[Unmet clinical need and new therapeutic options.].

The debate around unmet clinical need (UCN) is still very much alive. How do we define UCN? How does it influence the definition of clinically relevant outcomes in a therapeutic area? Who defines UCN? What are the consequences of recognizing different grading of UCN? In this paper we will address these questions and finally formulate proposals for the Italian context. The paper is based on a discussion within a panel of experts.

Lowering the recommended age for the free and active offer of influenza vaccination in Italy: clinical and economic impact analysis in the Liguria region.

Objective: we estimated the epidemiological and budget impact of lowering the recommended age for influenza immunization with quadrivalent vaccine actively offered and administered free of charge to persons over 50 years old by public immunization services.

Methods: a multi-cohort, deterministic, static Markov model was populated by real-world data on the clinical and economic impact of Influenza-Like Illness and Lower Respiratory Tract Infection over 1 year. Four scenarios featuring different vaccine coverage rates were compared with the base case; coverage rates in subjects with and without risk factors were considered separately.

The potential public health impact of Herpes Zoster vaccination in the 65 years of age cohort in Italy.

Herpes Zoster (HZ) presents a considerable public health burden in Italy among people aged ≥50 years. This study aimed to assess the clinical and economic impact of HZ vaccination in the 65 years of age (YOA) cohort in Italy, by comparing the new Adjuvanted Recombinant Zoster Vaccine (RZV) with the currently available Zoster Vaccine Live (ZVL). A static Markov model was developed to follow all 65 YOA subjects from the year of vaccination over their lifetime by comparing three different HZ vaccination strategies: no vaccination, vaccination with ZVL and vaccination with RZV.

Clinical effects and economical impact of dutasteride and finasteride therapy in Italian men with LUTS.

Objectives: To investigate differences in the risk of benign prostatic hyperplasia (BPH)- related hospitalization, for surgical and non-surgical reasons, and of new prostate cancer (PCa) diagnosis between patients under dutasteride or finasteride treatment.

Material And Methods: A retrospective cohort study was conducted using data from record-linkage of administrative databases. Men aged ≥ 40 years old who had received a prescription for at least 10 boxes/year (index years: 2004-06) were included.

[Community-acquired pneumonia: a budget impact model].

Community-acquired pneumonia (CAP) is an infectious disease with high morbidity and mortality and a major social and economic impact. A budget impact model was developed to estimate the impact on hospital direct costs of different antibiotic therapies suggested by international and national (FADOI) guidelines on treatment of patients hospitalized with CAP. The model includes the costs of drugs, staffing, consumables and in-patient stays in two different scenarios: intravenous therapy only and switch therapy; it compares levofloxacin (monotherapy) versus other combination therapies as suggested by the guidelines and includes the cost of failure of first-line treatment.

Asthma mortality and long-acting beta2-agonists in five major European countries, 1994-2004.

Objectives: Over the last few decades, important changes occurred in the pharmacological approach to asthma control. However, the possible link between pharmacologic treatment and asthma death remains controversial.

Study Design And Setting: Age-standardized asthma mortality rates were computed over the 1994-2004 period for France, Germany, Spain, the UK, and Italy.

Steroidal seven-membered A-ring epoxy lactones by oxidation of the corresponding Delta 4-3-ketosteroids.

Treatment of Delta 4-3-ketosteroids with m-chloroperbenzoic acid at 0 degrees C produced the corresponding steroidal seven-membered A-ring epoxy lactones. The adopted procedure allowed for efficient recovery and separation of the products with definite stereochemistry.