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Eight years of the East African Community Medicines Regulatory Harmonization initiative: Implementation, progress, and lessons learned

Mer, 12/08/2020 - 23:00

by Jane H. Mashingia, Vincent Ahonkhai, Noel Aineplan, Aggrey Ambali, Apollo Angole, Mawien Arik, Samvel Azatyan, Peter Baak, Emmanuel Bamenyekanye, Aimable Bizoza, Chimwemwe Chamdimba, Petra Doerr, Adam Fimbo, Alex Gisagara, Hidaya Hamad, Rachelle Harris, Dan Hartman, Joseph Kabatende, Charles Karangwa, Agnes Sitta Kijo, Murray Lumpkin, Shani Maboko, David Matle, Apollo Muhairwe, John Patrick Mwesigye, Bonaventure Nyabenda, Alexander Schulze, Andreas Seiter, Gordon Sematiko, Margareth Sigonda, Hiiti Sillo, Burhani Simai, Fred Siyoi, Stanley Sonoiya, Paul Tanui, Mike Ward, Felistas Yano, David Mukanga

Jane H. Mashingia and colleagues reveal the progress made to date for the East African Community Medicines Regulatory Harmonization initiative.

Coming together to improve access to medicines: The genesis of the East African Community’s Medicines Regulatory Harmonization initiative

Mer, 12/08/2020 - 23:00

by Hiiti Sillo, Aggrey Ambali, Samvel Azatyan, Chimwemwe Chamdimba, Eliangiringa Kaale, Joseph Kabatende, Murray Lumpkin, Jane H. Mashingia, David Mukanga, Bonaventure Nyabenda, Gordon Sematiko, Margareth Sigonda, Burhani Simai, Fred Siyoi, Stanley Sonoiya, Mike Ward, Vincent Ahonkhai

Hiiti Sillo and colleagues reveal how the East African Community’s Medicines Regulatory Harmonization initiative improves access to important medicines in Africa.

Optimizing the East African Community’s Medicines Regulatory Harmonization initiative in 2020–2022: A Roadmap for the Future

Mer, 12/08/2020 - 23:00

by Mawien Arik, Emmanuel Bamenyekanye, Adam Fimbo, Joseph Kabatende, Agnes Sitta Kijo, Burhani Simai, Fred Siyoi, Samvel Azatyan, Aggrey Ambali, Emer Cooke, Jane H. Mashingia, John Patrick Mwesigye, Margareth Ndomondo-Sigonda, Hiiti Sillo, Stanley Sonoiya, Paul Tanui, Mike Ward, Thomas Delano

Margareth Ndomondo-Sigonda outlines future challenges for the East African Medicines Regulatory Harmonization initiative.

A new approach to an old problem: Overview of the East African Community’s Medicines Regulatory Harmonization initiative

Mer, 12/08/2020 - 23:00

by Margareth Ndomondo-Sigonda, Gugu Mahlangu, Margaret Agama-Anyetei, Emer Cooke

Improving access to quality medicines in East Africa: An independent perspective on the East African Community Medicines Regulatory Harmonization initiative

Mer, 12/08/2020 - 23:00

by Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Alexander Giaquinto and co-authors discuss the East African Community's Medicines Regulatory Harmonization initiative.

Social distancing to slow the US COVID-19 epidemic: Longitudinal pretest–posttest comparison group study

Mar, 11/08/2020 - 23:00

by Mark J. Siedner, Guy Harling, Zahra Reynolds, Rebecca F. Gilbert, Sebastien Haneuse, Atheendar S. Venkataramani, Alexander C. Tsai

Background

Social distancing measures to address the US coronavirus disease 2019 (COVID-19) epidemic may have notable health and social impacts.

Methods and findings

We conducted a longitudinal pretest–posttest comparison group study to estimate the change in COVID-19 case growth before versus after implementation of statewide social distancing measures in the US. The primary exposure was time before (14 days prior to, and through 3 days after) versus after (beginning 4 days after, to up to 21 days after) implementation of the first statewide social distancing measures. Statewide restrictions on internal movement were examined as a secondary exposure. The primary outcome was the COVID-19 case growth rate. The secondary outcome was the COVID-19-attributed mortality growth rate. All states initiated social distancing measures between March 10 and March 25, 2020. The mean daily COVID-19 case growth rate decreased beginning 4 days after implementation of the first statewide social distancing measures, by 0.9% per day (95% CI −1.4% to −0.4%; P < 0.001). We did not observe a statistically significant difference in the mean daily case growth rate before versus after implementation of statewide restrictions on internal movement (0.1% per day; 95% CI −0.04% to 0.3%; P = 0.14), but there is substantial difficulty in disentangling the unique associations with statewide restrictions on internal movement from the unique associations with the first social distancing measures. Beginning 7 days after social distancing, the COVID-19-attributed mortality growth rate decreased by 2.0% per day (95% CI −3.0% to −0.9%; P < 0.001). Our analysis is susceptible to potential bias resulting from the aggregate nature of the ecological data, potential confounding by contemporaneous changes (e.g., increases in testing), and potential underestimation of social distancing due to spillover effects from neighboring states.

Conclusions

Statewide social distancing measures were associated with a decrease in the COVID-19 case growth rate that was statistically significant. Statewide social distancing measures were also associated with a decrease in the COVID-19-attributed mortality growth rate beginning 7 days after implementation, although this decrease was no longer statistically significant by 10 days.

Disparities in United States hospitalizations for serious infections in patients with and without opioid use disorder: A nationwide observational study

Ven, 07/08/2020 - 23:00

by June-Ho Kim, Danielle R. Fine, Lily Li, Simeon D. Kimmel, Long H. Ngo, Joji Suzuki, Christin N. Price, Matthew V. Ronan, Shoshana J. Herzig

Background

Patients with opioid use disorder (OUD) who are hospitalized for serious infections requiring prolonged intravenous antibiotics may face barriers to discharge, which could prolong hospital length of stay (LOS) and increase financial burden. We investigated differences in LOS, discharge disposition, and charges between hospitalizations for serious infections in patients with and without OUD.

Methods and findings

We utilized the 2016 National Inpatient Sample—a nationally representative database of all discharges from US acute care hospitals. The population of interest was all hospitalizations for infective endocarditis, epidural abscess, septic arthritis, or osteomyelitis. The exposure was OUD, and the primary outcome was LOS until discharge, assessed by using a competing risks analysis to estimate adjusted hazard ratios (aHRs). Adjusted odds ratio (aOR) of discharge disposition and adjusted differences in hospital charges were also reported. Of 95,470 estimated hospitalizations for serious infections (infective endocarditis, epidural abscess, septic arthritis, and osteomyelitis), the mean age was 49 years and 35% were female. 46% had Medicare (government-based insurance coverage for people age 65+ years), and 70% were non-Hispanic white. After adjustment for potential confounders, OUD was associated with a lower probability of discharge at any given LOS (aHR 0.61; 95% CI 0.59–0.63; p < 0.001). OUD was also associated with lower odds of discharge to home (aOR 0.38; 95% CI 0.33–0.43; p < 0.001) and higher odds of discharge to a post-acute care facility (aOR 1.85; 95% CI 1.57–2.17; p < 0.001) or patient-directed discharge (also referred to as “discharge against medical advice”) (aOR 3.47; 95% CI 2.80–4.29; p < 0.001). There was no significant difference in average total hospital charges, though daily hospital charges were significantly lower for patients with OUD. Limitations include the potential for unmeasured confounders and the use of billing codes to identify cohorts.

Conclusions

Our findings suggest that among hospitalizations for some serious infections, those involving patients with OUD were associated with longer LOS, higher odds of discharge to post-acute care facilities or patient-directed discharge, and similar total hospital charges, despite lower daily charges. These findings highlight opportunities to improve care for patients with OUD hospitalized with serious infections, and to reduce the growing associated costs.

Relative contribution of diet and physical activity to increased adiposity among rural to urban migrants in India: A cross-sectional study

Ven, 07/08/2020 - 23:00

by Sanjay Kinra, Poppy Alice Carson Mallinson, Jenny A. Cresswell, Liza J. Bowen, Tanica Lyngdoh, Dorairaj Prabhakaran, Kolli Srinath Reddy, Mario Vaz, Anura V. Kurpad, George Davey Smith, Yoav Ben-Shlomo, Shah Ebrahim

Background

In common with many other low- and middle-income countries (LMICs), rural to urban migrants in India are at increased risk of obesity, but it is unclear whether this is due to increased energy intake, reduced energy expenditure, or both. Knowing this and the relative contribution of specific dietary and physical activity behaviours to greater adiposity among urban migrants could inform policies for control of the obesity epidemic in India and other urbanising LMICs. In the Indian Migration Study, we previously found that urban migrants had greater prevalence of obesity and diabetes compared with their nonmigrant rural-dwelling siblings. In this study, we investigated the relative contribution of energy intake and expenditure and specific diet and activity behaviours to greater adiposity among urban migrants in India.

Methods and findings

The Indian Migration Study was conducted between 2005 and 2007. Factory workers and their spouses from four cities in north, central, and south of India, together with their rural-dwelling siblings, were surveyed. Self-reported data on diet and physical activity was collected using validated questionnaires, and adiposity was estimated from thickness of skinfolds. The association of differences in dietary intake, physical activity, and adiposity between siblings was examined using multivariable linear regression. Data on 2,464 participants (median age 43 years) comprised of 1,232 sibling pairs (urban migrant and their rural-dwelling sibling) of the same sex (31% female) were analysed. Compared with the rural siblings, urban migrants had 18% greater adiposity, 12% (360 calories/day) more energy intake, and 18% (11 kilojoules/kg/day) less energy expenditure (P < 0.001 for all). Energy intake and expenditure were independently associated with increased adiposity of urban siblings, accounting for 4% and 6.5% of adiposity difference between siblings, respectively. Difference in dietary fat/oil (10 g/day), time spent engaged in moderate or vigorous activity (69 minutes/day), and watching television (30 minutes/day) were associated with difference in adiposity between siblings, but no clear association was observed for intake of fruits and vegetables, sugary foods and sweets, cereals, animal and dairy products, and sedentary time. The limitations of this study include a cross-sectional design, systematic differences in premigration characteristics of migrants and nonmigrants, low response rate, and measurement error in estimating diet and activity from questionnaires.

Conclusions

We found that increased energy intake and reduced energy expenditure contributed equally to greater adiposity among urban migrants in India. Policies aimed at controlling the rising prevalence of obesity in India and potentially other urbanising LMICs need to be multicomponent, target both energy intake and expenditure, and focus particularly on behaviours such as dietary fat/oil intake, time spent on watching television, and time spent engaged in moderate or vigorous intensity physical activity.

Development and validation of a model for predicting incident type 2 diabetes using quantitative clinical data and a Bayesian logistic model: A nationwide cohort and modeling study

Ven, 07/08/2020 - 23:00

by Lua Wilkinson, Nengjun Yi, Tapan Mehta, Suzanne Judd, W. Timothy Garvey

Background

Obesity is closely related to the development of insulin resistance and type 2 diabetes (T2D). The prevention of T2D has become imperative to stem the rising rates of this disease. Weight loss is highly effective in preventing T2D; however, the at-risk pool is large, and a clinically meaningful metric for risk stratification to guide interventions remains a challenge. The objective of this study is to predict T2D risk using full-information continuous analysis of nationally sampled data from white and black American adults age ≥45 years.

Methods and findings

A sample of 12,043 black (33%) and white individuals from a population-based cohort, REasons for Geographic And Racial Differences in Stroke (REGARDS) (enrolled 2003–2007), was observed through 2013–2016. The mean participant age was 63.12 ± 8.62 years, and 43.7% were male. Mean BMI was 28.55 ± 5.61 kg/m2. Risk factors for T2D regularly recorded in the primary care setting were used to evaluate future T2D risk using Bayesian logistic regression. External validation was performed using 9,710 participants (19% black) from Atherosclerotic Risk in Communities (ARIC) (enrolled 1987–1989), observed through 1996–1998. The mean participant age in this cohort was 53.86 ± 5.65 years, and 44.6% were male. Mean BMI was 27.15 ± 4.92 kg/m2. Predictive performance was assessed using the receiver operating characteristic (ROC) curves and area under the curve (AUC) statistics. The primary outcome was incident T2D. By 2016 in REGARDS, there were 1,602 incident cases of T2D. Risk factors used to predict T2D progression included age, sex, race, BMI, triglycerides, high-density lipoprotein, blood pressure, and blood glucose. The Bayesian logistic model (AUC = 0.79) outperformed the Framingham risk score (AUC = 0.76), the American Diabetes Association risk score (AUC = 0.64), and a cardiometabolic disease system (using Adult Treatment Panel III criteria) (AUC = 0.75). Validation in ARIC was robust (AUC = 0.85). Main limitations include the limited generalizability of the REGARDS sample to black and white, older Americans, and no time to diagnosis for T2D.

Conclusions

Our results show that a Bayesian logistic model using full-information continuous predictors has high predictive discrimination, and can be used to quantify race- and sex-specific T2D risk, providing a new, powerful predictive tool. This tool can be used for T2D prevention efforts including weight loss therapy by allowing clinicians to target high-risk individuals in a manner that could be used to optimize outcomes.

Temporal variations in the distribution of self-harm episodes and methods across the Australian asylum seeker population: An observational study

Gio, 06/08/2020 - 23:00

by Kyli Hedrick, Gregory Armstrong, Guy Coffey, Rohan Borschmann

Background

Temporal patterns in the frequency and characteristics of self-harm episodes across the Australian asylum seeker population may have implications for self-harm prevention and public health policy. The aim of this study was to examine how the distribution of self-harm episodes and method(s) of self-harm used across the Australian asylum seeker population vary according to the 24-hour cycle, day, and month, and to establish a basis for further research.

Methods and findings

We conducted an observational study of all 949 self-harm incidents reported across the Australian asylum seeker population (representing a monthly average of 28,992 adults) between 1 August 2014 and 31 July 2015, obtained by Freedom of Information (FOI) from the Department of Immigration. Time of self-harm, day, and month of occurrence were investigated across all five Australian asylum seeker populations (i.e., community-based arrangements, community detention, onshore immigration detention, offshore immigration detention [Nauru], and offshore immigration detention [Manus Island]). Significant variations in distributions over the 24-hour cycle were observed by processing arrangements. Compared with the average distribution across all other processing arrangements, self-harm more commonly occurred among community-based asylum seekers (36.3%) between 12:00 AM and 3:59 AM (p < 0.001), in asylum seekers on Manus Island (36.4%) between 4:00 PM and 7:59 PM (p = 0.02), and among asylum seekers in onshore detention (20.4%) between 8:00 PM and 11:59 PM (p < 0.001). Compared with the average distribution across all other methods, self-poisoning (by medication) (25%) was significantly more likely to occur between 12:00 AM and 3:59 AM (p = 0.009), and self-battery (42%) between 8:00 AM and 11:59 AM (p < 0.001). The highest and lowest monthly self-harm episode rates for the whole asylum seeker population were in August (2014) (5 episodes per 1,000 asylum seekers; 95% confidence interval [CI] 1–11) and in both January and February (2015) (2.1 episodes per 1,000 asylum seekers; 95% CI 0.6–7.2), respectively; however, the overlapping CIs indicate no statistically significant differences across the months. When examining monthly trends by processing arrangements, we observed that self-harm was significantly more likely to occur in August (2014) than other months of the year among asylum seekers in onshore detention (19%) (p < 0.001), in January (2015) on Manus Island (18%) (p = 0.002), and in October (2014) on Nauru (15%) (p < 0.001). The main study limitations were that we could not investigate certain characteristics associated with self-harm (e.g., gender, country of origin), as the Department of Immigration did not routinely collect such data. There was also the potential risk of making a type 1 error, given the exploratory nature of the comparisons we undertook; we minimised this by lowering our significance threshold from 0.05 to 0.01.

Conclusions

Self-harm in the Australian asylum seeker population was found to vary according to time of day and month of the year, by processing arrangements. A series of procedure-related and detention-related factors were observed to be associated with the temporal variations in self-harm. These findings should form the basis for further investigation into temporal variations in self-harm among asylum seekers, which may in turn lead to effective self-harm prevention strategies.

Ambient air pollution and cause-specific risk of hospital admission in China: A nationwide time-series study

Gio, 06/08/2020 - 23:00

by Jiangshao Gu, Ying Shi, Yifang Zhu, Ning Chen, Haibo Wang, Zongjiu Zhang, Ting Chen

Background

The impacts of air pollution on circulatory and respiratory systems have been extensively studied. However, the associations between air pollution exposure and the risk of noncommunicable diseases of other organ systems, including diseases of the digestive, musculoskeletal, and genitourinary systems, remain unclear or inconclusive. We aimed to systematically assess the associations between short-term exposure to main air pollutants (fine particulate matter [PM2.5] and ozone) and cause-specific risk of hospital admission in China over a wide spectrum of human diseases.

Methods and findings

Daily data on hospital admissions for primary diagnosis of 14 major and 188 minor disease categories in 252 Chinese cities (107 cities in North China and 145 cities in South China) from January 1, 2013, to December 31, 2017, were obtained from the Hospital Quality Monitoring System of China (covering 387 hospitals in North China and 614 hospitals in South China). We applied a 2-stage analytic approach to assess the associations between air pollution and daily hospital admissions. City-specific associations were estimated with quasi-Poisson regression models and then pooled by random-effects meta-analyses. Each disease category was analyzed separately, and the P values were adjusted for multiple comparisons. A total of 117,338,867 hospital admissions were recorded in the study period. Overall, 51.7% of the hospitalized cases were male, and 71.3% were aged <65 years. Robust positive associations were found between short-term PM2.5 exposure and hospital admissions for 7 major disease categories: (1) endocrine, nutritional, and metabolic diseases; (2) nervous diseases; (3) circulatory diseases; (4) respiratory diseases; (5) digestive diseases; (6) musculoskeletal and connective tissue diseases; and (7) genitourinary diseases. For example, a 10-μg/m3 increase in PM2.5 was associated with a 0.21% (95% CI 0.15% to 0.27%; adjusted P < 0.001) increase in hospital admissions for diseases of the digestive system on the same day in 2-pollutant models (adjusting for ozone). There were 35 minor disease categories significantly positively associated with same-day PM2.5 in both single- and 2-pollutant models, including diabetes mellitus, anemia, intestinal infection, liver diseases, gastrointestinal hemorrhage, renal failure, urinary tract calculus, chronic ulcer of skin, and back problems. The association between short-term ozone exposure and respiratory diseases was robust. No safety threshold in the exposure–response relationships between PM2.5 and hospital admissions was observed. The main limitations of the present study included the unavailability of data on personal air pollution exposures.

Conclusions

In the Chinese population during 2013–2017, short-term exposure to air pollution, especially PM2.5, was associated with increased risk of hospitalization for diseases of multiple organ systems, including certain diseases of the digestive, musculoskeletal, and genitourinary systems; many of these associations are important but still not fully recognized. The effect estimates and exposure–response relationships can inform policy making aimed at protecting public health from air pollution in China.

Incidence of and trends in hip fracture among adults in urban China: A nationwide retrospective cohort study

Gio, 06/08/2020 - 23:00

by Chenggui Zhang, Jingnan Feng, Shengfeng Wang, Pei Gao, Lu Xu, Junxiong Zhu, Jialin Jia, Lili Liu, Guozhen Liu, Jinxi Wang, Siyan Zhan, Chunli Song

Background

Hip fracture is a public health concern because of its considerable morbidity, excess mortality, great risk of disability, and high societal healthcare costs. China has the largest population of older people in the world and is experiencing rapid population aging and facing great challenges from an increasing number of hip fractures. However, few studies reported the epidemiology, especially at a national level. We aimed to evaluate trends in hip fracture incidence and associated costs for hospitalization in China.

Methods and findings

We conducted a population-based study using data between 2012 and 2016 from the national databases of Urban Employee Basic Medical Insurance and Urban Resident Basic Medical Insurance in China, covering about 480 million residents. Data from around 102.56 million participants aged 55 years and older during the study period were analyzed. A total of 190,560 incident hip fracture patients (mean age 77.05 years, standard deviation 8.94; 63.99% female) were identified. Primary outcomes included the age- and sex-specific incidences of hip fracture. Associated annual costs for hospitalization were also calculated. Incidence was described as per 100,000 person-years at risk, and 95% confidence intervals were computed assuming a Poisson distribution. Hip fracture incidence overall in China did not increase during the study period despite rapid population aging. Incidence per 100,000 was 180.72 (95% CI 137.16, 224.28; P < 0.001) in 2012 and 177.13 (95% CI 139.93, 214.33; P < 0.001) in 2016 for females, and 121.86 (95% CI 97.30, 146.42; P < 0.001) in 2012 and 99.15 (95% CI 81.31, 116.99; P < 0.001) in 2016 for males. For both sexes, declines in hip fracture incidence were observed in patients aged 65 years and older, although incidence was relatively stable in younger patients. However, the total absolute number of hip fractures in those 55 years and older increased about 4-fold. The total costs for hospitalization showed a steep rise from US$60 million to US$380 million over the study period. Costs for hospitalization per patient increased about 1.59-fold, from US$4,300 in 2012 to US$6,840 in 2016. The main limitation of the study was the unavailability of data on imaging information to adjudicate cases of hip fracture.

Conclusions

Our results show that hip fracture incidence among patients aged 55 and over in China reached a plateau between 2012 and 2016. However, the absolute number of hip fractures and associated medical costs for hospitalization increased rapidly because of population aging.

A gender-sensitised weight-loss and healthy living program for men with overweight and obesity in Australian Football League settings (Aussie-FIT): A pilot randomised controlled trial

Gio, 06/08/2020 - 23:00

by Dominika Kwasnicka, Nikos Ntoumanis, Kate Hunt, Cindy M. Gray, Robert U. Newton, Daniel F. Gucciardi, Cecilie Thøgersen-Ntoumani, Jenny L. Olson, Joanne McVeigh, Deborah A. Kerr, Sally Wyke, Philip J. Morgan, Suzanne Robinson, Marshall Makate, Eleanor Quested

Background

Recent evidence shows that sport settings can act as a powerful draw to engage men in weight loss. The primary objective of this pilot study was to test the feasibility of delivering and to evaluate preliminary efficacy of Aussie-FIT, a weight-loss program for men with overweight/obesity delivered in Australian Football League (AFL) settings, in preparation for a future definitive trial.

Methods and findings

This 6-month pilot trial took place in Perth, Australia. Participants were overweight/obese (Body Mass Index [BMI] ≥ 28 kg/m2), middle-aged (35–65 years old) men. Participants were recruited in May 2018, and the intervention took place between June and December 2018. The intervention involved 12 weekly 90-min face-to-face sessions, incorporating physical activity, nutrition, and behaviour change information and practical activities delivered by coaches at 2 clubs. Data were collected at baseline and immediately postintervention. For trial feasibility purposes, 6-month follow-ups were completed. Outcomes were differences in weight loss (primary outcome) and recruitment and retention rates, self-reported measures (for example, psychological well-being), device-measured physical activity, waist size, and blood pressure at 3 months. Within 3 days of advertising at each club, 426 men registered interest; 306 (72%) were eligible. Men were selected on a first-come first-served basis (n = 130; M age = 45.8, SD = 8; M BMI = 34.48 kg/m2, SD = 4.87) and randomised by a blinded researcher. Trial retention was 86% and 63% at 3- and 6-month follow-ups (respectively). No adverse events were reported. At 3 months, mean difference in weight between groups, adjusted for baseline weight and group, was 3.3 kg (95% CI 1.9, 4.8) in favour of the intervention group (p < 0.001). The intervention group’s moderate-to-vigorous physical activity (MVPA) was higher than the control group by 8.54 min/day (95% CI 1.37, 15.71, p = 0.02). MVPA among men attracted to Aussie-FIT was high at baseline (intervention arm 35.61 min/day, control arm 38.38 min/day), which may have limited the scope for improvement.

Conclusions

Aussie-FIT was feasible to deliver; participants increased physical activity, decreased weight, and reported improvements in other outcomes. Issues with retention were a limitation of this trial. In a future, fully powered randomised controlled trial (RCT), retention could be improved by conducting assessments outside of holiday seasons.

Trial registration

Australian New Zealand Clinical Trials Registry: ACTRN12617000515392.

Correction: Modelled health benefits of a sugar-sweetened beverage tax across different socioeconomic groups in Australia: A cost-effectiveness and equity analysis

Mer, 29/07/2020 - 23:00

by Anita Lal, Ana Maria Mantilla-Herrera, Lennert Veerman, Kathryn Backholer, Gary Sacks, Marjory Moodie, Mohammad Siahpush, Rob Carter, Anna Peeters

Projected impact of a reduction in sugar-sweetened beverage consumption on diabetes and cardiovascular disease in Argentina: A modeling study

Mar, 28/07/2020 - 23:00

by M. Victoria Salgado, Joanne Penko, Alicia Fernandez, Jonatan Konfino, Pamela G. Coxson, Kirsten Bibbins-Domingo, Raul Mejia

Background

Sugar-sweetened beverage (SSB) consumption is associated with obesity, diabetes, and hypertension. Argentina is one of the major consumers of SSBs per capita worldwide. Determining the impact of SSB reduction on health will inform policy debates.

Methods and findings

We used the Cardiovascular Disease Policy Model-Argentina (CVD Policy Model-Argentina), a local adaptation of a well-established computer simulation model that projects cardiovascular and mortality events for the population 35–94 years old, to estimate the impact of reducing SSB consumption on diabetes incidence, cardiovascular events, and mortality in Argentina during the period 2015–2024, using local demographic and consumption data. Given uncertainty regarding the exact amount of SSBs consumed by different age groups, we modeled 2 estimates of baseline consumption (low and high) under 2 different scenarios: a 10% and a 20% decrease in SSB consumption. We also included a range of caloric compensation in the model (0%, 39%, and 100%). We used Monte Carlo simulations to generate 95% uncertainty intervals (UIs) around our primary outcome measures for each intervention scenario. Over the 2015–2024 period, a 10% reduction in SSBs with a caloric compensation of 39% is projected to reduce incident diabetes cases by 13,300 (95% UI 10,800–15,600 [low SSB consumption estimate]) to 27,700 cases (95% UI 22,400–32,400 [high SSB consumption estimate]), i.e., 1.7% and 3.6% fewer cases, respectively, compared to a scenario of no change in SSB consumption. It would also reduce myocardial infarctions by 2,500 (95% UI 2,200–2,800) to 5,100 (95% UI 4,500–5,700) events and all-cause deaths by 2,700 (95% UI 2,200–3,200) to 5,600 (95% UI 4,600–6,600) for “low” and “high” estimates of SSB intake, respectively. A 20% reduction in SSB consumption with 39% caloric compensation is projected to result in 26,200 (95% UI 21,200–30,600) to 53,800 (95% UI 43,900–62,700) fewer cases of diabetes, 4,800 (95% UI 4,200–5,300) to 10,000 (95% UI 8,800–11,200) fewer myocardial infarctions, and 5,200 (95% UI 4,300–6,200) to 11,000 (95% UI 9,100–13,100) fewer deaths. The largest reductions in diabetes and cardiovascular events were observed in the youngest age group modeled (35–44 years) for both men and women; additionally, more events could be avoided in men compared to women in all age groups. The main limitations of our study are the limited availability of SSB consumption data in Argentina and the fact that we were only able to model the possible benefits of the interventions for the population older than 34 years.

Conclusions

Our study finds that, even under conservative assumptions, a relatively small reduction in SSB consumption could lead to a substantial decrease in diabetes incidence, cardiovascular events, and mortality in Argentina.

Predicting obesity reduction after implementing warning labels in Mexico: A modeling study

Mar, 28/07/2020 - 23:00

by Ana Basto-Abreu, Rossana Torres-Alvarez, Francisco Reyes-Sánchez, Romina González-Morales, Francisco Canto-Osorio, M. Arantxa Colchero, Simón Barquera, Juan A. Rivera, Tonatiuh Barrientos-Gutierrez

Background

In October 2019, Mexico approved a law to establish that nonalcoholic beverages and packaged foods that exceed a threshold for added calories, sugars, fats, trans fat, or sodium should have an “excess of” warning label. We aimed to estimate the expected reduction in the obesity prevalence and obesity costs in Mexico by introducing warning labels, over 5 years, among adults under 60 years of age.

Methods and findings

Baseline intakes of beverages and snacks were obtained from the 2016 Mexican National Health and Nutrition Survey. The expected impact of labels on caloric intake was obtained from an experimental study, with a 10.5% caloric reduction for beverages and 3.0% caloric reduction for snacks. The caloric reduction was introduced into a dynamic model to estimate weight change. The model output was then used to estimate the expected changes in the prevalence of obesity and overweight. To predict obesity costs, we used the Health Ministry report of the impact of overweight and obesity in Mexico 1999–2023. We estimated a mean caloric reduction of 36.8 kcal/day/person (23.2 kcal/day from beverages and 13.6 kcal/day from snacks). Five years after implementation, this caloric reduction could reduce 1.68 kg and 4.98 percentage points (pp) in obesity (14.7%, with respect to baseline), which translates into a reduction of 1.3 million cases of obesity and a reduction of US$1.8 billion in direct and indirect costs. Our estimate is based on experimental evidence derived from warning labels as proposed in Canada, which include a single label and less restrictive limits to sugar, sodium, and saturated fats. Our estimates depend on various assumptions, such as the transportability of effect estimates from the experimental study to the Mexican population and that other factors that could influence weight and food and beverage consumption remain unchanged. Our results will need to be corroborated by future observational studies through the analysis of changes in sales, consumption, and body weight.

Conclusions

In this study, we estimated that warning labels may effectively reduce obesity and obesity-related costs. Mexico is following Chile, Peru, and Uruguay in implementing warning labels to processed foods, but other countries could benefit from this intervention.

Changes in the amount of nutrient of packaged foods and beverages after the initial implementation of the Chilean Law of Food Labelling and Advertising: A nonexperimental prospective study

Mar, 28/07/2020 - 23:00

by Marcela Reyes, Lindsey Smith Taillie, Barry Popkin, Rebecca Kanter, Stefanie Vandevijvere, Camila Corvalán

Background

In June 2016, the first phase of the Chilean Food Labelling and Advertising Law that mandated front-of-package warning labels and marketing restrictions for unhealthy foods and beverages was implemented. We assess foods and beverages reformulation after this initial implementation.

Methods and findings

A data set with the 2015 to 2017 nutritional information was developed collecting the information at 2 time periods: preimplementation (T0: January–February 2015 or 2016; n = 4,055) and postimplementation (T1: January–February 2017; n = 3,025). Quartiles of energy and nutrients of concern (total sugars, saturated fats, and sodium, per 100 g/100 mL) and the proportion of products with energy and nutrients exceeding the cutoffs of the law (i.e., products “high in”) were compared pre- and postimplementation of the law in cross-sectional samples of products with sales >1% of their specific food or beverage groups, according to the Euromonitor International Database; a longitudinal subsample (i.e., products collected in both the pre- and postimplementation periods, n = 1,915) was also analyzed. Chi-squared, McNemar tests, and quantile regressions (simple and multilevel) were used for comparing T0 and T1. Cross-sectional analysis showed a significant decrease (T0 versus T1) in the proportion of product with any “high in” (from 51% [95% confidence interval (CI) 49–52] to 44% [95% CI 42–45]), mostly in food and beverage groups in which regulatory cutoffs were below the 75th percentile of the nutrient or energy distribution. Most frequent reductions were in the proportion of “high in” sugars products (in beverages, milks and milk-based drinks, breakfast cereals, sweet baked products, and sweet and savory spreads; from 80% [95% CI 73–86] to 60% [95% CI 51–69]) and in “high in sodium” products (in savory spreads, cheeses, ready-to-eat meals, soups, and sausages; from 74% [95% CI 69–78] to 27% [95% CI 20–35]). Conversely, the proportion of products “high in” saturated fats only decreased in savory spreads (p < 0.01), and the proportion of “high in” energy products significantly decreased among breakfast cereals and savory spreads (both p < 0.01). Quantile analyses showed that most of the changes took place close to the cutoff values, with only few exceptions of overall left shifts in distribution. Longitudinal analyses showed similar results. However, it is important to note that the nonexperimental nature of this study does not allow to imply causality of these findings.

Conclusions

Our results show that, after initial implementation of the Chilean Law of Food Labelling and Advertising, there was a significant decrease in the amount of sugars and sodium in several groups of packaged foods and beverages. Further studies should clarify how food reformulation will impact dietary quality of the population.

Obesity, clinical, and genetic predictors for glycemic progression in Chinese patients with type 2 diabetes: A cohort study using the Hong Kong Diabetes Register and Hong Kong Diabetes Biobank

Mar, 28/07/2020 - 23:00

by Guozhi Jiang, Andrea O. Luk, Claudia H. T. Tam, Eric S. Lau, Risa Ozaki, Elaine Y. K. Chow, Alice P. S. Kong, Cadmon K. P. Lim, Ka Fai Lee, Shing Chung Siu, Grace Hui, Chiu Chi Tsang, Kam Piu Lau, Jenny Y. Y. Leung, Man-wo Tsang, Grace Kam, Ip Tim Lau, June K. Li, Vincent T. Yeung, Emmy Lau, Stanley Lo, Samuel K. S. Fung, Yuk Lun Cheng, Chun Chung Chow, Ewan R. Pearson, Wing Yee So, Juliana C. N. Chan, Ronald C. W. Ma, Hong Kong Diabetes Register TRS Study Group , Hong Kong Diabetes Biobank Study Group

Background

Type 2 diabetes (T2D) is a progressive disease whereby there is often deterioration in glucose control despite escalation in treatment. There is significant heterogeneity to this progression of glycemia after onset of diabetes, yet the factors that influence glycemic progression are not well understood. Given the tremendous burden of diabetes in the Chinese population, and limited knowledge on factors that influence glycemia, we aim to identify the clinical and genetic predictors for glycemic progression in Chinese patients with T2D.

Methods and findings

In 1995–2007, 7,091 insulin-naïve Chinese patients (mean age 56.8 ± 13.3 [SD] years; mean age of T2D onset 51.1 ± 12.7 years; 47% men; 28.4% current or ex-smokers; median duration of diabetes 4 [IQR: 1–9] years; mean HbA1c 7.4% ± 1.7%; mean body mass index [BMI] 25.3 ± 4.0 kg/m2) were followed prospectively in the Hong Kong Diabetes Register. We examined associations of BMI and other clinical and genetic factors with glycemic progression defined as requirement of continuous insulin treatment, or 2 consecutive HbA1c ≥8.5% while on ≥2 oral glucose-lowering drugs (OGLDs), with validation in another multicenter cohort of Hong Kong Diabetes Biobank. During a median follow-up period of 8.8 (IQR: 4.8–13.3) years, incidence of glycemic progression was 48.0 (95% confidence interval [CI] 46.3–49.8) per 1,000 person-years with 2,519 patients started on insulin. Among the latter, 33.2% had a lag period of 1.3 years before insulin was initiated. Risk of progression was associated with extremes of BMI and high HbA1c. On multivariate Cox analysis, early age at diagnosis, microvascular complications, high triglyceride levels, and tobacco use were additional independent predictors for glycemic progression. A polygenic risk score (PRS) including 123 known risk variants for T2D also predicted rapid progression to insulin therapy (hazard ratio [HR]: 1.07 [95% CI 1.03–1.12] per SD; P = 0.001), with validation in the replication cohort (HR: 1.24 [95% CI 1.06–1.46] per SD; P = 0.008). A PRS using 63 BMI-related variants predicted BMI (beta [SE] = 0.312 [0.057] per SD; P = 5.84 × 10−8) but not glycemic progression (HR: 1.01 [95% CI 0.96–1.05] per SD; P = 0.747). Limitations of this study include potential misdiagnosis of T2D and lack of detailed data of drug use during follow-up in the replication cohort.

Conclusions

Our results show that approximately 5% of patients with T2D failed OGLDs annually in this clinic-based cohort. The independent associations of modifiable and genetic risk factors allow more precise identification of high-risk patients for early intensive control of multiple risk factors to prevent glycemic progression.