polypill in the management of secondary prevenon in lan ... · polypill has proven to be safe and...
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PolypillintheManagementofSecondaryPreven6oninLa6nAmerica:ALookattheFuture Alvaro Sosa Liprandi MD, MTSAC, FACC Head of Cardiology. Sanatorio Güemes, Buenos Aires. Argentina Director. Lezica Cardiovascular Institute, San Isidro. Argentina Director. Instituto Cardiovascular Austral, Ushuaia Director. Idea Médica, Research & Education Director. Post Graduated Medical School in Cardiology. Buenos Aires University
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Yusuf et al, Lancet 2011
TOTAL
No drugs One drug Two drugs 3-4 drugs
100
75
50
25
0
PURE study, N= 153996; 17 countries; IHD= 5650
Low
Medium
High
Very Low
100
75
50
25
0
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The care gap Secondary Prevention
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TimetoMajorcardiacEventbyAdherenceLevels
BansilalSetal.JACC2016;68:789-801
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Medica6onNon-Adherence…America’sanotherdrugproblem
13%ofthetotalUS
healthcareexpenditure!
45%ofUSpopula6on
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Social and economic
Health care system
Condition related
Patient Related
Therapy related
FactorsReportedtoAffectAdherence
Socialandeconomic
Healthcaresystem
Condi6onrelated
§ Educa6onlevel§ SocialSupport§ Livingcondi6ons§ Insurance§ Medica6oncost§ Access
§ Cost§ Co-payments§ PoorAccess§ Longwait6mes§ Discon6nuityofcare
§ Chroniccondi6on§ Lackofsymptoms§ Depression§ Psychologicaldisorders
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FactorsReportedtoAffectAdherence
Pa6entsrelated Therapyrelated
§ Physicalfactors(cogni6velevel)§ Phycologicalfactors§ Informa6on§ Mo6va6on§ Alcohol/Substancesabuse
§ Complexityofmedica6ons(N°andtechniques)§ Dura6on§ Changesinregimen§ Sideeffects§ Nopercep6onofbenefit
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Improvingmedica6onadherence.Simplifica6onoftreatment:Polypill
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Improvingmedica6onadherence.Simplifica6onoftreatment:Polypill
Wald NJ, Law MR BMJ 2003
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Improvingmedica6onadherence.Simplifica6onoftreatment:Polypill
The Indian Polycap Study (TIPS) Lancet, 2009
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Improvingmedica6onadherence.Simplifica6onoftreatment:Polypill
The Indian Polycap Study (TIPS) Lancet, 2009
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Improvingmedica6onadherence.Simplifica6onoftreatment:Polypill
The Indian Polycap Study (TIPS) Lancet, 2009
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RCTsUSINGAPOLYPILLTOSTUDYTHEEFFECTONADHERENCE
47
70
0
20
40
60
80
Control Polypill
KanyiniGAP
46
81
020406080100
Control Polypill
IMPACT
60
85
020406080
100
Control Polypill
UMPIRE
• MedianFollowUp:15months
• n=2004• Primary+Secondary• Selfreportedno.ofdays• medica6onwastakenin
theprecedingweek
Selaketal.BMJ.2014(Published27May2014)
Pateletal.EuropeanJournalofPreven1veCardiology,2014
ThomS,etal.JAMA2013;310:918-929
• MedianFollowUp:12months• n=497• Primary• SelfReportednamesand
dosagesofallprescrip6onandOCDcurrentlybeingtaken.
• MedianFollowUp:18months
• n=623• Primary+Secondary• Selfreportedno.ofdays
medica6onwastakenintheprecedingweek
SpaceProgram:Results
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PrimaryEndpoints–AdherenceaWer1Year
Kanyini-GAP(1)IMPACT(2)UMPIRE(3)Overall
96/249(38.6%)106/218(48.6%)602/925(65.1%)
196/249(78.7%)172/233(73.8%)827/935(88.4%)
1 1/4 4
2.04(1.72,2.42)<0.011.52(1.30,1.78)<0.011.36(1.29,1.43)<0.011.58(1.32,1.90)<0.01
Control Polypill
ControlBeber
PolypillBeber
RiskRa6o(95%CI) Pvalue
SPACEProgram:Results
UMPIRE:n=2002,India&EuropeKanyini-GAP:n=623AustraliaIMPACT:n=513enNewZealand
2.Selaketal.BMJ.2014(Published27May2014)
1.Pateletal.EuropeanJournalofPreven1veCardiology,2014
3.ThomS,etal.JAMA2013;310:918-929
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Fixed-dOseCombina6onDrUgforSecondaryCardiovascularPreven6on.PhaseIIStudyStudySites
64 Clinical Sites in Spain, Italy, Argentina, Brazil and Paraguay (outpatients clinics and hospital-based clinic sites)
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PROJECTOVERVIEWPhase1:Observa6onalü Todeterminethepropor6onofpost-MI
pa6entsreceivingappropriatesecondarypreven6on
ü Toes6matethelevelofpa6entadherence
ü Toiden6fyfactorsthatcontributetopooradherence.
ü MoriskyGreen:Assessmentofadherence
Phase2:Prospec6veRCTü Tocompareadherencetotreatmentin
postMIpa6entsreceivingaFDCvs.thosewithconven6onaltreatment(3drugsprovidedseparately)
ü PrimaryEndpoint:AdherencemeasuredbyMorisky-GreenandPillCountcombined
ü ToevaluatetheeffectofTRINOMIAonBPandLDL-C
ü SafetyandtolerabilityofTRINOMIA
Adherence-Visit+MG+PillCount
3drugsseparately
CNIC-FS*-FERRERTRINOMIAAspirin100
Ramipril2,5-5-10Simvasta6n40
2118
695
Phase1
Phase2
* Fuster-Sanz
R
9months
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FOCUSPhase1–ResultsMORISKYGREEN:EVALUATIONOFADHERENCE(N=2118)
45,5
49,850,349,3
36,440
30,117,7
0 10 20 30 40 50 60
Global
EuropeItalySpain
AmericaArgenhna
BrazilParaguay
%adherent(OriginalMorisky-Green=20)
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FOCUSPhase1Results
Pahentcharacterishcs
Sociodemographic:ü Age**ü Sexü Socioeconomicstatusü Illiteracy*ü Educahonallevelü Occupahonalhistoryü Distancefrommedicalcentre**
Riskfactors:ü Diabetesü BMI*ü Hypertensionü Lipidlevelsü Smoking**ü Sedentary**ü Familyhistory
Clinical:ü AMIdate**ü AMIlocahonü HistoryofCHFü Historyofanginaü >10Pills*ü Complexityoftreatment*
Psychosocialfactors:ü Depression**(PHQ-9)ü Socialsupport**
FACTORSTHATINFLUENCEADHERENCE
*p<0.05**p<0.001
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FOCUSPhase2ResultsPOLYPILLVS.CONTROLAFTER9MONTHS
EFFECTONADHERENCE
59
68
545658606264666870
Control Polypill
p=0.049
MORISKYGREEN(20)
percen
tage
54,8 55,759
65,7
40
50
60
70
80
Visit1(1m) Visit3(9m)
MORISKY(20)+PILLCOUNT(80-110)
Control Polypill
Percen
tage
p=0.012
p=0.364
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INTENTIONTOTREAT Control Polypill pvalue
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
PERPROTOCOL
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
TherewerenodifferencesbetweengroupsinBPorLDL-cholesterol
FOCUSPhase2Results
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AdverseEffectsControl (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 for eg.- Non-specific angina
FOCUSPhase2Results
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Q 3 / 2016 Q 2 / 2016
- Kick-off project,
Bibliographic review
2ª round Questionnaire
Fieldwork, Analysis
Q 4 / 2016
Results Presentations Publications
Q1 / 2017
1ª round Questionnaire
Fieldwork, Analysis
Timelines
Position paper: Pollypill as a strategy to improve adherence in primary and secondary prevention. A Latin American Perspective
Consensus expert panel – UCLA / DELPHI methods
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Conclusions
Ø Improvingadherencetotreatmentsshouldbeaprimarygoalinanabempttoreducecardiovascularmortality.
Ø The loss of adherence to essenhal medicines is amulh-causal phenomenon, in which the complexityofthetreatmentisonlyonepartoftheproblem.
Ø The simplificahon of the treatment through thepolypill has proven to be safe and effechve toimprovetheadherenceofourpahents.
Ø The implementahon of this simple strategy will beparhcularly useful in terms of public health,especiallyinlow-andmoderate-incomecountries