Three-year outcomes of bariatric surgery in patients with obesity and hypertension a randomized clinical trial

Carlos A. Schiavon, Deepak L. Bhatt, Dimas Ikeoka, Eliana V. Santucci, Renato Nakagawa Santos, Lucas P. Damiani, Juliana D. Oliveira, Rachel Helena V. Machado, Helio Halpern, Frederico L.J. Monteiro, Patricia M. Noujaim, Ricardo V. Cohen, Marcio G. de Souza, Celso Amodeo, Luiz A. Bortolotto, Otavio Berwanger, Alexandre B. Cavalcanti, Luciano F. Drager

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73 Scopus citations

Abstract

Background: Midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain. Objective: To determine the 3-year effects of Roux-en-Y gastric bypass (RYGB) on blood pressure (BP) compared with medical therapy (MT) alone. Design: Randomized clinical trial. (ClinicalTrials.gov: NCT01784848) Setting: Investigator-initiated study at Heart Hospital (HCor), São Paulo, Brazil. Participants: 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/m2 were randomly assigned (1:1 ratio). Intervention: RYGB plus MT or MT alone. Measurements: 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). Results: Among 100 patients (76% female; mean BMI, 36.9 kg/m2 [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]; P < 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 (P < 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 B12 and 2 patients required reoperation. Limitation: Single-center, nonblinded trial. Conclusion: RYGB is an effective strategy for midterm BP control and hypertension remission, with fewer medications required in patients with hypertension and obesity.

Original languageEnglish
Pages (from-to)685-693
Number of pages9
JournalAnnals of Internal Medicine
Volume173
Issue number9
DOIs
StatePublished - 3 Nov 2020
Externally publishedYes

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