Magazine article Drug Topics

New Once-Weekly Treatment for Type 2 Diabetes

Magazine article Drug Topics

New Once-Weekly Treatment for Type 2 Diabetes

Article excerpt

NEW DRUG REVIEW

On April 15, 2014, FDA approved albiglutide (Tanzeum; QaxoSmithKline) for use in addition to diet and exerdse to improve glycémie control in patients with type 2 diabetes. It is the newest glucagon-like peptide-1 receptor agonist (GLP-1) approved for once-weekly dosing. GLP-1 agonists stimulate glucose-dependent insulin release from the pancreas, slow gastric emptying, inhibit glucagon release, and promote satiety.

As with all GLP-1 agonists, albiglutide has been associated with an increased risk of pancreatitis and possibly thyroid tumors. It has a boxed warning and a REMS program to ensure that the benefits of use outweigh the associated risks and that patients are informed of these risks. Information regarding the albiglutide REMS program can be found at www.tanzeumrems.com.

Efficacy

FDA based its approval on a series of eight trials, in which more than 2,000 type 2 diabetes patients were treated with albiglutide. Albiglutide was investigated as both a monotherapy for use in conjunction with diet and exercise, and as a combination therapy added to: metformin; a sulfonylurea plus metformin; a thiazolidinedione with and without metformin; insulin glargine monotherapy; and insulin glargine plus other antidiabetic medications.

These studies compared the efficacy of albiglutide to placebo or to an active therapy (sulfonylurea, dipeptidylpeptidase IV PPP-IV] inhibitor, thiazolidinedione, and both rapid and longacting insulins (lispro and glargine). Overall, albiglutde demonstrated a significant reduction in hemoglobin Ale without a significant participant weight reduction.

A noninferiority study compared albiglutide to liraglutide, a once-daily GLP-1 agonist. In this open-label trial, participants taking liraglutide achieved greater reductions in Ale. However, participants receiving albiglutide experienced fewer gastrointestinal adverse effects and injection-site reactions.

Safety

Adverse reactions occurring more frequently with albiglutide compared to placebo include hypoglycemia, infection (upper respiratory infection, influenza, sinusitis), cough, back pain, injection-site reactions, and elevation in liver enzymes. Mild-to-moderate gastrointestinal reactions (nausea, vomiting, diarrhea, reflux, and dyspepsia) were also more common with albiglutide use and occurred more commonly in association with renal dysfunction.

Bast-marketing reports indicate GLP-1 agonist therapy may be associated with acute renal failure or worsening of chronic kidney disease, which may lead to dialysis. Dehydration and adverse gastrointestinal reactions have been associated with many of these reports. …

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