Pharmacokinetics of new oral anticoagulants: implications for use in routine care

Introduction: Since 2008, new oral anticoagulants (NOACs) have been approved for the prevention of venous thromboembolism (VTE) in patients receiving hip or knee replacement surgery, prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF), treatment of deep vein thrombosis (DVT), and pulmonary embolism (PE). Premarketing randomized clinical trials (RCTs) of NOACs demonstrated their non-inferiority in terms of efficacy vs. warfarin (traditional oral anticoagulant–TOA), with lower risk of serious adverse drug reactions, especially cerebral hemorrhages. In clinical practice, pharmacokinetic aspects of NOACs have to be carefully taken into account to …

Safety and potential interaction of immunosuppressive drugs for the treatment of inflammatory bowel disease in elderly patients

Inflammatory bowel diseases, including Crohn's disease and ulcerative colitis, are chronic diseases associated with increased morbidity and reduced quality of life. Age may represent a risk factor for adverse events, due to the multimorbidity and polypharmacy, common in elderly patients. Elderly are often not included in clinical trials evaluating efficacy and safety of study drugs for the treatment of inflammatory bowel diseases. Several drugs, such as aminosalicylates, systemic corticosteroids, immunosuppressant drugs, biological drugs and Janus Kinase inhibitors, are available for the management of inflammatory bowel diseases. With the increasing spectrum of therapeutic options, it is th…

Interaction risk with proton pump inhibitors in general practice: significant disagreement between different drug-related information sources.

Aims To compare information on drug–drug interactions (DDIs) reported on two standard drug-related information sources (Summary of Product Characteristics and Drugdex system by Micromedex), by assessing the prevalence and predictors of potential DDI with proton pump inhibitors (PPIs) in general practice. Methods From the ‘Caserta-1’ Local Health-Service database, 156 general practitioners (GPs) were recruited. From more than 180 000 individuals registered on their lists, we selected patients receiving co-prescription of PPI and medications at interaction risk, according to the Italian Summary of Product Characteristics (SPC) of PPI and Drugdex information, during the year 2003. Thereafter, …

How Have Intravitreal Anti-VEGF and Dexamethasone Implant Been Used in Italy? A Multiregional, Population-Based Study in the Years 2010–2016

Purpose. To describe intravitreal anti-VEGF drug and dexamethasone use in four Italian regions. Methods. Four regional claims databases were used to measure drug prevalence, compare dosing intervals to those recommended in the summary of product characteristics (SPC), and identify switchers. Bilateral treatment and diabetic macular edema (DME) coding algorithms were validated, linking claims with a sample of prospectively collected ophthalmological data. Results. Overall, 41,836 patients received ≥1 study drug in 2010–2016 (4.8 per 10,000 persons). In 2016, anti-VEGF drug use ranged from 0.8 (Basilicata) to 5.7 (Lombardy) per 10,000 persons while intravitreal dexamethasone use ranged from 0…

STATINS FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR EVENTS IN ELDERLY PATIENTS: A PICTURE FROM CLINICAL PRACTICE WITHOUT STRONG EVIDENCE FROM CLINICAL TRIALS

COVID-19 Patient Management in Outpatient Setting: A Population-Based Study from Southern Italy

Evidence on treatments for early-stage COVID-19 in outpatient setting is sparse. We explored the pattern of use of drugs prescribed for COVID-19 outpatients’ management in Southern Italy in the period February 2020–January 2021. This population-based cohort study was conducted using COVID-19 surveillance registry from Caserta Local Health Unit, which was linked to claims databases from the same catchment area. The date of SARS-CoV-2 infection diagnosis was the index date (ID). We evaluated demographic and clinical characteristics of the study drug users and the pattern of use of drugs prescribed for outpatient COVID-19 management. Overall, 40,030 patients were included in the analyses, with…

Italian guidelines on management of persons with multimorbidity and polypharmacy

AbstractMultimorbidity and polypharmacy are emerging health priorities and the care of persons with these conditions is complex and challenging. The aim of the present guidelines is to develop recommendations for the clinical management of persons with multimorbidity and/or polypharmacy and to provide evidence-based guidance to improve their quality of care. The recommendations have been produced in keeping with the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Overall, 14 recommendations were issued, focusing on 4 thematic areas: (1.) General Principles; (2.) target population for an individualized approach to care; (3.) individualized care of patients with mul…

Assessment of intravitreal anti-VEGF drugs and dexamethasone for retinal diseases in real world setting: A multi-centre prospective study from Southern Italy

Describe drug utilisation and clinical outcomes of intravitreal anti-VEGF drug and dexamethasone use in the real-world setting in Southern Italy using data from multi-centre study of retinal disease. Clinical data of retinal disease patients treated with anti-VEGF drugs and dexamethasone implant in 6 out-patient ophthalmology centres from Southern Italy were collected by means of an electronic case report form. Patients receiving at least one intravitreal injection/implant of the study drugs were followed for up to two years and described in terms of demographics and clinical characteristics. Drug utilisation patterns were described. A sign-rank test was used to compare clinical data on vi…