Brand Name(s):Byetta , Bydureon
Indication:Diabetes mellitus – Type 2
NICE NG28 Update Type 2 diabetes in adults: management
NICE guidelines [NG18]
Diabetes (type 1 and type 2) in children and young people: diagnosis and management
Full document available at:http://www.nice.org.uk/guidance/ng18
BYETTA is indicated for treatment of Type 2 diabetes mellitus in combination with:- metformin- sulphonylureas- thiazolidinediones- metformin and a sulphonylurea- metformin and a thiazolidinedione – in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. – BYETTA is also indicated as adjunctive therapy to basal insulin with or without metformin and/or pioglitazone in adults who have not achieved adequate glycaemic control with these agents.
Exenatide is to be initiated by a consultant endocrinologist, diabetic nurse specialist or general practitioner or nurse practitioner with special interest in diabetes.
The transfer time to hand over prescribing from Specialist to Primary care will be 1 month, with a requirement that the patient will receive a specialist follow up at 6 months (maximum).
Renal function should be checked annually and if there is clinical suspicion of deterioration. In the latter case, the drug should not be restarted unless the absence of severe renal impairment (creatinine clearance less than 30ml/min) has been confirmed.
Exenatide has been associated with spontaneous acute pancreatitis. Should this occur, the drug should be stopped immediately. The initiating prescriber will counsel the patient about the predominant symptom which would indicate onset (persistent severe abdominal pain).
Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes
NICE technology appraisal guidance 248
Prolonged-release exenatide in triple therapy regimens (that is, in combination with metformin and a sulphonylurea, or metformin and a thiazolidinedione) is recommended as a treatment option for people with type 2 diabetes as described in ‘Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87); that is, when control of blood glucose remains or becomes inadequate (HbA1c of 7.5% or more [59 mmol/mol] or other higher level agreed with the individual), and the person has: a body mass index (BMI)of 35 kg/m2 or more in those of European family origin (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight or a BMI < 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities. Treatment with prolonged-release exenatide in a triple therapy regimen should only be continued as described in 'Type 2 diabetes: the management of type 2 diabetes' (NICE clinical guideline 87); that is, if a beneficial metabolic response has been shown (defined as a reduction of at least 1 percentage point in HbA1c [11 mmol/mol] and a weight loss of at least 3% of initial body weight at 6 months). Prolonged-release exenatide in dual therapy regimens (that is, in combination with metformin or a sulphonylurea) is recommended as a treatment option for people with type 2 diabetes, as described in 'Liraglutide for the treatment of type 2 diabetes mellitus' (NICE technology appraisal 203); that is, only if: the person is intolerant of either metformin or a sulphonylurea, or a treatment with metformin or a sulphonylurea is contraindicated, and the person is intolerant of thiazolidinediones and dipeptidyl peptidase-4 (DPP-4) inhibitors, or a treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated. Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes Treatment with prolonged-release exenatide in a dual therapy regimen should only be continued as described in 'Liraglutide for the treatment of type 2 diabetes mellitus' (NICE technology appraisal guidance 203); that is, if a beneficial metabolic response has been shown (defined as a reduction of at least 1 percentage point in HbA1c [11 mmol/mol] at 6 months). Issued: February 2012 .............................. Reports of renal impairment, including acute renal failure and worsened chronic renal failure have been received. Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment MHRA Drug safety update Volume 2, Issue 8 March 2009 .............................. Exenatide can be considered as an alternative to insulin in type 2 diabetic patients on maximum tolerated doses of metformin and/or sulphonylureas with HbA1c more than 7.5%, where BMI is more than 30kg/m2.