Pharmacoutilization of epoetins in na\uc3\uafve 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 na\uc3\uafve 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 (\uce\u94Hb) 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 \uc2\ub1 standard deviation (SD) age was 62.5\uc2\ub114.7 years; this cohort of patients was slightly significantly younger than the biosimilar users (71.8\uc2\ub111.8 years). The mean \uc2\ub1SD overall Hb level prior to treatment was lower among patients who started with biosimilar products (9.6\uc2\ub11.1 g/dL) compared to those who started with a reference product (10.1\uc2\ub12.1 g/dL). No significant differences in \uce\u94Hb were observed between biosimilar and originator groups during the followup period. The mean \uef\u82\u81\uef\u81\ubd\uef\u80 SD cost per patient was \ue2\u82\uac667.98\uc2\ub1573.93 and \ue2\u82\uac340.85\uc2\ub1235.73 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

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

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

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

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

Adherence to therapeutic guidelines among patients treated with statins. Results from STAR study

INTRODUCTION: the objective of this study was to analyze adherence to therapeutic guidelines among patients treated with lipid lowering drugs (statins).MATERIAL AND METHODS: a retrospective observational study including 5 Local Health Units (LHUs) was conducted using administrative databases. Patients who received at least one prescription for statins between January 1st, 2007 and June 30th, 2008 were selected and followed for 12 months. Patients were classified according to their level of absolute cardiovascular risk (moderate, high, very high according to Nota 13 AIFA).RESULTS: a total of 71,855 patients were included (14,133 newly treated patients with statins, representing 19.4% of total sample), (age 68.8±10.7, male 51%). Level of absolute cardiovascular risk were: moderate risk (45.4%), high risk (33.4%), very high risk (16.3%), familial hypercholesterolemia (4.9%). Statins assumed by patients in analysis were stratified in two groups (first or second choice), accordingly to their efficacy (level of LDL cholesterol reduction) in relation to the patient’s cardiovascular risk (coherently with new Nota 13 AIFA, 2011). Among patients with a very high cardiovascular risk, only 52.8% used statins indicated by Nota13 as a first choice while 2.9% used a second choice statin and 44.3% used an inadequate statin and/or dosage; among familial hypercholesterolemia patients, those percentages were, respectively: 53.8%, 21.1% and 25.1%. When only patients naïve to statins treatment were analyzed, similar percentages were found. Only few patients in very high risk group used adequate dosages: among patients treated with rosuvastatin and atorvastatin, 11.2% used atorvastatin 40 mg, and 0.2% used atorvastatin 80 mg (this population was not analyzed for events because of low numerosity) while 4.1% used rosuvastatin 20 mg and 0.2% used rosuvastatin 40 mg; overall, 84.3% of patients in this group used inadequate dosages. Cardiovascular events at one year of follow up were 1.6% for patients treated with rosuvastatin 20 mg, 1.6% for rosuvastatin 40 mg and 6.1% for atorvastatin 40 mg; death rates (any cause) were 0.9%, 0.0%, 2.6% respectively. The analysis of the sub-population of patients treated with rosuvastatin 20 mg with previous CV event showed a percentage of patients with a CV event during the observational period of 3.4%, a percentage of patients with cerebrovascular event of 0.9% and a mortality percentage of 0.9%.Conclusions: in real practice setting, the percentage of patients prescribed for recommended statins and dosages is low

Secondary malignancies after treatment for indolent non-Hodgkin's lymphoma: a 16-year follow-up study.

Relatively little information is available on the incidence of secondary cancer in non-Hodgkin's lymphoma. The aim of this long-term follow-up study was to determine the incidence, the time free of second tumors, and risk factors for developing secondary cancer in a homogeneous group of patients with non-Hodgkin's lymphoma. DESIGN AND METHODS: We evaluated a total of 563 patients with indolent non-Hodgkin's lymphoma enrolled in Gruppo Italiano Studio Linfomi trials from 1988 to 2003. RESULTS: After a median follow-up of 62 months, 39 patients (6.9%) developed secondary cancer: 12 myelodysplastic syndromes/acute myeloid leukemia, and 27 solid tumors. The overall standardized incidence ratio of secondary malignancy in patients with non-Hodgkin's lymphoma was higher than the risk of malignancy in the general population. The standardized incidence ratio was elevated in male patients and in patients under 65 years old at first treatment. Overall, the cumulative incidence of secondary cancer at 12 years was 10.5%, after correction in a competing-risk model. Univariate and multivariate Cox regression analyses showed that older age at the time of diagnosis, male sex, and fludarabine-containing therapy had significant negative impacts on the time free of second tumors. CONCLUSIONS: We have identified subgroups of non-Hodgkin's lymphoma patients with increased standardized incidence ratios of secondary malignancy and variables that have a negative impact on the time free of second tumors. This information could help physicians to select the most appropriate treatments. Finally, taking into account the possible occurrence of secondary neoplasia, long-term monitoring must be considered

Healthcare Resources Use in Patients with Human Immunodeficiency Virus (HIV). Real-World Evidence From Six Italian Local Health Units

AIM: The aim of the study was to evaluate healthcare resource use and related costs for the management of people living with Human Immunodeficiency Virus (PLWHIV) with and without comorbidities, and to compare the burden of comorbidities in PLWHIV to the general population.METHODS: An observational retrospective analysis, based on administrative and laboratory databases from 6 Italian Local Health Units (LHUs) was performed. Individuals receiving either an HIV treatment [Antiretroviral therapy (ART) – ATC code: J05A)], or with an HIV positive laboratory test result between January 1st, 2014 and December 31st, 2014 were included. The date of first ART prescription or positive test of HIV was used as the Index Date (ID). Patients enrolled were followed-up for all time available from the ID (follow-up period) and their clinical characteristics were investigated from one year prior to the ID (characterization period). Comorbidities were measured by using the Charlson Comorbidity Index; findings were compared with those of a sample of the general population with the same age and sex distribution (OsMed 2015). Healthcare resource use and related cost was evaluated during the follow-up period.RESULTS: 1,214 patients were included, 837 were PLWHIV without any comorbidities and 377 were PLWHIV with at least one comorbidity. Mean prevalence of prescriptions for treatment of comorbidities was higher in the HIV-infected population than in the Italian general population. The annual healthcare cost of managing HIV patients with comorbidities, was significantly higher than that for patients without comorbidities (€ 10,615 vs. € 8,665, p < 0.001).CONCLUSIONS: Study results showed that 30% of PLWHIV had at least one comorbidity. The cost of managing PLWHIV who have comorbidities was significantly higher than that of managing PLWHIV without comorbidities. Our data confirm that care and treatment services should be adapted to address the specific needs of people living with both HIV and comorbidities

Piezoelectric Signals in Vascularized Bone Regeneration

The demand for bone substitutes is increasing in Western countries. Bone graft substitutes aim to provide reconstructive surgeons with off-the-shelf alternatives to the natural bone taken from humans or animal species. Under the tissue engineering paradigm, biomaterial scaffolds can be designed by incorporating bone stem cells to decrease the disadvantages of traditional tissue grafts. However, the effective clinical application of tissue-engineered bone is limited by insufficient neovascularization. As bone is a highly vascularized tissue, new strategies to promote both osteogenesis and vasculogenesis within the scaffolds need to be considered for a successful regeneration. It has been demonstrated that bone and blood vases are piezoelectric, namely, electric signals are locally produced upon mechanical stimulation of these tissues. The specific effects of electric charge generation on different cells are not fully understood, but a substantial amount of evidence has suggested their functional and physiological roles. This review summarizes the special contribution of piezoelectricity as a stimulatory signal for bone and vascular tissue regeneration, including osteogenesis, angiogenesis, vascular repair, and tissue engineering, by considering different stem cell sources entailed with osteogenic and angiogenic potential, aimed at collecting the key findings that may enable the development of successful vascularized bone replacements useful in orthopedic and otologic surgery

Detection of a fluorescent-labeled avidin-nucleic acid nanoassembly by confocal laser endomicroscopy in the microvasculature of chronically inflamed intestinal mucosa

Inflammatory bowel diseases are chronic gastrointestinal pathologies causing great discomfort in both children and adults. The pathogenesis of inflammatory bowel diseases is not yet fully understood and their diagnosis and treatment are often challenging. Nanoparticle-based strategies have been tested in local drug delivery to the inflamed colon. Here, we have investigated the use of the novel avidin-nucleic acid nanoassembly (ANANAS) platform as a potential diagnostic carrier in an experimental model of inflammatory bowel diseases. Fluorescent- labeled ANANAS nanoparticles were administered to mice with chemically induced chronic inflammation of the large intestine. Localization of mucosal nanoparticles was assessed in vivo by dual-band confocal laser endomicroscopy. This technique enables characterization of the mucosal microvasculature and crypt architecture at subcellular resolution. Intravascular nanoparticle distribution was observed in the inflamed mucosa but not in healthy controls, demonstrating the utility of the combination of ANANAS and confocal laser endomicroscopy for highlighting intestinal inflammatory conditions. The specific localization of ANANAS in inflamed tissues supports the potential of this platform as a targeted carrier for bioactive moieties in the treatment of inflammatory bowel disease