Diabetes Specialists Call For Drug Regulators To Step In To Clarify Lantus Concerns, UK

Main Category: Diabetes
Article Date: 06 Jul 2009 - 1:00 PDT

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BRITAIN'S top diabetes specialists added their weight to calls for European drug regulatory bodies to launch an urgent investigation into the popular insulin treatment glargine (Lantus). The move by the Association of British Clinical Diabetologists (ABCD) follows this week's publication of four studies, which raise possible concern about an increased risk of the development of cancer in people who use this long-acting insulin therapy.

"For Britain's growing number of people with insulin-treated diabetes, many of whom use Lantus, there is a need for clarity, common sense- and reassurance," said ABCD Chairman, Dr Peter Winocour. "The European drug regulatory authorities are uniquely placed to provide this and we urge them to take action.

"We know from our work in hospitals across the NHS that there is a lot of concern in the diabetes community about these research findings, both among people with the condition as well as those who care for them.

"Although the latest research is inconclusive - it neither confirms or excludes a link - it has generated anxiety."

While ABCD said it fully recognised patients' concerns, it advised those who had found Lantus helpful on an individual basis against a change in treatment.

"At the present time, we do not recommend that people using Lantus change to another long-acting insulin," said Dr Winocour.

"Where people are concerned about the risk, and are keen to change Lantus insulin to an alternative, they should only do so after discussing the situation first with a diabetes specialist.

"On no account should people stop taking insulin - to do so could cause them to become very ill."

Lantus is a widely used insulin in the UK which has been available for almost 10 years. It has been of benefit to many patients, particularly those at risk of overnight hypoglycaemia.

Four studies involving the drug are published on the website of Diabetologia, a highly-respected, peer-reviewed scientific journal.

The largest study came from a German health insurance registry. It found there was no increased rate of the diagnosis of cancer associated with Lantus compared to other insulins. However, when the data were adjusted for dose, there was a modest association with overall incidence in the diagnosis of cancer, when Lantus was the only insulin prescribed.

A study performed in Sweden demonstrated no increase in overall incidence in the diagnosis of cancer, but there was there was an increased risk for breast cancer associated with Lantus insulin used alone.

Two further studies performed in the UK did not confirm these results.

The studies were based on reviews of case records recording diabetes treatment and the diagnosis of cancer.

Dr Winocour added: "All the reports are observational epidemiological studies, which can only examine relationships and are unable to show cause and effect.

"They must be seen in this respect and considered inconclusive, not least having given differing results."

An extensive and thoughtful editorial in Diabetologia reflected on the importance of the issue, as the suggested link between Lantus and the diagnosis of cancer was plausible.

A firm statement was made that there was no evidence from this research of any harm from glargine in type 1 diabetes, in men generally, or showing any association with premenopausal breast cancer.

Interpretation of these studies is complicated by confounding factors such as the type of older, more obese patients with type 2 diabetes who would be treated with glargine alone. Age and obesity are two factors which have been proven to increase the risk of cancer.

However, ABCD recommends that this suspicion of increased risk for the diagnosis of cancer with glargine insulin is investigated urgently by the European drug regulatory authorities, because of the concern that will be felt by people with diabetes and specialists caring for them.

Source
Association of British Clinical Diabetologists

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