Protective action of natural and induced immunization against the occurrence of delta or alpha variants of SARS-CoV-2 infection: a test-negative case-control study.

BACKGROUND: The evolution of SARS-CoV-2 has led to the emergence of several new variants, and few data are available on the impact of vaccination on SARS-CoV-2 variants. We aimed to assess the association between natural (previous infection) and induced (partial or complete vaccination) exposure to SARS-CoV-2 and the onset of new infection supported by the delta variant, and of comparing it with that supported by alpha. METHODS: We performed a test-negative case-control study, by linking population-based registries of confirmed diagnoses of infection with SARS-CoV-2, vaccinations against Covid-19 and healthcare utilization databases of the Italian Lombardy Region. Four hundred ninety-six persons who between 27 December 2020 and 16 July 2021 had an infection by the delta variant were 1:1 matched with citizens affected by alphavariant and 1:10 matched with persons who had a negative molecular test, according to gender, age and date of molecular ascertainment. We used a conditional logistic regression for estimating relative risk reduction of either variants associated with natural and/or induced immunization and corresponding 95% confidence interval (CI). RESULTS: Previous infection was associated with 91% (95% CI 85% to 95%) reduced relative risk of reinfection, without evidence of significant differences between delta and alpha cases (p=0.547). Significant lower vaccinal protection against delta than alpha variant infection was observed with reduced relative risk associated with partial vaccination respectively of 29% (7% to 45%), and 62% (48% to 71%) (p=0.001), and with complete vaccination respectively of 75% (66% to 82%) and 90% (85% to 94%) (p=0.003). CONCLUSIONS: Lower protection towards infections caused by the delta variant with respect to alpha variant was noticed, even after the completion of the vaccination cycle. This finding would support efforts to maximize both vaccine uptake with two doses and fulfilment with individual protection measures, especially as the delta variant is rampant worldwide presently.

Impact of the post-COVID-19 condition on health care after the first disease wave in Lombardy.

BACKGROUND: Lombardy was affected in the early months of 2020 by the SARS-CoV-2 pandemic with very high morbidity and mortality. The post-COVID-19 condition and related public health burden are scarcely known. SETTING AND DESIGN: Using the regional population administrative database including all the 48,932 individuals who survived COVID-19 and became polymerase-chain-reaction negative for SARS-CoV-2 by 31 May 2020, incident mortality, rehospitalizations, attendances to hospital emergency room, and outpatient medical visits were evaluated over a mid-term period of 6 months in 20,521 individuals managed at home, 26,016 hospitalized in medical wards, and 1611 in intensive care units (ICUs). These data were also evaluated in the corresponding period of 2019, when the region was not yet affected by the pandemic. Other indicators and proxies of the health-care burden related to the post-COVID condition were also evaluated. MAIN RESULTS: In individuals previously admitted to the ICU and medical wards, rehospitalizations, attendances to hospital emergency rooms, and out-patient medical visits were much more frequent in the 6-month period after SARS-CoV-2 negativization than in the same prepandemic period. Performances of spirometry increased more than 50-fold, chest CT scans 32-fold in ICU-admitted cases and 5.5-fold in non-ICU cases, and electrocardiography 5.6-fold in ICU cases and twofold in non-ICU cases. Use of drugs and biochemical tests increased in all cases. CONCLUSIONS: These results provide a real-life picture of the post-COVID condition and of its effects on the increased consumption of health-care resources, considered proxies of comorbidities.

Effectiveness and safety of GLP-1 receptor agonists versus SGLT-2 inhibitors in type 2 diabetes: an Italian cohort study.

BACKGROUND: GLP-1 receptor agonists (GLP-1 RA) and SGLT-2 inhibitors (SGLT-2i) have shown to reduce the risk of major adverse cardiovascular events (MACE), death and worsening nephropathy when added to standard of care. However, these two dug classes differ in efficacy and safety. We compared the effectiveness and safety profile of GLP-1 RA and SGLT-2i in a large and unselected cohort of patients with type 2 diabetes resident in Lombardy from 2015 to 2020. METHODS: Using linkable administrative health databases, we included patients aged 50 years and older initiating GLP-1 RA or SGLT-2i. Clinical events were: death, hospital admission for myocardial infarction (MI), stroke, heart failure (HF), and renal disease as individual and composite outcomes (MACE-3: all cause-death, non-fatal MI, non-fatal stroke; MACE-4: MACE-3 plus unstable angina). Outcomes were evaluated separately in subjects with and without previous cardiovascular (CV) diseases. Treatments were compared using Cox proportional hazards regression model after Propensity Score Matching (PSM) in both intention-to-treat (ITT) and per protocol (PP) analyses. Serious adverse events were also evaluated. RESULTS: The analysis comprised 20,762 patients per cohort. The ITT analysis showed a significant risk reduction for non-fatal MI (HR 0.77; CI 95% 0.66-0.90), MACE-3 (HR 0.91; CI 95% 0.84-0.98), and MACE-4 (HR 0.92; CI 95% 0.86-0.99) in GLP-1RA compared with SGLT-2i users, while no difference was reported in the incidence of HF hospitalization and stroke between the two cohorts. Similar benefits were found in the subgroup of patients without previous CV diseases only. PP analysis largely confirmed the main results. The incidence of serious adverse events was low in both cohorts (< 1%). CONCLUSIONS: GLP-1RA showed to be equally safe and more effective than SGLT-2i in reducing the risk of MACE-3, MACE-4 and MI. This study adds to the growing body of real-world evidence addressing the specific clinical properties of GLP-1RA and SGLT-2i in everyday practice to tailor treatment to the individual patient.

Diabetes mellitus duration and mortality in patients hospitalized with acute myocardial infarction.

BACKGROUND: Diabetes mellitus (DM) is associated with an increased mortality risk in patients hospitalized with acute myocardial infarction (AMI); however, no studies have investigated the impact of the duration of DM on in-hospital mortality. In this study, we evaluated in-hospital mortality in AMI patients according to DM status and its duration. METHODS: Using health administrative databases of Lombardy, DM patients≥50 years hospitalized with AMI from 2010 to 2019 were included in the analysis and were stratified according to the duration of DM: <5, 5-10, and > 10 years. The primary endpoint was mortality during AMI hospitalization and the secondary endpoint was 1-year mortality in comparison with No-DM patients. Logistic and Cox regressions analyses were used to estimate odds ratios (ORs, CI 95%) and hazard ratios (HRs, CI 95%) for the outcomes, according to DM status and duration and AMI type (STEMI and NSTEMI). RESULTS: Our study cohort comprised 29,566 and 109,247 DM and No-DM patients, respectively. Adjusted ORs and HRs showed a significantly higher risk of in-hospital mortality (OR 1.50, 95% CI 1.43-1.58) and 1-year mortality (HR 1.51, 95% CI 1.46-1.55) in DM patients in comparison with those without. These risks increased progressively with the duration of DM, with the highest risk observed in patients with DM duration ≥ 10 years (OR 1.59, 95% CI 1.50-1.69 for in-hospital mortality and HR 1.59, 95% CI 1.53-1.64 for 1-year mortality). These findings were similar in STEMI and in NSTEMI patients. CONCLUSIONS: Our study demonstrates that the duration of DM parallels mortality risk in patients hospitalized with AMI, highlighting that DM duration should be considered as an important early prognostic risk factor in patients with AMI.

Metformin use is associated with a decrease in the risk of hospitalization and mortality in COVID-19 patients with diabetes: A population-based study in Lombardy.

AIM: To compare the association of metformin use and coronavirus disease 2019 (COVID-19) outcomes in a cohort of 31 966 patients with diabetes in Lombardy. METHODS: We used a COVID-19 linkable administrative regional database to select patients with diabetes who were aged 40 years or older. They had at least two prescriptions of antidiabetic drugs in 2019 and a positive test for severe acute respiratory syndrome coronavirus-2 from 15 February 2020 to 15 March 2021. The association of metformin use and clinical outcomes was assessed by multivariable logistic regression analyses and after propensity score matching (PSM). Clinical outcomes were all-cause mortality, in-hospital mortality, hospitalization for COVID-19, and admission to an intensive care unit (ICU). RESULTS: In multivariable models, metformin use was associated with a significantly lower risk of total mortality (OR 0.70; 95% CI 0.66-0.75), in-hospital mortality (OR 0.68; 95% CI 0.63-0.73), hospitalization for COVID-19 (OR 0.86; 95% CI 0.81-0.91), and ICU admission (OR 0.81; 95% CI 0.69-0.94) compared with metformin non-users. Results were similar after PSM; metformin was associated with a significantly lower risk of total mortality (OR 0.79; 95% CI 0.73-0.86), in-hospital mortality (OR 0.74; 95% CI 0.67-0.81), and ICU admission (OR 0.77; 95% CI 0.63-0.95). CONCLUSIONS: In this large cohort, metformin use was associated with a protective effect in COVID-19 clinical outcomes, suggesting that it might be a potentially useful drug to prevent severe COVID-19 disease, although randomized controlled trials (RCTs) are needed to confirm this. While awaiting the results of RCTs, we suggest continuing prescribing metformin to COVID-19 patients with diabetes.

Changes in antiepileptic drug prescriptions over a decade in childbearing women in Lombardy region, Italy.

AIMS: To describe the antiepileptic drug (AED) prescription pattern in pregnant women and women of childbearing age in the 2010-2019 period in the Lombardy region, Italy. METHODS: The Lombardy region administrative healthcare databases (2010-2019) were analysed. AEDs were classified as drugs belonging to the N03A subgroup of the Anatomical Therapeutic Chemical Classification System. Women aged 15-49 years were considered as being of childbearing age, while exposure during pregnancy was estimated taking into account the 12 months before delivery (International Classification of Diseases, Ninth Revision, Clinical Modification, ICD-9-CM codes in the diagnosis record from 650 to 659). RESULTS: During 2019, 16 605 women of childbearing age (prevalence: 14.8‰) received at least 1 AED prescription. Pregabalin was the most widely used antiepileptic in women of childbearing age (22.3%), followed by valproic acid (20.0%). In 2010, the prevalence of valproic acid prescription to women of childbearing age was 30.2%; in 2019 this was 20.0%. In pregnant women, this prevalence was 24.9% in 2010 and 14.1% in 2019. Starting from 2017, levetiracetam and lamotrigine were the most commonly drugs prescribed to pregnant women. CONCLUSION: Despite the decrease in valproic acid prescription over time, this drug is still among the most used AEDs, in particular in women of childbearing age. Educational interventions for healthcare professionals and women are needed in order to reduce the risk of unplanned pregnancy.

Lower risk of death and cardiovascular events in patients with diabetes initiating glucagon-like peptide-1 receptor agonists or sodium-glucose cotransporter-2 inhibitors: A real-world study in two Italian cohorts.

AIM: To examine the efficacy and safety of glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors compared with other antihyperglycaemic agents (AHAs) in large and unselected populations of the Lombardy and Apulia regions in Italy. MATERIALS AND METHODS: An observational cohort study of first-time users of GLP-1RAs, SGLT2 inhibitors or other AHAs was conducted from 2010 to 2018. Death and cardiovascular (CV) events were evaluated using conditional Cox models in propensity-score-matched populations. Adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) were calculated for each region and in a meta-analysis for pooled risks. RESULTS: After propensity-score matching, the Lombardy cohort included 18 716 and 11 683 patients and the Apulia cohort 9772 and 6046 patients for the GLP-1RA and SGLT2 inhibitor groups, respectively. Use of GLP-1RAs was associated with lower rates of death (HR 0.61, CI 0.56-0.65, Lombardy; HR 0.63, CI 0.55-0.71, Apulia), cerebrovascular disease and ischaemic stroke (HR 0.70, CI 0.63-0.79; HR 0.72, CI 0.60-0.87, Lombardy), peripheral vascular disease (HR 0.72, CI 0.64-0.82, Lombardy; HR 0.80, CI 0.67-0.98, Apulia), and lower limb complications (HR 0.67, CI 0.56-0.81, Lombardy; HR 0.69, CI 0.51-0.93, Apulia). Compared with other AHAs, SGLT2 inhibitor use decreased the risk of death (HR 0.47, CI 0.40-0.54, Lombardy; HR 0.43, CI 0.32-0.57, Apulia), cerebrovascular disease (HR 0.75, CI 0.61-0.91, Lombardy; HR 0.72, CI 0.54-0.96, Apulia), and heart failure (HR 0.56, CI 0.46-0.70, Lombardy; HR 0.57, CI 0.42-0.77, Apulia). In the pooled cohorts, a reduction in heart failure was also observed with GLP-1RAs (HR 0.89, 95% CI 0.82-0.97). Serious adverse events were quite low in frequency. CONCLUSION: Our findings from real-world practice confirm the favourable effect of GLP-1RAs and SGLT2 inhibitors on death and CV outcomes across both regions consistently. Thus, these drug classes should be preferentially considered in a broad type 2 diabetes population beyond those with CV disease.

Use of preventive drugs during the last year of life in older adults with cancer or chronic progressive diseases.

PURPOSE: To evaluate the prescription of preventive medications with questionable usefulness in community dwelling elderly adults with cancer or chronic progressive diseases during the last year of life. METHODS: Through the utilization of the healthcare databases of the Lombardy region, Italy, we identified two retrospective cohorts of patients aged 65 years or more, who died in 2018 and had a diagnosis of either a solid cancer (N = 19 367) or a chronic progressive disease (N = 27 819). We estimated prescription of eight major classes of preventive drugs 1 year and 1 month before death; continuation or initiation of preventive drug use during the last month of life was also investigated. RESULTS: Over the last year of life, in both oncologic and non-oncologic patients, we observed a modest decrease in the prescription of blood glucose-lowering drugs, anti-hypertensives, lipid-modifying agents, and bisphosphonates, and a slight increase in the prescription of vitamins, minerals, antianemic drugs, and antithrombotic agents (among oncologic patients only). One month before death, the prescription of preventive drugs was still common, particularly for anti-hypertensives, antithrombotics, and antianemics, with more than 60% of patients continuing to be prescribed most preventive drugs and an over 10% starting a therapy with an antithrombotic, an antianemic, or a vitamin or mineral supplement. CONCLUSION: These findings support the need for an appropriate drug review and improvement in the quality of drug prescription for vulnerable populations at the end-of-life.

Perinatal outcome and healthcare resource utilization in the first year of life after antiepileptic exposure during pregnancy.

Healthcare administrative databases of Italy's Lombardy Region were analyzed with the aim to assess perinatal outcomes and healthcare resource utilization during the first year of life in infants exposed to antiepileptic drugs (AEDs) during pregnancy. Drug prescriptions dispensed in the 12 months before delivery to women, who delivered between 2005 and 2011, were analyzed. Neonates were classified as cases if exposed to AEDs, and each case was randomly matched to seven controls. No significant differences were observed in the risk of congenital malformations between 526 cases and 3682 controls except for valproic acid (odds ratio (OR): 2.29; 95% confidence interval (CI): 1.24-4.22) where cases were more likely to be small for gestational age (χ2 = 7.66; p = 0.006). Cases also had a higher probability than controls of needing at least one specialist visit in a child neuropsychiatry outpatient service (OR: 1.74; 95% CI: 1.22-2.49).

Antiepileptic drug use in Italian children over a decade.

PURPOSE: The aim of the study was to evaluate prescription profiles of antiepileptic drugs (AEDs) and to assess hospitalizations and specialist visits in pediatric patients with epilepsy. METHODS: The data sources were administrative health databases of Italy's Lombardy Region, which collect prescriptions for drugs, diagnostic tests, specialist visits, and hospital discharge forms. All patients aged 0-16 years with at least seven AED (group N03A of the International Anatomical Therapeutic Chemical Classification) prescriptions over two consecutive years between 2003 and 2010 were identified and classified as prevalent or incident cases (no prescriptions in two previous years). The first prescription to incident cases was analyzed. For each incident case, drug prescriptions, specialist visits, diagnostic tests, and hospitalizations in the 24 months following the first (index) prescription were monitored. RESULTS: A total of 6527 incident cases (5.4/10,000 person-years, 95% CI 5.4-5.5) were identified. Valproic acid and carbamazepine were the most prescribed drugs (65.9 and 15.0%, respectively). The use of newer AEDs increased over time. In the 24-month observation period, 74% of incident cases continued the treatment with the index AED. The percentage of cases who changed therapy was higher in preschoolers (34%) and decreased with age. In all, 21% of incident cases were hospitalized for epilepsy and 86% had a specialist visit in the 24 months after the first AED prescription. CONCLUSIONS: In conclusion, older AEDs, particularly valproic acid, remained the first therapeutic approach to pediatric epilepsy in Italy. For three quarters of cases, the initial AED treatment was likely effective and well tolerated.

Emergency department visits in older people: pattern of use, contributing factors, geographical differences and outcomes.

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.

Changes in clinical outcomes for community-dwelling older people exposed to incident chronic polypharmacy: a comparison between 2001 and 2009.

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.

Acute renal failure in patients treated with dronedarone or amiodarone: a large population-based cohort study in Italy.

PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Comparing recurrent antibiotic prescriptions in children treated with a brand name or a generic formulation.

PURPOSE: The 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. RESULTS: In 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.

Antipsychotic drug exposure and risk of pulmonary embolism: a population-based, nested case-control study.

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Epidemiologic Trends in Hospitalized Ischemic Stroke from 2002 to 2010: Results from a Large Italian Population-Based Study.

BACKGROUND: To describe the incidence of ischemic stroke, short-term mortality, recurrences, and prescription patterns. METHODS: 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. RESULTS: 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). CONCLUSIONS: Stroke incidence, recurrence, and 30-day mortality decreased from 2002 to 2010 concomitant with an increase in prescriptions of secondary stroke prevention drugs.

Changes in drug prescribing to Italian community-dwelling elderly people: the EPIFARM-Elderly Project 2000-2010.

PURPOSE: 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. METHODS: 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. RESULTS: 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 %). CONCLUSION: 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.

Electrocardiographic monitoring for new prescriptions of quetiapine co-prescribed with acetylcholinesterase inhibitors or memantine from 2005 to 2009. A population study on community-dwelling older people in Italy.

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.