Publications by authors named "Mihaela Nica"

Article Synopsis
  • - The study analyzed the factors behind treatment changes in 4,739 patients with active relapsing-remitting and secondary progressive multiple sclerosis from the Italian MS Register, focusing on those who experienced relapses within the past two years.
  • - Results revealed that over half of the patients switched their disease-modifying therapy (DMT) due to clinical relapses, with those who switched being typically younger and less disabled than non-switchers.
  • - The use of high-efficacy DMTs, particularly anti-CD20 drugs like Alemtuzumab and Ocrelizumab, was shown to significantly lower the risk of needing to switch treatments due to disease activity.
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Purpose: A retrospective analysis of real-world data was performed to assess the epidemiology and economic burden of multiple sclerosis (MS), relapsing-remitting MS (RRMS), and secondary-progressive MS (SPMS) in Italy.

Patients And Methods: An observational study on administrative databases from a sample of Italian entities was carried-out. Between 01/2010-12/2017, patients with ≥1 MS diagnosis code (ICD-9-CM:340 and/or exemption code:046) and/or ≥1 disease-modifying therapies (DMTs) prescription, were included.

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Background: Definitions for reliable identification of transition from relapsing-remitting multiple sclerosis (MS) to secondary progressive (SP)MS in clinical cohorts are not available.

Objectives: To compare diagnostic performances of two different data-driven SPMS definitions.

Methods: Data-driven SPMS definitions based on a version of Lorscheider's algorithm (DDA) and on the EXPAND trial inclusion criteria were compared, using the neurologist's definition (ND) as gold standard, in terms of sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), Akaike information criterion (AIC) and area under the curve (AUC).

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Background: Multiple sclerosis (MS) is a chronic neuroinflammatory and neurodegenerative disease negatively impacting patients' physical, psychological and social well-being with a significant economic burden.

Objectives: The study estimates MS burden and cost of illness in Italy from a societal perspective in 2019.

Methods: Information on the impact of the disease on daily activities, symptoms, employment, resource utilization and the role of caregivers was collected through questionnaires completed by 944 patients and caregivers.

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Background: Siponimod is an effective treatment for patients with secondary progressive multiple sclerosis (SPMS), with active disease evidenced by relapses or imaging features characteristic of multiple sclerosis inflammatory activity, however there is a need to evaluate its economic value and sustainability compared to other disease modifying-therapies (DMTs).

Objective: To estimate the siponimod cost-effectiveness profile and its relative budget impact compared with other DMTs, by using the Italian National Healthcare System perspective.

Methods: We performed: 1) a cost-effectiveness analysis (CEA) vs interferon beta-1b using an analytical Markov model and a life time-horizon, and 2) a budget impact analysis by using 3-years time-horizon.

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Background: Fingolimod is the first oral agent approved for treatment of relapsing-remitting multiple sclerosis (RRMS). We aimed to evaluate fingolimod effectiveness in a real-world sample of RRMS patients.

Methods: A retrospective, multicentre study in patients treated with fingolimod, whom clinical and radiological data were collected in the 2 years preceding and following the initiation of fingolimod.

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Background: The proper identification of chronic migraine is one of the mainstays for general practitioners. This study therefore aims to assess the epidemiology and determinants of chronic migraine in primary care in Italy by testing five operational case definition algorithms.

Methods: Five case definition algorithms defining chronic migraine were developed to estimate the prevalence and incidence rate of chronic migraine in the Health Search database.

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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).

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Introduction: Chronic heart failure (CHF) is a major public health concern. From a public health perspective, the epidemiology of CHF needs to be distinguished from that of its related acute form. Data stemming from primary care are crucial to better know and update the prevalence and incidence rates of CHF.

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Background: Gender differences are evident in many common health conditions, especially respiratory diseases such as asthma and chronic obstructive pulmonary disease (COPD). The aim of this review was to identify published studies describing gender differences in asthma and COPD, in particular regarding pathophysiology, diagnosis and treatment, with a focus on Italian data.

Methods: a literature review was performed from April to November 2015, using the PubMed scientific database and the following ??eywords: "gender differences" and "asthma" for the asthma review and "gender differences" and "COPD" for the COPD review.

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Background: Today, there is a poor knowledge about gender differences in adverse drug reactions (ADRs) to cardiovascular drugs such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs). Therefore, the aim of this study was to analyze spontaneous reports of suspected ADRs induced by ACE-inhibitors and ARBs, between January 2001 and June 2015, recorded in a Region of Southern Italy (Campania Region).

Methods: We performed a descriptive gender-related analysis of regional safety data, obtained from the spontaneous reporting system.

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Background: MetaGeM is a wide gender-medicine project comprising post hoc and meta-analyses by gender of clinical outcomes, therapeutic approaches, and safety data from previously conducted observational studies to explore possible gender differences in real-life clinical settings. We report the results of the safety meta-analysis of seven MetaGeM studies, evaluating gender differences in adverse event (AE) incidence and severity.

Methods: Data were collected between February 2002 and July 2013.

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