In January 2015, the position statement of the American Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) on management of hyperglycaemia in type 2 diabetes (T2DM) was updated. The consensus document recognises an “increasing array of antihyperglycemic drugs” with uncertainty regarding selection and sequence due to “a paucity of comparative effectiveness research on long- term treatment outcomes”. As previously, the authors argue for individualisation of HbA1c targets and treatment strategies, and sanction use of any class of anti-diabetic therapy as second-line after metformin.
Also in January, NICE made available a draft of its update for the clinical guideline (CG) for management of T2DM in adults, planned for launch in September 2015. Comparison of the section on blood glucose management reveals stark contrasts with the ADA/EASD statement.
Whilst individualization of targets is mentioned, there is major focus on HbA1c levels of 7.5% (58mmol/mol), which for many patients (especially the elderly) will be unachievable and possibly harmful. The draft is also highly prescriptive with specific (and complex) algorithms for initial therapy, first intensification and second intensification of treatment. Metformin remains first-line but most clinicians in the UK (and everywhere else) were surprised to see repaglinide replacing sulphonylureas in those for whom metformin cannot be used. The elevation of pioglitazone to preferred second-line therapy is also perplexing and worthy of further comment.
In the previous NICE glycaemic update (CG87, 2009), thiazolidienediones (TZDs) were limited to third-line use, with a common interpretation being that human insulin should be considered beforehand. Since then, rosiglitazone has been banned from use in the EU (2010), pioglitazone has been withdrawn from France because of bladder cancer concerns (2011) and side-effects of bony fracture and congestive cardiac failure have been confirmed. Not withstanding potential positive cardiovascular effects of pioglitazone (known since 2005), the only positive thing that has happened for this drug is dropping of patent (i.e. becoming much cheaper in 2012).
So, cynicism reigns and it will be interesting to see whether NICE holds firm with it’s current recommendations or bows to pressure.
Professor Steve Bain