A5047162922- Pharmaceutical studies and practices
- Pharmaceutical Practices and Patient Outcomes
- Pharmacovigilance and Adverse Drug Reactions
- Diabetes Treatment and Management
- Pharmaceutical Economics and Policy
- Drug-Induced Hepatotoxicity and Protection
- Neurological Disorders and Treatments
- Pharmacological Effects and Toxicity Studies
- Drug-Induced Adverse Reactions
- SARS-CoV-2 and COVID-19 Research
- Schizophrenia research and treatment
- Health Systems, Economic Evaluations, Quality of Life
- Child and Adolescent Health
- Gout, Hyperuricemia, Uric Acid
- Cancer Immunotherapy and Biomarkers
- Liver Disease Diagnosis and Treatment
- CAR-T cell therapy research
- Attention Deficit Hyperactivity Disorder
- Liver Disease and Transplantation
- Medication Adherence and Compliance
- COVID-19 Clinical Research Studies
- Biosimilars and Bioanalytical Methods
- Pediatric Pain Management Techniques
- Pituitary Gland Disorders and Treatments
- Pharmacogenetics and Drug Metabolism
Regione Campania
2012-2023
University of Campania "Luigi Vanvitelli"
2014-2023
Italian Medicines Agency
2023
Pharmac
2020
Erasmus MC
2012-2019
Erasmus University Rotterdam
2012-2017
University of Naples Federico II
2017
University of Messina
2016
Azienda Ospedaliera Universitaria Policlinico "G. Martino"
2016
657 Oslo
2014
<h3>Objective</h3> To assess the epidemiology of gout and hyperuricaemia in Italian general population during years 2005–2009. <h3>Methods</h3> Using primary care database (Health Search/CSD Longitudinal Patient Database), prevalence, incidence recurrence rates and/or (serum urate level >360 mmol/l (6 mg/dl)) outpatients aged ≥18 2005–2009 were estimated. Rates together with 95% CI measured overall stratified by age, gender calendar year. The characteristics patients newly diagnosed...
Immune checkpoint inhibitors (ICIs) are widely used in the treatment of many cancers as they improve clinical outcomes. However, ICIs have also been associated with development immune-related adverse drug reactions (ADRs). Among ADRs, cardiac ADRs rare, but high mortality rates. The objective this study was to evaluate occurrence reported European spontaneous reporting system. We retrieved individual case safety reports on ICI-induced from website suspected ADR ( www.adrreports.eu )...
As chimeric antigen receptor T-cell therapies are becoming increasingly available in the armamentarium of hematologist, there is an emerging need to monitor post-marketing safety. We aimed better characterize their safety profile by focusing on cytokine release syndrome and identifying signals. queried US Food Drug Administration Adverse Event Reporting System (October 2017–September 2020) analyze suspected adverse drug reactions tisagenlecleucel (tisa-cel) axicabtagene ciloleucel (axi-cel)....
Remdesivir was recommended for hospitalized patients with COVID-19. As already reported in the Summary of Product Characteristics, most remdesivir’s safety concerns are hepatoxicity and nephrotoxicity related. However, some cases have raised regarding potential cardiac events associated remdesivir; therefore, Pharmacovigilance Risk Assessment Committee European Medicines Agency requested to investigate all available data. Therefore, we analyzed Individual Case Safety Reports (ICSRs)...
To identify which drugs are associated with reports of suspected hepatic injury in children and adolescents.Using a worldwide pharmacovigilance database, VigiBase, we conducted case/non-case study on adverse drug reactions (ADRs) occurring the population <18 years old. Cases were all records ADRs non-cases other ADR records. Records regarding topically administered excluded from both groups. The association between was calculated using reporting odds ratio (ROR) as measure disproportionality...
We sought to evaluate the prescribing pattern of statins according national and regional health policy interventions assess specifically adherence therapy in outpatient setting Southern Italy.A population-based study was performed on persons ≥15 years old, living catchment area Caserta (Southern Italy), registered Arianna database between 2004 2010. Prevalence incidence new treatments with were calculated for each year stratified by drug. Adherence measured Medication Possession Ratio....
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is) were associated with a risk of neurocognitive adverse drug reactions (ADRs).We aimed to investigate the occurrence neuropsychiatric ADRs related PCSK9Is.We analyzed Individual Case Safety Reports (ICSRs) sent through European pharmacovigilance database that reported alirocumab or evolocumab as suspected and at least one neurological psychiatric ADR. The reporting odds ratio (ROR) was computed compare probability ICSRs between...
Adverse drug reaction (ADR) reporting by patients has a fundamental role in pharmacovigilance. The main objectives of the present study were to assess impact pharmacist-based intervention promoting direct patient reporting, evaluate ability identify and report ADRs determine their pattern.The involved 96 pharmacists Campania region Italy, who interviewed customers asked them whether they had experienced an ADR. Patients ADR invited complete form. quality completed forms was evaluated before...
Objective: To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database.Methods: Reports suspected ADRs related to children and adolescents were extracted from 2001 – 2012. After exclusion duplicates, vaccines reports containing missing age data, report investigated terms implicated event across different age-categories.Results: Among 123,129 selected reports, 8338 (6.8%) concerned pediatrics. Of these, 52.2% involved male...
The aim of the study was to analyze prescribing pattern both newer and older AEDs.A population almost 150 000 individuals registered with 123 general practitioners included in this study. Patients who received at least one AED prescription over 2005-2011 were identified. 1 year prevalence cumulative incidence use, by drug class individual drug, calculated period. Potential predictors starting therapy AEDs also investigated.The use per 1000 inhabitants increased from 10.7 (95% CI10.1, 11.2)...
Objectives. To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design. A prospective observational study. Setting. Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units Campania Region (Italy). Participants. 775 (53.81% female) with mean age 56.0 (SD 15.2). The follow-up/patient was 3.48 (95% confidence interval 3.13 to 3.84). Main outcome measures. We collected all AEs associated drugs, including serious...
Background The introduction of immune checkpoint inhibitors (ICIs) in clinical practice has brought significant benefits for patients. Seven ICIs are available Europe: nivolumab, pembrolizumab, atezolizumab, avelumab, durvalumab, cemiplimab and ipilimumab. Despite their proven efficacy, these innovative drugs may cause serious immune-related adverse reactions (irADRs). Given the significance ADRs patients' health, we analyzed individual case safety reports (ICSRs) related to ICIs, focusing...
The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor COVID-19 through Covid-19 Vaccine Monitor (CVM) EudraVigilance surveillance systems published pivotal clinical trials.In a prospective cohort vaccinees aged between 5 17 years, measured frequency commonly reported (local/systemic solicited) serious adverse drug events (ADRs) following first second...