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, Bo Ahrén
European Endocrinology, Volume 13, pp 56-61; https://doi.org/10.17925/EE.2017.13.02.56

Abstract:
The discovery of the incretin hormone glucagon like peptide-1 (GLP-1), and its usefulness in the treatment of type 2 diabetes mellitus (T2DM) followed by the finding that dipeptidyl peptidase-4 (DPP-4) inhibition prevents GLP-1 inactivation, led to the discovery of DPP-728. In 1999, studies with DPP-728 established the first proof-of-concept that DPP-4 inhibition improves glycaemic control in patients with T2DM. Further efforts to improve the binding kinetics of DPP-728 resulted in the discovery of vildagliptin (LAF237). In the last 20 years, a plethora of studies conducted by Novartis in collaboration with external investigators has demonstrated the mechanism of action of vildagliptin and its efficacy as monotherapy and as an add-on therapy for patients with T2DM. The studies establish that vildagliptin is a selective DPP-4 inhibitor that blocks GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) inactivation, thereby prolonging their action, resulting in improved glycaemic control. This review aims to discuss the discovery and development of vildagliptin, with an emphasis on mechanism of action and clinical efficacy.
Christopher G Parkin, Melissa Holloway, Jeffrey Truesdell, Tomas C Walker
European Endocrinology, Volume 13, pp 76-80; https://doi.org/10.17925/ee.2017.13.02.76

Abstract:
Introduction: Information about continuous glucose monitoring (CGM) use in the UK is limited. We conducted an online survey of a representative sample of current CGM users in England, Scotland and Wales to address this deficit. Methods: The 29-item online survey was conducted between 29 December 2016 and 25 January 2017. Persons with type 1 diabetes (T1D) and caregivers of T1D children/adolescents were recruited from mailing lists, using Nielsen and Harris Polling databases. Results: 315 patients and caregivers responded to the survey – 170 adult patients and 145 caregivers. Among respondents, 144 received full funding for CGM use, 72 received partial funding and 83 received no funding. Most reported improvements in glycated haemoglobin (HbA1c) (67.0%), fewer hypoglycaemia episodes (70.2%), improved hypoglycaemia awareness (77.5%) and better diabetes management (92.4%). Self-funders reported significantly higher CGM use (76.1%) than those who were fully funded (58.9%) and/or partially funded (65.9%), p=0.0008. Fewer than 50% of all respondents reported receiving guidance in interpreting CGM data from their diabetes care team; 30.1% of self-funders reported receiving no CGM support from their diabetes team compared with fully funded (2.8%) and partially funded (1.4%) respondents, p<0.0001. Conclusions: Patients with T1D and their caregivers are realising benefits from CGM use but are largely unsupported by the UK healthcare system.
European Endocrinology, Volume 13, pp 73-75; https://doi.org/10.17925/ee.2017.13.02.73

Abstract:
Continuous glucose monitoring (CGM) technology provides real-time glucose concentration data to people with diabetes. The data enable timely treatment decisions that can lead to avoidance or mitigation of hypoglycaemia, with potential cost savings. This commentary discusses CGM implementation and funding policies in the UK, and regional disparities that confront many people with diabetes who could benefit from the technology.
, Alan Cruess, Cornelia Dunger-Baldauf, Philippe Margaron, Howard Snow, , Basel Novartis Pharma Ag
European Endocrinology, Volume 13, pp 91-98; https://doi.org/10.17925/ee.2017.13.02.91

Abstract:
Introduction: The structured Benefit–risk Action Team (BRAT) approach aims to assist healthcare decision makers in treatment assessments. We applied BRAT to compare the benefit–risk profile of ranibizumab 0.5 mg versus laser photocoagulation for the treatment of diabetic macular oedema (DMO). Methods: One-year data for the ranibizumab 0.5 mg pro re nata (PRN) and laser arms of the phase III trials RESPOND (NCT01135914; n=220), RESTORE (NCT00687804; n=345), and REVEAL (NCT00989989; n=396) were included in the analysis. The benefit measures included ≥10 letters gain/avoidance of loss in best-corrected visual acuity (BCVA), achieving central retinal thickness (CRT) <275 μm, and 25-item Visual Function Questionnaire (VFQ-25) outcomes. The risks measures included endophthalmitis, intraocular pressure increase, hypertension, proteinuria, arterial/venous thromboembolic events and deaths. Results: Ranibizumab treatment provided significant benefits compared with laser for ≥10 letter BCVA gain at month 12 (387/1,000 versus 152/1,000 patients), CRT <275 μm at 12 months (474/1,000 versus 348/1,000 patients), and improvement of ≥6.06 on the VFQ-25 near activities subscale (325/1,000 versus 245/1,000 patients). Results for the risk measures were similar for both treatments. Conclusions: Superior clinically relevant outcomes were observed with ranibizumab 0.5 mg PRN compared with laser without compromising on safety. This analysis further supports the positive benefit–risk profile of ranibizumab 0.5 mg PRN.
, Joel C Marrs
European Endocrinology, Volume 13, pp 86-90; https://doi.org/10.17925/ee.2017.13.02.86

Abstract:
Cardiovascular disease (CVD) remains a leading cause of death in patients with type 2 diabetes (T2D). In addition to glycemic control, a major focus of diabetes treatment involves cardiovascular (CV) risk reduction. In 2008, the US Food and Drug Administration (FDA) instituted a new requirement that new drugs developed and studied for the treatment of T2D must undergo CV safety testing. Since the advent of this new policy, canagliflozin, empagliflozin, liraglutide and semaglutide have demonstrated superior CV event reduction – via a composite of reduction in CV death, nonfatal myocardial infarction (MI), and nonfatal stroke – compared with placebo in patients with T2D and existing CVD, or at high risk of CVD. Multiple studies are underway to evaluate the CV outcomes of other antihyperglycemic agents. In a time when there are numerous drugs in the T2D armamentarium, positive CV outcomes data influence drug selection and aids practitioners in making more individualised therapeutic recommendations for their patients.
European Endocrinology, Volume 13, pp 54-55; https://doi.org/10.17925/EE.2017.13.02.54

Abstract:
After many years of limited therapeutic opportunities, the treatment of type 2 diabetes has become more target and pathophysiologically driven. A typical example is represented by the development of the dipeptidyl peptidase-4 (DPP-4) inhibitors, allowing for more physiological regulation of the endocrine pancreas and leading to a previously unmet risk-to-benefit balance. Vildagliptin, one of the earliest DPP-4 inhibitors, has been tested across the entire spectrum of type 2 diabetes and has been in clinical use for 20 years. This publication critically reviews the main steps in the clinical development of this agent.
, Plamen Kozlovski, , James E Foley, , Marc Evans, Carmen Serban, Leuven Katholieke Universiteit Leuven, Basel Novartis Pharma Ag, Llandough Hospital Diabetes Resource Centre
European Endocrinology, Volume 13, pp 68-72; https://doi.org/10.17925/ee.2017.13.02.68

Abstract:
Vildagliptin is one of the most extensively studied dipeptidyl peptidase-4 (DPP-4) inhibitors in terms of its clinical utility. Over the last decade, a vast panorama of evidence on the benefit–risk profile of vildagliptin has been generated in patients with type 2 diabetes mellitus (T2DM). In this article, we review the cumulative evidence on the safety of vildagliptin from the clinical development programme, as well as reports of rare adverse drug reactions detected during the post-marketing surveillance of the drug. Across clinical studies, the overall safety and tolerability profile of vildagliptin was similar to placebo, and it was supported by real-world data in a broad population of patients with T2DM, making DPP-4 inhibitors, like vildagliptin, a safe option for managing patients with T2DM.
, Cláudia Matta-Coelho, Vera Fernandes, Olinda Marques
European Endocrinology, Volume 13, pp 99-101; https://doi.org/10.17925/EE.2017.13.02.99

Abstract:
This case study aims to discuss the unusual forms of hyperthyroidism presentation, the nonspecific symptoms and precipitating events. A 70-year-old male was taken to the emergency department for hyperglycaemia, nausea, vomiting and altered mental status with a week of evolution. He had a past medical history of type 2 diabetes, hypertension and dyslipidemia. He had no history of any recent intercurrent illness or infection. At the emergency room, besides hyperglycaemia, ketonemia and slightly elevated C-reactive protein, the basic laboratory panel workup was normal, as was the head computed tomography. He was admitted for metabolic compensation and to study the altered neurological status. During hospitalisation, despite the good glycemic control, he had no improvements in neurological status. At day four of hospitalisation, thyrotoxicosis with thyroid storm criteria was diagnosed. He started on adequate treatment with complete clinical recovery. The associated morbidity and mortality of thyroid storm requires immediate recognition and treatment. Elderly patients are frequently misdiagnosed or diagnosed later due to fewer and less pronounced signs and symptoms.
Shraddha Chaugule, Nick Oliver, , Claudia Graham
European Endocrinology, Volume 13, pp 81-85; https://doi.org/10.17925/ee.2017.13.02.81

Abstract:
Objective: To assess the economic impact of providing real time continuous glucose monitoring (CGM) for people with type 1 diabetes (T1D) and impaired awareness of hypoglycaemia (IAH) within North West (NW) London clinical commissioning groups (CCGs). Methods: The eligible population for CGM and inputs for the economic budget impact model developed were derived from published data. The model includes cost of CGM; cost savings associated with lower hypoglycaemia related hospital admissions, accidents and emergency visits; self-monitoring of blood glucose (SMBG) strip usage; and glycated haemoglobin (HbA1c) reduction-related avoided complications and insulin pump use. Results: The cost of CGM for T1D-IAH (n=3,036) in the first year is £10,770,671 and in the fourth year is £11,329,095. The combined cost off-sets related to reduced hypoglycaemia admissions, SMBG strip usage and complications are £8,116,912 and £8,741,026 in years one and four, respectively. The net budget impact within the NW London CCGs is £2,653,760; £2,588,068 in years one and four respectively. Conclusions: Introduction of CGM for T1D-IAH patients will have a minimal budget impact on NW London CCGs, driven by cost of CGM and offsets from lower hypoglycaemia-related costs, reduced SMBG strip usage, avoided HbA1c-related complications and lower insulin pump use.
Sanjay Kalra, Yashdeep Gupta
European Endocrinology, Volume 13, pp 51-53; https://doi.org/10.17925/ee.2017.13.02.51

Abstract:
‘B eta-cell failure’ is a frequently used term to describe the structural and functional inability of the cells to fulfil their metabolic responsibility. This editorial reviews the anatomy and physiology of the beta cell, and describes factors which regulate this. The authors focus on semantics, comparing the phrases ‘beta-cell failure’, ‘functional mass’, and ‘beta-cell insufficiency’. They suggest the use of ‘beta-cell insufficiency’, with descriptors such as ‘partial’ and ‘complete’, or ‘reversible’ and ‘irreversible’, to convey betacell dysfunction in type 2 diabetes. A three-phase taxonomic structure: beta-cell sufficiency, partial/reversible beta-cell insufficiency and complete/irreversible beta-cell insufficiency, is proposed as a tool to understand pathophysiology and facilitate therapeutic decision-making.
, , Basel Novartis Pharma Ag
European Endocrinology, Volume 13; https://doi.org/10.17925/ee.2017.13.02.62

Abstract:
The last decade has witnessed the role of dipeptidyl peptidase-4 (DPP-4) inhibitors in producing a conceptual change in early management of type 2 diabetes mellitus (T2DM) by shifting emphasis from a gluco-centric approach to holistically treating underlying pathophysiological processes. DPP-4 inhibitors highlighted the importance of acknowledging hypoglycaemia and weight gain as barriers to optimised care in T2DM. These complications were an integral part of diabetes management before the introduction of DPP-4 inhibitors. During the development of DPP-4 inhibitors, regulatory requirements for introducing new agents underwent substantial changes, with increased emphasis on safety. This led to the systematic collection of adjudicated cardiovascular (CV) safety data, and, where 95% confidence of a lack of harm could not be demonstrated, the standardised CV safety studies. Furthermore, the growing awareness of the worldwide extent of T2DM demanded a more diverse approach to recruitment and participation in clinical trials. Finally, the global financial crisis placed a new awareness on the health economics of diabetes, which rapidly became the most expensive disease in the world. This review encompasses unique developments in the global landscape, and the role DPP-4 inhibitors, specifically vildagliptin, have played in research advancement and optimisation of diabetes care in a diverse population with T2DM worldwide.
European Endocrinology, Volume 13, pp 19-20; https://doi.org/10.17925/ee.2017.13.01.19

Abstract:
Anumber of new drugs are moving through the osteoporosis therapy pipeline. Some show great promise for patients while one has fallen by the wayside at the last hurdle. New, effective therapies are warmly welcomed but there are still uncertainties around management of osteoporosis with currently available drugs that are contributing to what is commonly being referred to as the ‘treatment gap’; a differential between those patients who would benefit from treatment versus those who actually are receiving it. Furthermore, in parallel to the common public health disease of osteoporosis, there have been tangible developments in therapies available for some rare bone and calcium diseases.
, Ana Raquel Ferreira, Marcia Alves, Joana Guimaraes
European Endocrinology, Volume 13, pp 30-32; https://doi.org/10.17925/EE.2017.13.01.30

Abstract:
Takotsubo cardiomyopathy (TC) is characterised by acute, transient left ventricular apical ballooning precipitated by emotional or physiologically stressful stimuli and has been previously associated with Grave’s disease based on a few clinical reports. More recently, the association with exogenous thyrotoxicosis and radioiodine-induced thyroiditis has also been described. Iatrogenic hyperthyroidism on patients on levothyroxine replacement therapy for hypothyroidism has not been reported as a cause of TC. The authors describe two female patients with TC associated with levothyroxine over-replacement. A 74-year-old and a 48-year-old female patient, medicated with levothyroxine (respectively, 2.27 μg/kg and 1.85 μg/kg) for autoimmune thyroiditis were admitted to our emergency room with precordial pain. The first had an electrocardiogram with ST-segment elevation in the anterior precordial leads, and the latter had sinus tachycardia with deep T-wave inversion and QT interval prolongation. Further investigation revealed a mild elevation of cardiac biomarker levels and severe apical hypokinesis, but no significant coronary lesions on catheterisation. The suppressed thyroid stimulating hormone (TSH) levels were verified in the cardiac intensive care unit: 0.21 and 0.07 mIU/l (0.35–5.50) respectively. Both patients showed improvement of the apical hypokinesis on the discharge echocardiogram and normalisation of cardiac biomarker levels. Levothyroxine dose was reduced. This case report focuses on the cardiovascular risks of thyrotoxicosis, emphasises the importance of correct dose adjustment on patients under levothyroxine replacement therapy and stresses that TSH should be determined in patients presenting with acute coronary syndrome and typical findings of TC.
, Rachel Kurtzman, Anne Eaton, Eliza Dewey, Craig Bickford, Stephanie Fish, Leonard Wartofsky, R. Michael Tuttle
European Endocrinology, Volume 13, pp 26-29; https://doi.org/10.17925/EE.2017.13.01.26

Abstract:
Background: The Thyroid Cancer Care Collaborative developed a web-based clinical decision-making module (CDMM) to inform riskadjusted decisions on post-thyroidectomy radioactive iodine (RAI) use in papillary thyroid cancer (PTC). Methods: In a pilot study, we evaluated the CDMM in 19 PTC cases representing low- (five), intermediate- (seven) and high-risk (seven) disease. Two PTC experts and 10 PTC physicians reviewed cases and assigned risk level and RAI recommendation. The experts used a standard approach while the others used the CDMM. We assessed agreement between responses using a weighted Kappa. Results: Between experts, risk-assignment was concordant in 100%, 57% and 86% of low-, intermediate- and high-risk cases, respectively. Between CDMM users, risk-assignment was concordant in 100%, 29% and 14% in low-, intermediate- and high-risk cases, respectively (p=0.01). CDMM-assigned risk agreed with the expert-assigned risk in 100%, 25% and 0% of low-, intermediate- and high-risk cases, respectively (Kappa=0.69). For RAI use, the experts agreed in 15 cases while CDMM users agreed in eight. On further analysis, interpretation of extrathyroidal extension and lymph node staging led to discrepancies with the CDMM. Conclusions
European Endocrinology, Volume 13, pp 21-25; https://doi.org/10.17925/EE.2017.13.01.21

Abstract:
Biosynthetic human insulin and insulin analogues are the mainstay of insulin therapy for both type 1 and type 2 diabetes although access to human insulin at affordable prices remains a global issue. The world is experiencing an exponential rise in the prevalence of diabetes presenting an urgent need to establish effective diabetes therapy in countries burdened by inadequate health care budgets, malnutrition and infectious diseases. Recombinant human insulin has replaced animal insulins and animal-based semisynthetic human insulin thereby available in sufficient quantities and at affordable prices able to provide global access to insulin therapy. In many patients, analog insulins can offer additional clinical benefit, although at a considerably higher price thus severely restricting availability in low income countries. The approval process for recombinant human insulins (i.e. biosimilars) and analogue insulins is highly variable in the developing countries in contrast to Europe and in North America, where it is well established within a strict regulatory framework. This review aims to discuss the future access to human insulin therapy in a global context with an ever increasing burden of diabetes and significant economic implications.
European Endocrinology, Volume 13, pp 17-18; https://doi.org/10.17925/ee.2017.13.01.17

Abstract:
The prevalence of obesity is increasing exponentially worldwide, becoming an international public health issue that affects quality of life, increases the risk of illness and raises healthcare costs in countries in all parts of the world. In this editorial, we analyse the latest progress in the management of obesity and associated cardiovascular risk factors, and summarise the latest randomised controlled trials that have had the biggest influence on the current changes we are experiencing in obesity management.
Karla Victoria Rodriguez-Velver, María Azucena Zapata-Rivera, Juan Montes-Villarreal, , José Gerardo González-González, Jesús Zacarías Villarreal-Pérez, Rene Rodríguez-Gutierrez
European Endocrinology, Volume 12, pp 104-106; https://doi.org/10.17925/EE.2016.12.02.104

Abstract:
Tumour-induced osteomalacia (TIO), is a rare paraneoplasatic syndrome found in >95% of benign tumours that secrete fibroblast growth factor 23 - a phosphaturic circulating hormone. A rare case of a TIO secondary to a sarcoma, in a 21-year old man with history of bone fractures and distinctive physical and biochemical characteristics is presented and discussed.
Jenna L Bowen,
European Endocrinology, Volume 12, pp 79-84; https://doi.org/10.17925/EE.2016.12.02.79

Abstract:
Background: Patch pumps are a relatively new method of insulin delivery. This study explores the accuracy of patch-pumps by reporting on comparative pulse-accuracy study of two patch pumps. Methods: The accuracy of two patch pumps (Cellnovo, [Cellnovo Ltd., Swansea, UK] and OmniPod®[Ypsomed Ltd, Escrick, UK]) was evaluated micro-gravimetrically. Pulse accuracy was analysed by comparing single and time-averaged pulses for each device. Results: Single-pulses outside accuracy thresholds ±5%, ±10%, ±15%, ±20%, ±25% and ±30% were: Cellnovo; 79.6%, 55.6%, 35.0%, 19.9%, 9.7% and 4.3%; OmniPod; 86.2%, 71.6%, 57.4%, 45.5%, 35.2% and 25.4%. For 10, 20 and 40 pulse-windows mean values outside ±15% accuracy level were: Cellnovo; 7.3%, 1.5% and 0.4%, OmniPod; 37.6%, 31.8% and 25.9. Conclusions: This study showed that not all patch pumps are the same. The pumping mechanisms employed in these pumps play a significant role in the accuracy and precision of such devices.
Daniel Igor Branovan, Mikhail Fridman, Maxim Lushchyk, Valentina Drozd, Olga Krasko, Olga Nedzvedz, Nikolay Shiglik, Larisa Danilova
European Endocrinology, Volume 12, pp 85-88; https://doi.org/10.17925/EE.2016.12.02.85

Abstract:
Introduction: Recently, radiofrequency ablation (RFA) has been increasingly used for the treatment of thyroid nodules. However, immediate morphological changes associated with bipolar devices are poorly shown. Aims: To present the results of analysis of gross and microscopic alterations in human thyroid tissue induced by RFA delivered through the application of the original patented device. Materials and methods: In total, there were 37 surgically removed thyroid glands in females aged 32–67 at presentation: 16 nodules were follicular adenoma (labelled as ‘parenchymal’ solid benign nodules) and adenomatous colloid goitre was represented by 21 cases. The thyroid gland was routinely processed and the nodules were sliced into two parts – one was a subject for histological routine processing according to the principles that universally apply in surgical pathology, the other one was used for the RFA procedure. Results: No significant difference in size reduction between parenchymal and colloid nodules was revealed (p>0.1, t-test) straight after the treatment. In addition, RFA equally effectively induced necrosis in follicular adenoma and adenomatous colloid goitre (p>0.1, analysis of variance test). As expected, tumour size correlated with size reduction (the smaller the size of the nodule, the greater percentage of the nodule volume that was ablated): r=−0.48 (p<0.0001). Conclusion: The results make it possible to move fromex vivoexperiments to clinical practice.
Sanjay Kalra
European Endocrinology, Volume 12, pp 76-78; https://doi.org/10.17925/ee.2016.12.02.76

Abstract:
The large multinational, randomised, double-blind LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation) trial recently reported the cardiovascular (CV) benefits achieved with liraglutide therapy in type 2 diabetes mellitus (T2DM). This editorial analyses the primary and secondary CV outcomes (CVO) results of the LEADER trial, and discusses the impact these will have on clinical practice of diabetes in specific, and medicine in general. It delves into the evolution of clinical and biochemical outcomes used in diabetes, and discusses the role of liraglutide in shaping future outcomes. The editorial describes the potential role of liraglutide in primary, secondary and tertiary prevention of CV disease (CVD), and suggests exaptation of this molecule for use in cardiology, nephrology and neurology.
Bimota Nambam, Michael J Haller
European Endocrinology, Volume 12, pp 89-95; https://doi.org/10.17925/EE.2016.12.02.89

Abstract:
Multiple clinical trials investigating the efficacy and safety of immunotherapeutic interventions in new onset type 1 diabetes (T1D) have failed to yield long term clinical benefit. Lack of efficacy has frequently been attributed to an incomplete understanding of the pathways involved in T1D and the use of single immunotherapeutic agents. Recent mechanistic studies have improved our knowledge of the complex etiopathogenesis of T1D. This in turn has provided the framework for new and ongoing clinical trials in new onset T1D patients and at-risk subjects. Focus has also shifted towards the potential benefits of synergistic combinatorial approaches, both in terms of efficacy and the potential for reduced side effects. These efforts seek to develop intervention strategies that will preserve β-cell function, and ultimately prevent and reverse clinical disease.
European Endocrinology, Volume 12, pp 96-98; https://doi.org/10.17925/EE.2016.12.02.96

Abstract:
Subclinical hypothyroidism (SH) is a common condition, with prevalence estimates ranging from 4–20%, depending on the population demographics. Although epidemiological analysis associates it with an increased risk of cardiovascular disease, clinical practice guidelines express uncertainty about whether to monitor or to treat. As we await large-scale, well-designed randomised clinical trials regarding treatment of SH, a review of pathophysiological considerations may be informative to better understand this disorder.
European Endocrinology, Volume 12, pp 99-103; https://doi.org/10.17925/ee.2016.12.02.99

Abstract:
Neonatal screening for congenital hypothyroidism, along with eradication of iodine deficiency in large parts of the world, has made it possible to prevent the development of permanent neurological impairment due to thyroid hormone deficiency in the developing brain. The first successful screening programme was demonstrated in Canada in 1973 and since then it has been standard of care in most developed societies. In India there is no national programme for neonatal screening, and screening is only done in selected larger hospitals on newborns whose parents fund it. This review summarises the current understanding of the various strategies for newborn screening that could potentially be employed in India with resource constraints. Once a case is detected, the further evaluation and determination of etiology is summarised. Treatment and long term follow-up with levothyroxine replacement is also described in detail as per current understanding.
Brian L Levy, Thomas W McCann,
European Endocrinology, Volume 12, pp 18-23; https://doi.org/10.17925/EE.2016.12.01.18

Abstract:
Living with type 1 diabetes (T1D) presents many challenges in terms of daily living. Insulin users need to frequently monitor their blood glucose levels and take multiple injections per day and/or multiple boluses through an insulin infusion pump, with the consequences of failing to match the insulin dose to the body's needs resulting in hypoglycaemia and hyperglycaemia. The former can result in seizures, coma and even death; the latter can have both acute and long-term health implications. Many patients with T1D also fail to meet their treatment goals. In order to reduce the burdens of self-administering insulin, and improve efficacy and safety, there is a need to at least partially remove the patient from the loop via a closed-loop 'artificial pancreas’ system. The Hypoglycaemia-Hyperglycaemia Minimizer (HHM) System, comprising a continuous, subcutaneous insulin infusion pump, continuous glucose monitor (CGM) and closed-loop insulin dosing algorithm, is able to predict changes in blood glucose and adjust insulin delivery accordingly to help keep the patient at normal glucose levels. Early clinical data indicate that this system is feasible, effective and safe, and has the potential to dramatically improve the therapeutic outcomes and quality of life for people with T1D.
Baptist Gallwitz
European Endocrinology, Volume 12, pp 31-32; https://doi.org/10.17925/EE.2016.12.01.31

Abstract:
Cardiovascular safety has to be proven for antidiabetic therapy for type 2 diabetes according to the guidance from regulatory bodies. Recently, the results of the respective study for the sodium-glucose transporter-2 (SGLT-2) inhibitor empagliflozin were published. Unlike similar studies for other antidiabetic agents that proved cardiovascular safety by non-inferiority compared with standard treatment with regard to a combined cardiovascular primary endpoint, empagliflozin showed superiority with a significantly lower incidence of cardiovascular events.
Kirsten Stinkens,
European Endocrinology, Volume 12, pp 33-34; https://doi.org/10.17925/EE.2016.12.01.33

Abstract:
The use of sodium-glucose cotransporter 2 inhibitors is associated with an increased risk of diabetic ketoacidosis. This risk has been reported in particular in off-label use of these agents in type 1 diabetes, but reports of risks in type 2 diabetes patients also exist. In type 2 diabetes ketoacidosis is rare and is present particularly in patients who have undergone prolonged starvation, serious infection, alcohol abuse or surgery. The pleiotropic advantages of sodium-glucose cotransporter 2 inhibitors do not outweigh the risk for a diabetic ketoacidosis, but caution is warranted.
, Tomas Walker
European Endocrinology, Volume 12, pp 24-30; https://doi.org/10.17925/EE.2016.12.01.24

Abstract:
Self-monitoring of blood glucose (SMBG) is now recognised as a core component of diabetes self-management. However, there are many limitations to SMBG use in individuals with diabetes who are treated with intensive insulin regimens. Many individuals do not test at the recommended frequencies. Additionally, because SMBG only provides a blood glucose reading at a single point in time, hypoglycaemia and hyperglycaemia can easily go undetected, limiting the user’s ability to take corrective action. Inaccuracies due to user error, environmental factors and weaknesses in SMBG system integrity further limit the utility of SMBG. Real-time continuous glucose monitoring (CGM) displays the current glucose, direction and velocity of glucose change and provides programmable alarms. This trending information and ‘around-the-clock’ vigilance provides a significant safety advantage relative to SMBG. No published clinical studies have evaluated outcomes when CGM is used as a replacement for SMBG; however, recent in silico studies support this indication. This article reviews the limitations of SMBG and discusses recent evidence that supports CGM-based decisions as an effective approach to managing insulin-treated diabetes.
European Endocrinology, Volume 12, pp 12-17; https://doi.org/10.17925/EE.2016.12.01.12

Abstract:
Insulin replacement therapy is the standard of care for patients with type 1 and advanced type 2 diabetes mellitus. Porcine and bovine pancreatic tissue was the source of the hormone for many years, followed by semisynthetic human insulin obtained by modification of animal insulin. With the development of recombinant DNA technology, recombinant (biosynthetic) human insulin became available in large amounts by biosynthesis in microorganisms (Escherichia coli, yeast) providing reliable supplies of the hormone worldwide at affordable costs. The purity and pharmaceutical quality of recombinant human insulin was demonstrated to be superior to animal and semisynthetic insulin and patients with diabetes could be safely and effectively transferred from animal or semisynthetic human insulin to recombinant human insulin with no change expected in insulin dose. The decision for change remains a clinical objective, follow-up after any change of insulin product is recommended to confirm clinical efficacy. This review provides a summary and retrospective assessment of early clinical studies with recombinant insulins (Insuman®, Humulin®, Novolin®).
European Endocrinology, Volume 12, pp 35-36; https://doi.org/10.17925/EE.2016.12.01.35

Abstract:
Diabetes technologies have progressed rapidly over recent years with a dedicated conference entering its 10th year, stronger and larger than ever. The long-awaited automated insulin delivery systems represent the latest devices in engineering excellence however it is important that we do not lose sight of the fact that there is a person at the end of this technology, simply wanting a better life with diabetes with reduced diabetes burden. This commentary explores the relationship between technology and the psychosocial aspects of that technology in the context of user experience, clinical guidelines and the inclusion of psychosocial aspects alongside medical outcomes in research trials.
European Endocrinology, Volume 12; https://doi.org/10.17925/ee.2016.12.01.37

Abstract:
The International Diabetes Federation has recently published a position statement on bariatric surgery. Facing a global diabetes crisis, it has added various types of surgery on the gastrointestinal tract as powerful options among the armamentarium to normalise glycaemia, avoid regular medications and decrease costs in severely obese patients. Laparoscopic sleeve gastrectomy has been shown to be effective for the treatment of type 2 diabetes, with extremely low mortality and acceptable morbidity. It decreases caloric consumption, modifies gut hormones, changes gastric emptying, and lowers glycaemia. In the long term, if recurrences in weight or diabetes occur, it can be converted to a duodenal switch, potentially reaching 90% of patients with partial or complete remission.
Brian Ng-Cheng-Hin,
European Endocrinology, Volume 12, pp 39-43; https://doi.org/10.17925/EE.2016.12.01.39

Abstract:
Medullary thyroid cancer (MTC) is a rare cancer comprising approximately 5% of all thyroid cancers. The majority arises sporadically but around 25% are hereditary forming part of the Multiple Endocrine Neoplasia (MEN) type 2 syndromes. The initial management is surgical, the extent of resection determined by radiological stage, presence of and specific REarranged during Transfection (RET) oncogene mutation and level of serum calcitonin. External beam radiotherapy may be utilised in the adjuvant setting to improve local control rates. Conventional cytotoxic agents remain essentially futile in the management of advanced MTC with response rates of around 15–20% at best. Over the last decade, alongside a greater understanding of the molecular pathogenesis of MTC we have seen the development of small molecule agents including tyrosine kinase inhibitors targeting vascular endothelial growth factor receptors (VEGFRs) and RET with activity in advanced MTC. This review will examine the evidence for this therapeutic approach, when to consider initiating and how to manage toxicities arising from such therapies in the treatment of advanced MTC.
Emilia Sbardella,
European Endocrinology, Volume 12, pp 44-46; https://doi.org/10.17925/ee.2016.12.01.44

Abstract:
Neuroendocrine tumours (NETs) are a heterogeneous group of neoplasms whose incidence has increased significantly in recent years, and whose optimal management remains controversial. We report the latest innovations in their management, in particular the results of three trials concerning the use of the mammalian target of rapamycin (mTOR) inhibitor, everolimus, in non-functional NETs of lung/gastrointestinal (GI) origin, the first randomised trial of radiolabelled177Lu-DOTATATE in patients with mid-gut NETs, and the use of the 5-HT synthesis inhibitor, telotristat etiprate, in patients with the carcinoid syndrome.
European Endocrinology, Volume 12, pp 47-48; https://doi.org/10.17925/EE.2016.12.01.47

Abstract:
Over the past two decades, we have studied various parathyroid hormone (PTH) 1-34 regimens, including once-daily and twice-daily injections without the concurrent conventional therapy. We recently studied PTH delivery by insulin pump, which produced normal, steady-state serum and urine calcium levels. The recent approval of PTH 1-84 represents an important milestone in the treatment of hypoparathyroidism. As PTH 1-84 and PTH 1-34 have similar pharmacokinetic (PK) and pharmacodynamic profiles, one can assume that many of the principles learned from studies of PTH 1-34 also apply to PTH 1-84 in the management of this rare disease.
European Endocrinology, Volume 11; https://doi.org/10.17925/ee.2015.11.02.114

Abstract:
Unhealthful lifestyle behaviors are a primary source of the global burden of noncommunicable diseases (NCDs) and account for about 63 % of all global deaths. Recently, there has been an increased interest in evaluating the benefit of adhering to low-risk lifestyle behaviors and ideal cardiovascular health metrics. Although a healthful lifestyle has repeatedly been shown to improve mortality, the population prevalence of healthy living remains low. The new discipline of lifestyle medicine has recently emerged as a systematized approach for the management of chronic disease. The practice of lifestyle medicine requires skills and competency in addressing multiple health risk behaviors and improving self-management. This article focuses on the effects of a healthful lifestyle on chronic disease and defining lifestyle medicine as a unique discipline. It also reviews the role of effective provider–patient communication as an essential element for fostering behavior change—the main component of lifestyle medicine. The principles of communication and behavior change are skill based and are grounded in scientific theories and models. Communication and counseling must be contextualized to the patients’ economic situation, access to care, social support, culture, and health literacy.
Mona Mohamed Ibrahim Abdalla
European Endocrinology, Volume 11, pp 90-95; https://doi.org/10.17925/ee.2015.11.02.90

Abstract:
Ghrelin is an orexigenic peptide predominantly secreted from the stomach and stimulates appetite and growth hormone (GH) release. Studies have provided evidence that ghrelin exercises a wide range of functions, including regulation of food intake and energy metabolism, modulation of cardiovascular function, stimulation of osteoblast proliferation and bone formation and stimulation of neurogenesis and myogenesis. In the gastrointestinal system, ghrelin affects multiple functions, including secretion of gastric acid, gastric motility and pancreatic protein output. Most of these functions have been attributed to the actions of acylated ghrelin. The balance among its secretion rate, degradation rate and clearance rate determines the circulating level of ghrelin. This review explains what ghrelin is, its physiological functions and the factors that influence its level.
, Christopher J Thompson
European Endocrinology, Volume 11, pp 96-97; https://doi.org/10.17925/EE.2015.11.02.96

Abstract:
The excess mortality in craniopharyngiomas is attributable to their size, site and the traditional surgical approach; aggressive resection predisposes to hypothalamic complications such as obesity, somnolence, thirst disorders and neurocognitive dysfunction. Recently, treatment has been modified to partial resection and radiotherapy. The role of the endocrinologist has expanded from identification and replacement of hormone deficits to include management of hypothalamic disease. Future treatment of craniopharyngioma with neo-adjuvant chemotherapy to minimise surgical resection may improve the outcomes for these patients.
Michael Bromba, , Brian L Levy
European Endocrinology, Volume 11, pp 67-69; https://doi.org/10.17925/EE.2015.11.02.67

Abstract:
Satisfaction with the latest-generation insulin pump (LGIP) was assessed in patients with diabetes mellitus enrolled in the Comparing Perception of Insulin Therapies for T1D Patients with the Aim to Improve Quality of Care (CHOICE) study. The Insulin Treatment Satisfaction Questionnaire (ITSQ), a measure of insulin treatment satisfaction, together with additional questions assessed respondents’ perceptions of glucose control, their satisfaction with major LGIP features and preference for the LGIP versus their previous treatment, was used. The LGIP (Animas® Vibe™) was considered to be a better method for delivering insulin compared with their therapy before switching and was rated high for treatment satisfaction. These findings should be useful to clinicians when considering the possibility of transferring a patient from their existing treatment regimen to a LGIP.
Rafael Machado Tironi, Registrar, Tironi Rafael Machado, Preiser Jean-Charles
European Endocrinology, Volume 11, pp 75-78; https://doi.org/10.17925/EE.2015.11.02.75

Abstract:
The ‘diabetes of injury’ typically associated with critical illness has recently been thoroughly revisited and much better characterised following major therapeutic advances. The occurrence of severe hyperglycaemia, moderate hypoglycaemia or high glycaemic variability has been associated with an increased mortality and rate of complications in large independent cohorts of acutely ill patients. Hence, current guidelines advocate the prevention and avoidance of each of these three dysglycaemic domains, and the use of a common metrics for a quantitative description of dysglycaemic events, such as the proportion of time spent in the target glycaemic range as a unifying variable. Using a common language will help to face the future challenges, including the definition of the most appropriate blood glucose (BG) target according to the category of admission, the time interval from the initial injury and the medical history. The clinical testing of technological improvements in the monitoring systems and the therapeutic algorithms should be assessed using the same metrics.
European Endocrinology, Volume 11; https://doi.org/10.17925/ee.2015.11.02.112

Abstract:
There is growing evidence for an etiological interaction between infectious diseases and diabetes, as well as for bidirectional influence of clinical presentation, spread, and outcomes. Some HIV treatments increase diabetes risk, and some infectious diseases may determine unique phenotypes of diabetes. Individuals who have type 2 diabetes have increased risk for tuberculosis and viral hepatitis and have poorer treatment outcomes. Joint noncommunicable diseases (NCDs) and infectious diseases clinics are the ideal method of tackling the double burden of these diseases in developing countries.
, Michael Joubert
European Endocrinology, Volume 11, pp 70-74; https://doi.org/10.17925/EE.2015.11.02.70

Abstract:
Many patients with type 2 diabetes struggle to achieve adequate glucose control despite escalation of therapy including complex insulin regimens with multiple daily injections (MDIs). Previous randomised controlled trials failed to show a significant improvement in glycaemic control with pump therapy over multiple injections. The OPT2MISE study enrolled 495 adult patients with poorly controlled type 2 diabetes despite an intensified insulin regimen using rapid and slow-acting insulin analogues. After a 2-month run-in period, patients were randomised to switch to pump therapy or to maintain their MDI regimen. After 6 months, patients with pump therapy achieved a better glycaemic control than those who used multiple injections (glycated haemoglobin [HbA1c] difference of -0.7 %), and twice as many patients reached the target range of 8 % or less in the pump-therapy group compared with the injection group. Patients using pump therapy had a 20 % reduction of their total daily insulin dose. A moderate weight gain was observed with both treatments, and no severe hypoglycaemia nor ketoacidosis occurred in the pump therapy group. Pump therapy may now be considered as a valuable option in type 2 diabetes patients who fail to respond to an intensified insulin regimen.
European Endocrinology, Volume 11, pp 81-89; https://doi.org/10.17925/EE.2015.11.02.81

Abstract:
Obstructive sleep apnoea (OSA) is common and is associated with many vascular risk factors, such as hypertension, insulin resistance, albuminuria, dyslipidaemia, increased inflammation and endothelial dysfunction. Epidemiological studies have shown that OSA is associated with increased cardiovascular disease (CVD) and that continuous positive airway pressure (CPAP) might reduce CVD events in patients with OSA. In addition, OSA has also been shown to be associated with albuminuria, chronic kidney disease, a wide range of ocular diseases and peripheral neuropathy. Considering that CVD and microvascular complications are major contributors to the morbidity, mortality and the economic burden of diabetes and that OSA is common in patients with type 2 diabetes (T2D), it is important to understand the role of OSA in the development and/or progression of vascular disease in patients with T2D and to explore the impact of CPAP on diabetes-related vascular outcomes. The purpose of this article is to review the evidence for the relationship and impact of OSA on vascular disease and vascular risk factors particularly in patients with T2D.
European Endocrinology, Volume 11, pp 98-99; https://doi.org/10.17925/ee.2015.11.02.98

Abstract:
Any surgeon treating a patient with adrenal disease should be a member of a multi-disciplinary team involving dedicated specialists, including an endocrinologist, anaesthetist, radiologist, intensivist and geneticist. In an era of epidemic numbers of adrenal incidentalomas, great care must be taken to determine not only the endocrine diagnosis, but also the benefits (if any) of adrenal surgery. Finally, the surgeon must be competent in both minimally invasive and gross resectional surgical techniques and know when to adopt these two very different surgical approaches.
European Endocrinology, Volume 11; https://doi.org/10.17925/ee.2015.11.02.106

Abstract:
Long-term pharmacologic strategies that may be used in conjunction with lifestyle changes to address the obesity epidemic have, until recently, been an unmet clinical need. Interestingly, pharmacologic interventions to date have not specifically focused on modifying the behavioral aspects of eating. Food intake is influenced by multiple pathways, including the homeostatic regulation of energy balance controlled by the hypothalamus and the mesolimbic reward system, dysregulation of which can lead to reward eating, food craving, and overconsumption of food. A growing body of evidence suggests that targeting the reward system can be a successful intervention for obesity management. Sustained-release naltrexone/bupropion is a novel combination therapy that targets both the hypothalamic melanocortin system and the reward system. In clinical trials, naltrexone/bupropion has been associated with sustained and clinically meaningful weight loss together with beneficial effects on eating behavior and improvements in cardiometabolic factors. Craving and control of food intake were also measured and correlated with improved outcome.
European Endocrinology, Volume 11, pp 100-101; https://doi.org/10.17925/EE.2015.11.02.100

Abstract:
Turner syndrome is one of the most common genetic disorders, affecting one in 2,000–2,500 live-born girls. In order to provide appropriate healthcare, a multi-disciplinary team of closely cooperating endocrinologists, gynaecologists, geneticists, cardiologists, otolaryngologists, fertility specialists, psychologists, nurse educators and social workers is needed.
Sanjay Kalra,
European Endocrinology, Volume 11, pp 79-80; https://doi.org/10.17925/EE.2015.11.02.79

Abstract:
This editorial focuses on appropriate terminology related to basal insulin therapy. The authors analyse current usage of ‘basal insulin failure’, and propose ‘basal insulin inadequacy’ as a better descriptor for persons not responding to basal insulin alone. The pharmacokinetic and pharmacodynamic differences between various basal insulin preparations are highlighted. Based upon these, a drug-specific definition for insulin inadequacy is suggested, instead of a generic class-based labelling.
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