The Evidence for Populationwide Reduction in Sodium Intake: Why All the Fuss?

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The Evidence for Populationwide Reduction in Sodium Intake: Why All the Fuss? CIA-Harvard Menus of Change National Leadership Summit June 10, 2014 Cambridge, MA General Session IV Lawrence J Appel, MD, MPH C. David Molina, Professor of Medicine Director, Welch Center for Prevention, Epidemiology and Clinical Research Johns Hopkins University School of Medicine The Johns Hopkins University

Research Disclosure McCormick Science Foundation

Magnitude of the BP Epidemic 54% of strokes and 47% of coronary heart disease events attributed to elevated BP 1 26% of adults worldwide (971 million) have hypertension 2 Lifetime risk 3 of developing hypertension is 90% 1 Lawes CM Lancet 2008;371:1513 2 Kearney Lancet 2005;305:217 3 Vasan JAMA 2002; 287:1003

Big Picture: Worldwide, Elevated BP is the Leading Cause of Preventable Deaths Global health risks: http://www.who.int/healthinfo/global_burden_disease, WHO, 12/09

Systolic Blood Pressure As Sodium Intake Is Reduced, So is Blood Pressure 8.9 mmhg Typical Diet Optimal diet approach to -6.7* p<.0001 lower BP combines sodium -3.0 P<.0001 reduction and improved diet DASH Diet Sacks, NEJM 2001 1,500 2,400 3,300 Sodium Level: mg/d per day *P=0.03 for non-linearity, -2.1 vs -4.6 mmhg

Effects of Na Reduction on CVD Events

Sodium Reduction Lowers CVD Risk: Meta-Analysis of Trials Events Na/Cntl Trial TOHP I 17 / 32 TOHP II 71 / 80 Morgan 6 / 5 TONE 36 / 46 Total 130 / 163 He FJ, MacGregor GA. Lancet. 2011;378:380 382

Range of Estimated Mean Effects from 4% Na Reduction/Year for 10 Years: Life-years Added and Deaths Prevented over 10 Years Low Estimate High Estimate Person-years of life added 919,000 1,817,000 Total deaths 274,000 505,000 CHD Deaths 145,000 383,000 Stroke Deaths 30,000 83,000 Major CVD deaths 192,000 516,000 Coxson, HTN 2013;61:564-70

Why the fuss about sodium? Scientific issues specific to sodium Methodologic landmines Challenges of measuring sodium Interpretation of low diet and low urinary sodium excretion High cost of high quality sodium research in humans Other scientific issues, not specific to sodium Interpretation of unexpected j-shaped relationships in observational studies Implications of non-bp effects of BP reducing therapies

Why the fuss about sodium? Commercial interests Cheap ingredient, increases profit Role of government Evidence to guide policy Role of surrogate outcomes Level of evidence for prevention policy when clinical trials with hard outcomes cannot be done

Methodological Issues

Is Sodium Reduction Harmful? Three Lines of Evidence Adverse effects on biomarkers Plasma renin activity, sympathetic nervous system activity, glycemia, lipid levels Epidemiologic studies with inverse or j- shaped relationship Heart failure trials from a single center in Palermo, Italy

No Effect of Reducing Sodium Intake on LDL Cholesterol Typical Diet LDL-C mmol/l +0.04 P=0.3 0.0 P=0.9 DASH Diet Harsha, Hypertension 2004;43;393 1,500 2,400 3,300 Sodium Level: mg/d per day

Major Methodological Challenges in Observational Studies that Relate Sodium Intake to CVD Errors with Greatest Potential to Alter Direction of Association Systematic error in sodium assessment Reverse causality Errors with Some Potential to Alter Direction of Association Residual confounding Imbalance across groups Low follow-up rate 26 studies with 31 independent samples Errors with Potential to Lead to a False Null Random error in sodium assessment On average, 2.5 issues/study Insufficient power

Measurement of Na Intake Optimal Multiple, high quality 24 hour urine collections Suboptimal 24 hour urine collected with limited or no attention to quality control Spot, overnight or timed urines 24 hour dietary recalls Food frequency questionnaire

Hazard Ratio (HR) Case of Systematic Error Leading to Bias: Increased CVD Mortality in Persons with Lowest Na (by Quartile of Na Intake in mg/d) 3 2 1.8 1.94 1.48 P=0.03 Q1 vs Q4 1 1 0 1st 2nd 3rd 4th 1 Cohen, JGIM 2008;23:1297-302 Na Quartile of based on mg of Na/d

Evidence of Contamination in a Cohort Study 1 (NHANESIII) Reporting Increased Mortality in Persons with Low Sodium Intake on 24Hr Dietary Recall Quartile of Sodium Intake: 1 st (Lowest) 2nd 3rd 4 th (Highest) Na (mg/d) 1,501 2,483 3,441 5,497 1 Cohen, JGIM 2008;23:1297-302

Evidence of Contamination in a Cohort Study 1 (NHANESIII) Reporting Increased Mortality in Persons with Low Sodium Intake on 24Hr Dietary Recall Quartile of Sodium Intake: 1 st (Lowest) 2nd 3rd 4 th (Highest) Na (mg/d) 1,501 2,483 3,441 5,497 Energy Intake (kcal) 1,282 1,762 2,152 2,938 1 Cohen, JGIM 2008;23:1297-302

Evidence of Contamination Evidence in a Cohort of Massive Study 1 (NHANESIII) Reporting Underreporting Increased Mortality of Calorie in Persons Intake with Low Sodium Intake Leading on 24Hr to Systematic Dietary Recall Error in Estimate or Sodium Intake Quartile of Sodium Intake: 1 st (Lowest) 2nd 3rd 4 th (Highest) Na (mg/d) 1,501 2,483 3,441 5,497 Energy Intake (kcal) 1,282 1,762 2,152 2,938 BMI (kg/m 2 ) 25.8 26.4 26.3 26.6 1 Cohen, JGIM 2008;23:1297-302

J-Shaped Relationship of Total Mortality with Urine Sodium Excretion in Patients with Type 1 Diabetes Extremely low levels are most likely the result of extreme undercollection Thomas, Diabetes Care 2011: 861-6

Example of Low Sodium Excretion Related to Under-collection 78 year old women, screened for a trial No special diet 172 pounds, 5 2, BMI 31 kg/m 2 Two 24 hour urine collections required Detailed instructions provided Urine Lab Range 1st 2nd Sodium (mmol/24hr) 18 21 Volume (ml/24hr) 800 725 Creatinine (g/24 hr).63 to 2.5.41.09

Unanticipated J-Shaped Relationship: An Investigation

All Cause Mortality in Persons with Incident Diabetes (All Participants) Tobias, D. K., et al. (2014). "Body-mass index and mortality among adults with incident type 2 diabetes." N Engl J Med 370(3): 233-244.

All Cause Mortality in Persons with Incident Diabetes (Excluding Early Deaths) Tobias, D. K., et al. (2014). "Body-mass index and mortality among adults with incident type 2 diabetes." N Engl J Med 370(3): 233-244.

All Cause Mortality in Persons with Incident Diabetes (Just Never Smokers) Tobias, D. K., et al. (2014). "Body-mass index and mortality among adults with incident type 2 diabetes." N Engl J Med 370(3): 233-244.

All Cause Mortality in Persons with Incident Diabetes (Just Never Smokers, Excluding Early Deaths) Tobias, D. K., et al. (2014). "Body-mass index and mortality among adults with incident type 2 diabetes." N Engl J Med 370(3): 233-244.

TOHP Phase 3: Observational Study with No Evidence of Biases Leading to Systematic Error

Direct, Progressive Relationship of CVD with Urinary Sodium Excretion* in 2,275 Individuals with Prehypertension Cook, Circ 2014:129:981 *Based on 24 hr urine collections (median = 5)

Heart Failure Trials: The adverse impact of bad science on public policy

Effects of Lower (80 mmol/d) vs Usual (120 mmol/d) Sodium on Outcomes in Patients with Heart Failure Readmissions Readmissions or Death Paterna, Clinical Science (2008) 114, 221 230

Peculiarities of 6 Heart FailureTrials o Massive concurrent therapy o 100% High dose lasix (250 1000mg/d) o 100% ACEI (Captopril 75-150mg/d) o ~80% Spironolactone (25mg/d) o Details of dietary intervention unclear o? Just advice o Funding source mentioned in 1/6 papers o Trial registration: 1/6 papers o Two sets of trials with possibly duplicate data leading to retraction of a meta-analysis, other papers with identical text

Retraction by Heart raw data no longer available having been lost as a result of computer failure

Recommendations Sodium Intake

2010 Dietary Guidelines: Sodium Recommendation Reduce intake to less than 2300 mg/day Further reduce intake to 1500 mg/day for: Adults ages 51+ African Americans ages 2+ People ages 2+ with high blood pressure, diabetes, or chronic kidney disease

Conclusion Elevated blood pressure is the leading cause of preventable death worldwide No (minimal) debate about lowering sodium intake to 2,300 mg/d Major methodological issues limit the usefulness of recent studies as a basis for guiding policy, much less reversing recommendations

Bottom Line (Unchanged) The estimated benefits of sodium reduction are substantial and warrant major public health efforts to reduce salt intake Prevailing recommendations align with best evidence and do not warrant any change in policy

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