Diabetes Experts Sound Caution Over Extended Role Of New Drugs, UK

Main Category: Diabetes
Article Date: 17 Jun 2009 - 5:00 PDT

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MEDICAL experts have cautioned against indiscriminate use of new classes of medication for Britain's increasing number of people with diabetes - saying the drug advances needed "careful adoption" to meet their full treatment potential.

The Association of British Clinical Diabetologists (ABCD) explored the safety and effectiveness of one new therapy in particular - exenatide - as part of a unique research project. This involved the experiences of over 7,000 diabetes patients nationwide - making it the biggest international database of its kind.

ABCD do suggest that new types of oral and injectable medication - used as an alternative to insulin - have an important role to play in improving the clinical outcomes of a selected number of patients with obese type 2 diabetes. This is the more common form of the condition, affecting around 75 per cent of people with diabetes.

But the Association advised against a routine role for these drugs at this early stage, after its research highlighted the need for careful patient selection.

Patients at risk of pancreatitis, such as those with a high alcohol intake; a history of gall stones; or on steroids should only be considered for exenatide under specialist medical supervision with careful monitoring, it warned.

Bus and lorry drivers with diabetes, as well as patients who have undergone or who are contemplating bariatric surgery, also require specialist input in selection for exenatide use.

ABCD is the national organisation representing more than 500 consultant physicians and registrars in Britain who specialise in diabetes mellitus - an increasingly common condition that is known to affect more than two million of the population, although the actual figure is feared to be far higher.

Over the last two years, it has built up considerable experience in the prescribing of these newly-developed drugs (oral gliptins and injectable incretin mimetics). It has drawn upon this expertise to identify 'best practice' in their future use.

Its views have been published to coincide with the long-awaited update on diabetes treatment by NICE, the National Institute for Clinical Excellence.

ABCD chairman, Dr Peter Winocour, said the Association's research, combined with the NICE guidance, placed an important spotlight on the future treatment regimes for diabetes.

He said: "By pooling our expertise, ABCD is in a unique position to share our experience throughout the diabetes community - and ensure that patients continue to receive the highest possible quality of care. These drugs are welcome additions in the fight against diabetes but, as with anything new, they need careful adoption and must be used judicially. We have been able to identify the appropriate cohort of patients who may benefit the most from these therapies. We recommend widening their use in some groups - but urge caution in others, especially those with abnormal liver and kidney function."

The views of ABCD were shaped by a confidential web-based audit among its members regarding the use of exenatide, one of the new injectable therapies for obese type 2 diabetes.

It also took into consideration limited NICE guidance published previously as well as the findings of other diabetes specialists across America and Europe, who have also suggested a more restricted role for these "less well-validated therapies".

ABCD's preliminary position statement will now inform drug prescribing and clinical practice among diabetes experts nationwide.

Dr Winocour added: "We have learned from past experience with other novel diabetes therapies that adverse side effects can become apparent even after pre-licensing testing. Our audit will help to identify adverse effects sooner rather than later, ensuring the right treatments continue to be provided to the right patients in the right way.

"The potential positives and negatives of all treatment options need to be carefully employed and discussed fully so informed decisions can be made in partnership with the patient. We are also advising that patients are fully aware of potential side effects, such as abdominal pain, nausea, vomiting and early satiety (feeling over-full)."

Source
The Association of British Clinical Diabetologists