Showing papers by "Lorenzo G. Mantovani published in 2022"
TL;DR: During the post-first lockdown AD use increased, with higher incidence- and similar prevalence values compared with those expected in the absence of the outbreak, and this pandemic has impacted AD drug use in the general population with potential rebound effects during the period between waves.
Abstract: In Italy, during the COVID-19 waves two lockdowns were implemented to prevent virus diffusion in the general population. Data on antidepressant (AD) use in these periods are still scarce. This study aimed at exploring the impact of COVID-19 lockdowns on prevalence and incidence of antidepressant drug use in the general population. A population-based study using the healthcare administrative database of Tuscany was performed. We selected a dynamic cohort of subjects with at least one ADs dispensing from 1 January 2018 to 27 December 2020. The weekly prevalence and incidence of drug use were estimated across different segments: pre-lockdown (1 January 2018–8 March 2020), first lockdown (9 March 2020–15 June 2020), post-first lockdown (16 June 2020–15 November 2020) and second lockdown (16 November 2020–27 December 2020). An interrupted time-series analysis was used to assess the effect of lockdowns on the observed outcomes. Compared to the pre-lockdown we observed an abrupt reduction of ADs incidence (Incidence-Ratio: 0.82; 95% Confidence-Intervals: 0.74–0.91) and a slight weekly decrease of prevalence (Prevalence-Ratio: 0.997; 0.996–0.999). During the post-first lockdown AD use increased, with higher incidence- and similar prevalence values compared with those expected in the absence of the outbreak. This pandemic has impacted AD drug use in the general population with potential rebound effects during the period between waves. This calls for future studies aimed at exploring the mid–long term effects of this phenomenon.
8 citations
TL;DR: This study quantifies the time-varying effects of vaccine-induced and hybrid immunity after the booster dose and observed that the protection waned more rapidly in infection-naïve recipients starting from the third month, adding important evidence that can be used to inform COVID-19 vaccination strategies.
Abstract: This longitudinal observational study investigated the risk of breakthrough SARS-CoV-2 infection up to 6 months after a booster dose of an mRNA COVID-19 vaccine in infection-naïve vs. previously infected healthcare workers (HCWs), and whether this difference varied over time. A Cox proportional hazard regression model with Aalen’s additive analysis was fitted to examine the association between the risk of infections and predictor variables. Overall, we observed an incidence rate of 2.5 cases per 1000 person-days (95% confidence interval [CI] 2.0–3.0), which dropped at 0.8 per 1000 person-days (95% CI 0.3–2.0) in recipients with prior SARS-CoV-2 infection. The fitted analysis indicated an adjusted hazard ratio of 0.32 (95% CI 0.13–0.80; p-value = 0.01) for those with hybrid immunity with a slope that became steeply negative roughly starting from day 90. No difference was seen according to participants’ smoking habits. Characteristics of infected HCWs were also described. Our study quantifies the time-varying effects of vaccine-induced and hybrid immunity after the booster dose (during the Omicron variant predominance in Italy) and observed that the protection waned more rapidly in infection-naïve recipients starting from the third month. The results add important evidence that can be used to inform COVID-19 vaccination strategies.
8 citations
TL;DR: The Patient Reported Outcome for Multiple Sclerosis (PROMS) Initiative as discussed by the authors was launched at the 35th Congress of the European Committee for Treatment and Research in multiple sclerosis (ECTRIMS) in 2019.
Abstract: On 12 September 2019, the global Patient Reported Outcome for Multiple Sclerosis (PROMS) Initiative was launched at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The multi-stakeholder PROMS Initiative is jointly led by the European Charcot Foundation (ECF) and the Multiple Sclerosis International Federation (MSIF), with the Italian Multiple Sclerosis Society (AISM) acting as the lead agency for and on behalf of the global MSIF movement. The initiative has the ambitious mission to (i) maximize the impact of science with and of patient input on the life of people affected by MS, and (ii) to represent a unified view on Patient-Reported Outcomes for MS to people affected by MS, healthcare providers, regulatory agencies and Health Technologies Assessments agencies. Equipped with an innovative participatory governance of an international and interdisciplinary network of different stakeholders, PROMS has the potential to guide future breakthroughs in MS patient-focused research and care. In this paper we present the progresses of the global PROMS Initiative and discuss the open questions that we aim to address.
6 citations
TL;DR: In this paper , the authors evaluated the prevalence and factors associated with sarcopenia, defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) 2019 definition, and to evaluate the prevalence of the single criteria that define the EWGSOP 2 definition (muscle strength, muscle quantity and physical performance), in a cohort of consecutive patients with IPF prospectively followed up in 9 hospitals in Northern Italy between December 2018 and May 2021.
Abstract: Sarcopenia gained importance in the evaluation of patients with chronic respiratory diseases, including idiopathic pulmonary fibrosis (IPF), since it may impact negatively on clinical outcomes.Aim of this study is to evaluate the prevalence and factors associated with sarcopenia, defined according to the European Working Group on Sarcopenia in Older People 2 (EWGSOP2) 2019 definition, and to evaluate the prevalence of the single criteria that define the EWGSOP2 definition (muscle strength, muscle quantity and physical performance), in a cohort of consecutive patients with IPF prospectively followed up in 9 hospitals in Northern Italy between December 2018 and May 2021.Enrolled patients underwent an extensive pulmonary and nutritional assessment, including bioelectrical impedance analysis, dynamometry and 4-m gait speed test, both at IPF diagnosis and at 6-month follow-up.Out of the 83 patients (81% males, mean age 72.5 years) with IPF at disease diagnosis enrolled in the study, 19 (22.9%) showed sarcopenia, including 2 (2.4%) with severe sarcopenia, 5 (6.0%) with confirmed sarcopenia and 12 (14.5%) with probable sarcopenia. Sarcopenia was associated with a significantly higher severity of the disease and sedentary lifestyle, while no differences were observed in regards to body mass index, history of weight loss and comorbidities between patients with and without sarcopenia. Out of the 64 patients without sarcopenia at baseline, 16 cases showed alteration of muscle quantity and/or physical performance. In the 51 patients with complete data at 6-month follow-up, there were no cases of severe sarcopenia, 1 case (2.0%) showed confirmed sarcopenia, while the prevalence of probable sarcopenia was 19.6% (10 cases). No differences in regards to antifibrotic treatment received and onset of gastrointestinal side effects were observed between patients with and without sarcopenia at follow-up.The prevalence of sarcopenia in patients with IPF both at diagnosis and at 6-month follow-up was low but not negligible and was associated with higher severity of the disease and sedentary lifestyle. In IPF patients, a comprehensive diagnostic work-up including all the criteria defining the EWGSOP2 definition might be more useful than a series testing for prompt recognition of nutritional and physical performance abnormalities.
4 citations
TL;DR: The role of statins among patients with established cardiovascular diseases (CVDs) who are hospitalized with COVID-19 is still debated as mentioned in this paper , and the prior use of statin exposure was associated with a less severe CoV-19 prognosis.
Abstract: Background: The role of statins among patients with established cardiovascular diseases (CVDs) who are hospitalized with COVID-19 is still debated. This study aimed at assessing whether the prior use of statins was associated with a less severe COVID-19 prognosis. Methods: Subjects with CVDs infected with SARS-CoV-2 and hospitalized between 20 February 2020 and 31 December 2020 were selected. These were classified into two mutually exclusive groups: statins-users and non-users of lipid-lowering therapies (non-LLT users). The relationship between statins exposure and the risk of Mechanical Ventilation (MV), Intensive Care Unit (ICU) access and death were evaluated by using logistic and Cox regressions models. Results: Of 1127 selected patients, 571 were statins-users whereas 556 were non-LLT users. The previous use of statins was not associated with a variation in the risk of need of MV (Odds Ratio [OR]: 1.00; 95% Confidence Intervals [CI]: 0.38–2.67), ICU access (OR: 0.54; 95% CI: 0.22–1.32) and mortality at 14 days (Hazard Ratio [HR]: 0.42; 95% CI: 0.16–1.10). However, a decreased risk of mortality at 30 days (HR: 0.39; 95% CI: 0.18–0.85) was observed in statins-users compared with non-LLT users. Conclusions: These findings support the clinical advice for patients CVDs to continue their treatment with statins during SARS-CoV-2 infection.
3 citations
TL;DR: In this article , the authors developed a Markov model comparing costs, patient survival, and quality-of-life, and calculated the Incremental Cost-Effectiveness Ratio (ICER) of a wearable cardioverter defibrillator (WCD) vs. current standard of care in post-MI patients.
3 citations
TL;DR: In this article , the value associated with a treat-to-target (T2T) strategy based on tight control of mild-moderate ulcerative colitis (UC) was assessed.
Abstract: There are no data to assess the value associated with a treat‐to‐target (T2T) strategy based on tight control of mild–moderate ulcerative colitis (UC).
3 citations
TL;DR: In this paper , the authors compared the benefits of azithromycin for treatment of patients with positive SARS-CoV-2 test results in the community and found that the benefits were not significant.
3 citations
TL;DR: In this paper , the authors evaluated the rate of correct indication for pancreatectomy defined as high grade dysplasia (HGD) at histology in 961 patients who underwent surveillance for a median of 5.1 years.
Abstract: Surveillance costs and appropriateness of surgery of "low-risk" BD-IPMNs are relevant issues. In this study we evaluated the rate of correct indication for pancreatectomy defined as high grade dysplasia (HGD) at histology in 961 patients who underwent surveillance for a median of 5.1 years. Undertreatment and overtreatment were defined as invasive cancer and low grade dysplasia (LGD) at histology, respectively. Of the 66 patients (6.9%) who were operated, only 16 (23.8%) had a HGD while 40 (59.7%) had a LGD and 10 (14.9%) an invasive cancer, without differences regarding timing of surgery. The mean surveillance cost was € 194.9 ± 107.6 per patient-year, with a median cost of € 277.1 ± 148.2 in the correct surgery group compared with € 222.7 ± 111.6 and € 197 ± 102.7 in the overtreatment and undertreatment groups. The surveillance mean cost from diagnosis to surgery was € 854.8. Rate of appropriate surgery in BD-IPMNs under surveillance is low.
2 citations
TL;DR: Haemophilia management and patients’ quality of life significantly improved and data on current patients', caregivers’ and clinicians’ satisfaction and limitations of treatments and haemophilic management are limited.
Abstract: Introduction: Haemophilia management and patients’ quality of life significantly improved. However, data on current patients’, caregivers’ and clinicians’ satisfaction and limitations of treatments and haemophilia management are limited.
2 citations
TL;DR: The appropriate evaluation of influenza vaccines based on epidemiological and economic data is of the utmost importance for accurately informing policymakers and allocating resources for seasonal influenza vaccination programs.
Abstract: © 2022 The Authors. Published by SEEd srl. This is an open access article under the CC BY-NC 4.0 license (https://creativecommons.org/licenses/by-nc/4.0) BACKGROUND Seasonal influenza is an acute viral respiratory disease which circulates globally with constantly evolving epidemiology [1]. Influenza viruses can infect up to 20% of the global population each year, resulting in more than 650,000 annual deaths [2]. Seasonal influenza is therefore a major cause of illness, associated with substantial health and economic burdens, due to its impact on healthcare – with increased medical resource utilization and costs, and on society – with enormous death toll and loss of production [3]. Effective vaccines and timely vaccination programs are crucial strategies for the control of seasonal influenza, the spread and severity of which is unpredictable. Influenza viruses are constantly changing due to different types of mutation in viral genes that result in altered surface glycoproteins (hemagglutinin and neuraminidase), which enables viruses to escape the antigen-specific immunity that is induced by prior infections and/or vaccination [1]. Changes in antigenic sites result from either common point mutations during viral replication, which cause small changes in surface proteins (antigenic drift), or from less frequent significant genetic reassortment and the consequent emergence of novel virus subtypes or clades (antigenic shift) [4]. Antigenic evolution and regional variations in environmental strain / clade dominance require that the antigen composition of seasonal influenza vaccines is changed annually [1,4]. Annual vaccination is the best way to prevent influenza disease in people aged 6 months and older [3]. Influenza vaccines are proven to be economically favorable in specific populations including older adults, people with chronic medical problems, pregnant women, and children – from both healthcare and societal perspectives [3]. Therefore, the appropriate evaluation of influenza vaccines based on epidemiological and economic data is of the utmost importance for accurately informing policymakers and allocating resources for seasonal influenza vaccination programs [2,3].
TL;DR: The aim of this study was to assess the mortality of IPF patients included in the cohort of the tertiary outpatient IPF clinic at the “San Gerardo” Hospital, located in Monza (Lombardy, the most populated Italian region) in relation to the social and healthcare changes due to COVID-19 pandemic.
TL;DR: In this article , the authors designed a randomized controlled trial to evaluate the effectiveness of perioperative continuous infusion of amino acids in decreasing acute kidney injury (AKI) in cardiac surgery patients.
TL;DR: In this paper , the prevalence and distribution of various types of malocclusions in the pediatric population were verified using cephalometric analyzes of the patients and were differentiated on the basis of gender and ethnicity.
Abstract: Background: Epidemiological investigations define the prevalence and distribution of the various types of malocclusions, and can help to identify etiological factors and set the most correct orthodontic therapy. Aim: The goal of this study was to verify the prevalence and distribution of various types of malocclusions in the pediatric population. Methods: The study was performed on a sample of 350 patients (ages 5–9) being treated at the ASST Grande Ospedale Metropolitano Niguarda in Milan. A comparison was presented with one similar epidemiological investigation conducted 22 years earlier by the same researchers. The values of the malocclusion indices were reported from the cephalometric analyzes of the patients and were differentiated on the basis of gender and ethnicity. Results: The predominant traits of malocclusion in the general population of the analyzed sample were: skeletal class II (47.43%), hyper-divergence (40.86%), maxillary retrusion (46%), mandibular retrusion (66%), maxillary hypoplasia (50%), mandibular hypoplasia (49.14%), Wits index > 2 mm (22.57%); overjet > 4 mm (31.1%) and overbite > 4 mm (24.86%). Substantial differences were found between Italian patients and patients belonging to different ethnic groups in almost all parameters, and between the male and female genders in some of them. Patients in the 2000 study had a higher prevalence of Class II and hyper-divergence. Conclusions: This epidemiological investigation can suggest different approaches in setting the orthodontic treatment plan based on the ethnic group of the patient taken in charge and encourage more specific and large-scale analytical studies on the subject.
TL;DR: In this article , the authors compared the effectiveness of direct oral anticoagulants (DOACs) and vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis.
Abstract: Background Direct oral anticoagulants (DOACs) provide a safe, effective alternative to vitamin K antagonists (VKAs) for venous thromboembolism (VTE) treatment, as shown via intention-to-treat comparative effectiveness analysis. However, on-treatment analysis is imperative in observational studies because anticoagulation choice and duration are at investigators' discretion. Objectives The aim of the study is to compare the effectiveness of DOACs and VKAs on 12-month outcomes in VTE patients using on-treatment analysis. Methods The Global Anticoagulant Registry in the FIELD - VTE (GARFIELD-VTE) is a world-wide, prospective, non-interventional study observing treatment of VTE in routine clinical practice. Results In total, 8,034 patients received VKAs ( n = 3,043, 37.9%) or DOACs ( n = 4,991, 62.1%). After adjustment for baseline characteristics and follow-up bleeding events, and accounting for possible time-varying confounding, all-cause mortality was significantly lower with DOACs than VKAs (hazard ratio: 0.58 [95% confidence interval 0.42–0.79]). Furthermore, patients receiving VKAs were more likely to die of VTE complications (4.9 vs. 2.2%) or bleeding (4.9 vs. 0.0%). There was no significant difference in rates of recurrent VTE (hazard ratio: 0.74 [0.55–1.01]), major bleeding (hazard ratio: 0.76 [0.47–1.24]), or overall bleeding (hazard ratio: 0.87 [0.72–1.05]) with DOACs or VKAs. Unadjusted analyses suggested that VKA patients with active cancer or renal insufficiency were more likely to die than patients treated with DOAC (52.51 [37.33–73.86] vs. 26.52 [19.37–36.29] and 9.97 [7.51–13.23] vs. 4.70 [3.25–6.81] per 100 person-years, respectively). Conclusion DOACs and VKAs had similar rates of recurrent VTE and major bleeding. However, DOACs were associated with reduced all-cause mortality and a lower likelihood of death from VTE or bleeding compared with VKAs.
TL;DR: Compared to interferon beta-1b, siponimod seems to be cost-effective in SPMS patients and sustainable, with less than 1% overall budget increased in the next 3 years.
Abstract: 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. The results were reported as incremental cost-effectiveness ratio (ICER) and net-monetary benefit (NMB) for CEA, using a willingness to pay threshold of €40,000 per QALY gained, and as difference in the overall budget (Euro) between the scenario with and without siponimod for budget impact. Results In the base case scenario siponimod resulted cost-effective compared with interferon beta-1b 28,891€ per QALY. Overall, the market access of siponimod was associated to an increased budget of about 3€ millions (+0.9%) in the next 3 years simulated. Conclusion Compared to interferon beta-1b, siponimod seems to be cost-effective in SPMS patients and sustainable, with less than 1% overall budget increased in the next 3 years. Future studies need to confirm our results in the real word setting and in other countries.
TL;DR: Standardized ET incidence was comparable in the UK and France, showing a slight increase in both countries, reporting a higher value among people aged 60 years and older.
Abstract: Introduction Although essential tremor (ET) is considered a common adult movement disorder, evidence on its incidence is still scant. This study aims at estimating ET incidence in two European countries, namely, the UK and France. Methods Incident cases of ET were identified within the Health Improvement Network (THIN®) database between 1st January 2014 and 31 December 2019. Yearly crude and standardized incidence rates (IR) were estimated across the study period for both countries. Poisson regression models were built to assess temporal trends in IRs and differences between sexes and age classes. Results In total, 4,970 and 4,905 incident cases of ET were identified in the UK and France, respectively. The yearly average crude IR (per 100,000 person-years) was 18.20 (95%CI: 15.09–21.32) in UK and 21.42 (17.83–25.00) in France, whereas standardized ones were 19.51 (18.97–20.01) and 19.50 (18.97-20.05). Regression analyses showed slightly increasing trends in both countries, higher incidence among males, and a significant increase with age. Yearly average IR increased from 3.96 (0.95–6.97) and 5.28 (1.12–9.44) in subjects aged <20 years to 49.27 (26.29–72.24) and 51.52 (30.19–72.86) in those aged >80 year in UK and France. Conclusions Standardized ET incidence was comparable in the UK and France, showing a slight increase in both countries, reporting a higher value among people aged 60 years and older. This study outlines the need to conduct future studies to estimate the burden of ET in terms of disease control and healthcare resource utilization.
TL;DR: Dimethyl fumarate is dominant (societal perspective), or cost-effective (NHS perspective), referring to a threshold of € 50,000 per QALY gained, vs teriflunomide for the first-line treatment of RRMS, in the Italian setting.
Abstract: BACKGROUND: The objective of this economic analysis was to compare the cost-effectiveness of dimethyl fumarate vs teriflunomide for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) in the Italian setting. Additionally, the cost-effectiveness analysis was used to predict some patient-relevant outcomes such as burden of relapses and survival with disability over time.METHODS: A Markov model was used to conduct the cost-effectiveness analysis. The model measured health outcomes and costs of RRMS patients treated with either dimethyl fumarate or teriflunomide. Data from a published mixed treatment comparison were used for efficacy and safety input. Local economic data were used to calculate costs. A supplementary analysis was carried out to assess ICER variability over time from the Italian National Healthcare Service (NHS) and societal perspectives. Further analyses were conducted to compare clinical effectiveness of the alternatives over time, in terms of incidence of relapses, proportion of patients with EDSS (Expanded Disability Status Scale) score ≤3 and EDSS score ≥6.RESULTS: In the base-case analysis (lifetime horizon; societal perspective) dimethyl fumarate was dominant over teriflunomide (6.526 vs 5.953 QALYs – quality-adjusted life-years; € 1.01 M vs € 1.03 M). The most relevant cost savings (per-patient) with dimethyl fumarate were related to relapses (-€ 5,096), inpatient care (-€ 5,767), informal care (-€ 9,603), long-term absence/early retirement (-€ 14,187). The additional analysis of ICER by time horizon shows that dimethyl fumarate is cost-effective vs teriflunomide (i.e., ICER <€ 50,000 per QALY gained) at already 6 years and at 15 years in societal or NHS perspectives, respectively. Results favoured dimethyl fumarate vs teriflunomide also for: cumulative burden of relapses (-0.23 and -1.37 relapses saved per patient already at 1 year and 10 years, respectively), proportion of patients with mild disability (+4.0% at 10 years), proportion of patients with severe disability (-4.0% at 10 years).CONCLUSIONS: Dimethyl fumarate is dominant (societal perspective), or cost-effective (NHS perspective), referring to a threshold of € 50,000 per QALY gained, vs teriflunomide for the first-line treatment of RRMS, in the Italian setting.
TL;DR: In this article , an observational cohort study of patients with primary MS (PPMS) and secondary progressive MS (SPMS) was conducted on 2 Italian MS centers disease registries over an observational time of 34 years.
TL;DR: Higher rates of cardiovascular death in DACH may reflect the higher risk profile of these patients and lower rates of non-haemorrhagic stroke could be associated with increased NOAC use, which was associated with a mismatch of risk-adapted anticoagulation (over-and-undertreatment) in Dach.
10 Feb 2022
TL;DR: In Italy, drug prices are fixed based on comparison prices in other European countries as mentioned in this paper , and position within three classes of drugs determines the level of patient co-payment, and generics have been recognized and included since 1996.
Abstract: Italy has had a national health service since 1978, to provide access to care to all citizens. The service uses 3-year plans to aim to meet demands and needs. The pharmaceutical sector is well developed with regard to R & D and production. Drug prices are fixed based on comparison prices in other European countries. Position within 3 classes of drugs determines the level of patient co-payment. Generics have been recognized and included since 1996. Numerous recent events are likely to change the pharmaceutical sector, since recent regulations have not succeeded in reducing prices or utilization. [Article copies available for a fee from The Haworth Document Delivery Service: 1-800-HAWORTH. E-mail address: <docdelivery@haworthpress.com> Website: <http://www.HaworthPress.com> Ó 2003 by The Haworth Press, Inc. All rights reserved.]
TL;DR: Despite an expected increase in outpatient costs (visits and diagnostic tests) and pharmaceutical costs, the reduction in terms of number and length of hospitalizations and the higher adherence to international quality of care guidelines support the effectiveness of the EAC model.
Abstract: Early diagnosis and tight control improve outcomes of rheumatoid arthritis (RA). However, whether establishing an early arthritis clinic (EAC) is sustainable for national health systems is not known. This analysis aimed to compare effectiveness and costs of an EAC compared to patients followed by the current standard of care.
TL;DR: An economic evaluation of a 1-hour high-sensitivity troponin-T protocol based on the RAPID-TnT randomized trial, conducting a formal patient-level cost-effectiveness with a 12month follow-up in individuals presenting to Emergency Department with suspected acute coronary syndrome is presented.