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Moderne Strategie di Prevenzione Cardiovascolare Come ottimizzare i benefici della terapia con statine G. Paolo Reboldi.

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Presentation on theme: "Moderne Strategie di Prevenzione Cardiovascolare Come ottimizzare i benefici della terapia con statine G. Paolo Reboldi."— Presentation transcript:

1 Moderne Strategie di Prevenzione Cardiovascolare Come ottimizzare i benefici della terapia con statine G. Paolo Reboldi

2 ESC 2007: Fourth Joint Task Force Recommendations Three strategies for the prevention of CVD can be distinguished: population, high-risk secondary prevention The three strategies are necessary and complement each other. Prevention strategies and policy issues European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

3 ESC 2007: Fourth Joint Task Force Recommendations To prevent one single cardiovascular event, it will be necessary to intervene in many subjects with no apparent benefit to them (prevention paradox). The number of subjects in whom an intervention is needed to prevent one case will vary in different populations or population subgroups (e.g in women) depending on their underlying prevalences and distribution of risk factors, and the incidence rate of disease. Prevention strategies and policy issues European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

4 ESC 2007: Fourth Joint Task Force Recommendations Those with: known CVD; type 2 diabetes or type 1 diabetes with microalbuminuria; very high levels of individual risk factors. are already at INCREASED CVD RISK and need management of all risk factors. For all other people, the SCORE risk charts can be used to estimate total risk This is critically important because many people have mildly raised levels of several risk factors that, in combination, can result in unexpectedly high levels of total CVD risk. How do I assess CVD risk quickly and easily? European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

5 ESC 2007: Fourth Joint Task Force Recommendations European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

6 ESC 2007: Fourth Joint Task Force Recommendations The prevention paradox: high risk individuals gain most from preventive measures, but most CVD deaths come from apparently low risk subjects because they are so numerous. Prevention strategies and policy issues European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

7 ESC 2007: Fourth Joint Task Force Recommendations The prevention paradox: most CVD deaths come from apparently low risk subjects European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

8 ESC 2007: Fourth Joint Task Force Recommendations Relative risk reductions seem to be constant at all lipid levels, but absolute risk reductions are small in those with low lipid levels, with little evidence of a reduction in total mortality. The universal use of statins may be unrealistic in some economies Should statins be given to all? European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

9 Il piano di costo-efficacia Statine in pazienti ad Alto Rischio CV Dominante Effettimaggiori Costiminori Effettiminori Costimaggiori WTP Questionabile Inaccettabile PotenzialmenteVantaggioso Statine in pazienti a Basso Rischio CV WTP WTP

10 Cost effectiveness of statins per categories of absolute risk. Centiles and median refer to the distribution of published cost effectiveness ratio per category of absolute risk Franco OH J. Epidemiol. Community Health 2005;59;

11 Questionable cost-effectiveness of statins for primary prevention of cardiovascular events Messori A et al BMJ Oct 4;327(7418):808-9

12 Effect of annual statin cost on cost-effectiveness for the combination of aspirin and a statin versus aspirin alone. Statin cost is expressed in 2003 dollars. Base-case value is shown with the dotted vertical line. Primary Prevention of Coronary Heart Disease Events in Men Pignone at al Ann Intern Med. 2006;144:

13 Ganz, D. A. et. al. Ann Intern Med 2000;132: Combined Risk reduction by statins (fatal MI, nonfatal MI and stroke) Vs. CERs Expensive Intervention ($ 2000/y) Cheap Intervention ($ 250/y) Paying for an expensive intervention is convenient only if the benefit is great. Paying for a cheap Intervention is convenient also if the benefit is small !!

14 Use of different statins in European countries in 2000 Total use in million defined daily doses. Rate use in defined daily doses/1000 of population covered/day. Walley et al BMJ 2004;328;

15 Statine, andamento temporale del consumo territoriale di classe A-SSN ( )

16 Prevalenza duso di farmaci nei pazienti con ipertensione ed ipertensione + diabete con o senza eventi CV % di pazienti che hanno usato almeno una volta nel corso del 2006 una delle categorie terapeutiche

17 Prevalenza duso e durata del trattamento nei pazienti con ipertensione ed ipertensione + diabete con o senza eventi CV

18 Statine, distribuzione in quartili del consumo territoriale 2006 di classe A-SSN (DDD/1000 abitanti die pesate)

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20 Terapie Dimissione per SCA: Registri Italiani vs. Standard CCORT/CCS Casella G, et al. G Ital Ital Cardiol 2006; 7: – Centro Studi ANMCO In-ACS Outcome, Data on File Gli standard di qualità CCORT/CCS, elaborati dalla società canadese di cardiologia, rappresentano la percentuale minima di pazienti ideali che dovrebbero ricevere il trattamento raccomandato.

21 Adherence to chronic cardiovascular therapies: persistence over the years and dose coverage Rates of persistence and coverage in patients Analysis of GPs Prescription in Ravenna, Italy (diamonds, persistence; bars, coverage) Poluzzi E et al Br J Clin Pharmacol 63:3 346– Patients were defined as persistent when they received at least one prescription of any agent of the considered therapeutic category in 2000, 2001 and Patients were defined as covered when the amount of drugs of the same category received during each of the 3 years of the study was consistent with a daily treatment. To this purpose, we identified the minimal daily dose recommended for maintenance therapy for each drug and calculated the total number of minimal doses of each agent received, by the patient, year by year. Patients reaching at least 300 minimal doses per year were considered as covered, allowing a tolerance of 20% over the 365-day period New patients on treatmentPatients already on treatment

22 Adherence to chronic cardiovascular therapies: persistence over the years and dose coverage Percentage of 3-year coverage and ORs among patients already on treatment, in the presence of combined therapy with other drug categories. Poluzzi E et al Br J Clin Pharmacol 63:3 346– LLD=Lipid Lowering Drugs AHA= Anti-hypertensive Agents OHA=Oral hypoglycemic Agents

23 Prescription of lipid lowering agents and time from the acute event P < Italian General Practitioners Database; 3588 patients (mean age 68.7), with an average time from event of 6 years. Filippi et al Journal of Cardiovascular Medicine 2006, 7:422–426

24 Relationship Between Adherence to Evidence-Based Pharmacotherapy and Long-term Mortality After Acute Myocardial Infarction Kaplan-Meier Estimates of Time to Death for Statin Users According to Adherence Level Rasmussen et al. JAMA. 2007;297: High (PDC 80%) Intermediate (PDC 40%-79%) Low (PDC <40%) PDC Proportion of Days Covered Adjusted Hazard Ratio Low vs High 1.25 ( );P=.001 Int. vs High ;P=.03

25 Self-reported Medication Adherence and Cardiovascular Events in Patients With Stable Coronary Heart Disease: The Heart and Soul Study Proportion surviving without a cardiovascular event (myocardial infarction, stroke or coronary heart disease death) by self-reported medication adherence at baseline, adjusted for age, sex, race, educational level, smoking, diabetes mellitus, hypertension, depressive symptoms, number of cardiovascular medications, use of -blocker, use of statin, left ventricular ejection fraction, weekly angina, high-density lipoprotein cholesterol level and low-density lipoprotein cholesterol level (P =.006). Gehi et al Arch Intern Med. 2007;167: Adherent > 75% in the past month Non-Adherent 75% in the past month

26 Clinical Crossroads: A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans Mr P has long-standing hypertension, obesity, and diabetes mellitus and has experienced life- threatening cardiovascular events. Mr P is receiving evidence-based clinical care but has adhered to his medical regimen poorly and remains at considerable risk of future catastrophic cardiovascular events. He has been prescribed many medications, including, aspirin, atenolol, lisinopril, amlodipine atorvastatin, furosemide, glyburide, metformin, insulin, and allopurinol Bodenheimer T JAMA. 2007;298(17):

27 Clinical Crossroads: A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans Although Mr P was cared for using evidence- based medicine, it appears that for Mr P, evidence-based medicine failed. Mr P's blood pressure was uncontrolled during visits in 2001, 2003, 2004, and His body mass index hovered around 38, well above the obesity threshold of 30. Between 2004 and 2006, his hemoglobin A1c level fluctuated between 5% and 8.8%. His total cholesterol level rose from 132 mg/dL (3.42 mmol/L) in 2004 to 256 mg/dL (6.63 mmol/L) in 2005 Why Does Evidence-Based Medicine Often Fail? Bodenheimer T JAMA. 2007;298(17):

28 Clinical Crossroads: A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans Step 1: Research uncovers the evidence. Step 2: Clinicians learn the evidence. Step 3: Clinicians use the evidence at every visit for every patient. Step 4: Clinicians make sure that patients understand the evidence. Step 5: Clinicians assist and encourage patients to incorporate the evidence into their lives. Bodenheimer T JAMA. 2007;298(17): Practicing evidence-based medicine should be a 5-step process:

29 Clinical Crossroads: A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans Step 3: Use the evidence! only 55% of patients received recommended care. N Engl J Med. 2003;348(26): Step 4: Patients must understand! Less than 50% of patients leave an office visit not understanding what they were told by the physician. Agency for Healthcare Research and Quality; 2005 Step 5: Assist and encourage patients! patients participated in medical decisions only 9% of the tim, 96% wanted to be offered choices and to be asked their opinion Med Care. 2005;43(10): Bodenheimer T JAMA. 2007;298(17): How Is the US Health Care System Performing on Steps 3, 4, and 5?

30 Challenges for improving medication adherence Patient characteristics: advanced age, cognitive impairment, depression, attitudes and beliefs about the importance of medications, the disease being treated and the potential for adverse effects. Barriers to adherence: adverse effects, polypharmacy, frequent dosing and high cost. System and Clinician related barriers: insufficient access to physicians, lack of trust between clinician and patient, physicians negative attitude to the value of guideline- recommended care. Simpson R JAMA 2006; 296:

31 CCU Acute Care Chronic Care Secondary Prevention Transition From Acute to Long-term Management X EBM based practice practice A bridge over troubled waters… X

32 Team medico preparato, attivo e propositivo Interazioni produttive Esiti clinici e funzionali Sistema Sanitario Risorse e Politiche Comunità Organizzazione dellassistenza sanitaria Disease Management Chronic Care Model Paziente attivo e informato Autogestione empowerment Piano di erogazione dei servizi Sistemi Informativi Clinici Analisi Decisionale EBM Modificata da: Bodenheimer et al JAMA Oct 16;288(15):


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