Search

Silvia Tognella,1 Claudio Micheletto,2 Alessandro Roggeri,3 Guido Polese,4 Denise Artioli,1 Gianenrico Senna,5 Marco Caminati,5,6 Daniela Paola Roggeri3 1Pulmonology Unit, Mater Salutis Hospital, Legnago (Verona), Italy; 2Pulmonology Unit, Azienda Ospedaliera Universitaria Integrata, Verona, Italy; 3ProCure Solutions, Nembro, Bergamo, Italy; 4Pulmonology Unit, Magalini Hospital, Villafranca (Verona), Italy; 5Asthma Center and Allergy Unit, Verona University Hospital, Verona, Italy; 6Department of Medicine, Allergy and Clinical Immunology Section, University of Verona and Verona University Hospital, Verona, 37134, ItalyCorrespondence: Alessandro RoggeriProCure Solutions, Via Camozzi 1/C, Nembro, 24027, BG, ItalyTel +39 035 521121Email alessandro.roggeri@procuresolutions.itPurpose: A Regional Technical Commission was set in 2017 by Veneto region (Italy) to provide opinions and recommendations on drug prescriptions and to implement treatment-pathway guidelines for severe asthma. In this observational study, we describe the first structured, integrated, multidisciplinary, patient-centered outpatient clinic for the care of severe-asthma patients in Italy, and characterize patients referring to the center for specialist visits.Patients and Methods: To characterize patients that accessed the outpatient clinic in 2018, data on demographic characteristics, treatments, severity of asthma, phenotypes, and relevant comorbidities by phenotype were collected. Use of biologic agents and indicators of the performance of the outpatient clinic were described.Results: A structured multidisciplinary outpatient pathway for taking charge of patients and for administration and monitoring of biological agents was developed. A total of 146 patients accessed the outpatient clinic in 2018: 62.3% had uncontrolled asthma upon admission and 27.4% were already being treated with biologic agents. Among patients with uncontrolled asthma, 66% had severe uncontrolled asthma, 22% had moderate–severe uncontrolled asthma, and 12% had mild–moderate uncontrolled asthma. Main asthma phenotypes in uncontrolled-asthma patients were allergic (58% of patients), eosinophilic (22%), allergic plus eosinophilic (10%) and non-atopic asthma (10%). Among patients affected by severe asthma, 47% had allergic asthma, 28% had eosinophilic asthma, 13% had allergic plus eosinophilic asthma, and 12% had non-atopic asthma. Nasal polyps were more frequent in eosinophilic and allergic plus eosinophilic asthma, while gastro-esophageal reflux disease was more frequent in non-atopic asthma.Conclusion: This structure of an outpatient clinic for the treatment of severe asthma, with its dedicated pathway and multidisciplinary approach, may allow a stricter control of asthma and optimization of therapies, as well as minimization of drug misuse.Keywords: asthma, severe, multidisciplinary, outpatient

Daniela Paola Roggeri, Alessandro Roggeri ProCure Solutions, Nembro, Bergamo, Italy Purpose: Hepatic encephalopathy (HE) is associated with a reduced survival, an increased risk of hospitalization for recurrences, and a reduced health-related quality of life. The purpose of the present economic analysis was to evaluate the impact on the Italian National Health Service (INHS) expenditure of the treatment with rifaximin 550 mg twice daily (Tixteller®/Tixtar®) for the reduction of the recurrences of overt HE, with respect to the current treatment approach. Patients and methods: Costs associated with patients treated with rifaximin 550 mg twice daily were estimated considering the reduction in hospitalizations for HE recurrences revealed by registrative clinical trial (−50%) applied to the hospitalization rate (42.5%) emerging from an Italian observational real-world study; costs associated with patients not treated with rifaximin were estimated based on the hospitalization rate, resulting from the same Italian observational study. Sensitivity analyses considering possible different discount levels to INHS structures for rifaximin were performed. The INHS perspective for a period of 3 years was considered. Results: The treatment with rifaximin 550 mg twice daily, although increasing drug costs, is associated with a reduction in hospitalizations for HE recurrences that leads to an overall reduction of total costs charged to INHS, which could be estimated, based on the forecasted uptake of the treatment, at about €130,000 in the first year, reaching ~€260,000 in the third year. Considering a possible discount for rifaximin 550 mg to INHS structure of 20%, the total saving at the third year accounts for ~€3,000,000. Moreover, a relevant reduction in the number of hospitalizations and bed days is associated with rifaximin treatment. Conclusion: The treatment with rifaximin 550 mg twice daily, even if associated with an increase in drug expenditure, results in a reduction in total health care costs charged to INHS due to a reduction in hospitalizations for HE recurrences. Keywords: overt hepatic encephalopathy recurrences, health care expenditure, costs, hospitalizations, budget impact

Daniela Paola Roggeri,1 Alessandro Roggeri,1 Elisa Rossi,2 Salvatore Cataudella,2 Nello Martini,3 1ProCure Solutions, Nembro, Bergamo, 2CINECA Interuniversity Consortium, Bologna, 3Accademia Nazionale di Medicina, Rome, Italy Purpose: Bronchiolitis is an acute inflammatory injury of the bronchioles, and is the most frequent cause of hospitalization for lower respiratory tract infections in preterm infants. This was a retrospective, observational, case-control study conducted in Italy, based on administrative database analysis. The aim of this study was to evaluate differences in health care costs of preterm infants with and without early hospitalization for bronchiolitis. Patients and methods: Preterm infants born in the period between January 1, 2009 and December 31, 2010 and hospitalized for bronchiolitis in the first year of life were selected from the ARNO Observatory database and observed for the first 4 years of life. These preterm infants were compared (paired 1–3) with preterm infants who were not hospitalized for bronchiolitis in the first year of life and with similar characteristics. Only direct health care costs reimbursed by the Italian National Health Service were considered for this study (drugs, hospitalizations, and diagnostic/therapeutic procedures). Results: Of 40,823 newborns in the accrual period, 863 were preterm with no evidence of prophylaxis, and 22 preterm infants were hospitalized for bronchiolitis (cases) and paired with 62 controls. Overall, cases had 74% higher average cost per infant in the first 4 years of life than controls (18,624€ versus 10,189€, respectively). The major cost drivers were hospitalizations, accounting for >90% in both the populations. The increase in total yearly health care cost between cases and controls remained substantial even in the fourth year of life for all cost items. A relevant increase in hospitalizations and drug consumption linked to respiratory tract diseases was noted in infants hospitalized for bronchiolitis during the entire follow-up period. Conclusion: Preterm infants hospitalized for bronchiolitis in the first year of life were associated with increased resource consumption and costs throughout the entire period of observation; even in the fourth year, the difference versus paired controls was relevant. Keywords: bronchiolitis, cost, preterm, hospitalizations

Alessandro Roggeri,1 Claudio Micheletto,2 Daniela Paola Roggeri1 1ProCure Solutions, Nembro, Bergamo, Italy, 2Respiratory Unit, Mater Salutis Hospital, Legnago, Verona, Italy Background: Different inhalation devices are characterized by different techniques of use. The untrained switching of device in chronic obstructive pulmonary disease (COPD) and asthma patients may be associated with inadequate inhalation technique and, consequently, could lead to a reduction in adherence to treatment and limit control of the disease. The aim of this analysis was to estimate the potential economic impact related to errors in inhalation in patients switching device without adequate training. Methods: An Italian real-practice study conducted in patients affected by COPD and asthma has shown an increase in health care resource consumption associated with misuse of inhalers. Particularly, significantly higher rates of hospitalizations, emergency room visits (ER), and pharmacological treatments (steroids and antimicrobials) were observed. In this analysis, those differences in resource consumption were monetized considering the Italian National Health Service (INHS) perspective. Results: Comparing a hypothetical cohort of 100 COPD patients with at least a critical error in inhalation vs 100 COPD patients without errors in inhalation, a yearly excess of 11.5 hospitalizations, 13 ER visits, 19.5 antimicrobial courses, and 47 corticosteroid courses for the first population were revealed. In the same way, considering 100 asthma patients with at least a critical error in inhalation vs 100 asthma patients without errors in inhalation, the first population is associated with a yearly excess of 19 hospitalizations, 26.5 ER visits, 4.5 antimicrobial courses, and 21.5 corticosteroid courses. These differences in resource consumption could be associated with an increase in health care expenditure for INHS, due to inhalation errors, of €23,444/yr in COPD and €44,104/yr in asthma for the considered cohorts of 100 patients. Conclusion: This evaluation highlights that misuse of inhaler devices, due to inadequate training or nonconsented switch of inhaled medications, is associated with a decrease in disease control and an increase in health care resource consumption and costs. Keywords: inhalers, devices, switch, training, errors, costs, asthma, COPD

Daniela Paola Roggeri,1 Alessandro Roggeri,1 Elisa Rossi,2 Elisa Cinconze,2 Antonio Gasbarrini,3 PierAlessandro Monici Preti,4 Marisa De Rosa,2 1ProCure Solutions, Nembro, Bergamo, 2CINECA, Interuniversity Consortium, Bologna, 3Catholic University of Sacred Heart, Policlinic A Gemelli, Rome, 4Alfa Wassermann, Bologna, Italy Purpose: Hepatic encephalopathy (HE) is a recurrent severe complication of progressive hepatic cirrhosis. The aim of this study is to evaluate the average annual direct healthcare costs for the treatment of patients with overt HE in Italy. Patients and methods: This retrospective, observational study analyzed information from the database of ARNO Observatory. Patients with at least one hospitalization due to overt HE in the period from January 1, 2011 to December 31, 2011, were selected and observed during the year following the hospitalization. Costs for drugs, diagnostic and therapeutic procedures, and hospitalizations were estimated from the Italian National Health Service perspective. Results: Out of a population of 2,678,462 subjects, 381 patients were identified, of whom, 21.5% died during the first hospitalization and 5.8% during the follow-up; the survival rate was 72.7% at the end of the observation period. The direct healthcare costs per patient amounted to €13,393/year (15,295 USD) (88% for hospitalizations, 8% for drugs, and 4% for diagnostic procedures). During the follow-up, 42.5% of patients had at least one rehospitalization due to HE. Patients readmitted for HE had an average annual cost of €21,272 (24,293 USD), almost doubled if compared to patients without readmissions (€12,098 [13,816 USD]). Conclusion: This analysis showed that patients with HE had relevant direct healthcare costs, in which hospitalizations were the most important cost drivers. Keywords: hepatic encephalopathy, costs, hospitalizations, relapses

Daniela Paola Roggeri,1 Mario Cozzolino,2 Sandro Mazzaferro,3 Diego Brancaccio,4 Ernesto Paoletti,5 Alessandro Roggeri,1 Anna Maria Costanzo,6 Umberto di Luzio Paparatti,6 Vincenzo Festa,6 Piergiorgio Messa7 1ProCure Solutions, Nembro, Bergamo, 2Department of Health Sciences, University of Milan, Milan, 3Department of Cardiovascular, Respiratory, Nephrologic and Geriatric Sciences, Sapienza University of Rome, Rome, 4Dialysis Unit NephroCare Simone Martini, Milan, 5Department of Nephrology, San Martino Hospital, Genoa, 6AbbVie Italy, Campoverde, Latina, 7Nephrology, Dialysis and Renal Transplant, Fondazione Ca Granda IRCCS Policlinico, Milan, Italy On behalf of the FARO Study Group Background: The aim of this analysis was to estimate biochemical parameters and the costs of treatment of secondary hyperparathyroidism (SHPT) in a subpopulation of the FARO-2 study. Methods: The FARO-2 observational study aimed at evaluating the patterns of treatment for SHPT in naïve hemodialysis patients. Data related to pharmacological treatments and biochemical parameters (parathyroid hormone [PTH], calcium, phosphate) were recorded at entry to hemodialysis (baseline) and 6 months later (second survey). The analysis was performed from the Italian National Health Service perspective. Results: Two prominent treatment groups were identified, ie, one on oral calcitriol (n=105) and the other on intravenous paricalcitol (n=33); the intravenous calcitriol and intravenous paricalcitol + cinacalcet combination groups were not analyzed due to low patient numbers. At baseline, serum PTH levels were significantly higher in the intravenous paricalcitol group (P

Alessandro Roggeri,1 Claudio Micheletto,2 Daniela Paola Roggeri11ProCure Solutions, Bergamo, Italy; 2Respiratory Unit, Mater Salutis Hospital, Legnago, Verona, ItalyPurpose: Fixed-dose combinations of inhaled corticosteroids and long-acting ß2-agonists have proven to prevent and reduce chronic obstructive pulmonary disease (COPD) exacerbations. The aim of this analysis was to explore the clinical consequences and direct health care costs of applying the findings of the PATHOS (An Investigation of the Past 10 Years Health Care for Primary Care Patients with Chronic Obstructive Pulmonary Disease) study to the Italian context.Patients and methods: Effectiveness data from the PATHOS study, a population-based, retrospective, observational registry study conducted in Sweden, in terms of reduction in COPD and pneumonia-related hospitalizations, were considered, in order to estimate the differences in resource consumption between patients treated with budesonide/formoterol and fluticasone/salmeterol. The base case considers the average dosages of the two drugs reported in the PATHOS study and the actual public price in charges to the Italian National Health Service, while the difference in hospitalization rates reported in the PATHOS study was costed based on Italian real-world data.Results: The PATHOS study demonstrated a significant reduction in COPD hospitalizations and pneumonia-related hospitalizations in patients treated with budesonide/formoterol versus fluticasone/salmeterol (-29.1% and -42%, respectively). In the base case, the treatment of a patient for 1 year with budesonide/formoterol led to a saving of €499.90 (€195.10 for drugs, €193.10 for COPD hospitalizations, and €111.70 for pneumonia hospitalizations) corresponding to a -27.6% difference compared with fluticasone/salmeterol treatment.Conclusion: Treatment of COPD with budesonide/formoterol compared with fluticasone/salmeterol could lead to a reduction in direct health care costs, with relevant improvement in clinical outcomes.Keywords: disease management, pharmacoeconomics, direct health care costs, hospitalizations

BACKGROUND: Diabetes risk is often complicated by a mixed hyperlipoproteinemia not sufficiently controlled by a single antihyperlipidemic drug; however, there are some concerns about the safety of combined statin and fibrate treatments. OBJECTIVE: The aim of this study was to compare the efficacy and safety profile of fluvastatin + fenofibrate combination therapy and those of fluvastatin monotherapy in the treatment of combined hyperlipidemia, type 2 diabetes mellitus (DM), and coronary heart disease (CHD) (ie, high risk for cardiovascular disease [CVD]). METHODS: This 12-month, randomized, double-blind, controlled trial was conducted at the University of Pavia, Pavia, Italy. Patients aged 18 to 80 years with combined hyperlipidemia, type 2 DM, and CHD were randomly assigned to receive combination therapy with extended-release fluvastatin 80 mg + micronized fenofibrate 200 mg or monotherapy with extended-release fluvastatin 80 mg. All treatments were given in tablet form, once daily with the evening meal, for 12 months. Lipid variables (low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], total cholesterol [TC], and triglycerides [TG]) at 6 and 12 months were the primary efficacy variables, and glycemic status (glycosylated hemoglobin [HbA(1c)], fasting plasma glucose, and postprandial plasma glucose levels) at 6 and 12 months was the secondary efficacy variable. Tolerability was assessed using physical examination, including vital-sign assessment, body-weight measurement, electrocardiography, adverse events, and laboratory tests. A pharmacoeconomic analysis of both treatment regimens was also carried out using the incremental cost-effectiveness ratio (ICER). RESULTS: A total of 48 patients (24 men, 24 women; mean [SD] age, 60 [5] years) were enrolled. After 6 months, all primary efficacy variables, except for TG level, showed significant improvements from baseline only in the combination-therapy group (changes: LDL-C, -25%; HDL-C, +12%; and TC, -19%; all, P < 0.05 vs baseline). After 12 months, lipid variables showed significant improvements over baseline in both groups (all, P < 0.05), except for TG in the monotherapy group. Significant changes in LDL-C, HDL-C, and TG were found in the combination-therapy group (-35%, +34%, -32%, respectively) versus the monotherapy group (-25%, +14%, -17%, respectively; all, P < 0.05 between groups). The change from baseline in HbA(1c) level was significant with combination therapy (-12% vs -7%; P < 0.05). Both treatments were well tolerated, with no significant differences in the incidences of adverse events between the 2 groups. The ICER showed that each 1% decrease in LDL-C level achieved with the fenofibrate + fluvastatin combination added a cost of 14.97 Euros/y (US 12.25 US dollars/y), and each 1% increase in HDL-C level added a cost of 7.48 Euros/y (6.12/y US dollars), over the cost of monotherapy. CONCLUSIONS: In this selected sample of patients with combined hyperlipidemia, type 2 DM, and CHD, the combination of extended-release fluvastatin + micronized fenofibrate was associated with a more improved lipid profile than fluvastatin monotherapy, and was a well-tolerated and cost-effective therapeutic choice to treat these patients at high risk for CVD. [ABSTRACT FROM AUTHOR]

Background: Patients on dialysis often have secondary hyperparathyroidism (SHPT), a disorder associated with renal osteodystrophy, progressive vascular calcification, cardiovascular disease, and death. The objective of this retrospective observational study was to evaluate, in dialysis patients with SHPT, the impact of different levels of adherence to cinacalcet therapy on hospitalisations and direct healthcare costs charged to the Lombardy Regional Health Service (Italy)., Methods: Data recorded in the administrative databases on all citizens undergoing dialysis between 1 January 2011 and 31 December 2011 were selected. For the aim of this study, patients with SHPT already on dialysis in the first 6 months of 2009 who had been treated with cinacalcet for at least 365 days were selected and retrospectively analysed through to end of 2012. Healthcare resource utilisation, cinacalcet adherence, and costs for medication, hospitalisations, and diagnostic/therapeutic procedures were estimated., Results: A total of 994 patients were identified (mean age 63.0 years, females 43.5%). The first patient tertile had an adherence to cinacalcet of <64.1%, whereas the third had an adherence of over 91.5%. Patients in the third adherence tertile experienced fewer all-causes hospitalisations than those in the first tertile (-19.2%; p =0.01423), fractures (-37.1%; p =0.59422), cardiovascular disease (-23.8%; p =0.04025), and sepsis (-32.3%; p =0.01386). The increase in costs for cinacalcet-adherent patients is almost completely offset by the reduction in costs for hospitalisations., Conclusions: The results of the analysis suggest that there may be some correlation between a high level of cinacalcet adherence and a decrease in hospitalisations., Competing Interests: Disclosure and potential conflicts of interest: Alessandro Roggeri and Daniela Paola Roggeri report consultancy fees from AstraZeneca and Amgen, outside the submitted work. Mario Cozzolino reports personal fees from Vifor Pharma, personal fees from Amgen, grants and personal fees from Shire, and grants and personal fees from Baxter, outside the submitted work. All other authors declare that they have no conflict of interest. https://www.drugsincontext.com/wp-content/uploads/2020/03/dic.2020-1-1-COI.pdf, (Copyright © 2020 Roggeri A, Conte F, Rossi C, Cozzolino M, Zocchetti C, Roggeri DP.)

End-stage renal disease (ESRD) is increasing worldwide as a consequence of population aging and increasing chronic illness. Treatment consists mostly of dialysis and kidney transplantation (KTx), and KTx offers advantages for life expectancy and long-term cost reductions compared with dialysis. This study uses the administrative database of the Lombardy Region to analyze the costs of a cohort of patients with ESRD receiving KTx, covering a time period of 24 months before transplant to 12 months after. During 2011, 276 patients underwent kidney transplantation (8.7% preemptive and 91.3% non-preemptive). In the period before transplantation, the main cost driver was dialysis (66.6% for the period from -24 to -12 months and 73.8% for the period from -12 to 0 months), while in the 12 months after KTx, the most relevant cost was surgery. The total cost -24 to -12 months pre-KTx was 35 049.2€; the cost -12 to 0 months was 36 745.9€; and the cost 12 months after KTx was 43 805.8€. Non-preemptive patients showed much higher costs both pre- and post-KTx than preemptive patients. This study highlights how KTx modifies the resource consumption and costs composition of patients with ESRD vs those undergoing dialysis treatment and how KTx may be economically beneficial, especially preemptive intervention., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

Background: Chronic kidney disease (CKD) progression is associated with significant comorbidities and costs. In Italy, limited evidence of healthcare resource consumption and costs is available. We therefore aimed to investigate the direct healthcare costs in charge to the Lombardy Regional Health Service (RHS) for the treatment of CKD patients in the first year after starting hemodialysis and in the 2 years prior to dialysis., Methods: Citizens resident in the Lombardy Region (Italy) who initiated dialysis in the year 2011 (Jan 1 to Dec 31) were selected and data were extracted from Lombardy Regional databases on their direct healthcare costs in the first year after starting dialysis and in the 2 years prior to it was analyzed. Drugs, hospitalizations, diagnostic procedures and outpatient costs covered by RHS were estimated. Patients treated for acute kidney injury, or who died or stopped dialysis during the observational period were excluded., Results: From the regional population (>9,700,000 inhabitants), 1067 patients (34.3 % females) initiating dialysis were identified, of whom 82 % underwent only hemodialysis (HD), 13 % only peritoneal dialysis (PD) and the remaining 5 % both treatments. Direct healthcare costs/patient were € 5239, € 12,303 and € 38,821 (€ 40,132 for HD vs. € 30,444 for PD patients) for the periods 24-12 months pre-dialysis, 12-0 months pre-dialysis, and in the first year of dialysis, respectively., Conclusions: This study highlights a significant economic burden related to CKD and an increase in direct healthcare costs associated with the start of dialysis, pointing to the importance of prevention programs and early diagnosis.

Background and Objective: Chronic kidney disease (CKD) is a highly morbid disorder. The most severe form of CKD is end-stage renal disease (ESRD), in which the patient requires some form of renal replacement therapy to survive. The increasing incidence, prevalence, and costs of ESRD are major national healthcare concerns. The objective of this study was to determine the cost effectiveness of two innovative therapies, paricalcitol versus cinacalcet + calcitriol (oral) in patients with CKD stage 5 (CKD 5) in the healthcare setting in Italy in 2013., Methods: A Markov process model was developed employing data sources from the published literature, paricalcitol clinical trials, official Italian price/tariff lists, and national population statistics. The analysis is based on a comparison of treatment with paricalcitol versus cinacalcet + calcitriol (oral) in CKD 5. The perspective of the study was that of the payer [Italian National Health Service (INHS)]. The primary efficacy outcomes in the paricalcitol and cinacalcet + calcitriol (oral) clinical trials (reduction of secondary hyperparathyroidism, complications, and mortality) were extrapolated to effectiveness outcomes: number of life-years gained (LYG) and number of quality-adjusted life-years (QALYs). Clinical and economic outcomes were discounted at 3 %., Results: The base-case analysis is based on a 5-year time horizon. From the INHS perspective, the use of paricalcitol leads to a cost saving of €1,853 and an increase in LYG (0.136) and a gain in QALYs (0.089). Consequently, the use of paricalcitol is dominant over the use of combination cinacalcet + calcitriol (oral paricalcitol leads to cost savings and a higher effectiveness). Sensitivity analyses confirmed the robustness of the model., Conclusion: The results showed that the favorable clinical benefit of paricalcitol results in positive health economic benefits. This study suggests that the use of paricalcitol in patients with ESRD may be cost effective from the perspective of the INHS.

Background: Several studies have reported gender and socioeconomic differences in the use of revascularization procedures in patients with acute myocardial infarction. However, it is not clear whether these differences influence patients' survival. Moreover, most of the studies neither considered STEMI and NSTEMI separately, nor included primary PCI, which nowadays is the treatment of choice in case of AMI. In an unselected population of patients admitted to hospital with a first episode of STEMI and NSTEMI we examined gender and socioeconomic differences in the use of cardiac invasive procedures and in one-year mortality., Methods: Subjects hospitalized with a first episode of STEMI (n=3506) or NSTEMI (n=2286) were selected from the Piedmont (Italy) hospital discharge database. We considered the percentage of patients undergoing PCI, primary PCI and CABG, and in-hospital mortality. Out of hospital mortality was calculated through record linkage with the regional register. The relation between outcomes and gender or educational level was investigated using appropriate multivariate regression models adjusting for available confounders., Results: After adjustment for age, comorbidity and hospital characteristics, women and low educated patients had a lower probability of undergoing revascularization procedures. However, neither in-hospital, nor 30-day, nor 1-year mortality showed gender or social disparities., Conclusions: Despite gender and socioeconomic differences in the use of revascularization, no differences emerged in in-hospital and 1-year mortality. These findings could suggest that patients are differently, but equitably, treated; differences are more likely due to an inability to fully adjust for clinical conditions rather than to a selection process at admission., (Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.)

Background: Acute coronary syndrome (ACS) is the most common cause of morbidity and mortality in Italy and worldwide. Aim of this study was to evaluate the average annual direct healthcare costs for the treatment of patients with a recent hospitalization for ACS., Design and Methods: The direct medical costs of patients with a first ACS hospitalization (index event) in the period from 1 January 2008 to 31 December 2008 were estimated for a 1-year follow-up period. The resource consumption was measured in terms of: reimbursed drugs, diagnostic procedures, outpatient visits, and hospitalizations. The analysis was performed from the Italian National Health Service perspective., Results: A total of 2,758,872 subjects were observed, 7082 (35.8% women) of whom being hospitalized for ACS during the accrual period (2.6 ‰). Among patients with ACS, 60% were medically treated, 33.1% were treated with percutaneous coronary intervention (PCI), and 6.9% died during the index hospitalization. Dual antiplatelet treatment (ASA plus clopidogrel) was prescribed in 25.9% of the medically treated ACS patients and in 70.1% of the ACS patients treated with PCI. The average yearly cost per patient for the total ACS population was 11,464€/year (drugs 1,304€; hospitalizations 9,655€; diagnostic and outpatient visits 505€). The average annual cost was 10,862€ for medically treated patients and 14,111€ for patients treated with PCI. Patients who died of cardiovascular events during follow up had an average cost of 16,231€/patient., Conclusions: Patients with ACS had higher direct healthcare costs, their management and rehospitalizations being the main cost drivers., (© Authors 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.)

The objective of this study was to estimate resource consumption and direct healthcare costs of patients with a first hospitalization for acute coronary syndrome (ACS) in 2008 in the Piedmont Region, Italy. Subjects hospitalized with a first episode of ACS in 2008 were selected from the regional hospital discharge database. All hospitalizations, drug prescriptions, and outpatient episodes of care in the 12 months following discharge were considered to estimate resource consumption and direct healthcare costs from the Piedmont Regional Health Service perspective. The analysis was carried out separately for ST-elevation myocardial infarction (STEMI), non-ST-elevation myocardial infarction (NSTEMI), and unstable angina (UA) populations. In the accrual period, 7765 subjects (1.75‰ of the total population) were hospitalized for ACS (64.2% men). The average age was 66.5 for men and 75.4 for women. The average in-hospital mortality was 6.5% (n = 508). The total ACS population was classified as: STEMI 45.2%, NSTEMI 29.4%, and UA 25.4%. The average yearly costs per patient alive at the end of follow-up (n = 6851) were 14,160.8&OV0556; (18,678.7 USD): 83.9% for inpatient admissions [11,881.2&OV0556; (15,671.8 USD)], 9.3% for drugs [1311.6&OV0556; (1730.1 USD)], 5.0% for diagnostic and therapeutic procedures and outpatient visits [708.2&OV0556; (934.1 USD)], and 1.8% for 1-day hospital stays [259.8&OV0556; (342.7 USD)]. The average yearly direct healthcare costs by ACS event were 14,984.5&OV0556; (19,765.2 USD) for STEMI, 14,554.1&OV0556; (19,197.4 USD) for NSTEMI, and 12,481.5&OV0556; (16,463.6 USD) for UA. In each subpopulation, costs were significantly higher for men than for women. ACS imposes a significant burden in terms of morbidity and mortality and generates major public health service costs.

Purpose: To assess the outcomes of patients admitted for ACS and the prescription pattern of antiplatelets of patients discharged alive., Methods: From the ARNO Observatory database, we performed a record linkage analysis of hospital discharge and prescription databases, which included 2,758,872 subjects of 7 Italian Local Health Authorities. The accrual period lasted from January 1 to December 31, 2008. Discharge records and prescription patterns were analyzed for 1 year before and after the accrual period., Results: Of 2,758,872 subjects, 7,082 (2.6‰) were hospitalized for ACS. Mean age was 72±13 years, females and diabetics accounted for 36% and 25% of the cases. Of the 7,082 patients, in-hospital death occurred in 6.9%. Of the survivors, 64.5% was treated medically, 35.5% with PCI. Of the patients discharged alive, 65.8% were treated with an antiplatelet, 21.9% aspirin alone, 33.1% aspirin plus a thienopyridine (mostly clopidogrel), 10.5% a thienopyridine alone. Dual antiplatelet treatment was prescribed more frequently in patients treated with PCI than in those treated medically (57.3% vs 19.7%, p<0.0001). At least one re-hospitalization occurred in 58.6% (18.5% for a recurrent episode of ACS, 24.8% for other CV reasons, 15.3% for non CV reasons). Prescription continuity to antiplatelets was observed in 68.0% and 60.3% of the patients, respectively at 6 and 12 months after discharge., Conclusion: In a large community setting, the prescription rate of antiplatelets after ACS seems to be far from the guidelines recommendation. Rates of 1 year re-hospitalizations after ACS remain high, recurrence of ACS accounted for just one third of the cases.

Background and Objectives: Secondary hyperparathyroidism (SHPT) is a frequent complication of CKD with incidence, prevalence, and costs increasing worldwide. The objective of this analysis was to estimate therapy cost of SHPT in a sub-population of the FARO study., Materials and Methods: In the FARO study, an observational survey aimed to evaluate patterns of treatment in patients with SHPT who had undergone hemodialysis, pharmacological treatments and biochemical parameters evolution data were collected in four surveys. Patients maintaining the same treatment in all sessions were grouped by type of treatment and evaluated for costs from the Italian National Health Service perspective., Results: Four cohorts were identified: patients treated with oral (PO) calcitriol (n=182), intravenous (IV) calcitriol (n=34), IV paricalcitol (n=62), and IV paricalcitol+cinacalcet therapy (n=20); the cinacalcet monotherapy group was not analysed due to low number of patients (n=9). Parathyroid hormone (PTH) level at baseline and effectiveness of treatments in suppressing PTH level were assessed to test comparability among cohorts: calcitriol PO patients were significantly less severe than others (PTH level at baseline lower than 300 pg/ml; p<0.0001); calcitriol IV patients did not reach significant reduction in PTH level. Paricalcitol and paricalcitol+cinacalcet treatment groups results were comparable, while only the IV paricalcitol cohort's PTH level, weekly dosage, and cost decreased significantly from the first to the fourth survey (p=0.020, p=0.012, and p=0.0124, respectively). Total costs per week of treatment (including calcium-based phosphate binder and sevelamer) were significantly lower in the paricalcitol vs paricalcitol+cinacalcet cohort (p<0.001). Major limitations of this study are related to the survey design: not controlled and lack of comparability between cohorts; however, reflective of true practice patterns., Conclusions: The IV Paricalcitol cohort had significantly lower treatment costs compared with patients treated with paricalcitol+calcimemtics (p<0.001), without a significant difference in terms of baseline severity and PTH control.