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Clinical and cost-effectiveness of oral sodium bicarbonate therapy for older patients with chronic kidney disease and low-grade acidosis (BiCARB): a pragmatic randomised, double-blind, placebo-controlled trial

journal contribution
posted on 2023-08-30, 16:59 authored by Miles D. Witham, Margaret Band, Aimun Ahmed, Michael Almond, Gowrie Balasubramaniam, Kolitha Basnayake, Deepak Bhatnagar, Anthony Chan, Huey Yi Chong, Peter T. Donnan, Neill Duncan, Geeta Hampson, May K. Hu, Philip A. Kalra, Gwen Kennedy, Adam Kirk, Edmund J. Lamb, Stewart Lambie, Roberta Littleford, Paul McNamee, Biswa Mishra, Sandip Mitra, Johann Nicholas, Deidre Plews, Petra Rauchhaus, Roy L. Soiza, Paul E. Stevens, Deepa Sumukadas, Wai Tse, Graham Warwick, Martin Wilkie, Georgia Winnett, Alison Avenell
BACKGROUND: Chronic kidney disease with metabolic acidosis is common in older people, but the effectiveness of oral sodium bicarbonate therapy in this group is unclear. We tested whether oral sodium bicarbonate provides net health benefit for older people with advanced chronic kidney disease and serum bicarbonate concentrations < 22 mmol/L. METHODS: Pragmatic multicentre, parallel group, double-blind, placebo-controlled randomised trial. We recruited adults aged ≥ 60 years with estimated glomerular filtration rate of < 30 mL/min/1.73 m2, not receiving dialysis, with serum bicarbonate concentration < 22 mmol/L, from 27 nephrology and geriatric medicine departments in the UK. Participants received oral sodium bicarbonate (up to 3 g/day) or matching placebo given for up to 2 years, randomised in a 1:1 ratio. The primary outcome was between-group difference in the Short Physical Performance Battery (SPPB) at 12 months, adjusted for baseline values, analysed by intention to treat. Secondary outcomes included generic and disease-specific quality of life (EQ-5D and KDQoL tools), anthropometry, renal function, walk distance, blood pressure, bone and vascular health markers, and incremental cost per quality-adjusted life year gained. RESULTS: We randomised 300 participants between May 2013 and February 2017, mean age 74 years, 86 (29%) female. At 12 months, 116/152 (76%) participants allocated to bicarbonate and 104/148 (70%) allocated to placebo were assessed; primary outcome data were available for 187 participants. We found no significant treatment effect for the SPPB: bicarbonate arm 8.3 (SD 2.5) points, placebo arm 8.8 (SD 2.2) and adjusted treatment effect - 0.4 (95% CI - 0.9 to 0.1, p = 0.15). We found no significant treatment effect for glomerular filtration rate (0.6 mL/min/1.73 m2, 95% CI - 0.8 to 2.0, p = 0.39). The bicarbonate arm showed higher costs and lower quality of life as measured by the EQ-5D-3L tool over 1 year (£564 [95% CI £88 to £1154]); placebo dominated bicarbonate under all sensitivity analyses. Adverse events were more frequent in those randomised to bicarbonate (457 versus 400). CONCLUSIONS: Oral sodium bicarbonate did not improve physical function or renal function, increased adverse events and is unlikely to be cost-effective for use by the UK NHS for this patient group.

History

Refereed

  • Yes

Volume

18

Page range

91

Publication title

BMC Medicine

ISSN

1741-7015

Publisher

BioMed Central

File version

  • Supplemental material

Language

  • eng

Legacy posted date

2020-04-01

Legacy creation date

2020-04-01

Legacy Faculty/School/Department

Faculty of Health, Education, Medicine & Social Care

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