Bariatric Surgery Reduces or Eliminates Need for Blood Pressure Medication in Patients With Obesity in New 3-Year Randomized Clinical Trial

CINCINNATI, Aug. 26, 2020 /PRNewswire/ -- Patients with mild to moderate obesity who underwent bariatric surgery kept their blood pressure under control and required fewer or no medications compared to patients on standard medical therapy, according to a new landmark study published online in Annals of Internal Medicine. GATEWAY*, a three-year study funded by a grant from Ethicon**, part of Johnson & Johnson Medical Devices Companies***, is the first randomized clinical trial to compare the effectiveness of these two interventions for the treatment of hypertension. Early results from the GATEWAY study, first published in 2018 in the medical journal Circulation,¹ showed similar results.

In the new three-year study, nearly three-quarters (73%) of gastric bypass patients were able to stop taking 30% or more of their antihypertensive medications and still maintain a blood pressure of less than 140/90 mm Hg, the study's primary endpoint. Only 11% of those on standard medical therapy alone were able to do the same over the three-year follow-up period.

Notably, while 35% of bariatric surgery patients achieved remission of their hypertension without the need for continued medication, only 2% of patients on medical therapy ever did. No patients in the medical therapy group achieved a blood pressure lower than 130/80 mm Hg, a target achieved by 31% of gastric bypass patients. In addition, patients on drug therapy experienced a modest weight gain compared to surgical patients who on average lost 27.8% of their total body weight.

"The latest GATEWAY results showed that early improvements and even remission of high blood pressure in bariatric surgery patients are sustainable over a longer period of time while those on conventional medical treatment continue to face difficulties with both hypertension and obesity," said lead study investigator Carlos Aurelio Schiavon, MD,^ a bariatric surgeon at Hospital do Coracão (HCor) in Brazil, the center where the trial was conducted. "This new high-level evidence should be factored into the treatment recommendations of cardiologists and primary care doctors who care for patients with obesity and hypertension."

The single center randomized study included 100 patients all of whom had obesity (BMI between 30.0 and 39.9 kg/m2) and were taking at least two blood pressure medications at maximum doses or more than two medications at moderate doses.

Nearly half the adults in the United States (108 million, or 45%) have hypertension² and 42.4% have obesity,³ which are independent risk factors for heart disease and stroke, leading causes of death.⁴ When a patient has both conditions, the risk of cardiovascular mortality may nearly double.⁵ The Centers for Disease Control and Prevention (CDC) reports that only about 1 in 4 adults (24%) with high blood pressure have it under control.³

"Bariatric surgery is the most effective and durable treatment for the disease of obesity and GATEWAY adds to the mounting body of high-level evidence that shows its benefits extend far beyond weight loss," said Raymond Fryrear, MD, VP & Integrated Leader, Pre-Clinical, Clinical and Medical Affairs, Ethicon, Inc. "Randomized clinical trials remain the cornerstone of evidence-based medicine and Ethicon continues to invest in these studies in support of the global medical community and patients who could benefit from this surgical option."

Three landmark randomized clinical trials – MOMS⁶, STAMPEDE⁷ and most recently GATEWAY – all sponsored by Ethicon in the last few years – have helped to further establish bariatric and metabolic surgery as a highly effective treatment option for type 2 diabetes, early chronic kidney disease and hypertension in patients with obesity. While previous studies have resulted in similar findings, none were randomized clinical trials, considered the "gold standard" for research because they produce the highest level of evidence in assessing the effectiveness of treatment.

About Ethicon
Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care 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 worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

About Johnson & Johnson Medical Devices Companies 
As the world's most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of health care. With unparalleled breadth, depth and reach in surgery, orthopaedics, vision and interventional solutions we are working to profoundly change the way care is delivered. We are in this for life.

*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.
^ Carlos Aurelio Schiavon, MD is a paid consultant for Ethicon, Inc.
There are risks with any surgery, such as adverse reactions to medications, problems with anesthesia, problems breathing, bleeding, blood clots, inadvertent injury to nearby organs and blood vessels, even death. Bariatric surgery has its own risks, including failure to lose weight, nutritional or vitamin deficiencies, and weight regain. Patients should consult their physicians to determine if this procedure is appropriate for their condition.

¹ Schiavon CA, Bersch-Ferreira AC, Santucci EV, et al. Effects of bariatric surgery in obese patients with hypertension: the GATEWAY randomized trial (Gastric bypass to treat obese patients with steady hypertension). Circulation. 2018;137:1132-1142. [PMID: 29133606] doi:10.1161/CIRCULATIONAHA.117.032130
² https://www.cdc.gov/bloodpressure/facts.htm 
³ https://www.cdc.gov/nchs/products/databriefs/db360.htm#ref1 
⁴ 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 
⁵ Landsberg et al. Obesity Related Hypertension. The Journal of Clinical Hypertension. Figure 2. http://onlinelibrary.wiley.com/doi/10.1111/jch.12049/epdf 
⁶ https://jamanetwork.com/journals/jamasurgery/article-abstract/2766660 
⁷ http://www.nejm.org/doi/full/10.1056/NEJMoa1600869

SOURCE Ethicon, Inc.