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Valentin Fuster, M.D., Ph.D. High Risk Population Subclinical Disease (HRP) & Post-MI (Polypill) Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No.

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1 Valentin Fuster, M.D., Ph.D. High Risk Population Subclinical Disease (HRP) & Post-MI (Polypill) Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures Dallas, Nov 13-6, 2013 No Disclosures

2 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

3 Modified from G Niccoli et. al. JACC Cardiovasc Img. 2013;6:1108 GW Stone, J Narula JACC: Cardiov. Imag. 2013:6;1124 A Arbab-Zadeh, M Nakano, R Virmani, V Fuster, et. al. Circ. 2012;125:1147 1. Vulnerable Plaque ? B) Mild at Angiography, Significant at IVUS & Pathology STABLE PLAQUE Angiogr., IVUS UNSTABLE PLAQUE Angiogr., IVUS, Pathology RUPTURED PLAQUE Pathology

4 Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease D Butler. Nature. 2011;477:261 (UN. NCD). At Present R. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030 V Fuster, BB Kelly, R Vedanthan, Circulation. 2011;123:1671

5 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

6 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

7 2. Vulnerable Patient – Non-invasive Burden A) Large Population & Silent Disease D Butler. Nature. 2011;477:261 (UN. NCD). At Present R. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030 V Fuster, BB Kelly, R Vedanthan, Circulation. 2011;123:1671

8 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

9 PESA & AWHS HRP > 55y, PESA & AWHS HRP > 55y, 40-54y, n= 8,000, FU 0,3,6 y N=6000 FU 3y 40-54y, n= 8,000, FU 0,3,6 y N=6000 FU 3y Omics (Framingham) Telomeres (S.blot, qPCR, Fresh) a). Predictive ? b). Economics ? c). Life Style & Imaging ? Pesa Systemic Score B).

10 Carotid Plaque Burden, mm 3 3D US - Manual Sweep 2D vs Transducer Focal structure into the arterial lumen of at least 0.5 mm or 50% of surrounding IMT value. 37% missed at Classical 2D CardioSCORE-R7-ApoA1, Apo B, B2M, CEA, CRP, Lp(a),Transferrin H Sillesen, P Muntendam, E Falk, V Fuster et.al JACC Imag. 2012;7:681..

11 Calcification of the Coronary Arteries (CAC)

12 1. Cross Interaction Between Carotid Plaque Area & CAC (n = 1480) (n = 1477) (n = 1479) (n = 1478) Carotid Plaque Area Quartiles IMT vs Focal: + Ilio-Femoral: +++ U Baber, R Mehran, E Falk, V Fuster et al, 2013

13 2. PESA Systemic Score With Age And Gender (N=2578, Age 40-54yo, 35% Women) LJ Jimenez Borregueva, AI Fernandez Ortiz, V Fuster et. al. 2013

14 P-value<.0001 0.0 5.0 10.0 15.0 133712291124402 High Risk 244522072023737 Intermediate Risk 204917861603555 Low Risk Number at risk 03657301095 Analysis time, Days 3a. Cumulative MACE by Framingham Score Cumulative Incidence, % U Baber, R Mehran, E Falk, V Fuster et al, 2013

15 Analysis time, Days 3b. Cumulative MACE by 2D US Carotid Plaque No PlaqueTertile 1 Tertile 2Tertile 3 0.0 5.0 10.0 05001000 Cumulative Incidence, % P-value<.0001 U Baber, R Mehran, E Falk, V Fuster et al, 2013

16 P-value<.0001 0.0 5.0 10.0 15.0 03657301095 Analysis time, Days 3c. Cumulative MACE by Coronary Calcium Score Cumulative Incidence, % CAC 0CAC 0-100 CAC 100-400CAC > 400 U Baber, R Mehran, E Falk, V Fuster et al, 2013

17 Status at follow-up examination Predicted Framingham Predicted Framingham plus score Reclassified Net correctly reclassified (%) <3%3%-6%>6% Increased risk Decreased risk Coronary artery calcium Non-Case<3% 22401030 4118157.21 3%-6% 5881465308 >6% 47180672 Case <3% 2711 29223.41 3%-6% 135927 >6% 1868 NRI 10.62 2D ultra sound Non-Case<3% 22341081 4367705.96 3%-6% 5541480327 >6% 44172683 Case <3% 2711 31205.37 3%-6% 125829 >6% 1769 NRI 11.33 4a. Reclassification: INCORRECT, CORRECT

18 CACS 4b. 2D-US Transducer + CAC Impact on Events (Intermediate FRS Group) U Baber, R Mehran, E Falk, V Fuster et al, 2013

19 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

20 PESA & AWHS HRP > 55y, PESA & AWHS HRP > 55y, 40-54y, n= 8,000, FU 0,3,6 y N=7000 FU 3y 40-54y, n= 8,000, FU 0,3,6 y N=7000 FU 3y e). Omics (Framingham) Telomeres (S.blot, qPCR, Fresh) a). Predictive ? b). Economics ? c). Life Style & Imaging ? Pesa Systemic Score C1). d). 5 More Yrs of Follow-Up

21 C2). In-vivo, Diabetic Carotid - PET/MRI RR Moustafa, J Rudd et. al. Circ Cardiov. Imag. 2010;3:536 R Corti & V Fuster EHJ 2011 (April 19) JD Spence. Circ. 2013;127:739 Diffuse: Inflammatory / Lipid – Transcr. Doppler: M-emboli / Stroke

22 C3). DBD & Traditional CV Risk Factors White Matter Lesion Volume and Cognitive Decline 1. V Novak, I Hajjar. Nat. Rev. Cardiol. 2010;7:686(HMS) 2. WB White et al.Circ 2011;124:2312 (Farmington,Yale) 3. AHA/ASA, Stroke 2011; 42:2672 - WHO - Dementia report 2012 4. JB Toledo et al. Brain July 10, 2013 5. C Russo et. al. Circ. 2013;128:1105 6. JR Kizer Circ 2013;128:1045 Ischemia affects 60 to 90% of patients with Alzheimer’s

23 C4). Aging / Senescence Cellular Telomere & Telomerase B Niemann et. al. JACC 2011; 57: 577. R Madonna, R De Caterina et. al EHJ 2011;32:1190 (Houston &Chieti, Italy) JC Kovacic, EG Nabel, V Fuster – Circ. 2011;123:1650 F Fyhrquist et al., Nat Rev Cardiol 2013; 10:274 – Healthy Lifestyle 1 3

24 Valentin Fuster, M.D., Ph.D. High Risk Population Subclinical Disease (HRP) & Post-MI (Polypill) Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures Dallas, Nov 13-6, 2013 No Disclosures

25 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

26 1) Major Documents on Global CV Health Promoting Cardiovascular Health in the Developing World; A Critical Challenge to Achieve Global Health. Ed. V Fuster and B Kelly. IOM of the Natl. Academies. Natl. Academies Press. Washington DC.2010.

27 Circ. 2011;123:1671 Scientific American, May 2014 (In Press) 2012 2) Promoting Cardiovascular Health Worldwide

28 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

29 JM Castellano, R Copeland-Halperin, V Fuster, Global Health. 2013;8:263 L Osterberg, et. al. N Engl J Med. 2005;353:487. GN Varghese et. al. Drug Benefit Trends. 2008;20:17. National Council on Patient Information and Education. August 2007. 1) Low-Compliance vs Low-Adherence Definition of Terms Compliance, Implies Passive Participation by The Patient (Life Style or Behavior, fluctuates). Adherence, Implies Active Participation by The Patient (Drugs, around the Clock)

30 2). TRIALS TARGETS FOR RISK FACTOR CONTROL? Risk Factors - Proportion of Participants at Goal % – 1 year TrialsLDLSBPDBP Hb A1C Meet Goals BaseFU BARI-2D755670521420 COURAGE515555591219 FREEDOM556353551220 Freedom, Bari-2D, Courage Investigators, 2013 (In Press) PURE (S Yusuf et al.) Lancet 2011; Aug 28 - Poor Countries,7% !!! NHANES, AHA, NHLBI-JNC-7, NHLBI-NCEP P Muntner, V Fuster et al., AHJ 2011; 161: 719

31 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

32 1) Projected Impact Of Polypill Use Among US Adults: Adherence and a 9 Year Event Rate – CAD & Stroke P Muntner, V Fuster, M Woodward et. al. Am Heart J. 2011;161:719 WHO. Adherence to Long-Term: evidence for Action, 2003 S Schuster et.al. Z Kardiol.1997;86:273- N Danchin et.al AHJ 2005;150:1147

33 New England Health Institute (NEHI) Research Brief: August 2009. MC Roebuck, et al. Health Aff. 2011;30(1):91 – MI-FREE AHA Nov 2011 2) The Cost of Low-Adherence in the US could be up to $300 Billion Each Year Medication Adherence May Lead to Lower Health Care Use and Costs Despite Increased Drug Spending

34 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

35 1) TENETS OF LOW ADHERENCE TO MEDICATIONS –“NO” 1.There is no such thing as a “non-adherent personality.” 1 2.Patients - 83%- don’t tell physicians of their adherence. Physicians -74%- believe their patients are adherent. 2 3.Adherence to prescription medications is largely not related to compliance or self-care and lifestyle. 3 4.Effects of demographics - age, gender, education, & income - on adherence are small. 4 1 D Hevey. 2007 2 KL Lapane Am J Manag Care 2007;13:613 - AL Goldberg, Soc Sci Med 1998;47:1873 3 CA McHurney, Curr Med Res Opin 2009; 25:21 4 MR DiMateo, Med Care 2004; 42:200

36 2) TENETS OF LOW ADHERENCE TO MEDICATIONS –“YES” 5.Patients want to know why the medication is prescribed, duration, possible side effects, what could happen if they don’t take it, and cost / affordability. 5 6.Health care professionals should communicate less poorly on prescription medications - av. 49 sec, appropiate 3%. 6 7.Taking medications is a decision-making process. Patients actively decide about their medications. 7 5 CA McHurney, Cur Med Res Opin 2009;25:215 BJ Bailey, Progr Cardiov Nurs 1997; 12:23 - DK Ziegler, Arch Int Med 2001;161:706 6 DM Tarn, Patient Educ Cours 2008; 72:311, Arch Int Med 2006; 166:1855 7 SL William, Clin Interv Aging 2007; 25:453

37 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

38 CA McHorney. Curr Med Res Opin. 2009;25(1):215 Medication Adherence. Merck 2011. 1).The Adherence Estimator For a New Prescription Concerns Commitment Cost

39 Medication Adherence. Merck 2011. 2). Who Should Focus on These Patients and Promote Adherence

40 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

41 1) CNIC-FERRER POLYPILL FOR 2ary PREVENTION. G Sanz, V Fuster Am. H J 2011;162:811 Semin.Thor.Cardiov.Surg 2011;23:24 Nature Rev Cardiology, 2013-In Press ASA, Statin, ACE-Inhibitor Argentina Brazil Paraguay Italy Spain FOCUS 1 & 2 UMPIRE: High Risk, Two Polypills as FOCUS +Hctz or Atenolol vs Usual Care 86% Adherence vs 65%, Lower BP and LDL-C - Events NS --- JAMA 2013;310:918

42 2). POLYPILL STUDIES PUBLISHED OR IN COURSE CompanyPolypillActive components Red Heart Pill 1ASA 75 mg, Lisinopril 10 mg, Dr Reddy’s Secondary PreventionSimv. 20 mg, Aten. 50 mg India UMPIRE Red Heart Pill 2ASA 75 mg, Lisinopril 10 mg, Primary PreventionSimv. 20 mg, Hctz. 12.5 mg Cardia RamitorvaASA 100 mg, Simv 20 mg,Ram 5mg India Primary Prevention Aten. 50 mg, Hctz. 12.5 mg Zyduscadila ZycadASA 75 mg, Atorv. 10 mg, India Secondary PreventionRam 5mg, Metoprolol 50 mg Polyran 1ASA 81 mg, Atorv. 20 mg, Alborz Darou Prim / Secon. Prevention?Enalapril 5mg, Hctz 25 mg Iran Polyran 2ASA 81 mg, Ator 20 mg, Prim / Secon. Prevention?Valsartan 40mg, Hctz 25 mg CNIC-FERRER TrinomiaASA 100 mg, Simv. 40 mg, Spain Secondary preventionRam 2.5 / 5 / 10 mg

43 Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

44 1) A Community Call Population Ageing & Cost The Lancet NCD Action (G Alleyne et. al.) Lancet. 2013;381:566

45 2) A Community Call The Message A. Compliance & Adherence are a Marathon, Not a Sprint B. Compliance & Adherence are the Key Drivers Enabling Patients to Achieve Their Treatment Goals World Health Organization 2003-2011

46 Valentin Fuster, M.D., Ph.D. High Risk Population Subclinical Disease (HRP) & MI (Polypill) Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures Dallas, Nov 13-6, 2013 No Disclosures

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50 U Baber, R Mehran, V Fuster et al, 2013

51 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

52 C3). Cortical Atrophy (Alzheimer’s), White Matter Abnormalities & Lacunar Stroke JC Kovacic, V Fuster et. al. Circulation. 2011;123:1900 MA Lim et. al. Clin Geriatr Med. 2009;25:191.

53 C4). The Hallmarks of Aging Aging is characterized by a progressive loss of physiological integrity, leading to impaired function and increased vulnerability to death. This deterioration is the primary risk factor for major human pathologies, including cancer, diabetes, cardiovascular disorders, and neurodegenerative diseases C Lopez-Otin et al., Cell 2013; 153:1194

54 Aging Is The Leading Risk Factor For Most Serious Chronic Disabilities T Tchkonia et. al. J Clin Invest. 2013;123:966

55 ENVIRONMENTAL OXIDATIVE STRESS F Fyhrquist et al., Nat Rev Cardiol 2013; 10:274 Induction of telomere shortening Smoking Alcohol abuse Obesity Sedentary lifestyle Mental stress Inhibition of telomere shortening Healthy lifestyle

56 Promoting Health and Improving Survival Into Very Old Age The identification of strategies that can promote health and productivity into old age is one of the most important challenges facing public health. The current study’s findings, which suggest that modifiable social and behavioral factors increase survival among older people, but only when achieved early in life, preferably in childhood MM Glymour, TL Osypuk. BMJ 2012; 345:e6452

57 High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

58 1) UN Targets Top Killers – 4 Warnings D Butler. Nature. 2011;477:261 (UN. NCD). At Present R. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030 PREMISE (S Mendis et al) Bull. WHO 2005, 2007- LM-I, Pop / $ High V Fuster et al, Circ. 2011;123:1671 – H-I $ Rx / Prom. Health High

59 Global Health. 2013;8:263

60 % Patients, Non-Adherence / Compliance 2a) Manhattan Project 2a) Manhattan Project Quantificacion, Low-Adherence / Low-Compliance Quantificacion, Low-Adherence / Low-Compliance

61 PM Ho, BMC Cardiov. Discord. 2006;6:48 – Arch.Int.Med. 2006;166: 1842-MI RH Chapman, Arch Inter Med 2005;165:1147- BP & Lipid Rx AS Gadkari AS, et. al. Curr Med Res Opin. 2010;26(3):648 Data available from Merck, MI-FREE, AHA Nov 2011 Adherence Decreases Signicantly Over the First 6 Months 2b) Timing - Adherence Decreases Significantly Over the First 6 Months (40%) A Critical Window of Opportunity

62 2c) Quantificacion – Worldwide CHD / Stroke 2c) Quantificacion – Worldwide CHD / Stroke (N=153996) Non-Adherence to Medications Non-Adherence to Medications CV drug categoryHigh-incomeUpper-middleLower-middleLow-incomeOverall (%)income (%)income (%)(%) Antiplatelets62.024.621.98.825.3 Beta blockers40.025.410.29.717.4 ACE inhibitors 49.830.011.15.219.5 ARBs BP-lowering73.848.437.419.241.8 agents Statins66.517.64.33.314.6 All decreasing trends from higher- to lower-income, p<0.0001 PURE (S Yusuf et al.) – Lancet 2011; Aug 28

63 WHO. Adherence to long-term therapies: evidence for action. 2003. N Col et. al. Arch Intern Med. 1990;150(4):841. DL Hershman et al. Breast Cancer Res Treat. 2011;126(2):529. WHO. Adherence to Long-Term: evidence for Action, 2003 N Col et al. Arch Intern Med. 1990;150:841 – MI-FREE, AHA N 2011 Dl Hershman et al Breast Cancer Res Treat. 2011;126:529 DDl Hershman et al. Breast Cancer Res Treat. 2001;126:52 N 1a) Low-Adherence is a Major Inefficiency In Our Health Care System

64 German MITRA Registry (MI, 6067) French Registry (MI, 2320) N=6067 S Schuster et al. Z Kardiol. 1997;86:273 N Danchin et al AHJ 2005;150:1147 N=2320 1b) Patient’s Lack Of Adherence To Medication 1b) Patient’s Lack Of Adherence To Medication

65 Study 1 Economy and Health system characteristics: GNI GNI Health care accesibility Health care accesibility Out-of pocket expenditure Out-of pocket expenditure Treatment accesibility Treatment accesibility Treatment affordability Treatment affordability Prices of foods Prices of foods Patient’s characteristics: Demographics Demographics Psycosocial factors Psycosocial factors Healths status Healths status Clinical variables Clinical variables Blood sample Blood sample 1) The FOCUS project: study 1 (N=4000) PEP: Adherence test (Morisky-Green) Study 2

66 Study 1 Polypill 3 drugs separately Randomization Final visit 6-9 months 1st visit Medication 2nd visit 1month Clinical status Blood pressure Blood sample Adverse effects Adherence test Pill counting PEP: Adherence test Pill counting Pill counting SEP: Blood pressure Lipid profile Lipid profile Adverse effects Adverse effects 3rd visit 4 month 1)The FOCUS Project: Study 2 Design (N=1340) 1)The FOCUS Project: Study 2 Design (N=1340)


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