Alogliptin is the newest antidiabetic drug approved by the Food and Drug Administration (FDA) for type 2 diabetes. It's being sold as a single agent under the trade name Nesina and as part of two combination drugs; when combined with the biguanide metformin, it's called Kazano, and when it's combined with the thiazolidinedione pioglitazone, it's called Oseni.
Alogliptin belongs to the class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors. After a meal is consumed, the incretin hormones glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide are released from the small intestine into the bloodstream. These hormones stimulate the release of insulin from ? cells in the pancreas. The more glucose in the blood, the more hormones are released, but when glucose levels are low, the hormones don't stimulate the release of insulin. The incretin hormones are rapidly inactivated by the DPP-4 enzyme. Drugs that inhibit DPP-4 prolong the effectiveness of incretin hormones, helping to stimulate insulin release and lower fasting and postprandial blood glucose levels. Alogliptin's therapeutic effect lasts for 24 hours, and the drug is therefore administered orally once per day with or without food.
Alogliptin has been studied in several clinical trials in patients with type 2 diabetes. It was administered either as monotherapy or in combination with metformin; a sulfonylurea, such as glyburide or glipizide; a thiazolidinedione, given either alone or in combination with metformin or a sulfonylurea; or insulin, either alone or in combination with metformin. Treatment with alogliptin produced statistically and clinically significant reductions in long-term glucose control, as determined using glycated hemoglobin (HbA1c) and fasting plasma glucose levels.
In postmarketing use of alogliptin outside the United States, acute pancreatitis, severe allergic reactions, and liver injury (sometime fatal) have been reported. The drug's labeling carries warnings of these potentially serious adverse effects. Alogliptin is unlikely to cause hypoglycemia on its own, but the risk increases when the drug is administered with a sulfonylurea or with insulin. The labeling of other DPP-4 inhibitors, such as sitagliptin (Januvia), also carries warnings of the risk of acute pancreatitis and hypoglycemia; these appear to be class effects. The most common adverse effects of alogliptin are nasopharyngitis, headache, and upper respiratory tract infection.
Alogliptin shouldn't be used to treat type 1 diabetes or when diabetic ketoacidosis is present. The FDA is requiring postmarketing studies for the drug and combination treatments to determine the risks and extent of adverse effects, as well as studies to determine safety, efficacy, and appropriate dosing when the drug is administered to children.
Nurses should provide patient education regarding the potential for acute pancreatitis, liver damage, and allergic reactions and instruct patients to notify their prescriber immediately if they have symptoms of acute pancreatitis (such as persistent, severe abdominal pain that may radiate to the back, possibly with vomiting), liver problems (such as unexplained nausea, vomiting, stomach pain, fatigue, loss of appetite, dark urine, or jaundice [as noted in the eyes]), or allergic reactions (such as hives; skin rash; swelling of the face, lips, tongue, or throat; or difficulty breathing or swallowing). Nurses should review the signs of hypoglycemia with patients, especially if they receive a sulfonylurea or insulin in addition to alogliptin.
To read the FDA news release regarding the approval of these three medications, go to http://1.usa.gov/W8StND.