Eliminating artificial trans fatty acids in Argentina: estimated effects on the burden of coronary heart disease and costs

Élimination des acides gras trans artificiels en Argentine: effets estimés sur la charge des cardiopathies coronariennes et sur les coûts associés

La eliminación de los ácidos grasos de tipo trans artificiales en Argentina: efectos estimados en la carga de cardiopatías coronarias y los costes

القضاء على الأحماض الدهنية المتحولة الصناعية في الأرجنتين: الآثار التقديرية على عبء الأمراض القلبية الوعائية ونفقاتها

在阿根廷消除人工反式脂肪酸: 对冠心病负担及成本的预估影响

Устранение искусственных трансжирных кислот в Аргентине: ожидаемое воздействие на бремя ишемической болезни сердца и на сопутствующие расходы

Adolfo Rubinstein Natalia Elorriaga Osvaldo U Garay Rosana Poggio Joaquin Caporale Maria G Matta Federico Augustovski Andres Pichon-Riviere Dariush Mozaffarian About the authors

Abstract

Objective

To estimate the impact of Argentine policies to reduce trans fatty acids (TFA) on coronary heart disease (CHD), disability-adjusted life years (DALYs) and associated health-care costs.

Methods

We estimated the baseline intake of TFA before 2004 to be 1.5% of total energy intake. We built a policy model including baseline intake of TFA, the oils and fats used to replace artificial TFAs, the clinical effect of reducing artificial TFAs and the costs and DALYs saved due to averted CHD events. To calculate the percentage of reduction of CHD, we calculated CHD risks on a population-based sample before and after implementation. The effect of the policies was modelled in three ways, based on projected changes: (i) in plasma lipid profiles; (ii) in lipid and inflammatory biomarkers; and (iii) the results of prospective cohort studies. We also estimated the present economic value of DALYs and associated health-care costs of coronary heart disease averted.

Findings

We estimated that projected changes in lipid profile would avert 301 deaths, 1066 acute CHD events, 5237 DALYs and 17 million United States dollars (US$) in health-care costs annually. Based on the adverse effects of TFA intake reported in prospective cohort studies, 1517 deaths, 5373 acute CHD events, 26 394 DALYs and US$ 87 million would be averted annually.

Conclusion

Even under the most conservative scenario, reduction of TFA intake had a substantial effect on public health. These findings will help inform decision-makers in Argentina and other countries on the potential public health and economic impact of this policy.

Résumé

Objectif

Estimer l'impact des politiques argentines de réduction des acides gras trans (AGT) sur les cardiopathies coronariennes (CC), les années de vie corrigées du facteur incapacité (AVCI) et les coûts des soins de santé associés.

Méthodes

Nous sommes partis d'une estimation de l'apport de référence en AGT avant 2004 représentant 1,5% de l'apport énergétique total. Nous avons conçu un modèle pour ces politiques, en intégrant cet apport en AGT de référence, les huiles et graisses utilisées pour remplacer les AGT artificiels, les effets cliniques de la réduction des AGT artificiels, les coûts associés ainsi que les AVCI épargnées du fait des accidents coronariens évités. Pour calculer le pourcentage de réduction des CC, nous avons calculé les risques de CC sur un échantillon en population, avant et après la mise en œuvre de ces politiques. Les effets de ces politiques ont été modélisés de trois manières, en fonction des changements projetés: (i) au niveau des profils lipidiques plasmatiques; (ii) au niveau des biomarqueurs lipidiques et inflammatoires et (iii) en fonction des résultats des études prospectives de cohortes. Nous avons également estimé la valeur économique actuelle des AVCI et du coût des soins de santé associés correspondant aux cardiopathies coronariennes évitées.

Résultats

Selon nos estimations, les changements projetés des profils lipidiques devraient permettre d'éviter 301 décès, 1 066 accidents coronariens aigus, 5 237 AVCI et 17 millions de dollars des États-Unis d'Amérique ($US) de dépenses annuelles en soins de santé. À partir des effets défavorables des apports en AGT indiqués dans les études prospectives de cohortes, ce sont 1 517 décès, 5 373 accidents coronariens aigus, 26 394 AVCI et 87 millions de $US de dépenses qui pourraient être évités chaque année.

Conclusion

Même dans le scénario le plus prudent, la réduction de l'apport en AGT a un effet considérable sur la santé publique. Ces résultats permettront d'informer les décideurs en Argentine et dans d'autres pays sur les impacts potentiels de ce type de politiques sur le plan économique et en termes de santé publique.

Resumen

Objetivo

Estimar el impacto de las políticas argentinas para la reducción de los ácidos grasos de tipo trans (AGT) en las cardiopatías coronarias, los años de vida ajustados en función de la discapacidad (AVAD) y los costes de la atención sanitaria asociados.

Métodos

Se estimó que la ingesta base de AGT antes de 2004 era de 1,5% de la ingesta de energía total. Se construyó un modelo de política que incluía la ingesta base de AGT, los aceites y grasas utilizados para reemplazar los AGT artificiales, el efecto clínico de reducir los AGT artificiales y el coste y los AVAD salvados debido a los casos de cardiopatías coronarias evitadas. Para calcular el porcentaje de reducción de cardiopatías coronarias, se calcularon los riesgos de cardiopatías coronarias en un modelo basado en la población antes y después de la implementación. El efecto de las políticas fue modelado de tres formas, en base a cambios estimados: (i) perfiles de plasma de lípidos; (ii) marcados biológicos inflamatorios de lípidos; y (iii) los resultados de estudios de cohortes prospectivos. También se estimó el valor económico actual de los AVAD y los costes de atención sanitaria asociados a las cardiopatías coronarias evitadas.

Resultados

Se estimó que los cambios estimados en el perfil de lípidos evitarían 301 muertes, 1.066 casos graves de cardiopatías coronarias, 5.237 AVAD y 17 millones de dólares estadounidenses (USD) en atención sanitaria cada año. Basándose en los efectos adversos del consumo de AGT de los estudios de cohortes prospectivos, se evitarían 1.517 muertes, 5.373 casos graves de cardiopatías coronarias, 26.394 AVAD y 87 millones de USD cada año.

Conclusión

Incluso bajo el escenario más conservador, la reducción del consumo de AGT tuvo un efecto sustancial en la salud pública. Estos resultados ayudarán a informar a los responsables de la toma de decisiones en Argentina y otros países sobre el potencial impacto económico y de salud pública de esta política.

ملخص

الغرض تقدير أثر السياسات الأرجنتينية للحد من الأحماض الدهنية المتحولة (TFA) على مرض القلبي الوعائي (CHD)، وسنوات العمر المصححة باحتساب مدد العجز (DALYs)، ونفقات الرعاية الصحية المرتبطة بها.

الطريقة

تشير تقديراتنا إلى أن نسبة المدخول الأساسي من الأحماض الدهنية المتحولة قبل عام 2004 كانت تبلغ 1.5% من إجمالي مدخول الطاقة. لذلك، قمنا بوضع نموذج لسياسة تتضمن المدخول الأساسي من الأحماض الدهنية المتحولة والزيوت والدهون المستخدمة لتحل محل تلك الأحماض الدهنية المتحولة، والأثر الإكلينيكي لتقليل الأحماض الدهنية المتحولة والتكاليف وسنوات العمر المصححة باحتساب مدد العجز التي يتم توفيرها بسبب تحاشي وقائع الإصابة بالأمراض القلبية الوعائية. ولكي يتم حساب النسبة المئوية لتقليل الإصابة بالأمراض القلبية الوعائية، فقد احتسبنا مخاطر تلك الأمراض على عينة تستند إلى شريحة سكانية قبل تنفيذ السياسة وبعدها. وتم وضع نماذج لأثر السياسات باتباع ثلاث طرق استناداً إلى التغييرات المتوقعة: (1) في أنماط دهون البلازما، و(2) في الدهون والمحددات الحيوية الالتهابية (Inflammatory biomarkers، و(3) نتائج الدراسات الأترابية الاستباقية (Prospective cohort studies). كما وضعنا تقديرًا للقيمة الاقتصادية الحالية لسنوات العمر المصححة باحتساب مدد العجز وما يرتبط بها من تكاليف للرعاية الصحية لمرض القلب الوعائي الذي تم تحاشي الإصابة به.

النتائج

تشير تقديراتنا إلى أن التغييرات المتوقعة في نمط الدهون سيؤدي إلى تحاشي 301 حالة وفاة، و1066 واقعة إصابة بحالات حادة من الأمراض القلبية الوعائية، وإنقاذ 5237 سنة عمر مصححة باحتساب مدد العجز، و17 مليون دولار أمريكي سنويًا من نفقات الرعاية الصحية. وبناءً على الآثار الجانبية لمدخول الأحماض الدهنية المتحولة التي وردت تقارير بشأنها في الدراسات الأترابية الاستباقية، فسيتم تجنب 1517 حالة وفاة، و5373 واقعة إصابة بحالات حادة من الأمراض القلبية الوعائية، وإنقاذ 26,394 سنة عمر مصححة باحتساب مدد العجز، و87 مليون دولار أمريكي سنويًا.

الاستنتاج

حتى في ظل السيناريوهات الأكثر تحفظًا، فقد كان للحد من مدخول الأحماض الدهنية المتحولة أثر كبير على الصحة العامة. ومن شأن هذه النتائج أن تفيد في تقديم المعلومات الكافية لصناع القرار بالأرجنتين وغيرها من البلدان بشأن الأثر المحتمل على الصحة العامة والآثار الاقتصادية لهذه السياسية.

摘要

目的

旨在评估阿根廷境内关于减少使用反式脂肪酸 (TFA) 的政策对冠心病 (CHD)、残疾调整生命年 (DALY) 和相关医疗保健成本产生的影响。

方法

我们估计出 2004 年之前对反式脂肪酸 (TFA) 的基准摄入量为总能量摄入的 1.5%。 我们构建了政策模型,包括对反式脂肪酸 (TFA) 的基准摄入量、用于代替人工反式脂肪酸 (TFA) 的油脂、减少使用人工反式脂肪酸 (TFA) 的临床效果,以及因预防冠心病 (CHD) 事件而节约的成本和残疾调整生命年 (DALY)。 为了计算冠心病 (CHD) 减少的百分比,我们在实施前后基于研究人群计算了冠心病 (CHD) 风险。 根据预测的变化,以三种方式模拟政策的影响: (i) 血浆中的血脂;(ii) 脂质和炎性标记物;以及 (iii) 前瞻性群组研究的结果。 我们还估计了残疾调整生命年 (DALY) 在当下的经济价值,以及预防冠心病的相关医疗保健成本。

结果

我们估计,血脂变化预计每年将会避免 301 人死亡、1066 例急性冠心病 (CHD) 事件和 5237 个残疾调整生命年 (DALY),并可节约 1700 万美元 (US$) 的医疗保健成本。 基于前瞻性群组研究中所报告的摄入反式脂肪酸 (TFA) 后产生的不良影响,每年可防止 1517 人死亡、5373 例急性冠心病 (CHD) 事件和 26 394 个残疾调整生命年 (DALY),并可节约 8700 万美元 (US$)。

结论

即使是在最为保守的情况中,减少摄入反式脂肪酸 (TFA) 也可对公众健康产生重大影响。 这些调查结果将有助于让阿根廷和其他国家的决策制定者了解潜在的公众健康问题和这项政策的经济影响。

Резюме

Цель.

Оценить воздействие применяемых в Аргентине политик по уменьшению количества трансжирных кислот в пище (ТЖК) на развитие ишемической болезни сердца (ИБС), на количество лет жизни, утраченных в результате болезни, и на сопутствующие расходы на здравоохранение.

Методы.

По нашим оценкам, до 2004 года 1,5% общего количества пищевых калорий приходилось на ТЖК, и эту величину мы приняли за базовый уровень. Мы разработали модель политики, включающую базовый уровень потребления ТЖК, жиры и масла, которыми планировалось заменить искусственные ТЖК, клинический эффект от снижения уровня ТЖК, а также уровень экономии и количество спасенных лет жизни в результате предотвращения случаев ИБС. Для расчета процентной доли снижения ИБС были рассчитаны риски возникновения ИБС для популяционной выборки до и после реализации вышеуказанной политики. Эффект от применения политик моделировался тремя путями в зависимости от предполагаемых изменений: (i) по профилям липидов в плазме, (ii) по липидам и биомаркерам воспалительного процесса и (iii) по результатам проспективных когортных исследований. Мы также оценили текущее экономическое значение спасенных лет жизни и уменьшения сопутствующих расходов на лечение в случае предотвращения ишемической болезни сердца.

Результаты.

По предварительным оценкам, предполагаемые изменения в профиле липидов позволят предотвратить 301 смерть, 1066 острых случаев ИБС, спасти 5237 лет жизни и сэкономить 17 млн долл. США на ежегодных расходах на здравоохранение. Если исходить из неблагоприятных последствий употребления пищевых ТЖК, о которых сообщалось в проспективных когортных исследованиях, то ежегодно можно будет предотвратить 1517 смертей, 5373 острых случая ИБС, спасти 26 394 года жизни и сэкономить 87 млн долл. США на медицинских расходах.

Вывод.

Даже при самом неблагоприятном сценарии уменьшение употребления ТЖК в значительной мере повлияет на здоровье населения. Эти результаты помогут информировать ответственных лиц в Аргентине и других странах о потенциальном воздействии такой политики на здоровье населения и национальную экономику.

Introduction

Artificial trans fatty acids (TFAs) are produced during the industrial processing of vegetable oils. The main source of such TFAs is partially hydrogenated vegetable oils.1Heymsfield SB, Darby PC, Muhlheim LS, Gallagher D, Wolper C, Allison DB. The calorie: myth, measurement, and reality. Am J Clin Nutr. 1995 Nov;62(5) Suppl:1034S-41S.PMID 7484918Consumption of TFAs alters the plasma lipid profile2Mozaffarian D, Clarke R. Quantitative effects on cardiovascular risk factors and coronary heart disease risk of replacing partially hydrogenated vegetable oils with other fats and oils. Eur J Clin Nutr. 2009 May;63 Suppl 2:S22-33.http://dx.doi.org/10.1038/sj.ejcn.1602976PMID 19424216
http://dx.doi.org/10.1038/sj.ejcn.160297...
),(3Mozaffarian D, Katan MB, Ascherio A, Stampfer MJ, Willett WC. Trans fatty acids and cardiovascular disease. N Engl J Med. 2006 Apr 13;354(15):1601 -13.http://dx.doi.org/10.1056/NEJMra054035PMID 16611951
http://dx.doi.org/10.1056/NEJMra054035...
in such a way that it increases the risk of coronary heart disease (CHD).4Mozaffarian D, Aro A, Willett WC. Health effects of trans-fatty acids: experimental and observational evidence.. Eur J Clin Nutr 2009 May;63 Suppl 2:S5 -21.http://dx.doi.org/10.1038/sj.ejcn.1602973PMID 19424218
http://dx.doi.org/10.1038/sj.ejcn.160297...
A 2% increase in energy intake from TFAs may increase the risk for a coronary event by up to 23%.3Mozaffarian D, Katan MB, Ascherio A, Stampfer MJ, Willett WC. Trans fatty acids and cardiovascular disease. N Engl J Med. 2006 Apr 13;354(15):1601 -13.http://dx.doi.org/10.1056/NEJMra054035PMID 16611951
http://dx.doi.org/10.1056/NEJMra054035...
Other potential adverse effects of TFAs include systemic inflammation, endothelial dysfunction, insulin resistance and arrhythmias.2Mozaffarian D, Clarke R. Quantitative effects on cardiovascular risk factors and coronary heart disease risk of replacing partially hydrogenated vegetable oils with other fats and oils. Eur J Clin Nutr. 2009 May;63 Suppl 2:S22-33.http://dx.doi.org/10.1038/sj.ejcn.1602976PMID 19424216
http://dx.doi.org/10.1038/sj.ejcn.160297...

Based on these adverse effects, several countries have implemented policies to reduce industrial TFA consumption,5Colon-Ramos U, Monge-Rojas R, Campos H. Impact of WHO recommendations to eliminate industrial trans-fatty acids from the food supply in Latin America and the Caribbean. Health Policy Plan. 2014;Aug 29(5):529-41.PMID 24150503including nutrition guidelines, awareness programmes, voluntary or mandatory labelling of the TFA content of foods and health warning labels. Voluntary or legislated programmes to encourage industry to reformulate food products without TFAs and support the production of healthy alternatives have led to improvements in some countries.6Nishida C, Uauy R. WHO Scientific Update on health consequences of trans fatty acids: introduction.. Eur J Clin Nutr 2009 May;63 Suppl 2:S1 -4.http://dx.doi.org/10.1038/ejcn.2009.13PMID 19424215
http://dx.doi.org/10.1038/ejcn.2009.13...
Mandatory food labelling in Canada7Ratnayake WM, L'Abbe MR, Mozaffarian D. Nationwide product reformulations to reduce trans fatty acids in Canada: when trans fat goes out, what goes in?. Eur J Clin Nutr 2009 Jun;63(6):808-11.http://dx.doi.org/10.1038/ejcn.2008.39PMID 18594558
http://dx.doi.org/10.1038/ejcn.2008.39...
and the United States of America8Van Camp D, Hooker NH, Lin CT. Changes in fat contents of US snack foods in response to mandatory trans fat labelling. Public Health Nutr. 2012 Jun;15(6):1130-7.http://dx.doi.org/10.1017/S1368980012000079PMID 22314147
http://dx.doi.org/10.1017/S1368980012000...
have led some manufacturers to reduce or eliminate artificial TFAs in their products. However, many food products still contain such TFAs, especially when served in restaurants, schools, cafeterias and coffee shops.9Angell SY, Silver LD, Goldstein GP, Johnson CM, Deitcher DR, Frieden TR, et al. Cholesterol control beyond the clinic: New York City's trans fat restriction. Ann Intern Med. 2009 Jul 21;151(2):129-34.http://dx.doi.org/10.7326/0003-4819-151-2-200907210-00010PMID 19620165
http://dx.doi.org/10.7326/0003-4819-151-...

In Argentina, before 2004, artificial TFAs were present in most sweet or salty solid snack foods, such as biscuits.1010 Peterson GAD, Espeche M, Mesa M, Jáuregui P, Díaz H, Simi M, et al. ; [Trans-fatty acids in food consumed by youth in Argentina.] Arch Argent Pediatr. 2004;102(2):102-9. Spanish.Between 2004 and 2014, Argentina implemented several policies to reduce artificial TFAs. After 2004, the industry voluntarily reformulated foods by replacing approximately 40% of TFAs from partially hydrogenated vegetable oils, mainly with TFA-free sunflower oil with high-oleic acid content.1111 L'Abbé M, Stender S, Skeaff CM, Ghafoorunissa, Tavella M. Approaches to removing trans fats from the food supply in industrialized and developing countries.. Eur J Clin Nutr 2009;63:S50-67.http://dx.doi.org/10.1038/ejcn.2009.14
http://dx.doi.org/10.1038/ejcn.2009.14...
Regulations enforcing mandatory labelling of artificial TFAs in food were introduced in 2006.1212 Resolution No. 149 and Resolution No. 638. Buenos Aires: Secretariat of Policies Regulation and Sanitary Relations, Secretariat of Agriculture Livestock Fisheries and Food; 2005.With support from the Pan American Health Organization,1313 Trans fat free Americas: Declaration of Rio de Janeiro. Washington: Pan American Health Organization; 2008. Available from:Available from:http://www.amro.who.int/English/AD/DPC/NC/transfat-declaration-rio.pdf [cited 2014 Feb 10].
http://www.amro.who.int/English/AD/DPC/N...
),(1414 [Trans fats free Americas: conclusions and recommendations, Washington, 26-27 April 2007.]; Washington: Pan American Health Organization 2007. Available from:Available from:http://www.msal.gov.ar/ent/images/stories/ciudadanos/pdf/Grasas_trans_Conclusiones_Task_Force.pdf Spanish. [cited 2014 February 10].
http://www.msal.gov.ar/ent/images/storie...
the Argentine Ministry of Health negotiated with industry to eliminate artificial TFAs. The country's food code was amended,1515 Resolution No 137 and Resolution No 941. Buenos Aires: Secretariat of Policies RaSRSoA, Livestock, Fisheries and Food; 2010.such that, by the end of 2014, industrially-produced TFAs in food should not exceed 2% of total fats in vegetable oils and margarines and 5% of total fats in other foods (Fig. 1).1616 Bonilla-Chacín ME. Promoting healthy living in Latin America and the Caribbean: governance of multisectoral activities to prevent risk factors for noncommunicable diseases. Washington: The World Bank; 2014.

Fig. 1
Trans fatty acids regulations in Argentina, 2004-2015

Here we estimate the potential reductions in annual CHD events, disability-adjusted life years (DALYs) and associated health-care costs attributable to reductions in artificial TFAs in the diet.

Methods

The main inputs of the policy model for the analysis were: (i) the estimated baseline intake of TFAs before 2004; (ii) the types of alternative oils and fats used to replace TFAs; (iii) the effects of the improvements in plasma lipid profile on CHD risks and (iv) the health-care costs and DALYs saved due to averted fatal and nonfatal CHD events. Although our study is not a full economic evaluation, we used the CHEERS statement as a guide for reporting.1717 Husereau D, Drummond M, Petrou S, Carswell C, Moher D, Greenberg D, et al.; CHEERS Task Force. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement. BMJ. 2013;346 mar25 1:f1049.http://dx.doi.org/10.1136/bmj.f1049PMID 23529982
http://dx.doi.org/10.1136/bmj.f1049...

Baseline intake of TFAs

To identify estimates of baseline TFA intake in Argentina and the fats used to improve the dietary fat profile between 2004 and 2014, we conducted a literature search using MEDLINE, Embase, LILACS databases and official documents from the government, academia, industry and other public and private organizations. For the database searches, we used the search string "trans fat OR trans fatty acids OR partially hydrogenated oils OR partially hydrogenated fat AND Argentina".

Because TFAs cannot be replaced on a 1:1 basis with other specific fatty acids, the unit of replacement was partially hydrogenated vegetable oils (comprised of various fatty acids, including TFAs). Thus, we evaluated both the total partially hydrogenated vegetable oils consumed and the usual proportion of TFAs in partially hydrogenated vegetable oils during 2004-2014. Our search was complemented by a consensus meeting of local experts and decision-makers including officials from the Ministry of Health, epidemiologists, nutritionists, cardiologists and food engineers closely involved with the oils' and fats' suppliers of TFA replacements. They identified key estimates for the model, including the baseline intake of TFA, the proportion of TFA from ruminants and the replacement fats used by industry. Our central estimate of baseline TFA consumption in 2004 was 1.5% of total energy intake, with a lower limit of 1%1818 Uicich RRA, Pueyrredón P, O'Donnel A. Estimación del consumo de ácidos grasos trans en la Argentina. Actualización Nutr. 2006;7:57-65.and an upper limit of 3%.1414 [Trans fats free Americas: conclusions and recommendations, Washington, 26-27 April 2007.]; Washington: Pan American Health Organization 2007. Available from:Available from:http://www.msal.gov.ar/ent/images/stories/ciudadanos/pdf/Grasas_trans_Conclusiones_Task_Force.pdf Spanish. [cited 2014 February 10].
http://www.msal.gov.ar/ent/images/storie...
The most common replacement oil was sunflower oil with high-oleic acid content (base case estimate 42.0%; range: 33.6-50.4), followed by interesterified fats (18.0%; range: 14.4-21.6) and beef tallow (12:0% range: 9.6-14.4; Table 1).

Table 1
Baseline TFA intake and replacements; epidemiological and cost inputs

Changes in lipid profile

Improvements in the plasma lipid profile were expected to result in improvements in CHD risks. We assessed the relevant changes in plasma lipid profiles and other biomarkers of CHD risk based on meta-analyses of controlled dietary feeding trials.2Mozaffarian D, Clarke R. Quantitative effects on cardiovascular risk factors and coronary heart disease risk of replacing partially hydrogenated vegetable oils with other fats and oils. Eur J Clin Nutr. 2009 May;63 Suppl 2:S22-33.http://dx.doi.org/10.1038/sj.ejcn.1602976PMID 19424216
http://dx.doi.org/10.1038/sj.ejcn.160297...
),(4Mozaffarian D, Aro A, Willett WC. Health effects of trans-fatty acids: experimental and observational evidence.. Eur J Clin Nutr 2009 May;63 Suppl 2:S5 -21.http://dx.doi.org/10.1038/sj.ejcn.1602973PMID 19424218
http://dx.doi.org/10.1038/sj.ejcn.160297...
These estimates were used to drive projections of CHD risks, as outlined below.

CHD risk

To estimate reductions in CHD risk in the national population, we adapted a cardiovascular risk calculator, based on the Framingham risk equation and ASSIGN scores.3030 Cardiovascular risk calculator [Internet]. Edinburgh: University of Edinburgh; 2010. Available from:Available from:http://cvrisk.mvm.ed.ac.uk/calculator/excelcalc.htm [cited 2013 March 5].
http://cvrisk.mvm.ed.ac.uk/calculator/ex...
We used individual level data on CHD risk factors from a national prospective cohort study.3131 Rubinstein AL, Irazola VE, Calandrelli M, Elorriaga N, Gutierrez L, Lanas F, et al. Multiple cardiometabolic risk factors in the Southern Cone of Latin America: A population-based study in Argentina, Chile, and Uruguay. Int J Cardiol. 2015 Mar 15;183:82-8.http://dx.doi.org/10.1016/j.ijcard.2015.01.062PMID 25662056
http://dx.doi.org/10.1016/j.ijcard.2015....
The study collected baseline data in 2011-2012 on age, gender, smoking, systolic blood pressure, diabetes, left ventricular hypertrophy and the ratio total cholesterol (TC)/high-density lipoprotein cholesterol (HDL-C). We combined these results with demographic data for Argentina using the 2010 census to create a national CHD risk profile.3232 Censo 2010 [Internet]. Buenos Aires: National Institute of Statistics and Census of Argentina INDEC; 2014. Available from:Available from:http://www.censo2010.indec.gov.ar/index_cuadros.asp Spanish. [cited 2014 Feb 10].
http://www.censo2010.indec.gov.ar/index_...

According to the consensus of our expert panel, between 2004 and 2014, most of the partially hydrogenated vegetable oils in the diet were replaced by healthier fats. In 2011-2012, when the prospective cohort study took place, 75% had been replaced. We used the observed TC/HDL-C ratio for each person in the 2011-2012 cohort study to calculate the expected TC/HDL-C ratios in 2004 and 2014. This calculation was based on the estimated baseline intake of TFA, the established effects of TFA on the TC/HDL-C ratio and the types and percentages of different fats/oils used by industry for replacements. According to the distributions of TC/HDL-C and other risk factors in the population in 2004 and 2014, we calculated the difference in the CHD risk between both years.

Three alternative scenarios were analysed: (i) the effects of improved dietary fat profile on the ratio of TC/HDL-C and the relation of this ratio to the incidence of CHD (scenario 1);3333 Stampfer MJ, Sacks FM, Salvini S, Willett WC, Hennekens CH. A prospective study of cholesterol, apolipoproteins, and the risk of myocardial infarction.. N Engl J Med 1991 Aug 8;325(6):373-81.http://dx.doi.org/10.1056/NEJM199108083250601PMID 2062328
http://dx.doi.org/10.1056/NEJM1991080832...
(ii) the CHD risk reduction through changes in other biomarkers such as apolipoprotein (apo) B, ApoA1, lipoprotein (a), triglycerides and C-reactive protein (scenario 2); and (iii) the reported relation of TFA intake, substituted for carbohydrate intake, with the incidence of CHD in a pooled analysis of prospective studies and attributed to several pathophysiological effects of TFA (scenario 3).2Mozaffarian D, Clarke R. Quantitative effects on cardiovascular risk factors and coronary heart disease risk of replacing partially hydrogenated vegetable oils with other fats and oils. Eur J Clin Nutr. 2009 May;63 Suppl 2:S22-33.http://dx.doi.org/10.1038/sj.ejcn.1602976PMID 19424216
http://dx.doi.org/10.1038/sj.ejcn.160297...

Mortality from CHD

We estimated the annual number of deaths caused by CHD using national mortality statistics for 2010. We included deaths coded according to the International Classification of Diseases (ICD-10) as I20-I25. We also assumed that 80% of the sudden deaths (ICD-10 code R96) were due to CHD.3434 Directorate of Statistics and Health Information. Buenos Aires: Ministry of Health; 2010.),(3535 Myerburg RJ, Junttila MJ. Sudden cardiac death caused by coronary heart disease. Circulation. 2012 Feb 28;125(8):1043-52.http://dx.doi.org/10.1161/CIRCULATIONAHA.111.023846PMID 22371442
http://dx.doi.org/10.1161/CIRCULATIONAHA...
We increased the number of CHD deaths by 21.5%, to account for the underreporting of CHD as a cause of death.3636 Forouzanfar MH, Moran AE, Flaxman AD, Roth G, Mensah GA, Ezzati M, et al. Assessing the global burden of ischemic heart disease, part 2: analytic methods and estimates of the global epidemiology of ischemic heart disease in 2010. Glob Heart. 2012 Dec 1;7(4):331-42.http://dx.doi.org/10.1016/j.gheart.2012.10.003PMID 23505617
http://dx.doi.org/10.1016/j.gheart.2012....

The difference in CHD risk predicted by the cardiovascular risk calculator was calibrated to the annual mortality from CHD. We assumed that the reduction in CHD deaths was proportional to the difference in estimated CHD risk. We also assumed that the difference in 10 year-CHD risk was equally distributed in each year of the decade 2004-2014, by age and sex.

Morbidity from CHD

Total acute CHD events - fatal and non-fatal acute myocardial infarctions and acute coronary syndrome - were estimated from national data on CHD deaths based upon sex-specific 28 day-CHD case-fatality rate for acute myocardial infarctions in southern Latin America (38% in women; 44% in men).3636 Forouzanfar MH, Moran AE, Flaxman AD, Roth G, Mensah GA, Ezzati M, et al. Assessing the global burden of ischemic heart disease, part 2: analytic methods and estimates of the global epidemiology of ischemic heart disease in 2010. Glob Heart. 2012 Dec 1;7(4):331-42.http://dx.doi.org/10.1016/j.gheart.2012.10.003PMID 23505617
http://dx.doi.org/10.1016/j.gheart.2012....
For acute coronary syndrome, we used one-third of the case-fatality rate of acute myocardial infarctions, according to local sources.2121 Bazzino O, Díaz R, Tajer C, Paviotti C, Mele E, Trivi M, et al.; The ECLA Collaborative Group. Clinical predictors of in-hospital prognosis in unstable angina: ECLA 3. Am Heart J. 1999 Feb;137(2):322-31.http://dx.doi.org/10.1053/hj.1999.v137.93029PMID 9924167
http://dx.doi.org/10.1053/hj.1999.v137.9...
All values were calibrated by age-sex hospital case-fatality rate in Argentina, obtained from the national hospital discharge registry for the public sector.3737 Dirección de Estadísticas e Información en Salud. Base de datos de egresos hospitalarios. Buenos Aires: Ministerio de Salud; 2008. Spanish.

Calculation of DALYs

We calculated DALY using individual equations for years of life lost (YLL) and years of life with disability (YLD) according to the Global Burden of Disease Study.3838 Murray CJ, Acharya AK. Understanding DALYs (disability-adjusted life years). J Health Econ. 1997 Dec;16(6):703-30.http://dx.doi.org/10.1016/S0167-6296(97)00004-0PMID 10176780
http://dx.doi.org/10.1016/S0167-6296(97)...
Briefly, YLL were calculated from national health statistics as the difference between local life expectancy and age at death. YLD is the product of disability weight and length of survival with disability for CHD events. Disability weights for acute myocardial infarctions and acute coronary syndrome were considered equal.2020 Salomon JA, Vos T, Hogan DR, Gagnon M, Naghavi M, Mokdad A, et al. Common values in assessing health outcomes from disease and injury: disability weights measurement study for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2129-43.http://dx.doi.org/10.1016/S0140-6736(12)61680-8PMID 23245605
http://dx.doi.org/10.1016/S0140-6736(12)...
Survival length was estimated using the software DISMOD II (World Health Organization (WHO), Geneva, Switzerland).3939 Health statistics and information systems. Geneva: World Health Organization; 2015. Available from:Available from:http://www.who.int/healthinfo/global_burden_disease/tools_software/en/ [cited 2014 March 10].
http://www.who.int/healthinfo/global_bur...
Finally, DALYs were reported with discounting at a 5% rate.

Costs

Cost inputs for the model were costs of acute CHD events, their follow-up and programmatic costs. A micro-costing approach was undertaken considering a health system perspective. Identification of resources related to CHD events, quantities and utilization rates were obtained from secondary local sources2222 Lowenstein Haber DM, Guardiani F, Pieroni P, Pfister L, Carrizo L, Villegas ED, et al. Realidad de la cirugía cardíaca en la República Argentina: Registro CONAREC XVI. Rev Argent Cardiol. 2010;78:228-37.

23 Gagliardi JCA. Higa C y colab. por los Investigadores del Consejo de Emergencias Cardiovasculares y Área de Investigación SAC. Infarto agudo de miocardio en la República Argentina: Análisis comparativo de sus características y conductas terapéuticas en los últimos 18 años. Resultados de las Encuestas SAC.. Rev Argent Cardiol 2006;74:125.

24 Gagliardi JA, De Abreu M, Mariani J, Silverstein MA, De Sagastizabal DM, Salzberg S, et al. Motivos de ingreso, procedimientos, evolución y terapéuticas al alta de 54.000 pacientes ingresados a unidades de cuidados intensivos cardiovasculares en la Argentina: Seis años del Registro Epi-Cardio.. Rev Argent Cardiol 2012;80:446-54.

25 Pérez GE, Costabel JP, González N, Zaidel E, Altamirano M, Schiavone M, et al. Infarto agudo de miocardio en la República Argentina. Registro CONAREC XVII.. Rev Argent Cardiol 2013;81(5):390-9.http://dx.doi.org/10.7775/rac.es.v81.i5.1391
http://dx.doi.org/10.7775/rac.es.v81.i5....

26 Linetzky B, Sarmiento RA, Barcelo J, Lowenstein D, Guardiani F, Feldman M, et al. Angioplastia coronaria en centros con residencia de cardiología en la Argentina: Estudio CONAREC XIV - Área de Investigación de la SAC.. Rev Argent Cardiol 2007;75(5):249-56.
-2727 Pichon-Riviere ARA, Souto A, Augustovski F. Base de datos de costos sanitarios Argentinos, [Documento Técnico N°3]. Buenos Aires: Instituto de Efectividad Clínica y Sanitaria; 2004. Available from:Available from:http://www.iecs.org.ar Spanish. [cited 2015 April 16].
http://www.iecs.org.ar...
and unit costs were derived from public, social security, and private tariffs of local health insurance institutions.

Costs of annual management of non-fatal CHD were calculated from the individual's age at the episode to the average Argentine life expectancy, by age and gender, and discounted at a 5% annual rate.2828 Augustovski F, Garay OU, Pichon-Riviere A, Rubinstein A, Caporale JE. Economic evaluation guidelines in Latin America: a current snapshot. Expert Rev Pharmacoecon Outcomes Res. 2010 Oct;10(5):525-37.http://dx.doi.org/10.1586/erp.10.56PMID 20950069
http://dx.doi.org/10.1586/erp.10.56...
Finally, costs borne by the Ministry of Health for the implementation of annual surveillance and monitoring of the compliance of the industry with the regulations were also estimated, and included costs of personnel, food analysis, and onsite training at food companies (Daniel Ferrante, Ministry of Health, personal communication, 2013).

All costs were converted to United States dollars, corresponding to the exchange rate of 2012.2929 Dólar estadounidense(USD) Para Peso argentino(ARS) [Internet]. Tipo de Cambio; 2015. Available from:Available from:http://usd.es.fxexchangerate.com/ars/ Spanish. [cited 2015 Jun 11].
http://usd.es.fxexchangerate.com/ars/...

Sensitivity analyses

To evaluate parameter uncertainty, we performed sensitivity analyses according to established guidelines.4040 Briggs AH, Weinstein MC, Fenwick EA, Karnon J, Sculpher MJ, Paltiel AD; ISPOR-SMDM Modeling Good Research Practices Task Force. Model parameter estimation and uncertainty analysis: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-6. Med Decis Making. 2012 Sep-Oct;32(5):722-32.http://dx.doi.org/10.1177/0272989X12458348PMID 22990087
http://dx.doi.org/10.1177/0272989X124583...
A deterministic sensitivity analysis was first performed to evaluate the uncertainty related to specific parameters and their relative importance, depicted in a tornado analysis (Fig. 2). Ranges used for the parameters were extracted from the published literature or expert opinions. To assess global uncertainty, a probabilistic sensitivity analysis was performed, incorporating the main parameters and their distributions. Uncertainty in results was reported using 95% confidence intervals (CI) based on 1000 Monte Carlo simulations. All model inputs including TFA-related, epidemiological and costs parameters are shown in Table 1.

Results

Mortality, case-fatality and acute coronary events per 100 000 population are shown in Table 2.

Table 2
Cardiovascular disease events, Argentina, 2010

Based on an estimated 24 875 deaths from CHD in 2010, we estimated 83 830 CHD acute events in Argentina in people older than 34 years old. The results reported here assume a baseline consumption of 1.5% of total energy intake as TFA in 2004.

Based on the most conservative scenario of TFA replacements only influencing CHD events through changes in the TC/HDL-C ratio (scenario 1), we estimated 301 CHD deaths, 572 acute myocardial infarctions, 1066 acute CHD events and 5237 DALYs averted after 2014, compared with the expected events if the policy had not been implemented (Table 3). In addition, more than US$ 17 million would be saved annually due to averted acute CHD events and lower costs of chronic treatment and follow-up.

Table 3
Annual CHD deaths and CHD acute events and DALYs averted, and costs savings attributable to the full implementation of the policy

When effects of TFA on CHD were calculated considering additional effects on other biomarkers (scenario 2), under the central estimate of 1.5% energy intake of TFA, a total of 3109 acute CHD events, 15 271 DALYs, and more than US$ 50 million in costs will be averted after 2014. If the effects of TFA on CHD were based on observed relationships with clinical events reported in prospective cohort studies (scenario 3), which may more fully account for the various effects of TFA, 1517 CHD deaths, 2884 acute myocardial infarctions, 5373 acute CHD events and 26 394 DALYs were averted, resulting in estimated savings of USD 87 million (Table 3). The proportion of events averted by the artificial TFA reduction policy in 2014 ranged from 1.26% (scenario 1) to 6.35% (scenario 3) of total CDH events (Table 3). The estimated reductions in CHD were sensitive to the assumed baseline TFA intake in 2004 (Fig. 2).

Fig. 2
Deterministic sensitivity analysis of the parameters used to estimate the impact of trans fatty acids' regulations in Argentina, 2004-2014

Discussion

Given the estimated 84 000 annual CHD events in Argentina, at an annual incidence rate of almost 500 cases per 100 000 adults older than 34 years old, the current policy of near elimination of industrial TFA might avert between 1.3% and 6.35% of CHD events each year. The decrease would save between US$ 17 million and US$ 87 million in management of CHD complications and follow-up. Even in the most conservative scenario, the reduction of TFA intake has a substantial public health impact.

Although there is limited information about the distribution of TFA intakes in subpopulations in most countries, it is likely that many subgroups, particularly low-income populations, could have mean TFA intakes considerably higher than the population mean.4141 Astrup A. The trans fatty acid story in Denmark. Atheroscler Suppl. 2006 May;7(2):43-6.http://dx.doi.org/10.1016/j.atherosclerosissup.2006.04.010PMID 16723283
http://dx.doi.org/10.1016/j.atherosclero...
There might be subpopulations that consume more industrially processed foods and fast foods with high-TFA content. Legislative strategies to ban artificial TFAs from foods have been more successful than labelling or education as shown in Austria, Denmark, Iceland, Sweden, Switzerland and USA.9Angell SY, Silver LD, Goldstein GP, Johnson CM, Deitcher DR, Frieden TR, et al. Cholesterol control beyond the clinic: New York City's trans fat restriction. Ann Intern Med. 2009 Jul 21;151(2):129-34.http://dx.doi.org/10.7326/0003-4819-151-2-200907210-00010PMID 19620165
http://dx.doi.org/10.7326/0003-4819-151-...
),(4141 Astrup A. The trans fatty acid story in Denmark. Atheroscler Suppl. 2006 May;7(2):43-6.http://dx.doi.org/10.1016/j.atherosclerosissup.2006.04.010PMID 16723283
http://dx.doi.org/10.1016/j.atherosclero...

42 O'Keeffe C, Kabir Z, O'Flaherty M, Walton J, Capewell S, Perry IJ. Modelling the impact of specific food policy options on coronary heart disease and stroke deaths in Ireland. BMJ Open. 2013;3(7):e002837.PMID 23824313
-4343 Downs SM, Thow AM, Leeder SR. The effectiveness of policies for reducing dietary trans fat: a systematic review of the evidence. Bull World Health Organ. 2013 Apr 1;91(4):262-9H.http://dx.doi.org/10.2471/BLT.12.111468PMID 23599549
http://dx.doi.org/10.2471/BLT.12.111468...
In Denmark, the ban on artificial TFAs is thought to have played some part in the decrease of CHD.1111 L'Abbé M, Stender S, Skeaff CM, Ghafoorunissa, Tavella M. Approaches to removing trans fats from the food supply in industrialized and developing countries.. Eur J Clin Nutr 2009;63:S50-67.http://dx.doi.org/10.1038/ejcn.2009.14
http://dx.doi.org/10.1038/ejcn.2009.14...

WHO has identified removal of artificial TFAs from the food supply as an intervention with favourable return of invested money to reduce the economic impact of noncommunicable diseases in low- and middle-income countries.4444 World Economic Forum, World Health Organization. From burden to "best buys": reducing the economic impact of non-communicable diseases in low- and middle-income countries. Geneva: World Economic Forum; 2011. Available from:Available from:http://www.who.int/nmh/publications/best_buys_summary.pdf [cited 2015 April 16].
http://www.who.int/nmh/publications/best...
However, most such countries have not yet included the restriction of TFAs' intake as a policy. Governments have been concerned about the feasibility, achievability and public health effect of removing them from the food supply. Thus, little is known about the potential effects on the reduction of CHD burden and cost savings that could be attributable to the implementation of TFA-reduction policies in these countries. Some middle-income countries such as Brazil,5Colon-Ramos U, Monge-Rojas R, Campos H. Impact of WHO recommendations to eliminate industrial trans-fatty acids from the food supply in Latin America and the Caribbean. Health Policy Plan. 2014;Aug 29(5):529-41.PMID 24150503Costa Rica,5Colon-Ramos U, Monge-Rojas R, Campos H. Impact of WHO recommendations to eliminate industrial trans-fatty acids from the food supply in Latin America and the Caribbean. Health Policy Plan. 2014;Aug 29(5):529-41.PMID 24150503India4545 Downs SM, Thow AM, Ghosh-Jerath S, McNab J, Reddy KS, Leeder SR. From Denmark to Delhi: the multisectoral challenge of regulating trans fats in India.. Public Health Nutr 2013 Dec;16(12):2273-80.http://dx.doi.org/10.1017/S1368980012004995PMID 23164094
http://dx.doi.org/10.1017/S1368980012004...
and Mexico5Colon-Ramos U, Monge-Rojas R, Campos H. Impact of WHO recommendations to eliminate industrial trans-fatty acids from the food supply in Latin America and the Caribbean. Health Policy Plan. 2014;Aug 29(5):529-41.PMID 24150503are following the Argentine example and are introducing policy and surveillance systems to monitor the content of TFA in foods.

A study modelling a legislative intervention to reduce artificial TFA to 0.5% of total energy intake in the United Kingdom of Great Britain and Northern Ireland, estimated that approximately 2700 deaths annually would be prevented, saving the equivalent of approximately 235 million pounds sterling a year.4646 Barton P, Andronis L, Briggs A, McPherson K, Capewell S. Effectiveness and cost effectiveness of cardiovascular disease prevention in whole populations: modelling study. BMJ. 2011;343 jul28 1:d4044.http://dx.doi.org/10.1136/bmj.d4044PMID 21798967
http://dx.doi.org/10.1136/bmj.d4044...
Another modelling study estimated a similar potential impact of this policy in Ireland.4747 O'Keeffe C, Kabir Z, O 'Flaherty M, Walton J, Capewell S, Perry IJ. Modelling the impact of specific food policy options on coronary heart disease and stroke deaths in Ireland.. BMJ Open 2013;3(7):e002837. PMID 23824313Unlike these studies, our model is based on individual data on CHD risk from an Argentine population-based sample, calibrated with national statistics, as well as with local data on dietary fat profiles. Moreover, our study is modelling the impact of a policy that is being implemented.

Potential limitations of this study should be considered. First, to calculate CHD risk in Argentina we used a cardiovascular risk calculator.3030 Cardiovascular risk calculator [Internet]. Edinburgh: University of Edinburgh; 2010. Available from:Available from:http://cvrisk.mvm.ed.ac.uk/calculator/excelcalc.htm [cited 2013 March 5].
http://cvrisk.mvm.ed.ac.uk/calculator/ex...
The calculator is based on equations developed a couple of decades ago when the CHD incidence was higher. This could overestimate absolute risk in light of secular trends towards lower CHD risk.4848 de Fatima Marinho de Souza M, Gawryszewski VP, Ordu ñez P, Sanhueza A, Espinal MA. Cardiovascular disease mortality in the Americas: current trends and disparities. Heart. 2012 Aug;98(16):1207 -12.http://dx.doi.org/10.1136/heartjnl-2012-301828PMID 22826558
http://dx.doi.org/10.1136/heartjnl-2012-...
On the other hand, these risk equations are widely validated for predicting CHD risk. Overestimation would not likely influence our estimates of proportional risk reduction, since relative risks were calibrated with Argentine absolute risks. Second, we used the global percentage estimates to adjust for underreporting of mortality from CHD. Third, costs of food reformulation by industry were not considered, based on our health system perspective. Yet, potential incremental costs for industry to reduce artificial TFA may be at least partly offset by higher pricing or sales due to marketing advantages.1111 L'Abbé M, Stender S, Skeaff CM, Ghafoorunissa, Tavella M. Approaches to removing trans fats from the food supply in industrialized and developing countries.. Eur J Clin Nutr 2009;63:S50-67.http://dx.doi.org/10.1038/ejcn.2009.14
http://dx.doi.org/10.1038/ejcn.2009.14...
In the USA, switching to newer frying oils that were free of TFA was cost neutral.3838 Murray CJ, Acharya AK. Understanding DALYs (disability-adjusted life years). J Health Econ. 1997 Dec;16(6):703-30.http://dx.doi.org/10.1016/S0167-6296(97)00004-0PMID 10176780
http://dx.doi.org/10.1016/S0167-6296(97)...
Fourth, we did not have precise data on baseline TFA, the level of which would influence results. Conversely, our nutritional inputs, particularly those related to the TFA baseline intake before 2004, and the partially hydrogenated vegetable oils' replacements used by the industry thereafter, were obtained after a thorough literature search for sources of TFA in Argentina. This information was reviewed by experts to reach consensus on information gaps to derive a reasonable central estimate and appropriate upper and lower bounds.

In conclusion, our findings suggest that artificial TFA reduction interventions, as an example of a nutritional policy aimed to reach the overall population, have beneficial impact on the total burden of CHD in Argentina. These findings will help inform decision-makers in both Argentina and other countries on the potential public health and economic impact of this policy.

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Publication Dates

  • Publication in this collection
    Sept 2015

History

  • Received
    16 Nov 2014
  • Reviewed
    15 Mar 2015
  • Accepted
    10 Apr 2015
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