{"id":55512,"date":"2023-04-04T17:03:39","date_gmt":"2023-04-04T15:03:39","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/gi-dynamics-announces-an-update-to-the-worldwide-registry-data-for-1022-patients-recently-published-in-diabetes-care-the-journal-of-the-american-diabetes-association\/"},"modified":"2023-04-04T17:03:39","modified_gmt":"2023-04-04T15:03:39","slug":"gi-dynamics-announces-an-update-to-the-worldwide-registry-data-for-1022-patients-recently-published-in-diabetes-care-the-journal-of-the-american-diabetes-association","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/gi-dynamics-announces-an-update-to-the-worldwide-registry-data-for-1022-patients-recently-published-in-diabetes-care-the-journal-of-the-american-diabetes-association\/","title":{"rendered":"GI Dynamics Announces an Update to the Worldwide Registry Data for 1,022 Patients Recently Published in Diabetes Care, the Journal of the American Diabetes Association"},"content":{"rendered":"
\n

\nData demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology<\/i><\/p>\n

BOSTON–(BUSINESS WIRE)–GI Dynamics\u00ae Inc.<\/a>, a medical device company that is developing EndoBarrier\u00ae for patients with type 2 diabetes and obesity, is pleased to announce updated positive data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry showing improvements in weight, glycemic control, blood pressure, and cholesterol.<\/p>\n

<\/a><\/p>\n

\nThe article recently published in Diabetes Care, \u201cEndoscopic Duodenal-Jejunal Bypass Liner Treatment for Type 2 Diabetes and Obesity: Glycemic and Cardiovascular Disease Risk Factor Improvements in 1,022 Patients Treated Worldwide,\u201d authored by Robert Ryder, M.D. of City Hospital, Birmingham, U.K, demonstrates treatment with EndoBarrier reduced microvascular and macrovascular risk factors that could reduce the complications of type 2 diabetes (T2D).<\/p>\n

\nThe duodenal-jejunal bypass liner was developed to mimic the small-bowel mechanisms of Roux-en-Y gastric bypass while being less invasive. Over 3,000 patients have been treated with EndoBarrier worldwide, and in 2017 a secure, online registry was established by ABCD for the collection of safety and efficacy data for EndoBarrier treated patients worldwide.<\/p>\n

\nThe ABCD Worldwide EndoBarrier Registry, led by Dr. Ryder, collected data from 34 centers in ten countries. As of October 2022, data had been entered on 1,022 patients and continues to support a positive benefit:risk profile for patients with type 2 diabetes and\/or obesity treated with EndoBarrier.<\/p>\n

\nAccording to Dr. Ryder, \u201cThere is an increasing number of patients with refractory uncontrolled T2D and obesity worldwide with no readily available treatment option, and the potential demand is too great for available metabolic surgery resources. The overall clinical benefit of EndoBarrier is highlighted in the Worldwide Registry data analyses demonstrating clinically significant reductions in weight during EndoBarrier implantation and additional associated improvements in HbA1c, blood pressure and cholesterol. This reduction in microvascular and macrovascular risk factors could serve to reduce the overall complications associated with type 2 diabetes.\u201d<\/p>\n

\nAs shown below, EndoBarrier treatment was associated with considerable reduction in weight, HbA1c, systolic blood pressure and cholesterol:<\/p>\n\n\n\n\n\n\n\n
\n

\nParameter<\/b><\/p>\n<\/td>\n

\n

\nn<\/b><\/p>\n<\/td>\n

\n

\nBaseline<\/b><\/p>\n<\/td>\n

\n

\nEndoBarrier Explant<\/b><\/p>\n<\/td>\n

\n

\nDifference<\/b><\/p>\n<\/td>\n

\n

\nP-value<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nWeight (kg)<\/p>\n<\/td>\n

\n

\n811<\/p>\n<\/td>\n

\n

\n120.2\u00b125.3<\/p>\n<\/td>\n

\n

\n106.9\u00b123.8<\/p>\n<\/td>\n

\n

\n-13.3\u00b19.7<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nHbA1c (%)<\/p>\n<\/td>\n

\n

\n646<\/p>\n<\/td>\n

\n

\n8.3\u00b11.8<\/p>\n<\/td>\n

\n

\n7.1\u00b11.3<\/p>\n<\/td>\n

\n

\n-1.3\u00b11.5<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nSystolic BP (mmHg)<\/p>\n<\/td>\n

\n

\n448<\/p>\n<\/td>\n

\n

\n135.7\u00b118.0<\/p>\n<\/td>\n

\n

\n129.5\u00b117.0<\/p>\n<\/td>\n

\n

\n-6.3\u00b119.2<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nCholesterol (mmol\/L)<\/p>\n<\/td>\n

\n

\n467<\/p>\n<\/td>\n

\n

\n4.8\u00b11.2<\/p>\n<\/td>\n

\n

\n4.2\u00b11.0<\/p>\n<\/td>\n

\n

\n-0.6\u00b11.03<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nn=patient population<\/i><\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\nAnalysis of the data according to baseline HbA1c clearly shows the higher the initial HbA1c the greater the reduction with EndoBarrier treatment. Similarly, the study showed the higher the initial BMI, the greater the reduction. There were no differences in HbA1c or weight reduction by age or sex.<\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n

\nHbA1c Ranges (%)<\/b><\/p>\n<\/td>\n

\n

\nn<\/b><\/p>\n<\/td>\n

\n

\nBaseline<\/b><\/p>\n<\/td>\n

\n

\nEndoBarrier removal<\/b><\/p>\n<\/td>\n

\n

\nDifference<\/b><\/p>\n<\/td>\n

\n

\nP-value<\/b><\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c<\/p>\n<\/td>\n

\n

\n646<\/p>\n<\/td>\n

\n

\n8.3\u00b11.8<\/p>\n<\/td>\n

\n

\n7.1\u00b11.3<\/p>\n<\/td>\n

\n

\n-1.3\u00b11.5<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 7<\/p>\n<\/td>\n

\n

\n141<\/p>\n<\/td>\n

\n

\n7.5\u00b10.3<\/p>\n<\/td>\n

\n

\n6.8\u00b10.8<\/p>\n<\/td>\n

\n

\n-0.7\u00b10.8<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 8<\/p>\n<\/td>\n

\n

\n158<\/p>\n<\/td>\n

\n

\n8.4\u00b10.3<\/p>\n<\/td>\n

\n

\n7.3\u00b11.0<\/p>\n<\/td>\n

\n

\n-1.1\u00b11.0<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 9<\/p>\n<\/td>\n

\n

\n96<\/p>\n<\/td>\n

\n

\n9.4\u00b10.3<\/p>\n<\/td>\n

\n

\n7.8\u00b11.1<\/p>\n<\/td>\n

\n

\n-1.6\u00b11.1<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll HbA1c \u2265 10<\/p>\n<\/td>\n

\n

\n111<\/p>\n<\/td>\n

\n

\n11.2\u00b11.2<\/p>\n<\/td>\n

\n

\n8.0\u00b11.5<\/p>\n<\/td>\n

\n

\n-3.2\u00b11.7<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nBMI Ranges<\/b><\/p>\n<\/td>\n

\n

\n\u00a0<\/p>\n<\/td>\n

\n

\n\u00a0<\/p>\n<\/td>\n

\n

\n\u00a0<\/p>\n<\/td>\n

\n

\n\u00a0<\/p>\n<\/td>\n

\n

\n\u00a0<\/p>\n<\/td>\n<\/tr>\n

\n

\nAll<\/p>\n<\/td>\n

\n

\n808<\/p>\n<\/td>\n

\n

\n41.2\u00b110.0<\/p>\n<\/td>\n

\n

\n36.6\u00b18.8<\/p>\n<\/td>\n

\n

\n-4.6\u00b13.6<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nBMI 23.0 \u2013 29.9<\/p>\n<\/td>\n

\n

\n24<\/p>\n<\/td>\n

\n

\n28.3\u00b11.9<\/p>\n<\/td>\n

\n

\n26.0\u00b12.2<\/p>\n<\/td>\n

\n

\n-2.2\u00b11.9<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nBMI 30.0 \u2013 34.9<\/p>\n<\/td>\n

\n

\n144<\/p>\n<\/td>\n

\n

\n32.9\u00b11.4<\/p>\n<\/td>\n

\n

\n29.8\u00b12.6<\/p>\n<\/td>\n

\n

\n-3.1\u00b12.4<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nBMI 35.0 \u2013 39.9<\/p>\n<\/td>\n

\n

\n253<\/p>\n<\/td>\n

\n

\n37.6\u00b11.4<\/p>\n<\/td>\n

\n

\n33.3\u00b12.9<\/p>\n<\/td>\n

\n

\n-4.3\u00b12.6<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nBMI \u226540<\/p>\n<\/td>\n

\n

\n387<\/p>\n<\/td>\n

\n

\n47.5\u00b110.4<\/p>\n<\/td>\n

\n

\n41.9\u00b19.7<\/p>\n<\/td>\n

\n

\n-5.5\u00b14.2<\/p>\n<\/td>\n

\n

\n<0.001<\/p>\n<\/td>\n<\/tr>\n

\n

\nn=patient population<\/i><\/p>\n<\/td>\n<\/tr>\n<\/table>\n

\n\u201cThe Worldwide Registry continues to demonstrate the positive impact of EndoBarrier on behalf of patients suffering from T2D and obesity. The clinical benefits we have seen are compelling and reinforce our belief that EndoBarrier has the potential to offer a less invasive, reversible option compared to traditional bariatric surgeries. The resulting therapeutic benefits could dramatically enhance the lives of these high-risk patients,\u201d commented Joe Virgilio, President and CEO of GI Dynamics.<\/p>\n

\nAbout GI Dynamics<\/b><\/p>\n

\nGI Dynamics Inc.<\/a> is the developer of EndoBarrier, an endoscopically delivered device therapy which offers a non-surgical, alternative treatment for the treatment of type 2 diabetes and obesity. EndoBarrier is not approved for sale in the United States and is limited by federal law to investigational use only.<\/p>\n

\nFounded in 2003, GI Dynamics is headquartered in Boston, Massachusetts. For more information, please visit gidynamics.com or follow us on Twitter<\/a> and LinkedIn<\/a>.<\/p>\n

Contacts<\/b> <\/p>\n

\nGI Dynamics Media Contact:<\/b>
Joseph Virgilio
\n
jvirgilio@gidynamics.com<\/a>
(781) 357-3296<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Data demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology BOSTON–(BUSINESS WIRE)–GI Dynamics\u00ae Inc., a medical device company that is developing EndoBarrier\u00ae for patients with type 2 diabetes and obesity, is pleased to announce updated positive data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry showing improvements … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-55512","6":"format-standard","7":"category-industry"},"yoast_head":"\nGI Dynamics Announces an Update to the Worldwide Registry Data for 1,022 Patients Recently Published in Diabetes Care, the Journal of the American Diabetes Association - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/gi-dynamics-announces-an-update-to-the-worldwide-registry-data-for-1022-patients-recently-published-in-diabetes-care-the-journal-of-the-american-diabetes-association\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GI Dynamics Announces an Update to the Worldwide Registry Data for 1,022 Patients Recently Published in Diabetes Care, the Journal of the American Diabetes Association - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Data demonstrate favorable safety and efficacy profile for the duodenal jejunal bypass liner (DJBL) technology BOSTON–(BUSINESS WIRE)–GI Dynamics\u00ae Inc., a medical device company that is developing EndoBarrier\u00ae for patients with type 2 diabetes and obesity, is pleased to announce updated positive data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry showing improvements ... 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