Factors associated with fragility fractures in type 2 diabetes: An analysis of the randomised controlled Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study.

AIMS: Fracture risk is elevated in some type 2 diabetes patients. Bone fragility may be associated with more clinically severe type 2 diabetes, although prospective studies are lacking. It is unknown which diabetes-related characteristics are independently associated with fracture risk. In this post-hoc analysis of fracture data from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial (ISRCTN#64783481), we hypothesised that diabetic microvascular complications are associated with bone fragility. MATERIALS AND METHODS: The FIELD trial randomly assigned 9795 type 2 diabetes participants (aged 50-75 years) to receive oral co-micronised fenofibrate 200 mg (n = 4895) or placebo (n = 4900) daily for a median of 5 years. We used Cox proportional hazards models to identify baseline sex-specific diabetes-related parameters independently associated with incident fractures. RESULTS: Over 49,470 person-years, 137/6138 men experienced 141 fractures and 143/3657 women experienced 145 fractures; incidence rates for the first fracture of 4∙4 (95% CI 3∙8-5∙2) and 7∙7 per 1000 person-years (95% CI 6∙5-9∙1), respectively. Fenofibrate had no effect on fracture outcomes. In men, baseline macrovascular disease (HR 1∙52, 95% CI 1∙05-2∙21, p = 0∙03), insulin use (HR 1∙62, HR 1∙03-2∙55, p = 0∙03), and HDL-cholesterol (HR 2∙20, 95% CI 1∙11-4∙36, p = 0∙02) were independently associated with fracture. In women, independent risk factors included baseline peripheral neuropathy (HR 2∙04, 95% CI 1∙16-3∙59, p = 0∙01) and insulin use (HR 1∙55, 95% CI 1∙02-2∙33, p = 0∙04). CONCLUSIONS: Insulin use and sex-specific complications (in men, macrovascular disease; in women, neuropathy) are independently associated with fragility fractures in adults with type 2 diabetes.

Cardiovascular risk prediction in type 2 diabetes before and after widespread screening: a derivation and validation study.

BACKGROUND: Until recently, most patients with diabetes worldwide have been diagnosed when symptomatic and have high cardiovascular risk, meaning most should be prescribed cardiovascular preventive medications. However, in New Zealand, a world-first national programme led to approximately 90% of eligible adults being screened for diabetes by 2016, up from 50% in 2012, identifying many asymptomatic patients with recent-onset diabetes. We hypothesised that cardiovascular risk prediction equations derived before widespread screening would now significantly overestimate risk in screen-detected patients. METHODS: New Zealanders aged 30-74 years with type 2 diabetes and without known cardiovascular disease, heart failure, or substantial renal impairment were identified from the 400 000-person PREDICT primary care cohort study between Oct 27, 2004, and Dec 30, 2016, covering the period before and after widespread screening. Sex-specific equations estimating 5-year risk of cardiovascular disease were developed using Cox regression models, with 18 prespecified predictors, including diabetes-related and renal function measures. Equation performance was compared with an equivalent equation derived in the New Zealand Diabetes Cohort Study (NZDCS), which recruited between 2000 and 2006, before widespread screening. FINDINGS: 46 652 participants were included in the PREDICT-1° Diabetes subcohort, of whom 4114 experienced first cardiovascular events during follow-up (median 5·2 years, IQR 3·3-7·4). 14 829 (31·8%) were not taking oral hypoglycaemic medications or insulin at baseline. Median 5-year cardiovascular risk estimated by the new equations was 4·0% (IQR 2·3-6·8) in women and 7·1% (4·5-11·2) in men. The older NZDCS equation overestimated median cardiovascular risk by three times in women (median 14·2% [9·7-20·0]) and two times in men (17·1% [4·5-20·0]). Model and discrimination performance measures for PREDICT-1° Diabetse equations were also significantly better than for the NZDCS equation (eg, for women: R2=32% [95% CI 29-34], Harrell's C=0·73 [0·72-0·74], Royston's D=1·410 [1·330-1·490] vs R2=24% [21-26], C=0·69 [0·67-0·70], and D=1·147 [1·107-1·187]). INTERPRETATION: International treatment guidelines still consider most people with diabetes to be at high cardiovascular risk; however, we show that recent widespread diabetes screening has radically changed the cardiovascular risk profile of people with diabetes in New Zealand. Many of these patients have normal renal function, are not dispensed glucose-lowering medications, and have low cardiovascular risk. These findings have clear international implications as increased diabetes screening is inevitable due to increasing obesity, simpler screening tests, and the introduction of new-generation glucose-lowering medications that prevent cardiovascular events. Cardiovascular risk prediction equations derived from contemporary diabetes populations, with multiple diabetes-related and renal function predictors, will be required to better differentiate between low-risk and high-risk patients in this increasingly heterogeneous population and to inform appropriate non-pharmacological management and cost-effective targeting of expensive new medications. FUNDING: Health Research Council of New Zealand, Heart Foundation of New Zealand, and Healthier Lives National Science Challenge.

Increased prevalence of albuminuria among non-European peoples with type 2 diabetes.

BACKGROUND: A high incidence of albuminuria, varying by ethnicity, has been found in a number of populations worldwide. There have been few opportunities to explore the prevalence of albuminuria as a marker of chronic kidney disease while adjusting for other risk factors in the different ethnic groups in New Zealand. METHODS: We examined the association between albuminuria and ethnicity using cross-sectional data from a large cohort study of type 2 diabetes conducted in New Zealand. RESULTS: The study population was 65 171 adults in primary care with type 2 diabetes, not on renal replacement therapy; median age was 64.7 years, median diabetes duration 5.1 years and 48.5% were non-European. Microalbuminuria or greater was present in 50% of Maori, 49% of Pacific people, 31% of Indo- and East-Asians and 28% of Europeans. Regression analyses were used to examine the association between ethnicity and albuminuria-measured as albumin:creatinine ratio-after controlling for study site and other known risk variables: age, sex, duration of diabetes, smoking status, socioeconomic status, body mass index, systolic and diastolic blood pressure, triglyceride levels, HbA(1C) and being on an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker. After controlling for these risk factors and compared with Europeans, odds ratios for 'advanced' albuminuria (≥100 mg/mmol) were 3.9 (95% confidence interval: 3.2-4.6) in Maori, 4.7 (3.6-6.3) in Pacific people, 2.0 (1.5-2.7) in Indo-Asians and 4.1 (3.2-5.1) in East-Asians. CONCLUSION: Non-European ethnicities appear to carry significantly higher risks of albuminuria in type 2 diabetes.

Can administrative health utilisation data provide an accurate diabetes prevalence estimate for a geographical region?

AIM: To validate the New Zealand Ministry of Health (MoH) Virtual Diabetes Register (VDR) using longitudinal laboratory results and to develop an improved algorithm for estimating diabetes prevalence at a population level. METHODS: The assigned diabetes status of individuals based on the 2014 version of the MoH VDR is compared to the diabetes status based on the laboratory results stored in the Auckland regional laboratory result repository (TestSafe) using the New Zealand diabetes diagnostic criteria. The existing VDR algorithm is refined by reviewing the sensitivity and positive predictive value of the each of the VDR algorithm rules individually and as a combination. RESULTS: The diabetes prevalence estimate based on the original 2014 MoH VDR was 17% higher (n = 108,505) than the corresponding TestSafe prevalence estimate (n = 92,707). Compared to the diabetes prevalence based on TestSafe, the original VDR has a sensitivity of 89%, specificity of 96%, positive predictive value of 76% and negative predictive value of 98%. The modified VDR algorithm has improved the positive predictive value by 6.1% and the specificity by 1.4% with modest reductions in sensitivity of 2.2% and negative predictive value of 0.3%. At an aggregated level the overall diabetes prevalence estimated by the modified VDR is 5.7% higher than the corresponding estimate based on TestSafe. CONCLUSION: The Ministry of Health Virtual Diabetes Register algorithm has been refined to provide a more accurate diabetes prevalence estimate at a population level. The comparison highlights the potential value of a national population long term condition register constructed from both laboratory results and administrative data.

Cardiovascular outcomes in the Irbesartan Diabetic Nephropathy Trial of patients with type 2 diabetes and overt nephropathy.

BACKGROUND: Patients with diabetes have increased risk for adverse cardiovascular events. Angiotensin-converting enzyme inhibitors are protective in type 1 diabetes. However, no definitive studies have examined the use of angiotensin-receptor blockers in patients with type 2 diabetes and overt nephropathy. The primary outcomes of the Irbesartan Diabetic Nephropathy Trial were doubling of serum creatinine levels, end-stage renal disease, and death from any cause. OBJECTIVE: To compare rates of cardiovascular events among patients with type 2 diabetic nephropathy who received conventional antihypertensive therapy with an angiotensin-receptor blocker (irbesartan) or a calcium-channel blocker (amlodipine), or placebo. DESIGN: Randomized double-blind, placebo-controlled trial with a median follow-up of 2.6 years. A time event analysis was used. SETTING: 209 centers in the Americas, Europe, Israel, and Australasia. PARTICIPANTS: 1715 adults with type 2 diabetic nephropathy and hypertension; serum creatinine levels of 89 micromol/L (1.0 mg/dL) to 266 micromol/L (3.0 mg/dL) in women and 106 micromol/L (1.2 mg/dL) to 266 micromol/L (3.0 mg/dL) in men; and urinary protein excretion rates of at least 900 mg/d. INTERVENTION: Treatment with irbesartan, amlodipine, or placebo. MEASUREMENTS: Time to cardiovascular death, myocardial infarction, congestive heart failure, strokes, and coronary revascularization. RESULTS: The three groups were not statistically different in the composite of cardiovascular events. Among the components of the composite, there was a trend toward a decrease in strokes in patients receiving amlodipine versus those receiving placebo (hazard ratio, 0.65 [95% CI, 0.35 to 1.22]; P = 0.18). Likewise, patients receiving amlodipine had a significantly lower rate of myocardial infarction when compared with placebo recipients (hazard ratio, 0.58 [CI, 0.37 to 0.92]; P = 0.02). In contrast, patients receiving irbesartan had a significantly lower incidence of congestive heart failure when compared with placebo recipients (hazard ratio, 0.72 [CI, 0.52 to 1.00]; P = 0.048) or amlodipine recipients (hazard ratio, 0.65 [CI, 0.48 to 0.87]; P = 0.004). CONCLUSION: The composite cardiovascular event rate did not differ in patients with type 2 diabetes and overt nephropathy treated with irbesartan, amlodipine, or placebo in addition to conventional antihypertensive therapy.

Development of a Virtual Diabetes Register using Information Technology in New Zealand.

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.

Development and validation of a predictive risk model for all-cause mortality in type 2 diabetes.

AIMS: Type 2 diabetes is common and is associated with an approximate 80% increase in the rate of mortality. Management decisions may be assisted by an estimate of the patient's absolute risk of adverse outcomes, including death. This study aimed to derive a predictive risk model for all-cause mortality in type 2 diabetes. METHODS: We used primary care data from a large national multi-ethnic cohort of patients with type 2 diabetes in New Zealand and linked mortality records to develop a predictive risk model for 5-year risk of mortality. We then validated this model using information from a separate cohort of patients with type 2 diabetes. RESULTS: 26,864 people were included in the development cohort with a median follow up time of 9.1 years. We developed three models initially using demographic information and then progressively more clinical detail. The final model, which also included markers of renal disease, proved to give best prediction of all-cause mortality with a C-statistic of 0.80 in the development cohort and 0.79 in the validation cohort (7610 people) and was well calibrated. Ethnicity was a major factor with hazard ratios of 1.37 for indigenous Maori, 0.41 for East Asian and 0.55 for Indo Asian compared with European (P<0.001). CONCLUSIONS: We have developed a model using information usually available in primary care that provides good assessment of patient's risk of death. Results are similar to models previously published from smaller cohorts in other countries and apply to a wider range of patient ethnic groups.

Predictors of cardiovascular events in patients with type 2 diabetic nephropathy and hypertension: a case for albuminuria.

Individuals with type 2 diabetes and nephropathy represent a particularly high-risk group for both adverse cardiac as well as renal events. Using the Irbesartan in Diabetic Nephropathy Trial (IDNT) cohort, our objective was to determine baseline characteristics of individuals with type 2 diabetic nephropathy and hypertension predictive for cardiac events. IDNT identified 1715 individuals with type 2 diabetic nephropathy and hypertension having serum creatinine of 1.0 to 3.0 mg/dL and urinary albumin excretion rates > or = 900 mg/day. A cardiovascular (CV) composite was used consisting of CV death, nonfatal MI, hospitalization for heart failure, stroke, amputation, and coronary and peripheral revascularization. Using multivariable Cox regression analysis, 41 baseline characteristics determined a priori were analyzed for their potential relationship to risk of experiencing a CV event. Of the 1715 individuals, 518 (30.2%) had at least one of the CV composite end points. Older age, male gender, longer duration of diabetes, history of cardiovascular disease, history of CHF, high urinary albumin:creatinine ratio, and low serum albumin were strong predictors for CV events; of these, prior history of CVD (RR 2.00, 95% CI 1.63-2.45; P < 0.0001) and high urinary albumin:creatinine ratio (RR 1.29 per natural log unit, 95% CI 1.13-1.48; P = 0.0002) at baseline were highly predictive for cardiovascular events. In conclusion, among individuals with hypertension and diabetic nephropathy, both the degree of albuminuria and lower serum albumin levels provide additional prognostic information concerning cardiovascular risk, in addition to traditional coronary risk factors.

The skeletal effects of pioglitazone in type 2 diabetes or impaired glucose tolerance: a randomized controlled trial.

OBJECTIVE: Preclinical studies, observational studies, and clinical trials suggest that thiazolidinediones (TZDs) reduce bone mineral density (BMD) and increase fracture risk. Most of the evidence on the skeletal effects of TZDs is from studies of rosiglitazone. We set out to investigate the magnitude and etiology of the adverse skeletal effects of pioglitazone. DESIGN: Double-blind, randomized controlled trial. TRIAL REGISTRATION: AUSTRALIA NEW ZEALAND CLINICAL TRIALS REGISTRY, ACTR.ORG.AU IDENTIFIER: ACTRN12607000610437, date of registration 28/11/07. METHODS: A total of 86 people with type 2 diabetes mellitus (T2DM) or impaired glucose tolerance (IGT), median age 64 years, were randomized to receive either pioglitazone 30 mg/day or placebo for 1 year, in addition to their usual diabetes treatments. The primary outcome was change in lumbar spine BMD; secondary outcomes included changes in BMD at other sites and in biochemical markers of bone turnover. RESULTS: Change in spine BMD was not altered by treatment with pioglitazone (Ptreatment×time=0.5). After 1 year, the mean (95% CI) between-groups difference in lumbar spine BMD was -0.7% (-2.1, 0.7). Pioglitazone increased bone loss at the proximal femur (Ptreatment×time=0.03). After 12 months, the between-groups difference in total hip BMD was -1.2% (-2.1, 0.2). Pioglitazone did not alter change in BMD at other skeletal sites, nor did it affect changes in the levels of either of the biochemical markers of bone turnover, procollagen type 1 N-terminal propeptide, or ß-C-terminal telopeptide of type 1 collagen. CONCLUSIONS: Over 1 year, treatment with pioglitazone 30 mg/day did not produce consistent effects on either BMD or bone turnover in people with T2DM or IGT. The mechanism(s) by which pioglitazone increases fracture risk in T2DM is unclear.

The future of population registers: linking routine health datasets to assess a population's current glycaemic status for quality improvement.

OBJECTIVES: To determine the diabetes screening levels and known glycaemic status of all individuals by age, gender and ethnicity within a defined geographic location in a timely and consistent way to potentially facilitate systematic disease prevention and management. DESIGN: Retrospective observational study. SETTING: Auckland region of New Zealand. PARTICIPANTS: 1 475 347 people who had utilised publicly funded health service in New Zealand and domicile in the Auckland region of New Zealand in 2010. The health service utilisation population was individually linked to a comprehensive regional laboratory repository dating back to 2004. OUTCOME MEASURES: The two outcomes measures were glycaemia-related blood testing coverage (glycated haemoglobin (HbA1c), fasting and random glucose and glucose tolerance tests), and the proportions and number of people with known dysglycaemia in 2010 using modified American Diabetes Association (ADA) and WHO criteria. RESULTS: Within the health service utilisation population, 792 560 people had had at least one glucose or HbA1c blood test in the previous 5.5 years. Overall, 81% of males (n=198 086) and 87% of females (n=128 982) in the recommended age groups for diabetes screening had a blood test to assess their glycaemic status. The estimated age-standardised prevalence of dysglycaemia was highest in people of Pacific Island ethnicity at 11.4% (95% CI 11.2% to 11.5%) for males and 11.6% (11.4% to 11.8%) for females, followed closely by people of Indian ethnicity at 10.8% (10.6% to 11.1%) and 9.3% (9.1% to 9.6%), respectively. Among the indigenous Maori population, the prevalence was 8.2% (7.9% to 8.4%) and 7% (6.8% to 7.2%), while for 'Others' (mainly Europeans) it was 3% (3% to 3.1%) and 2.2% (2.1% to 2.2%), respectively. CONCLUSIONS: We have demonstrated that the data linkage between a laboratory repository and national administrative datasets has the potential to provide a systematic and consistent individual level clinical information that is relevant to medical auditing for a large geographically defined population.

Effects of age, gender, BMI, and anatomical site on skin thickness in children and adults with diabetes.

OBJECTIVE: We aimed to assess the effects of age, sex, body mass index (BMI), and anatomical site on skin thickness in children and adults with diabetes. METHODS: We studied 103 otherwise healthy children and adolescents with type 1 diabetes aged 5-19 years, and 140 adults with type 1 and type 2 diabetes aged 20-85 years. The thicknesses of both the dermis and subcutis were assessed using ultrasound with a linear array transducer, on abdominal and thigh skin. RESULTS: There was an age-related thickening of both dermis (p<0.0001) and subcutis (p = 0.013) in children and adolescents. Girls displayed a substantial pubertal increase in subcutis of the thigh (+54%; p = 0.048) and abdomen (+68%; p = 0.009). Adults showed an age-related decrease in dermal (p = 0.021) and subcutis (p = 0.009) thicknesses. Pubertal girls had a thicker subcutis than pubertal boys in both thigh (16.7 vs 7.5 mm; p<0.0001) and abdomen (16.7 vs 8.8 mm; p<0.0001). Men had greater thigh dermal thickness than women (1.89 vs 1.65 mm; p = 0.003), while the subcutis was thicker in women in thigh (21.3 vs 17.9 mm; p = 0.012) and abdomen (17.7 vs 9.8 mm; p<0.0001). In boys, men, and women, both dermis and subcutis were thicker on the abdomen compared to thigh; in girls this was only so for dermal thickness. In both children and adults, the skin (dermis and subcutis) became steadily thicker with increasing BMI (p<0.0001). CONCLUSIONS: Skin thickness is affected by age, pubertal status, gender, BMI, and anatomical site. Such differences may be important when considering appropriate sites for dermal/subcutaneous injections and other transdermal delivery systems.

Prevalence of diagnosed and undiagnosed diabetes and prediabetes in New Zealand: findings from the 2008/09 Adult Nutrition Survey.

AIM: To describe the prevalence of diagnosed and undiagnosed diabetes and prediabetes for New Zealand adults. METHODS: The 2008/09 New Zealand Adult Nutrition Survey was a nationally representative, cross-sectional survey of 4,721 New Zealanders aged 15 years and above. Self-reported diabetes and the 2010 American Diabetes Association cutoffs for HbA1c were used to define diagnosed diabetes, undiagnosed diabetes and prediabetes. Prevalence rates were calculated and age-specific diagnosed diabetes rates were compared with those from the Virtual Diabetes Register. RESULTS: Overall, prevalence of diabetes was 7.0%, and prevalence of prediabetes 18.6%. Prevalence of diabetes was higher in men (8.3%, 95% CI: 6.4, 10.1) than in women (5.8%, 95% CI: 4.7, 7.0), and was higher among the obese (14.2%, 95% CI: 11.6, 16.9) compared with the normal weight group (2.4%, 95% CI: 1.4, 3.6). Prevalence of undiagnosed diabetes was highest among Pacific people (6.4%, 95% CI: 3.8, 9.1) compared with Maori (2.2%, 95% CI: 1.2, 3.1) and New Zealand European and Others (1.5%, 95% CI: 0.9, 2.1). CONCLUSION: The high prevalence of prediabetes indicates the prevalence of diabetes will continue to increase in New Zealand. Implementation of effective evidence-based prevention strategies is required to reduce the increasing costs of the diabetes epidemic.

Derivation and validation of a renal risk score for people with type 2 diabetes.

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 METHODS: The nationwide derivation cohort included adults with type 2 diabetes from the 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. RESULTS: The 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. CONCLUSIONS: These 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.

Understanding the new HbA1c units for the diagnosis of Type 2 diabetes.

In New Zealand laboratories the measurement of glycated haemoglobin (HbA1c) for diagnosis of diabetes is now only reported in SI units of mmol/mol. HbA1c is now recommended as the preferred test to diagnose diabetes in most circumstances. The requirement for a second positive test in asymptomatic individuals is retained. An HbA1c greater than and equal to 50 mmol/mol (repeated on a second occasion in asymptomatic patients) is diagnostic of diabetes and a value less than and equal to 40 mmol/mol represents normal glucose tolerance. For patients with an initial HbA1c result of 41-49 mmol/mol, cardiovascular risk assessment and lifestyle interventions are recommended with repeat HbA1c screening in 6-12 months. For patients whose HbA1c is less than and equal to 40 mmol/mol, repeat screening (including for CVD risk) at intermittent intervals is recommended as per published guidelines.

New Zealand Diabetes Cohort Study cardiovascular risk score for people with Type 2 diabetes: validation in the PREDICT cohort.

INTRODUCTION: New Zealand (NZ) guidelines recommend treating people for cardiovascular disease (CVD) risk on the basis of five-year absolute risk using a NZ adaptation of the Framingham risk equation. A diabetes-specific Diabetes Cohort Study (DCS) CVD predictive risk model has been developed and validated using NZ Get Checked data. AIM: To revalidate the DCS model with an independent cohort of people routinely assessed using PREDICT, a web-based CVD risk assessment and management programme. METHODS: People with Type 2 diabetes without pre-existing CVD were identified amongst people who had a PREDICT risk assessment between 2002 and 2005. From this group we identified those with sufficient data to allow estimation of CVD risk with the DCS models. We compared the DCS models with the NZ Framingham risk equation in terms of discrimination, calibration, and reclassification implications. RESULTS: Of 3044 people in our study cohort, 1829 people had complete data and therefore had CVD risks calculated. Of this group, 12.8% (235) had a cardiovascular event during the five-year follow-up. The DCS models had better discrimination than the currently used equation, with C-statistics being 0.68 for the two DCS models and 0.65 for the NZ Framingham model. DISCUSSION: The DCS models were superior to the NZ Framingham equation at discriminating people with diabetes who will have a cardiovascular event. The adoption of a DCS model would lead to a small increase in the number of people with diabetes who are treated with medication, but potentially more CVD events would be avoided.

Glycemic control over 5 years in 4,900 people with type 2 diabetes: real-world diabetes therapy in a clinical trial cohort.

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 DESIGN AND METHODS: 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.

Benefits and safety of long-term fenofibrate therapy in people with type 2 diabetes and renal impairment: the FIELD Study.

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 and moderate renal impairment benefit from long-term fenofibrate, without excess drug-related safety concerns compared with those with no or mild renal impairment. Fenofibrate treatment should not be contraindicated in moderate renal impairment, suggesting that current guidelines may be too restrictive.

Can the prevalence of diagnosed diabetes be estimated from linked national health records? The validity of a method applied in New Zealand.

INTRODUCTION: With projected global increases in the prevalence of Type 2 diabetes, the health sector requires timely assessments of the prevalence of this disease to monitor trends, plan services, and measure the efficacy of prevention programmes. AIM: To assess the validity of a method to estimate the prevalence of diagnosed diabetes from linked national health records. METHODS: We measured the agreement between a diabetes diagnosis (using combined national lists of drug dispensing, outpatient attendance, laboratory tests (HbA1c) and hospital diagnoses) and a primary care diabetes diagnosis in a (PREDICT™) cohort of 53,911 adult New Zealanders. The completeness of the diagnosis of diabetes in the cohort was estimated using capture-recapture methods. RESULTS: The primary care cohort had a high prevalence of recorded diabetes (20.9%, 11,266/53,911), similar to our derived prevalence of 20.1%. Of the participants with a diagnosis of diabetes, 89% (10,182/11,266) had a similar derived diagnosis, indicating that only about one in 10 people with a primary care diagnosis had not been either admitted to hospital, seen at outpatient clinics, prescribed diabetes drugs or undertaken regular HbA1c tests. The capture-recapture prevalence of diagnosed diabetes in this cohort was 23.7% indicating that primary care diagnoses in the cohort were about 90% complete. DISCUSSION: A method for estimating the prevalence of diagnosed diabetes from national health data shows high-level agreement with primary care records. Linked health data can provide an efficient method for estimating the prevalence of diagnosed diabetes in regions where such records are individually linked.