In final draft guidance published today, NICE has recommended dapagliflozin (Forxiga, Bristol-Myers Squibb and Astra Zeneca) for some people with type 2 diabetes.
Type 2 diabetes is a long-term condition that causes a person’s blood sugar level to become too high. It occurs when the body does not produce enough insulin for it to function properly, or when the body’s cells do not use insulin properly. Insulin is a hormone made by the pancreas, and is central to regulating blood sugar and fat metabolism in the body.
Dapagliflozin is recommended in combination therapy with blood-sugar-lowering drug metformin as an option for treating type 2 diabetes, if it is used as described for DPP4-inhibitorsi in Type 2 diabetes: the management of type 2 diabetes (NICE clinical guideline 87). The draft guidance also recommends dapagliflozin in combination with insulin as an option for treating type 2 diabetes.
Dapagliflozin in a triple therapy regimen in combination with metformin and sulfonylurea, another blood-sugar-lowering drug, is not recommended for treating type 2 diabetes, except in the context of research as part of a clinical trial.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: ”We are pleased to recommend dapagliflozin for some people with type 2 diabetes. It is a serious problem in the UK and dapagliflozin provides another treatment option for some people with this condition.”
Dapagliflozin is a sodium-glucose cotransporter-2 (SGLT-2) inhibitor that blocks the reabsorption of glucose in the kidneys and promotes excretion of excess glucose in the urine.
Following the consultation on the draft recommendations in February, NICE requested further clarification and information from the manufacturers. NICE also asked the decision support unitii to further review the economic analysis provided by the manufacturer and to perform exploratory analyses for dapagliflozin in dual therapy and as an add-on to insulin therapy.
Final guidance is expected to be published in June 2013.
References
i. DPP-4 inhibitors lower blood sugar levels by blocking an enzyme known as dipeptidyl peptidase IV (DPP-4), which is responsible for breaking down the proteins that stimulate the insulin-producing cells, and slows gastric emptying time after a meal.
ii. The Decision Support Unit is commissioned by the NICE to provide a research and training resource to support the Institute’s Technology Appraisal Programme.
Related NICE guidance
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Published
Exenatide prolonged-release suspension for injection in combination with oral antidiabetic therapy for the treatment of type 2 diabetes. NICE technology appraisal guidance 248 (2012).
Liraglutide for the treatment of type 2 diabetes mellitus. NICE technology appraisal guidance 203 (2010).
Type 2 diabetes: the management of type 2 diabetes (partial update of CG66). NICE clinical guideline 87 (2009).
Type 2 diabetes: the management of type 2 diabetes (partially updated by CG87). NICE clinical guideline 66 (2008).
Diabetes in pregnancy: management of diabetes and its complications from pre-conception to the postnatal period. NICE clinical guideline 63 (2008).
Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus (review). NICE technology appraisal guidance 151 (2008).
Type 2 diabetes: prevention and management of foot problems. NICE clinical guideline 10 (2004).
About NICE
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
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