Publications (68)

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    [Show abstract] [Hide abstract] ABSTRACT: Background: Previous studies have stated that atrial fibrillation (AF) is associated with a higher risk of dementia. However, none have examined the competition between death and incident dementia in patients with AF. We evaluated the risk of incident dementia in patients with AF in comparison to people without this arrhythmia, considering of the competing risk of death. Methods: AF and non-AF cohorts were identified using the large administrative database of the Lombardy Region and followed for ten years. Patients with incident dementia were identified if they had an ICD 9 code referring to dementia at hospital discharge or a prescription for any anti-dementia drug. The association of AF with dementia or death was assessed with the multivariable Cox proportional-regression model, sensitivity analysis with a 1:1 propensity score matching and competing-risk analysis. Results: In 2003 a total of 27,431 patients were hospitalized for AF in the Lombardy Region, while the cohort of non-AF counted 1,600,200 people. AF was associated with a higher risk of dementia (17%) and death (51%) at multivariable Cox analysis. These results were confirmed by the model fitted after propensity score matching. However, competing risk analysis found the association between AF and incident dementia was no longer significant (HR 0.99; 95% CI 0.94-1.04). Conclusions: In this real-world population the association between AF and dementia was no longer statistically significant when death was considered a competing risk.
    Full-text available · Article · Jun 2016 · International journal of cardiology
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    [Show abstract] [Hide abstract] ABSTRACT: Aims: Heart failure (HF) and chronic obstructive pulmonary disease (COPD) frequently co-exist, and each is a major public health issue. In a large cohort of hospitalized HF patients, we evaluated: (i) the impact of COPD on clinical outcomes; (ii) whether outcomes and treatments changed from 2002 to 2009; and (iii) the relationship between outcomes and treatments focusing on beta-blockers (BBs) and bronchodilators (BDs). Methods and results: From linkable Lombardy administrative health databases, we selected individuals with a discharge diagnosis of HF with or without concomitant COPD (HF yesCOPD and HF noCOPD) in 2002 and 2009. Patients were followed up for 4 years. Outcomes were total mortality, first readmission for HF, and their combination. Unadjusted and adjusted Cox proportional models and competing risk analyses were used. We identified 11 274 patients with HF noCOPD and 2837 with HF yesCOPD. HF yesCOPD patients in 2002 and 2009 had a 20% higher risk of the outcomes. From 2002 to 2009, BB and BD prescriptions increased significantly. In HF noCOPD patients, risks for mortality [adjusted hazard ratio (HR) 0.91, 95% confidence interval (CI) 0.86-0.97], first HF readmission (HR 0.79, 95% CI 0.74-0.85), and the combined endpoint (HR 0.88, 95% CI 0.84-0.92) declined (all P < 0.003) while in HF yesCOPD only the risk for first HF readmission dropped (HR 0.86, 95% CI 0.76-0.97; P = 0.018). BBs were associated with significantly lower mortality in both groups, but with a higher risk for first HF readmission in HF noCOPD. Outcomes did not significantly differ in HF yesCOPD treated or not with BDs. Conclusions: The prognosis of patients hospitalized for HF, either with or without COPD, seemed to improve between 2002 and 2009, with possibly better survival of those on BBs. Because of residual confounding in observational studies, a randomized controlled trial should be considered to confirm these results.
    Full-text available · Article · Apr 2016 · European Journal of Heart Failure
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    [Show abstract] [Hide abstract] ABSTRACT: Aims To assess the pattern of use of Emergency Departments (EDs), factors contributing to the visits, geographical distribution and outcomes in people aged 65 years or more living in the Italian Lombardy Region in 2012. Methods Based on an administrative database the study population was divided into groups according to the number of ED visits. A multinomial logistic regression model was performed to compare the characteristics of each group. The Getis–Ord’s G statistic was used to evaluate the clusters of high and low visit prevalence odd ratios (OR) at district level. To estimate the severity of the disease leading to ED attendance, visits were stratified based on the level of emergency and outcome. Results About 2 million older people were included in the analyses: 78 % had no ED visit, 15 % only 1, 7 % 2 or more. Male sex, age 85 years or more, high number of drugs, ED visits and hospital admissions in the previous year and the location of an ED within 10 km from the patient’s place were all factors associated with a higher risk to have more ED visits. Clusters of high and low prevalence of visits were found for occasional users. Overall, 83 % of ED visit with a low emergency triage code at admission had as visit outcome discharge at home. Conclusions In older people several variables were associated with an increased risk to have a high number of ED visits. Most of the visits were done for non-urgent problems and significant geographic differences were observed for occasional users.
    Full-text available · Article · Mar 2016 · Aging - Clinical and Experimental Research
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    [Show abstract] [Hide abstract] ABSTRACT: Objective: To investigate the association between angiotensin converting enzyme inhibitors (ACEIs), angiotensin II receptors blockers (ARBs) and motor neuron disease (MND). Methods: This is a population-based nested case-control study. Data were obtained from a population registry and the administrative database of the Lombardy Region (Northern Italy) from 2000 through 2010. Included were 1,200 patients with newly diagnosed MND/ALS and 120,000 controls, randomly selected from the same population and matched for gender, age and area of residence. Exposure to ACEIs or ARBs was quantified using defined daily doses (DDDs). Cumulative DDD (cDDD) was estimated as the sum of dispensed DDDs in the preceding 5 years, excluding 1 year before the MND/ALS diagnosis. Overall exposure, levels of exposure, and individual drugs were all assessed. Subgroup analyses were performed according to age, sex, ALS and ACEI-ARB association. Results: There was no significant association between MND/ALS and antecedent use of ACEIs or ARBs. Data were confirmed in multivariable models and in subgroups. Conclusions: A protective role of ACEIs and ARBs in MND was not confirmed. Differences with a previous report (showing an inverse association between ACEIs and ALS) can be explained by different genetic background, dietary habits and susceptibility to environmental exposures, including drugs.
    Full-text available · Article · Feb 2016
  • [Show abstract] [Hide abstract] ABSTRACT: Aim: To evaluate the temporal trend and extent of screening for celiac disease in an Italian pediatric population of incident type 1 diabetes in the period 2006-2011, providing information on adherence to guidelines in primary care. Methods: Using the Lombardy region's administrative database, 1-17-year-old children and adolescents diagnosed with type 1 diabetes during the 2006-2011 period were identified. Among these patients, the number screened for celiac disease was calculated on the basis of specific antibodies. Results: Of the 1563 children and adolescents receiving a diagnosis of type 1 diabetes during the observational period, 53% were tested for celiac disease compared with 12% of individuals without diabetes. The extent to which screening was performed increased two-fold from the 2006-2008 to the 2009-2011 period (P<0.0001). Among the screened population, 1.8 of the non-type 1 diabetes population and 9.4% of the new cases of type 1 diabetes received a diagnosis of celiac disease (90% after type1 diabetes diagnosis and 10% before). Being female and less than 4 years old were factors associated with an increased risk of receiving both diagnoses. Conclusion: In conclusion, to the best of our knowledge, this is the first report in which celiac disease screening is measured in a type 1 diabetes population from the time of diagnosis up to at least 12 months afterwards. The results provide evidence that, although the rate of screening increased over time, nearly half of children with type 1 diabetes were not screened after diagnosis during the observed period, suggesting scarce adherence to guidelines in primary care.
    Article · Feb 2016 · European Journal of Gastroenterology & Hepatology
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    [Show abstract] [Hide abstract] ABSTRACT: Purpose: The purpose of this study is to explore the effect of incident chronic polypharmacy on 1-year hospitalization, institutionalization, and mortality among older people and to evaluate whether or not the effect differed according to index year (2001 or 2009), sex, and age. Methods: Data were obtained from the administrative database of the Lombardy region (Northern Italy). We compared community-dwelling elderly people with an incident exposure to chronic polypharmacy (five or more drugs during 1 month for at least 6 months in 1 year) in either index year (2001 and 2009) with not exposed elderly people in the same years. Multivariable logistic (institutionalization) and Cox (hospitalization and death) were performed including year, sex, age classes, and number of drugs as covariates and their respective interaction terms by chronic polypharmacy. Results: We analyzed 1,800,257 elderly subjects in 2001 and 1,567,575 in 2009, with a prevalence of chronic polypharmacy of 1.46% and 2.86%, respectively. Overall, 1-year hospitalization, institutionalization, and mortality rates were lower in 2009 than in 2001. Chronic polypharmacy was significantly associated with the outcomes in multivariable analyses: hazard or odds ratios 1.16 (95% confidence interval 1.14-1.17) for hospitalization, 1.21 (1.12-1.30) for institutionalization, and 1.11 (1.08-1.14) for death. There was no consistent effect modification by index year or sex, whereas chronic polypharmacy was no longer a risk factor for adverse outcomes among those older than 85 years (p < 0.0001 for interaction). Conclusions: Incident chronic polypharmacy remained an independent predictor of adverse outcomes among community-dwelling elderly people, despite a reduction over time of 1-year hospitalization, institutionalization, and mortality rates. Copyright © 2015 John Wiley & Sons, Ltd.
    Full-text available · Article · Dec 2015 · Pharmacoepidemiology and Drug Safety
  • Carla Carnovale · Marta Gentili · Ida Fortino · [...] · Sonia Radice
    Article · Dec 2015 · Expert Opinion on Drug Safety
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    Dataset: 2011
    File available · Dataset · Sep 2015
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    Dataset: 2011
    File available · Dataset · Sep 2015
  • Dataset: Fig. 1S
    Dataset · Sep 2015
  • [Show abstract] [Hide abstract] ABSTRACT: Diabetes mellitus (DM) and atrial fibrillation (AF) are worldwide public health challenges and major causes of death and cardiovascular events. The association between DM and AF is controversial in literature and data on outcomes of individuals with both diseases have not been evaluated in population studies. We tested the hypothesis that DM is independently associated to AF hospitalization and assessed the risk of stroke and mortality in people with both conditions. We conducted a population-based cohort-study of DM patients and their corresponding controls identified in a administrative health database of the Lombardy Region. Both cohorts were followed for nine years. A multivariable Cox proportional-hazards-regression model was used to estimate the hazard ratio (HR) for first hospitalization for AF and for clinical outcomes. Out of 9,061,258 residents, 285,428 (3.14%) DM subjects were identified, mean age 65.8±15 years, 49% were women. The cumulative incidence of AF in DM was 10.4% vs. 7.4% in non-DM. DM was a risk factor for AF (HR 1.32, 95% CI 1.30-1.34; p<0.0001). Oral anticoagulants were prescribed in 34.8% of DM patients with AF. DM associated with AF, presented the highest HR for stroke: 2.63; 95% CI 2.47-2.80 and for total death, HR 2.41; 95% CI 2.36-2.47. In this population study, DM was an independent risk factor for AF hospitalization. DM patients with AF had the highest risk of stroke and total mortality. Early identification of AF and a structured plan to optimize the comprehensive management of DM and AF patients is mandatory. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
    Article · Jul 2015 · Diabetes research and clinical practice
  • [Show abstract] [Hide abstract] ABSTRACT: Causes of ARF are numerous including drugs. In 2012, spontaneous reporting showed a possible association between dronedarone and ARF. To further investigate such association, a retrospective cohort study on health-service claim databases was performed taking amiodarone as comparison. All patients receiving new prescription of amiodarone or dronedarone between September 2010 and December 2012 were selected. Cox regression models to estimate the hazard ratios (HRs), with 95 % confidence intervals (CIs), for dronedarone versus amiodarone were performed. HRs were calculated: (i) for the entire cohort; (ii) for matched cohorts using propensity score; (iii) and high-dimensional propensity score. New users without previous episodes of ARF were 56,739 and 1761 on dronedarone and 54,978 on amiodarone. After 1:1 matching for propensity score, new users with dronedarone and amiodarone were 1467 and 1467, respectively. The cumulative incidence rate of ARF was 1.6 % (95 % CI 0.7-3.6 %) among dronedarone group and 2.3 % (1.0-5.1 %) among amiodarone group (p from log rank test = 0.4884). The unadjusted HR of ARF was 0.34 (0.18-0.64) in dronedarone new users compared to amiodarone; in propensity score matched cohort, it was 0.75 (0.26-2.16), and in high-dimensional propensity score, it was 0.83 (0.25-2.73). This large community-based study did not confirm the signal of an increased nephrotoxicity from dronedarone compared to amiodarone. Nevertheless, given the increasing number of reports collected from pharmacovigilance databases worldwide on this association, it is advisable for clinicians and patients to be aware of the possible kidney damage due to dronedarone in order to improve clinical outcomes with early intervention.
    Article · Jul 2015 · European Journal of Clinical Pharmacology
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    [Show abstract] [Hide abstract] ABSTRACT: To describe the incidence of ischemic stroke, short-term mortality, recurrences, and prescription patterns. Data from administrative health databases of the Lombardy Region from 2002 to 2010 (about 4 million people) were analyzed for stroke incidence and recurrence, mortality, and drug prescriptions after an ischemic stroke. A total of 43,352 patients with a first hospital admission for ischemic stroke were identified. During 8 years, stroke incidence decreased from 3.2 of 1000 to 2.4 of 1000 (P < .001) in people aged 65-74 years, from 7.1 of 1000 to 5.3 of 1000 (P < .001) at ages 75-84 years and from 11.9 of 1000 to 9.4 of 1000 (P < .001) at age 85 years or older. Stroke recurrences dropped by 30% (from 10.0% to 7.0%, P < .001) and 30-day mortality rate also decreased. Prescription trends showed linear increase in antiplatelets and lipid-lowering drugs, respectively, from 60.2% to 65.0% (P < .001) and from 19.1% to 34.6% (P < .001), whereas antihypertensive prescriptions did not change appreciably. Anticoagulant prescription increased in patients with atrial fibrillation, from 64.8% to 72.1% in the 65-74 years age group, (P = .004) and from 40.2% to 53.7% in the 75-84 years age group (P < .001); less than 20% of the 85 years or older age group were treated with anticoagulants (P < .0001). Stroke incidence, recurrence, and 30-day mortality decreased from 2002 to 2010 concomitant with an increase in prescriptions of secondary stroke prevention drugs. Copyright © 2015 National Stroke Association. Published by Elsevier Inc. All rights reserved.
    Full-text available · Article · Jun 2015 · Journal of stroke and cerebrovascular diseases: the official journal of National Stroke Association
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    [Show abstract] [Hide abstract] ABSTRACT: Only three observational studies investigated whether exposure to antipsychotics is associated with an increased risk of pulmonary embolism, with conflicting results. This study was therefore carried out to establish the risk of pulmonary embolism associated with antipsychotic drugs, and to ascertain the risk associated with first- and second-generation antipsychotic drugs, and with exposure to individual drugs. We identified 84,253 adult individuals who began antipsychotic treatment in a large Italian health care system. Cases were all cohort members who were hospitalized for non-fatal or fatal pulmonary embolism during follow-up. Up to 20 controls for each case were extracted from the study cohort using incidence density sampling and matched by age at cohort entry and gender. Each individual was classified as current, recent or past antipsychotic user. The occurrence non-fatal or fatal pulmonary embolism was the outcome of interest. Compared to past use, current antipsychotic use more than double the risk of pulmonary embolism (odds ratio 2.31, 95% confidence interval 1.16 to 4.59), while recent use did not increase the risk. Both conventional and atypical antipsychotic exposure was associated with an increase in risk, and the concomitant use of both classes increased the risk of four times (odds ratio 4.21, 95% confidence interval 1.53 to 11.59). Adding the results of this case-control study to a recent meta-analysis of three observational studies substantially changed the overall estimate, which now indicates that antipsychotic exposure significantly increases the risk of pulmonary embolism.
    Full-text available · Article · Apr 2015 · BMC Psychiatry
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    [Show abstract] [Hide abstract] ABSTRACT: Introduction: Lithium is a highly specific and evidence-supported drug for the acute and maintenance treatment of bipolar disorder. Methods: The purpose of this study was to calculate the prevalence and incidence of lithium use and to investigate the prescribing patterns of other mood-stabilizing agents in lithium users. We analyzed lithium utilization from 2000 to 2010 in a large area in Italy on the basis of dispensing data drawn from the regional administrative database. For each calendar year those who had at least one recorded dispensation of lithium were defined as lithium users. Those who received more than 4 dispensations per year were defined as lithium-treated. Results: Rates of lithium utilization did not change during the observation period, but the amount of drug prescribed increased as a result of longer treatment and higher doses. The prevalence of use showed an initial increase of 8% (2000-2002), followed by a 13% decrease (2002-2006) and a subsequent rise of 11% (2006-2010). The prevalence of treatment grew by 38% during the whole observation period. The proportion of former lithium users who received other drugs or discontinued any treatment increased from 41% in 2002 to 52% in 2006, and then fell to 40% in 2010. Conclusion: The initial decline (2002-2006) and the subsequent rise (2006-2010) of lithium use can be explained by a fall and rise of new prescriptions. This finding together with a similar but opposite change in prescriptions of the other mood-stabilizing agents suggests a temporary change in prescribing attitudes which was subsequently reconsidered. © Georg Thieme Verlag KG Stuttgart · New York.
    Full-text available · Article · Feb 2015 · Pharmacopsychiatry
  • [Show abstract] [Hide abstract] ABSTRACT: PurposeThe aim of this study was to investigate the rate of recurrent prescriptions and hospital admissions in children receiving a brand name or generic antibiotic prescription.Methods The data source was a database of reimbursed prescriptions. Outpatient children/adolescents <18 years old (Lombardy Region, Italy) were included. The observational period was February-April 2010. A recurrence was defined as an antibiotic prescription occurring within 28 days after an index prescription. The rate of recurrent prescriptions and hospital admissions was calculated for generic/brand name formulations and for each age strata (0-5, 6-11, and 12-17 years old) for four antibiotics: amoxicillin, amoxicillin clavulanate, clarithromycin, and cefaclor. The percentage of therapy switches was calculated. Cochran-Mantel-Haenszel test was used to compare the age-adjusted outcomes.ResultsIn all, 17.5% (57 346) of children received at least one recurrent prescription. The rate of recurrent prescriptions was slightly lower in children receiving any generic (OR 0.96; 95%CI 0.93-0.98), compared with any brand name, antibiotic. The percentage of hospital admissions occurring in children initially treated with a brand name (1.01%; 95%CI 0.98-1.08) or generic (1.03%; 0.96-1.06) antibiotic was not different (p = 0.43). For children receiving amoxicillin clavulanate, the hospital admission rate was slightly higher in the brand name group (p = 0.002), while no differences were found for the other active substances.Conclusions Children treated with generic antibiotics had no worse safety and effectiveness outcomes when compared with those receiving brand name ones. These results provide additional evidence on the safety of generic antibiotics. Copyright © 2014 John Wiley & Sons, Ltd.
    Article · Feb 2015 · Pharmacoepidemiology and Drug Safety
  • [Show abstract] [Hide abstract] ABSTRACT: To compare the utilization of health care resources (drug prescriptions, hospital admissions and health care services) by immigrant versus native elderly people (65 years or more), by using administrative database of the Lombardy Region. For each immigrant (an older people born out of Italy), one person born in Lombardy (native) was randomly selected and matched by age, sex and general practitioner. The 25,508 immigrants selected were less prescribed with at least one drug (OR 0.72, 95 % CI 0.67–0.76) and had a lesser use of health care services (OR 0.79, 95 % CI 0.75–0.84) than natives. No statistically significant differences were found for hospital admission rates (OR 0.99, 95 % CI 0.99–1.04). A lower rate of health care resource utilization was observed in elderly immigrants who had been living in the host region for as many as 10 years.
    Article · Jan 2015 · Journal of Immigrant and Minority Health
  • [Show abstract] [Hide abstract] ABSTRACT: Networks are well suited to display and analyze complex systems that consist of numerous and interlinked elements. This study aimed i) to generate a series of drug prescription networks (DPNs) displaying co-prescription in community-dwelling elderly people; ii) to analyse DPN structure and organization; iii) to compare various DPNs in order to unveil possible differences in drug co-prescription patterns across time and space. Data were extracted from the administrative prescription database of the Lombardy Region, Northern Italy, in 2000 and 2010. DPNs were generated, in which each node represents a drug chemical subclass, while each edge linking two nodes represents the co-prescription of the corresponding drugs to the same patient. At a global level, the DPN was a very dense and highly clustered network, while at the local level it was organized into anatomically homogeneous modules. In addition, the DPN was assortative by class, as similar nodes (representing drugs with the same anatomic, therapeutic and pharmacologic annotation) connected to each other more frequently than expected, which indicates that similar drugs are often co-prescribed. Finally, temporal changes in the co-prescription of specific drug subgroups (for instance, proton pump inhibitors) translated into topological changes of the DPN and its modules. In conclusion, complementing more traditional pharmacoepidemiology methods, the DPN-based method allows appreciating (and representing) general trends in the co-prescription of a specific drug (e.g., its emergence as a heavily co-prescribed hub) in comparison with other drugs.
    Article · Dec 2014 · Rejuvenation Research
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    [Show abstract] [Hide abstract] ABSTRACT: Purpose: The aims of this study are to analyse, in community-dwelling people aged 65+ living in Italy's Lombardy Region, electrocardiographic (ECG) monitoring for new users of the atypical antipsychotic quetiapine co-prescribed with acetylcholinesterase inhibitors (AChEIs) or memantine and to find independent predictors of ECG monitoring before and after the starting of this prescription. Methods: The Lombardy Region's administrative health database was used to retrieve prescriptions of ECG exams as well as prevalence rates of subjects aged 65+ who were prescribed such psychotropic drugs from 2005 to 2009. Multivariable analyses were adjusted for age, sex, number of drugs, treatment with beta-blockers, digoxin, verapamil or diltiazem, any antiarrhythmic drug and antidepressants. Results: Overall 2,623 community-dwelling older people started therapy with quetiapine, co-prescribed with AChEIs or memantine, during these 5 years. At least one ECG was performed in 714 cases (27.2 %) in the 6 months before-and in 398 cases (15.2 %) within 3 months after-the starting of this prescription. ECG monitoring was performed both before and after starting quetiapine in only 160 cases (6.1 %). At multivariable analyses, number of drugs taken, beta-blocker and antiarrhythmic drug use were found to be independent correlates of ECG monitoring whereas female sex was associated with a lower probability of receiving an ECG within 3 months after the initiation of quetiapine (odds ratio 0.78, 95 % CI 0.62-0.98). Conclusions: ECG monitoring for new prescriptions of quetiapine in older people suffering from behavioural and psychological symptoms in dementia was actually performed infrequently, independently of the age of drug users, especially in women. Our results support the need for greater awareness within the medical community of the importance of such ECG monitoring.
    Full-text available · Article · Sep 2014 · European Journal of Clinical Pharmacology
  • Dataset: Table S1
    Dataset · Aug 2014