Treatment patterns, health resource consumption, and costs of patients with migraine in an Italian real-world setting.

OBJECTIVE: This study aimed to describe the demographic and clinical characteristics of migraineurs prescribed ≥1 migraine prophylactic therapy, and to analyze their therapeutic pathways, healthcare resource consumption, and related costs. METHODS: This retrospective analysis was based on administrative databases from two regions and three local health units in Italy. Adult patients with ≥1 discharge diagnosis for migraine or ≥1 prescription for migraine-specific drugs, or ≥1 emergency room visit for migraine from 1 January 2010 to 31 December 2016 were included if they had received ≥1 migraine prophylactic therapy between 1 January 2011 and 31 December 2015 (enrollment period). The first date of the last migraine prophylactic treatment was considered as the index date (ID). Patients were characterized 1-year prior ID and followed-up for 1 year afterwards. RESULTS: Of the 166,362 identified migraineurs, 32,794 (mean age: 45.9 ± 13.9 years, 19.2% male) who received migraine prophylaxis were included in the analysis. At ID, 31,629 patients had received 1 prophylactic treatment with antidepressants (51.2%), neuromodulators (28.1%), beta blockers (12.4%), other migraine preparations (7.8%), and botulinum toxin A (0.5%). Focusing on patients with one prophylactic treatment at ID, 85.4% did not have any previous therapeutic failures whereas 14.6% had ≥1 previous failure. During follow-up, 5% of patients made a therapeutic switch after a mean period of 103.4 ± 97.9 days. Total mean annual cost for patients receiving migraine prophylaxis was 1193.64€ during characterization and 1303.86€ during follow-up periods. CONCLUSION: This real-world study gave insights on the characterization of migraineurs and patterns of prophylaxis utilization in Italian clinical settings, showing an underuse of prophylactic agents.

Treatment Pattern Analysis and Health-care Resource Consumption on Patients with Psoriatic Arthritis or Ankylosing Spondylitis Treated with Biological Drugs in a Northern Italian Region.

PURPOSE: To analyze the treatment patterns of psoriatic arthritis (PSA) or ankylosing spondylitis (AS) patients under biological therapies and to evaluate in this population the health-care resource consumption and related costs. PATIENTS AND METHODS: A retrospective analysis was performed on administrative databases of the Veneto region. Patients ≥18 years with at least one prescription of biological drugs and a diagnosis at any level for PSA or AS from January 1, 2011 to December 31, 2016 (inclusion period) were included. Index date (ID) was defined as date of first biological drug prescription during inclusion period. Patients were characterized the year before ID and followed-up for one year after ID. The drug utilization profile in terms of adherence, persistence and therapeutic regimen changes, and the health-care resource consumption was analyzed during follow-up. RESULTS: A total of 2602 patients were included: 1857 with PSA and 745 with AS. In the PSA cohort, 40.3% of patients were prescribed adalimumab, 35.6% etanercept, 8.0% golimumab, 7.5% infliximab, 5.6% ustekinumab and 3.0% certolizumab. Percentage of PSA patients adherent to treatment was higher among ustekinumab patients (91.3%) and lower among etanercept users (54.3%). Persistence ranged from 53.2% (infliximab) to 70.3% (etanercept). Regarding AS cohort, 45.5% of patients were prescribed adalimumab, 26% etanercept, 17.3% infliximab, 9.7% golimumab and 1.5% certolizumab. Adherence ranged from 46.9% (etanercept) to 90.9% (certolizumab) and persistence from 62.8% (adalimumab) to 81.8% (certolizumab). Mean annual health-care costs (including costs for drug treatment, diagnostic services, specialist visits and hospital admissions) ranged from €9727 (certolizumab) to €14,994 (ustekinumab) among PSA patients and from €9875 (infliximab) to €12,991 (golimumab) among AS patients. CONCLUSION: This study in Veneto region gave a picture of biological treatment patterns among PSA and AS patients in a real-world setting. Our findings showed the high degree of variability concerning utilization of each biological drug and provided insight on the economic burden of both diseases.

Low adherence to inhaled corticosteroids/long-acting ß2-agonists and biologic treatment in severe asthmatics.

Less than half of severe asthmatic patients show a >80% adherence rate to inhaled treatment just before and during biologic therapy. This has implications in biologic treatment sustainability and disease prevalence estimation. http://bit.ly/3cRTJB0.

Heart failure in the Veneto region of Italy: analysis of therapeutic pathways and the utilization of healthcare resources.

Objectives: Aim of the study was to describe the use and pharmacoutilization profiles of recommended drugs for HF patients, hospital re-admission rates, mortality rates and determine healthcare resource consumption and related costs for HF patients in an Italian region. Methods: We retrospectively analyzed data from the administrative database and included adult patients who were discharged alive with a primary or secondary HF diagnosis between 1 January 2010 and 31 December 2015. We assessed data on HF-related drug prescriptions at discharge and during a 12-month follow-up period, as well as treatment adherence and treatment modification. All-cause mortality, hospital HF re-admission, and mean direct cost per patient were also analyzed during the follow-up period. Results: A total of 69,164 patients were included. One in ten patients had discontinued all treatment initially prescribed by the end of follow-up. In total, 25.9% of patients were re-hospitalized with an HF diagnosis during the follow-up period; the mortality rate at 12 months was 24.3%. The mean annual cost per patient was €6,303.7, with nearly three-fourths attributable to hospitalizations. Conclusions: In our study, we observed an under-prescription of recommended drugs for the treatment of HF. Moreover, one out of four HF patients were re-hospitalized for HF-related causes and the healthcare costs related to hospitalization accounted for the great majority of the total healthcare resource costs.

Covalent surface modification of titanium oxide with different adhesive peptides: surface characterization and osteoblast-like cell adhesion.

A fundamental goal in the field of implantology is the design of innovative devices suitable for promoting implant-to-tissue integration. This result can be achieved by means of surface modifications aimed at optimizing tissue regeneration. In the framework of oral and orthopedic implantology, surface modifications concern both the optimization of titanium/titanium alloy surface roughness and the attachment of biochemical factors able to guide cellular adhesion and/or growth. This article focuses on the covalent attachment of two different adhesive peptides to rough titanium disks. The capability of biomimetic surfaces to increase osteoblast adhesion and the specificity of their biological activity due to the presence of cell adhesion signal-motif have also been investigated. In addition, surface analyses by profilometry, X-ray photoelectron spectroscopy, and time of flight-secondary ion mass spectrometry have been carried out to investigate the effects and modifications induced by grafting procedures.

Electrospun polyphosphazene nanofibers for in vitro rat endothelial cells proliferation.

A large variety of natural and synthetic polymers have been explored as scaffolds for the seeding and growth of different types of cells. To fabricate a scaffold that can be used as a synthetic extracellular matrix (ECM), it is important to replicate the nanoscale dimensions of natural ECM. The electrospinning process allows to produce ultrathin fibers so that this method represents a suitable approach to scaffold fabrication for tissue engineering applications. In this work, the feasibility of obtaining flat or tubular matrices from biocompatible poly[(ethyl phenylalanato)(1.4) (ethyl glycinato)(0.6) phosphazene] by electrospinning was evaluated and the effect of process parameters on the diameter of nanofibers was examined. The adhesion and growth of rat neuromicrovascular endothelial cells cultured on sheets and tubes composed by the polymer with an average fiber diameter of 850 +/- 150 nm were also reported. Microscopic examination of the seeded tubes demonstrated that, after 16 days of incubation, endothelial cells formed a monolayer on the whole surface. These results are the first step to demonstrate that tubes of biodegradable polyphosphazenes might be a feasible model to construct human tissues such as vessels or cardiac valves.

In vitro evaluation of poly[bis(ethyl alanato)phosphazene] as a scaffold for bone tissue engineering.

Polyphosphazenes with amino acid ester as side groups are biocompatible polymers that could provide valid scaffolds for cell growth. In the present study we investigate the adhesion and growth of osteoblasts obtained from rat bone marrow on matrices composed of thin fibers of poly[bis(ethyl alanato)phosphazene] (PAlaP), poly(d,l-lactic acid) (PDLLA), or PAlaP/PDLLA blend. Our data show that scaffolds of PAlaP or PAlaP/PDLLA blend enhanced the cell adhesion and growth in comparison with that observed in cultures seeded on polystyrene tissue culture plates. Although collagenase-digestible protein synthesis remained unchanged, all scaffolds induced a decrease in alkaline phosphatase activity, suggesting that osteoblasts are in the proliferation phase. Both PAlaP and PAlaP blended with PDLLA may represent a new and interesting substrate for bone tissue engineering.

Effect of synthetic peptides on osteoblast adhesion.

The quality of the early cell/material interactions is responsible for the long-term functional properties of any implanted device. Accordingly, "next generation" dental/orthopedic biomaterials should be able to promote osteoblast adhesion thus improving the integration process between surgically placed implants and biological tissues. Recent studies have identified a wide range of biochemical signals that can be exploited to promote adhesion, migration, proliferation and differentiation of cells. The clinical use of natural factors to promote osteoblast adhesion is complicated because those are often insoluble and unstable macromolecules and, in addition, it is difficult to obtain them in high quantities, with good purity grade and at low cost. A valid alternative could be the use of short peptides carrying the minimum active sequence of the natural macromolecular factor. This paper describes the properties of two classes of peptides, promoting different adhesion mechanisms, to enhance rat bone marrow osteoblast adhesion both to polystyrene and to acellular bone matrix.

Contact profilometry and correspondence analysis to correlate surface properties and cell adhesion in vitro of uncoated and coated Ti and Ti6Al4V disks.

A fundamental goal in the field of implantology is the design of specific devices able to induce a controlled and rapid "osseointegration". This result has been achieved by means of surface modifications aimed at optimizing implant-to-bone contact; furthermore, bone cell adhesion on implant surface has been directly improved by the application of biomolecules that stimulate new tissue formation, thus controlling interactions between biological environment and implanted materials. Actually, methods for biochemical factor delivery at the interface between implant surface and biological tissues are under investigation; a reliable technique is represented by the inclusion of biologically active molecules into biocompatible and biodegradable materials used for coating implant surface. This paper focuses the application of three polymeric materials already acknowledged in the clinical practice, i.e. poly-L-lactic acid (PLLA), poly-DL-lactic acid (PDLA), and sodium alginate hydrogel. They have been used to coat Ti (Ti2) and Ti6Al4V (Ti5) disks; their characteristics have been determined and their performances compared, with specific regard to the ability in allowing osteoblast adhesion in vitro. Moreover, profilometry data analysis permitted to identify a specific roughness parameter (peak density) which mainly controls the amount of osteoblast adhesion.