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Saturday, 27 July 2013

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
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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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Injectafer receives US FDA approval for the treatment of Iron Deficiency Anaemia

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 27 Jul 2013 - 0:00 PDT Current ratings for:
Injectafer receives US FDA approval for the treatment of Iron Deficiency Anaemia
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Injectafer® has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA). Luitpold Pharmaceuticals, Inc., the US partner of Vifor Pharma, a company of the Galenica Group, will immediately launch the product. Injectafer® will be produced at the Luitpold manufacturing facility in Columbus, Ohio.

Injectafer® (US brand name of Ferinject®, ferric carboxymaltose) has received US Food and Drug Administration (FDA) approval for the treatment of Iron Deficiency Anaemia (IDA) in adult patients who have had an unsatisfactory response to oral iron or who have intolerance to oral iron.

Injectafer® is the first non-dextran intravenous iron therapy to gain US FDA approval for the treatment of IDA in a diverse group of patients with this debilitating condition, irrespective of the underlying origin. Injectafer® is also indicated for Iron Deficiency Anaemia in adult patients with non-dialysis dependent Chronic Kidney Disease (ND-CKD).

The approval is based on the evaluation of two large, multi-centre, randomised, controlled clinical trials conducted by Luitpold Pharmaceuticals, Inc. that studied more than 3,500 patients, of which approximately 1,800 were treated with Injectafer®. Both trials met their efficacy and safety endpoints and were presented at the American Society of Nephrology's (ASN) Kidney Week 2011. The results of the VIT 31 study were recently published in the peer-reviewed journal "Transfusion"; results from the VIT 30 study (REPAIR-IDA trial) are anticipated to be published in another peer reviewed medical journal in the near future.

Luitpold Pharmaceuticals, Inc., the Vifor Pharma partner in the United States, will immediately launch Injectafer® to provide this important new drug to US physicians and their patients. In the US market, the product is available in 750mg vials and will be produced at the Luitpold manufacturing facility in Columbus, Ohio.

In the United States there are an estimated 7.5 million people with IDA, a condition that occurs when body iron stores are inadequate for normal red blood cell production. IDA is a frequent complication in many gastro-intestinal disease states and conditions, affecting up to one-third of inflammatory bowel disease patients, and up to 24% of patients undergoing bariatric bypass surgery. It is also prevalent in children and women, with over 3 million US women of childbearing age affected due to conditions such as heavy uterine bleeding, postpartum anaemia and pregnancy.

Ferinject® was approved by both the Swiss regulatory agency Swissmedic and the UK Medicines & Healthcare products Regulatory Agency (MHRA) in 2007. With the UK as Reference Member State, the MHRA has supported the subsequent approval of Ferinject® throughout the European Union. Ferinject® is currently registered for use in 46 countries and has been launched in 37 markets worldwide.

Injectafer® (US brand name of Ferinject®) is an innovative non-dextran intravenous (i.v.) iron replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject®. To date, Ferinject® (brand name of Injectafer® outside the US) has gained marketing authorisation in 46 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other diseases. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further clinical trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women's health are ongoing.

Iron Deficiency Anaemia (IDA) is a state in which iron stores are inadequate for normal blood formation, as the iron requirements exceed the supply. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale), and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically reduced. According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia* (IDA).

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

* Source: World Health Organization. Preventing and controlling Iron Deficiency Anaemia through primary health care. Available here.

Vifor Pharma Ltd.