alto, CA (Okay.W.M.); KfH Kidney Center, Munich, and University Clinic, Friedrich-Alexander University, Erlangen — both in Germany (J.F.E.M.); the Division of Medication, American Heart Affiliation Entire Hyper- tension Center, University of Chicago Medi- cine, Chicago (G.B.); and AdventHealth Translational Research Institute, Orlando, FL (R.P.). Dr. Perkovic also can additionally be contacted at vlado . perkovic@ u.s.a. . edu . au or at the Chancellery, University of Unique South Wales, Sydney, NSW 2052, Australia.

*The FLOW Trial Committees and Inves- tigators are listed in the Supplementary Appendix, accessible at NEJM.org.

This text became once published on Might just 24, 2024, and updated on September 17, 2024, at NEJM.org.

BACKGROUND Patients with kind 2 diabetes and chronic kidney illness are at excessive risk for kidney failure, cardiovascular events, and death. Whether medication with semaglutide would mitigate these dangers is unknown. METHODS We randomly assigned sufferers with kind 2 diabetes and chronic kidney illness (outlined by an estimated glomerular filtration price [eGFR] of 50 to 75 ml per minute per 1.73 m2 of body-floor blueprint and a urinary albumin-to-creatinine ratio [with albu- min measured in milligrams and creatinine measured in grams] of >300 and <5000 or an eGFR of 25 to <50 ml per minute per 1.73 m2 and a urinary albumin-to-creati- nine ratio of >100 and <5000) to receive subcutaneous semaglutide at a dose of 1.0 mg weekly or placebo. The vital consequence became once vital kidney illness events, a compos- ite of the onset of kidney failure (dialysis, transplantation, or an eGFR of <15 ml per minute per 1.73 m2), at the very least a 50% discount in the eGFR from baseline, or death from kidney-associated or cardiovascular causes. Prespecified confirmatory secondary out- comes were tested hierarchically. RESULTS Among the 3533 contributors who underwent randomization (1767 in the semaglutide community and 1766 in the placebo community), median follow-up became once 3.4 years, after early trial end became once instant at a prespecified interval in-between diagnosis. The risk of a vital-consequence tournament became once 24% lower in the semaglutide community than in the placebo community (331 vs. 410 first events; hazard ratio, 0.76; 95% self assurance interval [CI], 0.66 to 0.88; P = 0.0003). Results were same for a composite of the kidney-explicit com- ponents of the vital consequence (hazard ratio, 0.seventy 9; 95% CI, 0.66 to 0.94) and for death from cardiovascular causes (hazard ratio, 0.71; 95% CI, 0.56 to 0.89). The implications for all confirmatory secondary outcomes most fashioned semaglutide: the point out annual eGFR slope became once less steep (indicating a slower lower) by 1.16 ml per minute per 1.73 m2 in the semaglutide community (P<0.001), the risk of vital cardiovascular events 18% lower (hazard ratio, 0.82; 95% CI, 0.68 to 0.98; P = 0.029), and the risk of death from any dwelling off 20% lower (hazard ratio, 0.80; 95% CI, 0.67 to 0.95, P = 0.01). Severe negative events were reported in a lower share of contributors in the semaglutide community than in the placebo community (49.6% vs. 53.8%). CONCLUSIONS Semaglutide lowered the risk of clinically vital kidney outcomes and death from cardiovascular causes in sufferers with kind 2 diabetes and chronic kidney illness. (Funded by Novo Nordisk; FLOW ClinicalTrials.gov quantity, NCT03819153.)

a bs tr ac t

Effects of Semaglutide on Power Kidney Disease in Patients with Kind 2 Diabetes

Vlado Perkovic, M.B., B.S., Ph.D., Katherine R. Tuttle, M.D., Peter Rossing, M.D., D.M.Sc., Kenneth W. Mahaffey, M.D., Johannes F.E. Mann, M.D., George Bakris, M.D., Florian M.M. Baeres, M.D.,

Thomas Idorn, M.D., Ph.D., Heidrun Bosch-Traberg, M.D., Nanna Leonora Lausvig, M.Sc., and Richard Pratley, M.D., for the FLOW Trial Committees and Investigators*

CME

The Unique England Journal of Medication is produced by NEJM Group, a division of the Massachusetts Medical Society. Downloaded from nejm.org at Novo Nordisk–Bagsvaerd/Denmark on October 17, 2024. For personal use finest.

http://clinicaltrials.gov/label/NCT03819153

n engl j med 391;2 nejm.org July 11, 2024110

T h e n e w e ngl a nd j o u r na l o f m e dic i n e

Extra than half one billion folks globally are plagued by chronic kidney illness and are at excessive risk for kidney

failure, cardiovascular events, and death.1 Kind 2 diabetes is basically the most frequent dwelling off of chronic kidney illness in many countries. Renin–angio- tensin system (RAS) inhibitors,2,3 sodium–glucose cotransporter 2 (SGLT2) inhibitors, and finere- none had been proven to present protection to the kidneys and lower the risk of negative cardiovascular out- comes4-8 and resulting from this truth are guideline-directed med- ical therapies for chronic kidney illness in sufferers with kind 2 diabetes.9,10 Then all any other time, many pa- tients proceed to lose kidney function and chase on to comprise kidney failure or to die, most com- monly from cardiovascular events. Thus, the ef- fects of therapies equivalent to glucagon-love peptide 1 (GLP-1) receptor agonists are of mighty ardour.11

The FLOW (Review Renal Design with Semaglutide As soon as Weekly) trial assessed the ef- ficacy and security of subcutaneous semaglutide at a dose of 1.0 mg once weekly for the prevention of kidney failure, enormous loss of kidney func- tion, and death from kidney-associated or cardiovas- cular causes in sufferers with kind 2 diabetes and chronic kidney illness.

Me thods

Trial Influence and Oversight

We published the form of this worldwide, double-blind, randomized, placebo-managed trial previously.12 The trial became once overseen by an academ- ic-led guidance committee (explore the Supplementa- ry Appendix, accessible with the cumbersome text of this article at NEJM.org) in partnership with the trial sponsor, Novo Nordisk, which additionally managed trial operations. The trial guidance committee provided overall leadership; oversaw trial form, habits, and diagnosis; and became once to blame for reporting the consequences. Analyses were performed by the spon- sor and were independently verified with the use of the distinctive files by Statogen Consulting. The first creator wrote the first draft of the manu- script, and the general authors contributed to subse- quent revisions. Technical editorial support became once provided by OpenHealth and funded by the sponsor. The authors had win entry to to the cumbersome files dwelling, made the resolution to submit the manuscript for e-newsletter, and vouch for the accuracy and completeness of the tips and for the constancy of the trial to the protocol (accessible at NEJM.org).

Linked approval from regulatory authorities and institutional evaluate boards became once got. Every participant provided written told consent earlier than present process any trial-associated procedures.

Contributors

Adults with kind 2 diabetes (glycated hemoglo- bin stage, ≤10%) were eligible for inclusion in the trial in the occasion that they’d excessive-risk chronic kidney illness and were receiving a stable maximal labeled dose (or the maximal dose with out unacceptable facet outcomes) of RAS inhibitors (angiotensin-convert- ing–enzyme inhibitor or angiotensin-receptor blocker). Kidney illness became once outlined by an esti- mated glomerular filtration price (eGFR) of 25 to 75 ml per minute per 1.73 m2 of body-floor blueprint (calculated with the serum creatinine stage and the Power Kidney Disease Epidemiology Collaboration [CKD-EPI] 2009 system,13 which were frail to calculate all reported eGFR values unless otherwise indicated), with a urinary albu- min-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of larger than 300 and no more than 5000 if the eGFR became once 50 ml per minute per 1.73 m2 or greater or a urinary albumin-to-creatinine ratio of larger than 100 and no more than 5000 if the eGFR became once 25 to less than 50 ml per minute per 1.73 m2. Patients who were unable to receive RAS inhibition resulting from facet outcomes were eligible for inclusion. A cumbersome list of inclusion and exclusion standards, including a fluctuate of explicit kidney dis- ease diagnoses, is supplied in the Supplementary Appendix.

Trial Procedures

Eligible contributors were randomly assigned in a 1:1 ratio to receive semaglutide or matching placebo with the usage of a central interactive Web- based response system. The usage of SGLT2 inhibi- tors and mineralocorticoid-receptor antagonists (MRAs) became once permitted, and randomization became once stratified per SGLT2 inhibitor use at baseline. An 8-week dose-escalation routine became once frail, with dose escalation (as lengthy as unac- ceptable facet outcomes didn’t occur) from 0.25 mg per week for 4 weeks and 0.5 mg per week for one more 4 weeks, adopted by a repairs dose of 1.0 mg per week for the length of the dwell- der of the medication interval. If unacceptable ad- verse outcomes came about, dose-escalation intervals would possibly possibly well possibly be extended, medication would possibly possibly well possibly be paused,

A Rapid Rob is provided at

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n engl j med 391;2 nejm.org July 11, 2024 111

Effects of Semaglutide on Power Kidney Disease

or lower repairs doses would possibly possibly well possibly be frail. Labo- ratory-based inclusion standards were in step with native laboratory values recorded within 90 days earlier than the screening seek the advice of with or central laboratory values recorded at screening or at elective prescreen- ing visits.

Trial Outcomes

The vital consequence became once vital kidney illness events, a composite of onset of kidney failure (ini- tiation of lengthy-time interval dialysis, kidney transplanta- tion, or a discount in the eGFR to <15 ml per minute per 1.73 m2 sustained for ≥28 days), a sustained (for ≥28 days) 50% or larger reduc- tion in eGFR from baseline, or death from kid- ney-associated or cardiovascular causes. Three key confirmatory secondary outcomes were outlined and assessed with the usage of a proper hierarchi- cal testing intention: total eGFR slope (i.e., the annual price of exchange in eGFR from randomiza- tion to the dwell of the trial); vital cardiovascular events (a composite of nonfatal myocardial in- farction, nonfatal stroke, or death from cardio- vascular causes), assessed in a time-to-first-tournament diagnosis; and death from any dwelling off. deal of extra supportive secondary, exploratory, and other outcomes were additionally prespecified and are listed in the Supplementary Appendix.

Security became once assessed by gathering files on all severe negative events, negative events resulting in discontinuation of semaglutide or placebo, and negative events of special ardour. Well-known and sec- ondary outcomes rather than eGFR assessments derived from the central laboratory were adjudi- cated in a blinded model by an tournament adjudication committee (explore the Supplementary Appendix).

Statistical Prognosis

This trial became once tournament driven. We calculated that a minimum of 854 vital-consequence events would provide 90% energy to detect a 20% lower relative risk in the semaglutide community than in the placebo community at an overall one-sided significance stage of 2.5%. An interval in-between diagnosis of efficacy became once planned for after two thirds of the general planned quantity of vital-consequence events had came about.

Efficacy analyses were in step with the design- to-treat principle and integrated all irregular partici- pants who underwent randomization, irrespective of adherence to semaglutide or placebo or chang- es to background medicines. Time-to-first-tournament outcomes were analyzed with a stratified Cox

proportional-hazards mannequin with randomization assignment (semaglutide or placebo) as a mounted ingredient and stratified per SGLT2 inhibi- tor use at baseline. P values were got from a accept take a look at. For the vital consequence, the hazard ratio, 95% self assurance interval, and P value were adjusted for the community sequential form with the usage of probability-ratio ordering. The eGFR slope became once analyzed with a linear mixed-outcomes mannequin with randomization assignment, SGLT2 inhibitor use at baseline, time, and the interac- tion between randomization assignment and time as mounted outcomes, participant as a random intercept, and time as a random slope. Missing files were not imputed.

If superiority became once confirmed for the vital consequence, testing of the confirmatory secondary outcomes became once conducted in a prespecified hier- archical present to be decided that kind I error preserve watch over. To memoir for the prespecified interval in-between diagnosis, the nominal significance stage for the vital and confirmatory secondary outcomes became once calculated with the Lan–DeMets alpha-spending function and the explicit seen collection of vital-out- attain events accessible for the vital diagnosis. On the premise of the accessible collection of events, the one-sided nominal significance stage for the pri- mary and confirmatory secondary outcomes became once updated to 0.0161 (an comparable to a two-sided stage of 0.0322, which is frail in this file). Facts are provided in the Supplementary Appendix.

Actual supportive secondary outcomes were assessed by diagnosis of covariance with the use of plenty of imputation for lacking values below a lacking-at-random assumption. Analyses of supportive and exploratory outcomes were not adjusted for multiplicity, and self assurance intervals for these outcomes would possibly possibly well restful not be frail in field of speculation testing. All statistical analyses were conducted with SAS system, version 9.4 TS1M5 (SAS Institute).

R esult s

Trial Contributors

The trial became once performed at 387 net sites in 28 coun- tries (explore the Supplementary Appendix), with re- cruitment happening from June 2019 thru Might just 2021. Among the 5581 screened candidates (Fig. S1 in the Supplementary Appendix), 3533 met the entry standards and were randomly assigned to the semaglutide community (1767 contributors) or the pla-

n engl j med 391;2 nejm.org July 11, 2024112

T h e n e w e ngl a nd j o u r na l o f m e dic i n e

Table 1. Characteristics of the Contributors at Baseline.*

Characteristic Semaglutide (N = 1767)

Placebo (N = 1766)

Full (N = 3533)

Age — year 66.6±9.0 66.7±9.0 66.6±9.0

Female sex — no. (%) 519 (29.4) 550 (31.1) 1069 (30.3)

Geographic blueprint — no. (%)

Asia 478 (27.1) 434 (24.6) 912 (25.8)

Europe 472 (26.7) 491 (27.8) 963 (27.3)

North The US 423 (23.9) 442 (25.0) 865 (24.5)

Diversified 394 (22.3) 399 (22.6) 793 (22.4)

Flee or ethnic community — no. (%)†

White 1155 (65.4) 1168 (66.1) 2323 (65.8)

Asian 439 (24.8) 407 (23.0) 846 (23.9)

Sad 78 (4.4) 82 (4.6) 160 (4.5)

Diversified 95 (5.4) 109 (6.2) 204 (5.8)

Hispanic or Latinx ethnic community — no. (%)†

Sure 273 (15.4) 283 (16.0) 556 (15.7)

No 1421 (80.4) 1411 (seventy 9.9) 2832 (80.2)

Now not reported 73 (4.1) 72 (4.1) 145 (4.1)

Glycated hemoglobin stage — % 7.8±1.3 7.8±1.3 7.8±1.3

Body-mass index‡ 31.9±6.1 32.0±6.5 32.0±6.3

Body weight — kg 89.5±19.8 89.8±21.2 89.6±20.5

Systolic blood stress — mm Hg 138.9±16.1 138.4±15.4 138.6±15.8

Diastolic blood stress — mm Hg 76.8±10.0 76.1±10.0 76.4±10.0

Diabetes length — no. (%)

<15 year 774 (43.8) 753 (42.6) 1527 (43.2)

≥15 year 992 (56.1) 1013 (57.4) 2005 (56.8)

Earlier myocardial infarction or stroke — no. (%) 405 (22.9) 403 (22.8) 808 (22.9)

Power coronary heart failure — no. (%) 342 (19.4) 336 (19.0) 678 (19.2)

Smoking predicament — no. (%)§

Most up-to-date smoker 223 (12.6) 206 (11.7) 429 (12.1)

Earlier smoker 661 (37.4) 696 (39.4) 1357 (38.4)

Never smoked 883 (50.0) 864 (48.9) 1747 (49.4)

eGFR — ml/min/1.73 m2¶ 46.9±15.6 47.1±14.7 47.0±15.2

eGFR distribution — no. (%)¶

≥60 ml/min/1.73 m2 366 (20.7) 353 (20.0) 719 (20.4)

≥Forty five to <60 ml/min/1.73 m2 515 (29.1) 540 (30.6) 1055 (29.9)

≥30 to

<30 ml/min/1.73 m2 218 (12.3) 182 (10.3) 400 (11.3)

Median urinary albumin-to-creatinine ratio‖ 582.3 557.8 567.6

Category of albuminuria — no. (%)**

A1, normoalbuminuria 52 (2.9) 57 (3.2) 109 (3.1)

A2, microalbuminuria 509 (28.8) 495 (28.0) 1004 (28.4)

A3, macroalbuminuria 1205 (68.2) 1214 (68.7) 2419 (68.5)

n engl j med 391;2 nejm.org July 11, 2024 113

Effects of Semaglutide on Power Kidney Disease

cebo community (1766 contributors) and integrated in the analyses. Four contributors underwent ran- domization more than once, and finest the first randomization became once integrated in analyses; one par- ticipant became once excluded from the diagnosis resulting from a lack of adherence to Correct kind Clinical Narrate pointers at the relevant dwelling.

The baseline characteristics of the contributors were smartly balanced between the groups (Table 1 and Table S1). The point out age became once 66.6 years, and 1069 contributors (30.3%) were women. The point out eGFR became once 47.0 ml per minute per 1.73 m2, and the median urinary albumin-to-creatinine ratio (with albumin measured in milligrams and cre- atinine measured in grams) became once 567.6. According to the Kidney Disease: Making improvements to World Out- comes risk calculators,14 68% of the contributors were at very excessive risk for kidney illness pro- gression, kidney failure, cardiovascular events, or death. The contributors in the trial were broadly representative of the relevant population

and per those in outdated trials,4,5,8 as described in Table S2.

A prespecified single interval in-between diagnosis became once prompted in October 2023 after approximately 570 vital-consequence events had accumulated. An in- dependent files and security monitoring committee reviewed the tips and instant early com- pletion of the trial for efficacy. This recommen- dation became once accepted, contributors were recalled for final visits, and the trial became once accomplished with the final participant seek the advice of with happening on January 9, 2024. On the time final touch of the trial, the median participant follow-up became once 3.4 years (fluctuate, 0 to 4.5). The trial became once closed early at two net sites in Russia that had been sanctioned by the sponsor, and 14 contributors at the affected net sites ended participation early. In total, 34 par- ticipants withdrew consent, and vital predicament became once in a position to be confirmed at the dwell of trial for 3482 contributors (98.6%). Semaglutide or placebo became once permanently discontinued by 26% of contributors

Characteristic Semaglutide (N = 1767)

Placebo (N = 1766)

Full (N = 3533)

Treatment use — no. (%)

SGLT2 inhibitor 277 (15.7) 273 (15.5) 550 (15.6)

ACE inhibitor 625 (35.4) 615 (34.8) 1240 (35.1)

ARB 1066 (60.3) 1061 (60.1) 2127 (60.2)

Lipid-lowering drug 1418 (80.2) 1416 (80.2) 2834 (80.2)

Diuretic agent 870 (49.2) 910 (51.5) 1780 (50.4)

Insulin 1083 (61.3) 1085 (61.4) 2168 (61.4)

* Plus–minus values are methodology ±SD. For all characteristics other than the urinary albumin-to-creatinine ratio and estimated glomerular filtration price (eGFR), baseline became once outlined as the eligible overview associated to the randomization seek the advice of with if it became once conducted earlier than or at the date of first dose. If the overview became once lacking or conducted after the date of first dose, the overview from the screening seek the advice of with became once frail. Percentages would possibly possibly well not total 100 resulting from rounding. ACE denotes angiotensin-converting enzyme, ARB angiotensin-receptor blocker, and SGLT2 sodium–glucose cotrans- porter 2.

† Flee and ethnic community were reported by the contributors. “Diversified” comprises American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, and “not reported.”

‡ The body-mass index is the load in kilograms divided by the square of the height in meters. § Smoking became once outlined as smoking at the very least one cigarette or the an analogous day to day. ¶ For eGFR, the baseline overview is printed as the point out of the 2 assessments from the randomization seek the advice of with and

the screening seek the advice of with. If finest one of many assessments became once accessible, it became once frail as the baseline overview. The point out eGFR and the eGFR classes are in step with the serum creatinine stage and the Power Kidney Disease Epidemiology Collaboration 2009 equation.

‖ The urinary albumin-to-creatinine ratio became once calculated with albumin measured in milligrams and creatinine measured in grams.

** Albuminuria classes are in step with the urinary albumin-to-creatinine ratio, and the baseline overview is printed as the point out of the 2 assessments from the randomization seek the advice of with. If finest one of many assessments became once accessible, it became once frail as the baseline overview. Normoalbuminuria is printed by a urinary albumin-to-creatinine ratio of less than 30, microalbuminuria by a ratio of at the very least 30 and no more than 300, and macroalbuminuria by a ratio of 300 or larger.

Table 1. (Persevered.)

n engl j med 391;2 nejm.org July 11, 2024114

T h e n e w e ngl a nd j o u r na l o f m e dic i n e

6 12 18 24 42 48

Months since Randomization

A First Main Kidney Disease Tournament

Hazard ratio, 0.76 (95% CI, 0.66–0.88) P=0.0003

Placebo Semaglutide

1766 1767

1736 1738

1682 1693

1605 1640

1516 1572

1408 1489

30 25

5 10 15

0 0 6 12 18 24 42 4830 36

1048 1131

660 742

354 392

Pe rc

en ta

ge o

f P ar

tic ip

an ts

100

0 0

Pe rc

en ta

ge o

f P ar

tic ip

an ts

100

0 0

Pe rc

en ta

ge o

f P ar

tic ip

an ts

100

0 0

No. at Wretchedness

Pe rc

en ta

ge o

f P ar

tic ip

an ts

100

0 0 6 12 18 24 42 48

Months since Randomization

B First Kidney-Particular Facet Tournament

Hazard ratio, 0.seventy 9 (95% CI, 0.66–0.94)

Distinction in annual slope, 1.16 ml/min/1.73 m2/year (95% CI, 0.86–1.47)

P<0.001

Placebo Semaglutide

1766 1767

1736 1738

1682 1693

1605 1640

1516 1572

1408 1489

0 0 6 12 18 24 42 4830 36

1048 1131

660 742

354 392

No. at Wretchedness

6 12 18 24 42 48

Months since Randomization

C Death from Cardiovascular Causes

Hazard ratio, 0.71 (95% CI, 0.56–0.89)

1766 1767

1737 1739

1697 1703

1641 1665

1601 1627

1544 1583

0 0 6 12 18 24 42 4830 36

1185 1234

772 838

437 460

e G

FR (m

l/ m

in /1

.7 3

m 2 )

0 0 12 52 104 208

Weeks since Randomization

D Full eGFR Slope

Placebo Semaglutide

1766 1766

1663 1665

1490 1521

1609 1606

1573 1590

1441 1468

1284 1345

876 952

156

609 651

199 218

No. at Wretchedness

6 12 18 24 42 48

Months since Randomization

E First Main Cardiovascular Tournament

Hazard ratio, 0.82 (95% CI, 0.68–0.98) P=0.029

1766 1767

1721 1725

1663 1672

1583 1622

1535 1575

1478 1515

0 0 6 12 18 24 42 4830 36

1133 1176

731 793

418 430

Pe rc

en ta

ge o

f P ar

tic ip

an ts

100

0 0 6 12 18 24 42 48

Months since Randomization

F Death from Any Reason

Hazard ratio, 0.80 (95% CI, 0.67–0.95) P=0.01

Placebo Semaglutide

1766 1767

1737 1739

1697 1703

1641 1665

1601 1627

1544 1583

0 0 6 12 18 24 42 4830 36

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