Abstract
Aims/hypothesisOur 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.MethodsPost 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.ResultsOf 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/interpretationReplacing 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 registrationISRCTN registry, number 03267836.Graphical abstract
Highlights
Type 2 diabetes was viewed as a discrete endocrine disease, and its management was largely limited to prescribing medications that lower blood glucose and HbA1c, with a target, representing ‘good control’ of HbA1c < 53 mmol/mol (7%)
It is well established that lowering blood glucose and HbA1c will delay or prevent microvascular complications [1,2,3], but life expectancy for people with type 2 diabetes remains reduced despite best practice treatments directed at clinical guideline targets [4]
Baseline characteristics One hundred and forty-three participants (79 male, 64 female) from 23 practices allocated to intervention attended the first total diet replacement (TDR) appointment and commenced TDR (Fig. 1)
Summary
Type 2 diabetes was viewed as a discrete endocrine disease, and its management was largely limited to prescribing medications that lower blood glucose and HbA1c, with a target, representing ‘good control’ of HbA1c < 53 mmol/mol (7%). It is well established that lowering blood glucose and HbA1c will delay or prevent microvascular complications [1,2,3], but life expectancy for people with type 2 diabetes remains reduced despite best practice treatments directed at clinical guideline targets [4]. The excess morbidity and early mortality are importantly accounted for by vascular complications inherent in the underlying metabolic syndrome, and related to high BP, which commonly accompanies type 2 diabetes [5]. Our understanding of type 2 diabetes is changing, as evidence accumulates that it is primarily a nutritional disease process. It is driven by weight gain; in susceptible or predisposed individuals, body fat accumulates in ectopic sites, liver, pancreas and muscle including heart muscle. About 85% of people with type 2 diabetes have or will develop hypertension, which requires treatment under current guidelines (systolic BP [SBP] ≥140 mmHg, diastolic BP [DBP] ≥90 mmHg) [6, 7]
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