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Moderne Strategie di Prevenzione Cardiovascolare

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

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

4 ESC 2007: Fourth Joint Task Force Recommendations
How do I assess CVD risk quickly and easily? 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. 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
Prevention strategies and policy issues 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. 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
Should statins be given to all? 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 European Journal of Cardiovascular Prevention and Rehabilitation 2007, 14(Supp 2):E1–E40

9 Il piano di costo-efficacia
Potenzialmente Vantaggioso Costi maggiori WTP WTP Statine in pazienti a Basso Rischio CV Inaccettabile WTP Statine in pazienti ad Alto Rischio CV Effetti minori Effetti maggiori Plotting incremental costs versus incremental effectiveness helps to visually display the ICER of one intervention versus another and allows a comparison with the WTP. In Figure 1, the vertical axis represents the difference in costs, the horizontal axis represents the difference in effectiveness, with the origin representing the current standard of care which is usually compared to a new intervention. The ICER is plotted in one of four quadrants. If the ICER falls in the upper left quadrant, it is more costly and less effective than the current standard of care, and would therefore be rejected. An intervention with an ICER that is both less costly and more effective (falling in the lower right quadrant) is said to be ‘dominant’ to the current standard therapy, and therefore would usually be the preferred intervention. Interventions in the lower left quadrant are both less costly and less effective (a rare occurrence), and would be considered to be of questionable value. When the ICER falls in the upper right quadrant, with improved effectiveness but higher costs, the cost-effectiveness must be assessed. If the ICER is plotted relative to a line representing the WTP and it falls below the WTP line, it would be considered good value for money, but if it falls above the WTP line, it would be regarded as too expensive when the magnitude of the clinical improvement is taken into consideration. Questionabile Dominante Costi minori

10 Cost effectiveness of statins per categories of absolute risk
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. Primary Prevention of Coronary Heart Disease Events in Men Statin cost is expressed in 2003 dollars. Base-case value is shown with the dotted vertical line. Pignone at al Ann Intern Med. 2006;144:

13 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 !! Ganz, D. A. et. al. Ann Intern Med 2000;132:

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

15 Statine, andamento temporale del consumo territoriale di classe A-SSN (2000-2006)
Nei soggetti ad alto rischio (es. ipertensione + diabete + eventi cardiovascolari) la media di DDD supera in molte aree geografiche il numero potenziale di giorni di esposizione; tale dato dimostra pertanto l’utilizzo di un dosaggio superiore alla dose definita giornaliera. Questo comportamento potrebbe essere la conseguenza di atteggiamenti prescrittivi più aggressivi (uso di alte dosi) dove i valori target da raggiungere sono più bassi (Tavola A.9).

16 Prevalenza d’uso 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 descritte nella tavola. La somma delle percentuali può essere superiore al 100% in quanto ogni soggetto nel corso dell’anno può avere utilizzato diverse categorie di farmaci ° Nessuna prescrizione delle categorie terapeutiche considerate nella tavola (antiipertensivi, ipolipemizzanti, antiaggreganti piastrinici) % di pazienti che hanno usato almeno una volta nel corso del 2006 una delle categorie terapeutiche

17 Prevalenza d’uso e durata del trattamento nei pazienti con ipertensione ed ipertensione + diabete con o senza eventi CV Nei soggetti ad alto rischio (es. ipertensione + diabete + eventi cardiovascolari) la media di DDD supera in molte aree geografiche il numero potenziale di giorni di esposizione; tale dato dimostra pertanto l’utilizzo di un dosaggio superiore alla dose definita giornaliera. Questo comportamento potrebbe essere la conseguenza di atteggiamenti prescrittivi più aggressivi (uso di alte dosi) dove i valori target da raggiungere sono più bassi (Tavola A.9).

18 Statine, distribuzione in quartili del consumo territoriale 2006 di classe A-SSN (DDD/1000 abitanti die pesate) Nei soggetti ad alto rischio (es. ipertensione + diabete + eventi cardiovascolari) la media di DDD supera in molte aree geografiche il numero potenziale di giorni di esposizione; tale dato dimostra pertanto l’utilizzo di un dosaggio superiore alla dose definita giornaliera. Questo comportamento potrebbe essere la conseguenza di atteggiamenti prescrittivi più aggressivi (uso di alte dosi) dove i valori target da raggiungere sono più bassi (Tavola A.9).

19 Statine, distribuzione in quartili del consumo territoriale 2006 di classe A-SSN (DDD/1000 abitanti die pesate) Nei soggetti ad alto rischio (es. ipertensione + diabete + eventi cardiovascolari) la media di DDD supera in molte aree geografiche il numero potenziale di giorni di esposizione; tale dato dimostra pertanto l’utilizzo di un dosaggio superiore alla dose definita giornaliera. Questo comportamento potrebbe essere la conseguenza di atteggiamenti prescrittivi più aggressivi (uso di alte dosi) dove i valori target da raggiungere sono più bassi (Tavola A.9).

20 Terapie Dimissione per SCA: Registri Italiani vs. Standard CCORT/CCS
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. Casella G, et al. G Ital Ital Cardiol 2006; 7: – Centro Studi ANMCO In-ACS Outcome, Data on File

21 Rates of persistence and coverage in 32068 patients
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) New patients on treatment Patients already on treatment Cardiovascular diseases are the main cause of premature death in most Western countries. They represent an important source of disability and contribute in large part to the escalating cost of healthcare [1]. More than one-third of the adult Italian population and more than one-half of elderly subjects need pharmacological cardiovascular risk prevention [2] (see also Although cardiovascular drugs represent almost 50% of all reimbursed prescriptions (among these, 70% are antihypertensive prescriptions) [3], it is well known that hypertension, diabetes and hyperlipidaemia are not adequately controlled in a large proportion of cases [2]. In almost all cases, in order to guarantee efficacy (prevention of cardiovascular events or stroke) treatment with cardiovascular drugs should be chronically maintained in patients with hypertension, hyperlipidaemia, angina, diabetes or heart failure. Despite recommendations, studies in different countries, even in populations at high cardiovascular risk, have found poor adherence to chronic cardiovascular treatments [4–8]. Our group recently reported that the withdrawal rate is exceedingly common in subjects treated with antihypertensive agents (AHAs), particularly during the first year of treatment [9]. This finding prompted us to extend this study by comparing the pattern of use of different drug classes in terms of adherence to therapy, in conditions where risk perception may be different. The specific aim of this study was to evaluate the pattern of use of the main classes of chronically used cardiovascular drugs in an Italian population, focusing on adherence to treatment. In particular, we considered AHAs, lipid-lowering drugs (LLDs), oral hypoglycaemic agents (OHAs) and nitrates in order to estimate population exposure and to obtain information about adherence by patients, in terms of long-term persistence and dose coverage. Patient- and drug-related elements (e.g. age, gender, drug class, polypharmacy vs. monotherapy) associated with non-adherence were also considered. Patients were defined as persistent when they received at least one prescription of any agent of the considered therapeutic category in 2000, 2001 and 2002. 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 Poluzzi E et al Br J Clin Pharmacol 63:3 346–

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. Cardiovascular diseases are the main cause of premature death in most Western countries. They represent an important source of disability and contribute in large part to the escalating cost of healthcare [1]. More than one-third of the adult Italian population and more than one-half of elderly subjects need pharmacological cardiovascular risk prevention [2] (see also Although cardiovascular drugs represent almost 50% of all reimbursed prescriptions (among these, 70% are antihypertensive prescriptions) [3], it is well known that hypertension, diabetes and hyperlipidaemia are not adequately controlled in a large proportion of cases [2]. In almost all cases, in order to guarantee efficacy (prevention of cardiovascular events or stroke) treatment with cardiovascular drugs should be chronically maintained in patients with hypertension, hyperlipidaemia, angina, diabetes or heart failure. Despite recommendations, studies in different countries, even in populations at high cardiovascular risk, have found poor adherence to chronic cardiovascular treatments [4–8]. Our group recently reported that the withdrawal rate is exceedingly common in subjects treated with antihypertensive agents (AHAs), particularly during the first year of treatment [9]. This finding prompted us to extend this study by comparing the pattern of use of different drug classes in terms of adherence to therapy, in conditions where risk perception may be different. The specific aim of this study was to evaluate the pattern of use of the main classes of chronically used cardiovascular drugs in an Italian population, focusing on adherence to treatment. In particular, we considered AHAs, lipid-lowering drugs (LLDs), oral hypoglycaemic agents (OHAs) and nitrates in order to estimate population exposure and to obtain information about adherence by patients, in terms of long-term persistence and dose coverage. Patient- and drug-related elements (e.g. age, gender, drug class, polypharmacy vs. monotherapy) associated with non-adherence were also considered. LLD=Lipid Lowering Drugs AHA= Anti-hypertensive Agents OHA=Oral hypoglycemic Agents Poluzzi E et al Br J Clin Pharmacol 63:3 346–

23 Prescription of lipid lowering agents and time from the acute event
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 Adjusted Hazard Ratio Low vs High ( );P=.001 Int. vs High ;P=.03 Context  The extent to which drug adherence may affect survival remains unclear, in part because mortality differences may be attributable to "healthy adherer" behavioral attributes more so than to pharmacological benefits. Objective  To explore the relationship between drug adherence and mortality in survivors of acute myocardial infarction (AMI). Design, Setting, and Participants  Population-based, observational, longitudinal study of 31 455 elderly AMI survivors between 1999 and 2003 in Ontario. All patients filled a prescription for statins, -blockers, or calcium channel blockers, with the latter drug considered a control given the absence of clinical trial–proven survival benefits. Main Outcome Measures  Patient adherence was subdivided a priori into 3 categories—high (proportion of days covered, 80%), intermediate (proportion of days covered, 40%-79%), and low (proportion of days covered, <40%)—and compared with long-term mortality (median of 2.4 years of follow-up) using multivariable survival models (and propensity analyses) adjusted for sociodemographic factors, illness severity, comorbidities, and concomitant use of evidence-based therapies. Results  Among statin users, compared with their high-adherence counterparts, the risk of mortality was greatest for low adherers (deaths in 261/1071 (24%) vs 2310/14 345 (16%); adjusted hazard ratio, 1.25; 95% confidence interval, ; P = .001) and was intermediary for intermediate adherers (deaths in 472/2407 (20%); adjusted hazard ratio, 1.12; 95% confidence interval, ; P = .03). A similar but less pronounced dose-response–type adherence-mortality association was observed for -blockers. Mortality was not associated with adherence to calcium channel blockers. Moreover, sensitivity analyses demonstrated no relationships between drug adherence and cancer-related admissions, outcomes for which biological plausibility do not exist. Conclusion  The long-term survival advantages associated with improved drug adherence after AMI appear to be class-specific, suggesting that adherence outcome benefits are mediated by drug effects and do not merely reflect an epiphenomenon of "healthy adherer" behavioral attributes. High (PDC ≥80%) Intermediate (PDC 40%-79%) Low (PDC <40%) PDC Proportion of Days Covered Rasmussen et al. JAMA. 2007;297:

25 Self-reported Medication Adherence and Cardiovascular Events in Patients With Stable Coronary Heart Disease: The Heart and Soul Study Adherent > 75% in the past month Non-Adherent ≤ 75% in the past month 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:

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 Why Does Evidence-Based Medicine Often Fail?
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 Step 1: Research uncovers the evidence.
Clinical Crossroads: A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans Practicing evidence-based medicine should be a 5-step process: 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):

29 Clinical Crossroads: A 63-Year-Old Man With Multiple Cardiovascular Risk Factors and Poor Adherence to Treatment Plans How Is the US Health Care System Performing on Steps 3, 4, and 5? 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):

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, physician’s negative attitude to the value of guideline-recommended care. Simpson R JAMA 2006; 296:

31 Transition From Acute to Long-term Management
EBM based practice A bridge over troubled waters… Chronic Care Secondary Prevention CCU Acute Care EBM based practice This slide was adapted from the AHA Get With the Guidelines program. During an AHA presentation, Dr. Gray Elrodt from Berkshire Medical Center in western Massachusetts stated that “We have all the evidence that demonstrates what will impact efficacy, and the development of guidelines. Effectiveness is where it really happens. There is a “big gap” between the two as demonstrated in this slide—and how do we bridge the gap between efficacy and implementation. Despite compelling scientific evidence and national treatment guidelines supporting the use of secondary prevention medical therapies, these treatments continue to be underutilized in CVD patients receiving conventional care.” X X References Adapted from the American Heart Association. Get With The Guidelines

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


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