Add GLP-1 Receptor Agonists: Reports of Diabetic Ketoacidosis when Concomitant Insulin was Rapidly Reduced or Discontinued

GLP-1 Receptor Agonists%3A Reports of Diabetic Ketoacidosis when Concomitant Insulin was Rapidly Reduced or Discontinued.-.md

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+<br>Trulicity▼) are glucagon-like peptide-1 (GLP-1) receptor agonists (also known as GLP-1 mimetic therapies) and are authorised for use in adults with type 2 diabetes to improve glycaemic control, except for Saxenda, which is indicated for weight management. GLP-1 receptor agonists act by stimulating insulin secretion from the pancreas in a glucose-dependent manner, as well as slowing gastric emptying and suppressing glucagon secretion. GLP-1 receptor agonists are not substitutes for insulin. Serious and life-threatening cases of diabetic ketoacidosis have been reported in association with exenatide, liraglutide, and dulaglutide, particularly after rapid reduction or discontinuation of concomitant insulin. An EU review of these reports concluded that the cases could be attributed to abrupt discontinuation or dose reduction of insulin while initiating GLP-1 receptor agonist therapy, resulting in a poor glycaemic control. This review did not identify euglycaemic diabetic ketoacidosis as a safety concern specific to treatment with GLP-1 receptor agonist therapies. When [Medic GLP Website](http://cgi.www5b.biglobe.ne.jp/~akanbe/yu-betsu/joyful/joyful.cgi?page=20)-1 receptor agonist therapy is added to existing treatment with insulin, a reduction in the dose of insulin may be considered to reduce the risk of hypoglycaemia.<br>
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+<br>A stepwise approach to insulin dose adjustment is recommended, taking into account a patient’s glucose levels and individual insulin requirements. The Summaries of Product Characteristics and Patient Information Leaflets for exenatide, liraglutide, and dulaglutide are being updated to note that a stepwise approach is recommended for insulin dose reduction and to advise that blood glucose self-monitoring is necessary when adjusting the dose of insulin, particularly during initiation of GLP-1 receptor agonist therapy. The GLP-1 receptor agonists lixisenatide (Lyxumia) and semaglutide (Ozempic▼) are also authorised for use in the UK. Lixisenatide and semaglutide were not subject to the EU review. At the time of publication, we have not received any UK reports of diabetic ketoacidosis in association with lixisenatide and semaglutide. However, the theoretical risk of diabetic ketoacidosis when changes are made to insulin dose cannot be excluded. Up until the end of May 2019, the MHRA’s Yellow Card Scheme has received 26 reports of diabetic ketoacidosis, and 10 reports of reactions relating to ketone body formation (increased blood ketones, ketonuria) in patients taking exenatide, liraglutide, and dulaglutide.<br>
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+<br>In around a third of the UK cases reported, insulin was either discontinued or the dose was rapidly reduced at initiation of the GLP-1 receptor agonist. In the remaining cases, it is difficult to establish the role of these agents due to possible precipitating factors for diabetic ketoacidosis, such as other medicines or underlying conditions. Although nausea and vomiting may be considered adverse drug reactions of GLP-1 receptor agonists, these are also well-known symptoms of diabetic ketoacidosis and should be taken seriously when initiating GLP-1 receptor agonists and adjusting insulin doses. Many of the cases of diabetic ketoacidosis and related reactions occurred within 2 weeks of initiation of GLP-1 receptor agonists. Nausea and vomiting were commonly co-reported reactions. Inform patients of the signs and symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, excessive thirst, increased frequency of urination, difficulty breathing, confusion, unusual fatigue, or sleepiness) and the need for urgent medical attention if they occur. Please continue to report suspected adverse drug reactions (ADRs) associated with GLP-1 receptor agonists on a [Yellow Card](https://www.google.com/search?q=Yellow%20Card&btnI=lucky). Reporting suspected ADRs, even those known to occur in association with the medicine, adds to knowledge about the frequency and severity of these reactions and can be used to identify patients who are most at risk. Your report helps the safer use of medicines. Healthcare professionals, patients, and caregivers can report suspected ADRs via the Yellow Card website or via the Yellow Card app. Download the app today via iTunes Yellow Card for iOS devices or via PlayStore Yellow Card for Android devices.<br>
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