Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.

The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus.

Obese subjects involvement in a population-based survey: the use of information and communication technologies (ICT) to avoid stigmatization.

BACKGROUND: Epidemiological and health promotion studies in obese subjects are hampered by the difficulty of obtaining a representative sample from the community. The enrollment process can be at high risk of stigmatization. The purpose of this study is to describe an original information and communication technologies (ICT) strategy to get around these ethical and methodological difficulties. METHODS: A multimedia campaign of communication was organized on the topic of overweight and quality of life (QoL). A specific website was developed to collect via a questionnaire QoL data as well as information related to patient's needs and health perception from participants. To promote the website, multiple information supports were largely diffused. Primary care professionals were solicited to enhance the enrollment. The campaign started with a press conference covered by the main television channels. RESULTS: The ICT-based approach allowed the participation of 4,155 subjects homogeneously distributed with respect to body mass index, age, gender and socioeconomic level. A high percentage of subjects fully completed the web-based questionnaire. The press conference allowed reaching a quarter of the total sample within 5 days. CONCLUSIONS: Overweight remains a major public health problem. This survey showed that a holistic approach supported by ICT is a promising way to recruit obese subjects without stigmatizing the disorder.

Critical assessment of diabetic xerosis.

INTRODUCTION: Diabetes mellitus is commonly responsible for skin changes including discrete to mild xerosis. AREAS COVERED: This review focuses on some selected relevant bioinstrumental methods assessing diabetes xerosis. Peer-reviewed articles on objective non-invasive methods were scrutinized. The reviewed methods address i) the xerosis severity grading scale, ii) corneodynamics referring to the desquamation rate, iii) electrometric assessment of skin hydration including skin capacitance mapping and iv) implication of the imperceptible perspiration. The subjective clinical assessment often fails to disclose diabetic xerosis with confidence and precision. By contrast, a multipronged biometrological approach identifies a cluster of diabetic patients who experience alterations in the structural and functional maturation of the stratum corneum. EXPERT OPINION: A multipronged biometrological approach helps identifying the changes in the stratum corneum of diabetic xerosis. There is a continuum between the 'dry skin' feeling, xerosis and ichthyosiform presentations, particularly on the shins and feet of diabetic patients.

Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness.

Portable insulin infusion devices are effective and safe insulin delivery systems for managing diabetes mellitus, especially type 1 diabetes. Rapidly absorbed insulin analogues, such as insulin lispro or insulin aspart, may offer an advantage over regular human insulin for insulin pumps. Several open-label randomised crossover trials demonstrated that continuous subcutaneous insulin infusion (CSII) with insulin lispro provided a better control of postprandial hyperglycaemia and a slightly but significantly lower glycated haemoglobin level, with lower daily insulin requirement and similar or even less hypoglycaemic episodes. A CSII study comparing insulin lispro and insulin aspart demonstrated similar results with the two analogues, and better results than those with regular insulin. Because these analogues have a quicker onset and a shorter duration of action than regular insulin, one might expect an earlier and greater metabolic deterioration in case of CSII interruption, but a more rapid correction of metabolic abnormalities after insulin boluses when reactivating the pump. These expectations were confirmed in randomised protocols comparing the metabolic changes occurring during and after CSII interruption of various durations when the pump infused either insulin lispro or regular insulin. The extra cost resulting from the use of CSII and insulin analogues in diabetes management should be compensated for by better metabolic control and quality of life. In conclusion, CSII delivering fast-acting insulin analogues may be considered as one of the best methods to replace insulin in a physiological manner by mimicking meal and basal insulin requirements, without higher risk of hypoglycaemia or ketoacidosis in well-educated diabetic patients.