RESUMEN
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.
Asunto(s)
Presión Sanguínea , Derivación Gástrica , Hipertensión/fisiopatología , Obesidad/cirugía , Adulto , Antihipertensivos/uso terapéutico , Presión Sanguínea/efectos de los fármacos , Índice de Masa Corporal , Brasil , Femenino , Derivación Gástrica/efectos adversos , Humanos , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Masculino , Persona de Mediana Edad , Obesidad/diagnóstico , Obesidad/fisiopatología , Factores de Tiempo , Resultado del Tratamiento , Pérdida de PesoRESUMEN
INTRODUCTION: Obesity and overweight are becoming progressively more prevalent worldwide and are independently associated with a significant increase in the risk of cardiovascular diseases. Systemic arterial hypertension is frequently found in association with obesity and contributes significantly to increased cardiovascular risk. We hypothesise that Roux-en-Y gastric bypass (RYGB) surgery, a procedure that effectively reduces body weight, can also positively impact blood pressure control in obese and hypertensive individuals. METHODS AND ANALYSIS: A unicentric, randomised, controlled, unblinded clinical trial. Sixty obese (body mass index between 30 and 39.9) and moderately well controlled hypertensive patients, in use of at least two antihypertensive medications at maximum doses or more than two in moderate doses, will be randomly allocated, using an online, electronic and concealed method, to receive either RYGB plus optimised clinical treatment (OCT) or OCT alone. The primary end point is the reduction of antihypertensive medication at 1 and 2 years of follow-up. Data analysis will primarily be conducted on an intention-to-treat basis. ETHICS AND DISSEMINATION: The study was approved by the local institutional review board that works in total compliance with the latest version of the Helsinki Declaration, the Good Clinical Practices (GCP), the 'America's Document' and the national regulatory laws. Before the beginning of any study-related activities, each study participant is asked to provide a signed informed consent. TRIAL REGISTRATION NUMBER: NCT01784848.