Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs)

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1 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

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

3 2) Promoting Cardiovascular Health Worldwide Circ. 2011;123: Scientific America 2013 (In Preparation)

4 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

5 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) 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.

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

7 Adherence Decreases Signicantly Over the First 6 Months 2) Timing - Adherence Decreases Significantly Over the First 6 Months (40%) A Critical Window of Opportunity 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

8 2a) Quantificacion Worldwide CHD / Stroke (N=153996) Non-Adherence to Medications CV drug category High-income Upper-middle Lower-middle Low-income Overall (%) income (%) income (%) (%) Antiplatelets Beta blockers ACE inhibitors ARBs BP-lowering agents Statins All decreasing trends from higher- to lower-income, p< PURE (S Yusuf et al.) Lancet 2011; Aug 28

9 2b) Quantificacion United States Guidelines of Non-Adherence to Medications Age 55 y (n=2554) History of CVD* (n=592) Recom. Use Actual Use % Recom. Use Actual Use % Aspirin (%) Antihypert. (%) Statins (%) NHANES, AHA, NHLBI-JNC-7, NHLBI-NCEP P Muntner, V Fuster et al., Am Heart J 2011; 161:719

10 2b) H-IC, Treatment Gaps % Should Use > 3 CV Drugs Vs % Use > 3 CV Drugs SMART (M Lafeber et al) EJPC, May 2012 (UMC Utrecht ( )

11 2c). 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 COURAGE FREEDOM Freedom, Bari-2D, Courage Investigators, 2012 (Subm.) 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

12 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

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

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

15 1b) POST MI Rates Of Medication Use For The Entire Cohort 3 Medications at Discharge Survival of Pts D/C all at 1 mo. Vs those using 1 or more PREMIER (PM Ho et. al) Arch Intern Med. 2006;166:1842 (1521 Post MI, 19 US Hospitals)

16 1c) Projected Impact Of Polypill Use Among US Adults: Medication Use and CV Risk Reduction P Muntner, V Fuster, M Woodward et. al. Am Heart J. 2011;161:719

17 New England Health Institute (NEHI) Research Brief: August MC Roebuck, et al. Health Aff. 2011;30(1):91 MI-FREE AHA Nov ) 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

18 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

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

20 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 Health care professionals should communicate less poorly on prescription medications - av. 49 sec, appropiate 3% 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: SL William, Clin Interv Aging 2007; 25:453

21 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

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

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

24 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

25 Polypill CNIC-Ferrer: Adherence Economics FOCUS 1 General Adherence BIO-EQUIVALENCE FOOD INTERACTION PHARMACOKINETIC INTERACTION WITH ASPIRIN FOCUS 2 Polypill Adherence ASA, Statin, ACE-Inhibitor PHARMACODINAMIC INTERACTION WITH RAMIPRIL PHARMACOKINETIC INTERACTION WITH SYMVASTATIN Argentina Brazil Paraguay PHARMACODYNAMIC INTERACTION WITH SYMVASTATIN PHARMACODYNAMIC INTERACTION WITH ASPIRIN PHARMACOKINETIC INTERACTION WITH RAMIPRIL Italy Spain

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

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

28 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 Red Heart Pill 2 Primary Prevention ASA 75 mg, Lisinopril 10 mg, Simv. 20 mg, Hctz mg Cardia Ramitorva ASA 100 mg, Simv 20 mg,ram 5mg India Primary Prevention Aten. 50 mg, Hctz mg Zyduscadila Zycad ASA 75 mg, Atorv. 10 mg, India Secondary Prevention Ram 5mg, Metoprolol 50 mg Alborz Darou Iran Polyran 1 ASA 81 mg, Atorv. 20 mg, Prim / Secon. Prevention? Enalapril 5mg, Hctz 25 mg 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

29 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

30 1,2) Science, Health & Education (SHE) Compliance / Adherence for Three Ages Motivation Motivation Motivation Extended healthy lives in part due to medical research generates dramatic returns - Albert & Mary Lasker Found

31 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

32 Alarming Challenge in 2ary Prevention Low Compliance (Life Style) & Adherence (Drugs) 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

33 Treatment Gaps in 2ary Prevention 15 Comments Low Compliance (Life Style) & Adherence (Drugs) 1. IOM From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Implications (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) Community & Adherence (2) 4. A Final Message (1)

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38 Available Polypills And Studies Company Polypill Studies (N) Results Dr Reddys India USVL India Zyduscadila India Cadila India Red H. Pill 1 R ASA 75 Lisin.10 Simva 20, Aten.50mg Red H. Pill 2 R ASA 75 Lisin.10 Simva 20, Hyd.12.5mg Polytorva R ASA 75, Rami.10, Ator 5 mg, Ramitorva R ASA 75,Rami.10, Ator10 mg, Polycap R ASA75, Rami.5, Simva 10, Ate.50, Hyd12.5mg Sri-Lanka Study (216) Pill Collaborative (378) Gap Study (2000) UMPIRE/PESCA (2004) IMPACT (600) TIPS (2053) TIPSK (518) 80% adherence. No diff. in reduction of risk SBP reduction 9.9 mmhg; LDL-c reduction 0.8 mml/l. Non-inferior to its individual components in BP. LDL-C less than simv. Alborz Darou Iran CNIC-Ferrer Spain Polyiran 1 R ASA81, Ator 20, Enal. 5, Hyd 25mg Polyiran 2 R ASA81, Ator 20, Val. 40, Hyd 25mg Trinomia R ASA 100, Rami , Simva 40 mg, Iran Study (475) POLYIRAN (31000) Spanish PD study (107) FOCUS (1340) Modest reductions in BP (4.5 mmhg,) and LDL cholesterol (0,46 mmol/l) Reductions in BP and LDL cholesterol=comparators No SAE