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  • Clinical Pharmacist
  • 2009;
  • 1:
  • 301

Liraglutide added to type 2 diabetes arsenal

Wed, 15/07/2009 - 12:34
Pancreas

Pancreas


In the pancreas, beta cells (purple) secrete insulin and alpha cells (pink) secrete glucagon (CNRI | SPL)

Patients whose type 2 diabetes is poorly controlled on their existing medicines could benefit from the addition of liraglutide — a newly available once-daily injection.

Launched by Novo Nordisk as Victoza, liraglutide is a glucagon-like peptide-1 (GLP-1) analogue.

The launch follows the publication of new data comparing liraglutide with exenatide, a similar medicine available for use twice a day (Lancet 2009;374:39).

It was found that liraglutide delivered better improvements in HbA1c (the primary endpoint) than did exenatide over a 26-week period (P<0.0001).

“This study further demonstrates the efficacy of the new drug class of GLP-1 receptor agonists,” commented Elizabeth Hackett, principal pharmacist for diabetes, University Hospitals of Leicester NHS Trust.

She pointed out that the open-label study also showed more patients on liraglutide reached an HbA1c of 7% or less  than did those receiving exenatide (54% versus 43%, respectively).

“However,” Ms Hackett added, “exenatide was superior to liraglutide when comparing postprandial glucose after breakfast and dinner. Both drugs demonstrated similar weight loss.”

She told Clinical Pharmacist: “Since the majority of patients with type 2 diabetes are overweight, this class of drugs is particularly beneficial in that it promotes weight loss in most patients, where other classes of antidiabetic agents tend to cause weight gain or are weight neutral.

“Since the GLP-1 receptor agonists cause glucose-dependent insulin release, hypoglycaemia is uncommon and in most cases can be attributed to other agents being taken concurrently.”

Licensed indication

Liraglutide is licensed for the treatment of adults with type 2 diabetes to achieve glycaemic control, in combination with:

  • Metformin or a sulphonylurea, for patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with these drugs
  • Metformin and a sulphonylurea or metformin and a thiazolidinedione for patients with insufficient glycaemic control despite dual therapy

Speaking at the launch briefing in London, Anthony Barnett, consultant physician and clinical director of diabetes and endocrinology at Heart of England NHS Foundation Trust, Birmingham, explained that liraglutide stimulates insulin secretion and limits glucagon secretion to lower glucose levels only when they are high.

When liraglutide is used with metformin, Professor Barnett remarked, “severe hypoglycaemia is virtually unheard of”.

In the Lancet study, patients receiving liraglutide experienced less persistent nausea and fewer occurrences of minor hypoglycaemia compared with those taking exenatide.

Said Ms Hackett: “The authors suggest that liraglutide should be considered as a treatment option for patients with type 2 diabetes, especially those in whom weight and hypoglycaemia are major concerns.”

Although liraglutide has been licensed in the EU, Ms Hackett told Clinical Pharmacist that “the FDA has expressed concerns regarding the increased thyroid tumours seen in studies in rodents”.

At the press briefing a spokesman for Novo Nordisk explained that calcitonin levels were measured for all patients in the phase III trial programme to study any possible trends towards thyroid cancer. “We’ve seen no increase whatsoever, confirmed with our two-year data with even higher dosages,” he stressed.

In May 2009 the National Institute for Health and Clinical Excellence issued an update to its clinical guideline on the management of type 2 diabetes, describing how newer antidiabetic medicines should be used (The Pharmaceutical Journal 2009;282:635).

The guideline does not make recommendations for liraglutide, however a spokesman for Novo Nordisk revealed that NICE is to undertake a full technology appraisal of the drug, expected to be published in 2010.

Professor Barnett said he hoped NHS organisations would use liraglutide in line with NICE’s recommendations for exenatide in the interim.