Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension)
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,...
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Published in | Circulation (New York, N.Y.) Vol. 137; no. 11; pp. 1132 - 1142 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
by the American College of Cardiology Foundation and the American Heart Association, Inc
13.03.2018
Lippincott Williams & Wilkins |
Subjects | |
Online Access | Get full text |
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Abstract | 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/m. 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:URLhttps://clinicaltrials.gov. Unique identifierNCT01784848. |
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AbstractList | 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/m
2
. 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 (76% 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. 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/m. 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:URLhttps://clinicaltrials.gov. Unique identifierNCT01784848. 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.BACKGROUNDRecent 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.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.METHODSIn 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.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.RESULTSWe 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.Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension.CONCLUSIONSBariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension.URL: https://clinicaltrials.gov. Unique identifier: NCT01784848.CLINICAL TRIAL REGISTRATIONURL: https://clinicaltrials.gov. Unique identifier: NCT01784848. Supplemental Digital Content is available in the text. 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. 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. 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/m . 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. 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; <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; =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. Bariatric surgery represents an effective strategy for blood pressure control in a broad population of patients with obesity and hypertension. URL: https://clinicaltrials.gov. Unique identifier: NCT01784848. |
Author | Berwanger, Otavio Santos, Renato Nakagawa Bueno, Priscila Torres Monteiro, Frederico L.J Uchoa, Carlos H Oliveira, Juliana Dantas Schiavon, Carlos Aurelio Bortolotto, Luiz Halpern, Helio Santucci, Eliana Vieira Torreglosa, Camila Ragne Cohen, Ricardo Vitor Amodeo, Celso Cavalcanti, Alexandre Biasi Frayha, Julia Caldas Damiani, Lucas Petri Ikeoka, Dimas Drager, Luciano F Noujaim, Patricia Malvina Bersch-Ferreira, Angela Cristine de Souza, Marcio Gonçalves |
AuthorAffiliation | Research Institute (C.A.S., A.C.B.-F., E.V.S., J.D.O., C.R.T., P.T.B., J.C.F., R.N.F., L.P.D., A.B.C., O.B.) Surgical Center (P.M.N., H.H., F.L.J.M.) Intensive Unit (D.I.), Heart Hospital, São Paulo, Brazil. Oswaldo Cruz German Hospital, São Paulo, Brazil (R.V.C.). Heart Institute, Hypertension Unit, São Paulo, Brazil (C.H.U., L.B., L.F.D.). Department of Hypertension, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (M.G.d.S., C.A.) |
AuthorAffiliation_xml | – name: Research Institute (C.A.S., A.C.B.-F., E.V.S., J.D.O., C.R.T., P.T.B., J.C.F., R.N.F., L.P.D., A.B.C., O.B.) Surgical Center (P.M.N., H.H., F.L.J.M.) Intensive Unit (D.I.), Heart Hospital, São Paulo, Brazil. Oswaldo Cruz German Hospital, São Paulo, Brazil (R.V.C.). Heart Institute, Hypertension Unit, São Paulo, Brazil (C.H.U., L.B., L.F.D.). Department of Hypertension, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (M.G.d.S., C.A.) |
Author_xml | – sequence: 1 givenname: Carlos surname: Schiavon middlename: Aurelio fullname: Schiavon, Carlos Aurelio organization: Research Institute (C.A.S., A.C.B.-F., E.V.S., J.D.O., C.R.T., P.T.B., J.C.F., R.N.F., L.P.D., A.B.C., O.B.) Surgical Center (P.M.N., H.H., F.L.J.M.) Intensive Unit (D.I.), Heart Hospital, São Paulo, Brazil. Oswaldo Cruz German Hospital, São Paulo, Brazil (R.V.C.). Heart Institute, Hypertension Unit, São Paulo, Brazil (C.H.U., L.B., L.F.D.). Department of Hypertension, Dante Pazzanese Institute of Cardiology, São Paulo, Brazil (M.G.d.S., C.A.) – sequence: 2 givenname: Angela surname: Bersch-Ferreira middlename: Cristine fullname: Bersch-Ferreira, Angela Cristine – sequence: 3 givenname: Eliana surname: Santucci middlename: Vieira fullname: Santucci, Eliana Vieira – sequence: 4 givenname: Juliana surname: Oliveira middlename: Dantas fullname: Oliveira, Juliana Dantas – sequence: 5 givenname: Camila surname: Torreglosa middlename: Ragne fullname: Torreglosa, Camila Ragne – sequence: 6 givenname: Priscila surname: Bueno middlename: Torres fullname: Bueno, Priscila Torres – sequence: 7 givenname: Julia surname: Frayha middlename: Caldas fullname: Frayha, Julia Caldas – sequence: 8 givenname: Renato surname: Santos middlename: Nakagawa fullname: Santos, Renato Nakagawa – sequence: 9 givenname: Lucas surname: Damiani middlename: Petri fullname: Damiani, Lucas Petri – sequence: 10 givenname: Patricia surname: Noujaim middlename: Malvina fullname: Noujaim, Patricia Malvina – sequence: 11 givenname: Helio surname: Halpern fullname: Halpern, Helio – sequence: 12 givenname: Frederico surname: Monteiro middlename: L.J fullname: Monteiro, Frederico L.J – sequence: 13 givenname: Ricardo surname: Cohen middlename: Vitor fullname: Cohen, Ricardo Vitor – sequence: 14 givenname: Carlos surname: Uchoa middlename: H fullname: Uchoa, Carlos H – sequence: 15 givenname: Marcio surname: de Souza middlename: Gonçalves fullname: de Souza, Marcio Gonçalves – sequence: 16 givenname: Celso surname: Amodeo fullname: Amodeo, Celso – sequence: 17 givenname: Luiz surname: Bortolotto fullname: Bortolotto, Luiz – sequence: 18 givenname: Dimas surname: Ikeoka fullname: Ikeoka, Dimas – sequence: 19 givenname: Luciano surname: Drager middlename: F fullname: Drager, Luciano F – sequence: 20 givenname: Alexandre surname: Cavalcanti middlename: Biasi fullname: Cavalcanti, Alexandre Biasi – sequence: 21 givenname: Otavio surname: Berwanger fullname: Berwanger, Otavio |
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Snippet | BACKGROUND:Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the... Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the impact of... Background: Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution. Randomized trials designed to assess the... Supplemental Digital Content is available in the text. Recent research efforts on bariatric surgery have focused on metabolic and diabetes mellitus resolution.... |
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SubjectTerms | Adult Antihypertensive Agents - therapeutic use Blood Pressure - drug effects Body Mass Index Brazil Female Gastric Bypass - adverse effects Humans Hypertension - diagnosis Hypertension - drug therapy Hypertension - physiopathology Male Middle Aged Obesity - diagnosis Obesity - physiopathology Obesity - surgery Original s Time Factors Treatment Outcome Weight Loss |
Title | Effects of Bariatric Surgery in Obese Patients With Hypertension: The GATEWAY Randomized Trial (Gastric Bypass to Treat Obese Patients With Steady Hypertension) |
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