Treatment of Medication-Related Osteonecrosis of the Jaw and its Impact on a Patient\ue2\u80\u99s Quality of Life: A Single-Center, 10-Year Experience from Southern Italy

Introduction: No official guidelines are available for the management of medication-related osteonecrosis of the jaw (MR-ONJ). The additional benefit of surgery after pharmacological treatment is debated by both clinicians and patients. Objective: The aim of this study was to evaluate the changes in patients\u2019 MR-ONJ-related quality of life (QoL) after pharmacological treatment with or without surgery in a large cohort affected by MR-ONJ. Methods: Anonymized data on patients diagnosed with MR-ONJ were extracted from the database of the Osteonecrosis of the Jaw Treatment Center (University of Messina, Italy) in the years 2005\u20132015. QoL was evaluated at the moment of MR-ONJ diagnoses (T0), after pharmacological treatment with or without surgery (T1 and T2, respectively), based on scores from the European Organisation for Research and Treatment of Cancer (EORTC) QOL Module for Head and Neck Cancer (global oral health status [GOHS]) and a visual analog scale (VAS), stratified by indication for use. Results: Among 100 patients, 36% were affected by osteoporosis (OSTEO group) and 64% were affected by cancer (ONC group). Considering T0, QoL scores were higher in the OSTEO group then in the ONC group. At T1, GOHS and VAS increased in both groups (OSTEO group: +9.9% and +39.9%; ONC group: +35.4 and +97.2%, respectively). Pharmacological treatment was effective in reducing pain (OSTEO group: 1222.0%; ONC group: 1244.8%), and social contact troubles (OSTEO group: 1240.3%; ONC group: 1226.7%). At T2, GOHS and VAS further increased. Scores related to \u2018pain\u2019 and the troubles related to the \u2018social dimension\u2019 also decreased (OSTEO group: 1291.3% and 1272.0%; ONC group: 50.8% and 1216.4%, respectively). Conclusions: MR-ONJ-related QoL increased after pharmacological treatment and, more notably, after surgery, which may offer benefits to selected patients. QoL data may help clinicians in promoting tailored management of MR-ONJ. \ua9 2017 Springer Internationa

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). Pre-marketing randomized clinical trials of NOACs demonstrated their non-inferiority in terms of efficacy vs. warfarin (traditional oral anticoagulant \u2013 TOA), with lower risk of serious adverse drug reactions, especially cerebral haemorrhages. In clinical practice, pharmacokinetic aspects of NOACs have to be carefully taken into account to optimize the benefit-risk profile of these drugs. Areas covered: An overview of major issues related to pharmacokinetics of NOACs, such as drug-drug interactions, over- and under-dosage in special populations (e.g. elderly, underweight and patients with chronic kidney disease patients), and impact on adherence and persistence to NOACs therapy and ultimately clinical outcomes in real world setting is provided. Expert Opinion: NOACs have been proven to be a better option than traditional anticoagulants due to better tolerability and ease of use. However, given specific pharmacokinetic characteristics, NOACs therapy has to be carefully tailored and monitored in relation to patients\u2019 characteristics with the final goal to maximize benefits and minimize risks

Real world use of biological drugs in patients with psoriasis/psoriatic arthritis: a retrospective, population-based study from Southern Italy in the years 2010-2014

BACKGROUND: Biological drugs, such as infliximab, etanercept, adalimumab, ustekinumab, golimumab and certolizumab are third-line therapy for psoriasis (PsO) and psoriatic arthritis (PsA), but they may be used at earlier stage in severe forms. This study investigated the pattern of use and costs of biological drugs for PsO/PsA in a large population from Southern Italy during the years 2010-2014. METHODS: This was a retrospective, population-based, drug-utilization study, using healthcare administrative databases of the ASL (Local Health Unit) and two hospitals of Messina Province (Sicily) in the years 2010-2014. Incident users of adalimumab, ustekinumab, infliximab, etanercept and golimumab for PsO/PsA were characterized. Yearly prevalence of use and costs, as well as time to treatment discontinuation and switch were assessed. RESULTS: During the study period, 517 patients received at least one study drugs prescription for PsO/PsA and 304 (58.8%) were incident users, mostly treated with adalimumab (33.6%). Incident users were mostly males (59.8%), with a median age of 49 years. The prevalence of biological drugs users in PsO/PsA increased from 4.3 to 6.9 per 10,000 inhabitants from 2011 to 2014. Pharmaceutical expenditure of the study drugs almost doubled (from 2.6 to 4.7 million euros over 5 years of observation). During the first year of treatment, discontinuation occurred in 31.8% of incident users and switch was not infrequent (7.4%). CONCLUSIONS: Prevalence of use and costs of biological drugs for PsO/PsA substantially increased in recent years in a large population of Southern Italy. Larger uptake of lowest cost biological drugs, and biosimilars whenever available, may help access to the most innovative drugs

How did the Introduction of Biosimilar Filgrastim Influence the Prescribing Pattern of Granulocyte Colony-Stimulating Factors? Results from a Multicentre, Population-Based Study, from Five Italian Centres in the Years 2009\u20132014

Background Granulocyte colony-stimulating factors (G-CSFs) are biological products for which the main indication of use is chemotherapy-induced neutropenia. Biosimilars of G-CSFs have been available in Europe since 2007. Objective The objective of this study was to investigate the prescribing pattern of G-CSFs in five Italian centres using different healthcare policy interventions to promote the use of biosimilars in routine care. Methods This retrospective, population-based drug utilization study was conducted during the years 2009\u20132014 using the administrative databases of the Caserta, Treviso and Palermo Local Health Units (LHUs) and the Tuscany and Umbria regions. G-CSF users were characterized and the prevalence of use, proportion of biosimilar users and switching pattern of different G-CSFs were evaluated over time and across centres. Results Overall, 30,247 patients were treated with G-CSFs in the years 2009\u20132014, of which 29,083 (96.2 %) were na\uefve users. The overall prevalence of G-CSF use increased from 0.8 per 1000 inhabitants in 2009 to 1.1 per 1000 in 2014. An increase in the proportion of the use of the biosimilar filgrastim by the total G-CSF users was observed in all centres: from 0.2 % (2009) to 66.2 % (2014). However, heterogeneity across different centres was reported, with the largest increase in Treviso LHU (from 0 to 89.1 % from 2009 to 2014). During the first year of treatment, switching between different G-CSFs was frequent (20.3 %). Conclusions Heterogeneity in the use of G-CSF and, in particular, biosimilar filgrastim across different Italian centres was observed, probably due to different regional healthcare policy interventions. During the first year of treatment, switching between different G-CSFs was frequent. Considering the impact of biological drugs on pharmaceutical expenses, it is necessary to harmonize healthcare policies promoting the use of biological drugs with the lowest cost