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The Lombardy Region has one of the most widespread and advanced models of Palliative Care (PC) in the country. However, there is a relative lack of updated data referring to the activity of the Lombardy PC network.This work aims to describe the activity carried out in the two main PC care settings (home care and hospice) in 2019 through the analysis of the data sent by each Unit to the Lombardy Region. Data were analysed on a regional basis and considering the 8 Health Protection Agencies (ATS) separately.In 2019, PC activity was provided by 114 home care units (1.14/100,000 inhabitants) and 70 hospice for a total of 812 beds (8.1 beds/100,000 inhabitants). Overall, 25,514 patients were assisted for a total of 29,892 care pathway. 77.6% of the patients assisted were oncologic and about 67% of the patients who died of cancer in Lombardy were intercepted by CP. 54.4% of patients were taken care of in home care, although with a significant difference between cancer patients (58%) and non-cancer patients (42%). In home care, average activation time was 2.8 days and in 81% of cases the assistance was activated within 24-48 hours; in hospice, average activation time was 3.5 days, with 60% of admissions within 24 hours and over 30% with waiting time ≥3 days. The median duration of home palliative care was approximately 21 days (average 40.5), that in hospice was 9 days (average 17.2). In the home care pathways, the prevalent outcome was the death of the patient at home (64%) and hospitalization in hospice (17.2%), while 86% of hospitalizations in hospice ended with death.This accurate report of the Lombardy PC activity indicates that PC satisfy various qualitative indicators of structural and care process identified by national regulations. However, PC still remain predominantly intended for cancer patients, with relatively short duration of care, particularly in the hospice setting.

to quantify the variability of COVID-19 mortality from the beginning of the pandemic to mid-July 2021, in relation to the immigrant status and by Region and period.observational incidence study.the study population consists of the residents at the beginning of 2020 in seven Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio, Sicily) aged=74 years.absolute frequency of deaths occurred in subjects who tested positive for SARS-CoV-2, crude and standardized rates (standard: Italian population at the beginning of 2020), and mortality rates ratios (obtained using Poisson models), by immigrant status and stratified by gender, Region of residence, and period. The study period was divided into 5 subperiods: 22.02.2020-25.05.2020, 26.05.2020-02.10.2020, 03.10.2020-26.02.2021, 27.02.2021-16.07.2021.the study includes more than one half of the Italian population and most of the immigrants residing in the country, who are younger than Italians and experienced fewer COVID-19 deaths. Deaths among those who tested positive varied greatly between Regions and periods; standardized rates showed considerable increases over time among immigrants. In terms of rate ratios, there were excesses among immigrant males in the third period (MRR: 1.46; 95%CI 1.30-1.65) and in the fourth period (MRR: 1.55; 95%CI 1, 34-1.81). Among immigrant females, there is an indication of lower risk in the third period (MRR: 0.79; 95%CI 0.65-0.97) and of greater risk in the fourth period (MRR: 1. 46; 95%CI 1.21-1.77). Finally, the effect is modified by the Region of residence, both in the third and in the fourth period for males and only in the fourth period for females.the risk of premature mortality due to COVID-19 is linked to immigrant status and with an intensity that varies by gender, Region, and period. More accessible tools for prevention, diagnosis and early healthcare can support immigrant communities in managing the risk factors linked to the spread of infections and, in particular, counteract their evolution into more severe disease outcomes.

to describe differences in the incidence of SARS-CoV-2 infections between Italians and foreigners residing in seven Italian Regions during the different phases of the pandemic and by gender.retrospective observational study.all confirmed SARS-CoV-2 infections from 02.02. 2020 to 16.07.2021 in the seven Regions under study were included. Italian resident population calculated by the National Institute of Statistics as of 01.01.2020 was used to calculate the rates. The considered period is divided into 5 sub-periods (phases).number of confirmed SARS-CoV-2 infections in the five phases of the pandemic and crude rates by citizenship (Italian vs foreign). Distribution of infections by age group and by week. Crude and age-adjusted incidence rates ratios (IRR) were calculated, by Region, gender, and phase of the pandemic.an epidemic curve delay was observed in foreigners in the first phase of the epidemic, in particular in the northern Regions, the most affected in that phase. The first phase of the epidemic was characterized by a greater proportion of cases occurred in people aged over 60 years than the other phases, both in Italians and in foreigners. The incidence among foreigners is higher during the summer of 2020 (intermediate period: June-September 2020) and during the last period (May-July 2021) in all Regions. The overall figure shows a lower incidence among foreigners than Italians, except for males in Tuscany.the lower incidence rates among foreigners should be interpreted with caution as the available data suggest that it is at least partly attributable to less access to diagnostic tests. Regional differences found in the study deserve further research together with the effect of gender and country of origin.

to analyze the difference of the SARS-CoV-2 infection impact between Italian and foreigner subjects, evaluating the trend of infections and access to diagnostic tests (molecular or antigenic swabs for the detection of SARS- CoV-2) in the two different populations, inducing the detection of new positive cases in the population.retrospective population study for the period February 2020-June 2021.Italian and foreign resident population on 1st January of the years 2020 and 2021 in the Regions participating to the project: Piedmont, Lombardy, Veneto, Emilia-Romagna (Northern Italy), Tuscany, Lazio (Central Italy), and Sicily (Southern Italy).in the two populations, for every week and aggregated by macropandemic period were calculated: • the test rate (people tested on the population); • the swab positivity rate (positive subjects on those who are tested); • the new positives (positive subjects on study population); • the percentage of foreigners among the new positive cases. The ratio of the value of the indicators in the foreign and Italian populations (with 95% confidence interval) was calculated to evaluate the association between nationality (Italian vs not Italian) and outcome. The analyses were conducted at the regional level and at pool level.the trend of new positives by nationality (Italian vs not Italian) has a similar tendency in the different pandemic waves. However, the incidence of new positives during pandemic waves among foreigners is lower than in Italians, while it tends to increase during intermediate periods. Except for the summer periods, foreigners are less tested than Italians, but the percentage of new positives out of the total of new ones tested is higher among foreigners compared to Italians. The relative weight of new positives among foreigners tends to increase in periods with the greatest risk of inflow of SARS-CoV-2 for foreigners.the epidemic trends in the two populations are similar, although foreigners tend to show lower incidence values, probably in part because they are tested less frequently. Furthermore, in foreigners compared to Italians, there is a greater risk of contracting SARS-CoV-2 infection, especially in periods of relaxation of containment Coronavirus measures, reopening of national borders, production and commercial activities.

Introduction We aimed to assess harms (post-vaccine myocarditis and pericarditis) and benefits (preventing severe disease) of COVID-19 vaccination. Methods We conducted a population-based retrospective cohort study. Using the integrated platform of the vaccination campaign of Lombardy Region (Italy), after the exclusion of 24,188 individuals not beneficiaries of the Regional Health Service, 9,184,146 citizens candidates to vaccine at December 27, 2020 were followed until November 30, 2021 (the loss to follow-up rate was 0.5%). From the date of administration of each vaccine dose to day 28 post-administration, three periods that covered exposure to the first, second, and third dose were defined. The benefit–risk profile of vaccines was performed by comparing the number needed to harm (NNH) and number needed to treat (NNT) by sex, age, and vaccine type. Results Incidence rates of myocarditis were 9.9 and 5.2 per million person-months during the exposure and no-exposure periods, respectively, and the incidence rates of pericarditis were 19.5 and 15.9 per million person-months, respectively. The risk of myocarditis was highest following exposure to the second dose of the Moderna vaccine (adjusted HR: 5.5, 95% CI: 3.7 to 8.1). Exposure to the Moderna vaccine was also associated with an increased risk of pericarditis (adjusted HR 2.2, 1.5 to 3.1). NNT was higher than NNH (9471 vs. 7213) for 16 to 19-year-old men who received the Moderna vaccine, while all other sex, age, and vaccine subgroups had a favourable harm-benefit profile. Conclusions Men 16 to 19 years of age has the highest rates of myocarditis within a few days after receiving the Moderna vaccines. The balance between harms and benefits was almost always in favour of vaccination.

to describe the epidemiology of SARS-CoV-2 infection in relation with the use of nasal swabs in the immigrant population in Italy, using data from the COVID-19 national surveillance system and to verify if a difference is present comparing natives and immigrant.descriptive study based on longitudinal health-administrative data.general population of six Italian Regions (Piedmont, Lombardy, Veneto, Emilia-Romagna, Tuscany, Lazio) covering about 55% of the resident population and 72% of foreigners' population.regional rates of access to at least a nasal swab, separately by country of origin.across all the periods, a lower rate in the foreigners' group was observed, with the only exception of the period May-June 2021. Considering separately High Migratory Pressure Countries (HMPCs) and Highly Developed Countries (HDCs), a higher proportion of nasal swabs performed in people coming from HDC with respect to HMPCs and natives was noticed. This observation is consistent in males and females.during the first wave of the pandemic, Italians have had a higher proportion of nasal swabs compared to migrants across all Regions. This difference disappeared in the following periods, probably due to a major availability of diagnostic tests.

Intravitreal anti-vascular endothelial growth factor (VEGF) drugs aflibercept and ranibizumab are used in neovascular retinal diseases but may be associated with non-ocular haemorrhage. Our objective was to compare the risk of non-ocular haemorrhage with intravitreal aflibercept versus intravitreal ranibizumab and with individual intravitreal anti-VEGFs versus intravitreal dexamethasone. A retrospective cohort study was conducted using four Italian claims databases, covering 18 million inhabitants from 2011 to 2016. Incident aflibercept users were matched 1:4 to incident ranibizumab users. The outcome was incident non-ocular haemorrhage requiring hospitalisation. Incidence per 1000 person-years (PYs) was estimated. Patients were followed for 180 days using an intention-to-treat (ITT) approach. An as-treated (AT) approach was also employed, using grace periods of 60 or 90 days. Analyses were repeated for aflibercept versus dexamethasone and ranibizumab versus dexamethasone. Hazard ratios (HRs) with 95% confidence intervals (CIs) were estimated using Cox proportional hazards models. We identified incident users of intravitreal ranibizumab (n = 21,766), aflibercept (n = 3150) and dexamethasone (n = 3900). The incidence of haemorrhage was four events per 1000 PYs for each drug. Aflibercept was not associated with increased risk versus ranibizumab at 180 days (HR 0.97 [95% CI 0.37–2.56]). Results were consistent in the AT analysis (HR 1.19 [95% CI 0.52–2.75]). No increased risk was found for aflibercept and ranibizumab at 180 days versus dexamethasone (HR 0.70 [95% CI 0.30–2.60] and HR 0.67 [95% CI 0.33–1.38], respectively). No association was identified between intravitreal aflibercept and non-ocular haemorrhage versus ranibizumab. A comparable risk for these intravitreal anti-VEGFs and intravitreal dexamethasone was observed.

ObjectivesTo develop a population-based risk stratification model (COVID-19 Vulnerability Score) for predicting severe/fatal clinical manifestations of SARS-CoV-2 infection, using the multiple source information provided by the healthcare utilisation databases of the Italian National Health Service.DesignRetrospective observational cohort study.SettingPopulation-based study using the healthcare utilisation database from five Italian regions.ParticipantsBeneficiaries of the National Health Service, aged 18–79 years, who had the residentship in the five participating regions. Residents in a nursing home were not included. The model was built from the 7 655 502 residents of Lombardy region.Main outcome measureThe score included gender, age and 29 conditions/diseases selected from a list of 61 conditions which independently predicted the primary outcome, that is, severe (intensive care unit admission) or fatal manifestation of COVID-19 experienced during the first epidemic wave (until June 2020). The score performance was validated by applying the model to several validation sets, that is, Lombardy population (second epidemic wave), and the other four Italian regions (entire 2020) for a total of about 15.4 million individuals and 7031 outcomes. Predictive performance was assessed by discrimination (areas under the receiver operating characteristic curve) and calibration (plot of observed vs predicted outcomes).ResultsWe observed a clear positive trend towards increasing outcome incidence as the score increased. The areas under the receiver operating characteristic curve of the COVID-19 Vulnerability Score ranged from 0.85 to 0.88, which compared favourably with the areas of generic scores such as the Charlson Comorbidity Score (0.60). A remarkable performance of the score on the calibration of observed and predicted outcome probability was also observed.ConclusionsA score based on data used for public health management accurately predicted the occurrence of severe/fatal manifestations of COVID-19. Use of this score may help health decision-makers to more accurately identify high-risk citizens who need early preventive or treatment interventions.

ObjectivesHospice and home palliative care have been associated to a reduction of aggressive treatments in the end-of-life, but data in the Italian context are scanty. Therefore, we aim to investigate the role of palliative care on indicators of end-of-life intensity of care among patients with cancer in Lombardy, the largest Italian region.MethodsWithin a retrospective study using the healthcare utilisation databases of Lombardy, Italy, we selected all residents who died in 2019 with a diagnosis of cancer. We considered as exposure variables admission to palliative care and time at palliative care admission, and as indicators of aggressive care hospitalisations, diagnostic/therapeutic procedures, in-hospital death, emergency department visits and chemotherapy over a time window of 30 days before death; chemotherapy in the last 14 days was also considered.ResultsOur cohort included 26 539 individuals; of these, 14 320 (54%) were admitted to palliative care before death. Individuals who were admitted to palliative care had an odds ratio (OR) of 0.27 for one hospitalisation, 0.14 for ≥2 hospitalisations, 0.25 for hospital stay ≥12 days, 0.38 for minor diagnostic/therapeutic procedures, 0.18 for major diagnostic/therapeutic procedures, 0.02 for in-hospital death, 0.35 for one emergency department visit, 0.29 for ≥2 emergency department visits and 0.66 for chemotherapy use in the last 30 days; the OR was 0.56 for chemotherapy use in the last 14 days.ConclusionsThis large real-world analysis confirms and further support the importance of palliative care assistance for patients with cancer in the end- of- life; this is associated to a significant reduction in unnecessary treatments.

To investigate the association of the 2019–2020 influenza vaccine with prognosis of patients positive for SARS-CoV-2A, a large multi-database cohort study was conducted in four Italian regions (i.e., Lazio, Lombardy, Veneto, and Tuscany) and the Reggio Emilia province (Emilia-Romagna). More than 21 million adults were residing in the study area (42% of the population). We included 115,945 COVID-19 cases diagnosed during the first wave of the pandemic (February–May, 2020), 34.6% of these had been vaccinated against influenza. Three outcomes were considered: hospitalization, death, and intensive care unit (ICU) admission/death. The adjusted relative risk (RR) of being hospitalized in the vaccinated group when compared with the non-vaccinated group was 0.87 (95% CI: 0.86–0.88). This reduction in risk was not confirmed for death (RR = 1.04, 95% CI: 1.01–1.06), or for the combined outcome of ICU admission or death. In conclusion, our study, conducted on the vast majority of the population during the first wave of the pandemic in Italy, showed a 13% statistically significant reduction in the risk of hospitalization in some geographical areas and in the younger population. No impact of seasonal influenza vaccination on COVID-19 prognosis in terms of death and death or ICU admission was estimated.

We evaluated the performance of the exponentially weighted moving average (EWMA) model for comparing two families of predictors (i.e., structured and unstructured data from visits to the emergency department (ED)) for the early detection of SARS-CoV-2 epidemic waves. The study included data from 1,282,100 ED visits between 1 January 2011 and 9 December 2021 to a local health unit in Lombardy, Italy. A regression model with an autoregressive integrated moving average (ARIMA) error term was fitted. EWMA residual charts were then plotted to detect outliers in the frequency of the daily ED visits made due to the presence of a respiratory syndrome (based on coded diagnoses) or respiratory symptoms (based on free text data). Alarm signals were compared with the number of confirmed SARS-CoV-2 infections. Overall, 150,300 ED visits were encoded as relating to respiratory syndromes and 87,696 to respiratory symptoms. Four strong alarm signals were detected in March and November 2020 and 2021, coinciding with the onset of the pandemic waves. Alarm signals generated for the respiratory symptoms preceded the occurrence of the first and last pandemic waves. We concluded that the EWMA model is a promising tool for predicting pandemic wave onset.

In Italy, direct oral anticoagulant drugs (DOACs) were authorized for stroke prevention in patients with non-valvular atrial fibrillation (NVAF) in 2013. There is conflicting evidence on their benefit-risk profile under real world conditions.The Italian Medicines Agency funded this study to investigate effectiveness and safety of DOACs compared to vitamin K antagonists (VKAs) in three Italian regions. An observational study was conducted with a sequential propensity-score-matched new user parallel-cohort design in the period July 2013-December 2015 using administrative health data. DOAC users with NVAF diagnosis were 1:1 matched to VKA users based on a PS which accounted for over 90 potential confounders at baseline. Applying an as-treated approach with a 90-day renewal grace time, patients were followed from the day after the first prescription of the study drug until occurrence of the outcome, death, discontinuation, switch, end of health plan enrolment, or study end. Outcomes were total and cardiovascular mortality, acute myocardial infarction, ischemic and haemorrhagic stroke, and gastrointestinal bleeding. Analyses were performed, using Cox proportional hazard models stratified by matched set. The results of the regional analyses were combined through a random-effects meta-analysis.During the first 30 months of authorisation for NVAF, DOACs were increasingly prescribed. Overall, 72,434 new anticoagulant users were enrolled, 34% of whom received a DOAC. After PS matching, 37,266 patients contributed to the analysis. No differences between the study groups were found for total and cardiovascular mortality, myocardial infarction and ischemic stroke. DOAC users were at higher risk of gastrointestinal bleeding (HR 1.41, 95%CI 1.07-1.86) and at a not significant lower risk of haemorrhagic stroke (HR 0.36, 95%CI 0.10-1.33).The present study confirms findings from previous research regarding bleeding events, whereas we did not find a reduced risk of mortality in DOAC users. Further research on single active agents and specific populations is warranted.

This study assessed whether patients being treated for schizophrenia spectrum and affective disorders in Lombardy receive adequate treatment and sought predictors of adequate treatment.Patients were aged ≥ 18, were residents of Italy's Lombardy region, and were treated in 2007 for schizophrenia spectrum and affective disorders (N = 44,462). The patients were assessed as part of a retrospective analysis of pharmaceutical and mental health services databases. Adequacy of 12-month treatment from the first psychiatric contact in 2007 was assessed at the patient level. A hierarchical log-binomial regression model was fitted to estimate relative risk and 95% confidence intervals for association between patients, characteristics of the departments of mental health (DMH), and receipt of minimally adequate treatment.About half the patients with serious mental disorders did not receive adequate care; 45.5% of patients with depressive disorders, 55.7% of those with bipolar disorders, and 49.3% of those with schizophrenia spectrum disorders received minimally adequate treatment. Diagnosis of a schizophrenia spectrum disorder or bipolar disorder and male gender predicted adequate treatment, whereas employment and high comorbidity predicted inadequate treatment. Patients who received mental health services in the past year were significantly more likely to receive adequate treatment compared with those who had received services in the past five years or new patients.Minimally adequate treatment is a useful indicator to monitor quality of care in Italy's regional mental health system. These data should be used at regional and local levels to implement clinical audits, to create benchmark measures, and to define new quality-improvement projects to meet specific DMH needs.

Background: Fluoroquinolones are widely used both in primary care and in hospital settings. Since the last comparison performed in Italy on the safety profiles of different fluoroquinolones, a new molecule, prulifloxacin, has been introduced into the market and several warnings concerning this class of drugs have been released. The aim of this study was to reassess the safety profiles of fluoroquinolones using the database of the Italian Interregional Group of Pharmacovigilance (IGP) and the administrative data of fluoroquinolone prescriptions. Methods: All adverse drug reactions (ADRs) reported in four Italian regions (Lombardy, Veneto, Emilia Romagna and Tuscany) were retrieved from the IGP database. Consumption data (defined daily dose [DDD]/1000 inhabitants/ day) were used as denominators. Both single reports and all ADRs (classified by System Organ Classes and MedDRA Preferred Term [PT]) due to fluoroquinolones were considered as numerators of each analysis, comparing two periods (2005 vs 2006). All fluoroquinolones with at least ten reports per year were included in the analysis. Results: On the basis of 272 reports (532 single ADRs or PTs), patients did not show any statistically significant differences between 2005 and 2006 in terms of sex, age and number of concurrent medications. After adjustment for drug consumption, moxifloxacin showed the highest reporting rate (84.6 reports/ DDD/1000 inhabitants/day; 15.4 serious reports/DDD/1000 inhabitants/day) followed by prulifloxacin (72.2; 22.2 serious) and levofloxacin (55.3; 30.6serious) in 2005. An increment of ADR/report rates was observed over the 2 years for all fluoroquinolones except prulifloxacin, which had the lowest ADR reporting rate in 2006 (25.0; 12.5 serious). In 2006, the rate of serious ADRs associated with prulifloxacin was lower than with ciprofloxacin, while in 2005 serious events were almost equal for both compounds (55.6 vs 47.6 serious ADRs/DDD/1000 inhabitants/day). Ciprofloxacin showed the highest proportion of cutaneous PTs (e.g. rash, exanthema). Tendinopathies were mainly due to levofloxacin. Conclusions: These data suggest that different fluoroquinolones are characterized by different rates and types of ADRs. Among them, prulifloxacin was associated with more ADRs than other fluoroquinolones in 2005 but with fewer ADRs in 2006, when its consumption increased. Although these findings may represent an encouraging perspective towards a more appropriate use of fluoroquinolones because of their individual safety profiles, further pharmacoepidemiological studies must be performed to substantiate these results. © 2010 Adis Data Information BV. All rights reserved.

Older people use more healthcare than younger people and aging of the population is considered to be one of the main factors leading to consumption of healthcare resources. The aim of this study was to evaluate rates of hospitalization, use of out-patient services and medicine confections among the elderly population (65 years) in the local health authority of Varese (Italy), in the three-year period from 2003-2005, and to calculate the trend for the years 2006 and 2007. Rates of hospitalization and drug use remained stable while use of out-patient services showed an increasing trend. In spite of the influence of aging on consumption of healthcare resources, the use of medical services is determined mainly by the health state of the population: monitoring of the burden of morbidity in the population should therefore be improved.

Study objective: Although lipid lowering drugs are effective in preventing morbidity and mortality from cardiovascular events, the extent of their adverse effects is not clear. This study explored the association between prescription of lipid lowering drugs and the risk of peripheral neuropathy. Design: A population based case-control study was carried out by linkage of several automated databases. Setting: Resident population of a northern Italian Province aged 40 years or more. Participants: Cases were patients discharged for peripheral neuropathy in 1998–1999. For each case up to 20 controls were randomly selected among those eligible. Altogether 2040 case patients and 36 041 controls were included in the study. Exposure ascertainment: Prescription drug database was used to assess exposure to lipid lowering drugs at any time in the one year period preceding the index date. Analysis: Conditional logistic regression model for matched data was used to estimate the risk of peripheral neuropathy associated with exposure to statins, fibrates, and other lipid lowering drugs. Main results: Weak but significant effects of lipid lowering drugs as a whole (matched odds ratio: 1.27; 95% confidence intervals: 1.05 to 1.55), statins (1.19; 1.00 to 1.40), and fibrates (1.49; 1.03 to 2.17) were observed. Significant linear trends towards increased risk at increased exposure to both statins and fibrates were observed. Conclusions: The use of both statins and fibrates was associated with the risk of peripheral neuropathy. The primary purpose of this exploratory study is signal generation. This requires further investigations to evaluate the causal role of lipid lowering drugs on the onset of peripheral neuropathy.

Background Although it is well known that a variety of antibacterials may incidentally cause malignant arrhythmia, the list of drugs causing arrhythmia and the impact of these adverse effects are still uncertain. We investigated on this topic by using a large prescription database with different observational designs. Methods Prescription data on all incident users of several antibacterial and antiarrhythmic drugs over the period July 1997 through December 1999 were retrieved from the Drug Prescription Database (DPD) of the Italian Province of Varese. The association between the use of antibacterial and antiarrhythmic drugs was investigated by applying prescription sequence symmetry, cohort and nested case-control designs. Results Lower proarrhythmic effects were on an average obtained from prescription sequence symmetry approach with respect to both cohort and nested case-control. Evidence of association between exposure to drugs (erythromycin and ciprofloxacin) and the risk of arrhythmia was consistently found by the three approaches. No other signals were generated from the prescription sequence symmetry analysis. Two drugs (clarithromycin and levofloxacin) showed patterns compatible with an arrhythmic effect according to both cohort and nested case-control designs. Conclusions Prescription databases are useful tools to explore drug safety through both conventional and emerging observational designs. In spite of its appealing features, prescription sequence symmetry design shows lower sensitivity with respect to conventional designs. Evidence about the association between the use of certain macrolides and fluoroquinolones and the onset of arrhythmia is confirmed by this study. Copyright © 2004 John Wiley & Sons, Ltd.

Objective The effect of short-acting inhaled β 2 -agonists on mortality from chronic obstructive pulmonary disease (COPD) is controversial. Different observational designs were used to investigate about this topic. Study design and setting A population-based case-control design was performed, by linking automated health databases from the Varese Province of Italy. Deaths of COPD generated from the cohort of 135,871 patients for whom at least one prescription for drugs used to treat COPD had been dispensed between 1997 and 1999 entered into the study as cases. Up to 20 controls were randomly selected for each case from the cohort after matching on gender, age, and date of cohort entry. Risk ratios were estimated using the case–control, case-crossover, and case-time-control approaches. Results A total of 222 cases and 3022 controls met the inclusion criteria. Odds ratios (and corresponding 95% confidence intervals) corresponding to more than 0.5 defined-daily-doses were 2.6 (1.7, 4.0), 1.9 (1.1, 3.3), 2.1 (1.1, 4.0), and 2.3 (1.2, 4.6) by using crude and adjusted case-control, case-crossover, and case-time-control estimates, respectively. Conclusion Evidence that higher doses of short-acting inhaled β 2 -agonists are associated with higher mortality from COPD was consistently supplied by three observational approaches.

Purpose Drug treatment of idiopathic Parkinson's disease (IPD) is a difficult task, and comorbidity and comedication add to its complexity. Since in IPD there is little information about drug use, this study investigated drug prescribing and indications in IPD patients. Methods From June 1997 to April 1998, a cross-sectional survey of IPD outpatients was performed and demographic and clinical data and information about drug treatments was collected and analysed. Results In the 130 IPD patients included in the study, anti-Parkinson drug (APD) prescriptions increased with disease duration and severity. Levodopa was most frequently used, followed by dopamine agonists and anticholinergic agents. Levodopa with other APDs was given to older patients with later IPD onset. Prescriptions of drugs for other indications (non-APDs) were given to 80.8% of the patients and their number increased with patient age. Non-APD prescriptions concerned mainly the circulatory system, mental disorders, the musculo-skeletal system and the digestive system. Prescriptions for indications corresponding to secondary symptoms that often complicate IPD increased with patient age and also with IPD duration. Conclusion In IPD patients, disease duration and severity and patient age seem to be major determinants of drug use. Indications for drug prescription suggest that main comorbidity includes neuropsychiatric, circulatory, musculo-skeletal and digestive disorders. Analysis of prescribing patterns in IPD can provide a readily accessible indirect indicator of patient health status for both health services and epidemiologic research purposes. Copyright © 2002 John Wiley & Sons, Ltd.