ventajas e inconvenientes de la triple terapia en ... · ventajas e inconvenientes de la triple...

Ventajas e Inconvenientes de la Triple Terapia en Prevención Secundaria

José R. González JuanateyServicio de Cardiología y UCC. Hospital Clínico Universitario de

Santiago de Compostela

Cumplimentación Terapéutica CV

Aspectos Metodológicos

Papel de la Prevención Secundaria

Cumplimentación y Pronóstico

“Polipíldoras” como Alternativa

Definition

Evidence-based health care is... ...the explicit, judicious and conscientious use of current best evidence from health care research in making decisions about the health care of individuals or populations.

E X KT2 = ROIEfficacy Knowledge

Translation (type 2)

Return on InvestmentReal Outcomes of Importance

E X KT2 = ROIWhere: E is typically ≤ 0.25KT2 is typically ≤ 0.25

Clinician adherence

~ 50%

Patient adherence

~50%

.25 X .25 = .06

So: ROI is typically...


Clinician adherence

50%

Patient adherence50% 75%

.25 X .25 = .06


.38 .09


Clinician adherence 50%

75%

Patient adherence

50% 75%

.25 X .25 = .06


.56 .14

Clinician adherence

50% 75%

For atrial fibrillation:

E Efficacy of warfarin for preventing stroke = 62%

KT2 Physician adherence = 50%Patient adherence = 41%

ROI = 12%

Compliance Challenge

Patient compliance

Physician compliance

Get with the

guidelines

Get with the pills

“Los fármacos no funcionan en los pacientes que no los toman”, …..

ni con los médicos que no los prescriben!!!!!

De las Guías a la Práctica Clínica

Morbilidad y mortalidad CV

Por qué no se alcanzan los Objetivos de lasGuías?

Falta de adherencia del paciente

Restricciones en la Accesibilidad al fármaco

No prescripción segúnlas Guías. Adherencia médico

Aumento de losCostes

Sanitarios

A pesar del amplio consenso sobre cuáles son los fármacos más efectivos para la prevención secundaria de la Cardiopatía Isquémica y otras

enfermedades arterioscleróticas vasculares, las recomendaciones no se aplican correctamente

Physician Complianace. Applying evidence in practice

Barrier Solutions

• poor access to current best evidence and guidelines

• development and testing of information systems that integrate evidence and guidelines with patient care

4

application

Systems

Summaries

Synopses

Syntheses

Studies

Examples

Computerized decision support

Evidence-based textbooks

Evidence-based journal abstracts

Systematic reviews

Original journal articles

OldeSchool EBHC

New School EBHC

The evolution of information resources for evidence-based decisions

All of these resources require that clinicians link the evidence with individual patient problems...

Systems are needed to link directly from patient problems to evidence

Free – Google “EvidenceUpdates”

Patient Compliance. Influencing individual patient decisions, actions and outcomes

Barrier Solutions• failure to engage patients

• encouraging adherence to recommended treatments

decisions

5

Key adherence question“During the past week, have you

missed any of your pills?”Typical response:“No…I might have missed one on

Saturday night when we were out...”

Interpretation…Adherence rate is less than 50%.Problem…Health professionals don’t know this!

Intervention Communities were randomised to receive CHAP (n=20) or no intervention (n=19). In CHAPcommunities, residents aged 65 or over were invited to

attend volunteer run cardiovascular risk assessment and education sessions held in community based pharmacies over a 10 week period; automated blood pressure readings and self reported risk factor data were collected and shared with participants and their family physicians and pharmacists.

Reduced admission rates for a composite of MI, CHF, stroke

Cardiovascular Health Awareness Project Kaczorowski et al, BMJ 2011

CIHR Trial of the Year 2012

Strategies to improve adherence to medicationsfor CV diseses in socioeconomically disadvantaged

populations. The Behaviour Change Whell

Laba TL et al. Inter J cardiol 2013;1676:2430–2440

Attributing falls in CHD deaths to changes in risk factors or to treatments (IMPACT analyses)

Ford et al. NEJM 2007

Contribución en el descenso de mortalidad por cardiopatía isquémica1988-2005 Tratamiento del infarto de

miocardio 47% Modificación de los factores

de riesgo 50%

Tratamientos fase aguda del IAM

47%

Control factores de riesgo cardiovascular50%

Flores-Mateo G. Rev Esp Cardiol. 2011

Mortalidad por Cardiopatía Isquémica. Modelo IMPACT en España (1988-2005)

8.530 menos muertes

0

-15000

-30000

-450001988 2005

Empeoramiento factores de riesgo +13%•Aumento de obesidad +6%•Aumento de diabetes +7%

Mejora de factores de riesgo -54%•Mejora en la PA -19%•Reducción del tabaco -16%•Mejora colesterol -27%•Actividad física -2%Tratamientos farmacológico -48%•Para IAM -10%•Prevención secundaria -10%•Insuficiencia cardiaca -10%•Revascularización -2%•Antihipertensivos -5%•Estatinas (p. primaria) -2%Inexplicables -2%

Explicación de la caída en muerte CV en España: 1988-2005

Estudio IMPACT -2014 (datos presentados en el congreso ESC 2014)

MONICA: change in coronary-event rates vs change in coronary risk factor score, lagged registration period

MONICA : change in CHD mortality rates against change in Treatment Score

Lim S.S. et al, Lancet 2007

0,6 0,8 1

• Aspirina• IECA• Estatinas• BB

- 34 %- 20 %- 29 %- 27 %

RRR

Estos cuatro medicamentos constituyen la base de la prevención CV secundaria post IM

Beneficio de las intervenciones farmacológicas

HR

Potential Cumulative Impact of 4 Simple Secondary Prevention Treatments

Risk Factors Control and Direct CV and Kidney ProtectionRRR Event rate

None 8%

ASA 25% 6%

-Blockers 25% 4.5%

Lipid lowering 30% 3.0%

ACE-inhibitors 25% 2.3%

CUMULATIVE BENEFITS ARE LIKELY TO BE IN EXCESS OF75% RRR, WHICH IS SUBSTANTIAL

Registro APTOR: Prevención secundaria óptima: uso de AAS y 3 más de las siguientes actuaciones alalta y al cabo de 1 año: estatinas, betabloqueantes, IECAs/ARA2, ejercicio o dieta.

38%41%

34%

25%

63%

28%

71%

46%

0%

10%

20%

30%

40%

50%

60%

70%

80%

Spai

n UK

Fran

ce

Czec

h Re

publ

ic

Germ

any

Gree

ce

Nord

ic

Austr

ia-H

unga

ry

Belg

ium

-Net

herla

nds

Patie

nts (

%)

• En España, únicamente el 38% de los pacientes recibían tratamiento óptimo

Registro APTOR

Guías de Práctica Clínica‐Evidencia

European Heart Journal 2006; 27,1298–1304

Seguimiento: 26,3 meses

Estudio CIBAR. Mortalidad y Morbilidad

Adherencia

ExitusIngresos

28,6

No adherencia

Exitus y/oingreso

29,5

4,9

0

10%

40%

p<0,01

36,538,1

p<0,01

p<0,005

20%

9,2

30%

GPC

1.095 pacientesSeguimiento : 26,3 meses

Seguimiento: 26,3 meses

Adherencia

Exitus CVIngresos CV

15,2

No adherencia

Exitus y/oingreso CV

15,7

2,3

0

10%

25%

p=0,0519,6

21,9

p<0,01

p<0,05

5,6

20%

GPC

1.095 pacientesSeguimiento : 26,3 meses

Estudio CIBAR. Mortalidad y Morbilidad CV

26,224120

1,0

0,8

0,6

0,4

0,2

0,0

99,8%

97,5%

97,8%

94,8%

Meses

Supe

rviven

cia cardiovascular

Cumplen recomendaciones GPCNo cumplen recomendaciones GPC

p<0,005

Estudio CIBAR. Supervivencia cardiovascular

26,224120

1,0

0,8

0,6

0,4

0,2

0

90,2%

84,9%

90,2%

83,3%

Meses

Supe

rviven

cia libre de

ingreso CV

Cumplen recomendaciones GPCNo cumplen recomendaciones GPC

p<0,01

Estudio CIBAR. Supervivencia libre de Hospitalización causa cardiovascular

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25

GPC: Cumplimiento recomendaciones Guías de Práctica Clínica; DM: diabetes; ICC: insuficiencia cardíaca; IR: insuficiencia renal(TFG<60 ml/min); EF: ejercicio físico

1 100,1 3 5 70,70,3 0,5

GPC

ICC

DM

IR

EF

4,4 (2,4‐8,1) 0,001

1,9 (1,1‐3,5) 0,023

2,4 (1,3‐4,5) 0,005

0,43 (0,2‐0,8) 0,006

HR (IC‐95%) valor‐p

0,47 (0,2‐0,9) 0,031

Varia

bles

Estudio CIBAR.Determinantes Mortalidad CV

Resultados sobre la mortalidad al año

Zeymer U et al Curr Med Res Opin.2011 Aug;27(8):1563-70

3 fármacos

2 fármacos

0-1 fármacos

Global

RRR = - 36 % 3 vs 2

RRR = - 41 % 3 vs 0-1

Categoria de no adherencia

Desglose de causas

Sistema sanitario • Baja calidad de la relación entre el paciente y el proveedor• Falta de comunicación• Falta de continuidad en los cuidados.

Enfermedad • Asintomática (falta de recordatorios físicos)• Enfermedades mentales (p.Ej. Depresión)

Paciente • Impedimentos físicos• Alteraciones cognitivas• Problemas psicológicos o de comportamiento• Jóvenes• Raza no blanca.

Tratamiento • Complejidad de los tratamientos• Efectos adversos

Razones socioeconómicas

• Analfabetismo; bajo nivel cultural;• Coste alto de las medicaciones• Falta de apoyo social.

Razones para la no adherencia a los tratamientos

WHO 2003; Ho et al. Circulation 2009;119 (23):3028-3035

Datos de adherencia en España

Valencia (España) de 7053 pacientes con SCA seguidos durante 9 meses

(% pacientes que toman más de 75% de los días la medicación)

Sanfélix G. J Manag Care Pharm 2013;19:247-57.

Claxton. Clin Ther 2001; 23 (8): 1296-1310

Objetivo: Revisión de 76 estudios para evaluar la asociación entre las pautas terapéuticas y la adherencia (mediante monitorización electrónica) entre 1986-2000.Variables: Número de dosis ingeridas en relación a las prescritas.Tiempo de toma de la dosis en relación a lo prescrito.Resultados:Nº de DosisLa adherencia fue significativamente mayor:•En la toma de dosis única diaria

• en comparación con 3 veces al día (p = 0.008)

• en comparación a 4 veces al día (p < 0.001)

•En la toma de 2 dosis al día frente a 4 dosis al día (p = 0.001)

Frecuencia de las dosisUna pauta de dosificación más frecuente se asoció a menor adherencia.

79.0

69.0

65.0

51.0

0 10 20 30 40 50 60 70 80 90 100

Once daily dosing

Twice daily dosing

Three times daily dosing

Four times daily dosing

Mean adherence with dose taking (%, range)

Una al día

Dos al día

Tres al día

Cuatro al día

79,0

69,0

65,0

51,0

La falta de adherencia se relaciona con la polimedicación

Controlled BP (%)

Patients who are adherent are more likely to attain BP control

* <140/90 mmHg or <130/85 mmHg for patients with diabetesBramley et al. J Manag Care Pharm 2006;12:239–45

45% greater probability of control

Adherence(n = 165)(n = 46) (n = 629)

05

101520253035404550

Low (<50%) Medium (50-79%) High (>=80%)

Relative risk of a CV event

Adherence

Patients who are adherent are at lower CV risk

Mazzaglia et al. Circulation 2009;120:1598-1605

50% lower risk of a CV event

(n = 7,624)(n = 9,666) (n = 1,516)

0%10%20%30%40%50%60%70%80%90%

100%

Low (<40%) Medium (40-79%) High (>=80%)

Cumplimentación Terapéutica en Medicina CV

54%

19%

0% 20% 40% 60% 80%

Dos Dosis Diarias(n = 561)

p < 0,0001

Dosis Única Diaria(n = 8150)

Jackson y cols. Value Health Suppl 2006;9:A363

Persistencia (definida como los pacientes que tomaron el tratamiento de forma continuada durante 12 meses)

¿Que beneficios tiene ser adherente?

Revisión de estudios promovido por la ESCObjetivos: determinar cómo la falta de

adherencia influye en el riesgo relativo(RR) de ECV y de mortalidad por todaslas causas.

• Buena adherencia.

(≥80% de toma de medicación )

20% disminución del riesgo de ECV.38% disminución de mortalidad global

• 44 estudios incluidos, 1.978.919 participantes que padecieron 135.627 eventos cardiovasculares y 94.126 muertes por cualquier causa.

Chowdhury et al. Eur Heart J 2013

El 9,1% de todos los eventos son atribuibles a baja adherencia

Los beneficios de una buena adherencia


RR de ECV en función del grado de adherencia

RR de desarrollo de ECV en los pacientes con buena adherencia: 0.80 (0.77–0.84)

Los beneficios de una buena adherencia


RR de mortalidad total en función del grado de adherencia

RR de mortalidad por cualquier causa: 0.62 (0.57–0.67)

Effects of nonpersistence with medication on outcomes in high‐risk patients with CV disease. ONTARGET Trial

Bohm M et al. Am Heart J 2013;166:306–314

Discontinuation of Medication after a Non‐fatal event. ONTARGET

Bohm M et al. Am Heart J 2013;166:306–314

Relationship between medication adherence and post‐myocardial infarction outcomes: Medication adherence and

clinical outcomes

Choudhry NK et al. Am Heart J 2014;51:51–58

Highestbenefit

Relationship between medication adherence and post‐myocardial infarction outcomes: Medication adherence and

clinical outcomes

Choudhry NK et al. Am Heart J 2014;51:51–58

¿Protege la adherencia parcial?• Estudio MINERVA; relaciona incidencia de eventos con adherencia a estatinas e

IECAs:

- Muy adherentes 18.9% eventos CV

- Parcialmente adherentes 24.7% eventos CV

- No adherentes 26.3% eventos CV

Bansilal 2014

Sin diferencias (p=0.22)

•Los pacientes adherentes

sufren menos eventos

•La adherencia parcial no

revierte en el beneficio de una

disminución de eventos

Adherence to Secondary Prevention and Medications and Four‐yearOutcomes in Outpatients with Atherosclerosis. REACH Registry

Kumbhani DJ et al. Am J Med 2013;126:693–700Time Until CVD/MI/Stroke (months)

Less than 50% of patients are fully adherent with these

medications

Frecuency of dose categories after Acute MyocardialInfarction. Optimal Secondary Prevention Medication Dosing

Hospital Discharge Follow‐up

Arnold TL et al. J Am Coll Cardiol 2013;62:1791–1781

Frecuency of Follow‐up and medication dose after AcuteMyocardial Infarction. Optimal Secondary Prevention Medication Dosing

Arnold TL et al. J Am Coll Cardiol 2013;62:1791–1781

Reducción acumulada del riesgo de ECV modificando estilos de vida y Polipíldora*

*estimaciónWorking Group. Eur Hear J. 2013;doi:10.1093/eurheartj/eht407

Las combinaciones fijas de fármacos se asocian a mayor adherencia.

Las combinaciones fijas fármacos se asocian a mayor adherencia

Metaanálisis de estudios con polipíldoras demuestran que reducen PA y podrían reducir

eventos

Working Group. Eur Hear J. 2013;doi:10.1093/eurheartj/eht407

Half stand‐dose Polycap(TIPS‐1)

Standard‐dose Polycap(TIPS‐1 and TIPS‐2)

PILL collab group Wald 2012

LDL‐C and BP and AAS(e.g. Secondary prevention)

62% 48% 69% 57% 60% 56% 72% 64%

Combination pharmacotherapy to prevent CV disease: RCT

Cum RR of CVD with lifestyle modification + polypill in a smoker, with low fruits, vegs & exercise

InterventionCum risk reductions at different

adherence levels50% 75% 90%

Lifestyle + Polypill

Polypill + Combinedlifestyle modification

70.6% 82.0% 88.4%

Potential Cumulative Impact of 4 Simple Secondary Prevention Treatments

Risk Factors Control and Direct CV and Kidney Protection

RRR Event rate

None 8%

ASA 25% 6%

-Blockers* 25% 4.5%

Lipid lowering 30% 3.0%

ACE-inhibitors 25% 2.3%

-Blockers* benefit is time dependent and problems with SBP in ageing population

Compliance Challenge

Patient compliance

Physician compliance

Get with the

guidelines

Get with the pills Polypill

Strategies to Improve Adherence

Strategies to Improve Adherence

S — Simplify the regimenI — Impart knowledgeM—Modify patient beliefs and behaviorP — Provide communication and trustL — Leave the biasE — Evaluate adherence

http://www.acpm.org/?MedAdherTT_ClinRef

“A pill to prevent 80% of heart attacks” BMJ 2003

Polipíldora para prevención Cardiovascular:del Concepto a la Realidad

Reducción del numero de componentes para simplificar el tratamientoFavoreciendo la Adherencia

Estrategia Coste EfectivaFavoreciendo laasequibilidad

Favorece la accesibilidadglobal al tratamiento farmacológico

RCTS USING A POLYPILL TO STUDY THE EFFECT ON ADHERENCE

47

70

0102030405060708090100

Control Polypill

46

81

0102030405060708090

Control Polypill

60

85

0102030405060708090

Control PolypillSelak et al. BMJ . 2014

Patel et al. European Journal of Preventive Cardiology, 2014

Thom S, et al. JAMA . 2013;310:918‐929

KANYINI GAP IMPACT UMPIRERR=1,49 RR=1,75 RR=1,33

Castellano JM et al, J Am Coll Cardiol. 2014;64(6):613‐621

FOCUS project

Fixed‐dOse Combination DrUg for Secondary Cardiovascular PreventionA TWO PHASE STUDY

Castellano JM et al. A Polypill Strategy to Improve Adherence: Results From the FOCUS Project. J Am Coll Cardiol. 2014 Sep 1.pii: S0735-1097(14)05941-5. doi: 10.1016/j.jacc.2014.08.021 .

Phase 1: Observational • To determine the proportion of post‐MI patients

receiving appropriate secondary prevention• To estimate the level of patient adherence• To identify factors that contribute to poor adherence.

(Morisky Green: Assessment of adherence)• Availability of secondary prevention therapies

Phase 2: Prospective RCT• To compare adherence to treatment in post MI

patients receiving a FDC vs. those with conventional treatment (3 drugs provided separately)

• Primary Endpoint: Adherence measured by Morisky‐Green and Pill Count combined

• To evaluate the effect of TRINOMIA on BP and LDL‐C• Safety and tolerability of TRINOMIA

3 drugsseparately

CNIC‐FS*‐FERRERTRINOMIAAspirin 100

Ramipril 2,5‐5‐10Simvastatin 40

2118

695

Phase 1

Phase 2

Adherence‐MAQ + PillCount

* Fuster-Sanz

R

9 months 63 sites in 5 countries in Italy Spain, Brazil, Argentina and Paraguay

FOCUS Project


Attending Visit 3+ MAQ=20+Pill Count 80‐110 Attending all visits+MAQ=20+Pill Count 80‐110

p=0.019p=0.012

10% adherence increase with the CNIC-Ferrer polypill (Trinomia ASR) in patients with long-term evaluated CV disease

FOCUS Project: Phase 2, Results


INTENTION TO TREAT Control Polypill p value

SBP (mmHg) 0.88 (‐0.76;2.53) ‐0.32 (‐2.02;1.38) 0.32

DBP (mmHg) 0.38 (‐0.69;1.46) ‐0.11(‐1.13;0.90) 0.51

LDL‐chol (mg/dL) 2.17 (‐0.96;5.29) 5.27(‐0.31;10.86) 0.34

PER PROTOCOL

SBP (mmHg) 0.63 (‐1.47;2.74) ‐0.97(‐3.15;1.21) 0.30

DBP (mmHg) 0.49 (‐0.86;1.85) ‐0.58(‐1.91;0.74) 0.27

LDL‐chol (mg/dL) 2.90 (‐1.15;6.95) 5.13 (‐2.97;13.24) 0.64

There were no differences between groups on BP or LDL-cholesterol Possible differences in additional medication

FOCUS Project: Phase 2, Results


Control (n=345) n(%) Polypill (n=350) n(%)

AE 112 (32,5) 124 (35,4)SAE 23 (6,6) 21 (6,0)Patients interrupting Rx

13 (3,7) 14 (4,0)

Death* 1 (0,3) 1 (0,3)Re‐infarction 2 (0,6) 2 (0,6)Hospitalization 23 (6,7) 21 (6,0)Hematological AE 6 (1,7) 5 (1,4)Other Cardiac AE# 4 (1,1) 10 (2,8)Musculoskeletal AE 10 (3,8) 5 (1,4)Cough 6 (1,7) 5 (1,4)Dizziness 2 (0,6) 2 (0,6)Hypotension 7 (0,2) 0 (0,0)

*Control (cancer); Polypill (traffic accident)# Other cardiac AE included-Hypertension, Hypertriglicemia, High Cholesterol, Thoracic pain

No differences in the safety profile between groups

FOCUS Project: Phase 2, Results Safety

2002

SeguridadBioequivalencia

RCT Prevención Primaria

Wald & LawEstrategia vacunación6 componentes > 55añosReducción de ECV > 80 %

Tolerabilidad, PA, LDL‐CholTIPS‐1 (2009)PILL (2011)TIPS‐2 (2012)

AdherenciaUMPIREKANYINI‐GAPIMPACT

Evolución del concepto de la polipíldora

2014Eventos

HOPE‐3 (2016)TIPS‐3 (2019)

Variablesubrogada PROPS

Castellano JM, Sanz G, Fuster V. Can J Cardiol. 2014 May;30(5):520‐6.

2006

MINERVASECURE

La polipíldora: estrategia innovadora para laprevención cardiovascular

Concepto farmacológico: combinar variosfármacos que intervienen en los principalesprocesos causantes de la ECV, a dosis quemaximizan la eficacia y minimizan efectossecundarios.

Mejora AdherenciaPacientes/Médicos

Reducción de eventos Coste-efectivo

Conclusión

Evolución de la letalidad a 28 días. Primer IAM con onda Q.

Girona 1978-2006

-75-

4,2

8,1

6,5

18,4

12,8

9,5

12,7

0

5

10

15

20

1978-81 1982-85 1986-89 1990-93 1994-97 1998-01 2002-06

Exitus

%

P <0.001

51% fármacos

38% proc. invasivos

Sala C. Am Heart. J 2011; 62:444-50

Estimated reductions in CHD/Stroke of a Full dose Polycap in Those With Average Risk Factor Levels

% Relative Reduction

Reduction in Risk Factors

CHD Stroke

LDL‐C (mmol/L) Est (Simv 40) 1.1 35% 15%

DBP (mmHg) Est (3, full dose) 10.0 40% 50%

Platelet function Est (ASA 100 mg) Similar 32%* 16%

Combined Est ‐ 70 % 65 to 75%

*Without ASA, about a 50% RRR in CHD and stroke.

010203040506070

ASAonly

Statinonly

1 BPagent

2 BPagents

3 BPagents

Polycap(single)

Polycap(double)

Estim

ated

CVD

risk

redu

ctio

n, %

Effect of the 5 component Polycap on est RRR for CVD in hypertensives

66 62 197 108 127 150

P for trend <0.0001

70

Upsides and Downsides of the Polypill

Upsides: Lower costs, overcomes clin inertia, Could reduce CVD risk >65%, better adherence, more easily used by NPHW. Patient preferences.Downsides: Less flexibility in dosing and choice of the components of the combo, but in future 2 or 3 diff types of polypills available. Variable physician preference. Hard to commercialize (so, need new bus models).

Major Trials of the Polypill• HOPE 3: 12,700, factorial of comb BP lowering

+/-statin, intermediate risk.Results 2016. • TIPS 3: 5000 hi risk primary prevention (90%

Stage 1 hyp , 50% dysglycemics).Results 2018• Poly Iran: Mixture of

primary/secondary(n=7000).• HOPE 4: Strategy of global risk reduction in hi

risk primary/secondary using NPHW+ polypill + LS advice +trt supporter vs usual care. Pilot of 2000/full scale of 10,000

“The economics and politics of the project are fascinating. The ingredients are all off (or about to be off) patent, so the pill might be made very cheaply. This is good news, but large pharmaceutical companies are not keen. Not only will the profit margin be low but also many of their expensive drugs may be made redundant. A large generic company—perhaps one from India—might be best suited to manufacture the pill.”

Richard Smith, editor

“And what will happen to cardiologists and cardiac surgeons? Will they have to retrain as psychiatrists, hoping that nobody invents a “happy pill” to oblige further retraining.”

“. But do doctors need to be involved? We could do away with the screening. Maybe too we could buy the pills in supermarkets and pubs—perhaps even washing them down with a glass of red wine and preventing still more deaths.”

Richard Smith, editor

The phenomenal success in the battle against IHD … but how?

0

100

200

300

400

500

600

1970

1972

1974

1976

1978

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

age

stan

dard

ised

dea

ths/

100,

000

United StatesUnited KingdomAustraliaCanadaSpainFrance

But the Western model is not affordable in most countries…?

1. Western countries spend about 8%-18% of GDP (larger than LMIC) vs only 2-5% of GDP on health in LMIC; hi cost models not applicable globally.2. Shortage and maldistribution of doctors, nurses and pharmacists: Task shifting .3. Improve access to combo therapy(? Ess drug list) provided at no ( or v low) cost /universal health coverage for CVD prevention.4. Integrate CVD/NCD prevention with control of infectious diseases.

Malawi: a case studyBurden: 30% of adults have hypertension

6% of adults have diabetesFinances: 65% live off <$1.0/day

Human Resources: 2 doctors & 38 nurses/ 100,000 population Plan: -Integrating hypertension & DM control into TB & HIV control programmes

-Need NPHW and other non-health workers to control HTNBarriers: Human, drug stock-outs, access, distance, legal, patient attitudes about long term care

Brasil: Family Health Programmes as a platform for prevention & management of NCDs

• 2007: 72% of all deaths due to NCDs (i.e. half CVD/diabetes)• 50% decline in smoking between 1989 to 2009 • 2011: 32,000 family health care teams (1 MD, 1 Nurse, 1 Aux Nurse, 4‐

6 Community Health Workers), one per 1000 families (or 1/5000 people)

• Now covers half the population of Brasil ( 100 mill)• Priorities: a) Population groups: Preg women & children;

b) Conditions: TB, leprosy, HTN, diabetes• Impact: ‐increased use of primary health care

‐24% decline in NCD hosp‐Reduced mortality

How can hypertension be better controlled?

• 50% not detected: Opportunistic / efficient screening by NPHW.

• Clinical inertia and lack of control of other RF : Low(+full) dose combo BP therapy+ statins( +/-ASA).

• LS modification: advice+ reinforcement by NPHW.• Long term adherence: Pt supporter+ NPHW +

education(need for lifelong treatment even when BP is normal). Avoid “traditional” treatments.

• Enhance efficiency and decrease costs: NPHW + polypill + mgmt at home/community (greater access, less costs and time lost from work for patients).

Research to Action: HOPE-4.• Question: Can a community based strategy of

screening and treatment with a polypill by NPHW in hi & moderate risk individuals reduce CVD risk by 40% within 6 yrs?

• Setting: 190 communities( 10,000 people) in Columbia, Argentina, S Africa, Tanzania, Rwanda, India, Malaysia, Philippines & Canada.

• Intervention: Systematic screening for prevalent CVD, hypertension & diabetes .Communities randomized to active intervention ( NPHW based polycap+ LS advice ) or usual care.

• Outcomes: BP control, IH risk score, CVD & costs.

Interactions between societal determinants, risk factors and health systems on CVD and other NCDs

Societal Determinants

Behaviours & Risk Factors

Disease incidence & severity

Disease mortality

Risk factor control: -Health education-Treatments-Health SystemsHealth Systems:

Quality of health care—access, quality & affordability

Community structure, Architecture, Transport, Nature of Work, Food Policies§

Tobacco policies*

*Implemented §Potential

A Focussed Practical Strategy to Tackle CVD

1. Reduce tobacco use by 50% globally in 25 yrs (e.g. Brasil reduced smoking by 50% in 20 yrs!)

2. Family health teams to control hypertension (systematic screening, simple low dose combo of 2 BP lowering drugs + statins by NPHW; family supporters), diabetes and secondary prevention---integrate “horizontally” into other key programmes.

3. Universal (at no or very low cost) access to key drugs (ASA, diuretics, BB, CCB, statins) in combination (e.g. polypill) and metformin—and prescribed by NPHW

4. Basic universal coverage package to all for key prevention strategies and catastrophic illness.

Tob & HTN control, hi risk primary and secondary prevention

ACEI/ARB IN ACS PATIENTSDATA FROM CARDIOCHUS REGISTRY

Abu-Assi E, et al. Rev Esp Cardiol 2014 (submitted)

BETA-BLOCKERS IN ACS PATIENTSDATA FROM CARDIOCHUS REGISTRY

Curva de Kaplan Meiermostrando el beneficiopronóstico en términos demortalidad del tratamiento conbloqueadores beta tras el altapor un síndrome coronarioagudo después del propensityscore matching.

Abu-Assi E, et al. Rev Esp Cardiol 2014 (In press)

PACIENTES ADHERENCIA A LAS GPCSÍ NO p

Tº EVOLUCIÓN 6,8±5,6 8,5±6,2 <0,001

INFARTO 65% 46% <0,001

ANGIOPLASTIA 84% 66% <0,001

CIRUGÍA 20% 15% <0,05

HIPERTENSIÓN 62% 69% <0,05

DIABETES 28% 29% ns

DISLIPEMIA 74% 66% <0,005

INSUF CARDIACA 7% 14% <0,001

FIBRIL AURICULAR 5% 23% <0,001

ICTUS 6% 11% <0,005

ART PERIFÉRICA 13% 15% ns

EPOC 8% 23% <0,001

CIBAR. Barbanza Registry

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