L aderenza ai trattamenti cronici in ambito cardiovascolare: metodi di analisi ed esempi Elisabetta Poluzzi

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1 Bologna, 2 Dicembre 2008 Osservatorio ARNO - Esperienze e risultati nel Governo Clinico L aderenza ai trattamenti cronici in ambito cardiovascolare: metodi di analisi ed esempi Elisabetta Poluzzi Dipartimento di Farmacologia - Facoltà di Medicina e Chirurgia - Università di Bologna CReVIF Centro Regionale di Valutazione e Informazione sui Farmaci

2 Metodi di analisi 1. Terminologia molteplice 2. Metodologie eterogenee 3. Finalità differenti Risultati degli studi 1. Frequenza di aderenza 2. Determinanti di aderenza

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4 Esempi di definizioni da International Society for Pharmacoeconomics and Outcomes Research Cramer et al. Medication compliance and persistence: terminology and definitions. Value Health Jan-Feb;11(1):44-7. Medication compliance or medication adherence: the extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regimen. Medication persistence: the duration of time from initiation to discontinuation of therapy

5 Tilson. Adherence or Compliance? Changes in Terminology Ann Pharmacother 2004;38: The social contract between healthcare professionals and patients revolved around the original concept of compliance, understood as professional dominance: 1.the act or process of complying to a desire, demand, or proposal or coercion; 2.a disposition to yield to others. the prescriber chooses the therapy and specifies the conditions of its use, the caregiver exhorts the patient to proceed as required, and the dispenser reinforces the need to take as directed.

6 As pharmaceutical care evolved over the years, practitioners came to realize that the structure of their relationship with patients required significant changes. The new professional social contract calls for the patient to become a partner in decision making. The professional is now an informer, educator, and enabler charged with creating the context in which the partner can make his/her own decisions. The terminology describing the new contract between the healthcare provider and patient has been altered to reflect that transition. The term adherence appears to connote the new partnership more accurately than compliance 1.to give support or maintain loyalty; 2.to bind oneself by observance.

7 In che percentuale la popolazione in trattamento con farmaci cardiovascolari li utilizza per più anni e tutti i giorni? Poluzzi E et al. Adherence to chronic cardiovascular therapies: persistence over the years and dose coverage. Br J Clin Pharmacol Mar;63(3): Data analysis For each therapeutic category, prescriptions of each patient were analysed for the 3 years following recruitment. Therapeutic regimens were those recorded at recruitment. Adherence to treatment was then evaluated in terms of (i) persistence and (ii) coverage. (i) Patients were defined as persistent when they received at least one prescription of any agent of the considered therapeutic category in 2000, 2001 and (ii) 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.

8 Farmaci cardiovascolari (soprattutto antipertensivi) Occorre definire una minimal daily dose recommended for maintenance therapy 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.

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10 Rates of persistence (diamonds) and coverage (bars) of PATIENTS ALREADY ON TREATMENT

11 Rates of persistence (diamonds) and coverage (bars) of NEW PATIENTS

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13 La copertura con statine si differenzia in base al livello di rischio del paziente? Poluzzi E Adherence to statin therapy and patients' cardiovascular risk: a pharmacoepidemiological study in Italy., Eur J Clin Pharmacol Apr;64(4): La minimal daily dose recommended for maintenance therapy è la compressa Patients reaching at least 300 tablets were considered as being covered, allowing a tolerance of approximately 20% over the 365-day observation period.

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17 Quale classe di antipertensivi consente la maggiore durata di terapia nei pazienti incidenti? Mazzaglia G et al. Patterns of persistence with antihypertensive medications in newly diagnosed hypertensive patients in Italy: a retrospective cohort study in primary care. J Hypertens Nov;23(11): The Health Search Database is an Italian general practice research database that comprises the complete electronic medical records of all patients registered in the lists of participating physicians. For each of the six drug cohorts [diuretics (C03); a-blockers (C02CA); b-blockers (C07); ACE inhibitors (C09A); CCBs (C08); angiotensin receptor blockers (ARBs) (C09C)], the duration of exposure was calculated the total amount of active drug in each prescription by the recommended defined daily dose. Consecutive prescriptions of drugs belonging to the same cohort were combined as one treatment period if they were less than 2 months apart. The accumulation of person-time in a given cohort ended at the earliest of the following occasions: prescription of any antihypertensive drug belonging to another cohort; failure to obtain a repeat prescription within a period of 2 months from the end of the previous one; death; end of the follow-up.

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19 In quale percentuale i pazienti trattati con antipertensivi proseguono il trattamento? Corrao G, Zambon A, Parodi A, Poluzzi E, Baldi I, Merlino L, Cesana G, Mancia G. Discontinuation of and changes in drug therapy for hypertension among newly-treated patients: a population-based study in Italy. J Hypertens Apr;26(4): The duration of all prescriptions dispensed to each member of the cohort was calculated by dividing the total amount of drug prescribed by the defined daily dose. Starting from the index date, consecutively refilled prescriptions were assigned to a unique therapeutic cycle if a drug of the same therapeutic class was prescribed within 90 days following the end of the latest dispensation, and no antihypertensive drugs belonging to other therapeutic classes were dispensed during this period.

20 Discontinuation Cumulative incidence Combining Switching Months since starting antihypertensive treatment

21 conclusioni Quando si legge un lavoro, occorre controllare la terminologia e la metodologia utilizzata e chiedersi quali informazioni consente di ottenere. La ricerca metodologica dovrebbe mirare allo sviluppo di metodi semplici da applicare, per analizzare periodicamente i dati sulla aderenza alle terapie croniche. Ad oggi, l aderenza ai trattamenti cardiovascolari cronici in Italia è molto bassa, probabilmente per corresponsabilità di medico e paziente.