Antihypertensive medication needs and blood pressure control with weight loss in the Diabetes Remission Clinical Trial (DiRECT).
Antihypertensive medication needs and blood pressure control with weight loss in the Diabetes Remission Clinical Trial (DiRECT).
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糖尿病缓解临床试验（DiRECT）中降压药物需求和血压控制与体重减轻
DOI：
10.1007/s00125-021-05471-x
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发表时间：
2021-09
期刊：
影响因子：
8.2
通讯作者：
Lean MEJ
中科院分区：
文献类型：
--
作者：
Leslie WS;Ali E;Harris L;Messow CM;Brosnahan NT;Thom G;McCombie EL;Barnes AC;Sattar N;Taylor R;Lean MEJ
我们的目的是评估在开始以2型糖尿病缓解为目标的配方低能量饮食替代药物时，有计划地停用所有降压药和利尿剂药物的安全性和有效性。在糖尿病缓解临床试验的干预组(n = 143)和在开始完全饮食替代阶段停止服用降压药的子组(n = 69)中，对初始总饮食替代阶段的血压、抗高血压药物处方和症状的变化进行了专门的分析。After Weight-Plus全饮食替代方案每天提供约3470千焦(830千卡)，自动减少包括钠在内的所有营养素，以实现显著的负能量平衡和在12-20周内快速减肥，并定期监测血压，并根据目前的临床指南重新引入抗高血压方案。在143名开始完全饮食替代的干预组参与者中，78人(55%)在基线水平上接受高血压治疗。总体平均血压从开始总饮食替代(第1周)开始显著下降，在总饮食替代结束后第20周显著下降，在12个月和24个月时也显著下降。在之前接受高血压治疗的78名参与者中，65名(83%)按方案停止了所有降压药和利尿剂的药物治疗，4名(5%)停止了一些药物。这69名参与者没有立即(在第一周内)血压变化，但他们的平均血压从9周显著下降。个体中没有记录到血压过度上升，但在全饮食替代期间重新引入了抗高血压药物，以管理19/69(27.5%)参与者的血压升高，尽管体重有所下降，但大多在最初的3-7周内。之前服用一种药物的19名参与者中有5名需要重新服用降压药，之前服用两种或更多药物的参与者中有14/19需要重新服用降压药。在69名停止服用降压药的患者中，19名(28%)在24个月后仍未服用药物。在53名在24个月后糖尿病持续缓解(平均体重减轻11.4公斤)的参与者中，31人以前曾接受过高血压治疗。27人在基线时停止服药，15/27人需要重新引入降压药。据报道，51名参与者在总饮食替代期间出现轻度至中度头晕，暗示有一些体位性低血压，其中15人在开始完全饮食替代之前有头晕记录，其中9人服用降压药或利尿药。用3470千卡/天(830千卡)的饮食取代降压药物来诱导减肥，可以大幅降低血压，并可能增加轻微的头晕。停用降压药是安全的，但应该定期监测血压，特别是那些服用两种或两种以上降压药的人，因为超过三分之二的人需要重新服用一些药物。长期的支持对保持减肥至关重要。ISRCTN登记处，编号03267836。网上版载有经同行审查但未经编辑的补充材料，可在10.1007/s00125-021-05471-x查阅。
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. 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. 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. 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. ISRCTN registry, number 03267836. The online version contains peer-reviewed but unedited supplementary material available at 10.1007/s00125-021-05471-x.
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1.6
作者：
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