Bradycardia and Other Arrhythmias in Patients With Hepatorenal Syndrome‐Acute Kidney Injury Following Terlipressin Treatment: A Pooled Analysis of Three North American Phase <scp>III</scp> Clinical Studies
Bibliographic record
Abstract
BACKGROUND: Terlipressin is the FDA-approved systemic vasoconstrictor therapy for hepatorenal syndrome-acute kidney injury (HRS-AKI)-a rapidly progressive renal failure occurring in patients with decompensated cirrhosis and ascites. Bradycardia, a known effect of terlipressin, as well as other arrhythmias, has previously been reported in terlipressin-treated patients. AIM: To assess terlipressin-related cardiac adverse events (AEs) in patients with HRS-AKI. METHODS: Three North American-centric Phase III, randomised, placebo-controlled studies (OT-0401, REVERSE, CONFIRM) were pooled in the largest-to-date prospective database. Cardiac AEs were reported by the investigators for each trial and retrospectively analysed. RESULTS: Bradycardia was the only cardiac AE reported more frequently in terlipressin-treated patients compared with placebo (6.3% [22/349] vs. 0.8% [2/249]). In the terlipressin group, no bradycardia AEs were serious, 4.5% (1/22) of patients required a dose interruption, 9.1% (2/22) required a dose reduction, and none discontinued treatment due to bradycardia. The incidences of other arrhythmia AEs were similar in both treatment groups (terlipressin: 7.4% [26/349]; placebo 8.8% [22/249]). The incidence of atrial fibrillation serious AEs (SAEs) was low (terlipressin: 0.9% [3/349]; placebo: 1.6% [4/249]). There were no AE reports of torsades de pointes, while a QT interval prolongation was reported in two patients. CONCLUSIONS: In a pooled analysis, bradycardia was observed in 6% of terlipressin-treated patients but rarely required a dose interruption or reduction. Arrhythmia SAE incidences were low and similar in both treatment groups. Routine intensive cardiac monitoring for the detection of arrhythmias may not be necessary during terlipressin administration. TRIAL REGISTRATION: OT-0401: NCT00089570, REVERSE: NCT01143246 and CONFIRM: NCT02770716.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot 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.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.021 | 0.018 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.018 |
| Bibliometrics | 0.004 | 0.005 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
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.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".