Retrospective and observational study to assess the efficacy of citicoline in elderly patients suffering from stupor related to complex geriatric syndrome

A significant percentage of elderly subjects (50%–80%) suffering from sub-acute ischemic cerebrovascular disease, with or without moderate or severe cognitive memory decline and with or without associated behavioral and psychological symptoms, shows a complex syndrome. This syndrome is related to the progressive impairment of health conditions and/or stressing events (ie, hospitalization), characterized by confusion and/or stupor, which are consequently difficult to manage and require a great deal of care. Geriatric patients often suffer from multiple chronic illnesses, may take numerous medications daily, exhibit clinical instability, and may experience worsening of medical conditions following cerebral ischemic events and thus have an increased risk of disability and mortality. There are several studies in literature which demonstrate the efficacy of citicoline, thanks to its neuroprotective function, for the recovery and in postischemic cerebral rehabilitation. It has been shown that, even soon after an ischemic stroke, administration of oral citicoline (500–4000 mg/day) improves the general conditions evaluated with the Rankin scale and the National Institute of Health Stroke Scale 12. In particular, it has been shown that the CDP-choline improves the cognitive and mental performance in Alzheimer’s dementia and vascular dementia. We have evaluated the administration of citicoline in geriatric patients following a protocol of intravenous study on improvement of individual performances

Il farmaco: ricerca, sviluppo e applicazione in terapia

[Italiano]:Il farmaco: ricerca, sviluppo e applicazione in terapia si propone l’obiettivo di offrire una panoramica sul processo di Ricerca e Sviluppo che un farmaco compie a partire dal momento in cui viene progettato fino alla sua pratica utilizzazione. Quando una molecola è ritenuta potenzialmente adatta per creare un medicinale, si attiva un lungo percorso che ha come traguardo la realizzazione di un nuovo mezzo terapeutico e la sua approvazione per l’immissione in commercio. Un percorso scandito dalla rigorosa osservanza di regolamenti e leggi che si sono evoluti nel tempo di pari passo con il progresso scientifico e tecnologico, ma spesso anche a seguito di reazioni avverse o eventi dannosi irreversibili che hanno innescato processi di revisione delle norme e dei protocolli sperimentali. Questo libro parte con una densa ricognizione sulla storia della farmacologia occidentale, al fine di agevolare la comprensione del coacervo di vicende e circostanze che nel tempo hanno fatto da sfondo a tutte quelle dinamiche attraverso cui il processo di Ricerca e Sviluppo si è gradualmente affermato e consolidato. Notevole attenzione è stata poi dedicata ad alcuni risvolti divenuti oramai cruciali all’interno dell’articolato universo normativo in cui il farmaco è collocato, quali le terapie avanzate e i nuovi approcci per la ricerca clinica. Inoltre, gli autori si sono concentrati sulla prescrizione dei cosiddetti off-label e sulle tematiche di farmacoutilizzazione e farmacovigilanza che, nel giro di pochi decenni, sono assurte a sfere di conoscenza sempre più significative e influenti nelle prospettive presenti e future, non solo delle scienze farmaceutiche ma dell’intera società. Lo sforzo compiuto per redigere questo volume trova la sua ragion d’essere proprio nel voler mettere a disposizione dei lettori uno sguardo d’insieme sul farmaco e sulle complesse sfide che ancora lo attendono./ [English]:“The drug: research, development and application in therapy” is an in-depth study on the Research and Development process that a drug performs from the moment it is designed up to its practical use. When a molecule is considered suitable for a medicine, a long process is activated which has as its goal the creation of a new therapeutic tool and its approval for marketing. A path marked by the strict observance of regulations and laws that have evolved over time in step with scientific and technological progress. A path that however has often been determined also by tragic events following damaging adverse reactions that have triggered processes of revision of the norms and experimental protocols. This book starts with a summary on the history of Western pharmacology, written to allow the reader to understand the circumstances that have been the background to those dynamics through which the Research and Development process has gradually consolidated. An important part of the book is dedicated to some aspects that are crucial in the normative universe in which the drug is placed, such as the advanced therapies and new approaches for clinical research. The authors also focused on the prescriptions of off-label drugs and on the issues of pharmacoutilization and pharmacovigilance, two disciplines that, in a few years, have become increasingly influential in the present and future perspectives, not only of the pharmaceutical sciences but of the entire society

Cost/effectiveness analysis of atorvastatin in patients with acute coronary syndromes

Introduction: recent clinical trials found that high-dose statin therapy, compared with conventional-dose statin therapy, reduces the risk of cardiovascular events in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). With the introduction of simvastatin and pravastatin generics and the next patent expiration of atorvastatin, projected for 2011 in Italy, it is natural to ask: what is the most cost-effective treatment for a rational use of resources?Aim: the aim of this study was to estimate the cost-effectiveness of high-dose atorvastatin versus conventional standard-dose statins based on the scenario of atovastatin price evolution.Methods: a cost-effectiveness analysis was conducted in the perspective of the Italian National Health Service over the 4.9 years time horizon. Clinical data were obtained from a pooled analyses of the 3 clinical trials that directly compared high-dose atorvastatin with conventional standard-dose statins in patients with either ACS or CAD. Hospitalizations were quantified based on the Italian National Health Service tariffs and drug costs according to the Italian National Therapeutic Formulary (2009). Assuming the cost of atorvastatin reduces in line with that observed for simvastatin when the patent expires, 3 scenarios were constructed: atorvastatin current price (scenario 1); 55% price discount (scenario 2); 65% price discount (scenario 3). Effects were measured in terms of primary composite endpoint (coronary death or any adverse cardiovascular event). All costs were discounted at 3% per annum. Sensitivity analyses were performed to assess the robustness of findings. Results: intensive therapy with atorvastatin provided a hospitalization cost saving of 245,519.36 € per 1,000 patients. Under the assumptions established for scenario 1 and scenario 2, the incremental cost-effectiveness of treatment with atorvastatin 80 mg was estimated to be 20,289.72 € and 917.05 € for patient free from event, respectively; it was cost-saving for the scenario 3. Conclusions: high-dose atorvastatin represented a cost-effective use of healthcare resources in Italy. If the cost of atorvastatin reduces by 65% when the patent expires, for every million patient with SCA or CAD stable, treated for 5 years, the high-dose atorvastatin strategy potentially yields a cost-saving of ~2,4 billion € for the NHS

Cost/effectiveness analysis of atorvastatin in patients with acute coronary syndromes

Introduction: recent clinical trials found that high-dose statin therapy, compared with conventional-dose statin therapy, reduces the risk of cardiovascular events in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). With the introduction of simvastatin and pravastatin generics and the next patent expiration of atorvastatin, projected for 2011 in Italy, it is natural to ask: what is the most cost-effective treatment for a rational use of resources?Aim: the aim of this study was to estimate the cost-effectiveness of high-dose atorvastatin versus conventional standard-dose statins based on the scenario of atovastatin price evolution.Methods: a cost-effectiveness analysis was conducted in the perspective of the Italian National Health Service over the 4.9 years time horizon. Clinical data were obtained from a pooled analyses of the 3 clinical trials that directly compared high-dose atorvastatin with conventional standard-dose statins in patients with either ACS or CAD. Hospitalizations were quantified based on the Italian National Health Service tariffs and drug costs according to the Italian National Therapeutic Formulary (2009). Assuming the cost of atorvastatin reduces in line with that observed for simvastatin when the patent expires, 3 scenarios were constructed: atorvastatin current price (scenario 1); 55% price discount (scenario 2); 65% price discount (scenario 3). Effects were measured in terms of primary composite endpoint (coronary death or any adverse cardiovascular event). All costs were discounted at 3% per annum. Sensitivity analyses were performed to assess the robustness of findings. Results: intensive therapy with atorvastatin provided a hospitalization cost saving of 245,519.36 € per 1,000 patients. Under the assumptions established for scenario 1 and scenario 2, the incremental cost-effectiveness of treatment with atorvastatin 80 mg was estimated to be 20,289.72 € and 917.05 € for patient free from event, respectively; it was cost-saving for the scenario 3. Conclusions: high-dose atorvastatin represented a cost-effective use of healthcare resources in Italy. If the cost of atorvastatin reduces by 65% when the patent expires, for every million patient with SCA or CAD stable, treated for 5 years, the high-dose atorvastatin strategy potentially yields a cost-saving of ~2,4 billion € for the NHS

La prescrizione di antibiotici in regione Campania negli anni 2002-2011

Background For several years Campania region has been showing the highest number of prescribed DDD and the highest expenditure of all the Italian regions. This study aims to analyze the utilization of antibiotic drugs in the Campania region, focusing on intra-regional variability. Methods We collected from an administrative database all prescriptions for antibiotic drugs for the years 2002-2011, classified according to their therapeutic role using Anatomic Therapeutic Chemical (ATC) classification. Drugs consumption were quantified using Defined Daily Dose (DDD) system and trends have been calculated using Compound Average Grow Rate (CAGR). The drug expenditure was expressed in euro. Results In 2011 antimicrobial for systemic use (ATC: J01) was the third therapeutic group in terms of drug expenditure in Campania region (9,5% of total drug expenditure). The consumption was 28.4 DDD/1000 inhabitants/die. Therapeutic group consumption trends showed a reduction in cephalosporins and macrolides (CAGR 11/02 -4.1%, -1.0% respectively) as well as an increased consumption of quinolones (CAGR 11/02 2.0%). Penicillins, cephalosporins, carbapenems and monobactams were the most prescribed antibiotic classes in all age groups. Conclusions The present work shows a reduction in the consumption and expenditure for antibiotic drugs in Campania region, although above the national average yet. Further studies are needed to assess the effects of appropriateness policies recently established by regional authorities

Differences in drug use between men and women: An Italian cross sectional study

Background: Drugs are the most important treatment option for most diseases, and the majority of medical consultations result in a prescription. Women and men receive different drug prescriptions and differ in therapeutic response to pharmacological therapy. This disparity is due to biological factors (sex differences) or/and behavior, lifestyle and life experience (gender differences). Sex differences in drug use have been demonstrated in several therapeutic areas; however, there is a lack of overviews on sex and gender differences of drug use in an entire population. Methods: We conducted a descriptive cross - sectional drug use study, involving the entire Italian population in 2012, aimed at showing and analyzing differences between men and women as regards their exposure to drugs. The data source was IMS LifeLink Treatment DynamicsTMLRx Database and it included all prescribed drugs reimbursed by the Italian National Healthcare System in 2012 and covered 90% of the entire Italian population. The information about the prescriptions was stratified by men and women and age. Drug consumption was expressed as DDD/ 1000 ab die. Exposure to drug prescriptions was expressed as period prevalence (the proportion of the population dispensed ≥1 prescription in 2012 per 1000 inhabitants). Differences of prevalence between men and women were expressed as crude and age adjusted risk ratios with 95% CI. Results: Our findings suggested that the largest differences in drug prescriptions regarded drugs affecting bone structure and mineralization (RR 15.9), calcium (RR 8.6) and thyroid therapy (RR 5.4), dispensed more to women than men. Otherwise ACE inhibitors were more commonly used in men. Conclusions: This is the first study exploring difference in drug use between men and women and carried out on the entire Italian population. Our findings showed substantial differences between men and women in term of prevalence of drug prescriptions. Some differences in drug use may be explained by sex differences (variations in disease prevalence and severity, pathophysiology, or by other biological differences), other differences need further investigation to explain the apparent lack of a rational medical explanation for some findings. The findings may subsequently be used to plan future studies to address differences suggesting inequity in treatment approaches

Doctors commitment and long-term effectiveness for cost containment policies: lesson learned from biosimilar drugs

Agency is a pervasive feature of the health care market, with doctors acting as agents for both patients and the health care system. In a context of scarce resources, doctors are required to take opportunity cost into account when prescribing treatments, while cost containment policies cannot overlook their active role in determining health care resource allocation. This paper addresses this issue, investigating the effects of cost containment measures in the market of biosimilar drugs that represent a viable and cost-saving strategy for the reduction of health care expenditure. The analysis focuses on a particular region in Italy, where several timely policies to incentivize biosimilar prescribing were launched