HCor Research Institute, São Paulo, Brazil (C.A.S., E.V.S., R.N.S., L.P.D., J.D.O., R.H.M., A.B.C.).
Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, Massachusetts (D.L.B.).
Ann Intern Med. 2020 Nov 3;173(9):685-693. doi: 10.7326/M19-3781. Epub 2020 Aug 18.
Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain.
To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone.
Randomized clinical trial. (ClinicalTrials.gov: NCT01784848).
Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil.
Patients with hypertension receiving at least 2 medications at maximum doses or more than 2 medications at moderate doses and with a body mass index (BMI) between 30.0 and 39.9 kg/m were randomly assigned (1:1 ratio).
RYGB plus MT or MT alone.
The primary outcome was at least a 30% reduction in total number of antihypertensive medications while maintaining BP less than 140/90 mm Hg. Key secondary outcomes were number of antihypertensive medications, hypertension remission, and BP control according to current guidelines (<130/80 mm Hg).
Among 100 patients (76% female; mean BMI, 36.9 kg/m [SD, 2.7]), 88% from the RYGB group and 80% from the MT group completed follow-up. At 3 years, the primary outcome occurred in 73% of patients from the RYGB group compared with 11% of patients from the MT group (relative risk, 6.52 [95% CI, 2.50 to 17.03]; 0.001). Of the randomly assigned participants, 35% and 31% from the RYGB group and 2% and 0% from the MT group achieved BP less than 140/90 mm Hg and less than 130/80 mm Hg without medications, respectively. Median (interquartile range) number of medications in the RYGB and MT groups at 3 years was 1 (0 to 2) and 3 (2.8 to 4), respectively ( 0.001). Total weight loss was 27.8% and -0.1% in the RYGB and MT groups, respectively. In the RYGB group, 13 patients developed hypovitaminosis B and 2 patients required reoperation.
Single-center, nonblinded trial.
RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity.
Ethicon, represented in Brazil by Johnson & Johnson do Brasil.
减重手术对肥胖合并高血压患者的中期效果仍不确定。
评估与单纯药物治疗（MT）相比，胃旁路术（RYGB）对血压（BP）的 3 年影响。
随机临床试验。（ClinicalTrials.gov：NCT01784848）。
巴西圣保罗心脏医院（HCor）发起的研究。
接受至少 2 种最大剂量或 2 种以上中等剂量降压药物治疗且体重指数（BMI）在 30.0 至 39.9 kg/m 之间的高血压患者被随机分配（1:1 比例）。
RYGB 加 MT 或 MT 单独治疗。
主要结局为降压药物总数减少至少 30%，同时保持 BP 小于 140/90 mm Hg。次要关键结局为降压药物数量、高血压缓解率和根据当前指南（<130/80 mm Hg）的 BP 控制情况。
在 100 名患者（76%为女性；平均 BMI 为 36.9 kg/m[SD，2.7]）中，88%的 RYGB 组和 80%的 MT 组完成了随访。3 年后，RYGB 组有 73%的患者达到主要结局，而 MT 组仅有 11%的患者达到主要结局（相对风险，6.52[95%CI，2.50 至 17.03]；<0.001）。在随机分组的参与者中，RYGB 组分别有 35%和 31%的患者和 MT 组分别有 2%和 0%的患者在不服用药物的情况下达到 BP<140/90 mm Hg 和 BP<130/80 mm Hg。RYGB 组和 MT 组在 3 年时的中位（四分位间距）药物数量分别为 1（0 至 2）和 3（2.8 至 4）（<0.001）。RYGB 组和 MT 组的体重总减轻量分别为 27.8%和-0.1%。RYGB 组中有 13 名患者出现维生素 B 缺乏，2 名患者需要再次手术。
单中心、非盲试验。
RYGB 是一种有效的中期 BP 控制和高血压缓解策略，可减少肥胖合并高血压患者的药物需求。
Ethicon，由巴西的 Johnson & Johnson do Brasil 代理。
