High Risk Population Subclinical Disease (HRP) & Post-MI (Polypill)
Valentin Fuster, M.D., Ph.D.Valentin Fuster, M.D., Ph.D.
Dallas, Nov 13-6, 2013 No DisclosuresDallas, Nov 13-6, 2013 No Disclosures
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
Modified from G Niccoli et. al. JACC Cardiovasc Img. 2013;6:1108GW Stone, J Narula JACC: Cardiov. Imag. 2013:6;1124A 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
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
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
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
2. Vulnerable Patient – Non-invasive Burden A) Large Population & Silent Disease
D Butler. Nature. 2011;477:261 (UN. NCD). At PresentR. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030V Fuster, BB Kelly, R Vedanthan , Circulation. 2011;123:1671
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
PESA & AWHS PESA & AWHS HRP > 55y, HRP > 55y, 40-54y, n= 8,000 , FU 0,3,6 y 40-54y, n= 8,000 , FU 0,3,6 y N=6000 FU 3yN=6000 FU 3y
Omics (Framingham)Telomeres (S.blot, qPCR, Fresh)
a). Predictive ?b). Economics ?
c). Life Style & Imaging ? Pesa Systemic Score
B).
Carotid Plaque Burden, mm3 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..
Calcification of the Coronary Arteries (CAC)
1. Cross Interaction Between Carotid Plaque Area & CAC
(n = 1480) (n = 1477) (n = 1479) (n = 1478)
Carotid Plaque Area Quartiles
IMT vs Focal: +IMT vs Focal: +Ilio-Femoral: +++ Ilio-Femoral: +++
U Baber, R Mehran, E Falk, V Fuster et al, 2013
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
P-value<.0001
0.0
5.0
10.0
15.0
1337 1229 1124 402High Risk 2445 2207 2023 737Intermediate Risk2049 1786 1603 555Low Risk
Number at risk0 365 730 1095
Analysis time, Days
3a. Cumulative MACE by Framingham Score
Cu
mu
lati
ve I
nci
den
ce,
%
U Baber, R Mehran, E Falk, V Fuster et al, 2013
Analysis time, Days
3b. Cumulative MACE by 2D US Carotid Plaque
No Plaque Tertile 1Tertile 2 Tertile 3
0.0
5.0
10.0
0 500 1000
Cu
mu
lati
ve I
nci
den
ce,
%P-value<.0001
U Baber, R Mehran, E Falk, V Fuster et al, 2013
P-value<.0001
0.0
5.0
10.0
15.0
0 365 730 1095
Analysis time, Days
3c. Cumulative MACE by Coronary Calcium Score
Cum
ulat
ive
Inci
denc
e, %
CAC 0 CAC 0-100CAC 100-400 CAC > 400
U Baber, R Mehran, E Falk, V Fuster et al, 2013
Status at follow-up examination
Predicted Framingham
Predicted Framingham plus score
ReclassifiedNet correctly reclassified
(%)<3% 3%-6% >6%Increased
riskDecreased
risk
Coronary artery calciumNon-Case <3% 2240 103 0 411 815 7.21
3%-6% 588 1465 308>6% 47 180 672
Case <3% 27 1 1 29 22 3.41
3%-6% 13 59 27>6% 1 8 68
NRI 10.622D ultra sound
Non-Case <3% 2234 108 1 436 770 5.96
3%-6% 554 1480 327>6% 44 172 683
Case <3% 27 1 1 31 20 5.37
3%-6% 12 58 29>6% 1 7 69
NRI 11.33
4a. Reclassification: INCORRECT, CORRECT
CACS
4b. 2D-US Transducer + CAC Impact on Events (Intermediate FRS Group)
U Baber, R Mehran, E Falk, V Fuster et al, 2013
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
PESA & AWHS PESA & AWHS HRP > 55y,HRP > 55y, 40-54y, n= 8,000 , FU 0,3,6 y 40-54y, n= 8,000 , FU 0,3,6 y N=7000 FU 3yN=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
C2). In-vivo, Diabetic Carotid - PET/MRI
RR Moustafa, J Rudd et. al. Circ Cardiov. Imag. 2010;3:536R Corti & V Fuster EHJ 2011 (April 19) JD Spence. Circ. 2013;127:739Diffuse: Inflammatory / Lipid – Transcr. Doppler: M-emboli / Stroke
C3). DBD & Traditional CV Risk FactorsWhite 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, 20135. 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
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;123:1650F Fyhrquist et al., Nat Rev Cardiol 2013; 10:274 – Healthy Lifestyle
1
3
High Risk Population Subclinical Disease (HRP) & Post-MI (Polypill)
Valentin Fuster, M.D., Ph.D.Valentin Fuster, M.D., Ph.D.
Dallas, Nov 13-6, 2013 No DisclosuresDallas, Nov 13-6, 2013 No Disclosures
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)
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.
Circ. 2011;123:1671 Scientific American, May 2014 (In Press)
2012 2012
2) Promoting Cardiovascular HealthWorldwide
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)
JM Castellano, R Copeland-Halperin, V Fuster, Global Health. 2013;8:263L 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 Participationby The Patient (Life Style or Behavior, fluctuates).
Adherence, Implies Active Participation by The Patient (Drugs, around the Clock)
2). TRIALS TARGETS FOR RISK FACTOR CONTROL?
Risk Factors - Proportion of Participants at Goal % – 1 year
Trials LDL SBP DBP Hb A1C Meet Goals Base FU
BARI-2D 75 56 70 52 14 20
COURAGE 51 55 55 59 12 19
FREEDOM 55 63 53 55 12 20
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
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)
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;161:719WHO. Adherence to Long-Term: evidence for Action, 2003S Schuster et.al. Z Kardiol.1997;86:273- N Danchin et.al AHJ 2005;150:1147
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
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)
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
1D Hevey. 2007 2KL Lapane Am J Manag Care 2007;13:613 - AL Goldberg, Soc Sci Med 1998;47:18733CA McHurney, Curr Med Res Opin 2009; 25:21 4MR DiMateo , Med Care 2004; 42:200
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
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)
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
Medication Adherence. Merck 2011.
2). Who Should Focus on These Patients and Promote Adherence
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)
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 ArgentinaBrazilParaguayItalySpain
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
2). POLYPILL STUDIES PUBLISHED OR IN COURSE
Company Polypill Active components
Red Heart Pill 1 ASA 75 mg, Lisinopril 10 mg, Dr Reddy’s Secondary Prevention Simv. 20 mg, Aten. 50 mg
India UMPIRE Red Heart Pill 2 ASA 75 mg, Lisinopril 10 mg,
Primary Prevention Simv. 20 mg, Hctz. 12.5 mg
Cardia Ramitorva ASA 100 mg, Simv 20 mg,Ram 5mg India Primary Prevention Aten. 50 mg, Hctz. 12.5 mg
Zyduscadila Zycad ASA 75 mg, Atorv. 10 mg, India Secondary Prevention Ram 5mg, Metoprolol 50 mg
Polyran 1 ASA 81 mg, Atorv. 20 mg, Alborz Darou Prim / Secon. Prevention? Enalapril 5mg, Hctz 25 mg
Iran Polyran 2 ASA 81 mg, Ator 20 mg,
Prim / Secon. Prevention? Valsartan 40mg, Hctz 25 mg CNIC-FERRER Trinomia ASA 100 mg, Simv. 40 mg, Spain Secondary prevention Ram 2.5 / 5 / 10 mg
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)
1) A Community CallPopulation Ageing & Cost
The Lancet NCD Action (G Alleyne et. al.) Lancet. 2013;381:566
2) A Community CallThe 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
High Risk Population Subclinical Disease (HRP) & MI (Polypill)
Valentin Fuster, M.D., Ph.D.Valentin Fuster, M.D., Ph.D.
Dallas, Nov 13-6, 2013 No DisclosuresDallas, Nov 13-6, 2013 No Disclosures
U Baber, R Mehran, V Fuster et al, 2013
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
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.
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
Aging Is The Leading Risk Factor For Most Serious Chronic Disabilities
T Tchkonia et. al. J Clin Invest. 2013;123:966
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
Promoting Health and Improving Survival IntoVery 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
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
1) UN Targets Top Killers – 4 Warnings
D Butler. Nature. 2011;477:261 (UN. NCD). At PresentR. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030PREMISE (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
Global Health. 2013;8:263
% Patients, Non-Adherence / Compliance
2a) Manhattan Project 2a) Manhattan Project Quantificacion, Low-Adherence / Low-Quantificacion, Low-Adherence / Low-Compliance Compliance
PM Ho, BMC Cardiov. Discord. 2006;6:48 – Arch.Int.Med. 2006;166: 1842-MIRH Chapman, Arch Inter Med 2005;165:1147- BP & Lipid Rx AS Gadkari AS, et. al. Curr Med Res Opin. 2010;26(3):648Data available from Merck, MI-FREE, AHA Nov 2011
Adherence Decreases Signicantly Over the First 6 Months2b) Timing - Adherence Decreases
Significantly Over the First 6 Months (40%)
A Critical Window of Opportunity
2c)2c) Quantificacion –Quantificacion – Worldwide CHD / Stroke Worldwide CHD / Stroke (N=153996) Non-Adherence to MedicationsNon-Adherence to MedicationsCV drug category High-income Upper-middle Lower-middle Low-income Overall
(%) income (%) income (%) (%)
Antiplatelets 62.0 24.6 21.9 8.8 25.3
Beta blockers 40.0 25.4 10.2 9.7 17.4
ACE inhibitors 49.8 30.0 11.1 5.2 19.5ARBs
BP-lowering 73.8 48.4 37.4 19.2 41.8agents
Statins 66.5 17.6 4.3 3.3 14.6
All decreasing trends from higher- to lower-income, p<0.0001
PURE (S Yusuf et al.) – Lancet 2011; Aug 28
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, 2003N Col et al. Arch Intern Med. 1990;150:841 – MI-FREE, AHA N 2011Dl Hershman et al Breast Cancer Res Treat. 2011;126:529 DDl Hershman et al. Breast Cancer Res Treat. 2001;126:52
N1a) Low-Adherence is a Major Inefficiency
In Our Health Care System
German MITRA Registry (MI, 6067)German MITRA Registry (MI, 6067) French Registry (MI, 2320)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
Study 1
Economy and Health Economy and Health system characteristics:system characteristics:• GNIGNI• Health care accesibilityHealth care accesibility• Out-of pocket expenditureOut-of pocket expenditure• Treatment accesibilityTreatment accesibility• Treatment affordabilityTreatment affordability• Prices of foodsPrices of foods
Patient’s characteristics:Patient’s characteristics:• DemographicsDemographics• Psycosocial factorsPsycosocial factors• Healths statusHealths status• Clinical variablesClinical variables• Blood sampleBlood sample
1) The FOCUS project: study 1 (N=4000)1) The FOCUS project: study 1 (N=4000)
PEP: PEP: Adherence test Adherence test (Morisky-Green(Morisky-Green))
Study 2
Study 1PolypillPolypill
3 drugs separately3 drugs separately
RandomizationRandomization Final visitFinal visit6-9 6-9 monthsmonths
1st visit1st visit
MedicationMedication
2nd visit2nd visit1month1month
Clinical statusClinical statusBlood pressureBlood pressureBlood sampleBlood sampleAdverse effectsAdverse effectsAdherence testAdherence testPill countingPill counting
PEPPEP: Adherence test: Adherence test Pill countingPill countingSEP: SEP: Blood pressureBlood pressure Lipid profileLipid profile Adverse effectsAdverse effects
3rd visit 3rd visit 4 month4 month
1)The FOCUS Project: Study 2 Design (N=1340)1)The FOCUS Project: Study 2 Design (N=1340)
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