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Record W4308135424 · doi:10.1210/jendso/bvac150.1097

OR27-6 Effects of the SGLT2-Inhibitor Empagliflozin in Patients With Chronic Syndrome of Inadequate Antidiuresis (SIAD) - Results of a Double-Blind, Randomized, Placebo-Controlled, Crossover Trial

2022· article· en· W4308135424 on OpenAlexaboutno aff
Manfred Berres, Stephanie A. Bridenbaugh, Mirjam Christ-crain, Aaron Haslbauer, Cornelia Imber, Sophie Monnerat, Rianne Nobbenhuis, Julie Refardt, Clara Odilia Sailer, D. Vogt, Bettina Winzeler, Cihan Atila

Bibliographic record

VenueJournal of the Endocrine Society · 2022
Typearticle
Languageen
FieldMedicine
TopicElectrolyte and hormonal disorders
Canadian institutionsnot available
Fundersnot available
KeywordsEmpagliflozinPlaceboMedicineHyponatremiaCrossover studyInternal medicineRandomized controlled trialClinical endpointFree water clearanceGastroenterologyAnesthesiaRenal functionEndocrinologyType 2 diabetesDiabetes mellitus

Abstract

fetched live from OpenAlex

Abstract Introduction Hyponatremia is the most common electrolyte disorder and the syndrome of inappropriate antidiuresis (SIAD) is one of its main causes. However, treatment options for chronic SIAD-induced hyponatremia are inadequate. This is problematic because hyponatremia has been associated with neurocognitive deficits, although there is little data on its reversibility.We previously showed that the sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin is a promising short-term treatment option for hospitalized patients with SIAD-induced hyponatremia, promoting osmotic diuresis via urinary glucose excretion. However, there are no data on long-term treatment in outpatients nor its effect on neurocognitive function. Material and Methods In this double-blind, randomized, placebo-controlled, crossover trial we compared 4-week treatment with empagliflozin 25mg/day to placebo in addition to fluid restriction of ≤1.5L/24h in outpatients with chronic SIAD-induced hyponatremia (serum sodium <135mmol/L). At baseline and after both treatment cycles, patients underwent neurocognitive testing (Montreal Cognitive Assessment (MoCA) test). There was a 2-week wash-out period between the two treatment cycles, and a follow-up visit was scheduled 30 days after completion of the treatment phase.The primary endpoint was the difference in serum sodium levels (mmol/L) after 4 weeks of treatment with empagliflozin or placebo, calculated using a linear mixed-effects model. Results 14 patients, 50% female, with a median (IQR) age of 72 years (65-77) completed the trial.Median (IQR) serum sodium level at baseline was 131mmol/L (130-132). Under treatment with empagliflozin, median (IQR) serum sodium level increased to 134mmol/L (132-136), while no notable change was seen under placebo (130mmol/L (128-132)). This resulted in a 4.1 mmol/L (95% CI 1.7-6.5) higher serum sodium level after 4 weeks of empagliflozin treatment compared to placebo (p=0.004). This effect was independent of severity of SIAD.In addition, treatment with empagliflozin led to improved neurocognitive function, as shown by an increase of 1.2 points (SE 0.5) in the MoCA test (p=0.042).Treatment with empagliflozin was generally well tolerated, no serious adverse events occurred during the observation period. Conclusion This trial shows that the SGLT-2 inhibitor empagliflozin is a promising new treatment option for outpatients with chronic SIAD-induced hyponatremia. Furthermore, hyponatremia treatment led to an improvement of neurocognitive function. Presentation: Tuesday, June 14, 2022 11:00 a.m. - 11:15 a.m.

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)0.003
metaresearch head score (Gemma)0.002
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Randomized trial · Consensus signal: Randomized trial
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.005
Threshold uncertainty score0.016

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0030.002
Meta-epidemiology (narrow)0.0020.001
Meta-epidemiology (broad)0.0050.003
Bibliometrics0.0010.000
Science and technology studies0.0010.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0020.002
Insufficient payload (model declined to judge)0.0050.001

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 head0.006
GPT teacher head0.242
Teacher spread0.236 · 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 designRandomized trial
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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Citations0
Published2022
Admission routes1
Has abstractyes

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