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Record W3131399962 · doi:10.2215/cjn.15260920

Kidney, Cardiovascular, and Safety Outcomes of Canagliflozin according to Baseline Albuminuria

2021· article· en· W3131399962 on OpenAlexafffund
Meg Jardine, Zien Zhou, Hiddo J.L. Heerspink, Carinna Hockham, Qiang Li, Rajiv Agarwal, George L. Bakris, Christopher P. Cannon, David M. Charytan, Tom Greene, Adeera Levin, Jingwei Li, Brendon L. Neuen, Bruce Neal, Richard Oh, Megumi Oshima, Carol A. Pollock, David C. Wheeler, Dick de Zeeuw, Hong Zhang, Bernard Zinman, Kenneth W. Mahaffey, Vlado Perkovic

Bibliographic record

VenueClinical Journal of the American Society of Nephrology · 2021
Typearticle
Languageen
FieldMedicine
TopicDiabetes Treatment and Management
Canadian institutionsLunenfeld-Tanenbaum Research InstituteUniversity of TorontoMount Sinai HospitalUniversity of British Columbia
FundersJanssen Research and DevelopmentMitsubishi Tanabe Pharma CorporationNSW Ministry of HealthAstellas PharmaEisaiUniversity of New South WalesGeorge Institute for Global HealthKidney Foundation of CanadaNxStageMedical Research CouncilVerily Life SciencesNational Institute of Diabetes and Digestive and Kidney DiseasesSanofiMundipharma InternationalNational Health and Medical Research CouncilAstraZenecaAmarin CorporationNational Institutes of HealthRegeneron PharmaceuticalsIronwood Pharmaceuticals, IncorporatedRelypsaUniversity of ChicagoAlnylam PharmaceuticalsNovo NordiskMyoKardiaJanssen PharmaceuticalsUniversity of WashingtonAblynxDaiichi Sankyo EuropeServierGilead SciencesInnovent BiologicsPfizerVictor Chang Cardiac Research InstituteJapan Society for the Promotion of ScienceGlaxoSmithKlineCelgeneCSL BehringEli Lilly and CompanyAkebia TherapeuticsBristol-Myers SquibbAmgenKowa CompanyAmerican Heart Association
KeywordsMedicineAlbuminuriaCanagliflozinBaseline (sea)Acute kidney injuryInternal medicineUrologyKidneyDiabetes mellitusEndocrinologyType 2 diabetes

Abstract

fetched live from OpenAlex

Background and objectives The kidney protective effects of renin-angiotensin system inhibitors are greater in people with higher levels of albuminuria at treatment initiation. Whether this applies to sodium-glucose cotransporter 2 (SGLT2) inhibitors is uncertain, particularly in patients with a very high urine albumin-to-creatinine ratio (UACR; ≥3000 mg/g). We examined the association between baseline UACR and the effects of the SGLT2 inhibitor, canagliflozin, on efficacy and safety outcomes in the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) randomized controlled trial. Design, setting, participants, & measurements The study enrolled 4401 participants with type 2 diabetes, an eGFR of 30 to <90 ml/min per 1.73 m 2 , and UACR of >300 to 5000 mg/g. Using Cox proportional hazards regression, we examined the relative and absolute effects of canagliflozin on kidney, cardiovascular, and safety outcomes according to a baseline UACR of ≤1000 mg/g ( n =2348), >1000 to <3000 mg/g ( n =1547), and ≥3000 mg/g ( n =506). In addition, we examined the effects of canagliflozin on UACR itself, eGFR slope, and the intermediate outcomes of glycated hemoglobin, body weight, and systolic BP. Results Overall, higher UACR was associated with higher rates of kidney and cardiovascular events. Canagliflozin reduced efficacy outcomes for all UACR levels, with no evidence that relative benefits varied between levels. For example, canagliflozin reduced the primary composite outcome by 24% (hazard ratio [HR], 0.76; 95% confidence interval [95% CI], 0.56 to 1.04) in the lowest UACR subgroup, 28% (HR, 0.72; 95% CI, 0.56 to 0.93) in the UACR subgroup >1000 to <3000 mg/g, and 37% (HR, 0.63; 95% CI, 0.47 to 0.84) in the highest subgroup ( P heterogeneity =0.55). Absolute risk reductions for kidney outcomes were greater in participants with higher baseline albuminuria; the number of primary composite events prevented across ascending UACR categories were 17 (95% CI, 3 to 38), 45 (95% CI, 9 to 81), and 119 (95% CI, 35 to 202) per 1000 treated participants over 2.6 years ( P heterogeneity =0.02). Rates of kidney-related adverse events were lower with canagliflozin, with a greater relative reduction in higher UACR categories. Conclusions Canagliflozin safely reduces kidney and cardiovascular events in people with type 2 diabetes and severely increased albuminuria. In this population, the relative kidney benefits were consistent over a range of albuminuria levels, with greatest absolute kidney benefit in those with an UACR ≥3000 mg/g. Clinical Trial registry name and registration number: ClinicalTrials.gov: CREDENCE, NCT02065791. Podcast This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2021_02_22_CJN15260920_final.mp3

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.007
metaresearch head score (Gemma)0.013
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.007
Threshold uncertainty score0.038

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0070.013
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0010.002
Bibliometrics0.0010.001
Science and technology studies0.0000.001
Scholarly communication0.0010.001
Open science0.0000.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.030
GPT teacher head0.335
Teacher spread0.305 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

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Citations53
Published2021
Admission routes2
Has abstractyes

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