Insulin analogues have been getting a bad press over the past 12 months and the latest revamp of NICE guidelines is expected to outlaw their routine use in type 2 diabetes. This follows a Channel 4 News investigation and subsequent publication in ‘BMJ’ http://bmjopen.bmj.com/content/1/2/e000258.full suggesting savings of more than half a billion GBP over the last 10 years if only human insulin had been prescribed. So why have insulin manufacturers found their position so hard to defend?
Archives for 2011
The last few years have seen a significant rise in the number of patients requiring insulin. Unfortunately, the increasing number of different insulins and regimes available have been mirrored by a rapid increase in prescribing errors to the point at which insulin is the drug with the highest number of prescribing errors in the NHS. These errors were highlighted in a rapid response from the National Patient Safety Agency (NPSA) which described over 3881 patient safety incidents between 2003-2009 in England and Wales including one death and one severe harm incident. Although the latter hit the headlines, other errors including more minor incidents and ‘near misses’ undermine patient confidence as well as raise significant clinical governance issues.
On June 9th, France suspended new prescriptions of pioglitazone due to concerns over an increased risk of bladder cancer. Within hours the Germans followed suit….
In early studies of pioglitazone (a PPAR alpha agonist), there were observations of transitional cell neoplasia in the bladders of male rats (but not in females nor in mouse models). Subsequently the clinical development of ragaglitazar, a dual PPAR agonist, was halted due to bladder tumours in rats and in one mouse.
Diabetes is a condition which impacts significantly on many aspects of a person’s life. Its effect on driving is often the most profound. This impact varies depending on the type of licence and as a result can cause major employment issues. All patients are issued a licence of 3 years or less.
When the NICE updated the clinical guideline for management of hyperglycaemia in 2009 (CG87) it reiterated the place of metformin and sulphonylureas as first- and second-line treatments respectively. However, what is recommended when dual therapy does not achieve HbA1c targets?
Diabetes care is often a trade off between tighter glucose control on the one hand and hypoglycaemia (blood glucose <4.0mmol/l) on the other. Whilst clinicians often appear to concentrate on the former, hypoglycaemia is the one aspect of diabetes care that concerns patients. Hypoglycaemia occurs more commonly than is usually thought, 10-30% of patients with Type 1 diabetes having a severe episode each year. In Type 2 diabetes, the risk of hypoglycaemia rises depending on the duration of diabetes and the increasing use of insulin. Indeed, after 5 years of insulin treatment, the risk of hypoglycaemia is equal to patients with type 1 diabetes with 5 years of insulin treatment.
Glycated haemoglobin levels (HbA1c) has become one of the key targets in diabetes care, understood by patients and their health care professional. However, clinicians working in diabetes cannot fail to have noticed that their local chemical pathology departments have also been measuring HbA1c using a less familiar scale than the well known percentage scale, mmol/mol. This dual reporting has been going on since June 2009 but from June 2011 (Scotland Wales and Northern Ireland) and October 2011 (England), only the mmol/mol value will be recorded. But, why the change?
The decision by NICE to bring forward its review of diabetes therapies from 2012 to later this year is clearly an attempt to impact on prescribing, especially since the last review was only published 2 years earlier in May 2009 (Clinical Guideline [CG] 87, an update on CG 66 published twelve months before). So, what will be the likely focus of this update?
In 2007, agents known as incretins became available for the treatment of type 2 diabetes in the UK. Sitagliptin, an oral DPP-4 inhibitor, and exenatide, an injectable GLP-1 agonist have become widely used in clinical practice and have been followed on to the market by another three incretin agents. The area continues to develop with the anticipated launch of once-weekly GLP-1 agonist later this year and reports of the efficacy of once-a-month regimens.
In the 2008 NHS next stage review, ‘High quality Care for all‘, the government set a target that everyone with a long term condition should have a care plan to manage their condition. The process of Care planning offers people active involvement in deciding and agreeing how their diabetes (piloted in year of care) will be managed through a partnership approach with health professionals. Lofty aims to be sure but what is the basis for the care planning consultation and how can it be delivered?