Long-term Survival After Hospital Admission in Older Italians: Comparison Between Geriatrics and Internal Medicine Across Different Discharge Diagnoses and Risk Status.

BACKGROUND: In randomized clinical trials, compared to Internal Medicine, admission to Geriatrics improved clinical outcomes of frail older patients accessing the Emergency Department (ED). Whether this advantage is maintained also in the "real world" is uncertain. We compared long-term survival of patients admitted to Geriatrics or Internal Medicine wards after stratification for background risk and across a variety of discharge diagnoses. METHOD: Data were derived from the "Silver Code National Project," an observational study of 180,079 unselected 75+ years old persons, admitted via the ED to Internal Medicine (n = 169,717, 94.2%) or Geriatrics (n = 10,362) wards in Italy. The Dynamic Silver Code (DSC), based on administrative data, was applied to balance for background risk between participants admitted to Geriatrics or Internal Medicine. RESULTS: One-year mortality was 33.7%, lower in participants discharged from Geriatrics (32.1%) than from Internal Medicine (33.8%; p < .001), and increased progressively across four DSC risk classes (p < .001). Admission to Geriatrics was associated with survival advantage in DSC class II to IV participants, with HR (95% CI) of 0.88 (0.83-0.94), 0.86 (0.80-0.92), and 0.92 (0.86-0.97), respectively. Cerebrovascular diseases, cognitive disorders, and heart failure were the discharge diagnoses with the widest survival benefit from admission to Geriatrics, which was mostly observed in DSC class III. CONCLUSIONS: Admission to Geriatrics may provide long-term survival benefit in subjects who, based on the DSC, may be considered at an intermediate risk. Specific clinical conditions should be considered in the ED to improve selection of patients to be targeted for Geriatrics admission.

[Pharmaco-utilization and outcomes in patients treated with oral anticoagulants from 2014 to 2015: evidences from administrative databases of the Romagna Local Health Unit]. / Farmaco-utilizzazione ed esiti clinici in pazienti trattati con farmaci anticoagulanti orali nel periodo 2014-2015: evidenze da database amministrativi dell'Azienda Sanitaria Locale Romagna.

BACKGROUND: The present study aimed at describing (i) the characteristics of non-valvular atrial fibrillation (NVAF) patients newly treated with oral anticoagulants (vitamin K antagonists [VKA] or new oral anticoagulants [NOAC]), and (ii) their persistence to treatment assigned, clinical outcomes (bleeding and thromboembolic events) and mortality. METHODS: This study was conducted using administrative databases of an Italian Local Health Unit. All adult patients (aged ≥18 years) with NVAF and naïve to VKA (warfarin) or NOAC (rivaroxaban, apixaban, dabigatran) were included between January 1, 2014 and June 30, 2015. Propensity score matching was performed to check for confounding effects. Included patients were characterized for comorbidities, CHA2DS2-VASc and HAS-BLED score, antiplatelet drug use and followed up for at least 12 months to assess persistence to treatment and incidence of clinical outcomes. RESULTS: A total of 970 NVAF patients newly treated with oral anticoagulants were included; 595 (61.3%) received VKA and 375 (38.7%) NOAC. VKA naïve patients had a lower low and intermediate score for HAS-BLED and CHA2DS2-VASc compared to NOAC patients. Overall, 80.6% of naïve NAO patients and 73.4% of naïve AVK patients were persistent to treatment. Incidence of bleeding events was slightly higher in VKA patients (3.13/100 persons year) compared to NOAC patients (2.73/100 persons years), as well as incidence of thromboembolic events (3.48/100 persons year and 2.18/100 persons year, respectively). After propensity score matching no differences were observed. CONCLUSIONS: The majority of NVAF patients newly treated with oral anticoagulants received VKA-based therapy. Incidence of bleeding and thromboembolic events was slightly higher in VKA patients compared to NOAC patients.

Implications of COVID-19 Infection on Medication Adherence with Chronic Therapies in Italy: A Proposed Observational Investigation by the Fail-to-Refill Project.

Poor medication adherence leads to worsening of clinical outcomes and increases healthcare costs, especially in the context of chronic conditions. The effects of new COVID-19 infection and the measures taken in response to the outbreak are further increasing the concerns about medication adherence. Patients with chronic diseases, many of whom are older adults, have been strongly recommended to stay at home and avoid social contacts even with family members, who often provide support for regular use of therapies. Moreover, the mobilization of health personnel to the frontline of the COVID-19 infection could limit access to healthcare services. Within the Health-DB project, the Fail-To-Refill monitoring system was designed to evaluate the lack of adherence to chronic therapies in Italian clinical practice settings. Considering the date and dose coverage of last prescription, all patients due to refill this prescription for a chronic therapy in the last month were identified, and it was verified if they had the refill. The proposed future analysis, based on the data linkage between the current administrative flows of the Italian Local Health Units involved, will be carried out on a monthly basis from the beginning of the infection, and the "post-Covid-19" results will be compared with "pre-COVID-19" results, calculated for the last three years for patients with chronic therapies. Preliminary data herein presented showed a trend of increased failed refill during the months of lockdown for lipid-lowering and biologic therapies. The pre-COVID-19 trend compared to that of post-COVID-19 in the next months will be useful to estimate the percentage of failure to refill truly related to COVID-19 and on the measures adopted. The identification of patients that do not refill their prescriptions allows healthcare professionals to put in place actions aimed to promptly correct the lack of adherence, thus reducing the associated negative outcomes.

[Heart failure in Apulia Region - Italy (Local Health Unit Barletta-Andria-Trani): analysis of the therapeutic pathways, healthcare resource consumption and related costs.] / Lo scompenso cardiaco nella ASL Barletta-Andria-Trani (BT): analisi dei trattamenti farmacologici, del consumo di risorse e relativo costo per il Servizio Sanitario Nazionale.

BACKGROUND: Heart failure (HF) is commonly reported, it is estimated to affect 10% of subjects aged over 70 years. Objectives of this study were to describe clinical and demographic characteristics of patients with HF diagnosis, to analyze therapeutic pathways and to estimate healthcare resources consumption. METHODS: Data on patients aged ≥18 years with a hospitalization discharge diagnosis of HF between 01/01/2010 and 31/12/2014 and in treatment with HF-related drugs were extracted from the administrative databases of the Italian Local Health Unit of Barletta-Andria-Trani (BT). We described the pharmacological treatment prescribed and the use of drugs in combination both at the beginning and at the end of the 12-month follow-up period. The costs analysis was conducted with the perspective of the Italian National Health System. RESULTS: A total of 2 669 patients with HF were enrolled in the study, 1 960 as primary and 709 as secondary diagnosis (average age 77.0±10.4/76.5±11.1 years respectively, 49% and 55% were male, respectively). Mortality during 12 months of follow-up was 46% and 43% respectively. Mostly prescribed pharmacological treatments were diuretics (90.4% of patients with primary HF diagnosis and 79.4% of patients with secondary HF diagnosis), beta-blockers (53.7% and 58.8%, respectively) and aldosterone antagonists (57.5% and 42.5%, respectively); moreover, during the follow-up period, half of the patients presented a switch from the original therapy and 10% of the patients required an add-on. Healthcare resource consumption for patients discharged alive was € 11 872.4 for patients with primary diagnosis and € 12 493.7 for patients with secondary diagnosis of HF. Cost for hospitalizations during follow-up was around € 3 800 (32.3% of total costs) and € 3 600 (29.0% of total costs), respectively. CONCLUSIONS: Our findings are in accordance with what already published, both in a National and International context, on mortality rates in HF patients and related costs for the National Healthcare System. Results from the present study highlight the under-prescriptions of ACEi/ARBs, aldosterone antagonists and beta-blockers in HF patients.

The cost of preterm labor and preterm birth for mothers with uncomplicated pregnancies and their infants in Italy: a retrospective cohort study.

BACKGROUND: Preterm labor (PTL)/preterm birth (PTB) impose significant burden on health-care systems. Women with uncomplicated pregnancies at risk of PTL/PTB have not been widely investigated, and published evidence on the costs of these women and their infants in Italy is absent. We aimed to describe women with uncomplicated pregnancies and associated costs for these women and their infants. METHODS: Data on women aged 12-44 years with uncomplicated pregnancies who delivered between 1 September 2009 and 31 December 2014 with PTL diagnosis alone or PTL and PTB were included from four Italian databases. Costs were examined during pregnancy, delivery, and 3 years after delivery for mothers and infants, overall and by gestational age (GA). RESULTS: A total of 3058 mothers linked to 3333 infants were included. Costs during pregnancy were €1777. Costs during delivery for PTL/PTB mothers and their infants ranged from €3174 (GA ≥37) to €21007 (GA <28). Combined maternal and infant costs appeared higher for births with lower GAs (<37) in the three-year follow-up. CONCLUSIONS: In Italy, PTL/PTB mothers with uncomplicated pregnancies with infants at lower GAs appeared to incur higher medical costs compared to mothers with infants at higher GAs in all three time periods, with particularly marked differences found when considering mother and infant combined costs.

Insulin Glargine U100 Utilization in Patients with Type 2 Diabetes in an Italian Real-World Setting: A Retrospective Study.

BACKGROUND: This study is aimed at estimating the proportion of type 2 diabetes mellitus (T2DM) patients treated with basal insulin (insulin glargine U100) and at evaluating daily insulin dose, treatment pattern, and adherence to treatment of these patients. METHODS: Data from administrative and laboratory databases of 3 Italian Local Health Units were retrospectively collected and analyzed. All patients with a diagnosis of T2DM between 01/01/2012 and 31/12/2012 were considered, and those with at least a prescription of insulin glargine between 01/01/2013 and 31/12/2014 were included and followed up for one year. For each patient, we evaluated HbA1c levels both at baseline and during the follow-up period and the daily average dose of insulin. Medication adherence was defined by using medication possession ratio (MPR) and reported as proportion of patients with MPR ≥ 80%. RESULTS: 7,422 T2DM patients were available for the study. According to the antidiabetic medication prescribed, patients were categorized into four groups: insulin glargine only, insulin glargine plus oral glucose-lowering drugs, insulin glargine plus rapid-acting insulin, and insulin glargine plus DPP-4 inhibitors. Median daily dose of insulin among insulin glargine only patients was higher than in other groups (35 IU vs. 20 IU, p < 0.05), and a higher percentage of them achieved a target HbA1c value of less than 7.0% (53.8% vs. 30%, p < 0.001). Adherence to insulin treatment was lowest (41%) in the insulin glargine only group compared to other groups (ranging from 58.4% to 64.4%), p < 0.001. CONCLUSIONS: A large proportion of T2DM patients treated with insulin fail in achieving the glycemic target of HbA1c level < 7%, irrespective of treatment regimen; however, basal insulin only is associated with lower therapeutic unsuccess. Adherence to antidiabetes medications is also suboptimal in these patients and should be addressed to improve long-term outcomes of reducing and preventing microvascular and macrovascular complications.

Analysis of drug utilization and health care resource consumption in patients with psoriasis and psoriatic arthritis before and after treatment with biological therapies.

OBJECTIVES: To describe the therapeutic pathways of patients with psoriasis (PSO) and psoriatic arthritis (PsA) before and after treatment with biological therapies in a real-world setting and to determine the relative consumption of health care resources. DESIGN: Retrospective observational study. SETTING: Real-life clinical setting in 5 Italian local health units. PARTICIPANTS: A total of 351 male and female patients with at least 1 prescription for a biological drug from January 1, 2010 to December 31, 2013; patients with concomitant rheumatoid arthritis, ankylosing spondylitis, or Crohn's disease were excluded. RESULTS: The major health care cost (excluding drug costs) was represented by hospitalizations, mainly related to PSO /PsA-associated disorders and cardiometabolic disorders. Use of conventional drugs among biologics-naïve patients reached 50% in PSO and 80% in PsA; their use decreased following initiation of biological therapy. After the start of biological treatment, the incidence of hospitalization decreased both for PSO (from 12.3% to 3.2% in day hospital regimen and from 2.4% to 0.4% for conventional admission) and for PsA (from 11.1% to 8.1% and from 10.1% to 3.0%, respectively). Mean annual costs for hospitalization before biological treatment were €217 and €537 for PSO and PsA, respectively, while mean annual cost for concomitant drugs slightly increased after biologics initiation: from €249.8 to €269.4 for PSO and from €331.8 to €346.9 for PsA. The major consumption of health care resources occurred in the quarter preceding the beginning of biological treatment. CONCLUSION: The consumption of health resources is mostly related to hospitalization, seems to peak during the quarter before the beginning of biologics therapies, and subsequently decreases after biologics initiation. Further studies should focus on prescription scheme and economic burden of PSO and PsA in Italy to help optimize health care resources and potentiate services for patients.

All-cause mortality, cardiovascular events, and health care costs after 12 months of dual platelet aggregation inhibition after acute myocardial infarction in real-world patients: findings from the Platelet-aggregation Inhibition: Persistence with treatment and cardiovascular Events in Real world (PIPER) study.

OBJECTIVES: The aim of the study was to assess all-cause mortality and cardiovascular (CV) events in patients after a period of 12 months of treatment with dual antiplatelet therapy (DAPT) after hospitalization for acute myocardial infarction (AMI) in a real-world setting. Health care costs for the management of patients post-AMI was also assessed. METHODS: A retrospective analysis using data from the administrative databases of six local health units (LHUs) was performed. All beneficiaries of these LHUs hospitalized with AMI between January 01, 2010, and December 31, 2011, and exposed to a treatment period with DAPT up to 12 months after AMI discharge were included. All-cause mortality, CV hospitalizations, and health care costs occurring during the 36-month follow-up period from end of treatment with DAPT were considered. For the cost analysis, only patients still alive at the end of the follow-up period were included. RESULTS: A total of 2,721 patients were included (mean ± SD age 63.6±17.3 years, 67.8% males). About 17% and 18% of all patients had CV events and died during the follow-up period, respectively. The annual mean cost per patient was €3,523.27. During the follow-up period, 63 patients had a second AMI event; for whom, the mean health care cost per patient was €19,570.70. CONCLUSION: In a real-world setting in Italy, considering a 36-month follow-up period, all-cause mortality, CV events, and related health care cost of patients hospitalized with an AMI undergoing a 12-month treatment period with DAPT remained relevant. This study suggests that increased efforts aimed at the prevention of recurrent AMI are warranted, as well as an accurate risk stratification in order to improve long-term outcome.

Treatment patterns, health care resource utilization and costs of rheumatoid arthritis patients in Italy: findings from a retrospective administrative database analysis.

OBJECTIVES: This study aimed to: 1) describe treatment patterns and drug utilization profile (in terms of therapeutic strategy used, switch, persistence and drug consumption variation) among adult patients affected by rheumatoid arthritis (RA), and 2) estimate the health care resource utilization and its associated direct cost for the management of RA patients. METHODS: A retrospective cohort analysis, using administrative databases of six Local Health Units in Italy, was performed. All adult patients with a confirmed diagnosis of RA between January 1, 2010 and December 31, 2014 were enrolled. The date of the first RA diagnosis according to the study criteria during the study period represented the index date (ID) for each patient. Patients enrolled were observed from the ID for at least 12 months (follow-up period), and their clinical characteristics were investigated for 12 months prior to the ID. RESULTS: A total of 10,401 patients with a confirmed RA diagnosis were included. Mean age was 63.0 years and 25% were male; 67% of patients were untreated at ID. During the followup period, 67.8% of patients treated with biologic agents were persistent with initial therapy, compared to 45.7% for patients on conventional synthetic disease-modifying antirheumatic drugs (csDMARDs), while 11% of patients treated with biologic agents switched during the follow-up period, compared to 17.6% of csDMARDs-treated ones. At the end of the follow-up period, 14.7% of all patients in the analysis had an increase and 12.6% of them had a decrease in their initial drug consumption. The mean cost per RA patient was €3,743. CONCLUSION: Our study showed that there is still much that needs to be learned about the prescription of csDMARDs and biologics to RA patients in Italy and to identify areas for future research. The knowledge of RA management in a real-life clinical setting could offer an opportunity to improve the management of RA in Italy.

Patient characteristics and bleeding events in nonvalvular atrial fibrillation patients treated with apixaban or vitamin K antagonists: real-world evidence from Italian administrative databases.

AIM: This study aimed to evaluate the risk of major bleeding among two cohorts of nonvalvular atrial fibrillation patients newly initiating a vitamin K antagonist (VKA) or apixaban in a real-world setting in Italy. PATIENTS & METHODS: A retrospective study using a large administrative database of Italian local health units was performed, using data from ten local health units and patients were included from the date of new initiation of apixaban or VKAs from January 2012 to June 2015. RESULTS: Risk of major bleeding was calculated using an adjusted Cox regression model. Compared with VKA, apixaban had a significantly lower risk of major bleeding (hazard ratio = 0.44 [95% CI: 0.12-0.97]). CONCLUSION: In this analysis, apixaban was associated with a lower risk of major bleeding compared with VKA.

Modifications in drug adherence after switch to fixed-dose combination of perindopril/amlodipine in clinical practice. Results of a large-scale Italian experience. The amlodipine-perindopril in real settings (AMPERES) study.

OBJECTIVE: The purpose of this study was to assess the changes in adherence to treatment, in patients who switched from perindopril and/or amlodipine as a monotherapy (single-pill therapy, SPT) or two-pill combinations to fixed-dose combination (FDC) therapy. METHODS: A large retrospective cohort study, in three Italian Local Health Units, was performed. All adult subjects who received at least one prescription of anti-hypertensive drugs between January 1, 2010 and December 31, 2014 were selected. The date of the first anti-hypertensive prescription was defined as the index-date (ID). For each patient, we evaluated the anti-hypertensive therapy and the adherence to treatment during the two 12-month periods preceding and following the ID. Changes in the level of adherence have been compared in patients who switched to the FDC of perindopril/amlodipine after the ID, as well as in patients who did not. RESULTS: A total of 24,020 subjects were initially included in the study. Subjects treated with the free dose combination switched more frequently to FDC of perindopril/amlodipine than subjects treated with SPT (p < .001). Adherence to treatment was found to be higher in the 3,597 subjects who switched to the perindopril/amlodipine FDC therapy, than in the 20,423 subjects who did not. A significant decrease in the number of concomitant anti-hypertensive drugs has been observed in patients treated with the same FDC. CONCLUSIONS: The results show that perindopril/amlodipine FDC increases the rate of stay-on-therapy and reduces the number of concomitant anti-hypertensive drugs in subjects previously treated with the same drugs as a two-pill combination or as SPT.

Long-Term Use of Antiplatelet Therapy in Real-World Patients with Acute Myocardial Infarction: Insights from the PIPER Study.

The aim of this study was to assess long-term drug adherence and prognosis in real-world patients discharged on dual-antiplatelet therapy (DAPT) after acute myocardial infarction (AMI). A retrospective cohort analysis using administrative databases kept by eight local health units was performed. DAPT exposure (defined as ≥ 2 prescriptions), adherence, and the occurrence of major adverse events (MACE) were analyzed during a 36-month follow-up. The analysis included 11,101 patients who were discharged alive with a primary diagnosis of AMI. Of these, 5,919 patients (53.31%) were discharged on DAPT without a diagnosis of cancer or anemia, without transient DAPT discontinuation, and represented the study population. DAPT discontinuation occurred in 2,200 patients (37.2%) and in 1,995 (33.7%) after the first 6 and 12 months, respectively, whereas 423 patients (7.1%) were still on DAPT after 36 months. Patients who maintained DAPT up to 12 months had a significantly lower overall mortality, compared with patients who discontinued DAPT after 6 months. Exposure to DAPT at 3 years was associated with reduced all-cause mortality (hazard ratio [HR]: 0.067, 95% confidence interval [CI]: 0.027-0.162, p < 0.001) and reduced recurrent AMI (HR: 0.02, 95% CI: 0.003-0.173, p < 0.001). In conclusion, this study shows that prolonged DAPT over 12 months is maintained in a relevant number of patients after AMI. However, adherence to antiplatelet therapy in first 12 months after AMI is still unsatisfactory and efforts to enhance patients' compliance are warranted. Exposure to prolonged DAPT at 3 years seems to be associated with a significant reduction in all-cause mortality and AMI.

Epidemiology, patient profile, and health care resource use for hepatitis C in Italy.

OBJECTIVE: The objectives of this study were to estimate the prevalence of Hepatitis C among six Italian Local Health Units (LHUs), to describe patient and antiviral drug characteristics, and to estimate the health care consumption rates and related costs for the management of patients affected by hepatitis C virus (HCV) infection by using data from routine clinical practice. METHODS: We conducted a retrospective study using administrative databases of six Italian LHUs. All patients who had a record related to HCV during the enrollment period (July 1, 2009, to December 31, 2014) and who had at least 6 months of data available prior to the first HCV record were included. The date of the first record related to HCV during the enrollment period was considered as a proxy of diagnosis and used as the index date. Patients were followed from the index date up to 1 year, death, or exiting the database. Using the overall cohort of HCV adult patients as the numerator, we estimated the prevalence of HCV among six LHUs. The denominators were obtained from the National Institute of Statistics (N=1,665,682). We also evaluated descriptive patient's characteristics and treatment patterns, and estimated health care consumption rates and related costs for the management of the HCV patients. RESULTS: A total of 7,550 patients were analyzed, of whom 57% were male with a mean age of 57.6±16.4 years. The prevalence of HCV was estimated to be 0.45% (95% confidence interval 0.44-0.46). During the follow-up period, 78.6% of HCV patients had received no antiviral treatment. The annual health care cost associated with HCV infection was €6,022.7 (±7,922.6) while the cost specific to HCV care was €3,154.6 (±4,972.0). CONCLUSION: Our findings showed that, in the Italian real-world setting, only a small proportion of HCV-infected patients received an antiviral treatment. Despite the current low prevalence of HCV, the economic impact of such disease remains high.

Healthcare resource consumption and cost of care among patients with polycystic kidney disease in Italy.

OBJECTIVE: The aim of this study was to assess healthcare resource consumption and its associated costs among patients with polycystic kidney disease (PKD) in a real-world setting. METHODS: An observational retrospective cohort analysis was conducted using data from the administrative databases of four Italian local health units. Data for patients who were diagnosed with PKD during the inclusion period (January 1, 2010 to December 31, 2012) were extracted. The date on which a patient's first PKD hospitalization occurred during the inclusion period was defined as the index date (ID), and the ID was defined as the date of the first dialysis treatment recorded during the inclusion period for patients undergoing dialysis. Data regarding the clinical characteristics of patients included in the study during the 12 months prior to the ID (pre-ID; characterization period) were collected. All patients were then followed up for the 12 months following the ID (post-ID; follow-up period). Healthcare consumption and its associated costs were analyzed during the follow-up period. All costs are reported in euros (€). RESULTS: A total of 1,123 patients with PKD were included in this study, 61.9% of whom were male; the mean age of the patients was 57.7±24.5 years. At diagnosis, 11.2% and 1.1% of patients were affected by the dominant and recessive forms of PKD, respectively. Approximately 8% of the included patients were undergoing dialysis at ID (baseline). The incidence of dialysis was fourfold greater among patients with autosomal-dominant PKD (ADPKD) than among the total cohort (33.3% compared with an overall 8.3%). During the follow-up period, the average annual rates of healthcare resource consumption were greater among dialyzed than non-dialyzed patients. The average healthcare expenditures were €45,059.62 and €3,913.89 (p<0.001) per year for dialyzed and non-dialyzed PDK patients, respectively. Our findings suggest that in the real-world Italian context, consumption of healthcare among patients with PKD has increased at dialysis initiation due to the cost of outpatient specialist healthcare services as well as other costs. Research on the prevention of PKD-related complications and disease progression may help to facilitate a decrease in the costs associated with this condition.

Topical medication utilization and health resources consumption in adult patients affected by psoriasis: findings from the analysis of administrative databases of local health units.

AIM: The objectives of this study were to: 1) analyze the drug utilization pattern among adult psoriasis patients who were newly prescribed with topical medication; and 2) assess their adherence to topical therapy and the possibility of switching to other strategies in the treatment process. METHODS: An observational retrospective analysis was conducted based on administrative databases of two Italian local health units. All adult subjects who were diagnosed with psoriasis or who were newly prescribed for topical medication with at least one prescription between January 1, 2010, and December 31, 2014, were screened. Only patients who were "non-occasional users of topical drugs" (if they had at least two prescriptions of topical drugs in a time space of 2 years) were considered for the first and second objectives in the analysis. The date of the first prescription of topical agents was identified as the index date (ID), which was then followed for all time available from ID (follow-up period). The adherence to therapy was assessed on the basis of cycles of treatment covered in the 6 months before the end of the follow-up period. The mean health care costs in patients who switched to disease-modifying antirheumatic drugs (DMARDs) or biologics after the ID were evaluated. RESULTS: A total of 17,860 patients with psoriasis who were newly prescribed for topical medication were identified. A total of 2,477 were identified as "non-occasional users of topical drugs", of whom 70.2% had a prescription for a topical fixed combination regimen at ID. Around 19% adhered to their medication, whereas 6% switched to other options of psoriasis treatment. Multivariable logistic regression model shows that patients on fixed combination treatment were less likely to be non-adherent to treatment and less likely to switch to other treatments. The annual mean pharmaceutical costs were €567.70 and €10,606.10 for patients who switched to DMARDs and biologics, respectively. CONCLUSION: Our findings show that the use of fixed combination topical treatment can lead to improve the likelihood of patients being adherent to treatment and can decrease the likelihood of switching the treatment to DMARDs or biologics.

Pharmacoutilization of epoetins in naïve patients with hematological malignancies in an unselected Italian population under clinical practice setting: a comparative analysis between originator and biosimilars.

AIM: The purpose of this study was to assess the prescription of epoetins and consumption of health care resources (in terms of drug treatments) in naïve patients with hematological malignancies in a real-world setting; in particular, we compared the results between reference product and biosimilar products. METHODS: An observational retrospective study based on administrative and laboratory databases of three local health units was conducted. All adults diagnosed with hematological malignancies and who had received at least one epoetin (either reference product or biosimilars) prescription for the first time between 1 January 2010 and 30 April 2012 (enrollment period) were included. The date of the first prescription of epoetin within the enrollment period was defined as index date (ID). Patients were followed up for 4 weeks after ID (follow-up period) and were investigated for the 1-year period before the ID. The difference between the last hemoglobin (Hb) measurement after ID and the one prior to ID (ΔHb) was evaluated. The drug cost analysis was conducted from the perspective of the Italian National Health System. RESULTS: Overall, 69 patients were included in the study; 48 of them received reference epoetin product and 21 received biosimilars as first prescription. Among reference product users, the mean ± standard deviation (SD) age was 62.5±14.7 years; this cohort of patients was slightly significantly younger than the biosimilar users (71.8±11.8 years). The mean ± SD overall Hb level prior to treatment was lower among patients who started with biosimilar products (9.6±1.1 g/dL) compared to those who started with a reference product (10.1±2.1 g/dL). No significant differences in ΔHb were observed between biosimilar and originator groups during the followup period. The mean ± SD cost per patient was €667.98±573.93 and €340.85±235.73 for the reference product and biosimilar users, respectively (p=0.065). CONCLUSION: Our study showed that the use of biosimilar products might contribute to controlling health care costs (in terms of drug treatments) for patients with hematological malignancies being maintained by high-quality anemia therapy. Our findings also showed some discordances regarding the most appropriate therapeutic approach in daily clinical practice.

Comparative analysis of budesonide/formoterol and fluticasone/salmeterol combinations in COPD patients: findings from a real-world analysis in an Italian setting.

AIM: The objective of this study was to evaluate the different outcomes associated with the use of budesonide/formoterol compared to fluticasone/salmeterol in fixed combinations in patients with COPD in a "real-world" setting. The outcomes included exacerbation rates and health care costs. PATIENTS AND METHODS: An observational retrospective cohort analysis, based on administrative databases of three local health units, was conducted. Patients with at least one prescription of fixed-dose combination of inhaled corticosteroids and long-acting ß2-agonists (budesonide/formoterol or fluticasone/salmeterol), at dosages and formulations approved for COPD in Italy, between January 1, 2009 and December 31, 2011 (inclusion period), were included. Patients were followed until December 2012, death or end of treatment (follow-up period), whichever occurred first. Patients were included if they were aged ≥40 years and had at least 6 months of follow-up. Propensity score matching was performed to check for confounding effects. Number of hospitalizations for COPD and number of oral corticosteroid and antibiotic prescriptions during follow-up were analyzed using Poisson regression models. The cost analysis was conducted from the perspective of the National Health System. RESULTS: After matching, 4,680 patients were analyzed, of which 50% were males with a mean age of 64±13 years. In the Poisson regression models, the incidence rate ratio for budesonide/formoterol as compared to fluticasone/salmeterol was 0.84 (95% confidence interval [CI]: 0.74-0.96, P=0.010) for number of hospitalizations, 0.89 (95% CI: 0.87-0.92, P<0.001) for number of oral corticosteroid prescriptions and 0.88 (95% CI: 0.86-0.89, P<0.001) for number of antibiotic prescriptions. The mean annual expenditure for COPD management was €2,436 for patients treated with budesonide/formoterol and €2,784 for patients treated with fluticasone/salmeterol. CONCLUSION: Among patients with COPD, treatment with a fixed combination of budesonide/formoterol was associated with fewer exacerbations and a lower, but not significant, cost of illness than the treatment with fluticasone/salmeterol. Real-world analyses are requested to ameliorate interventions to address unmet needs, optimizing treatment pathways to improve COPD-related burden and outcomes.

Residual cardiovascular risk in patients who received lipid-lowering treatment in a real-life setting: retrospective study.

INTRODUCTION: The objective of this study was twofold: 1) to assess the residual cardiovascular (CV) risk among patients treated with statins according to guidelines and at the recommended dosages; and 2) to assess the difference, if any, in the frequency of CV events when patients were treated with other lipid-lowering agents alongside statins. METHODS: A retrospective observational study including one local health unit was conducted. Administrative databases were linked to laboratory test database in order to collect cholesterol values at baseline. Patients were included if they had filled at least one prescription for statins between January 1, 2009 and December 31, 2011; patients' records were considered for a 12-month time span. RESULTS: A total of 27,330 patients treated with statins were included (50% male, mean age 68.0±11.5 years). Among them, 770 were treated with statins according to guidelines and at the recommended dosages and had a low density lipoprotein-cholesterol value below the therapeutic target. Nevertheless, the risk of myocardial infarction or stroke remained: incidence rates were 1.3±1.0 per patient per year for moderate CV risk, 4.1±2.6 for high risk, and 12.5±11.0 for very high risk. This incremental risk was confirmed further using the Cox model, by correcting for age, sex, use of antiplatelet and/or antihypertensive therapy, and adherence to treatment. As a second analysis, we compared, after a propensity score matching, patients extracted from the overall sample who were treated with fibrates. Based on the Cox model, patients on fibrates had a risk for myocardial infarction or stroke lower than patients on statins. CONCLUSION: Among patients treated with statins according to guidelines and at the recommended dosages, a residual CV risk was observed. We concluded that intervention for managing residual CV risk during statin therapy should be implemented.

Therapy discontinuation or substitution in patients with cardiovascular disease, switching among different products of the same off-patent active substance: a 'real-world' retrospective cohort study.

OBJECTIVE: The present study investigated the effects of switching to different products of the same off-patent active substance (brand name or generic) on therapy discontinuation or substitution with another molecule of the same class, in patients with cardiovascular disease treated with statins and antihypertensives in a 'real-world' setting. DESIGN: A retrospective cohort study in a 'real-world' setting. SETTING: Analysis of data performed by integrating administrative databases that included approximately two million individuals who are assisted by the National Health System from three Local Health Units located in three different regions of Italy. PARTICIPANTS: All patients aged ≥18 years with at least one prescription of simvastatin, ramipril or amlodipine in the period 1 January to 31 December 2010 were included and followed up for 2 years. MAIN OUTCOME MEASURES: Prescription refills occurring during follow-up were evaluated. Frequency of discontinuation of therapy or substitution with another molecule of the same class (eg, from simvastatin to a different statin) during follow-up was identified. RESULTS: During follow-up, therapy discontinuation or substitution was found to be more frequent in patients switching to a different product of the same active substance compared with non-switching patients (11.5% vs 10.8% and 22.2% vs 20.8% (p=0.002), respectively, in the simvastatin group; 4.0% vs 3.5% and 24.6% vs 22.7% (p<0.001), respectively, in the amlodipine group). In the ramipril group, 8% of patients undertook a therapy substitution to another molecule; no trend towards a lower percentage of substitution was observed in the non-switching group, while 18% of patients discontinued treatment, with a significant difference in favour of patients not switching. These findings were partially confirmed by multivariate analysis. CONCLUSIONS: Switches among products of the same active substance are quite common in patients with cardiovascular disease. Our study suggests that switching may expose patients to a higher risk of therapy discontinuation or substitution.

Disease progression and health care resource consumption in patients affected by hepatitis C virus in real practice setting.

INTRODUCTION: Hepatitis C virus (HCV) infection represents serious health problems worldwide and is a major contributor to end-stage liver disease including cirrhosis and hepatocellular carcinoma (HCC). In Italy, ~2% of subjects are infected with HCV. The objective of this study was to describe treatment patterns, disease progression, and resource use in HCV. METHODS: An observational retrospective cohort analysis based on four Local Health Units administrative and laboratory databases was conducted. HCV-positive patients between January 1, 2009 and December 31, 2010 were included and followed-up for 1 year. To explore which covariates were associated to disease progression (cirrhosis, HCC, death for any cause), Cox proportional hazards models were performed. RESULTS: A total of 9,514 patients were analyzed of which 55.6% were male, aged 58.1±16.1, and prevalence 0.4%; 5.8% were positive to human immunodeficiency virus (HIV) infection, 3.0% to hepatitis B virus (HBV), and 1.6% to HCV+HBV+HIV; 26.1% had cirrhosis and 4.3% HCC. The majority of patients (76%) did not receive an antiviral treatment; the main factors affecting this decision were age, 44.1% of untreated patients being aged >65 years; 31% were affected by cirrhosis, 6.6% had ongoing substance or alcohol abuse, and 5.5% were affected by HCC. Disease progression in the observed timeframe was less frequent among treated patients (incidence rate per 100 patients/year: cirrhosis 2.1±0.7 vs 13.0±1.0, HCC 0.5±0.3 vs 3.6±0.5, death 0.5±0.3 vs 6.4±0.7). The annual expenditure for HCV management (drugs, hospitalizations, outpatient services) was €4,700 per patient. CONCLUSION: This observational, real-life study shows that only a small proportion of patients received antiviral therapy in the territorial services investigated; among patients who were not treated, this is reflected in a disease progression and cost of management higher than treated patients. These results suggest the importance of better defining the categories of patients who can really postpone treatment, and those who require immediate antiviral therapy.