No Adverse Effects of Veverimer on Volume Status or Blood Pressure in Patients with CKD and Metabolic Acidosis
Bibliographic record
Abstract
Background: Current American Heart Association guidelines recommend sodium (Na) restriction of <1.5 g/day. Drugs can be a source of Na, potentially contributing to inadequate control of blood pressure (BP) and volume. For example, each NaHCO3 tablet (650 mg) contains 170 mg of Na and multiple tablets per day are required to effectively treat metabolic acidosis. Veverimer is a non-absorbed polymer that treats metabolic acidosis by binding and removing HCl from the GI tract. It is not an exchange resin and does not introduce unwanted cations such as Na or K. We hypothesized that veverimer would not increase BP, weight or induce volume overload. In Phase 3 randomized, blinded placebo-controlled trials in acidotic patients (pts) with CKD (baseline mean eGFR 29 mL/min/1.73 m2), veverimer significantly increased serum bicarbonate (LS mean +4.7 mEq/L at Week 52) with safety profile similar to placebo (Wesson et al. Lancet, 2019). Methods: We analyzed parameters related to volume status in these Phase 3 trials. Results: In these studies, 97% and 31% of pts, had HTN and CHF, respectively and 193 pts were treated with veverimer or placebo for up to 52 weeks. Treatment with veverimer (v placebo) had no effect on weight, BP, urine Na/creatinine ratio, volumerelated adverse events, or increased use of diuretics or antihypertensives (Table). Conclusions: Veverimer, a novel non-absorbed HCl binder, effectively treats metabolic acidosis in CKD without adversely affecting BP or volume status. Funding: Commercial Support - Tricida, Inc.Data presented are mean (SD) or n (%)
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".