Subcutaneous trastuzumab with pertuzumab and docetaxel in HER2-positive metastatic breast cancer: Final analysis of MetaPHER, a phase IIIb single-arm safety study.

Purpose: Intravenous trastuzumab, pertuzumab, and docetaxel are first-line standard of care for patients with HER2-positive metastatic breast cancer (mBC). MetaPHER is the first study assessing the safety and tolerability of subcutaneous trastuzumab plus intravenous pertuzumab and chemotherapy in a global patient population with HER2-positive mBC.

Methods: In this open-label, single-arm, multicenter, phase 3b study, eligible patients were ≥ 18 years old with histologically/cytologically confirmed previously untreated HER2-positive mBC.

Accuracy of five serologic tests for the follow up of Strongyloides stercoralis infection.

Background: Traditional faecal-based methods have poor sensitivity for the detection of S. stercoralis, therefore are inadequate for post-treatment evaluation of infected patients who should be carefully monitored to exclude the persistence of the infection. In a previous study, we demonstrated high accuracy of five serology tests for the screening and diagnosis of strongyloidiasis.

Comparison of Health Care Resource Utilization by Immigrants Versus Native Elderly People.

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.

Transition to Adult Mental Health Services for Young People With ADHD.

Objective: To investigate the care management and continuity from child to adult mental health service for young adults with ADHD.

Method: A questionnaire survey from 18 Regional ADHD Pediatric Centers (RAPC) in Lombardy, Italy, was used to collect data on transition protocols and population served, and to track the pathway of care of ADHD patients once they reached adulthood.

Results: Twenty-eight percent of RAPC had transition protocols and 3% of the population annually served were potential referrals to adult service.

Effectiveness of nebulized beclomethasone in preventing viral wheezing: an RCT.

Objective: The goal of this study was to evaluate the effectiveness of nebulized beclomethasone in preventing the recurrence of viral wheezing.

Methods: The study was designed as a randomized, double-blind, placebo-controlled trial. Outpatient children aged 1 to 5 years with at least 1 episode of viral wheezing in the last 12 months, presenting to any of 40 Italian pediatricians for an upper respiratory tract infection, were randomly allocated to receive beclomethasone 400 μg or placebo twice daily for 10 days.

Diagnostic accuracy of five serologic tests for Strongyloides stercoralis infection.

Background: The diagnosis of Strongyloides stercoralis (S. stercoralis) infection is hampered by the suboptimal sensitivity of fecal-based tests. Serological methods are believed to be more sensitive, although assessing their accuracy is difficult because of the lack of sensitivity of a fecal-based reference ("gold") standard.

Childhood asthma management pre- and post-incident asthma hospitalization.

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.

Impact of islet size on pancreatic islet transplantation and potential interventions to improve outcome.

Better results have been recently reported in clinical pancreatic islet transplantation (ITX) due mostly to improved isolation techniques and immunosuppression; however, some limitations still exist. It is known that following transplantation, 30% to 60% of the islets are lost. In our study, we have investigated 1) the role of size as a factor affecting islet engraftment and 2) potential procedural manipulations to increase the number of smaller functional islets that can be transplanted.

Antipsychotics prescription and cerebrovascular events in Italian older persons.

Meta-analyses have found conflicting evidence on the link between antipsychotics and cerebrovascular events (CVEs). The primary aim of this study was to evaluate the association between any antipsychotic prescription and CVEs in Italian elderly; second, to compare the effect of typical and atypical antipsychotics on CVEs; and third, to investigate the effect of antipsychotics on CVEs in the subgroup of persons coprescribed with acetylcholinesterase inhibitors (AChEIs). Administrative claims from community-dwelling people aged 65 to 94 years living in Northern Italy were analyzed using a retrospective case-control design, from 2003 to 2005.

The use of ciprofloxacin and fluconazole in Italian neonatal intensive care units: a nationwide survey.

Background: Treatment and prophylaxis of sepsis in very low birth weight neonates is a matter of concern and research is being undertaken with the aim to give rise to shared approaches based on solid evidence. As part of a European initiative, a survey was set up to describe the use of two drugs in this area. The Italian national practices concerning neonatal sepsis, as well as calls for related guidance, are described.

Wide intra- and inter-country variability in drug use and dosage in very-low-birth-weight newborns with severe infections.

Purpose: To describe the use of ciprofloxacin and fluconazole for the treatment of sepsis in European neonatal intensive care units (NICUs) in order to better orient research aimed at acquiring essential knowledge in this critical area.

Methods: The survey consisted of an online questionnaire for all participating NICUs on treatment schemes employed, rationales behind drug choices and interest in participation in research involving the two drugs.

Results: A total of 189 level II and III NICUs participated in the survey, representing 25 countries, with Italy, UK and France providing the greatest number of centres (54 % of total).

Methods in pharmacoepidemiology: a review of statistical analyses and data reporting in pediatric drug utilization studies.

Purpose: To evaluate the quality of data reporting and statistical methods performed in drug utilization studies in the pediatric population.

Methods: Drug utilization studies evaluating all drug prescriptions to children and adolescents published between January 1994 and December 2011 were retrieved and analyzed. For each study, information on measures of exposure/consumption, the covariates considered, descriptive and inferential analyses, statistical tests, and methods of data reporting was extracted.

Spirometry testing in a population of Italian children: age and gender differences.

Aim: To estimate how many asthmatic children underwent spirometry testing in one year in a large Italian region, and evaluate sociodemographic determinants.

Methods: Data were retrieved from the administrative databases that store all pharmacological and diagnostic prescriptions issued to individuals living in the Lombardy Region. The analysis involved prescriptions dispensed to all 6-17 year olds (1,047,241 subjects) during 2008.

Burden of psychiatric disorders in the pediatric population.

In order to estimate the burden of mental disorders in a representative Italian pediatric population, an epidemiological study was performed using three administrative databases: a drug prescription, a hospital discharge form, and an outpatient ambulatory visit database. The population target was 1,616,268 children and adolescents under 18 years living in the Lombardy Region, Italy. A youth was defined as a case if during 2008 he/she received at least one psychotropic drug prescription or was hospitalized for a psychiatric disorder (International Classification of Disease codes 290-319), or attended a child neuropsychiatric outpatient unit for a visit and/or a psychological intervention or rehabilitation at least once.

Anti-asthma medication prescribing to children in the Lombardy Region of Italy: chronic versus new users.

Background: Although anti-asthma medications are amongst those most frequently under or over prescribed it is generally accepted that prescriptions for such agents can be used as a proxy for disease prevalence. The aims of this study were to estimate prevalence and incidence of childhood asthma in a representative Italian area by analysing three years of anti-asthmatic prescriptions and hospitalizations of subjects with chronic or first time treatment, and to underline appropriateness of therapeutic choices.

Methods: The analysis involved prescriptions given to 6-17 year olds between 2003 and 2005 in Italy's Lombardy Region.

One-year prospective follow-up of pharmacological treatment in children with attention-deficit/hyperactivity disorder.

Objectives: To delineate the safety and tolerability profile of methylphenidate and atomoxetine in children and adolescents with attention deficit hyperactivity disorder (ADHD) monitored for more than 1 year.

Design: A cohort study analyzing data from the national ADHD register on patients from the Lombardy Region treated with MPH or atomoxetine.

Participants: A total of 229 children (median age 11 years, range 6-17), enrolled in 15 regional centers between June 2007 and May 2010.

Differences in the drug prescriptions to children by Italian paediatricians and general practitioners.

Purpose: To compare family paediatricians' and general practitioners' habits on drug prescribing to children.

Methods: Prescriptions reimbursed by the Health Service and dispensed by the retail pharmacies of 15 local health units in the Lombardy Region of Italy during 2005 were analysed. Only family paediatricians and general practitioners who were in charge of children aged 6-13 years were included.

Determinants of the drug utilization profile in the paediatric population in Italy's Lombardy Region.

Aims: To evaluate the intraregional differences in drug prescribing to children and adolescents.

Methods: Prescriptions reimbursed by the National Health System, involving 1543 203 children and adolescents <18 years old and dispensed during 2005 by the retail pharmacies of 15 local health units (LHU) in the Lombardy Region, were analysed. Logistic regression analysis was performed to evaluate the association between drug prescription and age, gender, prescriber, and setting.