[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.
European Journal of Clinical Pharmacology 07/2015; 37(8). DOI:10.1007/s00228-015-1903-2 · 2.97 Impact Factor
[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.
[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.
Journal of Immigrant and Minority Health 01/2015; DOI:10.1007/s10903-014-0152-2 · 1.16 Impact Factor
[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.
Rejuvenation Research 12/2014; 18(2). DOI:10.1089/rej.2014.1628 · 3.31 Impact Factor
[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.
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.
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).
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.
European Journal of Clinical Pharmacology 09/2014; 70(12). DOI:10.1007/s00228-014-1750-6 · 2.97 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To describe prescribing patterns in elderly Italian diabetic patients of the Lombardy Region in 2000 and 2010 using an administrative database. Hospital admissions and mortality were also recorded and compared in the two index years.
Analyses were performed on the whole cohort of elderly diabetic patients and across age groups. Direct age standardization was done, with data from the Lombardy Region database for 2005 used as reference to compare diabetic populations in the two index years. Logistic regression models were used to analyze changes in hospital admissions and mortality and to calculate odds ratios.
Using data retrieved from the Lombardy Region database we identified 176,384 and 283,982 elderly diabetic patients in 2000 and 2010, respectively. The overall rates of patients treated with antidiabetic drugs were 92.5 % in 2000 and 97.0 % in 2010. Between 2000 and 2010 the prescribing of glibenclamide declined by 30.0 % (from 52.9 to 22.9 %, p < 0.001) and that of biguanides rose by 17.4 % (from 47.5 to 64.8 %, p < 0.001). In 2010 thiazolidinediones, dipeptidyl peptidase-4 inhibitors and incretin mimetic drugs were seldom prescribed. Drugs for cardiovascular prevention rose in all age classes from 2000 to 2010, and the rates of hospital admission overall fell from 32.0 to 26.8 % (p < 0.001) during the same period, with the exception of those aged ≥85 years. Between 2000 and 2010 the mortality rate decreased in patients aged 65-74 years (from 3.4 to 2.9 %, p < 0.0001) and rose significantly in those aged ≥85 years.
The drug prescription profile of elderly diabetic patients changed from 2000 to 2010, with a tendency toward recommended drugs. These changes may possibly be linked to the decrease in both hospital admissions and mortality in the diabetic group aged 65-74 years.
European Journal of Clinical Pharmacology 05/2014; 70(8). DOI:10.1007/s00228-014-1678-x · 2.97 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background:
The impact of diabetes on cardiovascular disease in both sexes is known, but the specifics have not been fully clarified. We investigated whether sex-related differences exist in terms of management and hospitalization in patients with newly diagnosed diabetes.
We examined the rates of hospitalization for cardiovascular causes, mortality, treatments and management of patients with diabetes compared to subjects without, from administrative database. Interaction between sex and diabetes on clinical outcomes were calculated using a Cox regression model. Pharmacological treatments and recommended examinations by sex were calculated using logistic regression.
From 2002 to 2006, 158,426 patients with diabetes and 314,115 subjects without were identified and followed up for a mean of 33 months (± 17.5). Diabetes confers a higher risk for all clinical outcomes. Females with diabetes have a risk profile for hospitalization for coronary heart disease comparable to males without (4.6% and 5.3%). Interaction between sex and diabetes shows that females with diabetes had an added 19% higher risk of total death (95% CI 1.13-1.24). No differences were observed in hospitalizations, although females with diabetes were less likely to undergo revascularization after myocardial infarction. Females received cardiovascular prevention drugs less frequently than males and had a slight tendency to get fewer examinations.
Diabetes is linked to a higher increase of mortality in females relative to males. This might reflect sex differences in the use of revascularization procedures or therapeutic regimens. Closer attention and implementation of standard care for females are necessary from the onset of diabetes.
European Journal of Internal Medicine 03/2014; 25(3). DOI:10.1016/j.ejim.2014.01.022 · 2.89 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To investigate the changes in the last decade (2000-2010) in drug prescribing among community-dwelling elderly people aged 65-94 years, in relation to age and sex.
We analyzed the data of nearly two million subjects ranging in age from 65 to 94 years recorded in the Drug Administrative Database of the Lombardy Region (Italy) from 2000 to 2010. Associations between drug use (at least one drug, one chronic drug, polypharmacy or chronic polypharmacy) and age, sex, and year of prescription were analyzed by logistic regression analysis. We also analyzed differences in changes linked to sex and age.
Between 2000 and 2010, the prescriptions of at least one drug or one chronic drug increased by 2 % (from 88.0 to 90.3 %; p < 0.0001) and 8 % (from 73.8 to 82.0 %; p < 0.0001), respectively, while the mean number of packages/person/year rose from 34.6 [standard deviation (SD) 32.4] to 48.5 (SD 42.2). During this same period, there was a 10 % increase in the prevalence of elderly people exposed to polypharmacy (≥5 different active substances) (from 42.8 to 52.7 %; p < 0.0001), and the prevalence of those exposed to chronic polypharmacy (≥5 different chronic drugs) doubled (from 14.9 to 28.5 %; p < 0.0001). Males were less frequently treated than females, except for chronic polypharmacy. People aged ≥80 years showed the largest increase in all prescribing patterns. Drug consumption in ATC groups A, H, and N (women) and in B and C (men) increased most, with the greatest absolute differences occurring in the consumption of proton pump inhibitors (31.1 %), platelet aggregation inhibitors (30.1 %), and statins (23.8 %).
Prescriptions to community-dwelling elderly people have increased substantially during the last 10 years. Although this might indicate an improvement in care, the large increase in the number of elderly people exposed to polypharmacy and chronic polypharmacy should be carefully analyzed in terms of quality of care, patient safety, and costs.
European Journal of Clinical Pharmacology 01/2014; 70(4). DOI:10.1007/s00228-013-1621-6 · 2.97 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Many hospitalizations for asthma could potentially be avoided with appropriate management. The aim of this study was to analyze data on disease management of a paediatric population with a hospitalization for asthma. The study population comprised 6-17 year old subjects belonging to three local health units of the Lombardy Region, northern Italy. Regional administrative databases were used to collect data on: the number of children with an incident hospitalization for asthma during the 2004-2006 period, anti-asthma therapy, specialist visit referrals, and claims for spirometry, released in the 12 months before and after hospitalization. Each patient's asthma management profile was compared with GINA guideline recommendations. Among the 183 hospitalized subjects, 101 (55%) received therapy before hospitalization and 82 (45%) did not. 10% did not receive any therapy either before or after hospital admission and in 13% the therapy was discontinued afterward. Based on GINA guidelines, asthma management adhered to recommendations only for 55% of subjects. Results may suggest that for half of hospitalized subjects, inaccurate diagnosis, under-treatment/scarce compliance with asthma guidelines by physicians, and/or scarce compliance to therapy by patients/their parents occurred. In all these cases, hospitalization would be a proxy indicator of preventable poor control of disease, rather than a proxy indicator of severity.
PLoS ONE 10/2013; 8(10):e76439. DOI:10.1371/journal.pone.0076439 · 3.23 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To investigate the incidence of major cardiovascular complications and mortality in the first years of follow-up in patients with newly diagnosed diabetes.
We examined incidence rates of hospitalization for cardiovascular reasons and death among new patients with diabetes using the administrative health database of the nine million inhabitants of Lombardy followed from 2002 to 2007. Age and sex-adjusted rates were calculated and hazard ratios (HR) were estimated with a matched population without diabetes of the same sex, age (±1 year) and general practitioner. There were 158,426 patients with newly diagnosed diabetes and 314,115 subjects without diabetes. Mean follow-up was 33.0 months (SD ± 17.5). 9.7% of patients with diabetes were hospitalized for cardiovascular events vs. 5.4% of subjects without diabetes; mortality rate was higher in patients with diabetes (7.7% vs. 4.4%). The estimated probability of hospitalization during the follow up was higher in patients with diabetes than in subjects without for coronary heart disease (HR 1.4, 95% CI 1.3-1.4), cerebrovascular disease (HR 1.3.95% CI 1.2-1.3), heart failure (HR 1.4, 95% CI 1.3-1.4) as was mortality (HR 1.4, 95% CI 1.4-1.4). Younger patients with diabetes had a risk of death or hospital admission for cardio-cerebrovascular events similar to subjects without diabetes ten years older.
The elevated morbidity and mortality risks were clear since the onset of diabetes and rose over time. These data highlight the importance of prompt and comprehensive patients care in addition to anti-diabetic therapy in patients with newly diagnosed diabetes.
[Show abstract][Hide abstract] ABSTRACT: What is known and objective:
Italian children receive a high number of antibiotic prescriptions, and the use of second-choice antibiotics is common. A few studies in other countries have demonstrated that the implementation of international guidelines for the most common paediatric diseases may reduce the associated costs. A cost analysis of the expenditure for antibiotic prescriptions in outpatient children in the Lombardy region (Italy) and for each of the region's local health units (LHUs) was performed using a pharmacoepidemiological approach. The safety and cost impact associated with a quali-quantitative improvement in antibiotic prescribing was estimated.
The data source was the Lombardy region's prescription database (year 2008) for outpatient children <14 years old. The average total expenditure for each package, and per capita, was calculated for each active substance considered and for each LHU. An estimate of the possible cost reduction was elaborated using, as a reference, the prescription profile of a group of paediatricians that has been involved in initiatives concerning care for years. The hospital admission rates for acute respiratory infections (ARI) and their major complications were evaluated at the regional level and in the group of children followed by the reference paediatricians.
Results and discussion:
The cost reduction estimate reveals a possible decrease in antibiotic expenditure of about 3·6 million euros (-19·5%) in the Lombardy region. Large variability was observed between different LHUs (-33·3 to +9·2% of difference). The hospital admission rate was not different when comparing the group of children followed by the reference paediatricians to the rest of the study population, but the hospital admission rate for ARI was lower in the reference group (χ(2) = 16·4, P < 0·001).
What is new and conclusion:
This is the first Italian study to evaluate the costs related to a specific prescription profile, which already exists in the real setting, hypothesizing its application in a large outpatient child population of the same geographical area. The results show that by improving prescribing appropriateness, it is possible to reduce the expenditure associated with antibiotic prescriptions to outpatient children in the Lombardy region by about one-fifth. The lower rate of hospital admissions for ARI suggests that the adopted profile is also beneficial to children's health.
Journal of Clinical Pharmacy and Therapeutics 10/2013; 38(5):373-378. DOI:10.1111/jcpt.12068 · 1.67 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Administrative databases have become an important tool to monitor diseases. Patients with epilepsy could be traced using disease-specific codes and prescriptions, but formal validation is required to obtain an accurate case definition. The aim of the study was to correlate administrative data on epilepsy with an independent source of patients with epilepsy in a district of Lombardy, Northern Italy, from 2000 to 2008.
Data of nearly 320 600 inhabitants in the district of Lecco collected from the Drug Administrative Database of the Lombardy Region were analysed. Among them were included patients who fulfilled the International Classification of Diseases 9 (ICD-9) codes and/or the disease-specific exemption code for epilepsy and those who had at least one EEG record and took antiepileptic drugs (AEDs) as monotherapy or in variable combinations. To ascertain epilepsy cases, 11 general practitioners (GPs) with 15 728 affiliates were contacted. Multiple versions of the diagnostic algorithm were developed using different logistic regression models and all combinations of the four independent variables.
Among the GP affiliates, 71 (4.5/1000) had a gold standard diagnosis of epilepsy. The best and most conservative algorithm included EEG and selected treatment schedules and identified 61/71 patients with epilepsy (sensitivity 85.9%, CI 76.0% to 92.2%) and 15 623/15 657 patients without epilepsy (specificity 99.8%,CI 99.7% to 99.8%). The positive and negative predictive values were 64.2% and 99.9%. Sensitivity (86.7%) and the positive predictive value (68.4%) increased only slightly when patients with single seizures were included.
A diagnostic algorithm including EEG and selected treatment schedules is only moderately sensitive for the detection of epilepsy and seizures. These findings apply only to the Northern Italian scenario.
Journal of epidemiology and community health 09/2013; DOI:10.1136/jech-2013-202528