Any diabetes story, which attracts the attention of both the BBC News website and the Daily Mail is worthy of investigation. This was how the report of Pagliuca, Millman and Gurtler (all co-first authors) was feted in October, following publication in the journal ‘Cell’.
Archives for 2014
Many women with diabetes are still becoming pregnant with avoidable increased risk as a result of patchy pre-conceptual care, exacerbated by unsatisfactory glucose control during pregnancy. Improving this will require increased awareness of the issue including more collaborative working between public health and primary and secondary care. Hopefully future NPID audits will demonstrate further progress.
On September 10th 2014, the European Commission granted marketing authorisation for an insulin glargine, indicated to treat diabetes in adults, adolescents and children from the age of 2 years. This was the first insulin to be approved through the European Medicines Agency’s biosimilar pathway and followed ‘tentative approval’ for the same product from the Food and Drug Administration. The ‘tentative’ approval is the result of a patent infringement lawsuit in the US and anticipated delays almost certainly mean that Europe (and possibly the UK) will see the first launch.
Whilst many patients are aware of the microvascular complications of diabetes – eyes, kidneys, peripheral nerves etc, the Cinderella complication, diabetic autononomic neuropathy (DAN) tends to affect significant numbers of patients who are either unaware of the problem or ascribe their symptoms to another condition. At the same time, as it is not regularly screened for as part of routine care, it is not until the patient has significant and often debilitating symptoms that it starts to receive attention. A sub type of the peripheral neuropathies, and depending on which methodology is used, its prevalence varies between 16-35% of patients. The ubiquitous nature of the autonomic nervous system renders virtually all organs susceptible to autonomic dysfunction but tend to fall into several groups with associated symptoms:
It is widely recognised that the tsunami of obesity is closely followed by one of Type 2 diabetes with its associated impact on the population and health services, specifically heart disease, obstructive sleep apnoea (OSA), certain types of cancer and a decreased life expectancy.
Glucagon-like peptide-1 receptor agonist (GLP-1RA) treatments were first launched in the United Kingdom in 2007, when exenatide was marketed by Eli Lilly as a twice daily injection (Byetta) for the treatment of patients with type 2 diabetes (T2DM). Since that time, there have been major changes in the way that GLP-1RAs can be administered, with new formulations being developed at a rate not seen with other diabetes therapies.
Renal failure secondary to diabetes is one of the three microvascular diabetic complications. In many ways, it is the most feared since there is not only the inevitable outcome of end-stage renal failure (ESRF) requiring dialysis or transplantation, but also a greatly increased risk of both small vessel and large vessel complications, especially cardiovascular disease (CVD).
At the 2014 American Diabetes Association meeting, there were many presentations on GLP-1RA injectable treatments.
Data were presented on use of liraglutide in moderate renal failure (eGFR 30-60 mL/min: stage 3 chronic kidney). In keeping with its known routes of metabolism and elimination, there were no adverse effects on renal function, nor reduction in efficacy.
The National Institute for Health and Care Excellence (NICE) have issued a draft full guideline (over 270 pages in length) on lipid modification which, for patients with type 2 diabetes, would replace the current recommendations (REF 1). It recommends the UKPDS tool to assess CV risk and offer of ‘high-intensity statin treatment’ for primary prevention of CVD in people who have a 10% or greater 10-year risk. This is in contrast to the previous advice in NICE CG 66 which suggested a risk cut-off of 20% and use of simvastatin 40mg OD (now classed as ‘medium-intensity’).
Insulin pump therapy or continuous subcutaneous insulin infusion (CSII) is a method of delivering insulin using a pager sized device which infuses insulin through a subcutaneous cannula at a variable rate depending on the patients’ blood glucose and dietary carbohydrate. As a result, it provides a degree of flexibility and control difficult to achieve with even multiple daily injections. This treatment has been around for nearly 25 years and even has its own NICE guidance (2008). There are two current criteria for CSII: – inability to gain appropriate control (A1c<69mmol/mol) or recurrent hypoglycaemia despite optimised injections. NICE guidance also describes the makeup of the specialist team required who initiate this therapy, specifically a consultant diabetologist, diabetes specialist nurse and dietician and the provision of structured education for the patients. However, despite the benefit of this treatment and comprehensive guidance, there has been concern that its provision is not as comprehensive as NICE intended. In view of this a national audit was performed in 2012 to accurately assess CSII utilisation.
For many years, there has been a divergence of opinion as to whether it was worth treating gestational diabetes. This controversy seemed to have been settled following the publication of the ACHOIS study in 2005 which showed that peri-natal complications were lower in the treatment group. In the UK, diagnostic and treatment guidelines for gestational diabetes were published by NICE in 2009 (most clinics use a 2hr oral glucose tolerance test glucose value >7.8mmol/l).
Although the prevalence of Type 2 diabetes (T2DM) in the general population, is approximately 5%, in some areas with significant S Asian communities, it is often 7-8% or often higher due to their increased susceptibility. In fact, by age 80 years, 50% of south Asians have diabetes, with a younger age of onset (10 years earlier) and greater effect on renal and cardiovascular outcomes than European comparators. The reason for this is a combination of genetic and environmental factors. S Asian patients tend to have a higher prevalence of the metabolic syndrome (comprising insulin resistance, hypertension, central obesity and dyslipidaemia).Insulin resistance in this population may appear as early as childhood and supports the concept (at least in part) of a genetic predisposition. This is certainly seen in antenatal clinics where there is a significant preponderance of Asian patients developing gestational diabetes. Fat distribution also differs between white and Asian patients, the latter having an increased level of intra-abdominal (Atherogenic) fat for a given BMI. This has lead to recent NICE guidance on CVD risk in Asian patients. However, it is worth pointing out that the multinational INTERHEART study showed that 80% of CV risk is due to traditional risk factors such as hypertension and an atherogenic lipid profile of low HDL cholesterol and higher triglycerides. . Furthermore, high levels of homocysteine and Lp(a), endothelial dysfunction, and inflammation may also be contributing factors. The other proposed mechanisms include disadvantaged socio-economic status, a ‘proatherogenic’ diet and a relative lack of physical activity.
Diabetes physicians based in the UK are renowned for their encyclopaedic knowledge of drug acquisition costs. This is attributed to the dominance of NICE (the National Institute for Health and Care Excellence) which has a major focus on ‘cost-effectiveness’, widely and perhaps cynically equated to ‘cost per tablet’. Several recent developments, however, suggest that Germany aims to challenge this UK dominance.
A new year and a chance to reassess the state of diabetes care. This was the purpose of the ‘State of the Nation’ report from Diabetes UK – the nation being England, covering the period 2011-2012. The report examined the Diabetes UK health care essentials, 15 basic health checks and services that everyone with diabetes (Type 1 or Type 2) should receive from their healthcare team. These include the 9 care processes recommended by NICE but also cover specialist care availability, emotional support and in patient care.