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Showing papers by "Bruce Neal published in 2017"


Journal ArticleDOI
TL;DR: Patients treated with canagliflozin had a lower risk of cardiovascular events than those who received placebo but a greater risk of amputation, primarily at the level of the toe or metatarsal.
Abstract: BackgroundCanagliflozin is a sodium–glucose cotransporter 2 inhibitor that reduces glycemia as well as blood pressure, body weight, and albuminuria in people with diabetes. We report the effects of treatment with canagliflozin on cardiovascular, renal, and safety outcomes. MethodsThe CANVAS Program integrated data from two trials involving a total of 10,142 participants with type 2 diabetes and high cardiovascular risk. Participants in each trial were randomly assigned to receive canagliflozin or placebo and were followed for a mean of 188.2 weeks. The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. ResultsThe mean age of the participants was 63.3 years, 35.8% were women, the mean duration of diabetes was 13.5 years, and 65.6% had a history of cardiovascular disease. The rate of the primary outcome was lower with canagliflozin than with placebo (occurring in 26.9 vs. 31.5 participants per 1000 patient-years; hazard ratio, 0.86; 95% c...

4,842 citations


Journal ArticleDOI
TL;DR: The GBD (Global Burden of Disease) 2015 study integrated data on disease incidence, prevalence, and mortality to produce consistent, up-to-date estimates for cardiovascular burden, finding that CVDs remain a major cause of health loss for all regions of the world.

2,525 citations


Journal ArticleDOI
Mohammad H. Forouzanfar1, Patrick Liu1, Gregory A. Roth1, Marie Ng1, Stan Biryukov1, Laurie B. Marczak1, Lily Alexander1, Kara Estep1, Kalkidan Hassen Abate2, Tomi Akinyemiju3, Raghib Ali4, Nelson Alvis-Guzman5, Peter Azzopardi, Amitava Banerjee6, Till Bärnighausen7, Till Bärnighausen8, Arindam Basu9, Tolesa Bekele10, Derrick A Bennett4, Sibhatu Biadgilign, Ferrán Catalá-López11, Ferrán Catalá-López12, Valery L. Feigin13, João C. Fernandes14, Florian Fischer15, Alemseged Aregay Gebru16, Philimon Gona17, Rajeev Gupta, Graeme J. Hankey18, Graeme J. Hankey19, Jost B. Jonas20, Suzanne E. Judd3, Young-Ho Khang21, Ardeshir Khosravi, Yun Jin Kim22, Ruth W Kimokoti23, Yoshihiro Kokubo, Dhaval Kolte24, Alan D. Lopez25, Paulo A. Lotufo26, Reza Malekzadeh, Yohannes Adama Melaku27, Yohannes Adama Melaku16, George A. Mensah28, Awoke Misganaw1, Ali H. Mokdad1, Andrew E. Moran29, Haseeb Nawaz30, Bruce Neal, Frida Namnyak Ngalesoni31, Takayoshi Ohkubo32, Farshad Pourmalek33, Anwar Rafay, Rajesh Kumar Rai, David Rojas-Rueda, Uchechukwu K.A. Sampson28, Itamar S. Santos26, Monika Sawhney34, Aletta E. Schutte35, Sadaf G. Sepanlou, Girma Temam Shifa36, Girma Temam Shifa37, Ivy Shiue38, Ivy Shiue39, Bemnet Amare Tedla40, Amanda G. Thrift41, Marcello Tonelli42, Thomas Truelsen43, Nikolaos Tsilimparis, Kingsley N. Ukwaja, Olalekan A. Uthman44, Tommi Vasankari, Narayanaswamy Venketasubramanian, Vasiliy Victorovich Vlassov45, Theo Vos1, Ronny Westerman, Lijing L. Yan46, Yuichiro Yano47, Naohiro Yonemoto, Maysaa El Sayed Zaki, Christopher J L Murray1 
10 Jan 2017-JAMA
TL;DR: In international surveys, although there is uncertainty in some estimates, the rate of elevatedSBP (≥110-115 and ≥140 mm Hg) increased substantially between 1990 and 2015, and DALYs and deaths associated with elevated SBP also increased.
Abstract: Importance Elevated systolic blood (SBP) pressure is a leading global health risk. Quantifying the levels of SBP is important to guide prevention policies and interventions. Objective To estimate the association between SBP of at least 110 to 115 mm Hg and SBP of 140 mm Hg or higher and the burden of different causes of death and disability by age and sex for 195 countries and territories, 1990-2015. Design A comparative risk assessment of health loss related to SBP. Estimated distribution of SBP was based on 844 studies from 154 countries (published 1980-2015) of 8.69 million participants. Spatiotemporal Gaussian process regression was used to generate estimates of mean SBP and adjusted variance for each age, sex, country, and year. Diseases with sufficient evidence for a causal relationship with high SBP (eg, ischemic heart disease, ischemic stroke, and hemorrhagic stroke) were included in the primary analysis. Main Outcomes and Measures Mean SBP level, cause-specific deaths, and health burden related to SBP (≥110-115 mm Hg and also ≥140 mm Hg) by age, sex, country, and year. Results Between 1990-2015, the rate of SBP of at least 110 to 115 mm Hg increased from 73 119 (95% uncertainty interval [UI], 67 949-78 241) to 81 373 (95% UI, 76 814-85 770) per 100 000, and SBP of 140 mm Hg or higher increased from 17 307 (95% UI, 17 117-17 492) to 20 526 (95% UI, 20 283-20 746) per 100 000. The estimated annual death rate per 100 000 associated with SBP of at least 110 to 115 mm Hg increased from 135.6 (95% UI, 122.4-148.1) to 145.2 (95% UI 130.3-159.9) and the rate for SBP of 140 mm Hg or higher increased from 97.9 (95% UI, 87.5-108.1) to 106.3 (95% UI, 94.6-118.1). Loss of disability-adjusted life-years (DALYs) associated with SBP of at least 110 to 115 mm Hg increased from 148 million (95% UI, 134-162 million) to 211 million (95% UI, 193-231 million), and for SBP of 140 mm Hg or higher, the loss increased from 95.9 million (95% UI, 87.0-104.9 million) to 143.0 million (95% UI, 130.2-157.0 million). The largest numbers of SBP-related deaths were caused by ischemic heart disease (4.9 million [95% UI, 4.0-5.7 million]; 54.5%), hemorrhagic stroke (2.0 million [95% UI, 1.6-2.3 million]; 58.3%), and ischemic stroke (1.5 million [95% UI, 1.2-1.8 million]; 50.0%). In 2015, China, India, Russia, Indonesia, and the United States accounted for more than half of the global DALYs related to SBP of at least 110 to 115 mm Hg. Conclusions and Relevance In international surveys, although there is uncertainty in some estimates, the rate of elevated SBP (≥110-115 and ≥140 mm Hg) increased substantially between 1990 and 2015, and DALYs and deaths associated with elevated SBP also increased. Projections based on this sample suggest that in 2015, an estimated 3.5 billion adults had SBP of at least 110 to 115 mm Hg and 874 million adults had SBP of 140 mm Hg or higher.

1,494 citations


Journal ArticleDOI
TL;DR: Canagliflozin reduced cardiovascular and renal outcomes with no statistical evidence of heterogeneity of the treatment effect across the primary and secondary prevention groups.
Abstract: BACKGROUND : Canagliflozin is a sodium glucose cotransporter 2 inhibitor that significantly reduces the composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke in patients with type 2 diabetes mellitus and elevated cardiovascular risk. The comparative effects among participants with and without a history of cardiovascular disease (secondary versus primary prevention) were prespecified for evaluation. METHODS : The CANVAS Program (Canagliflozin Cardiovascular Assessment Study) randomly assigned 10 142 participants with type 2 diabetes mellitus to canagliflozin or placebo. The primary prevention cohort comprised individuals ≥50 years of age with ≥2 risk factors for cardiovascular events but with no prior cardiovascular event, and the secondary prevention cohort comprised individuals ≥30 years of age with a prior cardiovascular event. The primary end point was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Secondary outcomes included heart failure hospitalization and a renal composite (40% reduction in estimated glomerular filtration rate, renal replacement therapy, or renal death). RESULTS : Primary prevention participants (N=3486; 34%) were younger (63 versus 64 years of age), were more often female (45% versus 31%), and had a longer duration of diabetes mellitus (14 versus 13 years) compared with secondary prevention participants (N=6656; 66%). The primary end point event rate was higher in the secondary prevention group compared with the primary prevention group (36.9 versus 15.7/1000 patient-years, P P P =0.02 for superiority) with no statistical evidence of heterogeneity (interaction P value=0.18) between the primary (HR, 0.98; 95% CI, 0.74-1.30) and secondary prevention (HR, 0.82; 95% CI, 0.72-0.95) cohorts. Renal outcomes (HR, 0.59; 95% CI, 0.44-0.79 versus HR, 0.63; 95% CI, 0.39-1.02; interaction P value=0.73) and heart failure hospitalization (HR, 0.68; 95% CI, 0.51-0.90 versus HR, 0.64; 95% CI, 0.35-1.15; interaction P value=0.91) were similarly reduced in the secondary and primary prevention cohorts, respectively. Lower extremity amputations were similarly increased in the secondary and primary prevention cohorts (HR, 2.07; 95% CI, 1.43-3.00 versus HR, 1.52; 95% CI, 0.70-3.29; interaction P value=0.63). CONCLUSIONS : Patients with type 2 diabetes mellitus and prior cardiovascular events had higher rates of cardiovascular outcomes compared with the primary prevention patients. Canagliflozin reduced cardiovascular and renal outcomes with no statistical evidence of heterogeneity of the treatment effect across the primary and secondary prevention groups. Additional studies will provide further insights into the effects of canagliflozin in these patient populations. CLINICAL TRIAL REGISTRATION : URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01032629 and NCT01989754.

345 citations


Journal ArticleDOI
11 Jul 2017-JAMA
TL;DR: The use of PAP, compared with no treatment or sham, was not associated with reduced risks of cardiovascular outcomes or death for patients with sleep apnea, and these findings do not support treatment with PAP with a goal of prevention of these outcomes.
Abstract: Importance Sleep apnea (obstructive and central) is associated with adverse cardiovascular risk factors and increased risks of cardiovascular disease. Positive airway pressure (PAP) provides symptomatic relief, whether delivered continuously (CPAP) or as adaptive servo-ventilation (ASV), but the associations with cardiovascular outcomes and death are unclear. Objective To assess the association of PAP vs control with cardiovascular events and death in patients with sleep apnea. Data Sources and Study Selection MEDLINE, EMBASE, and the Cochrane Library were systematically searched from inception date to March 2017 for randomized clinical trials that included reporting of major adverse cardiovascular events or deaths. Data Extraction and Synthesis Two authors independently extracted data using standardized forms. Summary relative risks (RRs), risk differences (RDs) and 95% CIs were obtained using random-effects meta-analysis. Main Outcomes and Measures The main outcomes were a composite of acute coronary syndrome (ACS) events, stroke, or vascular death (major adverse cardiovascular events); cause-specific vascular events; and death. Results The analyses included data from 10 trials (9 CPAP; 1 ASV) of patients with sleep apnea (N = 7266; mean age, 60.9 [range, 51.5 to 71.1] years; 5847 [80.5%] men; mean [SD] body mass index, 30.0 [5.2]. Among 356 major adverse cardiovascular events and 613 deaths recorded, there was no significant association of PAP with major adverse cardiovascular events (RR, 0.77 [95% CI, 0.53 to 1.13]; P = .19 and RD, −0.01 [95% CI, −0.03 to 0.01]; P = .23), cardiovascular death (RR, 1.15 [95% CI, 0.88 to 1.50]; P = .30 and RD −0.00 [95% CI, −0.02 to 0.02]; P = .87), or all-cause death (RR, 1.13 [95% CI, 0.99 to 1.29]; P = .08 and RD, 0.00 [95% CI, −0.01 to 0.01]; P = .51). The same was true for ACS, stroke, and heart failure. There was no evidence of different associations for CPAP vs ASV (all P value homogeneity >.24), and meta-regressions identified no associations of PAP with outcomes for different levels of apnea severity, follow-up duration, or adherence to PAP (all P values > .13). Conclusions and Relevance The use of PAP, compared with no treatment or sham, was not associated with reduced risks of cardiovascular outcomes or death for patients with sleep apnea. Although there are other benefits of treatment with PAP for sleep apnea, these findings do not support treatment with PAP with a goal of prevention of these outcomes.

280 citations


Journal ArticleDOI
TL;DR: The CREDENCE trial aims to compare the efficacy and safety of canagliflozin versus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with type 2 diabetes and established kidney disease.
Abstract: Background: People with diabetes and kidney disease have a high risk of cardiovascular events and progression of kidney disease. Sodium glucose co-transporter 2 inhibitors lower plasma glucose by reducing the uptake of filtered glucose in the kidney tubule, leading to increased urinary glucose excretion. They have been repeatedly shown to induce modest natriuresis and reduce HbA1c, blood pressure, weight, and albuminuria in patients with type 2 diabetes. However, the effects of these agents on kidney and cardiovascular events have not been extensively studied in patients with type 2 diabetes and established kidney disease. Methods: The Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial aims to compare the efficacy and safety of canagliflozin versus placebo at preventing clinically important kidney and cardiovascular outcomes in patients with diabetes and established kidney disease. CREDENCE is a randomized, double-blind, event-driven, placebo-controlled trial set in in 34 countries with a projected duration of similar to 5.5 years and enrolling 4,401 adults with type 2 diabetes, estimated glomerular filtration rate g= 30 to l90 mL/min/1.73 m(2), and albuminuria (urinary albumin: creatinine ratio g 300 to l= 5,000 mg/g). The study has 90% power to detect a 20% reduction in the risk of the primary outcome (alpha = 0.05), the composite of end-stage kidney disease, doubling of serum creatinine, and renal or cardiovascular death. Conclusion: CREDENCE will provide definitive evidence about the effects of canagliflozin on renal (and cardiovascular) outcomes in patients with type 2 diabetes and established kidney disease. (c) 2017 S. Karger AG, Basel

180 citations


Journal ArticleDOI
TL;DR: The CANGliflozin cardioVascular Assessment Study-Renal (CANVAS-R) as mentioned in this paper is a prospective, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes with a history or high risk of cardiovascular events.
Abstract: Aims The primary aim of the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R) is to determine whether the favourable effects of inhibition of the sodium glucose co-transporter 2 (SGLT2) on blood glucose, blood pressure and body weight are accompanied by protection against adverse renal outcomes. Materials and methods CANVAS-R is a prospective, randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes with a history or high risk of cardiovascular events. Patients were randomly assigned to once-daily placebo or canagliflozin 100 mg (with optional uptitration to 300 mg) for a planned average of 2.5 years of follow-up. The primary outcome is kidney disease progression, defined by class change in albuminuria. The two secondary outcomes are the composite of hospitalized heart failure or cardiovascular death, and cardiovascular death alone. Effects on end-stage renal disease and a range of other outcomes will also be explored. Results A total of 5812 participants were recruited at 422 sites in 24 countries between January 2014 and May 2015. The mean baseline age was 64 years, mean duration of diabetes was 14 years, mean glycated haemoglobin level was 8.3% and mean body mass index was 32 kg/m2. Of these participants, 37% were women, 71% had a history of cardiovascular disease, 22.3% had microalbuminuria and 8.7% had macroalbuminuria. The mean baseline estimated glomerular filtration rate was 76 mL/min/1.73 m2. The study will have at least 90% power ( P = .05) to detect a 22% or greater reduction in the risk of progression of albuminuria. Conclusions The trial should define the potential renoprotective effect of canagliflozin and will provide additional important new data about its effects on vascular outcomes, death and kidney failure.

116 citations


Journal ArticleDOI
TL;DR: Two large cardiovascular outcome trials of canagliflozin, comprising the CANVAS Program, will complete in early 2017, and accrued data for the sodium glucose co‐transporter 2 (SGLT2) inhibitors has identified questions and opportunities that were not apparent when the trials were designed.
Abstract: Two large cardiovascular outcome trials of canagliflozin, comprising the CANVAS Program, will complete in early 2017: the CANagliflozin cardioVascular Assessment Study (CANVAS) and the CANagliflozin cardioVascular Assessment Study-Renal (CANVAS-R). Accruing data for the sodium glucose co-transporter 2 (SGLT2) inhibitor class has identified questions and opportunities that were not apparent when the trials were designed. Accordingly, a series of modifications have been made to the planned analyses. These updates will ensure that the data from the CANVAS Program will maximize advances in scientific knowledge and patient care. The specification of the analysis strategy prior to knowledge of the trial results, their design by the independent scientific trial Steering Committee, the detailed a priori definition of the analysis plans, and the external review provided by the US Food and Drug Administration all provide maximally efficient and robust utilization of the data. The CANVAS Program should significantly advance our understanding of the effects of canagliflozin, and the broader SGLT2 inhibitor class, on a range of important efficacy and safety outcomes.

88 citations


Journal ArticleDOI
TL;DR: At the relatively low level of use observed in this trial, interpretive nutrition labels had no significant effect on food purchases, however, shoppers who used interpretive labels found them to be significantly more useful and easy to understand, and compared with frequent NIP users, frequent TLL and HSR users had significantly healthier food purchases.

88 citations



Journal ArticleDOI
TL;DR: These real-world data align with experimental findings and provide support for the policy choice of HSR, and recommendation/warning labels warrant further exploration, as they may be a stronger driver of healthy food purchases.
Abstract: Background: Front-of-pack nutrition labelling may support healthier packaged food purchases. Australia has adopted a novel Health Star Rating (HSR) system, but the legitimacy of this choice is unknown. Objective: To define the effects of different formats of front-of-pack labelling on the healthiness of food purchases and consumer perceptions. Design: Individuals were assigned at random to access one of four different formats of nutrition labelling—HSR, multiple traffic light labels (MTL), daily intake guides (DIG), recommendations/warnings (WARN)—or control (the nutrition information panel, NIP). Participants accessed nutrition information by using a smartphone application to scan the bar-codes of packaged foods, while shopping. The primary outcome was healthiness defined by the mean transformed nutrient profile score of packaged foods that were purchased over four weeks. Results: The 1578 participants, mean age 38 years, 84% female recorded purchases of 148,727 evaluable food items. The mean healthiness of the purchases in the HSR group was non-inferior to MTL, DIG, or WARN (all p 0.07), but WARN resulted in healthier packaged food purchases (mean difference 0.87; 95% confidence interval 0.03 to 1.72; p = 0.04). HSR was perceived by participants as more useful than DIG, and easier to understand than MTL or DIG (all p < 0.05). Participants also reported the HSR to be easier to understand, and the HSR and MTL to be more useful, than NIP (all p < 0.03). Conclusions: These real-world data align with experimental findings and provide support for the policy choice of HSR. Recommendation/warning labels warrant further exploration, as they may be a stronger driver of healthy food purchases.

Journal ArticleDOI
TL;DR: Front-of-pack labels that are more interpretive, such as the Health Star Rating, can be more effective at directing consumers towards healthier choices than reductive front-of thepack labels such asThe Daily Intake Guide.
Abstract: This study examined how front-of-pack labels and product healthfulness affect choice and willingness to pay across a range of foods. It was hypothesized that: (i) product choice and (ii) willingness to pay would be more aligned with product healthfulness when healthfulness was expressed through the Health Star Rating, followed by the Multiple Traffic Light, then the Daily Intake Guide, and (iii) the Nutrition Facts Panel would be viewed infrequently. Adults and children aged 10+ years (n = 2069) completed an online discrete choice task involving mock food packages. A 4 food type (cookies, corn flakes, pizza, yoghurt) × 2 front-of-pack label presence (present, absent) × 3 front-of-pack label type (Daily Intake Guide, Multiple Traffic Light, Health Star Rating) × 3 price (cheap, moderate, expensive) × 3 healthfulness (less healthy, moderately healthy, healthier) design was used. A 30 s time limit was imposed for each choice. Of the three front-of-pack labels tested, the Health Star Rating produced the largest differences in choices, with 40% (95% CIs: 38%-42%) of respondents selecting the healthier variant, 33% selecting the moderately healthy variant (95% CIs: 31%-35%), and 23% (95% CIs: 21%-24%) selecting the less healthy variant of the four products included in the study. The Multiple Traffic Light led to significant differences in choices between healthier (35%, 95% CIs: 33%-37%) and less healthy products (29%, 95% CIs: 27%-31%), but not moderately healthy products (32%, 95% CIs: 30%-34%). No significant differences in choices were observed by product healthfulness when the Daily Intake Guide was present. Only the Health Star Rating resulted in a significantly greater willingness to pay for healthier versus less healthy products. The Nutrition Facts Panel was viewed for only 7% of all mock packages. Front-of-pack labels that are more interpretive, such as the Health Star Rating, can be more effective at directing consumers towards healthier choices than reductive front-of-pack labels such as the Daily Intake Guide. The study results provide policy makers with clear guidance on the types of front-of-pack labels that are most likely to achieve positive health outcomes at a population level.


Journal ArticleDOI
29 Mar 2017-PLOS ONE
TL;DR: There is a need for the effectiveness of new interventions to be evaluated in the field using strong study designs and parallel economic evaluations, as relatively few economic evaluations of population salt reduction interventions are identified.
Abstract: Objective To summarise evidence describing the cost-effectiveness of population-based interventions targeting sodium reduction. Methods A systematic search of published and grey literature databases and websites was conducted using specified key words. Characteristics of identified economic evaluations were recorded, and included studies were appraised for reporting quality using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results Twenty studies met the study inclusion criteria and received a full paper review. Fourteen studies were identified as full economic evaluations in that they included both costs and benefits associated with an intervention measured against a comparator. Most studies were modelling exercises based on scenarios for achieving salt reduction and assumed effects on health outcomes. All 14 studies concluded that their specified intervention(s) targeting reductions in population sodium consumption were cost-effective, and in the majority of cases, were cost saving. Just over half the studies (8/14) were assessed as being of ‘excellent’ reporting quality, five studies fell into the ‘very good’ quality category and one into the ‘good’ category. All of the identified evaluations were based on modelling, whereby inputs for all the key parameters including the effect size were either drawn from published datasets, existing literature or based on expert advice. Conclusion Despite a clear increase in evaluations of salt reduction programs in recent years, this review identified relatively few economic evaluations of population salt reduction interventions. None of the studies were based on actual implementation of intervention(s) and the associated collection of new empirical data. The studies universally showed that population-based salt reduction strategies are likely to be cost effective or cost saving. However, given the reliance on modelling, there is a need for the effectiveness of new interventions to be evaluated in the field using strong study designs and parallel economic evaluations.

Journal ArticleDOI
TL;DR: The SaltSwitch smartphone app is effective in supporting people with cardiovascular disease to make lower salt food purchases and a larger trial with longer follow-up is warranted to determine the effects on blood pressure.
Abstract: BackgroundSaltSwitch is an innovative smartphone application (app) that enables shoppers to scan the barcode of a packaged food and receive an immediate, interpretive, traffic light nutrition label...

Journal ArticleDOI
TL;DR: Front-of-pack labels show greater promise in reducing bias created by health claims, and the NFP can reduce bias, but only if consumers view it and interpret it correctly, which often does not occur.
Abstract: The presence of health claims on food packaging can positively bias consumers' evaluations of foods. This review examined whether cognitive biases endure when other sources of nutrition information [the nutrition facts panel (NFP) and front-of-pack labels] appear on-pack with health claims. The following databases were searched: Web of Science, Ovid, Google Scholar, ScienceDirect, Scopus, ProQuest, and Wiley Online Library. The search terms ("health claim*" OR "nutri* claim") AND ("food label*" OR "front of pack") were used to identify studies. Twenty-four studies that examined health claims and front-of-pack labels or the NFP were included. The NFP can reduce bias, but only if consumers view it and interpret it correctly, which often does not occur. Front-of-pack labels show greater promise in reducing bias created by health claims. These findings are relevant to policymakers who are considering the effectiveness of mandating an NFP and/or a front-of-pack label alongside health claims.

Journal ArticleDOI
TL;DR: Sodium levels in two-thirds of foods covered by the South African sodium legislation were at or below the permitted upper levels at the mandatory implementation date of the legislation and many more were close to the limit.
Abstract: Background: In June 2016, the Republic of South Africa introduced legislation for mandatory limits for the upper sodium content permitted in a wide range of processed foods. We assessed the sodium levels of packaged foods in South Africa during the one-year period leading up to the mandatory implementation date of the legislation. Methods: Data on the nutritional composition of packaged foods was obtained from nutrition information panels on food labels through both in-store surveys and crowdsourcing by users of the HealthyFood Switch mobile phone app between June 2015 and August 2016. Summary sodium levels were calculated for 15 food categories, including the 13 categories covered by the sodium legislation. The percentage of foods that met the government’s 2016 sodium limits was also calculated. Results: 11,065 processed food items were included in the analyses; 1851 of these were subject to the sodium legislation. Overall, 67% of targeted foods had a sodium level at or below the legislated limit. Categories with the lowest percentage of foods that met legislated limits were bread (27%), potato crisps (41%), salt and vinegar flavoured snacks (42%), and raw processed sausages (45%). About half (49%) of targeted foods not meeting the legislated limits were less than 25% above the maximum sodium level. Conclusion: Sodium levels in two-thirds of foods covered by the South African sodium legislation were at or below the permitted upper levels at the mandatory implementation date of the legislation and many more were close to the limit. The South African food industry has an excellent opportunity to rapidly meet the legislated requirements.

Journal ArticleDOI
TL;DR: The available data leave some uncertainty about exact mean salt consumption in India but there is little doubt that population salt consumption far exceeds the WHO-recommended maximum of 5 g per person per day.
Abstract: Background: Member states of the WHO, including India, have adopted a target 30% reduction in mean population salt consumption by 2025 to prevent noncommunicable diseases. Our aim was to support this initiative by summarizing existing data that describe mean salt consumption in India. Method: Electronic databases – MEDLINE via Ovid, EMBASE, CINAHL and the Cochrane Database of Systematic Reviews – were searched up to November 2015 for studies that reported mean or median dietary salt intake in Indian adults aged 19 years and older. Random effects meta-analysis was used to obtain summary estimates of salt intake. Results: Of 1201 abstracts identified, 90 were reviewed in full text and 21 were included: 18 cross-sectional surveys (n = 225 024), two randomized trials (n = 255) and one case–control study (n = 270). Data were collected between 1986 and 2014, and reported mean salt consumption levels were between 5.22 and 42.30 g/day. With an extreme outlier excluded, overall mean weighted salt intake was 10.98 g/day (95% confidence interval 8.57–13.40). There was significant heterogeneity between the estimates for contributing studies (I2 = 99.97%) (P homogeneity ≤0.001), which was likely attributable to the different measurement methods used and the different populations studied. There was no evidence of a change in intake over time (P trend = 0.08). Conclusion: The available data leave some uncertainty about exact mean salt consumption in India but there is little doubt that population salt consumption far exceeds the WHO-recommended maximum of 5 g per person per day.

Journal ArticleDOI
TL;DR: In this article, low-dose combinations hold promise in this regard, but there are few data on verifiable verifiable efficacy and minimal side effects of lowdose combinations in blood pressure management.
Abstract: There is a critical need for blood pressure–lowering strategies that have greater efficacy and minimal side effects. Low-dose combinations hold promise in this regard, but there are few data on ver...

Journal ArticleDOI
TL;DR: Salt consumption in India is high, with mean population intake well above the World Health Organization recommended maximum of 5 g/day, and a national salt reduction program would likely avert much premature death and disability.
Abstract: BackgroundThe scientific evidence base in support of population‐wide salt reduction is strong, but current high‐quality data about salt intake levels in India are mostly absent. This project sought...

Journal ArticleDOI
TL;DR: Cost-effectiveness analyses showed that a package size cap and kJ reduction of SSBs are likely to offer excellent “value for money” as obesity prevention measures in Australia.
Abstract: Interventions targeting portion size and energy density of food and beverage products have been identified as a promising approach for obesity prevention. This study modelled the potential cost-effectiveness of: a package size cap on single-serve sugar sweetened beverages (SSBs) >375 mL ( package size cap ), and product reformulation to reduce energy content of packaged SSBs ( energy reduction ). The cost-effectiveness of each intervention was modelled for the 2010 Australia population using a multi-state life table Markov model with a lifetime time horizon. Long-term health outcomes were modelled from calculated changes in body mass index to their impact on Health-Adjusted Life Years (HALYs). Intervention costs were estimated from a limited societal perspective. Cost and health outcomes were discounted at 3%. Total intervention costs estimated in AUD 2010 were AUD 210 million. Both interventions resulted in reduced mean body weight ( package size cap : 0.12 kg; energy reduction : 0.23 kg); and HALYs gained ( package size cap : 73,883; energy reduction : 144,621). Cost offsets were estimated at AUD 750.8 million ( package size cap ) and AUD 1.4 billion ( energy reduction ). Cost-effectiveness analyses showed that both interventions were "dominant", and likely to result in long term cost savings and health benefits. A package size cap and kJ reduction of SSBs are likely to offer excellent "value for money" as obesity prevention measures in Australia.

Journal ArticleDOI
TL;DR: Australian consumers rated the perceived healthiness of mock food pack images that varied according to nutritional profile (healthy, moderately healthy, unhealthy); FoPL (Daily Intake Guide, Multiple Traffic Lights, Health Star Rating, or control); and food type (cookies, cornflakes, pizza, yoghurt).

Journal ArticleDOI
TL;DR: The FoodSwitch app was designed to show consumers at-a-glance nutritional information while supporting the collation of data to drive industry improvements and government policy, and is identified as a new method for tracking the global food supply.

Journal ArticleDOI
TL;DR: Several consumer behaviours related to use of salt during food preparation and consumption of salty products were related to actual salt consumption and therefore appear to offer an opportunity for intervention and a reasonable focus for a government-led education campaign targeting salt.
Abstract: Consumer knowledge is understood to play a role in managing risk factors associated with cardiovascular disease and may be influenced by level of education. The association between population knowledge, behaviours and actual salt consumption was explored overall, and for more-educated compared to less-educated individuals. A cross-sectional survey was done in an age-and sex-stratified random sample of 1395 participants from urban and rural areas of North and South India. A single 24-h urine sample, participants' physical measurements and questionnaire data were collected. The mean age of participants was 40 years, 47% were women and mean 24-h urinary salt excretion was 9.27 (8.87-9.69) g/day. Many participants reported favourable knowledge and behaviours to minimise risks related to salt. Several of these behaviours were associated with reduced salt intake-less use of salt while cooking, avoidance of snacks, namkeens, and avoidance of pickles (all p < 0.003). Mean salt intake was comparable in more-educated (9.21, 8.55-9.87 g/day) versus less-educated (9.34, 8.57-10.12 g/day) individuals (p = 0.82). There was no substantively different pattern of knowledge and behaviours between more-versus less-educated groups and no clear evidence that level of education influenced salt intake. Several consumer behaviours related to use of salt during food preparation and consumption of salty products were related to actual salt consumption and therefore appear to offer an opportunity for intervention. These would be a reasonable focus for a government-led education campaign targeting salt.

Journal ArticleDOI
TL;DR: The HSR nutrients discriminate well between core and discretionary packaged foods, however, discrimination was improved when added sugar was also included, arguing for inclusion of added sugar in an updated HSR algorithm and declaration ofadded sugar as part of mandatory nutrient declarations.
Abstract: Background: The Health Star Rating (HSR) is an interpretive front-of-pack labelling system that rates the overall nutritional profile of packaged foods. The algorithm underpinning the HSR includes total sugar content as one of the components. This has been criticised because intrinsic sugars naturally present in dairy, fruits, and vegetables are treated the same as sugars added during food processing. We assessed whether the HSR could better discriminate between core and discretionary foods by including added sugar in the underlying algorithm. Methods: Nutrition information was extracted for 34,135 packaged foods available in The George Institute’s Australian FoodSwitch database. Added sugar levels were imputed from food composition databases. Products were classified as ‘core’ or ‘discretionary’ based on the Australian Dietary Guidelines. The ability of each of the nutrients included in the HSR algorithm, as well as added sugar, to discriminate between core and discretionary foods was estimated using the area under the curve (AUC). Results: 15,965 core and 18,350 discretionary foods were included. Of these, 8230 (52%) core foods and 15,947 (87%) discretionary foods contained added sugar. Median (Q1, Q3) HSRs were 4.0 (3.0, 4.5) for core foods and 2.0 (1.0, 3.0) for discretionary foods. Median added sugar contents (g/100 g) were 3.3 (1.5, 5.5) for core foods and 14.6 (1.8, 37.2) for discretionary foods. Of all the nutrients used in the current HSR algorithm, total sugar had the greatest individual capacity to discriminate between core and discretionary foods; AUC 0.692 (0.686; 0.697). Added sugar alone achieved an AUC of 0.777 (0.772; 0.782). A model with all nutrients in the current HSR algorithm had an AUC of 0.817 (0.812; 0.821), which increased to 0.871 (0.867; 0.874) with inclusion of added sugar. Conclusion: The HSR nutrients discriminate well between core and discretionary packaged foods. However, discrimination was improved when added sugar was also included. These data argue for inclusion of added sugar in an updated HSR algorithm and declaration of added sugar as part of mandatory nutrient declarations.

Journal ArticleDOI
TL;DR: A low level of education is associated with an increased risk of vascular events and death in patients with type 2 diabetes, independently of common lifestyle associated cardiovascular risk factors.

Journal ArticleDOI
TL;DR: The dietary recall method used by the AHS likely substantially underestimated mean population salt consumption in Australia, resulting in an underestimate of daily salt intake for both Lithgow and Australia.
Abstract: Objective To update the estimate of mean salt intake for the Australian population made by the Australian Health Survey (AHS) Design A secondary analysis of the data collected in a cross-sectional survey was conducted Estimates of salt intake were made in Lithgow using the 24 h diet recall methodology employed by the AHS as well as using 24 h urine collections The data from the Lithgow sample were age- and sex-weighted, to provide estimates of daily salt intake for the Australian population based upon (i) the diet recall data and (ii) the 24 h urine samples Setting Lithgow, New South Wales, Australia Subjects Individuals aged ≥20 years residing in Lithgow and listed on the 2009 federal electoral roll Results Mean (95 % CI) salt intake estimated from the 24 h diet recalls was 6·4 (6·2, 6·7) g/d for the Lithgow population compared with a corresponding figure of 6·2 g/d for the Australian population derived from the AHS The corresponding estimate of salt intake for Lithgow adults based upon the 24 h urine collections was 9·0 (8·6, 9·4) g/d When the age- and sex-specific estimates of salt intake obtained from the 24 h urine collections in the Lithgow sample were weighted using Australian census data, estimated salt intake for the Australian population was 9·0 (8·6, 9·5) g/d Further adjustment for non-urinary Na excretion made the best estimate of daily salt intake for both Lithgow and Australia about 9·9 g/d Conclusions The dietary recall method used by the AHS likely substantially underestimated mean population salt consumption in Australia

Journal ArticleDOI
TL;DR: In urban and rural areas in North and South India, most spot urine-based equations provided reasonable estimates of mean population salt intake, according to a cross-sectional survey.
Abstract: This work was supported by a funding award made by the Global Alliance for Chronic Disease through the National Health and Medical Research Council of Australia (APP1040179). Johnson is supported by a National Health and Medical Research Council Postgraduate Scholarship (APP1074678). Webster is supported by a National Health and Medical Research Council/National Heart Foundation Career Development Fellowship (APP1082924). Neal is supported by a National Health and Medical Research Council of Australia Principal Research Fellowship (APP1106947). He also holds an NHMRC Program Grant (APP1052555). Maulik is an Intermediate Career Fellow of the WT/DBT India Alliance. Shivashankar is supported by a Wellcome Trust Capacity Strengthening Strategic Award Extension Phase to the Public Health Foundation of India and a consortium of UK universities (WT084754/Z/08/A).

Journal ArticleDOI
TL;DR: There are clear opportunities for India’s largest food companies to improve both the nutritional quality of individual products and to improve their product mix to include a greater proportion of healthy products.
Abstract: Availability of less-healthy packaged food and beverage products has been implicated as an important driver of obesity and diet-related disease. An increasing number of packaged foods and beverages are sold in India. Our objective was to evaluate the healthiness of packaged foods sold by India’s largest manufacturers. Healthiness was assessed using the Australian Health Star Rating (HSR) system and the World Health Organization’s European Regional Office (WHO Euro) Nutrient Profile Model. Sales-value-weighted mean healthiness and the proportions of “healthy” products (using a validated HSR cut-off of ≥3.5, and products meeting WHO Euro criteria as healthy enough to market to children) were calculated overall, by company and by food category. Nutrient information for 943 products sold by the 11 largest Indian manufacturers was obtained from nutrient labels, company websites or directly from the manufacturer. Healthiness was low overall (mean HSR 1.8 out of 5.0 stars) with a low proportion defined as “healthy” by both HSR (17%) and also by WHO Euro criteria (8%). There were marked differences in the healthiness of similar products within food categories. Substantial variation between companies (minimum sales-value-weighted mean HSR 0.5 for Company G, versus maximum HSR 3.0 for Company F) was a result of differences in the types of products sold and the nutritional composition of individual products. There are clear opportunities for India’s largest food companies to improve both the nutritional quality of individual products and to improve their product mix to include a greater proportion of healthy products.

Journal ArticleDOI
01 Oct 2017-Appetite
TL;DR: These data support the idea that the HSR system could be extended to Australian fast foods, and there are likely to be significant benefits to the community from the use of a single standardised signposting system for healthiness across all fresh, packaged and restaurant foods.