First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK

Main Category: Diabetes
Also Included In: Obesity / Weight Loss / Fitness
Article Date: 26 Jul 2013 - 2:00 PDT Current ratings for:
First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK

Combined diabetes and obesity, 'diabesity', is a serious health problem with considerably increased risks of premature heart attack, stroke and death. If not controlled, it can also affect the eyes leading to blindness, the kidneys leading to kidney failure and the feet leading to ulcers and amputation.

The number of patients with diabesity is increasing rapidly, both in the UK and world-wide. Despite all the available expertise and best use of the most modern treatments there are many patients who remain considerably overweight and with poor diabetes control, rendering them vulnerable to these complications.

For such patients a possible new treatment has become available. It is called endobarrier and consists of a 60cm tube-like liner made from a thin, flexible and durable impermeable polymer. It is inserted by the simple procedure of endoscopy and is anchored in place, just beyond the stomach, by a basket of very thin wire made of Nitinol-an alloy of nickel and titanium. The endobarrier prevents food from contacting the first two feet of small intestine and this leads to considerable weight loss (18% reduction) and improvement in diabetes control (87% of patients reach the target control level).

Because this treatment could well be just what is needed for the patients who remain in trouble from their diabetes despite the best treatments available, ABCD have initiated a national trial of the new device funded by a grant from their Diabetes Care Trust (ABCD ) Registered Charity Number 1139057. The study is supported by the NHS and is centred at Birmingham's City Hospital with supporting centres in London (King's College Hospital and Guy's and St Thomas' Hospitals) and Glasgow (Glasgow Royal Infirmary).

Dr Piya Sen Gupta, ABCD Research Fellow, who is conducting the study for ABCD, said: "This trial presents an exciting opportunity for patients with combined diabetes and weight problems, who currently have limited treatment options, to kick start their way back to health.

"It is a novel idea to use a device to treat diabesity when the usual medications have failed and it may offer a valuable treatment option, avoiding in some, the need for invasive bariatric surgery. By opening this study up to NHS patients in Birmingham, London and Glasgow, the results will be relevant throughout the UK. This study has been so named, as we do hope that it goes some way to REVISE-Diabesity"

The first patient to receive the new treatment in the trial is due to have her device inserted on the morning of Thursday 25th July, 2013, at Birmingham's City Hospital.

ABCD Chairman, Dr Chris Walton, said :"The twin epidemics of obesity and diabetes may bankrupt our healthcare systems. The projected spend on diabetes rises from the current 10% of NHS expenditure to 17% of NHS expenditure by 2035 and it is estimated that, for type 2 diabetes, the cost of complications of the disease is more than threefold the cost of treatment. ABCD is keen to research new technologies that confront obesity in diabetes and which may prevent the relentless progress to complications, so the placement of the first endobarrier device in this study is a landmark date''

Dr Bob Ryder, Principal Investigator for the ABCD study, said: "At the moment we have many patients who remain overweight and with poor diabetes control, despite all the available diabetes treatments. Because the endobarrier reduces weight and improves the diabetes control, it is a treatment that could break the cycle of problems for these patients who have otherwise come to the end of the line.

"The best thing about the endobarrier is that it is not permanent and after insertion at endoscopy, it is removed up to a year later, and we then have to hope that the improvement is sustained. This treatment is not currently an NHS treatment, but this is an NHS approved study, and if the trial proves successful and cost effective, we expect that the device will be considered by NICE for approval as part of mainstream NHS diabetes treatment in the future".

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our diabetes section for the latest news on this subject.

The Association of British Clinical Diabetologists (ABCD) is the national organisation of Consultant Physicians in Britain who specialise in Diabetes Mellitus. Most are also Acute General Physicians, and many are also Specialists in Endocrinology and Lipid Metabolism.

The Association of British Clinical Diabetologists (ABCD)

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posted by Dr.K.Ramakrishnan on 26 Jul 2013 at 10:12 am

Of course, the procedure is fantastic. Here some more clarifications needed. 1. Since the endobarrier is kept for one year ,is there a possibility of vital nutrient dificiency. 2. Can the procedure recommend for obesity and overwieght? 3. After one year is there any weightgain?

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'First patient receives innovative new treatment to tackle combined diabetes and obesity in NHS approved trial initiated by the ABCD, UK'

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Late Stage Lung Cancer Drug Gilotrif (Afatinib) Approved By FDA

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Main Category: Lung Cancer
Also Included In: Regulatory Affairs / Drug Approvals;  Cancer / Oncology
Article Date: 13 Jul 2013 - 0:00 PDT Current ratings for:
Late Stage Lung Cancer Drug Gilotrif (Afatinib) Approved By FDA

The FDA has approved the use of Gilotrif (afatinib) to treat patients with non-small cell lung cancer (NSCLC) who have certain epidermal growth factor receptor (EGFR) gene mutations in their tumors.

Lung cancer is one of the leading cancer-killers, with an estimated 159,480 people dying from the disease this year in the U.S. alone. Most cases of lung cancer are NSCLC (around 85 percent) and nearly one in 10 who have NSCLC have a EGFR gene mutation - most of them expressing exon 21 L858R substitution or EGFR exon 19 deletions.

As a a tyrosine kinase inhibitor, Gilotrif works by blocking proteins that are necessary for cancer cells to develop. The drug will be approved exclusively for patients with tumors that express the EGFR exon 21 L858R substitution or exon 19 deletions or gene mutations.

The drug was reviewed under the FDA's priority review program which speeds up the review for medications that may provide effective therapy when no existing treatment option exists.

The therascreen EGFR RGQ PCR Kit is used to determine whether a person's tumor cells express an EGFR mutation.

Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said that "today's approvals further illustrate how a greater understanding of the underlying molecular pathways of a disease can lead to the development of targeted treatments. Gilotrif is the second drug approved this year for patients with untreated metastatic NSCLC whose tumors have the EGFR exon 19 deletions or exon 21 L858R substitution mutations."

Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health commented that "the approval of companion diagnostic tests and drugs are important developments in oncology, as they help us bring safe and effective treatments to patients who need them."

Tumor samples from participants in the clinical trial were used to assess the efficacy of the "therascreen EGFR RGQ PCR Kit" in detecting EGFR mutations.

Earlier this year, the FDA approved the cobas EGFR Mutation Test that also detects epidermal growth factor receptor (EGFR) gene mutations. The cobas test is a companion diagnostic for the cancer drug Tarceva (erlotinib).

A total of 345 people with NSCLC whose tumors had EGFR mutations participated in the study. Those who took Gilotrif experienced a 4.2 month delay in tumor growth compared to those who received chemotherapy.

Side effects of Gilotrif include:

FeverSevere rashDecreased appetiteEye inflammationDecreased weightLung inflammationDecreased weightNose bleedSkin infection

Boehringer Ingelheim Pharmaceuticals, Inc is marketing the drug Gilotrif.

Kevin Lokay, vice-president and business unit head, Oncology, Boehringer Ingelheim Pharmaceuticals, Inc., said:

"We are truly excited to be able to offer GILOTRIF as a new treatment option for these patients. This approval is an achievement for Boehringer Ingelheim Oncology and the many teams and individuals who committed themselves to developing this therapy based on its potential identified in the clinical trial program. GILOTRIF marks the first, of what we expect will be many, oncology products to emerge from our research and development program."

Written by Joseph Nordqvist

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'Late Stage Lung Cancer Drug Gilotrif (Afatinib) Approved By FDA'

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