Aldo Pietro Maggioni, MD, FESC ANMCO Research Center Firenze, Italy

Transcription

1 Use and misuse of statins after an acute coronary syndrome (ACS): analysis of a prescription database of a community setting of more than 2,000,000 subjects Aldo Pietro Maggioni, MD, FESC ANMCO Research Center Firenze, Italy

2 ESC Guidelines 2008 Preventive Treatment after STEMI Recommendations Class LOE Beta-blockers Oral beta-blockers in all patients who tolerate these medications and without contraindications, regardless of blood pressure or LV function Ace-I and ARB Ace-I should be considered in all patients without contraindications, regardless of blood pressure or LV function ARB in all patients without contraindications who do not tolerate ACEinhibotors, regardless of blood pressure or LV function Statins Statins in all patients, in the absence of contraindications, irrespective of cholesterol levels, initiated as soon as possible to achieve LDLc < 100 mg/dl (2.5 mmol/l) I IIa IIa I A A C A Further reduction of LDLc < 80 mg/dl (mmol/l) should be considered in high risk patients IIa A N-3 PUFA Increased consumption of omega 3 fatty acids Supplementation with 1 gram of fish oils IIb IIa B B

3 Purpose of the study To assess in a community setting how patients discharged alive after an ACS are treated with statins More specifically, the rate of prescription of statins, the prescribed dosages and the 1- year adherence to treatment have been evaluated

4 Methods-1 From the ARNO database, we carried out a record linkage analysis of hospital discharge records for ACS and prescription databases This study included 2,042,968 subjects from 7 Local Italian Health Authorities of the National Health Service The accrual period lasted from January 1, 2007 to June 30, 2007

5 Methods-2 Discharge records and prescription patterns were analyzed also for 1 year before and after the accrual period to identify the events and the prescriptions reported before and after that period Adherence to statin therapy was defined when patients received a prescription of statin, during the 1 year follow-up, consistent with a daily treatment (at least 300 out of 365 days) A multivariable analysis (logistic regression model) was performed to identify the independent predictors of prescription continuity

6 Disclosures Aldo P Maggioni received honoraria for lectures from Astra Zeneca, that partially supported this study

7 Study design Patients discharged after ACS Accrual period 01/01/ /01/ /06/ /06/2008 Prior ACS (365 days before discharge) Follow-up (365 days after discharge)

8 Total population: 2,402,968 From 7 Local Italian Health Authorities from 4 Regions (North, Center e South Italy) Patients with Acute Coronary Syndrome (during the accrual period): 3,549 (1.5 ) 1-year follow up data available for 3,078 patients Patients, discharged alive, treated with at least one statin : 2,473/3,078 (80.3%) Atorvastatin: 1,350 (54.6%) Simvastatin: 653 (26.4%) Rosuvastatin 363 (14.7%) Pravastatin: 249 (10.1%) Simvastatin+Ezetimibe: 211 (8.5%) Fluvastatin: 120* (4.9%) Lovastatin: 15* (0.6%)

9 Patients with ACS: age and gender (n. 3,549 patients)

10 Patients with ACS: all-cause in-hospital deaths 264/3,549 (7.4%) 7.4%

11 Patients treated with statins at hospital discharge 2,473/3,078 (80.3%)

12 10/10mg 10/20mg 10/40mg % treated 10mg 20mg 40mg 80mg 40mg 80mg 20mg 40mg 20mg 40mg 5mg 10mg 20mg 40mg 10mg 20mg 40mg Use of statins after ACS: drugs and dosages (n. 2,473 patients) Type of agent

13 Adherence to statin treatment (n. 2,473 patients) Total

14 Prior MI Concomitant cancer Peripheral Artery Disease Diabetes mellitus Cerebrovascular disease Arterial hypertension Depression Age (70-79) Age(60-69) Age(50-59) Age (<50) Male gender Independent predictors of statin adherence 0,63 0,95 1 1,23 1,18 1,26 1,21 1,37 1,28 1,30 1,40 1,92 0,00 0,50 1,00 1,50 2,00 2,50

15 ESC Guidelines 2008 Preventive Treatment after STEMI Recommendations Class LOE Beta-blockers Oral beta-blockers in all patients who tolerate these medications and without contraindications, regardless of blood pressure or LV function Ace-I and ARB Ace-I should be considered in all patients without contraindications, regardless of blood pressure or LV function ARB in all patients without contraindications who do not tolerate ACEinhibotors, regardless of blood pressure or LV function Statins Statins in all patients, in the absence of contraindications, irrespective of cholesterol levels, initiated as soon as possible to achieve LDLc < 100 mg/dl (2.5 mmol/l) I IIa IIa I A A C A Further reduction of LDLc < 80 mg/dl (mmol/l) should be considered in high risk patients IIa A N-3 PUFA Increased consumption of omega 3 fatty acids Supplementation with 1 gram of fish oils IIb IIa B B

16 Concomitant treatments (n patients) Statins 2473 (80.3%) ACE-Is/ARBs 1804 (72.9%) Antiplatelets 2398 (97.0%) Betablockers 1900 (76.8%) N-3 PUFA 735 (29.7%) Statins, ACE-Is/ARBs, antiplatelets, betablockers 950 (30.8%) Statins, ACE-Is/ARBs, antiplatelets, betablockers, N-3 PUFA 449 (14.6%)

17 Limitations As in all datasets of administrative data, type and number of clinical variables are limited Information regarding bio-humoral measures, useful to evaluate the pharmacological effects of drugs, are lacking

18 Conclusions: facts vs recommendations In a community setting, the rate of prescription of statins seems to be satisfactory, while the guideline recommendation to use intensive statin treatment was not adequately followed Further, the continuity of treatment over time is confirmed to be suboptimal (67%) These findings show that there is still a gap between EB recommendations and what actually happens in routine clinical practice

19 Thanks to all doctors, nurses and pharmacists who are collecting data Marisa De Rosa from CINECA, Bologna, Italy for planning and coordinate the analysis Elisa Rossi, Rita Rielli, Michele Piastra, Miriam Gotti, Alessandra Berti, Lucia Gualandi from the statistical analysis group of CINECA, Bologna, Italy

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21 Conclusioni: fatti vs raccomandazioni Le statine sono state progressivamente incorporate nella pratica clinica Poco più di 1 soggetto su 2 continua nel tempo, come dovrebbe, un trattamento con statine Dopo SCA, circa 2 pazienti su 3 continuano un trattamento con statine per almeno un anno Le posologie utilizzate sono in genere inferiori a quanto raccomandato dalle linee guida

22 Conclusioni: utilità delle analisi di dati amministrativi correnti Nella gestione, pianificazione, e, se necessario, razionalizzazione della spesa sanitaria Per una misura dei gradi di aderenza alle raccomandazioni riportate nelle linee guida nazionali e internazionali più autorevoli Come strumento vivo, e in continua evoluzione, utile a chi scrive le linee guida e le propone alla comunità medica