Auckland, New Zealand
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Elley C.R.,University of Auckland | Robinson E.,University of Auckland | Kenealy T.,University of Auckland | Bramley D.,Waitemata District Health Board | Drury P.L.,Auckland Diabetes Center
Diabetes Care | Year: 2010

OBJECTIVE - To derive a 5-year cardiovascular disease (CVD) risk equation from usual-care data that is appropriate for people with type 2 diabetes from a wide range of ethnic groups, variable glycemic control, and high rates of albuminuria in New Zealand. RESEARCH DESIGN AND METHODS - This prospective open-cohort study used primary-care data from 36,127 people with type 2 diabetes without previous CVD to derive a CVD equation using Cox proportional hazards regression models. Data from 12,626 people from a geographically different area were used for validation. Outcome measure was time to first fatal or nonfatal cardiovascular event, derived from national hospitalization and mortality records. Risk factors were age at diagnosis, diabetes duration, sex, systolic blood pressure, smoking status, total cholesterol-to-HDL ratio, ethnicity, glycated hemoglobin (A1C), and urine albumin-to-creatinine ratio. RESULTS - Baseline median age was 59 years, 51% were women, 55% were of non-European ethnicity, and 33% had micro- or macroalbuminuria. Median follow-up was 3.9 years (141,169 person-years), including 10,030 individuals followed for at least 5 years. At total of 6,479 first cardiovascular events occurred during follow-up. The 5-year observed risk was 20.8% (95% CI 20.3-21.3). Risk increased with each 1% A1C (adjusted hazard ratio 1.06 [95% CI 1.05-1.08]), when macroalbuminuria was present (2.04 [1.89-2.21]), and in Indo-Asians (1.29 [1.14-1.46]) and Maori (1.23 [1.14-1.32]) compared with Europeans. The derived risk equations performed well on the validation cohort compared with other risk equations. CONCLUSIONS - Renal function, ethnicity, and glycemic control contribute significantly to cardiovascular risk prediction. Population- appropriate risk equations can be derived from routinely collected data. © 2010 by the American Diabetes Association.

Drury P.L.,Auckland Diabetes Center | Drury P.L.,University of Sydney | Ting R.,University of Sydney | Zannino D.,University of Sydney | And 11 more authors.
Diabetologia | Year: 2011

Aims/hypothesis: We investigated effects of renal function and albuminuria on cardiovascular outcomes in 9,795 low-risk patients with diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Methods: Baseline and year 2 renal status were examined in relation to clinical and biochemical characteristics. Outcomes included total cardiovascular disease (CVD), cardiac and non-cardiac death over 5 years. Results: Lower estimated GFR (eGFR) vs eGFR ≥90 ml min-1 1.73 m-2 was a risk factor for total CVD events: (HR [95% CI] 1.14 [1.01-1.29] for eGFR 60-89 ml min -1 1.73 m-2; 1.59 [1.28-1.98] for eGFR 30-59 ml min -1 1.73 m-2; p< 0.001; adjusted for other characteristics). Albuminuria increased CVD risk, with microalbuminuria and macroalbuminuria increasing total CVD (HR 1.25 [1.01-1.54] and 1.19 [0.76-1.85], respectively; p=0.001 for trend) when eGFR ≥90 ml min-1 1.73 m-2. CVD risk was further modified by renal status changes over the first 2 years. In multivariable analysis, 77% of the effect of eGFR and 81% of the effect of albumin:creatinine ratio were accounted for by other variables, principally low HDL-cholesterol and elevated blood pressure. Conclusions/interpretation: Reduced eGFR and albuminuria are independent risk factors for cardiovascular events and mortality rates in a low-risk population of mainly European ancestry. While their independent contributions to CVD risk appear small when other risk factors are considered, they remain excellent surrogate markers in clinical practice because they capture risk related to a number of other characteristics. Therefore, both should be considered when assessing prognosis and treatment strategies in patients with diabetes, and both should be included in risk models. © Springer-Verlag 2010.

Jo E.C.,Ministry of Health | Drury P.L.,Auckland Diabetes Center
Healthcare Informatics Research | Year: 2015

Objectives: The purpose of this study was to consider a Virtual Diabetes Registry System (VDR) and to investigate what it is and how it is used in New Zealand. New Zealand has specified diabetes mellitus (DM) as a national health priority. The Ministry of Health requires an accurate method for tracking the number of people with diagnosed with DM in the population. Methods: We combined five national databases, all of which included a unique patient identifier: hospital admissions coded for DM, outpatient attendances for DM, DM retinal screening, prescriptions of specific anti-diabetic therapies, laboratory orders for HbA1c, as well as Primary Health Organisation (PHO) enrolments and national mortality. The algorithm was progressively modified to improve sensitivity and specificity, and it was validated against primary care registers. The algorithm was still being used in 2014. Results: The prevalence of diagnosed diabetes in New Zealand at December 31, 2009 was 189,256 (4.4% of whole population). The VDR is now used to determine the official diagnosed diabetes prevalence in New Zealand; it is also used to determine the denominator of the health targets that the Ministry of Health should achieve for diabetes service indicators in New Zealand. Conclusions: This method appears to be superior to any other practicable national survey and to be both accurate and robust. The VDR has become an invaluable tool for monitoring prevalence and the policy making process, and for supporting clinical quality improvement. ©2015 The Korean Society of Medical Informatics

Ting R.-D.,University of Sydney | Ting R.-D.,Royal Prince Alfred Hospital | Keech A.C.,University of Sydney | Keech A.C.,Royal Prince Alfred Hospital | And 12 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - Diabetic patients with moderate renal impairment (estimated glomerular filtration rate [eGFR] 30-59 mL/min/1.73 m 2) are at particular cardiovascular risk. Fenofibrate's safety in these patients is an issue because it may elevate plasma creatinine. Furthermore, guidelines regarding fenofibrate dosing in renal impairment vary internationally. We investigated fenofibrate's effects on cardiovascular and end-stage renal disease (ESRD) events, according to eGFR, in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) Study. RESEARCH DESIGN AND METHODS - Type 2 diabetic patients (aged 50-75 years) with eGFR>30 mL/min/1.73 m 2 were randomly allocated to a fixed dose of fenofibrate (200 mg daily) (n = 4,895) or placebo (n = 4,900) for 5 years. Baseline renal function (Modification of Diet in Renal Disease equation) was grouped by eGFR (30-59, 60-89, and ≥90 mL/min/1.73 m 2). The prespecified outcome was total cardiovascular events (composite of cardiovascular death, myocardial infarction, stroke, and coronary/carotid revascularization). Serious adverse events and instances of ESRD (plasma creatinine >400 μmol/L, dialysis, renal transplant, or renal death) were recorded. Analysis was by intention to treat. RESULTS - Overall, fenofibrate reduced total cardiovascular events, compared with placebo (hazard ratio 0.89 [95% CI 0.80-0.99]; P = 0.035). This benefit was not statistically different across eGFR groupings (P = 0.2 for interaction) (eGFR 30-59 mL/min/1.73 m 2: 0.68 [0.47-0.97], P = 0.035; eGFR ≥90 mL/min/1.73 m 2: 0.85 [0.70-1.02], P = 0.08). ESRD rates were similar between treatment arms, without adverse safety signals of fenofibrate use in renal impairment. CONCLUSIONS - Patients with type 2 diabetes andmoderate renal impairment benefit from long-term fenofibrate, without excess drug-related safety concerns compared with those with no ormild renal impairment. Fenofibrate treatment should not be contraindicated in moderate renal impairment, suggesting that current guidelines may be too restrictive. © 2012 by the American Diabetes Association.

Davis T.M.E.,University of Western Australia | Ting R.,University of Sydney | Ting R.,Royal Prince Alfred Hospital | Best J.D.,University of Melbourne | And 13 more authors.
Diabetologia | Year: 2011

Aims/hypothesis: Fenofibrate caused an acute, sustained plasma creatinine increase in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) and Action to Control Cardiovascular Risk in Diabetes (ACCORD) studies. We assessed fenofibrate's renal effects overall and in a FIELD washout sub-study. Methods: Type 2 diabetic patients (n = 9,795) aged 50 to 75 years were randomly assigned to fenofibrate (n = 4,895) or placebo (n = 4,900) for 5 years, after 6 weeks fenofibrate run-in. Albuminuria (urinary albumin/creatinine ratio measured at baseline, year 2 and close-out) and estimated GFR, measured four to six monthly according to the Modification of Diet in Renal Disease Study, were pre-specified endpoints. Plasma creatinine was re-measured 8 weeks after treatment cessation at close-out (washout sub-study, n = 661). Analysis was by intention-to-treat. Results: During fenofibrate run-in, plasma creatinine increased by 10.0 μmol/l (p < 0.001), but quickly reversed on placebo assignment. It remained higher on fenofibrate than on placebo, but the chronic rise was slower (1.62 vs 1.89 μmol/l annually, p = 0.01), with less estimated GFR loss (1.19 vs 2.03 ml min-1 1.73 m-2 annually, p < 0.001). After washout, estimated GFR had fallen less from baseline on fenofibrate (1.9 ml min-1 1.73 m-2, p = 0.065) than on placebo (6.9 ml min-1 1.73 m-2, p < 0.001), sparing 5.0 ml min-1 1.73 m-2 (95% CI 2.3-7.7, p < 0.001). Greater preservation of estimated GFR with fenofibrate was observed with baseline hypertriacylglycerolaemia (n = 169 vs 491 without) alone, or combined with low HDL-cholesterol (n = 140 vs 520 without) and reductions of ≥0.48 mmol/l in triacylglycerol over the active run-in period (pre-randomisation) (n = 356 vs 303 without). Fenofibrate reduced urine albumin concentrations and hence albumin/creatinine ratio by 24% vs 11% (p < 0.001; mean difference 14% [95% CI 9-18]; p < 0.001), with 14% less progression and 18% more albuminuria regression (p < 0.001) than in participants on placebo. End-stage renal event frequency was similar (n = 21 vs 26, p = 0.48). Conclusions/interpretation: Fenofibrate reduced albuminuria and slowed estimated GFR loss over 5 years, despite initially and reversibly increasing plasma creatinine. Fenofibrate may delay albuminuria and GFR impairment in type 2 diabetes patients. Confirmatory studies are merited. Trial registration: ISRCTN64783481 Funding: The study was funded by grants from Laboratoires Fournier SA (Dijon, France; now part of Abbott Pharmaceuticals) and the National Health and Medical Research Council, Australia © 2010 Springer-Verlag.

Tan J.,Auckland Diabetes Center | Jaung R.,Auckland Diabetes Center | Gamble G.,University of Auckland | Cundy T.,Auckland Diabetes Center | Cundy T.,University of Auckland
Diabetes Research and Clinical Practice | Year: 2014

Aims: Patients with type 2 diabetes and macroalbuminuria are at high risk for end stage renal disease (ESRD), cardiovascular disease and death, but remission of proteinuria may improve prognosis. We examine the effectiveness of currently recommended treatments on inducing remission of proteinuria, and on morbidity and mortality. Methods: Observational study of 78 patients with type 2 diabetes (46 male) with mean age (SD) of 61.5 (11) years, with a urinary albumin/creatinine ratio (ACR) ≥ 50 mg/mmol. All were treated with agents blocking the renin-angiotensin system. Follow-up was from recognition of ACR ≥ 50. mg/mmol until death or March 2011 (median 6 years). Remission of proteinuria was defined as ≥70% reduction from peak ACR, sustained for ≥1 year. Results: Only 22 of 78 patients (28%) achieved remission of proteinuria. Thirty-six (46%) had at least one major event (death, dialysis or cardiovascular). Remission of proteinuria was associated with lower incidence of ESRD/death (9% vs 36%; p= 0.02) but cardiovascular events were not reduced (32% vs 30%). A third of patients had no retinopathy when albuminuria was first recognised, suggesting that non-diabetic renal pathologies were prominent. There was a significant interaction between the severity of diabetic retinopathy and remission of proteinuria on the risk of ESRD/death (p= 0.0003). Conclusions: Remission of proteinuria was achieved in only a third of patients despite efforts to achieve blood pressure targets <130/80. mmHg. Failure to attain remission of proteinuria was associated with increased risk of ESRD or death, a risk compounded by the presence of severe diabetic retinopathy. © 2013 Elsevier Ireland Ltd.

Best J.D.,University of Melbourne | Drury P.L.,Auckland Diabetes Center | Davis T.M.E.,University of Western Australia | Taskinen M.-R.,University of Helsinki | And 5 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - Glycemic control in type 2 diabetes generally worsens over time, requiring intensification of therapy. The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial provided the opportunity to observe glycemic control in a real-world setting. We assessed the adequacy of metformin, sulfonylureas, and insulin to maintain glycemic control and their effects on weight. RESEARCH DESIGNANDMETHODS - Diabetes control was measured at baseline and yearly for a median of 5 years in the 4,900 patients from the nonintervention arm of this study allocated to placebo. RESULTS - Median HbA 1c was 6.9% at baseline and increased by an average of 0.22% over 5 years (P < 0.001). Median weight was 86.3 kg at baseline and decreased by 0.4 kg over 5 years (P = 0.002). Baseline therapy was lifestyle measures only in 27%, oral agents without insulin in 59%, and insulin in 14%(7%also taking oral agents). Over 5 years, insulin use increased to 32% (21% also taking oral agents). Use of oral agents remained similar at 56%. Only 2% of patients at baseline and 4% after 5 years were taking oral agents other than metformin or sulfonylureas. Initiation of insulin therapy in 855 patients produced a sustained reduction of HbA 1c from a median of 8.2 to 7.7%, with a weight gain of 4.6 kg over 5 years. CONCLUSIONS - With intensification of traditional therapies, glycemic control deteriorated very little over 5 years in a large cohort of type 2 diabetes. However, the requirement for insulin therapy doubled, at the expense of significant weight gain and risk of hypoglycemia. © 2012 by the American Diabetes Association.

Hofman P.L.,University of Auckland | Derraik J.G.B.,University of Auckland | Pinto T.E.,University of Auckland | Tregurtha S.,Auckland Diabetes Center | And 7 more authors.
Diabetes Care | Year: 2010

OBJECTIVE- We aimed to establish the ideal injection techniques using 5-mm needles to reliably inject insulin into the subcutaneous fat in both children and adults and to quantify the associated pain and leakage of the test medium. RESEARCH DESIGN AND METHODS- A total of 259 subjects (122 children/ adolescents and 137 adults) were injected with sterile air corresponding to 20 IU insulin (200 μl) with 32-G 5-mm needles at 90° or 45°, in the abdomen and thigh, and with or without a pinched skin fold. Injection depth was assessed via ultrasonography. Subjects rated pain on a visual analog scale. Test medium injections into the abdomen and thigh (0.2- 0.6 ml) were also administered to assess injection leakage. RESULTS- Among children, 5.5% of injections were intramuscular (IM) and 0.5% were intradermal, while in adults, the incidence was 1.3 and 0.6%, respectively. The frequency of IM injections was greater in boys and negligible among adult women. Subcutaneous fat thickness was the primary predictor of the likelihood of IM injections (P < 0.001). A third of all patients reported experiencing no pain during insulin injection, with children/adolescents experiencing considerably more discomfort than adults. Some leakage of medium was observed, but was unrelated to injection volume and was generally minimal. CONCLUSIONS- 5-mm needles are reliably inserted into subcutaneous fat in both adults and children. These needles were associated with reduced pain and minimal leakage. We recommend an angled injection with a pinched skin fold for children, while in adults, the technique should be left to patient preference. © 2010 by the American Diabetes Association.

Krebs J.D.,University of Otago | Krebs J.D.,Diabetes and Research Center | Elley C.R.,University of Auckland | Parry-Strong A.,University of Otago | And 6 more authors.
Diabetologia | Year: 2012

Aims/hypothesis To compare the effectiveness of low-fat high-protein and low-fat high-carbohydrate dietary advice on weight loss, using group-based interventions, among overweight people with type 2 diabetes. Study design Multicentre parallel (1:1) design, blinded randomised controlled trial. Methods Individuals with type 2 diabetes aged 30-75 years and a BMI >27 kg/m 2 were randomised, by an independent statistician using sequentially numbered sealed envelopes, to be prescribed either a low-fat high-protein (30% of energy as protein, 40% as carbohydrate, 30% as fat) or a low-fat highcarbohydrate (15% of energy as protein, 55%as carbohydrate, 30% as fat) diet. Participants attended 18 group sessions over 12 months. Primary outcomes were change in weight and waist circumference assessed at baseline, 6 and 12 months. Secondary outcomes were body fatness, glycaemic control, lipid profile, blood pressure and renal function. A further assessment was undertaken 12 months after the intervention. Research assessors remained blinded to group allocation throughout. Intention-to-treat analysis was performed. Results A total of 419 participants were enrolled (mean±SD age 58±9.5 years,BMI 36.6±6.5 kg/m 2 and HbA 1c 8.1±1.2% (65 mmol/mol)). The study was completed by 70%(294/419). No differences between groups were found in change in weight or waist circumference during the intervention phase or the 12-month follow-up. Both groups had lost weight (2-3 kg, p<0.001) and reduced their waist circumference (2-3 cm, p<0.001) by 12 months and largely maintained this weight loss for the following 12 months. By 6 months, the difference in self-reported dietary protein between groups was small (1.1%total energy; p<0.001). No significant differences between groups were found in secondary outcomes: body fatness, HbA 1c, lipids, blood pressure and renal function. There were no important adverse effects. Conclusions/interpretation In a 'real-world' setting, prescription of an energy-reduced low-fat diet, with either increased protein or carbohydrate, results in similar modest losses in weight and waist circumference over 2 years. Trial registration: Australia New Zealand Clinical Trials Register ACTRN12606000490572 Funding: The Health Research Council of New Zealand (06/337). © 2012 Springer-Verlag.

Elley C.R.,University of Auckland | Robinson T.,University of Auckland | Moyes S.A.,University of Auckland | Kenealy T.,University of Auckland | And 4 more authors.
Diabetes Care | Year: 2013

OBJECTIVE Diabetes has become the leading cause of end-stage renal disease (ESRD). Renal risk stratification could assist in earlier identification and targeted prevention. This study aimed to derive risk models to predict ESRD events in type 2 diabetes in primary care. RESEARCH DESIGN AND METHODSdThe nationwide derivation cohort included adultswith type 2 diabetes fromthe New Zealand Diabetes Cohort Study initially assessed during 2000-2006 and followed until December 2010, excluding those with pre-existing ESRD. The outcome was fatal or nonfatal ESRD event (peritoneal dialysis or hemodialysis for ESRD, renal transplantation, or death from ESRD). Risk models were developed using Cox proportional hazards models, and their performance was assessed in a separate validation cohort. RESULTSdThe derivation cohort included 25,736 individuals followed for up to 11 years (180,497 person-years; 86% followed for≤5 years). At baseline, mean age was 62 years, median diabetes duration 5 years, and median HbA1c 7.2 (55 mmol/mol); 37% had albuminuria; and median estimated glomerular filtration rate (eGFR) was 77 mL/min/1.73 m2. There were 637 ESRD events (2.5%) during follow-up. Models that included sex, ethnicity, age, diabetes duration, albuminuria, serum creatinine, systolic blood pressure, HbA1c, smoking status, and previous cardiovascular disease status performed well with good discrimination and calibration in the derivation cohort and the validation cohort (n = 5,877) (C-statistics 0.89-0.92), improving predictive performance compared with previous models. CONCLUSIONSdThese 5-year renal risk models performed very well in two large primary care populations with type 2 diabetes. More accurate risk stratification could facilitate earlier intervention than using eGFR and/or albuminuria alone. © 2013 by the American Diabetes Association.

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