BACKGROUND Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of bariatric surgery in patients with obesity and hypertension are needed. METHODS In this randomized, single-center, nonblinded trial, we included patients with hypertension (using ≥2 medications at maximum doses or >2 at moderate doses) and a body mass index between 30.0 and 39.9 kg/m2. Patients were randomized to Roux-en-Y gastric bypass plus medical therapy or medical therapy alone. The primary end point was reduction of ≥30% of the total number of antihypertensive medications while maintaining systolic and diastolic blood pressure <140 mm Hg and 90 mm Hg, respectively, at 12 months. RESULTS We included 100 patients (70% female, mean age 43.8±9.2 years, mean body mass index 36.9±2.7 kg/m2), and 96% completed follow-up. Reduction of ≥30% of the total number of antihypertensive medications while maintaining controlled blood pressure occurred in 41 of 49 patients from the gastric bypass group (83.7%) compared with 6 of 47 patients (12.8%) from the control group with a rate ratio of 6.6 (95% confidence interval, 3.1-14.0; P<0.001). Remission of hypertension was present in 25 of 49 (51%) and 22 of 48 (45.8%) patients randomized to gastric bypass, considering office and 24-hour ambulatory blood pressure monitoring, respectively, whereas no patient submitted to medical therapy was free of antihypertensive drugs at 12 months. A post hoc analysis for the primary end point considering the SPRINT (Systolic Blood Pressure Intervention Trial) target reached consistent results, with a rate ratio of 3.8 (95% confidence interval, 1.4-10.6; P=0.005). Eleven patients (22.4%) from the gastric bypass group and none in the control group were able to achieve SPRINT levels without antihypertensives. Waist circumference, body mass index, fasting plasma glucose, glycohemoglobin, low-density lipoprotein cholesterol, triglycerides, high-sensitivity C-reactive protein, and 10-year Framingham risk score were lower in the gastric bypass than in the control group. CONCLUSIONS Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.

中文翻译：

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肥胖手术患者肥胖症的减肥手术效果：GATEWAY随机试验（胃旁路术治疗肥胖合并持续性高血压的患者）。

背景技术关于减肥手术的最新研究努力已经集中在代谢和糖尿病的解决上。需要进行随机试验以评估减肥手术对肥胖和高血压患者的影响。方法在这项随机，单中心，无盲试验中，我们纳入了高血压患者（使用≥2种最大剂量的药物或≥2种中等剂量的药物）且体重指数在30.0至39.9 kg / m2之间。患者被随机分配到Roux-en-Y胃搭桥术加药物治疗或仅药物治疗。主要终点是在12个月时将降压药总数减少≥30％，同时使收缩压和舒张压分别维持在<140 mm Hg和90 mm Hg。结果我们纳入了100例患者（女性占70％，平均年龄43.8±9.2岁，平均体重指数36.9±2.7 kg / m2），并完成了96％的随访。胃旁路组49例患者中有41例（83.7％）降低了降压药物总数并保持血压受控，而对照组的47例患者中有6例（12.8％）降低了30％以上值为6.6（95％置信区间，3.1-14.0； P <0.001）。分别考虑到办公室和24小时动态血压监测，分别有49位（51％）的患者中有25位（51％）和48位（22.8％）的患者出现了高血压缓解，而没有接受过药物治疗的患者没有高血压12个月时服用降压药。对考虑SPRINT（收缩压干预试验）目标的主要终点进行事后分析，结果一致，比率为3。8（95％置信区间，1.4-10.6； P = 0.005）。胃旁路手术组中的11例患者（22.4％）在没有使用降压药的情况下能够达到SPRINT水平。胃搭桥术的腰围，体重指数，空腹血糖，糖化血红蛋白，低密度脂蛋白胆固醇，甘油三酸酯，高敏C反应蛋白和10年Framingham风险评分均低于对照组。结论减肥手术是控制肥胖和高血压患者血压的有效策略。临床试验注册网址：https：//clinicaltrials.gov。唯一标识符：NCT01784848。胃旁路手术组中有4％的人，而没有降压药的对照组中没有人能达到SPRINT水平。胃搭桥术的腰围，体重指数，空腹血糖，糖化血红蛋白，低密度脂蛋白胆固醇，甘油三酸酯，高敏C反应蛋白和10年Framingham风险评分均低于对照组。结论减肥手术是控制肥胖和高血压患者血压的有效策略。临床试验注册网址：https：//clinicaltrials.gov。唯一标识符：NCT01784848。胃旁路手术组中有4％的人，而没有降压药的对照组中没有人能达到SPRINT水平。胃搭桥术的腰围，体重指数，空腹血糖，糖化血红蛋白，低密度脂蛋白胆固醇，甘油三酸酯，高敏C反应蛋白和10年Framingham风险评分均低于对照组。结论减肥手术是控制肥胖和高血压患者血压的有效策略。临床试验注册网址：https：//clinicaltrials.gov。唯一标识符：NCT01784848。和10年Framingham风险评分在胃旁路手术中低于对照组。结论减肥手术是控制肥胖和高血压患者血压的有效策略。临床试验注册网址：https：//clinicaltrials.gov。唯一标识符：NCT01784848。和10年Framingham风险评分在胃旁路手术中低于对照组。结论减肥手术是控制肥胖和高血压患者血压的有效策略。临床试验注册网址：https：//clinicaltrials.gov。唯一标识符：NCT01784848。