Adherence to statin treatment and health outcomes in an Italian cohort of newly treated patients: results from an administrative database analysis.

Adherence to statin treatment is expected to be associated with health outcomes. Much of the available evidence is derived from studies conducted on selected populations (eg, Medicaid population), on specific cohorts of patients (eg, patients with diabetes mellitus or those who have experienced acute myocardial infarction [AMI]), or with respect to a single outcome (eg, only death or only AMI). The aim of this study was to evaluate the association between adherence to statin therapy and all-cause mortality and cardiovascular morbidity (AMI and stroke) in an unselected cohort of newly treated patients. We performed a population-based retrospective cohort study that included adult patients with a first prescription of a statin from January 1, 2004, through December 31, 2006, using data from the administrative databases of the Local Health Unit of Florence in Italy. Adherence to statin treatment was estimated as the proportion of days covered (PDC) by filled prescriptions and classified as low (PDC, 21%-40%), intermediate-low (PDC, 41%-60%), intermediate-high (PDC, 61%-80%), and high (PDC, >80%). Cases with PDC ≤20% were excluded. A Cox regression model was used to investigate the association between adherence to treatment and all-cause mortality and hospitalization for AMI or stroke. The cohort consisted of 19,232 patients (9823 men and 9409 women) aged 18 to 102 years (mean [SD], 66.5 [11.4] years): 20.1% had been previously hospitalized for cardiovascular events and 17.6% had been treated with hypoglycemic drugs. Adherence to statins was low in 4427 patients (23.0%), intermediate-low in 3117 (16.2%), intermediate-high in 3784 (19.7%), and high in 7904 (41.1%). Lower-adherent patients were younger and had fewer comorbidities compared with higher-adherent patients. In our multivariable analyses, high adherence was significantly associated with decreased risk of all-cause death, AMI, or stroke. Compared with low adherence (hazard ratio [HR] = 1), the risk was lower in intermediate-low adherence (HR = 0.83; 95% confidence interval [CI], 0.71-0.98; P < 0.05) and much lower in intermediate-high (HR = 0.60; 95% CI, 0.51-0.70; P < 0.001) and high adherence (HR = 0.61; 95% CI, 0.54-0.71; P < 0.001). In this Italian cohort of newly treated patients, suboptimal adherence to statins occurred in a substantial proportion of patients and was associated with increased risk of adverse health outcomes.

Degli Esposti L ，Saragoni S ，Batacchi P ，Benemei S ，Geppetti P ，Sturani A ，Buda S ，Degli Esposti E ... -  《-》

Results of a retrospective database analysis of adherence to statin therapy and risk of nonfatal ischemic heart disease in daily clinical practice in Italy.

Previous studies have reported that statin use was associated with reductions in cardiovascular morbidity and mortality among patients with dyslipidemia, even without established cardiovascular disease. However, inadequate adherence may reduce statins' protective effects. The aim of this work was to investigate whether an association exists between statin adherence when used as primary prevention and risk of subsequent ischemic heart disease (IHD). People aged >or=18 years who were residents of Italy's Lombardy region and were newly treated with statins in 2002 to 2003 were assessed as part of a retrospective analysis of data from a health services database. Patients who were hospitalized for IHD during this period were identified with hospital discharge information from a health-services database; IHD-related hospitalizations were identified by International Classification of Diseases, Ninth Revision, Clinical Modification, codes for acute myocardial infarction (410), acute and subacute forms of IHD (411), and/or codes concerning coronary revascularization (36.0-36.9). Four groups of patients were excluded: those with >or=1 lipid-lowering drug within 2 years before the index prescription (to limit the sample to treatment initiators); those who had been hospitalized for cardiovascular disease or had used medications for IHD or heart failure within 2 years before the index date (to limit the study to primary prevention); those who did not have >or=1 year of follow-up; and those who received only 1 dispensation of a statin during the first year after the index prescription. Follow-up continued until hospitalization for IHD or any other cardiovascular cause, death from any cause, emigration, or the end of the study period (June 30, 2007). The proportion of days covered (PDC) by therapy with statins was the exposure variable; it served as a proxy for adherence. PDC (and therefore adherence) was categorized as very low (<or=25%), low (26%-50%), intermediate (51%-75%), or high (>or=75%) coverage. A proportional hazards model was fitted to estimate hazard ratio (HR) and 95% CIs for the association between time-dependent categories of PDC and time of IHD hospitalization, after correcting for covariates. A group of 90,832 patients was included; during follow-up, 1480 patients experienced a hospitalization for IHD. After the Cox proportional hazards model was adjusted for age, sex, type of statin dispensed at index prescription, current use of other selected drugs (ie, antidiabetics, antihypertensives, digitalis or organic nitrates, or other cardiac medications), Charlson comorbidity index, and whether or not a given patient switched statins, those with low, intermediate, or high statin coverage had HR (95% CI) values of 0.85 (0.72-0.98), 0.82 (0.71-0.95), and 0.81 (0.71-0.94), respectively, compared with patients with very low coverage. In these Italian subjects without a history of cardiovascular disease, low, intermediate, and high levels of adherence to statin pharmaco-therapy were associated with lower risk of nonfatal IHD compared with those who had very low (<or=25%) adherence. However, these findings have several limitations, such as the use of database information (rather than medical records), the assumption that PDC accurately represented actual adherence, and confounding (ie, unmeasured factors related to PDC or to adherence may have influenced clinical outcomes).

Corrao G ，Conti V ，Merlino L ，Catapano AL ，Mancia G ... -  《-》

Lower risk of major cardiovascular events associated with adherence to colesevelam HCI.

To examine the relationship between adherence to colesevelam and the risk of major cardiovascular events (acute myocardial infarction [AMI] and stroke) among patients newly treated with colesevelam. Retrospective cohort study using administrative claims data. MarketScan commercial and Medicare databases (2005-2011). A total of 42,549 adults with hyperlipidemia and/or type 2 diabetes mellitus who newly started colesevelam between January 1, 2005, and September 30, 2011, and who had continuous enrollment in employer-sponsored commercial health insurance or Medicare supplemental benefit plans for at least 6 months before and 12 months after the date of colesevelam initiation. Adherence was measured as the proportion of days covered (PDC) by prescription claims for colesevelam during the 1-year period after the drug initiation date. Patients were assigned to one of three adherence cohorts: adherent, PDC of 0.8 or more; partially adherent,PDC of 0.5-0.8; or nonadherent, PDC of less than 0.5. The primary outcome was time to the first hospitalization with a primary diagnosis for AMI or stroke during the follow-up period. Association of colesevelam adherence with the primary outcome was examined by multivariate Cox regression models, adjusting for demographics, comorbidity, and concomitant drugs. A sensitivity analysis between propensity score-matched cohorts was conducted to compare the outcome between adherent and nonadherent groups. Of the 42,549 patients included in the analysis, 7968 (18.7%) were adherent, 6197 (14.6%) were partially adherent, and 28,384 (66.7%) were nonadherent. Compared with nonadherent patients, adherent patients were older, more likely to be male and from the Northeast or North Central regions of the United States, and had more cardiovascular risk factors and concomitant drugs. Controlling for patient demographic and clinical characteristics, adherent patients were about 43% less likely to experience an AMI or stroke hospitalization during the follow-up period compared with nonadherent patients (hazard ratio 0.57, 95% confidence interval[CI] 0.44-0.73, p<0.0001). Results of the sensitivity analysis using propensity score matching techniques were consistent. Adherence to colesevelam was associated with lower risk of major cardiovascular events (AMI and stroke) among patients with hyperlipidemia and/or type 2 diabetes. Research to assess interventions to improve adherence to colesevelam and subsequently to evaluate the effects of these interventions on cardiovascular outcomes is warranted.

Ye X ，Qian C ，Liu J ，St Peter WL ... -  《-》

Statins after recent stroke reduces recurrence and improves survival in an aging Mediterranean population without known coronary heart disease.

The effect of a statin-based medical intervention on prevention of fatal and non-fatal stroke recurrence and the incidence of all-causes mortality have been explored previously in aging populations within the scope of clinical trials research. However, such evidence needs to be explored under conditions of routine clinical practice. The objective of this study was to determine whether statin therapy in patients with a first stroke episode reduces the incidence of 6-year recurrent fatal or non-fatal stroke and all-cause mortality in an aging Mediterranean population without known coronary heart disease followed in routine medical practice. A retrospective study was carried out using records on death, hospitalizations owing to stroke and history of statin therapy included in the Badalona Serveis Assistencials (BSA) database. The cohort studied consisted of consecutive patients covered by the BSA health provider plan with a first-ever acute stroke episode during January 2003 until December 2008, for whom there was available information covering the 6-year follow-up period. Recurrence rate (RR) and incidence rate (IR) of fatal/non-fatal stroke and all-causes mortality were computed. Association with statin therapy was assessed by means of calculation of relative risk (RR) and hazard ratio (HR) using multivariate logistic regression and Cox proportional hazards models controlling for confounding covariates. The cohort comprised a series of 601 consecutive patients [57% men, 75·9 (12·4) years old (88% >60 years)]. Of these, 32% received statins, which were associated with lower fatal/non-fatal recurrent stroke RR; 7% vs. 18% [adjusted RR=0·32 (CI: 0·16-0·61), P=0·001] and lower IR; 16·78 vs. 45·22 events/year-1000 subjects [adjusted HR=0·35 (0·19-0·64), P=0·001]. Similarly, observed all-causes mortality was lower in the cohort receiving statins; 11% vs. 16% [adjusted RR=0·29 (CI: 0·08-1·12), P=0·072], and also mortality rate; 26·09 vs. 36·25 deaths/year-1000 subjects [adjusted HR=0·23 (0·08-0·67), P=0·007]. Statin therapy in patients with first-ever acute stroke lowers the risk of 6-year stroke recurrence and improves survival in an aging Mediterranean cohort. These results add additional evidence in routine clinical practice to the observed effects of statins in clinical trials.

Sicras-Mainar A ，Planas-Comes A ，Frias-Garrido X ，Navarro-Artieda R ，de Salas-Cansado M ，Rejas-Gutiérrez J ... -  《-》

Association between copayment and adherence to statin treatment initiated after coronary heart disease hospitalization: a longitudinal, retrospective, cohort study.

Ye X ，Gross CR ，Schommer J ，Cline R ，St Peter WL ... -  《CLINICAL THERAPEUTICS》