Flavia Lombardo - Academia.edu (original) (raw)
Papers by Flavia Lombardo
Journal of Alzheimer's Disease, May 3, 2022
Research Square (Research Square), Aug 9, 2023
Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condit... more Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no signi cant improvements in therapeutic options for ALS patients in recent years. Currently, there is no cure for ALS, and the only approved treatment in Europe is riluzole, which has been shown to slow the disease progression and prolong survival by approximately three months. Recently, tauroursodeoxycholic acid (TUDCA) has emerged as a promising and effective treatment for neurodegenerative diseases due to its neuroprotective activities. Methods: The ongoing TUDCA-ALS study is a double-blinded, parallel arms, placebo-controlled, randomized multicenter phase III trial with the aim to assess the e cacy and safety of TUDCA as add-on therapy to riluzole in patients with ALS. The primary outcome measure is de ned as a minimum 20% improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) slope during the randomisation period (18 months) compared to the lead-in period (3 months), Randomization will be strati ed by country. Primary analysis will be conducted based on the intention-to-treat principle. Data recruitment commenced on February 22, 2019, and was closed on 23 rd December 2021. The database will be locked in September 2023. Discussion: This paper provides a comprehensive description of the statistical analysis plan in order to ensure reproducibility of the analysis and avoid selective reporting of outcomes and data-driven analysis. Sensitivity analyses have been included in the protocol to assess the impact of intercurrent events related to the Coronavirus disease 2019. By focusing on clinically meaningful and robust outcomes, this trial aims to determine whether TUDCA can be effective in slowing the disease progression in patients with ALS.
Background In recent years, considerable efforts have been directed towards the research and deve... more Background In recent years, considerable efforts have been directed towards the research and development of disease-modifying therapies for dementia. These drugs focus on prodromal (Mild Cognitive Impairment, MCI) and/or early stages of Alzheimer's disease. Evidence from literature demonstrates that a considerable proportion of MCI subjects never progress to dementia. Therefore it is of utmost importance to identify those individuals who are at a higher risk of developing dementia. Methods The ongoing INTERCEPTOR study is a multicenter, longitudinal, interventional, non-therapeutic cohort study designed to enroll 500 subjects with MCI aged 50-85 years. The primary aim is to identify a biomarker or a set of biomarkers able to accurately predict the conversion from MCI to AD within 3 years of follow-up. The biomarkers investigated in this study are neuropsychological tests (mini-mental state examination MMSE and delayed free recall), brain glucose metabolism ([ 18 F]FDG-PET), MRI volumetry of the hippocampus, EEG brain connectivity, cerebrospinal uid (CSF) markers (p-tau, t-tau, Aβ1-42, Aβ1-42/1-40 ratio, Aβ1-42 /p-Tau ratio) and APOE genotype. The baseline visit includes a full cognitive and neuropsychological evaluation, as well as the collection of clinical and socio-demographic information. Prognostic models will be developed using Cox regression, incorporating patient characteristics and biomarkers through stepwise selection. Model performance will be evaluated in terms of discrimination and calibration and subjected to internal validation using the bootstrapping procedure. The nal model will be visually represented as a nomogram. Discussion This paper contains a detailed description of the statistical analysis plan to ensure the reproducibility and transparency of the analysis. The prognostic model developed in this study aims to identify the population with MCI at higher risk of developing dementia, potentially eligible for drugs prescriptions. The nomogram could provide a valuable tool for clinicians for risk strati cation and early treatment decisions. Trial registration ClinicalTrials.gov NCT03834402.
Journal of Medical Virology, Jul 27, 2016
Background According to small studies carried out in preselected populations, the estimated preva... more Background According to small studies carried out in preselected populations, the estimated prevalence of anti-hepatitis C virus (HCV) antibodies in Poland ranges from 0.6 to 2.1%. Aims The aim of this study was to evaluate the prevalence of anti-HCV and HCV RNA among patients and healthcare workers. Methods Anti-HCV antibodies were measured (Elecsys, Roche) in serum samples from 26 057 adults, consecutive patients or healthcare workers, from hospitals and out patient clinics not involved in the management of liver diseases. The majority of them (18 233) consented to fill out an anonymous questionnaire related to possible risk factors for HCV infection. Anti-HCV-positive samples were assessed for HCV RNA (Cobas Amplicor, Roche). A multivariate logistic regression model and the v 2 test or the Fisher's exact test were applied. Results Anti-HCV antibodies were detected in 1.9% of individuals, and 31% of them demonstrated HCV RNA, which varied from 26% in hospitals to 66% in specialistic outpatient clinics. Prevalence of anti-HCV was significantly lower in healthcare workers (1.42%) than in patients (1.92%). Significant independent risk factors for anti-HCV positivity were as follows: male sex, more than three hospitalizations in a lifetime, blood transfusions before 1992, and intravenous drug use. The only significant risk factor for HCV RNA was intravenous drug use. An analysis carried out for multispecialistic hospitals demonstrated significantly lower prevalence of HCV RNA positivity in healthcare workers. Conclusion Prevalence of anti-HCV in the Polish population studied was up to 1.9%, but active infection could be diagnosed in only 31% of them. Intravenous drug use, blood transfusions before 1992, multiple hospitalizations, and male sex increase the risk of HCV infection.
PubMed, Sep 22, 2022
The Italian Fund for Alzheimer's and other dementias was approved and signed in December 2021. Th... more The Italian Fund for Alzheimer's and other dementias was approved and signed in December 2021. The Fund is financed with 15 million euros in three years. The main goal is to provide new strategies in the field of dementia with a Public Health perspective. The Fund includes eight main activities that will be monitored and supervised by the Italian National Institute of Health: 1) development of a guideline for the assessment, management and support for people with dementia and their families/carers; 2) updating of the Dementia National Plan (DNP); 3) implementation of the documents of the DNP; 4) conducting surveys dedicated to the Italian Dementia Services; 5) promotion of dementia prevention strategies; 6) training strategies for healthcare professionals, families and caregivers; 7) creation of a National Electronic Record for Dementia; 8) evaluation and monitoring of activities promoted by Regions and Autonomous Provinces in the field of dementia, together with the dementia National Permanent Table. These activities are outlined in detail in the present paper.
Journal of the Neurological Sciences, Oct 1, 2021
Journal of the Neurological Sciences, Oct 1, 2021
Background and aims: Many clinical trials on potentially disease-modifying drugs are focused to m... more Background and aims: Many clinical trials on potentially disease-modifying drugs are focused to mild cognitive impairment (MCI) prodromal-to-Alzheimer's disease. The MCI population actually includes patients with higher risk of progression to AD. Since the new drugs, if effective, will carry both elevated unit costs and not marginal side effects, they should be administered selectively to high-risk subjects. The Italian INTERCEPTOR project, promoted by the Italian Medicine Agency and the Italian Ministry of Health, is a multicenter, interventional, nontherapeutic cohort study in subjects with MCI, with the primary aim of identifying biomarkers that better predict the conversion to AD after 3 years of follow-up. Methods: A sample of 500 subjects with MCI was planned to be enrolled. The biomarkers under investigation obtained by the analysis of MMSE, CSF, FDG-PET, FCRST, APOE4, EEG, Volumetric MRI. Multivariate prediction model will provide the predictive performance of each biomarker and combinations. In applying biomarkers, three scenarios are considered: 1) use of cut-offs indicated by experts 2) defining new optimal cut-offs for the specific population 3) use of values in a continuous form in order to evaluate all predictive information. Finally, nomograms will be defined for use in clinical practice. Results: Due to COVID-19, the target sample size was not reached. The enrolment was closed on October 31st 2020. Overall 498 patients were screened, 362 recruited into the study and 17 dropped out. Conclusions: The findings will support the diagnostic path redefinition to identify those patients in the early stage eligible to prescription for disease-modifying medications.
Digestive and Liver Disease, Feb 1, 2016
European Psychiatry, 2013
Introduction A relative decline in systolic blood pressure has been found to occur prior to and a... more Introduction A relative decline in systolic blood pressure has been found to occur prior to and around the clinical onset of dementia but the reasons for this remain unclear. Aims and objectives In a large series of surveys carried out using identical methodology in populations with relatively low mean blood pressures we investigated the consistency of the association between dementia, dementia severity and resting blood pressure. Methods The analysed sample comprised 15,022 participants from eleven cross-sectional surveys carried out in seven low and middle income countries (Cuba, Dominican Republic, Peru, Venezuela, Mexico, China and India). Associations between dementia status (ascertained through a detailed assessment with extensive cross-cultural validation) and resting blood pressure were described for each sample and then compared in meta-analyses. Results In age- and sex-adjusted linear regression analyses, there was a high level of between-site heterogeneity in these associations (I-squared 60.2% for dementia and SBP). The only site with significant and consistent associations was Cuba (n=2944), the sample with highest mean systolic blood pressure, where dementia was associated with 7.9mmHg lower systolic blood pressure (95% CI 4.7-11.1) and 2.6mmHg lower diastolic blood pressure (95% CI 0.9-4.2). In general, associations between dementia and lower blood pressure were weak or absent in these surveys. Conclusions The association between dementia and low blood pressure, generally observed in Western settings was not observed in these populations with lower hypertension prevalence. These findings do not support a hypothesis that lower blood pressure in dementia is purely secondary to underlying neurodegeneration.
Lancet Neurology, Feb 1, 2023
European Journal of Internal Medicine, Sep 1, 2012
Background: The epidemiological pattern of hepatitis B virus infection in Italy has greatly chang... more Background: The epidemiological pattern of hepatitis B virus infection in Italy has greatly changed over the past decades. The aim of the study was to evaluate during time the epidemiological features of acute hepatitis B cases referred to an Infectious Disease Unit in NorthEast of Italy between 1978 and 1995. Patients and methods: Stored sera of 183 cases were tested for HBV markers, HBV genotypes, anti-Delta and anti-HCV. Results: Anti-HBcIgM was positive in all cases. Mean age increased from 30.2 years in 1978 to 37.5 in 1995 (P b 0.01). Significant increase was observed in proportion of cases reporting intravenous drug use from 11.5% to 29.6% (P b 0.03). Chronicity rate was as low as 1.1%. Mean days of hospitalization significantly decreased. HBV genotype determination showed that majority of cases was infected by genotype D, but its prevalence decreased from 88.2% in 1978 to 75.0% in 1995. Delta coinfection was present in 8.2%. The prevalence of HCV in patients with acute HBV was 35.0%; it fluctuated from 26.2% to 44.2%, mostly related (53.1%) to intravenous drug use. Dual infection did not lead to a more severe course of disease. Conclusions: From this retrospective study, remarkable fluctuations in the prevalence of dual HBV-HCV infection before the implementation of HBV vaccination were observed. Presence of anti-HCV did not affect the course of acute HBV.
European Journal of Clinical Pharmacology, Oct 22, 2013
To evaluate the effect of a broad range of covariates on the survival of a real-life long-term fo... more To evaluate the effect of a broad range of covariates on the survival of a real-life long-term follow-up cohort of community-dwelling patients with behavioural and psychological symptoms of dementia who were new users of atypical antipsychotic medications (APMs). This was a prospective cohort study of 1,618 subjects aged ≥65 years with dementia and BPSD ("behavioural and psychological symptoms of dementia") who were new users of atypical APMs and registered in a Dementia Evaluation Unit of Campania Region (Italy) from September 2006 to March 2010. The potential of baseline features to predict mortality was assessed with the Cox proportional hazards model. The average follow-up was 309 days. Of the 1,618 new users of atypical antipsychotics, 9.3 % experienced at least one adverse event, including death (5.1 %), drug therapeutic failure (3.0 %), extrapyramidal symptoms (0.5 %) and stroke (0.2 %). The crude all-cause mortality rate was 6.0 per 100 person-years [95 % confidence interval (CI) 4.8-7.4]; the rate was higher in patients aged >85 years (9.0 per 100 person-years, 95 % CI 6.4-12.7) and among male patients (7.5 per 100 person-years, 95% CI 5.3-10.6). In the multivariate analysis, only age was associated to all-cause mortality [hazard ratio (HR) 1.1; 95 % CI 1.0-1.1 and HR 1.4; 95 % CI: 0.9-2.2, respectively). In contrast, hallucination (HR 0.4; 95 % CI 0.2-0.6) and dosage change (HR 0.4; 95 % CI 0.2-0.78) were significantly associated with a lower risk of all-cause mortality. Among our patient cohort, the mortality rate of patients with BPSD receiving long-term treatment with atypical APMs was lower than that reported in other studies, and only age was found to be significant predictor factor of mortality.
European Journal of Internal Medicine, Dec 1, 2012
Background: Hepatitis B virus infection has decreased in Italy. The aims of this study were to id... more Background: Hepatitis B virus infection has decreased in Italy. The aims of this study were to identify changes, if any, in the epidemiological pattern of HBV infection in a southern Italian town first surveyed in 1996 and to assess the effectiveness of vaccination campaign against hepatitis B. Methods: In 2010, subjects were selected from the census by a systematic 1:4 random sampling procedure. Hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc) were detected by ELISA. Associations (odds ratios) linking exposure to hepatitis B virus infection to potential risk factors were estimated by univariate and multivariate analyses. Results: Of the 1100 eligible subjects, 1020 (92.0%) agreed to participate. The prevalences of HBsAg (0.6%) and anti-HBc (15.2%) were significantly lower than in 1996 (0.8% and 21.5%) (p b 0.01). No subject below 30 years of age (those that had been targeted for compulsory immunization) had been exposed to HBV infection. At multiple logistic regression analysis, age > 45 years (OR = 9.8; 95% CI = 5.1-18.7) and past use of glass syringes (OR = 1.9; 95% CI = 1.2-3.1) independently predicted the likelihood of anti-HBc positivity. Conclusions: These results, albeit obtained in a small town and thus not generalizable, confirm the continuous decreasing trend of HBV infection and demonstrate the effectiveness of the Italian hepatitis B vaccination program.
PLOS ONE, May 23, 2013
Background: We investigated temporal trends and geographic variations in both hospitalizations an... more Background: We investigated temporal trends and geographic variations in both hospitalizations and in-hospital mortality rates for acute diabetic complications (ADC) in the Italian universal health care system. Methods and Findings: A retrospective review of the medical records of patients with either primary or secondary discharge diagnosis of hyperglycaemic acute complications (ICD-9-CM codes 250.1, 250.2, 250.3) or hypoglycemic coma (ICD-9-CM code 251.0) was performed in period 2001-2010. Standardized rates by age and gender on 2001 Italian population and by diabetic population were calculated. We identified 7,601.883 diabetes-related hospital discharges. Out of them, 266,374 (3.5%) were due to ADC, either ketoacidosis/hyperosmolarity (94.4%) or hypoglycemic coma (5.6%). The rate of discharge for ADC decreased by 51.1% from 2001 to 2010 (14.4 vs. 7.1 discharge rate/1,000 diabetic people; 5.7% decrease per year, test for trend, p,0.001) with a similar trend for both hyperglycemic and hypoglycemic complications. Diabetic people in the younger age groups (#19 and 20-44 years old) had a significantly greater rate of discharge for ADC than people aged 65 years and over (#19 10-fold increase; 20-44: 2-fold increase). In-hospital mortality rate was 7.6%, with 211 preventable deaths in younger diabetic people (#44 years old). There was a large variability among Italian Regions and the ratio between the highest and the lowest regional discharge rate reached 300% in 2010. Conclusions: Decreasing temporal trend in hospitalizations for preventable ADC suggests improving outpatient care. In younger diabetic patients, however, both hospitalization rates and in-hospital mortality are still a matter of concern.
BMC Women's Health, Feb 27, 2010
Background: The present study describes Complementary and Alternative Medicine (CAM) use amongst ... more Background: The present study describes Complementary and Alternative Medicine (CAM) use amongst Italian women transitioning through menopause. Popularity and perceived effectiveness of CAM treatments, use of pharmaceutical medications, characteristics of CAM users, the extent of communication between medical practitioners and women about their use of CAM, and variables associated with CAM use were also investigated. Methods: Women, aged 45-65 years attending Family Planning and Women's Health clinics or Menopause Centres in Bologna were invited to complete a voluntary, anonymous, self administered questionnaire, which was used in a previous study in Sydney. The questionnaire was translated and adapted for use amongst Italian women. Data on general demographic and health characteristics, menopause related symptoms and the use of CAM and pharmaceutical treatments during the previous 12 months were collected. Results: In total, 1,203 women completed the survey, of which 1,106 were included in the final sample. Of women who had symptoms linked with menopause and/or used remedies to alleviate symptoms, 33.5% reported to have used CAM. Among these, 23.5% had consulted one or more practitioners and 24% had used at least one CAM product. Approximately nine out of ten respondents reported medical practitioners did not seek information about their use of CAM; while one third of CAM users did not disclose the use of CAM to their physician. Nevertheless, medical practitioners were the most popular source of information. From the multivariate analysis, variables associated with CAM use were: professional employment, time since the last natural menses, use of CAM for conditions other than menopause, and presence of some severe symptoms. Conclusions: The relatively high prevalence of CAM use by women transitioning through menopause should encourage research initiatives into determining which CAM treatments are the safest and effective. The increasing and likely concomitant use of CAM with HRT and other pharmaceuticals underlines the need for the implementation of a surveillance system to report and monitor possible drug-herb adverse events. The discrepancy between women preferring to seek information about CAM from their medical doctor and the difficulties noted in communication between doctor and patient should encourage educational initiatives on CAM by health-care agencies and institutions.
Infection, Dec 16, 2011
Universal anti-hepatitis B vaccination of infants and of 12-year-old children became mandatory in... more Universal anti-hepatitis B vaccination of infants and of 12-year-old children became mandatory in Italy in 1991. The purpose of this study was to evaluate the persistence of anti-hepatitis B surface (HBs) antibodies several years after a primary course of vaccination. In 2010, anti-HBs titers were measured in all subjects aged between 5 and 25 years residing in a southern Italian town. Individuals with an anti-hepatitis B antibody concentration of 10 IU/ml or more were considered to be protected. Of the 671 subjects evaluated, 149 (30%) lacked protective antibodies. Fifty-three (29.4%) of the subjects had been vaccinated ≤10 years earlier and 96 (30.3%) more than 10 years earlier (P = not significant). Subjects vaccinated in infancy were more likely to lack protective anti-HBs antibodies than subjects vaccinated at 12 years of age, regardless of the years elapsed since immunization. Most subjects maintained protective antibodies for a considerable number of years after vaccination. Vaccination in adolescence results in more prolonged immunogenicity than vaccination in infancy.
Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condit... more Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no significant improvements in therapeutic options for ALS patients in recent years. Currently, there is no cure for ALS, and the only approved treatment in Europe is riluzole, which has been shown to slow the disease progression and prolong survival by approximately three months. Recently, tauroursodeoxycholic acid (TUDCA) has emerged as a promising and effective treatment for neurodegenerative diseases due to its neuroprotective activities. Methods: The ongoing TUDCA-ALS study is a double-blinded, parallel arms, placebo-controlled, randomized multicenter phase III trial with the aim to assess the efficacy and safety of TUDCA as add-on therapy to riluzole in patients with ALS. The primary outcome measure is defined as a minimum 20% improvement in the ALS Functional Rating Scale-Rev...
1<p>Data for zero inflation are odds ratios (95% confidence interval); data for count model... more 1<p>Data for zero inflation are odds ratios (95% confidence interval); data for count model are ratio of counts (95% confidence interval).</p>*<p>Adjusted for age, gender, educational level, number of household assets, self-reported stroke, diabetes, number of physical illnesses, marital status, overall cognitive score and physical activity level.</p
Journal of Alzheimer's Disease, May 3, 2022
Research Square (Research Square), Aug 9, 2023
Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condit... more Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no signi cant improvements in therapeutic options for ALS patients in recent years. Currently, there is no cure for ALS, and the only approved treatment in Europe is riluzole, which has been shown to slow the disease progression and prolong survival by approximately three months. Recently, tauroursodeoxycholic acid (TUDCA) has emerged as a promising and effective treatment for neurodegenerative diseases due to its neuroprotective activities. Methods: The ongoing TUDCA-ALS study is a double-blinded, parallel arms, placebo-controlled, randomized multicenter phase III trial with the aim to assess the e cacy and safety of TUDCA as add-on therapy to riluzole in patients with ALS. The primary outcome measure is de ned as a minimum 20% improvement in the ALS Functional Rating Scale-Revised (ALSFRS-R) slope during the randomisation period (18 months) compared to the lead-in period (3 months), Randomization will be strati ed by country. Primary analysis will be conducted based on the intention-to-treat principle. Data recruitment commenced on February 22, 2019, and was closed on 23 rd December 2021. The database will be locked in September 2023. Discussion: This paper provides a comprehensive description of the statistical analysis plan in order to ensure reproducibility of the analysis and avoid selective reporting of outcomes and data-driven analysis. Sensitivity analyses have been included in the protocol to assess the impact of intercurrent events related to the Coronavirus disease 2019. By focusing on clinically meaningful and robust outcomes, this trial aims to determine whether TUDCA can be effective in slowing the disease progression in patients with ALS.
Background In recent years, considerable efforts have been directed towards the research and deve... more Background In recent years, considerable efforts have been directed towards the research and development of disease-modifying therapies for dementia. These drugs focus on prodromal (Mild Cognitive Impairment, MCI) and/or early stages of Alzheimer's disease. Evidence from literature demonstrates that a considerable proportion of MCI subjects never progress to dementia. Therefore it is of utmost importance to identify those individuals who are at a higher risk of developing dementia. Methods The ongoing INTERCEPTOR study is a multicenter, longitudinal, interventional, non-therapeutic cohort study designed to enroll 500 subjects with MCI aged 50-85 years. The primary aim is to identify a biomarker or a set of biomarkers able to accurately predict the conversion from MCI to AD within 3 years of follow-up. The biomarkers investigated in this study are neuropsychological tests (mini-mental state examination MMSE and delayed free recall), brain glucose metabolism ([ 18 F]FDG-PET), MRI volumetry of the hippocampus, EEG brain connectivity, cerebrospinal uid (CSF) markers (p-tau, t-tau, Aβ1-42, Aβ1-42/1-40 ratio, Aβ1-42 /p-Tau ratio) and APOE genotype. The baseline visit includes a full cognitive and neuropsychological evaluation, as well as the collection of clinical and socio-demographic information. Prognostic models will be developed using Cox regression, incorporating patient characteristics and biomarkers through stepwise selection. Model performance will be evaluated in terms of discrimination and calibration and subjected to internal validation using the bootstrapping procedure. The nal model will be visually represented as a nomogram. Discussion This paper contains a detailed description of the statistical analysis plan to ensure the reproducibility and transparency of the analysis. The prognostic model developed in this study aims to identify the population with MCI at higher risk of developing dementia, potentially eligible for drugs prescriptions. The nomogram could provide a valuable tool for clinicians for risk strati cation and early treatment decisions. Trial registration ClinicalTrials.gov NCT03834402.
Journal of Medical Virology, Jul 27, 2016
Background According to small studies carried out in preselected populations, the estimated preva... more Background According to small studies carried out in preselected populations, the estimated prevalence of anti-hepatitis C virus (HCV) antibodies in Poland ranges from 0.6 to 2.1%. Aims The aim of this study was to evaluate the prevalence of anti-HCV and HCV RNA among patients and healthcare workers. Methods Anti-HCV antibodies were measured (Elecsys, Roche) in serum samples from 26 057 adults, consecutive patients or healthcare workers, from hospitals and out patient clinics not involved in the management of liver diseases. The majority of them (18 233) consented to fill out an anonymous questionnaire related to possible risk factors for HCV infection. Anti-HCV-positive samples were assessed for HCV RNA (Cobas Amplicor, Roche). A multivariate logistic regression model and the v 2 test or the Fisher's exact test were applied. Results Anti-HCV antibodies were detected in 1.9% of individuals, and 31% of them demonstrated HCV RNA, which varied from 26% in hospitals to 66% in specialistic outpatient clinics. Prevalence of anti-HCV was significantly lower in healthcare workers (1.42%) than in patients (1.92%). Significant independent risk factors for anti-HCV positivity were as follows: male sex, more than three hospitalizations in a lifetime, blood transfusions before 1992, and intravenous drug use. The only significant risk factor for HCV RNA was intravenous drug use. An analysis carried out for multispecialistic hospitals demonstrated significantly lower prevalence of HCV RNA positivity in healthcare workers. Conclusion Prevalence of anti-HCV in the Polish population studied was up to 1.9%, but active infection could be diagnosed in only 31% of them. Intravenous drug use, blood transfusions before 1992, multiple hospitalizations, and male sex increase the risk of HCV infection.
PubMed, Sep 22, 2022
The Italian Fund for Alzheimer's and other dementias was approved and signed in December 2021. Th... more The Italian Fund for Alzheimer's and other dementias was approved and signed in December 2021. The Fund is financed with 15 million euros in three years. The main goal is to provide new strategies in the field of dementia with a Public Health perspective. The Fund includes eight main activities that will be monitored and supervised by the Italian National Institute of Health: 1) development of a guideline for the assessment, management and support for people with dementia and their families/carers; 2) updating of the Dementia National Plan (DNP); 3) implementation of the documents of the DNP; 4) conducting surveys dedicated to the Italian Dementia Services; 5) promotion of dementia prevention strategies; 6) training strategies for healthcare professionals, families and caregivers; 7) creation of a National Electronic Record for Dementia; 8) evaluation and monitoring of activities promoted by Regions and Autonomous Provinces in the field of dementia, together with the dementia National Permanent Table. These activities are outlined in detail in the present paper.
Journal of the Neurological Sciences, Oct 1, 2021
Journal of the Neurological Sciences, Oct 1, 2021
Background and aims: Many clinical trials on potentially disease-modifying drugs are focused to m... more Background and aims: Many clinical trials on potentially disease-modifying drugs are focused to mild cognitive impairment (MCI) prodromal-to-Alzheimer's disease. The MCI population actually includes patients with higher risk of progression to AD. Since the new drugs, if effective, will carry both elevated unit costs and not marginal side effects, they should be administered selectively to high-risk subjects. The Italian INTERCEPTOR project, promoted by the Italian Medicine Agency and the Italian Ministry of Health, is a multicenter, interventional, nontherapeutic cohort study in subjects with MCI, with the primary aim of identifying biomarkers that better predict the conversion to AD after 3 years of follow-up. Methods: A sample of 500 subjects with MCI was planned to be enrolled. The biomarkers under investigation obtained by the analysis of MMSE, CSF, FDG-PET, FCRST, APOE4, EEG, Volumetric MRI. Multivariate prediction model will provide the predictive performance of each biomarker and combinations. In applying biomarkers, three scenarios are considered: 1) use of cut-offs indicated by experts 2) defining new optimal cut-offs for the specific population 3) use of values in a continuous form in order to evaluate all predictive information. Finally, nomograms will be defined for use in clinical practice. Results: Due to COVID-19, the target sample size was not reached. The enrolment was closed on October 31st 2020. Overall 498 patients were screened, 362 recruited into the study and 17 dropped out. Conclusions: The findings will support the diagnostic path redefinition to identify those patients in the early stage eligible to prescription for disease-modifying medications.
Digestive and Liver Disease, Feb 1, 2016
European Psychiatry, 2013
Introduction A relative decline in systolic blood pressure has been found to occur prior to and a... more Introduction A relative decline in systolic blood pressure has been found to occur prior to and around the clinical onset of dementia but the reasons for this remain unclear. Aims and objectives In a large series of surveys carried out using identical methodology in populations with relatively low mean blood pressures we investigated the consistency of the association between dementia, dementia severity and resting blood pressure. Methods The analysed sample comprised 15,022 participants from eleven cross-sectional surveys carried out in seven low and middle income countries (Cuba, Dominican Republic, Peru, Venezuela, Mexico, China and India). Associations between dementia status (ascertained through a detailed assessment with extensive cross-cultural validation) and resting blood pressure were described for each sample and then compared in meta-analyses. Results In age- and sex-adjusted linear regression analyses, there was a high level of between-site heterogeneity in these associations (I-squared 60.2% for dementia and SBP). The only site with significant and consistent associations was Cuba (n=2944), the sample with highest mean systolic blood pressure, where dementia was associated with 7.9mmHg lower systolic blood pressure (95% CI 4.7-11.1) and 2.6mmHg lower diastolic blood pressure (95% CI 0.9-4.2). In general, associations between dementia and lower blood pressure were weak or absent in these surveys. Conclusions The association between dementia and low blood pressure, generally observed in Western settings was not observed in these populations with lower hypertension prevalence. These findings do not support a hypothesis that lower blood pressure in dementia is purely secondary to underlying neurodegeneration.
Lancet Neurology, Feb 1, 2023
European Journal of Internal Medicine, Sep 1, 2012
Background: The epidemiological pattern of hepatitis B virus infection in Italy has greatly chang... more Background: The epidemiological pattern of hepatitis B virus infection in Italy has greatly changed over the past decades. The aim of the study was to evaluate during time the epidemiological features of acute hepatitis B cases referred to an Infectious Disease Unit in NorthEast of Italy between 1978 and 1995. Patients and methods: Stored sera of 183 cases were tested for HBV markers, HBV genotypes, anti-Delta and anti-HCV. Results: Anti-HBcIgM was positive in all cases. Mean age increased from 30.2 years in 1978 to 37.5 in 1995 (P b 0.01). Significant increase was observed in proportion of cases reporting intravenous drug use from 11.5% to 29.6% (P b 0.03). Chronicity rate was as low as 1.1%. Mean days of hospitalization significantly decreased. HBV genotype determination showed that majority of cases was infected by genotype D, but its prevalence decreased from 88.2% in 1978 to 75.0% in 1995. Delta coinfection was present in 8.2%. The prevalence of HCV in patients with acute HBV was 35.0%; it fluctuated from 26.2% to 44.2%, mostly related (53.1%) to intravenous drug use. Dual infection did not lead to a more severe course of disease. Conclusions: From this retrospective study, remarkable fluctuations in the prevalence of dual HBV-HCV infection before the implementation of HBV vaccination were observed. Presence of anti-HCV did not affect the course of acute HBV.
European Journal of Clinical Pharmacology, Oct 22, 2013
To evaluate the effect of a broad range of covariates on the survival of a real-life long-term fo... more To evaluate the effect of a broad range of covariates on the survival of a real-life long-term follow-up cohort of community-dwelling patients with behavioural and psychological symptoms of dementia who were new users of atypical antipsychotic medications (APMs). This was a prospective cohort study of 1,618 subjects aged ≥65 years with dementia and BPSD (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;behavioural and psychological symptoms of dementia&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;quot;) who were new users of atypical APMs and registered in a Dementia Evaluation Unit of Campania Region (Italy) from September 2006 to March 2010. The potential of baseline features to predict mortality was assessed with the Cox proportional hazards model. The average follow-up was 309 days. Of the 1,618 new users of atypical antipsychotics, 9.3 % experienced at least one adverse event, including death (5.1 %), drug therapeutic failure (3.0 %), extrapyramidal symptoms (0.5 %) and stroke (0.2 %). The crude all-cause mortality rate was 6.0 per 100 person-years [95 % confidence interval (CI) 4.8-7.4]; the rate was higher in patients aged &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;85 years (9.0 per 100 person-years, 95 % CI 6.4-12.7) and among male patients (7.5 per 100 person-years, 95% CI 5.3-10.6). In the multivariate analysis, only age was associated to all-cause mortality [hazard ratio (HR) 1.1; 95 % CI 1.0-1.1 and HR 1.4; 95 % CI: 0.9-2.2, respectively). In contrast, hallucination (HR 0.4; 95 % CI 0.2-0.6) and dosage change (HR 0.4; 95 % CI 0.2-0.78) were significantly associated with a lower risk of all-cause mortality. Among our patient cohort, the mortality rate of patients with BPSD receiving long-term treatment with atypical APMs was lower than that reported in other studies, and only age was found to be significant predictor factor of mortality.
European Journal of Internal Medicine, Dec 1, 2012
Background: Hepatitis B virus infection has decreased in Italy. The aims of this study were to id... more Background: Hepatitis B virus infection has decreased in Italy. The aims of this study were to identify changes, if any, in the epidemiological pattern of HBV infection in a southern Italian town first surveyed in 1996 and to assess the effectiveness of vaccination campaign against hepatitis B. Methods: In 2010, subjects were selected from the census by a systematic 1:4 random sampling procedure. Hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc) were detected by ELISA. Associations (odds ratios) linking exposure to hepatitis B virus infection to potential risk factors were estimated by univariate and multivariate analyses. Results: Of the 1100 eligible subjects, 1020 (92.0%) agreed to participate. The prevalences of HBsAg (0.6%) and anti-HBc (15.2%) were significantly lower than in 1996 (0.8% and 21.5%) (p b 0.01). No subject below 30 years of age (those that had been targeted for compulsory immunization) had been exposed to HBV infection. At multiple logistic regression analysis, age > 45 years (OR = 9.8; 95% CI = 5.1-18.7) and past use of glass syringes (OR = 1.9; 95% CI = 1.2-3.1) independently predicted the likelihood of anti-HBc positivity. Conclusions: These results, albeit obtained in a small town and thus not generalizable, confirm the continuous decreasing trend of HBV infection and demonstrate the effectiveness of the Italian hepatitis B vaccination program.
PLOS ONE, May 23, 2013
Background: We investigated temporal trends and geographic variations in both hospitalizations an... more Background: We investigated temporal trends and geographic variations in both hospitalizations and in-hospital mortality rates for acute diabetic complications (ADC) in the Italian universal health care system. Methods and Findings: A retrospective review of the medical records of patients with either primary or secondary discharge diagnosis of hyperglycaemic acute complications (ICD-9-CM codes 250.1, 250.2, 250.3) or hypoglycemic coma (ICD-9-CM code 251.0) was performed in period 2001-2010. Standardized rates by age and gender on 2001 Italian population and by diabetic population were calculated. We identified 7,601.883 diabetes-related hospital discharges. Out of them, 266,374 (3.5%) were due to ADC, either ketoacidosis/hyperosmolarity (94.4%) or hypoglycemic coma (5.6%). The rate of discharge for ADC decreased by 51.1% from 2001 to 2010 (14.4 vs. 7.1 discharge rate/1,000 diabetic people; 5.7% decrease per year, test for trend, p,0.001) with a similar trend for both hyperglycemic and hypoglycemic complications. Diabetic people in the younger age groups (#19 and 20-44 years old) had a significantly greater rate of discharge for ADC than people aged 65 years and over (#19 10-fold increase; 20-44: 2-fold increase). In-hospital mortality rate was 7.6%, with 211 preventable deaths in younger diabetic people (#44 years old). There was a large variability among Italian Regions and the ratio between the highest and the lowest regional discharge rate reached 300% in 2010. Conclusions: Decreasing temporal trend in hospitalizations for preventable ADC suggests improving outpatient care. In younger diabetic patients, however, both hospitalization rates and in-hospital mortality are still a matter of concern.
BMC Women's Health, Feb 27, 2010
Background: The present study describes Complementary and Alternative Medicine (CAM) use amongst ... more Background: The present study describes Complementary and Alternative Medicine (CAM) use amongst Italian women transitioning through menopause. Popularity and perceived effectiveness of CAM treatments, use of pharmaceutical medications, characteristics of CAM users, the extent of communication between medical practitioners and women about their use of CAM, and variables associated with CAM use were also investigated. Methods: Women, aged 45-65 years attending Family Planning and Women's Health clinics or Menopause Centres in Bologna were invited to complete a voluntary, anonymous, self administered questionnaire, which was used in a previous study in Sydney. The questionnaire was translated and adapted for use amongst Italian women. Data on general demographic and health characteristics, menopause related symptoms and the use of CAM and pharmaceutical treatments during the previous 12 months were collected. Results: In total, 1,203 women completed the survey, of which 1,106 were included in the final sample. Of women who had symptoms linked with menopause and/or used remedies to alleviate symptoms, 33.5% reported to have used CAM. Among these, 23.5% had consulted one or more practitioners and 24% had used at least one CAM product. Approximately nine out of ten respondents reported medical practitioners did not seek information about their use of CAM; while one third of CAM users did not disclose the use of CAM to their physician. Nevertheless, medical practitioners were the most popular source of information. From the multivariate analysis, variables associated with CAM use were: professional employment, time since the last natural menses, use of CAM for conditions other than menopause, and presence of some severe symptoms. Conclusions: The relatively high prevalence of CAM use by women transitioning through menopause should encourage research initiatives into determining which CAM treatments are the safest and effective. The increasing and likely concomitant use of CAM with HRT and other pharmaceuticals underlines the need for the implementation of a surveillance system to report and monitor possible drug-herb adverse events. The discrepancy between women preferring to seek information about CAM from their medical doctor and the difficulties noted in communication between doctor and patient should encourage educational initiatives on CAM by health-care agencies and institutions.
Infection, Dec 16, 2011
Universal anti-hepatitis B vaccination of infants and of 12-year-old children became mandatory in... more Universal anti-hepatitis B vaccination of infants and of 12-year-old children became mandatory in Italy in 1991. The purpose of this study was to evaluate the persistence of anti-hepatitis B surface (HBs) antibodies several years after a primary course of vaccination. In 2010, anti-HBs titers were measured in all subjects aged between 5 and 25 years residing in a southern Italian town. Individuals with an anti-hepatitis B antibody concentration of 10 IU/ml or more were considered to be protected. Of the 671 subjects evaluated, 149 (30%) lacked protective antibodies. Fifty-three (29.4%) of the subjects had been vaccinated ≤10 years earlier and 96 (30.3%) more than 10 years earlier (P = not significant). Subjects vaccinated in infancy were more likely to lack protective anti-HBs antibodies than subjects vaccinated at 12 years of age, regardless of the years elapsed since immunization. Most subjects maintained protective antibodies for a considerable number of years after vaccination. Vaccination in adolescence results in more prolonged immunogenicity than vaccination in infancy.
Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condit... more Background: Amyotrophic Lateral Sclerosis (ALS) is a highly debilitating neurodegenerative condition. Despite recent advancements in understanding the molecular mechanisms underlying ALS, there have been no significant improvements in therapeutic options for ALS patients in recent years. Currently, there is no cure for ALS, and the only approved treatment in Europe is riluzole, which has been shown to slow the disease progression and prolong survival by approximately three months. Recently, tauroursodeoxycholic acid (TUDCA) has emerged as a promising and effective treatment for neurodegenerative diseases due to its neuroprotective activities. Methods: The ongoing TUDCA-ALS study is a double-blinded, parallel arms, placebo-controlled, randomized multicenter phase III trial with the aim to assess the efficacy and safety of TUDCA as add-on therapy to riluzole in patients with ALS. The primary outcome measure is defined as a minimum 20% improvement in the ALS Functional Rating Scale-Rev...
1<p>Data for zero inflation are odds ratios (95% confidence interval); data for count model... more 1<p>Data for zero inflation are odds ratios (95% confidence interval); data for count model are ratio of counts (95% confidence interval).</p>*<p>Adjusted for age, gender, educational level, number of household assets, self-reported stroke, diabetes, number of physical illnesses, marital status, overall cognitive score and physical activity level.</p