Blood Pressure Control Achieved With Fewer Or No Medications Within One Month Of Bariatric Surgery And Maintained Over 12 Months

ANAHEIM, Calif., Nov. 13, 2017 /PRNewswire/ -- Bariatric surgery may reduce or eliminate the need for high blood pressure medications in patients with obesity, often within one month, according to the GATEWAY* Study, the first randomized clinical trial that compared gastric bypass plus medical therapy to medical therapy alone for the treatment of hypertension. The findings were presented at the American Heart Association's Scientific Sessions 2017 and published simultaneously in the journal Circulation. This investigator-initiated study was funded with a grant from Ethicon, ** part of Johnson & Johnson Medical Devices Companies. ***

Within 30 days of surgery, 83.7 percent of gastric bypass patients maintained blood pressure control (140/90 mm Hg) with at least 30 percent fewer medications, and within a year, more than half (51%) showed remission and required no medications at all. The medical therapy group wasn't as successful with only 12.8 percent of them reducing their use of high blood pressure drugs by 30 percent and none achieving remission over 12 months. Surgical patients lost 29 percent of their body weight, compared to weight loss of less than 1 percent for the medical therapy alone group. An improvement in lipid profile and inflammatory markers and reduced cardiovascular risk was also achieved in the surgery group. After a year, a third (33%) of patients normalized their blood pressure to less than 120 mm Hg, and 69 percent of them did so without medication. A little more than a quarter (26%) of the medical therapy alone group achieved normalized blood pressure with an average of 2.8 medications per patient.

"This study suggests that cardiologists treating obese patients with hypertension, mainly those with severe obesity and using more than two drugs, can consider referring these patients for bariatric surgery, which is consistent with the American Heart Association, American College of Cardiology and The Obesity Society Clinical Practice Guidelines," said lead study investigator Carlos Aurelio Schiavon, MD, a bariatric surgeon at Hospital do Coracão (HCor) in Brazil. "Fewer or no medications means better compliance and weight loss with an improved metabolic and inflammatory profile combine to reduce the risk of major cardiovascular events for these patients."

In the study, researchers followed 100 patients aged 18 to 65 with hypertension and a body mass index (BMI) ranging from 30 to 39.9 kg/m(2 )who were being treated with at least two antihypertensive medications at maximum doses or more than two drugs at moderate doses. Patients were randomly assigned to have either gastric bypass surgery along with medical therapy or to continue with their current antihypertension regime. Patients were followed for one year and are scheduled to be followed for up to five years.

Obesity and hypertension are independent risk factors for cardiovascular disease and stroke.(1) When someone has both risk factors, the risk for cardiovascular mortality doubles. (2) Additionally, the prevalence of hypertension, which affects more than 85 million Americans,(3) increases with an individual's BMI.( 4)

Ethicon is engaged in a multi-year, multi-million-dollar effort to combat obesity through the development of products and services that optimize patient outcomes and groundbreaking research that demonstrates the impact of bariatric surgery on obesity and related diseases including type 2 diabetes and heart disease.

"The GATEWAY Study adds to the body of evidence that shows surgery is the most effective and durable treatment for obesity, and its benefits extend beyond weight loss with improvement or resolution of related health conditions including hypertension and type 2 diabetes," said Elliott Fegelman, MD, Therapeutic Area Lead for Metabolics at Johnson & Johnson Innovation.

Ethicon also sponsored the landmark STAMPEDE study, whose five-year outcomes were published in The New England Journal of Medicine (NEJM) earlier this year. The study showed bariatric surgery with intensive medical therapy is a better long-term treatment than intensive medical therapy alone for obese patients with uncontrolled type 2 diabetes.(5)

Facts about Obesity and Bariatric Surgery
According to American Society of Metabolic and Bariatric Surgery (ASMBS), qualifications for bariatric surgery include:

    --  BMI >= 40, or more than 100 pounds overweight.
    --  BMI >=35 and at least one or more obesity-related co-morbidities

The worldwide prevalence of obesity more than doubled between 1980 and 2014. According to the World Health Organization (WHO), more than 1.9 billion adults were overweight in 2016. Of this group, more than 600 million have obesity.(6 )In the United States, more than 2 in 3 adults are overweight or have obesity, and about 1 in 13 are considered to have extreme obesity. (7 )

Data suggests bariatric surgery has the greatest weight loss results of any treatment options for those with severe obesity,(8 )yet only 1 percent of the 26 million surgically-eligible patients in the U.S. have surgery each year. Obesity is the second leading cause of preventable death in the U.S.(9) and contributes to more than 40 other diseases, including high cholesterol, stroke, Type 2 diabetes, heart disease, cancer and arthritis.(10)

About Ethicon
From creating the first sutures, to revolutionizing surgery with minimally invasive procedures, Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing healthcare issues, and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. Learn more at www.ethicon.com, and follow us on Twitter @Ethicon.

    *GATEWAY (Gastric bypass to Treat obEse patients With steAdy hYpertension)
    **Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates.
    ***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, and cardiovascular businesses within Johnson & Johnson's Medical Devices segment.
    # All surgery presents risk.  Please consult with your doctor.

    1 Mozaffarian D, et. al. on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics- 2015 update: a report from the American Heart
     Association [published online ahead of print December 17,2014]. Circulation. doi: 10.1161/CIR.0000000000000152. Accessed from http://circ.ahajournals.org/content/131/4/e29
    (2) http://onlinelibrary.wiley.com/doi/10.1111/jch.12049/epdf
    (3) http://www.heart.org/HEARTORG/Conditions/HighBloodPressure/GettheFactsAboutHighBloodPressure/The-Facts-About-High-Blood-Pressure_UCM_002050_Article.jsp#.WfjNkkyZN0s
    4 Brown  C, et al. Body Mass Index and the Prevalence of Hypertension and Dyslipidemia.  Obes Res.2000, 8: 605-619 Accessed from https://www.ncbi.nlm.nih.gov/pubmed/11225709
    5 http://www.nejm.org/doi/full/10.1056/NEJMoa1600869
    6 http://www.who.int/mediacentre/factsheets/fs311/en/
    7 https://www.niddk.nih.gov/health-information/health-statistics/overweight-obesity
    8 Kaplan LM, et al. Bariatric- Times. 2012;9(9 suppl C):C12_C13
    9 https://www.ncbi.nlm.nih.gov/pubmed/12230315
    10 Kaplan L. J Gastrointest Surg. 2003;7(4) proceeding;443_451.

©2017 Ethicon, Inc.

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