Million Hearts® and Sodium: Best Practices and Opportunities August 22, 2013 2:00pm - 3:00pm

1. Million Hearts® and Sodium:Best Practices and Opportunities August 22, 2013 2:00pm - 3:00pm

2. Welcome & Overview Jill Birnbaum, JDVice President, State Advocacy & Public HealthAmerican Heart Association

3. Agenda

4. AHA Sodium Conference Highlights Emily Ann Miller, MPH, RDNational Program Lead, Sodium Reduction InitiativeAmerican Heart Association

5. Date: June 19-20, 2013; Arlington, VA • Attendees: 140 stakeholders from various sectors • Purpose: • Create an interactive and collaborative environment to discuss the status and future implications of reducing sodium in the food supply and to identify opportunities for stakeholder collaboration. • Not intended to debate the appropriate level of sodium intake, i.e. 2,300mg vs. 1,500mg, rather, to coalesce around our common ground

6. Planning Committee Elliott Antman, MD, Brigham and Women’s Hospital and Harvard Medical School – AHA President-Elect Larry Appel, MD, MPH, Johns Hopkins University – Chair, Sodium Reduction Advisory Task Force Doug Balentine, PhD, Unilever – Chair, Industry Nutrition Advisory Panel Rachel Johnson, PhD, MPH, RD, University of Vermont – Chair, Nutrition Committee Lyn Steffen, PhD, MPH, RD, University of Minnesota– EPI Council Liaison to Nutrition Committee

7. Objectives Assess the current status and future implications of efforts to reduce sodium in the food supply. Leverage expertise from different disciplines to identify and evaluate sodium reduction strategies; address opportunities and challenges. Discuss ways to translate sodium reduction strategies into practical application. Identify short-term and long-term goals sodium reduction goals and factors that impact timelines for achieving these goals. Identify collaboration opportunities among stakeholders. Identify metrics and methodologies for evaluating the collective impact of sodium reduction efforts on the food supply and on health outcomes.

8. Agenda • Plenary Sessions • Science behind sodium reduction and public health recommendations • Measurement of sodium intakes • Consumer knowledge, attitudes, and behaviors re: sodium • Food technology and solutions for sodium reduction • Food industry experiences and perspectives • Potential policy and education strategies for sodium reduction • Breakout sessions

9. Breakout Sessions Opportunity for participants to contribute their expertise and thoughts Intended to identify areas that are ripe for further investigation and possibly, future action 4 facilitator-led breakout groups Major takeaways from presentations; key determinants of success; guiding principles for future actions; most promising solutions and how to overcome their potential barriers; roles for various sectors

10. Themes from Breakout Sessions Complexity Commitment Collaboration Communication Consistency Common Ground

11. Themes from Breakout Sessions • Complexity • Sodium reduction involves much more than just taking out the salt • Commitment • It will be a long term effort; some progress has been made but there is much more work ahead; lowering sodium in the food supply is critical • Collaboration • It is imperative to have simultaneous, multi-sector efforts • Communication/Consistency • We need simple, positive, consistent messages that are culturally-appropriate and come from multiple voices • Common Ground • Incorporate sodium as part of a total health/total diet approach and reap multiple benefits for cardiovascular health

12. Conference Proceedings Proceedings to be published in an AHA journal Estimated timing: January 2014 THANK YOU! Emily Ann Miller, MPH, RD emilyann.miller@heart.org

13. Sodium Intake in Populations: Assessment of Evidence, 2013 IOM Report Cheryl Anderson, PhD, MPH, MSAssociate Professor, Department of Family and  Preventive MedicineUniversity of California San Diego School of Medicine

14. Sodium Intake in Populations: Assessment of Evidence

15. Statement of Task • Evaluate the results, study design, and methodological approaches to assessing the relationship between sodium and health outcomes in the literature since 2003. • Evaluate potential benefits/adverse impacts of reduced population sodium intake (i.e. 1,500 – 2,300 mg/day) in the population generally and for population subgroups (those with hypertension and prehypertension, those 51 years of age and older, African Americans, and those with diabetes, chronic kidney disease, and congestive heart failure). • Comment on the implications for population-based strategies to reduce sodium intake. • Identify data and methods gaps and suggest ways to address them.

16. Step 1: Literature Search

17. Step 2: Review and Evaluation of Studies • Criteria: • Generalizability to the populations of interest • General U.S. population • Subgroups (hypertensive/prehypertensive, 51 years and older, African American, those with diabetes, chronic kidney disease, and congestive heart failure) • Methodological appropriateness • Study design • Quantitative measures of dietary sodium intake • Confounder adjustment • Number and consistency of relevant studies available

18. Factors that Impacted Evaluation • Variability in the types and quality of measures used in observational studies and clinical trials • Lack of consistency among studies in the methods used for defining sodium intakes at both high and low ends of the range of typical intakes • Extreme variability in intake levels between and among population groups • precluded the committee from establishing a “healthy” intake range. • Committee could consider sodium intake levels only within the context of each individual study.

19. Overarching Findings • Many populations evaluated were outside the US • included groups that consumed mean levels of sodium much higher than the average amount consumed by adults in the US • The quantity and quality of relevant studies was less than optimal • limitations associated with the quantitative measures of sodium intake • potential for spurious findings related to incorrect measurement and reverse causality • Variability in the types and quality of measures used, so that measures could not be reliably calibrated across studies

20. Findings and Conclusions • General Population • Finding1:Results from studies linking dietary sodium intake with direct health outcomes were highly variable in methodological quality, particularly in assessing sodium intake. The range of limitations included over- or under-reporting of intakes or incomplete collection of urine samples. In addition, variability in data collection methodologies limited the committee’s ability to compare results across studies. • Conclusion1:Given the methodological flaws and limitations, when considered collectively, the evidence indicates a positive relationship between higher levels of sodium intake and risk of CVD. This evidence is consistent with existing evidence on blood pressure as a surrogate indicator of CVD risk.

21. General Population • Finding2:Evidence from studies on direct health outcomes was insufficient and inconsistent regarding an association between sodium intake below 2,300 mg per day and benefit or risk of CVD outcomes (including stroke and CVD mortality) or all-cause mortality in the general US population. • Conclusion2:Evidence from studies on direct health outcomes is inconsistent and insufficient to conclude that lowering sodium intakes below 2,300 mg/day either increases or decreases risk of CVD outcomes (including stroke and CVD mortality) or all-cause mortality in the general U.S. population.

22. Population Subgroups • Finding1:Evidence from multiple randomized controlled trials (RCTs) that were conducted by a single investigative team indicated that low sodium intake (e.g., to 1,840 mg/day) may lead to greater risk of adverse events in congestive heart failure (CHF) patients with reduced ejection fraction and who are receiving certain aggressive therapeutic regimens. This association also is supported by one observational study where low sodium intake levels in patients with CVD and diabetes were associated with higher risk of CHF events. • Conclusion1:Evidence suggests that low sodium intakes may lead to higher risk of adverse events in mid- to late-stage CHF patients with reduced ejection fraction and who are receiving aggressive therapeutic regimens. Because these therapeutic regimens were very different than current standards of care in the US, the results may not be generalizable. Similar studies in other settings and using regimens more closely resembling those in standard U.S. clinical practice are still needed.

23. Population Subgroups • Finding2:Data among prehypertensive participants from two related studies provided some evidence suggesting a continued benefit of lowering sodium intake in these patients down to 2,300 mg per day (and lower, although based on small numbers in the lower range). No evidence was found for benefit and some evidence suggesting risk of adverse health outcomes associated with sodium intake levels in ranges approximating 1,500 to 2,300 mg per day in other disease-specific population subgroups (those with diabetes, chronic kidney disease (CKD), or pre-existing CVD).

24. Population Subgroups • Finding2: In addition to inconsistencies in sodium intake measures, methodological flaws included the possibility of confounding and reverse causality. No relevant evidence was found on health outcomes for other population subgroups considered (i.e., persons 51 years of age and older, and African Americans). In studies that explored interactions, race, age, or the presence of hypertension or diabetes did not change the effect of sodium on health outcomes.

25. Population Subgroups • Conclusion2:With the exception of CHF patients, the current body of evidence addressing the association between low sodium intake and health outcomes in the population subgroups considered is limited. The evidence available is inconsistent and limited in its approaches to measuring sodium intake. The evidence also is limited by small numbers of health outcomes and the methodological constraints of observational study designs, including the potential for reverse causality and confounding.

26. Population Subgroups • Conclusion2: While the current literature provides some evidence for adverse health effects of low sodium intake among individuals with diabetes, CKD, or pre-existing CVD, the evidence on both the benefit and harm is not strong enough to indicate that these subgroups should be treated differently from the general U.S. population. Thus, the evidence on direct health outcomes does not support prior recommendations to lower sodium intake within these subgroups to, or even below, 1,500 mg/day.

27. Implications for Population-based Strategies • The available evidence on associations between sodium intake and direct health outcomes is consistent with population-based efforts to lower excessive dietary sodium intakes, but it is not consistent with efforts that encourage lowering of dietary sodium in the general population to 1,500 mg/day. • The evidence reviewed also suggests that dietary sodium intake may affect heart disease risk through pathways in addition to blood pressure.

28. Implications for Population-based Strategies • Further research may shed more light on the association between lower (1,500 to 2,300 mg) levels of sodium and health outcomes in the general population and subpopulations.  • The committee was not asked to draw conclusions about a specific target range of dietary sodium.  Other factors also precluded specifying a such range. These included methodologic problems in assessing sodium intake and difficulty calibrating those measures across different approaches to measuring intake and different study designs.

29. Committee • BRIAN L. STROM (Chair),University of Pennsylvania • CHERYL A.M. ANDERSON, University of California San Diego • JAMY ARD, Wake Forest Baptist Health • KIRSTEN BIBBINS-DOMINGO, University of California San Francisco • NANCY R. COOK, Brigham & Women’s Hospital • MARY KAY FOX,Mathematica Policy Research • NIELS GRAUDAL, Copenhagen University Hospital • JIANG HE, Tulane University • JOACHIM IX, Veterans Affairs San Diego Healthcare System • STEPHEN E. KIMMEL, University of Pennsylvania • ALICE H. LICHTENSTEIN, Tufts University • MYRON WEINBERGER, Indiana University

30. Future Direction of Procurement Policy Laurie Whitsel, PhDDirector of Policy ResearchAmerican Heart Association

31. The AHA’s 2010-2014 Strategic Policy Agenda Focuses on Achieving our 2020 Goals

32. Procurement Increasing attention on the importance of creating healthier work environments and healthier food options to the public in different settings.

33. Procurement • Potential Environments • government buildings • hospital systems • college/university campuses • Schools/child care centers • assisted living facilities • faith-based organizations • private corporations • theme parks/resorts • prisons • non-profit organizations

34. Procurement • Targets for nutrition standards for food and beverage procurement • Vending machines • Cafeterias • Concession stands • Meetings/conferences • Organizational events

35. Procurement • Numerous existing model standards • AHA • HHS/Federal Government • Municipal governments • National Alliance for Nutrition and Activity • Alliance for a Healthier Generation

36. Forthcoming AHA Paper • Will address such issues as: • Existing model standards • Barriers to implementation • Legal issues • Case studies • Importance of Evaluation

37. The Future of Procurement Policy Where do we go from here?

38. Procurement • A relatively new area of policy development • Will require an assessment of the impact of the numerous existing policies across the U.S. • Consistent evaluation for • Purchasing behavior • Availability of healthy food in purchasing • Affordability/Cost Issues • Health impact • Levels of adoption • Industry response

39. Million Hearts® Support and Engagement John ClymerExecutive DirectorNational Forum for Heart Diseaseand Stroke Prevention

40. The Million Hearts®Initiative • National initiative co-led by CDC and CMS • Partners across federal, state, and local government and private organizations Goal: Prevent 1 million heart attacks and strokes in 5 years

41. CDC Million Hearts®Collaboration • American Heart Association • National Forum for Heart Disease & Stroke Prevention • Association of State and Territorial Health Officials • National Association of City County Health Officials • National Association of Chronic Disease Directors

42. Key Components • Improve care for people who need treatment by encouraging a targeted focus on the “ABCS” • Empower Americans to make healthy choices such as not using tobacco and reducing sodium and trans fat consumption

43. Actions You Can Take • Align existing initiatives and programs with Million Hearts® goals • Convene partners, stakeholders, and policy makers for Million Hearts® for planning purposes • Share success stories on Million Hearts®

44. Ways to Use MillionHearts® to Achieve Your 0rganizations goals • Join Community Commons – Connect, Share, and Collaborate on Million Hearts® Activities • Become a Million Hearts® Partner • Pledge Support on the Million® Hearts Website – Be One in a Million Hearts®

45. State Engagement Guide • Includes information on the initiative • Ways to use Million Hearts® to achieve your organization’s goals • Lessons learned and key recommendations, Workshop descriptions • Examples, resources, and information on how the Collaboration organizations can assist in working with Million Hearts®

46. National Forum Members / Million Hearts® Partners • American College of Cardiology • American Heart Association • American Medical Group Foundation • Association of Black Cardiologists, Inc. • Association of State and Territorial Health Officials • Centers for Disease Control and Prevention • Health Resources and Services Administration • Indian Health Service • National Association of Chronic Disease Directors • National Association of County and City Health Officials • National Heart, Lung, and Blood Institute • National Lipid Association • Preventive Cardiovascular Nurses Association • U.S. Department of Health and Human Services • U.S. Department of Veterans Affairs, Ischemic Heart Disease Quality Enhancement Research Initiative • U.S. Food and Drug Administration, Office of Women's Health • WomenHeart • YMCA

47. Questions & Answers Jill Birnbaum, JDVice President, State Advocacy & Public HealthAmerican Heart Association

48. AHA Activities

49. Thank You! For more information, please visit millionhearts.hhs.gov www.nationalforum.org www.heart.org