NICE have issued a Final Appraisal Determination recommending the use of dapagliflozin (Forxiga®) in some people with T2D. The guidance states that dapagliflozin can be used in combination with existing glucose-lowering therapies such as metformin and insulin, but not as triple therapy with metformin and sulfonylureas.
Dapaglifozin belongs to the sodium-glucose cotransporter-2 (SGLT-2) inhibitor class, which work by preventing the re-absorption of glucose by the kidneys and thus increasing glucose elimination in the urine. Because the efficacy of dapagliflozin can be altered by changes in renal fuction, NICE has not recommended its use in people with moderate to severe renal impairment, which is defined as a creatinine clearance rate of under 60 ml/min or an estimated glomerular filtration rate under 60 ml/min/1.73 m2.
A systematic literature search performed by the manufacturers, Bristol-Myers Squibb and Astra Zeneca, of all relevant trials of dapagliflozin in adults with T2D idenfified a small number of adverse reactions associated its use. These include hypoglycaemia (if used in combination with insulin or a sulfonylurea ), back pain, dyslipidaemia, urinary tract and genital infection, polyuria, dysuria and an increased haematocrit.
The manufacturers estimate that more than 1 million people with diabetes in the UK could benefit from this therapy. Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, said: “We are pleased to recommend dapagliflozin for some people with T2D. It is a serious problem in the UK and dapagliflozin provides another treatment option for some people with this condition.”
Positive outcome for Vitaros®, VipidiaTM, VipdometTM and IncresyncTM
Takeda Pharmaceutical Company Limited has announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for three of their new T2D therapies, including dipeptidyl peptidase 4 (DPP-4) inhibitor Vipidia (alogliptin), and two fixed-dose combination therapies, Vipdomet (alogliptin-metformin) and Incresync (alogliptin-pioglitazone), which are designed for use in people with inadequately controlled T2D.
Before delivering this statement, the CHMP performed an extensive analysis of results from a robust clinical trial programme that gathered data from over 11 000 participants who were treated for up to 4 years, as well as findings from the ENDURE trial and the EXAMINE cardiovascular outcomes trial.
Alogliptin once-daily (25 mg) induced significant reductions in HbA1c and displayed a good tolerability profile, with a low incidence of hypoglycaemia. Alogliptin was also found to be weight neutral and various doses will become available to treat people with different stages of renal impairment.
Takeda UK Limited also received a positive opinion from the European Decentralised Procedure for Vitaros, a topical alprostadil cream intended for use in people with erectile dysfunction. Over the next few months, Takeda UK will begin work towards achieving marketing approval for Vitaros in the UK.
DiabetesBible.com: Online learning tool
Over 2000 doctors and nurses from around the world are now visiting Diabetesbible.com each month. Diabetesbible, a free website offering practical guidance on diabetes diagnosis and management, has become increasingly popular over the past 3 years.
Authored by Dr Jeremy Turner, a consultant diabetologist at the Norfolk and Norwich University Hospitals NHS Foundation Trust, Diabetesbible can be used as a real-time tool in prompting physicians to ask the right questions when considering any given diabetes diagnosis. Or, the website can be used as a training tool, allowing healthcare professionals to study the best way to approach a diabetes diagnosis through history, examination and investigation, and how to subsequently manage it. Diabetesbible, the sister website to endobible.com for endocrinologists, was highly commended in last year’s Quality in Care Diabetes Awards.
New partnership: Nipro and Takeda UK
As a part of a new long-term partnership, Takeda UK Limited and Nipro Diagnostics (UK) Limited have agreed to jointly co-promote the TRUEresult and TRUEyou range of blood glucose monitoring devices to NHS primary care organisations across the UK.
Chris Avery, Managing Director of Nipro Diagnostics (UK) Limited, said: “This partnership will allow us to serve our customers and patients even better. As in all other business areas of Nipro, we plan to be an undisputed challenger for the market leaders.”
Yasuhiro Fukutomi, Managing Director of Takeda UK Limited, commented: “Our organisation is looking forward to working with the Nipro Diagnostics UK team.”