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Lookup NU author(s): Alison Barnes, Professor Roy Taylor
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 2021, The Author(s). Aims/hypothesis: Our aim was to evaluate the safety and efficacy of a planned therapeutic withdrawal of all antihypertensive and diuretic medications, on commencing a formula low-energy diet replacement, targeting remission of type 2 diabetes. Methods: Post hoc analysis of changes in BP, antihypertensive medication prescriptions and symptoms during the initial total diet replacement phase was performed in the intervention arm of the Diabetes Remission Clinical Trial (n = 143) and in the subset (n = 69) who discontinued antihypertensive medications at the start of total diet replacement. The Counterweight-Plus total diet replacement provided about 3470 kJ/day (830 kcal) with automatic reductions in all nutrients, including sodium, to achieve marked negative energy balance and rapid weight loss over 12–20 weeks, with regular BP monitoring and an antihypertensive reintroduction protocol based on current clinical guidelines. Results: Of 143 intervention group participants who commenced total diet replacement, 78 (55%) were on treatment for hypertension at baseline. The overall mean BP fell significantly from the start of total diet replacement (week 1) and was significantly lower at week 20, after total diet replacement finished, and also at 12 and 24 months. Of the 78 participants previously on treatment for hypertension, 65 (83%) stopped all antihypertensive and diuretic medications as per protocol, and four (5%) stopped some drugs. These 69 participants experienced no immediate (within the first week) change in BP, but their mean BP fell significantly from 9 weeks. No excessive rises in BP were recorded in individuals, but antihypertensive medications were reintroduced during total diet replacement to manage raised BP for 19/69 (27.5%) participants, mostly within the first 3–7 weeks, despite some weight loss. Reintroduction of antihypertensive medications was necessary for 5/19 participants previously on one drug, and for 14/19 previously on two or more drugs. Of the 69 who stopped antihypertensives, 19 (28%) remained off medications at 24 months. Among the 53 participants who achieved sustained remissions of diabetes at 24 months (with a mean weight loss of 11.4 kg), 31 had been previously treated for hypertension. Twenty-seven stopped medication at baseline, and 15/27 required reintroduction of antihypertensive medications. Mild to moderate dizziness, suggesting some postural hypotension, was reported during total diet replacement by 51 participants, 15 of whom had recorded dizziness at baseline prior to starting total diet replacement, with nine of these on antihypertensive or diuretic medications. Conclusions/interpretation: Replacing antihypertensive medications with a 3470 kJ/day (830 kcal) diet to induce weight loss reduces BP substantially and may increase mild dizziness. It is safe to stop antihypertensives, but BP should be monitored regularly, particularly for those taking two or more antihypertensives, as over two-thirds will require reintroduction of some medications. Long-term support to maintain weight loss is vital. Trial registration: ISRCTN registry, number 03267836. Graphical abstract: [Figure not available: see fulltext.]
Author(s): Leslie WS, Ali E, Harris L, Messow CM, Brosnahan NT, Thom G, McCombie EL, Barnes AC, Sattar N, Taylor R, Lean MEJ
Publication type: Article
Publication status: Published
Journal: Diabetologia
Year: 2021
Volume: 64
Pages: 1927-1938
Online publication date: 31/05/2021
Acceptance date: 22/03/2021
Date deposited: 22/08/2023
ISSN (print): 0012-186X
ISSN (electronic): 1432-0428
Publisher: Springer Science and Business Media Deutschland GmbH
URL: https://doi.org/10.1007/s00125-021-05471-x
DOI: 10.1007/s00125-021-05471-x
Data Access Statement: Once the data collection and planned analyses of DiRECT are complete (expected 2024), anonymised participant level data will be shared on reasonable request. The study protocol and primary results of DiRECT have been published, using a pre-specified statistical analysis plan, and may be obtained from the corresponding author.
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