Roux-en-Y gastric bypass (RYGB) is an effective strategy for midterm blood pressure (BP) control and hypertension remission with fewer medications required in patients with hypertension and obesity, according to the three-year results from the GAstric Bypass to Treat obEse Patients With steAdy hYpertension (GATEWAY) randomised clinical trial. The outcomes were published in the paper, ‘Three-Year Outcomes of Bariatric Surgery in Patients With Obesity and Hypertension Randomized Clinical Trial’, in the Annals of Internal Medicine.
The trial, led by Dr Carlos Aurelio Schiavon from the Hospital do Coracão (HCor), São Paulo, Brazil, was undertaken to as the midterm effects of bariatric surgery on patients with obesity and hypertension remain uncertain and was designed to determine the three-year effects of RYGB on BP and other risk factors for cardiovascular events compared to compared with medical therapy (MT) alone in patients with arterial hypertension.
In this randomised, single-centre, non-blinded trial, 100 patients with hypertension (using at least two medications at maximum doses or more than two at moderate doses) and with BM30.0-39.9 were randomised to RYGB plus MT (n=50) vs medical therapy alone (n=50). The primary end point was reduction of at least 30% of the total antihypertensive medications, while maintaining systolic and diastolic blood pressure lower than 140mmHg and 90mmHg. Key secondary outcomes were number of antihypertensive medications, hypertension remission and BP control according to current guidelines (<130/80mmHg).
The outcomes revealed that from the 100 patients (76% female; mean BMI36.9), 88% from the RYGB group and 80% from the MT group completed follow-up. At three 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 140/90mmHg and less than 130/80mmHg without medications, respectively.
Median (interquartile range) number of medications in the RYGB and MT groups at three 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 re-operation.
"The findings from GATEWAY randomised clinical trial study suggests that bariatric surgery has durable effects over the control of blood pressure and improves the adherence to treatment by reducing the necessity of medications,” said principal investigator and lead author of the study, Dr Schiavon. “Patients with obesity and hypertension, mainly those taking many anti-hypertensives, should consider having bariatric surgery.”
The primary funding source for this trial was provided by Ethicon, represented in Brazil by Johnson & Johnson do Brasil.