Showing papers by "Bruce Neal published in 2018"

Canagliflozin and Heart Failure in Type 2 Diabetes Mellitus: Results From the CANVAS Program.

Abstract: BACKGROUND : Canagliflozin is a sodium glucose cotransporter 2 inhibitor that reduces the risk of cardiovascular events. We report the effects on heart failure and cardiovascular death overall, in those with and without a baseline history of heart failure, and in other participant subgroups. METHODS : The CANVAS Program (Canagliflozin Cardiovascular Assessment Study) enrolled 10 142 participants with type 2 diabetes mellitus and high cardiovascular risk. Participants were randomly assigned to canagliflozin or placebo and followed for a mean of 188 weeks. The primary end point for these analyses was adjudicated cardiovascular death or hospitalized heart failure. RESULTS : Participants with a history of heart failure at baseline (14.4%) were more frequently women, white, and hypertensive and had a history of prior cardiovascular disease (all P P P interaction =0.021). The effects of canagliflozin compared with placebo on other cardiovascular outcomes and key safety outcomes were similar in participants with and without heart failure at baseline (all interaction P values >0.130), except for a possibly reduced absolute rate of events attributable to osmotic diuresis among those with a prior history of heart failure ( P =0.03). CONCLUSIONS : In patients with type 2 diabetes mellitus and an elevated risk of cardiovascular disease, canagliflozin reduced the risk of cardiovascular death or hospitalized heart failure across a broad range of different patient subgroups. Benefits may be greater in those with a history of heart failure at baseline. CLINICAL TRIAL REGISTRATION : URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01032629 and NCT01989754.

Cardiovascular and Renal Outcomes With Canagliflozin According to Baseline Kidney Function: Data from the CANVAS Program

Abstract: Background: Canagliflozin is approved for glucose lowering in type 2 diabetes and confers cardiovascular and renal benefits. We sought to assess whether it had benefits in people with chronic kidne...

Blood pressure-lowering treatment strategies based on cardiovascular risk versus blood pressure: A meta-analysis of individual participant data.

Abstract: Background: Clinical practice guidelines have traditionally recommended blood pressure treatment based primarily on blood pressure thresholds. In contrast, using predicted cardiovascular risk has b ...

Percentage of ingested sodium excreted in 24-hour urine collections: A systematic review and meta-analysis.

Abstract: Aaron M. Lucko BHSc1 | Chelsea Doktorchik MSc2 | Mark Woodward PhD3,4 | Mary Cogswell DrPH, RN5 | Bruce Neal MB ChB, MRCP, PhD, FRCP, FAHA4 | Doreen Rabi MD, MSc, FRCPC6 | Cheryl Anderson PhD, MPH, MS7 | Feng J. He PhD8 | Graham A. MacGregor FRCP8 | Mary L'Abbe PhD9 | JoAnne Arcand PhD, RD10 | Paul K. Whelton MB, MD, MSc11 | Rachael McLean BA, MB, ChB, MPH, PhD12 | Norm R. C. Campbell MD13 | for the TRUE Consortium

Uptake of Australia’s Health Star Rating System

Abstract: In June 2014, Australia and New Zealand adopted a voluntary front-of-pack nutrition labelling scheme in the form of the Health Star Rating (HSR) system Our aim was to assess its uptake in Australia while a formal five-year review of the system is underway Numbers and proportions of products eligible to carry a HSR were recorded each year between 2014 and 2017 as part of an annual survey of four large Australian retail outlets Mean HSR values were determined for products that were and were not labelled with a HSR logo, and summary data presented overall, by HSR score, by major food category, and for leading manufacturers Results show that uptake is increasing: HSR appeared on 4348/15,767 (28%) of eligible products in 2017 and has now appeared on 7922 products since implementation Of those products displaying a HSR logo, more than three-quarters (764%) displayed a HSR of ≥30 Products displaying a HSR logo had a higher mean HSR (34), compared to products not displaying a HSR logo (27) Uptake was highest on convenience foods (44%), cereals (367%), and fruit and vegetable products (359%) More than 100 manufacturers were using the system, but retailers Coles, Woolworths and Aldi were together responsible for 54% of uptake For all except Coles, Woolworths and Campbell Arnott’s, the mean HSR of products displaying a logo on pack was higher than products made by that manufacturer not showing a HSR logo We conclude that to ensure the consistent and widespread uptake required for consumers to make informed food purchases, HSR should be made mandatory at the conclusion of the five-year review

Salt consumption by Australian adults: a systematic review and meta-analysis.

Abstract: Objective Salt reduction is a public health priority because it is a leading contributor to the global burden of disease. As in Australia there is uncertainty about the current level of salt intake, we sought to estimate current levels. Study design Random effects meta-analysis of data from 31 published studies and one unpublished dataset that reported salt or sodium consumption by Australian adults on the basis of 24-hour urine collections or dietary questionnaires. Data sources MEDLINE (via Ovid) and EMBASE (to August 2016). Data synthesis Thirty-one published studies and one unpublished dataset (1989-2015; 16 836 individuals) were identified. The mean weighted salt consumption estimated from 24-hour urine collections was 8.70 g/day (95% CI, 8.39-9.02 g/day); after adjusting for non-urinary salt excretion, the best estimate of salt intake in Australia is 9.6 g/day. The mean weighted intake was 10.1 g/day (95% CI, 9.68-10.5 g/day) for men and 7.34 g/day (95% CI, 6.98-7.70 g/day) for women. Mean weighted consumption was 6.49 g/day (95% CI, 5.94-7.03 g/day) when measured with diet diaries, 6.76 g/day (95% CI, 5.48-8.05 g/day) when assessed with food frequency questionnaires, and 6.73 g/day (95% CI, 6.34-7.11) when assessed by dietary recall. Salt intake had not decreased between 1989 and 2015 (R2 = -0.02; P = 0.36). Conclusion Salt intake in Australian adults exceeds the WHO-recommended maximum of 5 g/day and does not appear to be declining. Measuring salt intake with methods based on self-reporting can substantially underestimate consumption. The data highlight the need for ongoing action to reduce salt consumption in Australia and robust monitoring of population salt intake.

Defining 'Unhealthy': A Systematic Analysis of Alignment between the Australian Dietary Guidelines and the Health Star Rating System.

Abstract: The Australian Dietary Guidelines (ADGs) and Health Star Rating (HSR) front-of-pack labelling system are two national interventions to promote healthier diets. Our aim was to assess the degree of alignment between the two policies. Methods: Nutrition information was extracted for 65,660 packaged foods available in The George Institute’s Australian FoodSwitch database. Products were classified ‘core’ or ‘discretionary’ based on the ADGs, and a HSR generated irrespective of whether currently displayed on pack. Apparent outliers were identified as those products classified ‘core’ that received HSR ≤ 2.0; and those classified ‘discretionary’ that received HSR ≥ 3.5. Nutrient cut-offs were applied to determine whether apparent outliers were ‘high in’ salt, total sugar or saturated fat, and outlier status thereby attributed to a failure of the ADGs or HSR algorithm. Results: 47,116 products (23,460 core; 23,656 discretionary) were included. Median (Q1, Q3) HSRs were 4.0 (3.0 to 4.5) for core and 2.0 (1.0 to 3.0) for discretionary products. Overall alignment was good: 86.6% of products received a HSR aligned with their ADG classification. Among 6324 products identified as apparent outliers, 5246 (83.0%) were ultimately determined to be ADG failures, largely caused by challenges in defining foods as ‘core’ or ‘discretionary’. In total, 1078 (17.0%) were determined to be true failures of the HSR algorithm. Conclusion: The scope of genuine misalignment between the ADGs and HSR algorithm is very small. We provide evidence-informed recommendations for strengthening both policies to more effectively guide Australians towards healthier choices.

Measuring the Healthiness of the Packaged Food Supply in Australia.

Abstract: The increasing availability of packaged foods plays a key role in nutritional transition. This study examined the healthiness of the Australian packaged food supply using a range of different metrics; 40,664 packaged products from The George Institute's FoodSwitch database were included. Median and interquartile range (IQR) were determined for each measure of nutrient composition; mean and standard deviation (SD) for the measure based upon Health Star Rating (HSR); and proportions (%) for the measures based upon products with a higher HSR, classification of foods as either core or discretionary, extent of processing and proportions of foods that met reformulation targets for sodium, saturated fat and total sugars. Overall median (IQR) values were 1093 (1256) kJ/100 g for energy, 1.7 (6.3) g/100 g for saturated fat, 5.3 (21.4) g/100 g for total sugars, 163 (423) g/100 g for sodium and 50 (100) g or mL for serving size. Overall mean (SD) HSR was 2.8 (1.4), proportion with HSR < 3.5 was 61.8%, proportion of foods defined as discretionary was 53.0% and proportion of foods defined as highly processed was 60.5%. There were sodium targets set for 21,382/40,664 (53%) foods and achieved for 14,126/40,664 (35%). Corresponding figures for saturated fat were 328/40,664 (0.8%) and 130/40,664 (0.3%). Nutrient profiling, dietary guidelines and the extent of food processing provided comparable assessments of the nutritional quality of Australia's packaged food supply. Individual measures of nutrient composition did not, but may be of value for identifying specific foods of concern.

Resuming anticoagulants after anticoagulation-associated intracranial haemorrhage: systematic review and meta-analysis

Abstract: Objective To determine the adverse outcomes following resumption of anticoagulation in patients with anticoagulation-associated intracranial haemorrhage (ICH). Design We performed a systematic review and meta-analysis in this clinical population. The Preferred Reporting Items for Systemic Reviews and Meta-Analyses statement was followed, and two authors independently assessed eligibility of all retrieved studies and extracted data. Data sources Medline, Embase and the Cochrane Central Register of Controlled Trials, from inception to February 2017. Eligibility criteria and outcomes Randomised controlled trials or cohort studies that recruited adults who received oral anticoagulants at the time of ICH occurrence and survived after the acute phase or hospitalisation were searched. Primary outcomes, including long-term mortality, recurrent ICH and thromboembolic events. Secondary outcomes were the frequency of resuming anticoagulant therapy and related factors. Results We included 12 cohort studies (no clinical trials) involving 3431 ICH participants. The pooled frequency of resuming anticoagulant therapy was 38% (95% CI 32% to 44%), but this was higher in participants with prosthetic heart valves, subarachnoid haemorrhage or dyslipidaemia. There was no evidence that resuming anticoagulant therapy was associated with higher long-term mortality (pooled relative risk (RR) 0.60, 95% CI 0.30 to 1.19; p=0.14) or ICH recurrence (pooled RR 1.14, 95% CI 0.72 to 1.80; p=0.57). Resumption of anticoagulation was associated with significantly fewer thromboembolic events (pooled RR 0.31, 95% CI 0.23 to 0.42; p Conclusions Based on these observational studies, resuming anticoagulant therapy after anticoagulation-associated ICH has beneficial effects on long-term complications. Clinical trials are needed to substantiate these findings. PROSPERO registration number CRD42017063827.

Evaluation of Alignment between the Health Claims Nutrient Profiling Scoring Criterion (NPSC) and the Health Star Rating (HSR) Nutrient Profiling Models

Abstract: In Australia, manufacturers can use two government-endorsed approaches to advertise product healthiness: the Health Star Rating (HSR) front-of-pack nutrition labelling system, and health claims. Related, but different, algorithms determine the star rating of a product (the HSR algorithm) and eligibility to display claims (the Nutrient Profiling Scoring Criterion (NPSC) algorithm). The objective of this study was to examine the agreement between the HSR and NPSC algorithms. Food composition information for 41,297 packaged products was extracted from The George Institute’s FoodSwitch database. HSR and the NPSC scores were calculated, and the proportion of products in each HSR category that were eligible to display a health claim under the NPSC was examined. The highest agreement between the HSR scoring algorithm and the NPSC threshold to determine eligibility to display a health claim was at the HSR cut-off of 3.5 stars (k = 0.83). Overall, 97.3% (n = 40,167) of products with star ratings of 3.5 or higher were also eligible to display a health claim, and 94.3% (n = 38,939) of products with star ratings less than 3.5 were ineligible to display a health claim. The food group with greatest divergence was “edible oils”, with 45% products (n = 342) with HSR >3.5, but 64% (n = 495) eligible to display a claim. Categories with large absolute numbers of products with HSR <3.5, but eligible to display a claim, were “yoghurts and yoghurt drinks” (335 products, 25.4%) and “soft drinks” (299 products, 29.7%). Categories with a large number of products with HSR ≥3.5, but ineligible to display a claim, were “milk” (260 products, 21.2%) and “nuts and seeds” (173 products, 19.7%). We conclude that there is good agreement between the HSR and the NPSC systems overall, but divergence in some food groups is likely to result in confusion for consumers, particularly where foods with low HSRs are eligible to display a health claim. The alignment of the NPSC and HSR scoring algorithms should be improved.

Adiponectin, Free Fatty Acids, and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Acute Coronary Syndrome

Abstract: OBJECTIVE In observational cohorts, adiponectin is inversely associated and free fatty acids (FFAs) are directly associated with incident coronary heart disease (CHD). Adiponectin tends to be reduced and FFAs elevated in type 2 diabetes. We investigated relationships of adiponectin and FFA and major adverse cardiovascular events (MACEs) and death in patients with acute coronary syndrome (ACS) and type 2 diabetes using data from the AleCardio (Effect of Aleglitazar on Cardiovascular Outcomes After Acute Coronary Syndrome in Patients With Type 2 Diabetes Mellitus) trial, which compared the PPAR-α/γ agonist aleglitazar with placebo. RESEARCH DESIGN AND METHODS Using Cox regression adjusted for demographic, laboratory, and treatment variables, we determined associations of baseline adiponectin and FFAs, or the change in adiponectin and FFAs from baseline, with MACEs (cardiovascular death, myocardial infarction, or stroke) and death. RESULTS A twofold higher baseline adiponectin (n = 6,998) was directly associated with risk of MACEs (hazard ratio [HR] 1.17 [95% CI 1.08–1.27]) and death (HR 1.53 [95% CI 1.35–1.73]). A doubling of adiponectin from baseline to month 3 (n = 6,325) was also associated with risk of death (HR 1.20 [95% CI 1.03–1.41]). Baseline FFAs (n = 7,038), but not change in FFAs from baseline (n = 6,365), were directly associated with greater risk of MACEs and death. There were no interactions with study treatment. CONCLUSIONS In contrast to prior observational data for incident CHD, adiponectin is prospectively associated with MACEs and death in patients with type 2 diabetes and ACS, and an increase in adiponectin from baseline is directly related to death. These findings raise the possibility that adiponectin has different effects in patients with type 2 diabetes and ACS than in populations without prevalent cardiovascular disease. Consistent with prior data, FFAs are directly associated with adverse outcomes.

Spot urine samples compared with 24-h urine samples for estimating changes in urinary sodium and potassium excretion in the China Salt Substitute and Stroke Study.

Abstract: Background The capacity of spot urine samples for detecting changes in population sodium and potassium excretion is unclear. Methods Changes in urinary sodium and potassium excretion, over a 6-month to 2-year interval, were measured from 24-h urine samples and estimated from spot urine samples using several published methods in 3270 Chinese. Additional estimates were made by multiplying individual spot sodium and potassium concentrations by a single estimated 24-h urine volume derived from external data. Results The measured difference in 24-h urinary excretion between intervention and control groups was -0.35 g (95% CI: -0.68 to -0.02; P = 0.039) for sodium and 0.66 g (95% CI: 0.52 to 0.80; P 0.10). The estimates were -0.65 g for sodium and 1.11 g for potassium using individual spot urine concentrations and an externally derived standard urine volume (both P < 0.01). Conclusions The published equations were unable to detect the differences in sodium excretion measured by 24-h urine samples. A method based upon spot urine electrolyte concentrations and a standard urine volume may offer an alternative approach to measuring differences in sodium and potassium excretion between population groups without requiring 24-h urine, but will need further investigation.

Effects of a nationwide strategy to reduce salt intake in Samoa

Abstract: Objective:Salt reduction is one of the most cost-effective interventions for the prevention of noncommunicable diseases, but there are no studies evaluating the effectiveness of national strategies in low or lower middle income countries. This study aimed to examine the effect of an 18-month nation-

Stakeholders' perceptions regarding a salt reduction strategy for India: Findings from qualitative research.

Abstract: BACKGROUND:Scientific evidence indicates that high dietary salt intake has detrimental effects on blood pressure and associated cardiovascular disease (CVD). However, limited information is available on how to implement salt reduction in low and middle-income countries (LMICs) such as India, where the burden of hypertension and CVD is increasing rapidly. As part of a large study to create the evidence base required to develop a salt reduction strategy for India, we assessed the perspectives of various stakeholders regarding developing an India specific salt reduction strategy. METHODS:A qualitative research design was deployed to elicit various stakeholder's (government and policy-related stakeholders, industry, civil Society, consumers) perspectives on a salt reduction strategy for India, using in-depth interviews (IDIs) and focus group discussions (FGDs). We used an inductive approach for data analysis. Data were analyzed using thematic content analysis method. RESULTS:Forty-two IDIs and eight FGDs were conducted with various stakeholders of interest and relevance. Analysis indicated three major themes: 1. Barriers for salt reduction 2. Facilitators for salt reduction; 3. Strategies for salt reduction. Most of the stakeholders were in alignment with the need for a salt reduction programme in India to prevent and control hypertension and related CVD. Major barriers indicated by the stakeholders for salt reduction in India were social and cultural beliefs, a large unorganized food retail sector, and the lack of proper implementation of even existing food policies. Stakeholders from the food industry reported that there might be decreased sales due to salt reduction. Major facilitators included the fact that: salt reduction is currently a part of the National Multi-Sectoral Action Plan for the prevention and control of NCDs, salt reduction and salt iodine programme are compatible, and that few of the multinational food companies have already started working in the direction of initiating efforts for salt reduction. Based on the barriers and facilitators, few of the recommendations are to generate awareness among consumers, promote salt reduction by processed food industry, and implement consumer friendly food labelling. CONCLUSIONS:In this study of multiple key influential stakeholders in India, most of the stakeholders were in alignment with the need for a salt reduction programme in India to prevent and control hypertension and related CVD. The development and adoption of the National Multi-sectoral Action Plan to reduce premature non-communicable diseases (NCDs) in India, provides a potential platform that can be leveraged to drive, implement and monitor salt reduction efforts.

Can front-of-pack labels influence portion size judgements for unhealthy foods?

Abstract: OBJECTIVE: By clearly conveying the healthiness of a food, front-of-pack (FOP) labels have the potential to influence the portion size considered appropriate for consumption. The present study examined the how the Daily Intake Guide (DIG), Multiple Traffic Lights (MTL) and Health Star Rating (HSR) FOP labels affect judgements of appropriate portion sizes of unhealthy foods compared with when no FOP label is present. DESIGN: Respondents viewed mock packages of unhealthy variations of pizzas, cookies, yoghurts and cornflakes featuring the DIG, MTL, HSR or no FOP label, and indicated the portion size they believed should be eaten of each food on a single occasion. SETTING: The survey was completed on the respondent's personal computer. SUBJECTS: A total of 1505 Australian adults provided 4166 ratings across 192 mock packages relating to four product categories: pizza, yoghurt, cornflakes and cookies. RESULTS: Compared with no FOP label, the HSR resulted in a small but significant reduction in the portion size selected as appropriate for consumption of pizzas and cornflakes (P<0·05). The MTL resulted in smaller portions of cornflakes being selected compared with no FOP label (P<0·05). CONCLUSIONS: Respondents perceived smaller portion sizes as appropriate for some, but not all, of the foods tested when FOP labels with more interpretative formats (HSR, MTL) appeared on-pack compared with no FOP label. No effect was found for the less interpretive FOP label (the DIG). Interpretive FOP labels may have the potential to influence portion size judgements, albeit at modest levels.

Five year trends in the serve size, energy, and sodium contents of New Zealand fast foods: 2012 to 2016

Abstract: The nutritional composition of foods and beverages consumed away from the home has important implications for population health. Our objective was to determine if the serve size, energy, and sodium contents of fast foods sold at chain restaurants in New Zealand (NZ) changed between 2012 and 2016. Serve size and nutrient data were collected in annual cross-sectional surveys of all products sold at 10 major fast food chains. Changes over time may occur due to alterations in product availability or individual product reformulation. Linear regression adjusting for food group and chain was used to estimate overall changes in serve size and nutrients. Random effects mixed models were used to estimate reformulation changes on same products available for two or more years. Across all products (n = 5468) increases were observed in mean serve size (+ 9 (3, 15) g, + 5%), energy density (+ 54 (27, 81) kJ/100 g, + 6%), energy per serve (+ 178 (125, 231) kJ, + 14%), and sodium per serve (+ 55 (24, 87) mg, + 12%). Sodium density did not change significantly. Four of 12 food groups (Desserts, Pizza, Sandwiches, and Salads) and four of 10 fast food chains (Domino’s, Hell Pizza, Pizza Hut, and Subway) displayed large, undesirable changes for three or more (of five) outcomes (≥10%; p < 0.05). One food group (Asian) and one chain (St Pierre’s) displayed large, desirable changes for two or more outcomes. The only significant reformulation change was a drop in sodium density (− 22 (− 36, − 8) mg/100 g, − 7%). The serve size and energy density of NZ fast food products has increased significantly over the past 5 years. Lower sodium concentration in new and reformulated products has been offset by overall increases in serve size. Continued monitoring and development and implementation of Government-led targets for serve size and nutrient content of new and existing fast food products are required.

Homeostasis model assessment of insulin resistance and survival in patients with diabetes and acute coronary syndrome

Abstract: Objective Insulin resistance has been linked to development and progression of atherosclerosis and is present in most patients with type 2 diabetes. Whether the degree of insulin resistance predicts adverse outcomes in patients with type 2 diabetes and acute coronary syndrome (ACS) is uncertain. Design The Effect of Aleglitazar on Cardiovascular Outcomes after Acute Coronary Syndrome in Patients with Type 2 Diabetes Mellitus trial compared the peroxisome proliferator-activated receptor-α/γ agonist aleglitazar with placebo in patients with type 2 diabetes and recent ACS. In participants not treated with insulin, we determined whether baseline homeostasis model assessment of insulin resistance (HOMA-IR; n = 4303) or the change in HOMA-IR on assigned study treatment (n = 3568) was related to the risk of death or major adverse cardiovascular events (cardiovascular death, myocardial infarction, and stroke) in unadjusted and adjusted models. Because an inverse association of HOMA-IR with N-terminal pro-B-type natriuretic peptide (NT-proBNP) has been described, we specifically examined effects of adjustment for the latter. Results In unadjusted analysis, twofold higher baseline HOMA-IR was associated with lower risk of death [hazard ratio (HR): 0.79, 95% CI: 0.68 to 0.91, P = 0.002]. Adjustment for 24 standard demographic and clinical variables had minimal effect on this association. However, after further adjustment for NT-proBNP, the association of HOMA-IR with death was no longer present (adjusted HR: 0.99, 95% CI: 0.83 to 1.19, P = 0.94). Baseline HOMA-IR was not associated with major adverse cardiovascular events, nor was the change in HOMA-IR on study treatment associated with death or major adverse cardiovascular events. Conclusions After accounting for levels of NT-proBNP, insulin resistance assessed by HOMA-IR is not related to the risk of death or major adverse cardiovascular events in patients with type 2 diabetes and ACS.

Sodium and potassium content of 24 h urinary collections: a comparison between field- and laboratory-based analysers.

Abstract: Objective Measurement of mean population Na and K intakes typically uses laboratory-based assays, which can add significant logistical burden and costs. A valid field-based measurement method would be a significant advance. In the current study, we used 24 h urine samples to compare estimates of Na, K and Na:K ratio based upon assays done using the field-based Horiba twin meter v. laboratory-based methods. Design The performance of the Horiba twin meter was determined by comparing field-based estimates of mean Na and K against those obtained using laboratory-based methods. The reported 95 % limits of agreement of Bland-Altman plots were calculated based on a regression approach for non-uniform differences. Setting The 24 h urine samples were collected as part of an ongoing study being done in rural China. Subjects One hundred and sixty-six complete 24 h urine samples were qualified for estimating 24 h urinary Na and K excretion. Results Mean Na and K excretion were estimated as 170·4 and 37·4 mmol/d, respectively, using the meter-based assays; and 193·4 and 43·8 mmol/d, respectively, using the laboratory-based assays. There was excellent relative reliability (intraclass correlation coefficient) for both Na (0·986) and K (0·986). Bland-Altman plots showed moderate-to-good agreement between the two methods. Conclusions Na and K intake estimations were moderately underestimated using assays based upon the Horiba twin meter. Compared with standard laboratory-based methods, the portable device was more practical and convenient.