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. The association of the outcomes was assessed using a multiple Cox proportional hazard model. Propensity score matched analysis and a 5-to-1, greedy 1:1 matching algorithm were performed. The budget impact analysis of dutasteride vs finasteride in BPH-treated patient was performed. RESULTS: From an initial cohort of about 1.5 million of Italian men, 19620 were selected. The overall hospitalization for BPH-non surgical reasons, for BPH-related surgery and for new detection of PCa incidence rates (IRs) were 8.20 (95% CI, 7.62-8.23), 18.0 (95% CI, 17.12-18.93) and 8.62 (95% CI, 8.03-9.26) per 1000 person-years, respectively. The multivariate analysis after the propensity score-matching showed that dutasteride was associated with an independent reduced likelihood of hospitalization for BPH-related surgery (HR 0.82; 95% CI 0.73-0.93; p = 0.0025) and of newly detected PCa (HR: 0.76,95% CI, 0.65-0.85; p = 0.0116). The IR for BPH-non surgical reasons was 8.07 (95% CI, 7.10-9.17) and 9.25 (95% CI, 8.19-10.44) per 1000 person-years, respectively. The IR for BPH-related surgery was 18.28 (95% CI, 17.17-20.32) and 21.28 (95% CI, 19.24-23.06) per 1000 person-years among patients under dutasteride compared with those under finasteride, respectively. For new-onset PCa, the IR was 8.01 (95% CI, 7.07-9.08) and 9.38 (95% CI, 8.32-10.58) per 1000 person-years The pharmacoeconomical evaluation showed that the net budget impact of the use of dutasteride vs. finasteride in 1000 BPH-treated patient for 1 year induces a saving of 3933 €. CONCLUSIONS: The clinical effects of dutasteride and finasteride are slightly different. The likelihood of hospitalization for BPH-related surgery and of newly detected PCa seems to be in favor of dutasteride. The budget impact analyses showed a slightly benefit for dutasteride. Comparative prospective studies are necessary to confirm these results.

[Unmet clinical need and new therapeutic options.] / Unmet clinical need e nuovi farmaci.

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. This topic is even more stimulating as this work takes place in a historical period which, on the one hand, sees the start of a new course of negotiation rules recently published by AIFA and, on the other hand, poses unprecedented challenges that emerged during the pandemic crisis. The working group formulated suggestions and proposals to further enhance the role of the UCN in decision-making processes, also in the light of the new negotiation procedure, and to help refine the tools for grading the UCN and the value of medicines in the interests of patients and society as a whole.

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. RESULTS: compared with the base case, adopting scenarios 1-4 would reduce the annual number of influenza cases by 6.5%, 10.8%, 13.8% and 3.4%, Emergency Department accesses by 10.7%, 9.1%, 15.4% and 4.6%, complications by 8.9%, 9.9%, 14.7% and 4.1%, and the hospitalization of complicated cases by 11%, 9.1%, 15.4% and 4.5%, respectively. The four scenarios would require an additional investment (vaccine purchase and administration) of €316,996, €529,174, €677,539, and €168,633, respectively, in comparison with the base case. Scenario 1 proved to be cost-saving in the 60-64-year age-group. The incremental costs of implementing the other hypothetical scenarios ranged from 2.7% (scenario 4) to 13.2% (scenario 3). CONCLUSIONS: lowering the recommended age for influenza vaccination to 60 years would allow a high proportion of subjects at risk for severe influenza to be reached and would save money.

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. In the base-case scenario, three 65 YOA cohorts were assumed to be vaccinated within three years, with a vaccine coverage rate of 20%, 35% and 50% at Year 1, 2 and 3 respectively, as recommended by the National Immunization Plan. The three 65 YOA Italian cohorts accounted altogether for 2,290,340 individuals. Of these, it was assumed that 564,178 subjects could be vaccinated with either RZV or ZVL in three years. The vaccination with RZV could prevent an additional total number of 35,834 HZ and 8,131 postherpetic neuralgia (PHN) cases over ZVL, leading to additional total savings of €12.4 million for the national healthcare and social systems. The introduction of RZV can be expected to have higher impact on the burden of HZ disease in the 65 YOA cohort in Italy. The avoided HZ and PHN cases can lead to an associated reduction in economic burden to the healthcare and social systems.

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. Rates for children and young adults 5 to 34 years of age, middle age adults 35 to 64 years of age, and elderly adults > or = 65 years. Joinpoint regression was performed to identify years where significant changes in mortality trends occurred. Consumption of inhaled long-acting beta-2-agonists (LABA), including inhaled corticosteroids (ICS) when combined with LABAs in a single inhaler, derived from sales estimates. RESULTS: In 1994, the highest asthma mortality rates were in Germany (4.7/100,000), and the lowest ones were in Italy and Spain (0.5/100,000). Steady downward trends were observed in all the countries considered. The largest decline was registered in Germany and the smallest one was in the UK. LABA sales increased steadily since 1994, particularly in France, Spain, and the UK, reaching values around 14 Defined Daily Doses (DDD)/1,000 inhabitants in 2004. CONCLUSION: While the use of LABAs (with or without ICS) increased over the last decade, asthma mortality declined in major western European countries.

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.

[Community-acquired pneumonia: a budget impact model]. / Polmonite acquisita in comunità: un modello di impatto sul budget.

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. Budget impact analysis shows that the cost of CAP-hospitalized patients in Italy consists mainly in the cost of treatment failure while that of antibiotics is just a small component of total direct costs incurred by hospitals.