Publications by authors named "Valeria Raparelli"

84 Publications

Identification and inclusion of gender factors in retrospective cohort studies: the GOING-FWD framework.

BMJ Glob Health 2021 04;6(4)

Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada

Gender refers to the socially constructed roles, behaviours, expressions and identities of girls, women, boys, men and gender diverse people. Gender-related factors are seldom assessed as determinants of health outcomes, despite their powerful contribution. The Gender Outcomes INternational Group: to Further Well-being Development (GOING-FWD) project developed a standard five-step methodology applicable to retrospectively identify gender-related factors and assess their relationship to outcomes across selected cohorts of non-communicable chronic diseases from Austria, Canada, Spain, Sweden. Step 1 (identification of gender-related variables): Based on the gender framework of the Women Health Research Network (ie, identity, role, relations and institutionalised gender), and available literature for a certain disease, an optimal 'wish-list' of gender-related variables was created and discussed by experts. Step 2 (definition of outcomes): Data dictionaries were screened for clinical and patient-relevant outcomes, using the International Consortium for Health Outcome Measurement framework. Step 3 (building of feasible final list): a cross-validation between variables per database and the 'wish-list' was performed. Step 4 (retrospective data harmonisation): The harmonisation potential of variables was evaluated. Step 5 (definition of data structure and analysis): The following analytic strategies were identified: (1) local analysis of data not transferable followed by a meta-analysis combining study-level estimates; (2) centrally performed federated analysis of data, with the individual-level participant data remaining on local servers; (3) synthesising the data locally and performing a pooled analysis on the synthetic data and (4) central analysis of pooled transferable data. The application of the GOING-FWD multistep approach can help guide investigators to analyse gender and its impact on outcomes in previously collected data.
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http://dx.doi.org/10.1136/bmjgh-2021-005413DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8043043PMC
April 2021

Do Sex-Related Differences of Comorbidity Burden and/or In-Hospital Mortality Exist in Cancer Patients? A Retrospective Study in an Internal Medicine Setting.

Life (Basel) 2021 Mar 22;11(3). Epub 2021 Mar 22.

Clinica Medica Unit, Azienda Ospedaliero-University of Ferrara, 44121 Ferrara, Italy.

Cancer represents important comorbidity, and data on outcomes are usually derived from selected oncologic units. Our aim was to evaluate possible sex-related differences and factors associated with in-hospital mortality (IHM) in a consecutive cohort of elderly patients with cancer admitted to internal medicine. We included all patients admitted to our department with a diagnosis of cancer during 2018. Based on the International Classification of Diseases, 9th Revision, Clinical Modification, demography, comorbidity burden, and diagnostic procedures were evaluated, with IHM as our outcome. We evaluated 955 subjects with cancer (23.9% of total hospital admissions), 42.9% were males, and the mean age was 76.4 ± 11.4 years. Metastatic cancer was diagnosed in 18.2%. The deceased group had a higher modified Elixhauser Index (17.6 ± 7.7 vs. 14 ± 7.3, < 0.001), prevalence of cachexia (17.9% vs. 7.2%, < 0.001), and presence of metastasis (27.8% vs. 16.3%, = 0.001) than survivors. Females had a higher age (77.4 ± 11.4 vs. 75.5 ± 11.4, = 0.013), and lower comorbidity (10.2 ± 5.9 vs. 12.0 ± 5.6, < 0.001) than males. IHM was not significantly different among sex groups, but it was independently associated with cachexia and metastasis only in women. Comorbidities are highly prevalent in patients with cancer admitted to the internal medicine setting and are associated with an increased risk of all-cause mortality, especially in female elderly patients with advanced disease.
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http://dx.doi.org/10.3390/life11030261DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8004908PMC
March 2021

Sex, Gender, and Cardiovascular Health in Canadian and Austrian Populations.

Can J Cardiol 2021 Mar 27. Epub 2021 Mar 27.

Centre for Outcomes Research and Evaluation, McGill University Health Centre Research Institute, Montréal, Québec, Canada; Divisions of Clinical Epidemiology and General Internal Medicine, McGill University Health Centre Research Institute, Montréal, Québec, Canada. Electronic address:

Background: Evidence differentiating the effect of biological sex from psychosociocultural factors (gender) in different societies and its relation to cardiovascular diseases is scarce. We explored the association between sex, gender, and cardiovascular health (CVH) among Canadian (CAN) and Austrian (AT) populations.

Methods: The Canadian Community Health Survey (CCHS) (n = 63,522; 55% female) and Austrian Health Interview Survey (AT-HIS) (n = 15,771; 56% female) were analyzed in a cross-sectional survey design. The CANHEART/ATHEART index, a measure of ideal CVH composed of 6 cardiometabolic risk factors (smoking, physical activity, fruit and vegetable consumption, overweight/obesity, diabetes, and hypertension; range 0-6; higher scores reflecting better CVH) was calculated for both databases. A composite measure of psychosociocultural gender was computed for each country (range 0-1, higher score identifying characteristics traditionally ascribed to women).

Results: Median CANHEART 4 (interquartile range 3-5) and CAN gender scores 0.55 (0.49-0.60) were similar to median ATHEART 4 (3-5) and AT gender scores 0.55 (0.46-0.64). Although higher gender scores (CCHS: β = -1.33, 95% confidence interval [CI] -1.44 to -1.22; AT-HIS: β = -1.08, 95% CI -1.26 to -0.89)) were associated with worse CVH, female sex (CCHS: β = 0.35, 95% CI (0.33-0.37); AT-HIS: β = 0.60, 95% CI (0.55-0.64)) was associated with better CVH in both populations. In addition, higher gender scores were associated with increased prevalence of heart disease compared with female sex. The magnitude of this risk was higher in Austrians.

Conclusions: These results demonstrate that individuals with characteristics typically ascribed to women reported poorer cardiovascular health and higher risk of heart disease, independently from biological sex and baseline CV risk factors, in both countries. Female sex exhibited better CV health and a lower prevalence of heart disease than male in both populations. However, gender factors and magnitude of gender impact varied by country.
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http://dx.doi.org/10.1016/j.cjca.2021.03.019DOI Listing
March 2021

The Importance of Gender to Understand Sex Differences in Cardiovascular Disease.

Can J Cardiol 2021 May 13;37(5):699-710. Epub 2021 Feb 13.

Department of Translational Medicine, University of Ferrara, Ferrara, Italy; University of Alberta, Faculty of Nursing, Edmonton, Alberta, Canada.

Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. There is robust evidence of heterogeneity in underlying mechanism, manifestation, prognosis, and response to treatment of CVD between male and female patients. Gender, which refers to the socially constructed roles, behaviours, expressions, and identities of individuals, is an important determinant of CV health, and its consideration might help in attaining a broader understanding of the observed sex differences in CVD. Established risk factors such as hypertension, dyslipidemia, diabetes mellitus, obesity, and smoking are well known to contribute to CVD. However, despite the differences in CVD risk between male and female, most studies looking into the magnitude of effect of each risk factor have traditionally focused on male subjects. While biological sex influences disease pathophysiology, the psycho-socio-cultural construct of gender can further interact with this effect. Behavioural, psychosocial, personal, cultural, and societal factors can create, repress, or strengthen underlying biological CV health differences. Although mechanisms of action are largely unclear, it is suggested that gender-related factors can further exacerbate the detrimental effect of established risk factors of CVD. In this narrative review, we explore the current literature investigating the role of gender in CV risk and its impact on established risk factors as a fundamental step toward precision medicine.
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http://dx.doi.org/10.1016/j.cjca.2021.02.005DOI Listing
May 2021

Cardiovascular Pathophysiology, Epidemiology, and Treatment Considerations of Coronavirus Disease 2019 (COVID-19): A Review.

CJC Open 2021 Jan 5;3(1):28-40. Epub 2020 Sep 5.

Center of Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital/McGill University, Montreal, Quebec, Canada.

The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rapidly evolving, with important cardiovascular considerations. The presence of underlying cardiovascular risk factors and established cardiovascular disease (CVD) may affect the severity and clinical management of patients with COVID-19. We conducted a review of the literature to summarize the cardiovascular pathophysiology, risk factors, clinical presentations, and treatment considerations of COVID-19 patients with underlying CVD. Angiotensin-converting enzyme 2 (ACE2) has been identified as a functional receptor for the SARS-CoV-2 virus, and it is associated with the cardiovascular system. Hypertension, diabetes, and CVD are the most common comorbidities in COVID-19 patients, and these factors have been associated with the progression and severity of COVID-19. However, elderly populations, who develop more-severe COVID-19 complications, are naturally exposed to these comorbidities, underscoring the possible confounding of age. Observational data support international cardiovascular societies' recommendations to not discontinue ACE inhibitor/angiotensin-receptor blocker therapy in patients with guideline indications for fear of the increased risk of SARS-CoV-2 infection, severe disease, or death. In addition to the cardiotoxicity of experimental antivirals and potential interactions of experimental therapies with cardiovascular drugs, several strategies for cardiovascular protection have been recommended in COVID-19 patients with underlying CVD. Troponin elevation is associated with increased risk of in-hospital mortality and adverse outcomes in patients with COVID-19. Cardiovascular care teams should have a high index of suspicion for fulminant myocarditis-like presentations being SARS-CoV-2 positive, and remain vigilant for cardiovascular complications in COVID-19 patients.
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http://dx.doi.org/10.1016/j.cjco.2020.09.003DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7801216PMC
January 2021

Prevalence and clinical correlates of dementia among COVID-19-related deaths in Italy.

Alzheimers Dement (Amst) 2020 14;12(1):e12114. Epub 2020 Nov 14.

Department of Cardiovascular, Endocrine-metabolic Diseases and Aging Istituto Superiore di Sanità Rome Italy.

Introduction: We aimed at exploring the proportion of patients dying with COVID-19 and concomitant dementia in Italy, as well as their clinical characteristics and trajectories of care.

Methods: The proportion of COVID-19-related deaths occurring in people with dementia and the clinical characteristics of deceased individuals according to their dementia status were explored by considering the medical charts of a representative sample of patients deceased in Italian hospitals (n = 2621).

Results: A total of 415 individuals with dementia were identified in the study population, accounting for 15.8% of overall COVID-19-related deaths. Patients with dementia less frequently presented with cough, had lower chance of receiving supportive therapies and intensive care approaches, and showed a faster clinical worsening as compared with individuals with intact cognition.

Discussion: Dementia confers a relevant risk of adverse outcomes in case of SARS-CoV-2 infection and influences the clinical presentation, course and management of affected individuals.
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http://dx.doi.org/10.1002/dad2.12114DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666428PMC
November 2020

Blood pressure variability in normotensive perimenopausal women: Non-dipping status, maximum blood pressure and arterial stiffness.

Int J Cardiol 2021 02 16;325:149-154. Epub 2020 Oct 16.

McGill University Health Center Research Institute, Montreal, QC, Canada; Department of Medicine, McGill University, Montreal, QC, Canada.

Background: Postmenopausal women are more likely to have uncontrolled hypertension and are at higher risk of cardiovascular disease compared with age-matched men. Blood pressure variability is emerging as a predictor of adverse cardiovascular outcomes and may be implicated in the relationship between menopause and worsened vascular health in women. We conducted an observational study, BRAVE (Blood pRessure And Vascular hEalth around menopause) to study this relationship.

Method: Normotensive perimenopausal women were recruited. Blood pressure variability was measured through 24-h blood pressure monitoring. Vascular health was assessed through arterial stiffness (carotid-femoral pulse wave velocity), carotid intima-media thickness and endothelial function (reactive hyperemic index). Multivariate models were performed to identify factors associated with blood pressure variability and arterial stiffness in perimenopausal women.

Results: Forty-nine healthy women (mean age 52.9 ± 4.0, 63% postmenopausal) were recruited. There was a high prevalence (40%) of night non-dipping, a measure of an abnormal pattern of blood pressure variability. Aside from night dipping, other measures of blood pressure variability were similar between premenopausal and postmenopausal women. In the multivariate analysis, body mass index was the only factor associated independently with different measures of blood pressure variability, including the maximum overnight blood pressure (ß = 1.95, p < 0.01). The latter was also significantly associated with arterial stiffness (ß = 0.035, p = 0.048). Finally, poor sleep was independently associated with an increase in arterial stiffness.

Conclusions: Abnormal blood pressure variability, particularly night non-dipping, is common in normotensive perimenopausal women. Maximum overnight blood pressure is independently associated with arterial stiffness and may identify women at higher cardiovascular risk.
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http://dx.doi.org/10.1016/j.ijcard.2020.10.027DOI Listing
February 2021

The Pipeline of Therapeutics Testing During the Emergency Phase of the COVID-19 Outbreak.

Front Med (Lausanne) 2020 24;7:552991. Epub 2020 Sep 24.

Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.

The coronavirus disease 19 (COVID-19) pandemic poses a serious threat to the sustainability of healthcare systems and is currently having a significant effect on living conditions worldwide. No therapeutic agent has yet proven to be effective for the treatment of COVID-19. The management of this disease currently relies on supportive care and the off-label and compassionate use of antivirals and immunomodulators. Nevertheless, there has been a great worldwide effort to progress research and test the efficacy and safety/tolerability profiles of numerous candidate agents that may positively affect the various clinical syndromes associated with COVID-19. In parallel, vaccination and chemoprophylaxis strategies are being investigated. This article provides a summary of interventional studies targeting COVID-19 during the emergency phase of the outbreak to broadly inform clinicians and researchers on what happened and what they can expect in upcoming months. The clinicaltrials.gov database and the European Union (EU) Clinical Trials Register were investigated on March 31, 2020, to identify all ongoing phase 1-4 research protocols testing pharmacological interventions targeting SARS-CoV-2 infection and/or clinical syndromes associated with COVID-19. Overall, six phase 1, four phase 1-2, 14 phase 2, ten phase 2-3, 19 phase 3, and nine phase 4 studies were identified, and the features of these studies are described in the present review. We also provide an updated overview of the change overtime in the pipeline following this emergency phase and based on the current epidemiology of the COVID-19 pandemic.
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http://dx.doi.org/10.3389/fmed.2020.552991DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7542224PMC
September 2020

Sex differences in clinical phenotype and transitions of care among individuals dying of COVID-19 in Italy.

Biol Sex Differ 2020 10 16;11(1):57. Epub 2020 Oct 16.

Department of Cardiovascular, Endocrine-metabolic Diseases and Aging, Istituto Superiore di Sanità, Via Giano della Bella, 34, 00161, Rome, Italy.

Background: Among the unknowns posed by the coronavirus disease 2019 (COVID-19) outbreak, the role of biological sex to explain disease susceptibility and progression is still a matter of debate, with limited sex-disaggregated data available.

Methods: A retrospective analysis was performed to assess if sex differences exist in the clinical manifestations and transitions of care among hospitalized individuals dying with laboratory-confirmed SARS-CoV-2 infection in Italy (February 27-June 11, 2020). Clinical characteristics and the times from symptoms' onset to admission, nasopharyngeal swab, and death were compared between sexes. Adjusted multivariate analysis was performed to identify the clinical features associated with male sex.

Results: Of the 32,938 COVID-19-related deaths that occurred in Italy, 3517 hospitalized and deceased individuals with COVID-19 (mean 78 ± 12 years, 33% women) were analyzed. At admission, men had a higher prevalence of ischemic heart disease (adj-OR = 1.76, 95% CI 1.39-2.23), chronic obstructive pulmonary disease (adj-OR = 1.7, 95% CI 1.29-2.27), and chronic kidney disease (adj-OR = 1.48, 95% CI 1.13-1.96), while women were older and more likely to have dementia (adj-OR = 0.73, 95% CI 0.55-0.95) and autoimmune diseases (adj-OR = 0.40, 95% CI 0.25-0.63), yet both sexes had a high level of multimorbidity. The times from symptoms' onset to admission and nasopharyngeal swab were slightly longer in men despite a typical acute respiratory illness with more frequent fever at the onset. Men received more often experimental therapy (adj-OR = 2.89, 95% CI 1.45-5.74) and experienced more likely acute kidney injury (adj-OR = 1.47, 95% CI 1.13-1.90).

Conclusions: Men and women dying with COVID-19 had different clinical manifestations and transitions of care. Identifying sex-specific features in individuals with COVID-19 and fatal outcome might inform preventive strategies.
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http://dx.doi.org/10.1186/s13293-020-00334-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7562690PMC
October 2020

Methods for prospectively incorporating gender into health sciences research.

J Clin Epidemiol 2021 Jan 24;129:191-197. Epub 2020 Sep 24.

Research Institute of McGill University Health Centre, Division of Clinical Epidemiology McGill University, Montréal, Quebec, Canada. Electronic address:

Numerous studies have demonstrated that sex (a biological variable) and gender (a psychosocial construct) impact health and have discussed the mechanisms that may explain these relationships. Funding agencies have called for all health researchers to incorporate sex and gender into their studies; however, the way forward has been unclear to many, particularly due to the varied definition of gender. We argue that just as there is no standardized definition of gender, there can be no standardized measurement thereof. However, numerous measurable gender-related variables may influence individual or population-level health through various pathways. The initial question should guide the selection of specific gender-related variables based on their relevance to the study, to prospectively incorporate gender into research. We outline various methods to provide clarification on how to incorporate gender into the design of prospective clinical and epidemiological studies as well as methods for statistical analysis.
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http://dx.doi.org/10.1016/j.jclinepi.2020.08.018DOI Listing
January 2021

COVID-19 mortality among migrants living in Italy.

Ann Ist Super Sanita 2020 Jul-Sep;56(3):373-377

Dipartimento Malattie Cardiovascolari, Endocrino-Metaboliche e Invecchiamento, Istituto Superiore di Sanità, Rome, Italy.

We aimed to compare COVID-19-specific and all-cause mortality rates among natives and migrants in Italy and to investigate the clinical characteristics of individuals dying with COVID-19 by native/migrant status. The mortality rates and detailed clinical characteristics of natives and migrants dying with COVID-19 were explored by considering the medical charts of a representative sample of patients deceased in Italian hospitals (n = 2,687) between February 21st and April 29th, 2020. The migrant or native status was assigned based on the individual's country of birth. The expected all-cause mortality among natives and migrants living in Italy was derived by the last available (2018) dataset provided by the Italian National Institute of Statistics. Overall, 68 individuals with a migration background were identified. The proportions of natives and migrants among the COVID-19-related deaths (97.5% and 2.5%, respectively) were similar to the relative all-cause mortality rates estimated in Italy in 2018 (97.4% and 2.6%, respectively). The clinical phenotype of migrants dying with COVID-19 was similar to that of natives except for the younger age at death. International migrants living in Italy do not have a mortality advantage for COVID-19 and are exposed to the risk of poor outcomes as their native counterparts.
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http://dx.doi.org/10.4415/ANN_20_03_16DOI Listing
October 2020

The influence of sex and gender domains on COVID-19 cases and mortality.

CMAJ 2020 09;192(36):E1041-E1045

Research Institute of McGill University Health Centre (Tadiri, Pilote), Division of Clinical Epidemiology McGill University, Montréal, Que.; Division of Endocrinology and Metabolism (Gisinger, Kautzy-Willer), Department of Medicine III, Medical University of Vienna, Vienna, Austria; Department of Renal Medicine (Kublickiene), Institution for Clinical Science, Intervention and Technology, Karolinska Institute, Stockholm, Sweden; Clinical and Experimental Neuroscience (Herrero), Institutes for Aging Research and Bio-Health Research of Murcia. School of Medicine, University of Murcia, Murcia, Spain; Department of Experimental Medicine (Raparelli), Sapienza University of Rome, Rome, Italy; Faculty of Nursing (Norris), University of Alberta, Edmonton, Alta; Cardiovascular and Stroke Strategic Clinical Network (Norris), Alberta Health Services, Edmonton, Alta.

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http://dx.doi.org/10.1503/cmaj.200971DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7504881PMC
September 2020

Inherited and acquired thrombophilia in adults with retinal vascular occlusion: A systematic review and meta-analysis.

J Thromb Haemost 2020 12 6;18(12):3249-3266. Epub 2020 Oct 6.

Department of Experimental Medicine, Sapienza - University of Rome, Rome, Italy.

Background: Retinal vascular occlusion is a leading cause of sight loss. Both retinal artery occlusion (RAO) and retinal vein occlusion (RVO) have been associated with hypercoagulable states; however, the burden of thrombophilia in these patients is unclear.

Objectives: This study aims at estimating the prevalence of inherited and acquired thrombophilias in adults with RAO or RVO through a systematic review and meta-analysis of the literature.

Patients/methods: PubMed and EMBASE were systematically searched from inception to 29 February 2020. All studies reporting prevalences of factor V Leiden (FVL) and prothrombin (F-II) G20210A mutations, methylenetetrahydrofolate reductase (MTHFR) C677T and plasminogen activator inhibitor (PAI) 4G polymorphisms, antithrombin III (AT-III), protein C (PC) and protein S (PS) activity deficiencies, hyperhomocysteinemia, and antiphospholipid (APL) antibodies in adults with RAO or RVO were included. Pooled prevalences and 95% confidence intervals (CI) were calculated.

Results: Ninety-five studies were included; FVL and F-II mutations were found in 6% (95% CI: 5-8) and 3% (95% CI: 2-4) of individuals with RVO, respectively, whereas AT-III, PC, and PS activity deficiencies were found in <2%. The MTHFR C677T and PAI 4G homozygous polymorphism were observed in 13% (95% CI: 10-17) and 23% (95% CI: 16-31) of RVO, respectively; 8% presented APL antibodies. Similar findings were observed in individuals with RAO.

Conclusions: Compared with healthy subjects, patients with retinal vascular occlusion showed similar prevalences of inherited and acquired thrombophilias. These findings do not support routine thrombophilia screening in individuals with RAO or RVO.
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http://dx.doi.org/10.1111/jth.15068DOI Listing
December 2020

Need for innovative and timely synthesis of evidence during Covid-19 outbreak.

Eur J Intern Med 2020 Jul 7;77:165-166. Epub 2020 Jun 7.

Department of Experimental Medicine - Sapienza, University of Rome, Rome, Italy.

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http://dx.doi.org/10.1016/j.ejim.2020.06.007DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275984PMC
July 2020

Sex, Gender, and Precision Medicine.

JAMA Intern Med 2020 08;180(8):1128-1129

Faculty of Health, Medicine, and Life Sciences, Maastricht University, Maastricht, the Netherlands.

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http://dx.doi.org/10.1001/jamainternmed.2020.1599DOI Listing
August 2020

Clinical Characteristics of Hospitalized Individuals Dying With COVID-19 by Age Group in Italy.

J Gerontol A Biol Sci Med Sci 2020 09;75(9):1796-1800

Department of Cardiovascular, Endocrine-metabolic Diseases and Aging, Istituto Superiore di Sanità, Rome, Italy.

Background: Aim of the present study is to describe characteristics of COVID-19-related deaths and to compare the clinical phenotype and course of COVID-19-related deaths occurring in adults (<65 years) and older adults (≥65 years).

Method: Medical charts of 3,032 patients dying with COVID-19 in Italy (368 aged < 65 years and 2,664 aged ≥65 years) were revised to extract information on demographics, preexisting comorbidities, and in-hospital complications leading to death.

Results: Older adults (≥65 years) presented with a higher number of comorbidities compared to those aged <65 years (3.3 ± 1.9 vs 2.5 ± 1.8, p < .001). Prevalence of ischemic heart disease, atrial fibrillation, heart failure, stroke, hypertension, dementia, COPD, and chronic renal failure was higher in older patients (≥65 years), while obesity, chronic liver disease, and HIV infection were more common in younger adults (<65 years); 10.9% of younger patients (<65 years) had no comorbidities, compared to 3.2% of older patients (≥65 years). The younger adults had a higher rate of non-respiratory complications than older patients, including acute renal failure (30.0% vs 20.6%), acute cardiac injury (13.5% vs 10.3%), and superinfections (30.9% vs 9.8%).

Conclusions: Individuals dying with COVID-19 present with high levels of comorbidities, irrespective of age group, but a small proportion of deaths occur in healthy adults with no preexisting conditions. Non-respiratory complications are common, suggesting that the treatment of respiratory conditions needs to be combined with strategies to prevent and mitigate the effects of non-respiratory complications.
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http://dx.doi.org/10.1093/gerona/glaa146DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7314182PMC
September 2020

The Interplay Between Antioxidants and the Immune System: A Promising Field, Still Looking for Answers.

Nutrients 2020 May 26;12(6). Epub 2020 May 26.

Department of Translational and Precision Medicine, Sapienza University of Rome, 00161 Rome, Italy.

Modulation of the immune response has long been proposed as a therapeutic target in several widespread diseases, including cancer, autoimmune disorders, cardiovascular diseases[...].
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http://dx.doi.org/10.3390/nu12061550DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7352790PMC
May 2020

Novel glucose lowering agents are associated with a lower risk of cardiovascular and adverse events in type 2 diabetes: A population based analysis.

Int J Cardiol 2020 07 15;310:147-154. Epub 2020 Apr 15.

Department of Experimental Medicine, McGill University, Montreal, Qc, Canada; Research Institute, McGill University Health Centre, Montreal, QC, Canada; Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada. Electronic address:

Background: Recent randomized control trials have described a protective cardiovascular effect of novel glucose lowering drugs in patients at high cardiovascular risk. Whether these second-line agents have similar effects in the general population is unknown. We aimed to compare the risk of major cardiovascular and adverse events in new users of sodium-glucose cotransporter-2 inhibitors (SGLT-2i), dipeptidyl peptidase-4 inhibitor (DPP-4i), glucagon-like peptide 1 agonist (GLP-1a), and sulfonylurea in T2DM patients not controlled on metformin therapy.

Methods: Retrospective cohort study using the MarketScan database (2011-2015). We selected T2DM individuals who were newly dispensed sulfonylureas, SGLT-2i, DPP-4i, or GLP-1a, as second-line therapy, added to metformin. Cohort entry was defined by date of first prescription of the second-line agent. Time to first non-fatal cardiovascular or adverse event was compared using Cox regression models adjusted for confounders.

Results: Among 118,341 T2DM patients using metformin (mean age: 56), most were at low cardiovascular risk (4% with previous cardiovascular or cerebrovascular event). During a median follow-up of 10 months compared with sulfonylureas users, cardiovascular risk was lower in users of SGLT-2i (aHR = 0.61; 95% CI: 0.40-0.97), DPP-4i (aHR = 0.79; 95% CI: 0.69-0.90) and GLP-1a (aHR = 0.65; 95% CI: 0.48-0.89). Serious adverse events were rare but compared with sulfonylurea, the risk was lower in new users of novel glucose lowering agents.

Conclusion: In our analyses, which included patients with and without prior cardiovascular disease, initiating novel glucose lowering drugs as second-line therapy for T2DM was associated with a lower risk of cardiovascular and adverse events than sulfonylurea initiation.
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http://dx.doi.org/10.1016/j.ijcard.2020.03.025DOI Listing
July 2020

Gender-Related Determinants of Adherence to the Mediterranean Diet in Adults with Ischemic Heart Disease.

Nutrients 2020 03 13;12(3). Epub 2020 Mar 13.

Department of Clinical Sciences and Community Health, University of Milan, 20122 Milan, Italy.

Background: The reasons behind low adherence to the Mediterranean diet (Med-diet) are still not entirely known. We aimed to evaluate the effect of biological (i.e., sex-related) and psycho-socio-cultural (i.e., gender-related) factors on Med-diet adherence.

Methods: Baseline Med-diet adherence was measured using a self-administered questionnaire among adults with ischemic heart disease (IHD) from the EVA (Endocrine Vascular Disease Approach) study. A multivariable analysis was performed to estimate the effect of sex- and gender-related factors (i.e., identity, roles, relations, and institutionalized gender) on low adherence.

Results: Among 366 participants (66 ± 11 years, 31% women), 81 (22%) adults with low adherence demonstrated higher rates of diabetes, no smoking habit, lower male BSRI (Bem Sex Role Inventory) (median (IQR) 4.8 (4.1 to 5.5) vs. 5.1 (4.5 to 5.6) and = 0.048), and higher Perceived Stress Scale 10 items (PSS-10) (median (IQR) 19 (11 to 23) vs. 15 (11 to 20) and = 0.07) scores than those with medium-high adherence. In the multivariable analysis, only active smoking (odds ratio, OR = 2.10, 95% confidence interval, CI 1.14 to 3.85 and = 0.017), PPS-10 (OR = 1.04, 95% CI 1.00 to 1.08, and = 0.038) and male BSRI scores (OR = 0.70, 95% CI 0.52 to 0.95, and = 0.021) were independently associated with low adherence.

Conclusions: Male personality traits and perceived stress (i.e., gender identity) were associated with low Med-diet adherence regardless of the sex, age, and comorbidities. Therefore, gender-sensitive interventions should be explored to improve adherence in IHD.
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http://dx.doi.org/10.3390/nu12030759DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7146303PMC
March 2020

Sex Differences in Cardiovascular Effectiveness of Newer Glucose-Lowering Drugs Added to Metformin in Type 2 Diabetes Mellitus.

J Am Heart Assoc 2020 01 4;9(1):e012940. Epub 2020 Jan 4.

Department of Medicine McGill University Montreal QC Canada.

Background Randomized controlled trials showed that newer glucose-lowering agents are cardioprotective, but most participants were men. It is unknown whether benefits are similar in women. Methods and Results Among adults with type 2 diabetes mellitus not controlled with metformin with no prior use of insulin, we assessed for sex differences in the cardiovascular effectiveness and safety of sodium-glucose-like transport-2 inhibitors (SGLT-2i), glucagon-like peptide-1 receptor agonists (GLP-1RA), dipeptidyl peptidase-4 inhibitors, initiated as second-line agents relative to sulfonylureas (reference-group). We studied type 2 diabetes mellitus American adults with newly dispensed sulfonylureas, SGLT-2i, GLP-1RA, or dipeptidyl peptidase-4 inhibitors (Marketscan-Database: 2011-2017). We used multivariable Cox proportional hazards models with time-varying exposure to compare time to first nonfatal cardiovascular event (myocardial infarction/unstable angina, stroke, and heart failure), and safety outcomes between drugs users, and tested for sex-drug interactions. Among 167 254 type 2 diabetes mellitus metformin users (46% women, median age 59 years, at low cardiovascular risk), during a median 4.5-year follow-up, cardiovascular events incidence was lower in women than men (14.7 versus 16.7 per 1000-person-year). Compared with sulfonylureas, hazard ratios (HRs) for cardiovascular events were lower with GLP-1RA (adjusted HR-women: 0.57, 95% CI: 0.48-0.68; aHR-men: 0.82, 0.71-0.95), dipeptidyl peptidase-4 inhibitors (aHR-women: 0.83, 0.77-0.89; aHR-men: 0.85, 0.79-0.91) and SGLT-2i (aHR-women: 0.58, 0.46-0.74; aHR-men: 0.69, 0.57-0.83). A sex-by-drug interaction was statistically significant only for GLP-1RA (=0.002), suggesting greater cardiovascular effectiveness in women. Compared with sulfonylureas, risks of adverse events were similarly lower in both sexes for GLP-1RA (aHR-women: 0.81, 0.73-0.89; aHR-men: 0.80, 0.71-0.89), dipeptidyl peptidase-4 inhibitors (aHR-women: 0.82, 0.78-0.87; aHR-men: 0.83, 0.78-0.87) and SGLT-2i (aHR-women: 0.68, 0.59-0.78; aHR-men: 0.67, 0.59-0.78) (all sex-drug interactions for adverse events >0.05). Conclusions Newer glucose-lowering drugs were associated with lower risk of cardiovascular events than sulfonylureas, with greater effectiveness of GLP-1RA in women than men. Overall, they appeared safe, with a better safety profile for SGLT-2i than for GLP-1RA regardless of sex.
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http://dx.doi.org/10.1161/JAHA.119.012940DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6988160PMC
January 2020

Sex-Related Differences in Heart Failure With Preserved Ejection Fraction.

Circ Heart Fail 2019 12 9;12(12):e006539. Epub 2019 Dec 9.

BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (P.D., R.R., R.T.C., L.S., P.S.J., M.C.P., J.J.V.M.).

Background: To describe characteristics and outcomes in women and men with heart failure with preserved ejection fraction.

Methods: Baseline characteristics (including biomarkers and quality of life) and outcomes (primary outcome: composite of first heart failure hospitalization or cardiovascular death) were compared in 4458 women and 4010 men enrolled in CHARM-Preserved (Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity) (EF≥45%), I-Preserve (Irbesartan in heart failure with Preserved ejection fraction), and TOPCAT-Americas (Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist trial).

Results: Women were older and more often obese and hypertensive but less likely to have coronary artery disease or atrial fibrillation. Women had more symptoms and signs of congestion and worse quality of life. Despite this, the risk of the primary outcome was lower in women (hazard ratio, 0.80 [95% CI, 0.73-0.88]), as was the risk of cardiovascular death (hazard ratio, 0.70 [95% CI, 0.62-0.80]), but there was no difference in the rate for first hospitalization for heart failure (hazard ratio, 0.92 [95% CI, 0.82-1.02]). The lower risk of cardiovascular death in women, compared with men, was in part explained by a substantially lower risk of sudden death (hazard ratio, 0.53 [0.43-0.65]; <0.001). E/A ratio was lower in women (1.1 versus 1.2).

Conclusions: There are significant differences between women and men with heart failure with preserved ejection fraction. Despite worse symptoms, more congestion, and lower quality of life, women had similar rates of hospitalization and better survival than men. Their risk of sudden death was half that of men.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00853658, NCT01035255.
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http://dx.doi.org/10.1161/CIRCHEARTFAILURE.119.006539DOI Listing
December 2019

Sex-Specific Cut-Offs for High-Sensitivity Cardiac Troponin: Is Less More?

Cardiovasc Ther 2019 5;2019:9546931. Epub 2019 Feb 5.

Department of Experimental Medicine, Sapienza-University of Rome, Rome, Italy.

Management of patients presenting to the Emergency Department with chest pain is continuously evolving. In the setting of acute coronary syndrome, the availability of high-sensitivity cardiac troponin assays (hs-cTn) has allowed for the development of algorithms aimed at rapidly assessing the risk of an ongoing myocardial infarction. However, concerns were raised about the massive application of such a simplified approach to heterogeneous real-world populations. As a result, there is a potential risk of underdiagnosis in several clusters of patients, including women, for whom a lower threshold for hs-cTn was suggested to be more appropriate. Implementation in clinical practice of sex-tailored cut-off values for hs-cTn represents a hot topic due to the need to reduce inequality and improve diagnostic performance in females. The aim of this review is to summarize current evidence on sex-specific cut-off values of hs-cTn and their application and usefulness in clinical practice. We also offer an extensive overview of thresholds reported in literature and of the mechanisms underlying such differences among sexes, suggesting possible explanations about debated issues.
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http://dx.doi.org/10.1155/2019/9546931DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6739766PMC
March 2020

Sex and Gender-Related Issues in Heart Failure.

Heart Fail Clin 2020 Jan;16(1):121-130

Department of Experimental Medicine, Sapienza University of Rome, Policlinico Umberto I, Viale Regina Elena 324, Rome 00161, Italy; McGill University Health Centre Research Institute, Centre for Outcomes Research and Evaluation, Montreal, Quebec, Canada. Electronic address:

Understanding the role of sex- and gender-related factors, when dealing with a global growing epidemic such as heart failure, is a much needed and unmet goal for health care providers and scientists in order to design targeted strategies, aimed at improving both clinical and patient reported outcomes measures in women and men with heart failure. The present review provides an overview of the current available evidence on sex- and gender-related differences in heart failure.
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http://dx.doi.org/10.1016/j.hfc.2019.08.005DOI Listing
January 2020

Glutathione infusion before primary percutaneous coronary intervention: a randomised controlled pilot study.

BMJ Open 2019 08 8;9(8):e025884. Epub 2019 Aug 8.

Department of Heart and Great Vessels, Sapienza University of Rome, Rome, Italy.

Objective: In the setting of reperfused ST-elevation myocardial infarction (STEMI), increased production of reactive oxygen species (ROS) contributes to reperfusion injury. Among ROS, hydrogen peroxide (HO) showed toxic effects on human cardiomyocytes and may induce microcirculatory impairment. Glutathione (GSH) is a water-soluble tripeptide with a potent oxidant scavenging activity. We hypothesised that the infusion of GSH before acute reoxygenation might counteract the deleterious effects of increased HO generation on myocardium.

Methods: Fifty consecutive patients with STEMI, scheduled to undergo primary angioplasty, were randomly assigned, before intervention, to receive an infusion of GSH (2500 mg/25 mL over 10 min), followed by drug administration at the same doses at 24, 48 and 72 hours elapsing time or placebo. Peripheral blood samples were obtained before and at the end of the procedure, as well as after 5 days. HO production, 8-iso-prostaglandin F2α (PGF2α) formation, HO breakdown activity (HBA) and nitric oxide (NO) bioavailability were determined. Serum cardiactroponin T (cTpT) was measured at admission and up to 5 days.

Results: Following acute reperfusion, a significant reduction of HO production (p=0.0015) and 8-iso-PGF2α levels (p=0.0003), as well as a significant increase in HBA (p<0.0001)and NO bioavailability (p=0.035), was found in the GSH group as compared with placebo. In treated patients, attenuated production of HO persisted up to 5 days from the index procedure (p=0.009) and these changes was linked to those of the cTpT levels (r=0.41, p=0.023).

Conclusion: The prophylactic and prolonged infusion of GSH seems to determine a rapid onset and persistent blunting of HO generation improving myocardial cell survival. Nevertheless, a larger trial, adequately powered for evaluation of clinical endpoints, is ongoing to confirm the current finding.

Trial Registration Number: EUDRACT 2014-00448625; Pre-results.
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http://dx.doi.org/10.1136/bmjopen-2018-025884DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6701599PMC
August 2019

Editorial commentary: Marital status and cardiovascular disease: Can a soulmate prevent a "broken heart"?

Trends Cardiovasc Med 2020 05 2;30(4):221-222. Epub 2019 Jul 2.

Department of Translational and Precision Medicine, Sapienza - University of Rome, Rome, Italy. Electronic address:

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http://dx.doi.org/10.1016/j.tcm.2019.06.007DOI Listing
May 2020

Serum Albumin Is Inversely Associated With Portal Vein Thrombosis in Cirrhosis.

Hepatol Commun 2019 Apr 2;3(4):504-512. Epub 2019 Mar 2.

Department of Internal Medicine and Medical Specialties Sapienza University of Rome Rome Italy.

We analyzed whether serum albumin is independently associated with portal vein thrombosis (PVT) in liver cirrhosis (LC) and if a biologic plausibility exists. This study was divided into three parts. In part 1 (retrospective analysis), 753 consecutive patients with LC with ultrasound-detected PVT were retrospectively analyzed. In part 2, 112 patients with LC and 56 matched controls were entered in the cross-sectional study. In part 3, 5 patients with cirrhosis were entered in the study and 4 healthy subjects (HSs) were entered in the study to explore if albumin may affect platelet activation by modulating oxidative stress. In the 753 patients with LC, the prevalence of PVT was 16.7%; logistic analysis showed that only age (odds ratio [OR], 1.024; = 0.012) and serum albumin (OR, -0.422; = 0.0001) significantly predicted patients with PVT. Analyzing the 112 patients with LC and controls, soluble clusters of differentiation (CD)40-ligand ( = 0.0238), soluble Nox2-derived peptide (sNox2-dp; < 0.0001), and urinary excretion of isoprostanes ( = 0.0078) were higher in patients with LC. In LC, albumin was correlated with sCD40L (Spearman's rank correlation coefficient [ ], -0.33; < 0.001), sNox2-dp ( , -0.57; < 0.0001), and urinary excretion of isoprostanes ( -0.48; < 0.0001) levels. The study showed a progressive decrease in platelet aggregation, sNox2-dp, and urinary 8-iso prostaglandin F2α-III formation 2 hours and 3 days after albumin infusion. Finally, platelet aggregation, sNox2-dp, and isoprostane formation significantly decreased in platelets from HSs incubated with scalar concentrations of albumin. Low serum albumin in LC is associated with PVT, suggesting that albumin could be a modulator of the hemostatic system through interference with mechanisms regulating platelet activation.
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http://dx.doi.org/10.1002/hep4.1317DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6442692PMC
April 2019

Biomarkers in Heart Failure and Associated Diseases.

Dis Markers 2019;2019:8768624. Epub 2019 Feb 7.

School of Sport, Exercise & Health Sciences, Loughborough University, Loughborough LE11 3TU, UK.

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http://dx.doi.org/10.1155/2019/8768624DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6383412PMC
August 2019

The Sex-Specific Detrimental Effect of Diabetes and Gender-Related Factors on Pre-admission Medication Adherence Among Patients Hospitalized for Ischemic Heart Disease: Insights From EVA Study.

Front Endocrinol (Lausanne) 2019 25;10:107. Epub 2019 Feb 25.

Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.

Sex and gender-related factors have been under-investigated as relevant determinants of health outcomes across non-communicable chronic diseases. Poor medication adherence results in adverse clinical outcomes and sex differences have been reported among patients at high cardiovascular risk, such as diabetics. The effect of diabetes and gender-related factors on medication adherence among women and men at high risk for ischemic heart disease (IHD) has not yet been fully investigated. To explore the role of sex, gender-related factors, and diabetes in pre-admission medication adherence among patients hospitalized for IHD. Data were obtained from the Endocrine Vascular disease Approach (EVA) (ClinicalTrials.gov Identifier: NCT02737982), a prospective cohort of patients admitted for IHD. We selected patients with baseline information regarding the presence of diabetes, cardiovascular risk factors, and gender-related variables (i.e., gender identity, gender role, gender relations, institutionalized gender). Our primary outcome was the proportion of pre-admission medication adherence defined through a self-reported questionnaire. We performed a sex-stratified analysis of clinical and gender-related factors associated with pre-admission medication adherence. Two-hundred eighty patients admitted for IHD (35% women, mean age 70), were included. Around one-fourth of the patients were low-adherent to therapy before hospitalization, regardless of sex. Low-adherent patients were more likely diabetic (40%) and employed (40%). Sex-stratified analysis showed that low-adherent men were more likely to be employed (58 vs. 33%) and not primary earners (73 vs. 54%), with more masculine traits of personality, as compared with medium-high adherent men. Interestingly, women reporting medication low-adherence were similar for clinical and gender-related factors to those with medium-high adherence, except for diabetes (42 vs. 20%, = 0.004). In a multivariate adjusted model only employed status was associated with poor medication adherence (OR 0.55, 95%CI 0.31-0.97). However, in the sex-stratified analysis, diabetes was independently associated with medication adherence only in women (OR 0.36; 95%CI 0.13-0.96), whereas a higher masculine BSRI was the only factor associated with medication adherence in men (OR 0.59, 95%CI 0.35-0.99). Pre-admission medication adherence is common in patients hospitalized for IHD, regardless of sex. However, patient-related factors such as diabetes, employment, and personality traits are associated with adherence in a sex-specific manner.
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http://dx.doi.org/10.3389/fendo.2019.00107DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6397889PMC
February 2019

Correction to: Sex and Gender Differences in Ischemic Heart Disease: Endocrine Vascular Disease Approach (EVA) Study Design.

J Cardiovasc Transl Res 2020 Feb;13(1):26

Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.

The authors of this study protocol would like to amend it and clarify that medication adherence was assessed using the 4-item validated Morisky, Green, Levine scale [Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74] rather than the 4-item Morisky Medication Adherence Scale.
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http://dx.doi.org/10.1007/s12265-019-09870-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645460PMC
February 2020
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