Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation cost-effectiveness analysis

1. Micha R, Penalvo JL, Cudhea F, Imamura F, Rehm CD, Mozaffarian D. association between dietary factors and mortality from heart disease, stroke, and type 2 diabetes in the United States. JAMA. 2017;317(9):912–24. doi: 10.1001/jama.2017.0947 28267855

2. Mozaffarian D, Fahimi S, Singh GM, Micha R, Khatibzadeh S, Engell RE, et al. Global sodium consumption and death from cardiovascular causes. N Engl J Med. 2014;371(7):624–34. doi: 10.1056/NEJMoa1304127 25119608

3. Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, et al. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133(4):e38–360. doi: 10.1161/CIR.0000000000000350 26673558

4. Khavjou O, Phelps D, Leib A. Projections of cardiovascular disease prevalence and costs: 2015–2035. Dallas: American Heart Association; 2016 [cited 2018 Mar 12]. Available from: http://www.heart.org/idc/groups/ahaecc-public/@wcm/@global/documents/downloadable/ucm_491130.pdf.

5. Dietary Guidelines Advisory Committee. Scientific report of the 2015 Dietary Guidelines Advisory Committee. Washington (DC): US Department of Health and Human Services; 2015 [cited 2018 Mar 12]. Available from: http://health.gov/dietaryguidelines/2015-scientific-report/pdfs/scientific-report-of-the-2015-dietary-guidelines-advisory-committee.pdf.

6. Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, et al. Sources of sodium in US adults from 3 geographic regions. Circulation. 2017;135(19):1775–83. doi: 10.1161/CIRCULATIONAHA.116.024446 28483828

7. Mattes RD, Donnelly D. Relative contributions of dietary sodium sources J Am Coll Nutr. 1991;10(4):383–93. 1910064

8. Hyseni L, Elliot-Green A, Lloyd-Williams F, Kypridemos C, O’Flaherty M, McGill R, et al. Systematic review of dietary salt reduction policies: evidence for an effectiveness hierarchy? PLoS ONE. 2017;12(5):e0177535. doi: 10.1371/journal.pone.0177535 28542317

9. Food and Drug Administration. Draft guidance for industry: voluntary sodium reduction goals: target mean and upper bound concentrations for sodium in commercially processed, packaged, and prepared foods. Silver Spring: Food and Drug Administration; 2016.

10. Bibbins-Domingo K, Chertow GM, Coxson PG, Moran A, Lightwood JM, Pletcher MJ, et al. Projected effect of dietary salt reductions on future cardiovascular disease. N Engl J Med. 2010;362(7):590–9. doi: 10.1056/NEJMoa0907355 20089957

11. Pearson-Stuttard J, Bandosz P, Rehm CD, Penalvo J, Whitsel L, Gaziano T, et al. Reducing US cardiovascular disease burden and disparities through national and targeted dietary policies: a modelling study. PLoS Med. 2017;14(6):e1002311. doi: 10.1371/journal.pmed.1002311 28586351

12. Pearson-Stuttard J, Bandosz P, Rehm CD, Afshin A, Penalvo JL, Whitsel L, et al. Comparing effectiveness of mass media campaigns with price reductions targeting fruit and vegetable intake on US cardiovascular disease mortality and race disparities. Am J Clin Nutr. 2017;106(1):199–206. doi: 10.3945/ajcn.116.143925 28566311

13. National Center for Health Statistics. National Health and Nutrition Examination Survey data 2011–2014. Atlanta: Centers for Disease Control and Prevention; 2014.

14. Centers for Disease Control and Prevention. CDC WONDER: bridged-race population estimates 1990–2014 request. Atlanta: Centers for Disease Control and Prevention; 2017 [cited 2017 Feb 11]. Available from: https://wonder.cdc.gov/Bridged-Race-v2014.HTML.

15. Centers for Disease Control and Prevention. CDC WONDER: national population projections 2014–2060 request. Atlanta: Centers for Disease Control and Prevention; 2017 [cited 2017 Feb 11]. Available from: https://wonder.cdc.gov/population-projections-2014-2060.html.

16. Centers for Disease Control and Prevention. CDC WONDER: about underlying cause of death, 1999–2016. Atlanta: Centers for Disease Control and Prevention; 2017 [cited 2017 Apr 18]. Available from: https://wonder.cdc.gov/ucd-icd10.html.

17. Centers for Disease Control and Prevention National Center for Health Statistics. National Health and Nutrition Examination Survey: continuous NHANES. Atlanta: Centers for Disease Control and Prevention; 2016 [cited 2016 Nov 15]. Available from: https://wwwn.cdc.gov/nchs/nhanes/ContinuousNhanes/.

18. Stringhini S, Carmeli C, Jokela M, Avendano M, Muennig P, Guida F, et al. Socioeconomic status and the 25 x 25 risk factors as determinants of premature mortality: a multicohort study and meta-analysis of 1.7 million men and women. Lancet. 2017;389(10075):1229–37. doi: 10.1016/S0140-6736(16)32380-7 28159391

19. Singh GM, Danaei G, Farzadfar F, Stevens GA, Woodward M, Wormser D, et al. The age-specific quantitative effects of metabolic risk factors on cardiovascular diseases and diabetes: a pooled analysis. PLoS ONE. 2013;8(7):e65174. doi: 10.1371/journal.pone.0065174 23935815

20. Sullivan PW, Ghushchyan V. Preference-based EQ-5D index scores for chronic conditions in the United States. Med Decis Making. 2006;26(4):410–20. doi: 10.1177/0272989X06290495 16855129

21. Joo H, Dunet DO, Fang J, Wang G. Cost of informal caregiving associated with stroke among the elderly in the United States. Neurology. 2014;83(20):1831–7. doi: 10.1212/WNL.0000000000000986 25305152

22. Leal J, Luengo-Fernandez R, Gray A, Petersen S, Rayner M. Economic burden of cardiovascular diseases in the enlarged European Union. Eur Heart J. 2006;27(13):1610–9. doi: 10.1093/eurheartj/ehi733 16495286

23. Department of Health and Human Services, Food and Drug Administration. Justification of estimates for appropriations committees. Fiscal year 2012. Silver Spring: Food and Drug Administration; 2012 [cited 2018 Mar 14]. Available from: http://wayback.archive-it.org/7993/20180126110704/https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM243370.pdf.

24. Collins M, Mason H, O’Flaherty M, Guzman-Castillo M, Critchley J, Capewell S. An economic evaluation of salt reduction policies to reduce coronary heart disease in England: a policy modeling study. Value Health. 2014;17(5):517–24. doi: 10.1016/j.jval.2014.03.1722 25128044

25. Muth MK, Bradley S, Brophy J, Capogrossi K, Karns S, Viator C. Reformulation cost model. Contract No. HHSF-223-2011-10005B, Task Order 20. Final report. Research Triangle Park (NC): RTI International; 2015.

26. Kypridemos C, Guzman-Castillo M, Hyseni L, Hickey GL, Bandosz P, Buchan I, et al. Estimated reductions in cardiovascular and gastric cancer disease burden through salt policies in England: an IMPACTNCD microsimulation study. BMJ Open. 2017;7(1):e013791. doi: 10.1136/bmjopen-2016-013791 28119387

27. Alfons A, Kraft S, Templ M, Filzmoser P. Simulation of close-to-reality population data for household surveys with application to EU-SILC. Stat Methods Appl. 2011;20(3):383–407.

28. Barendregt JJ, Van Oortmarssen GJ, Vos T, Murray CJ. A generic model for the assessment of disease epidemiology: the computational basis of DisMod II. Popul Health Metr. 2003;1(1):4. doi: 10.1186/1478-7954-1-4 12773212

29. Smolina K, Wright FL, Rayner M, Goldacre MJ. Determinants of the decline in mortality from acute myocardial infarction in England between 2002 and 2010: linked national database study. BMJ. 2012;344:d8059. doi: 10.1136/bmj.d8059 22279113

30. Young F, Capewell S, Ford ES, Critchley JA. Coronary mortality declines in the U.S. between 1980 and 2000 quantifying the contributions from primary and secondary prevention. Am J Prev Med. 2010;39(3):228–34. doi: 10.1016/j.amepre.2010.05.009 20709254

31. Unal B, Critchley JA, Capewell S. Explaining the decline in coronary heart disease mortality in England and Wales between 1981 and 2000. Circulation. 2004;109(9):1101–7. doi: 10.1161/01.CIR.0000118498.35499.B2 14993137

32. Ford ES, Ajani UA, Croft JB, Critchley JA, Labarthe DR, Kottke TE, et al. Explaining the decrease in U.S. deaths from coronary disease, 1980–2000. N Engl J Med. 2007;356(23):2388–98. doi: 10.1056/NEJMsa053935 17554120

33. Strazzullo, D’Elia L, Kandala NB, Cappuccio FP. Salt intake, stroke, and cardiovascular disease: meta-analysis of prospective studies. BMJ. 2009;339:b4567. doi: 10.1136/bmj.b4567 19934192

34. Ioannidis JP. Commentary: salt and the assault of opinion on evidence. Int J Epidemiol. 2016;45(1):264–5. doi: 10.1093/ije/dyw015 26888871

35. Mente A, O’Donnell M, Rangarajan S, Dagenais G, Lear S, McQueen M, et al. Associations of urinary sodium excretion with cardiovascular events in individuals with and without hypertension: a pooled analysis of data from four studies. Lancet. 2016;388(10043):465–75. doi: 10.1016/S0140-6736(16)30467-6 27216139

36. O’Donnell M, Mente A, Rangarajan S, McQueen MJ, Wang X, Liu L, et al. Urinary sodium and potassium excretion, mortality, and cardiovascular events. N Engl J Med. 2014;371(7):612–23. doi: 10.1056/NEJMoa1311889 25119607

37. Cogswell ME, Mugavero K, Bowman BA, Frieden TR. Dietary sodium and cardiovascular disease risk—measurement matters. N Engl J Med. 2016;375(6):580–6. doi: 10.1056/NEJMsb1607161 27248297

38. Taylor R, Najafi F, Dobson A. Meta-analysis of studies of passive smoking and lung cancer: effects of study type and continent. Int J Epidemiol. 2007;36(5):1048–59. doi: 10.1093/ije/dym158 17690135

39. Aburto NJ, Ziolkovska A, Hooper L, Elliott P, Cappuccio FP, Meerpohl JJ. Effect of lower sodium intake on health: systematic review and meta-analyses. BMJ. 2013;346:f1326. doi: 10.1136/bmj.f1326 23558163

40. Lawes CMM, Vander Hoorn S, Law MR, Elliott P, MacMahon S, Rodgers A. Chapter 6: high blood pressure. In: Ezzati M, Lopez AD, Rodgers A, Murray CJL, editors. Comparative quantification of health risks. Geneva: World Health Organization; 2004 [cited 2018 Mar 12]. Available from: http://www.who.int/publications/cra/en/.

41. Food and Drug Administration. FNDDS mapping file request 082516. Silver Spring: Food and Drug Administration; 2016 [cited 2018 Mar 20]. Available from: https://www.regulations.gov/document?D=FDA-2014-D-0055-0410.

42. Neumann P, Sanders G, Russell L, Siegel J, Ganiats T. Cost-effectiveness in health and medicine. Oxford: Oxford University Press; 2016.

43. Neumann PJ, Cohen JT, Weinstein MC. Updating cost-effectiveness—the curious resilience of the $50,000-per-QALY threshold. N Engl J Med. 2014;371(9):796–7. doi: 10.1056/NEJMp1405158 25162885

44. Groot Koerkamp B, Stijnen T, Weinstein MC, Hunink MG. The combined analysis of uncertainty and patient heterogeneity in medical decision models. Med Decis Making. 2011;31(4):650–61. doi: 10.1177/0272989X10381282 20974904

45. Chobanian AV. The hypertension paradox—more uncontrolled disease despite improved therapy. N Engl J Med. 2009;361(9):878–87. doi: 10.1056/NEJMsa0903829 19710486

46. Capewell S, Capewell A. An effectiveness hierarchy of preventive interventions: neglected paradigm or self-evident truth? J Public Health (Oxf). 2017. doi: 10.1093/pubmed/fdx055 28525612

47. Cook NR, Appel LJ, Whelton PK. Sodium intake and all-cause mortality over 20 years in the trials of hypertension prevention. J Am Coll Cardiol. 2016;68(15):1609–17. doi: 10.1016/j.jacc.2016.07.745 27712772

48. He FJ, MacGregor GA. Reducing population salt intake worldwide: from evidence to implementation. Prog in Cardiovasc Dis. 2010;52(5):363–82. doi: 10.1016/j.pcad.2009.12.006 20226955

49. Levings JL, Cogswell ME, Gunn JP. Are reductions in population sodium intake achievable? Nutrients. 2014;6(10):4354–61. doi: 10.3390/nu6104354 25325254

50. Dotsch M, Busch J, Batenburg M, Liem G, Tareilus E, Mueller R, et al. Strategies to reduce sodium consumption: a food industry perspective. Crit Rev Food Sci Nutr. 2009;49(10):841–51. doi: 10.1080/10408390903044297 19960392

51. Beauchamp GK, Bertino M, Engelman K. Failure to compensate decreased dietary sodium with increased table salt usage. JAMA. 1987;258(22):3275–8. 3682116

52. Janssen AM, Kremer S, van Stipriaan WL, Noort MW, de Vries JH, Temme EH. Reduced-sodium lunches are well-accepted by uninformed consumers over a 3-week period and result in decreased daily dietary sodium intakes: a randomized controlled trial. J Acad Nutr Diet. 2015;115(10):1614–25. doi: 10.1016/j.jand.2015.01.008 25769746

53. Shepherd R, Farleigh CA, Wharf SG. Limited compensation by table salt for reduced salt within a meal. Appetite. 1989;13(3):193–200. 2596842

54. Pearson-Stuttard J, Guzman Castillo M, Penalvo JL, Rehm CD, Afshin A, Danaei G, et al. Modelling future cardiovascular disease mortality in the United States: national trends and racial and ethnic disparities. Circulation. 2016;133(10):967–78. doi: 10.1161/CIRCULATIONAHA.115.019904 26846769

55. Capewell S, Kypridemos C. Socioeconomic inequalities in dietary sodium intake: upstream versus downstream interventions. Am J Public Health. 2017;107(4):499–500. doi: 10.2105/AJPH.2017.303673 28272941

56. Danaei G, Ding EL, Mozaffarian D, Taylor B, Rehm J, Murray CJ, et al. The preventable causes of death in the United States: comparative risk assessment of dietary, lifestyle, and metabolic risk factors. PLoS Med. 2009;6(4):e1000058. doi: 10.1371/journal.pmed.1000058 19399161

57. Palar K, Sturm R. Potential societal savings from reduced sodium consumption in the U.S. adult population. Am J Health Promot. 2009;24(1):49–57. doi: 10.4278/ajhp.080826-QUAN-164 19750962

58. Smith-Spangler CM, Juusola JL, Enns EA, Owens DK, Garber AM. Population strategies to decrease sodium intake and the burden of cardiovascular disease: a cost-effectiveness analysis. Ann Intern Med. 2010;152(8):481–7,W170–3. doi: 10.7326/0003-4819-152-8-201004200-00212 20194225

59. Dall TM, Fulgoni VL 3rd, Zhang Y, Reimers KJ, Packard PT, Astwood JD. Potential health benefits and medical cost savings from calorie, sodium, and saturated fat reductions in the American diet. Am J Health Promot. 2009;23(6):412–22. doi: 10.4278/ajhp.080930-QUAN-226 19601481

60. D’Elia L, Rossi G, Ippolito R, Cappuccio FP, Strazzullo P. Habitual salt intake and risk of gastric cancer: a meta-analysis of prospective studies. Clin Nutr. 2012;31(4):489–98. doi: 10.1016/j.clnu.2012.01.003 22296873

61. World Cancer Research Fund International, Continuous Update Project. Diet, nutrition, physical activity and stomach cancer. London: World Cancer Research Fund International; 2016 [cited 2018 Mar 13]. Available from: https://wcrf.org/sites/default/files/Stomach-Cancer-2016-Report.pdf.

62. Micha R, Shulkin ML, Penalvo JL, Khatibzadeh S, Singh GM, Rao M, et al. Etiologic effects and optimal intakes of foods and nutrients for risk of cardiovascular diseases and diabetes: systematic reviews and meta-analyses from the Nutrition and Chronic Diseases Expert Group (NutriCoDE). PLoS ONE. 2017;12(4):e0175149. doi: 10.1371/journal.pone.0175149 28448503