In:
Clinical Pharmacology & Therapeutics, Wiley, Vol. 111, No. 1 ( 2022-01), p. 252-262
Abstract:
Oral alkalization with sodium bicarbonate (NaHCO 3 ) or citrate is prescribed for conditions ranging from metabolic acidosis to nephrolithiasis. Although most nephrologists/urologists use this method routinely, extracellular volume (ECV) increase is the main feared adverse event reported for NaHCO 3 . Thus far, no trial has specifically studied this issue in a real‐world setting. AlcalUN (NCT03035812) is a multicentric, prospective, open‐label cohort study with nationwide (France) enrollment in 18 (public and private) nephrology/urology units. Participants were adult outpatients requiring chronic ( 〉 1 month) oral alkalization by either NaHCO 3 ‐containing or no‐NaHCO 3 ‐containing agents. The ECV increase (primary outcome) was judged based on body weight increase (ΔBW), blood pressure increase (ΔBP), and/or new‐onset edema at the first follow‐up visit (V1). From February 2017 to February 2020, 156 patients were enrolled. After a median 106 days of treatment, 91 (72%) patients reached the primary outcome. They had lower systolic (135 (125, 141) vs. 141 (130, 150) , P = 0.02) and diastolic (77 (67, 85) vs. 85 (73, 90), P = 0.03) BP values, a higher plasma chloride (106.0 (105.0, 109.0) vs. 105.0 (102.0, 107.0), P = 0.02) at baseline, and a less frequent history of nephrolithiasis (32 vs. 56%, P = 0.02). Patients experienced mainly slight ΔBP ( 〈 10 mmHg). The primary outcome was not associated ( P = 0.79) with the study treatment (129 received NaHCO 3 and 27 received citrate). We subsequently developed three different models of propensity score matching; each confirmed our results. Chronic oral alkalization with NaHCO 3 is no longer associated with an ECV increase compared to citrate in real‐life settings.
Type of Medium:
Online Resource
ISSN:
0009-9236
,
1532-6535
Language:
English
Publisher:
Wiley
Publication Date:
2022
detail.hit.zdb_id:
2040184-X
SSG:
15,3
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