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2 September 2011
A once-weekly exenatide 2mg suspension for subcutaneous injection (Bydureon ▼®) has recently been launched for the management of type 2 diabetes. This prolonged- release formulation is licensed as an add-on therapy for patients who have not achieved adequate glycaemic control on maximally tolerated doses of oral therapies. As yet, there are no data that show that exenatide▼ reduces the risk of macrovascular or microvascular events.
Action
NICE guidance on the weekly formulation is anticipated in February 2012 and during the interim local decision-making bodies may need to consider whether weekly administration might have advantages for some patients. Such organisations may wish to take into account that the existing NICE Clinical Guideline advises a third-line role for the exenatide twice daily formulation (Byetta▼®) for people who meet specific criteria.
Background
Once-weekly exenatide (Bydureon®) is licensed for the treatment of type 2 diabetes mellitus in combination with metformin, a sulfonylurea, a thiazolidinedione (pioglitazone▼), metformin plus sulfonylurea or metformin plus thiazolidinedione (pioglitazone) in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies. The prolonged-release suspension for injection is given subcutaneously as a 2mg dose once weekly on the same day each week. The product is available as a pack of four 2mg vials sufficient for one month’s supply at a price of £73.36 (the dosing kit includes needles at no extra cost).
Exenatide, an incretin mimetic, has previously only been available as a twice-daily injection (Byetta▼®) at a cost of £68.24 for 30 days supply (does not include needles). Patients switching from the twice daily to weekly formulation may experience transient elevations in blood glucose concentrations, which generally improve within the first two weeks after initiation of therapy.
NICE guidance on exenatide once weekly is in progress, for second-line (dual therapy) or third-line (triple therapy) and is anticipated in February 2012. The NICE Clinical Guideline on newer agents for type 2 diabetes mellitus (CG87) recommends the twice-daily formulation of exenatide as a possible third-line therapy to first-line metformin and a second-line sulfonylurea when control of blood glucose remains or becomes inadequate (HbA1c ≥ 7.5% [59 mmol/mol], or other higher level agreed with the individual), and:
- the person has a body mass index (BMI) ≥ 35.0 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight,
- or a BMI < 35.0 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.
Treatment with the drug should only continue if a beneficial response occurs as measured by a reduction of at least 1.0 percentage point in HbA1c (about 11mmol/mol) and a weight loss of at least 3% of initial body weight at six months.
NICE have recently held a consultation regarding the need to update Clinical Guideline (CG 87) and a decision has been taken that the guideline should be updated at this time.
The once weekly formulation of exenatide has been the subject of a series of DURATION trials, some of which we have covered in rapid reviews. Details of the DURATION-1 trial (once-weekly versus twice-daily exenatide) are available here and we have also reviewed the associated extension of that study. We have discussed DURATION-2 (once-weekly exenatide versus metformin plus either sitagliptin▼ or pioglitazone) previously. Our review of DURATION-3 (once-weekly exenatide versus insulin glargine) can be found here and information on DURATION-6 (once-weekly exenatide versus liraglutide▼) is also available. As yet, there are no data that show that exenatide reduces the risk of macrovascular or microvascular events.
Further information on the management of type 2 diabetes is available from the e-learning section of the NPC’s website and from NHS Evidence.
Please comment on this Rapid Review using our feedback form.
Useful links to other organisations that provide information on managing the entry of new medicines can be found here.
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