Effects of Fenofibrate Treatment on Cardiovascular Disease Risk in 9,795 Individuals With Type 2 Diabetes and Various Components of the Metabolic Syndrome: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

OBJECTIVE—We explored whether cardiovascular disease (CVD) risk and the effects of fenofibrate differed in subjects with and without metabolic syndrome and according to various features of metabolic syndrome defined by the Adult Treatment Panel III (ATP III) in subjects with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

Effects of Fenofibrate Treatment on Cardiovascular Disease Risk in 9,795 Individuals With Type 2 Diabetes and Various Components of the Metabolic Syndrome: The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

OBJECTIVE—We explored whether cardiovascular disease (CVD) risk and the effects of fenofibrate differed in subjects with and without metabolic syndrome and according to various features of metabolic syndrome defined by the Adult Treatment Panel III (ATP III) in subjects with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

Survivors of intensive care with type 2 diabetes and the effect of shared care follow-up clinics: study protocol for the SWEET-AS randomised controlled feasibility study

Published online: 13 October 2016Background: Many patients who survive the intensive care unit (ICU) experience long-term complications such as peripheral neuropathy and nephropathy which represent a major source of morbidity and affect quality of life adversely. Similar pathophysiological processes occur frequently in ambulant patients with diabetes mellitus who have never been critically ill. Some 25 % of all adult ICU patients have diabetes, and it is plausible that ICU survivors with co-existing diabetes are at heightened risk of sequelae from their critical illness. ICU follow-up clinics are being progressively implemented based on the concept that interventions provided in these clinics will alleviate the burdens of survivorship. However, there is only limited information about their outcomes. The few existing studies have utilised the expertise of healthcare professionals primarily trained in intensive care and evaluated heterogenous cohorts. A shared care model with an intensivist- and diabetologist-led clinic for ICU survivors with type 2 diabetes represents a novel targeted approach that has not been evaluated previously. Prior to undertaking any definitive study, it is essential to establish the feasibility of this intervention. Methods: This will be a prospective, randomised, parallel, open-label feasibility study. Eligible patients will be approached before ICU discharge and randomised to the intervention (attending a shared care follow-up clinic 1 month after hospital discharge) or standard care. At each clinic visit, patients will be assessed independently by both an intensivist and a diabetologist who will provide screening and targeted interventions. Six months after discharge, all patients will be assessed by blinded assessors for glycated haemoglobin, peripheral neuropathy, cardiovascular autonomic neuropathy, nephropathy, quality of life, frailty, employment and healthcare utilisation. The primary outcome of this study will be the recruitment and retention at 6 months of all eligible patients. Discussion: This study will provide preliminary data about the potential effects of critical illness on chronic glucose metabolism, the prevalence of microvascular complications, and the impact on healthcare utilisation and quality of life in intensive care survivors with type 2 diabetes. If feasibility is established and point estimates are indicative of benefit, funding will be sought for a larger, multi-centre study. Trial registration: ANZCTR ACTRN12616000206426Yasmine Ali Abdelhamid, Liza Phillips, Michael Horowitz and Adam Dean

Letters and telegrams on Andrew Inglis Clark's resignation from the Braddon Ministry, Tasmania, 1897-8

Letters and telegrams on Andrew Inglis Clark's resignation from the Braddon Ministry, 1897-8, from A.H. Aspinall, E.N.C. Braddon, Gilbert E. Butler, William Cooke, P.O. Fysh, G. D'Emden, H.T. Gould, John Gunning, Charles W. Hazell, John Henry, Frederick Lodge, J.H. Macfarlane, Andrew Miller, F.J. Prichard, Richard Ross, W.H. Smith, F. Stephens, C.H. Talbot, Alfred A. Taylor, H. Thomas, G.J. Walford and J.N. Woolnough. C4/C390 (1-22

Efficacy and safety of atorvastatin in the prevention of cardiovascular end points in subjects with type 2 diabetes: the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in non-insulin-dependent diabetes mellitus (ASPEN).

OBJECTIVE: Cardiovascular disease (CVD) risk is increased in type 2 diabetes. The purpose of this study was to assess the effect of 10 mg of atorvastatin versus placebo on CVD prevention in subjects with type 2 diabetes and LDL cholesterol levels below contemporary guideline targets. RESEARCH DESIGN AND METHODS: Subjects were randomly assigned to receive 10 mg of atorvastatin or placebo in a 4-year, double-blind, parallel-group study. The composite primary end point comprised cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, recanalization, coronary artery bypass surgery, resuscitated cardiac arrest, and worsening or unstable angina requiring hospitalization. RESULTS: A total of 2,410 subjects with type 2 diabetes were randomized. Mean LDL cholesterol reduction in the atorvastatin group over 4 years was 29% versus placebo (P < 0.0001). When we compared atorvastatin versus placebo, composite primary end point rates were 13.7 and 15.0%, respectively (hazard ratio 0.90 [95% CI 0.73-1.12]). In the subset of 1,905 subjects without prior myocardial infarction or interventional procedure, 10.4% of atorvastatin- and 10.8% of placebo-treated subjects experienced a primary end point (0.97 [0.74-1.28]). In the 505 subjects with prior myocardial infarction or interventional procedure, 26.2% of atorvastatin- and 30.8% of placebo-treated subjects experienced a primary end point (0.82 [0.59-1.15]). Relative risk reductions in fatal and nonfatal myocardial infarction were 27% overall (P = 0.10) and 19% (P = 0.41) and 36% (P = 0.11) for subjects without and with prior myocardial infarction or interventional procedure, respectively. CONCLUSIONS: Composite end point reductions were not statistically significant. This result may relate to the overall study design, the types of subjects recruited, the nature of the primary end point, and the protocol changes required because of changing treatment guidelines. For these reasons, the results of the Atorvastatin Study for Prevention of Coronary Heart Disease Endpoints in Non-Insulin-Dependent Diabetes Mellitus (ASPEN) did not confirm the benefit of therapy but do not detract from the imperative that the majority of diabetic patients are at risk of coronary heart disease and deserve LDL cholesterol lowering to the currently recommended targets

Gestational diabetes mellitus screening and diagnosis criteria before and during the COVID-19 pandemic: a retrospective pre–post study

Objective: To determine whether perinatal outcomes after excluding gestational diabetes mellitus (GDM) on the basis of fasting venous plasma glucose (FVPG) assessment during the coronavirus disease 2019 (COVID-19) pandemic in 2020 were similar to those during the preceding year after excluding GDM using the standard oral glucose tolerance test (OGTT) procedure. Design: Retrospective pre–post study. Setting, participants: All women who gave birth in Queensland during 1 July – 31 December 2019 and 1 July – 31 December 2020. Main outcome measures: Perinatal (maternal and neonatal) outcomes for pregnant women assessed for GDM, by assessment method (2019: OGTT/glycated haemoglobin [HbA1c] assessment; 2020: GDM could be excluded by an FVPG value below 4.7 mmol/L). Results: 3968 of 29 113 pregnant women in Queensland during 1 July – 31 December 2019 (13.6%) were diagnosed with GDM, and 4029 of 28 778 during 1 July – 31 December 2020 (14.0%). In 2020, FVPG assessments established GDM in 216 women (1.1%) and excluded it in 1660 (5.8%). The frequencies of most perinatal outcomes were similar for women without GDM in 2019 and those for whom it was excluded in 2020 on the basis of FVPG values; the exception was caesarean delivery, for which the estimated probability increase in 2020 was 3.9 percentage points (95% credibility interval, 2.2–5.6 percentage points), corresponding to an extra 6.5 caesarean deliveries per 1000 births. The probabilities of several outcomes — respiratory distress, neonatal intensive care or special nursery admission, large for gestational age babies — were about one percentage point higher for women without GDM in 2020 (excluding those diagnosed on the basis of FVPG assessment alone) than for women without GDM in 2019. Conclusions: Identifying women at low absolute risk of gestational diabetes-related pregnancy complications on the basis of FVPG assessment as an initial step in GDM screening could reduce the burden for pregnant women and save the health system substantial costs.</p

A physician-initiated double-blind, randomised, placebo-controlled, phase 2 study evaluating the efficacy and safety of inhibition of NADPH oxidase with the first-in-class Nox-1/4 inhibitor, GKT137831, in adults with type 1 diabetes and persistently elevated urinary albumin excretion: protocol and statistical considerations.

PURPOSE:Kidney disease caused by type 1 diabetes can progress to end stage renal disease and can increase mortality risk. Nicotinamide adenine dinucleotide phosphate (NADPH) oxidase (Nox) plays a major role in producing oxidative stress in the kidney in diabetes, and its activity is attenuated by GKT137831, an oral Nox inhibitor with predominant inhibitory action on Nox-1 and Nox - 4. Previous studies have demonstrated renoprotective effects with GKT137831 in various experimental models of type 1 diabetes-related kidney disease. This study will evaluate the effect of GKT137831 in treating clinical diabetic kidney disease. DESIGN:This is a multi-center, randomised, placebo-controlled trial, parallel arm study evaluating the effect on albuminuria of treatment with GKT137831 200 mg BID for 48 weeks. The study will randomize 142 participants who have persistent albuminuria and estimated glomerular filtration rate (eGFR) at baseline of at least 40 ml/min/1.73m2. PRIMARY OUTCOME MEASURES:Difference between arms in urine albumin to creatinine ratio. Secondary outcome measures include eGFR. CONCLUSION:This study is important because it may identify a new way of halting renal disease progression in people with type 1 diabetes and albuminuria already receiving standard of care treatment.Anne T. Reutens, Karin Jandeleit-Dahm, Merlin Thomas, Ted Wu, Mark E. Cooper, Jonathan E. Sha

Favourable effects of fenofibrate on lipids and cardiovascular disease in women with type 2 diabetes: results from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study

Aims/hypothesis: In the double-blind placebo-controlled Fenofibrate Intervention and Event Lowering in Diabetes trial (n = 9,795), fenofibrate reduced major cardiovascular events in type 2 diabetes. Sex-related differences in fenofibrate response could be clinically relevant and were pre-specified analyses