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1.
Vaccines (Basel) ; 10(6)2022 May 26.
Article in English | MEDLINE | ID: covidwho-1869853

ABSTRACT

We aimed to identify individual features associated with increased risk of post-vaccine SARS-CoV-2 infection and severe COVID-19 illness. We performed a nested case-control study based on 5,350,295 citizens from Lombardy, Italy, aged ≥ 12 years who received a complete anti-COVID-19 vaccination from 17 January 2021 to 31 July 2021, and followed from 14 days after vaccine completion to 11 November 2021. Overall, 17,996 infections and 3023 severe illness cases occurred. For each case, controls were 1:1 (infection cases) or 1:10 (severe illness cases) matched for municipality of residence and date of vaccination completion. The association between selected predictors (sex, age, previous occurrence of SARS-CoV-2 infection, type of vaccine received, number of previous contacts with the Regional Health Service (RHS), and the presence of 59 diseases) and outcomes was assessed by using multivariable conditional logistic regression models. Sex, age, previous SARS-CoV-2 infection, type of vaccine and number of contacts with the RHS were associated with the risk of infection and severe illness. Moreover, higher odds of infection and severe illness were significantly associated with 14 and 34 diseases, respectively, among those investigated. These results can be helpful to clinicians and policy makers for prioritizing interventions.

2.
J Epidemiol Community Health ; 2022 May 12.
Article in English | MEDLINE | ID: covidwho-1846533

ABSTRACT

BACKGROUND: The pandemic may undermine the equity of access to and utilisation of health services for conditions other than COVID-19. The objective of the study is to evaluate the indirect impact of COVID-19 and lockdown measures on sociodemographic inequalities in healthcare utilisation in seven Italian areas. METHODS: In this multicentre retrospective study, we evaluated whether COVID-19 modified the association between educational level or deprivation and indicators of hospital utilisation and quality of care. We also assessed variations in gradients by sex and age class. We estimated age-standardised rates and prevalence and their relative per cent changes comparing pandemic (2020) and pre-pandemic (2018-2019) periods, and the Relative Index of Inequalities (RIIs) fitting multivariable Poisson models with an interaction between socioeconomic position and period. RESULTS: Compared with 2018-2019, hospital utilisation and, to a lesser extent, timeliness of procedures indicators fell during the first months of 2020. Larger declines were registered among women, the elderly and the low educated resulting in a shrinkage (or widening if RII <1) of the educational gradients for most of the indicators. Timeliness of procedures indicators did not show any educational gradient neither before nor during the pandemic. Inequalities by deprivation were nuanced and did not substantially change in 2020. CONCLUSIONS: The socially patterned reduction of hospital utilisation may lead to a potential exacerbation of health inequalities among groups who were already vulnerable before the pandemic. The healthcare service can contribute to contrast health disparities worsened by COVID-19 through more efficient communication and locally appropriate interventions.

3.
Lancet Infect Dis ; 22(5): 649-656, 2022 05.
Article in English | MEDLINE | ID: covidwho-1805380

ABSTRACT

BACKGROUND: Scarce information is available on the duration of the protective effect of COVID-19 vaccination against the risk of SARS-CoV-2 infection and its severe clinical consequences. We investigated the effect of time since vaccine completion on the SARS-CoV-2 infection and its severe forms. METHODS: In this retrospective observational analysis using the vaccination campaign integrated platform of the Italian region of Lombardy, 5 351 085 individuals aged 12 years or older who received complete vaccination from Jan 17 to July 31, 2021, were followed up from 14 days after vaccine completion until Oct 20, 2021. Changes over time in outcome rates (ie, SARS-CoV-2 infection and severe illness among vaccinated individuals) were analysed with age-period-cohort models. Trends in vaccine effectiveness (ie, outcomes comparison in vaccinated and unvaccinated individuals) were also measured. FINDINGS: Overall, 14 140 infections and 2450 severe illnesses were documented, corresponding to incidence rates of 6·7 (95% CI 6·6-6·8) and 1·2 (1·1-1·2) cases per 10 000 person-months, respectively. From the first to the ninth month since vaccine completion, rates increased from 4·6 to 10·2 infections, and from 1·0 to 1·7 severe illnesses every 10 000 person-months. These figures correspond to relative reduction of vaccine effectiveness of 54·9% (95% CI 48·3-60·6) for infection and of 40·0% (16·2-57·0) for severe illness. The increasing infection rate was greater for individuals aged 60 years or older who received adenovirus-vectored vaccines (from 4·0 to 23·5 cases every 10 000 person-months). The increasing severe illness rates were similar for individuals receiving mRNA-based vaccines (from 1·1 to 1·5 every 10 000 person-months) and adenovirus-vectored vaccines (from 0·5 to 0·9 every 10 000 person-months). INTERPRETATION: Although the risk of infection after vaccination, and even more of severe illness, remains low, the gradual increase in clinical outcomes related to SARS-CoV-2 infection suggests that the booster campaign should be accelerated and that social and individual protection measures against COVID-19 spread should not be abandoned. FUNDING: None.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Retrospective Studies , Vaccination
4.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-334408

ABSTRACT

Objective: To compare the estimates of preterm birth (PTB;22-36 weeks gestational age, GA) and stillbirth rates during COVID-19 pandemic in Italy with those recorded in the three previous years. Design. A population-based cohort study of liveborn and stillborn infants was conducted using data from Regional Health Systems and comparing the pandemic period (March 1st, 2020-March 31st, 2021, N= 362,129) to an historical period (January 2017- February 2020, N=1,117,172). The cohort covered 84.3% of the births in Italy. Methods. Logistic regressions were run in each Region and meta-analyses were performed centrally. We used an interrupted time series regression analysis to study the trend of preterm births from 2017 to 2021. Main Outcome Measures. The primary outcomes were PTB and stillbirths. Secondary outcomes were late PTB (32-36 weeks’ GA), very PTB (<32 weeks’ GA), and extreme PTB (<28 weeks’ GA), overall and stratified into singleton and multiples. Results. The pandemic period compared with the historical one was associated with a reduced risk for PTB (Odds Ratio: 0.90;95% Confidence Interval, CI: 0.87, 0.93), late PTB (0.91;0.87, 0.94), very PTB (0.87;0.84, 0.91), and extreme PTB (0.88;0.82, 0.94). In multiples, point estimates were not very different, but had wider CIs. No association was found for stillbirths (1.01;0.90, 1.13). A linear decreasing trend in PTB rate was present in the historical period, with a further reduction after the lockdown. Conclusions We demonstrated a decrease in PTB rate after the introduction of COVID-19 restriction measures, without an increase in stillbirths.

5.
Vaccines (Basel) ; 10(4)2022 Apr 15.
Article in English | MEDLINE | ID: covidwho-1792368

ABSTRACT

Background. Limited evidence exists on the balance between the benefits and harms of the COVID-19 vaccines. The aim of this study is to compare the benefits and safety of mRNA-based (Pfizer-BioNTech and Moderna) and adenovirus-vectored (Oxford-AstraZeneca) vaccines in subpopulations defined by age and sex. Methods. All citizens who are newly vaccinated from 27 December 2020 to 3 May 2021 are matched to unvaccinated controls according to age, sex, and vaccination date. Study outcomes include the events that are expected to be avoided by vaccination (i.e., hospitalization and death from COVID-19) and those that might be increased after vaccine inoculation (i.e., venous thromboembolism). The incidence rate ratios (IRR) of vaccinated and unvaccinated citizens are separately estimated within strata of sex, age category and vaccine type. When suitable, number needed to treat (NNT) and number needed to harm (NNH) are calculated to evaluate the balance between the benefits and harm of vaccines within each sex and age category. Results. In total, 2,351,883 citizens are included because they received at least one dose of vaccine (755,557 Oxford-AstraZeneca and 1,596,326 Pfizer/Moderna). A reduced incidence of COVID-19-related outcomes is observed with a lowered incidence rate ranging from 55% to 89% and NNT values ranging from 296 to 3977. Evidence of an augmented incidence of harm-related outcomes is observed only for women aged <50 years within 28 days after Oxford-AstraZeneca (being the corresponding adjusted IRR of 2.4, 95% CI 1.1-5.6, and NNH value of 23,207, 95% CI 10,274-89,707). Conclusions. A favourable balance between benefits and harms is observed in the current study, even among younger women who received Oxford-AstraZeneca.

6.
J Intern Med ; 2022 Apr 04.
Article in English | MEDLINE | ID: covidwho-1774863

ABSTRACT

BACKGROUND: Lombardy was affected in the early months of 2020 by the SARS-CoV-2 pandemic with very high morbidity and mortality. The post-COVID-19 condition and related public health burden are scarcely known. SETTING AND DESIGN: Using the regional population administrative database including all the 48,932 individuals who survived COVID-19 and became polymerase-chain-reaction negative for SARS-CoV-2 by 31 May 2020, incident mortality, rehospitalizations, attendances to hospital emergency room, and outpatient medical visits were evaluated over a mid-term period of 6 months in 20,521 individuals managed at home, 26,016 hospitalized in medical wards, and 1611 in intensive care units (ICUs). These data were also evaluated in the corresponding period of 2019, when the region was not yet affected by the pandemic. Other indicators and proxies of the health-care burden related to the post-COVID condition were also evaluated. MAIN RESULTS: In individuals previously admitted to the ICU and medical wards, rehospitalizations, attendances to hospital emergency rooms, and out-patient medical visits were much more frequent in the 6-month period after SARS-CoV-2 negativization than in the same prepandemic period. Performances of spirometry increased more than 50-fold, chest CT scans 32-fold in ICU-admitted cases and 5.5-fold in non-ICU cases, and electrocardiography 5.6-fold in ICU cases and twofold in non-ICU cases. Use of drugs and biochemical tests increased in all cases. CONCLUSIONS: These results provide a real-life picture of the post-COVID condition and of its effects on the increased consumption of health-care resources, considered proxies of comorbidities.

7.
Minerva Med ; 2022 Feb 22.
Article in English | MEDLINE | ID: covidwho-1703350

ABSTRACT

BACKGROUND: Hypercoagulability is often seen in Covid-19 patients and thromboembolic events appear frequent; antithrombotic treatment has been proposed therefore as part of standard treatment for Covid-19. Under these premises, prior-to-infection antithrombotic treatment may have a protective effect with respect to Covid-19 related thromboembolic events. Aim of the present work was to evaluate the impact of prior-to-infection anticoagulant or antiplatelet treatment on Covid-19 outcomes. METHODS: Beneficiaries of the Regional Health Service of the Lombardy region of Italy aged ≥40 years with a Covid-19 diagnosis made between February 21st and July 18th, 2020 were included in the present study. The impact on Covid-19 mortality of pre-existing and chronic therapy with anticoagulant drugs (vitamin-K antagonist or New Oral Anticoagulants) was evaluated. Analyses were repeated with antiplatelets drugs. RESULTS: Among 79,934 Sars-cov-2 patients beneficiaries of the Regional Healthcare System of the Lombardy Region who received a diagnosis between February 21st and July 18th, 2020, chronic preexisting anticoagulant assumption was present in 6.0% and antiplatelets in 12.7%. The overall unadjusted mortality rate was 20.6%, with male sex, age category and comorbidity burden being significantly associated to increased mortality risk. Anticoagulant chronic treatment was not associated with a reduction in mortality. Similar results were observed when repeating the analyses for pre-existing oral anti-platelet treatment. CONCLUSIONS: In a large population-based study evaluating more than 79,000 Covid-19 patients, pre-existing antithrombotic therapy was not associated to a benefit in terms of mortality. Further studies are needed to evaluate the role of antithrombotic therapy as standard treatment among Covid-19 patients.

8.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-321956

ABSTRACT

The COVID-19 pandemic has a non-negligible indirect impact on hospital care pathways, which is important to estimate. To this aim, we set up the Mimico-19 network of seven Italian regions (62% of the Italian population) representing different socio-demographic areas of the country with also a different burden of the epidemic. We retrospectively analysed regional hospital discharges data, computing twelve indicators of volumes and performance in three clinical areas: cardiology, oncology and orthopaedics, including time-dependent pathways and elective surgery. Weekly indicators for the period January-July 2020 were compared with the average of the corresponding indicators in 2018 and 2019;comparisons were performed within 3 sub-periods: pre-lockdown, lockdown and post-lockdown. The weekly trend of hospitalizations for ST-segment elevation myocardial infarction (STEMI) showed a 40% reduction, but the proportion of STEMI patients with a primary PTCA did not significantly change from previous years. Volumes of malignant neoplasms surgeries differed substantially by site, with a limited reduction for lung cancer (<20%) and greater declines (30-40%) for breast and prostate cancers. Hospitalizations for femoral neck fracture in the elderly decreased by 20%, but the percentage of timely interventions remained constantly higher than the previous years. General trends did not show important differences across regions, regardless of the different Covid-19 burden. Hospitalizations have generally decreased, but the capacity of a timely and effective response in time-dependent pathways of care was not jeopardized throughout the period. The drop in the care demand for cardiovascular diseases and cancers needs to be further investigated and monitored more thoroughly.

9.
BMC Med ; 20(1): 52, 2022 02 08.
Article in English | MEDLINE | ID: covidwho-1673914

ABSTRACT

BACKGROUND: The evolution of SARS-CoV-2 has led to the emergence of several new variants, and few data are available on the impact of vaccination on SARS-CoV-2 variants. We aimed to assess the association between natural (previous infection) and induced (partial or complete vaccination) exposure to SARS-CoV-2 and the onset of new infection supported by the delta variant, and of comparing it with that supported by alpha. METHODS: We performed a test-negative case-control study, by linking population-based registries of confirmed diagnoses of infection with SARS-CoV-2, vaccinations against Covid-19 and healthcare utilization databases of the Italian Lombardy Region. Four hundred ninety-six persons who between 27 December 2020 and 16 July 2021 had an infection by the delta variant were 1:1 matched with citizens affected by alphavariant and 1:10 matched with persons who had a negative molecular test, according to gender, age and date of molecular ascertainment. We used a conditional logistic regression for estimating relative risk reduction of either variants associated with natural and/or induced immunization and corresponding 95% confidence interval (CI). RESULTS: Previous infection was associated with 91% (95% CI 85% to 95%) reduced relative risk of reinfection, without evidence of significant differences between delta and alpha cases (p=0.547). Significant lower vaccinal protection against delta than alpha variant infection was observed with reduced relative risk associated with partial vaccination respectively of 29% (7% to 45%), and 62% (48% to 71%) (p=0.001), and with complete vaccination respectively of 75% (66% to 82%) and 90% (85% to 94%) (p=0.003). CONCLUSIONS: Lower protection towards infections caused by the delta variant with respect to alpha variant was noticed, even after the completion of the vaccination cycle. This finding would support efforts to maximize both vaccine uptake with two doses and fulfilment with individual protection measures, especially as the delta variant is rampant worldwide presently.


Subject(s)
COVID-19 , SARS-CoV-2 , COVID-19 Vaccines , Case-Control Studies , Humans , Vaccination
10.
Sci Rep ; 11(1): 21526, 2021 11 02.
Article in English | MEDLINE | ID: covidwho-1500514

ABSTRACT

Earlier in 2020, seven Italian regions, which cover 62% of the Italian population, set up the Mimico-19 network to monitor the side effects of the restrictive measures against Covid-19 on volumes and quality of care. To this aim, we retrospectively analysed hospital discharges data, computing twelve indicators of volume and performance in three clinical areas: cardiology, oncology, and orthopaedics. Weekly indicators for the period January-July 2020 were compared with the corresponding average for 2018-2019; comparisons were performed within 3 sub-periods: pre-lockdown, lockdown, and post-lockdown. The weekly trend of hospitalisations for ST-segment elevation myocardial infarction (STEMI) showed a 40% reduction, but the proportion of STEMI patients with a primary PTCA did not significantly change from previous years. Malignant neoplasms surgery volumes differed substantially by site, with a limited reduction for lung cancer (< 20%) and greater declines (30-40%) for breast and prostate cancers. The percentage of timely surgery for femoral neck in the elderly remained constantly higher than the previous 2 years whereas hip and knee replacements fell dramatically. Hospitalisations have generally decreased, but the capacity of a timely and effective response in time-dependent pathways of care was not jeopardized throughout the period. General trends did not show important differences across regions, regardless of the different burden of Covid-19. Preventive and primary care services should adopt a pro-active approach, moving towards the identification of at-risk conditions that were neglected during the pandemic and timely addressing patients to the secondary care system.


Subject(s)
COVID-19/epidemiology , Hospitalization/statistics & numerical data , Arthroplasty, Replacement, Hip/statistics & numerical data , Arthroplasty, Replacement, Knee/statistics & numerical data , Breast Neoplasms/pathology , Breast Neoplasms/surgery , COVID-19/therapy , COVID-19/virology , Female , Hospitalization/trends , Humans , Italy , Lung Neoplasms/pathology , Lung Neoplasms/surgery , Male , Prostatic Neoplasms/pathology , Prostatic Neoplasms/surgery , Quarantine , Retrospective Studies , SARS-CoV-2/isolation & purification , ST Elevation Myocardial Infarction/pathology , ST Elevation Myocardial Infarction/therapy
11.
Rheumatology (Oxford) ; 60(SI): SI25-SI36, 2021 10 09.
Article in English | MEDLINE | ID: covidwho-1462486

ABSTRACT

OBJECTIVES: To ascertain if the use of hydroxychloroquine(HCQ)/cloroquine(CLQ) and other conventional DMARDs (cDMARDs) and rheumatic diseases per se may be associated with COVID-19-related risk of hospitalization and mortality. METHODS: This case-control study nested within a cohort of cDMARD users was conducted in the Lombardy, Veneto, Tuscany and Lazio regions and Reggio Emilia province. Claims databases were linked to COVID-19 surveillance registries. The risk of COVID-19-related outcomes was estimated using a multivariate conditional logistic regression analysis comparing HCQ/CLQ vs MTX, vs other cDMARDs and vs non-use of these drugs. The presence of rheumatic diseases vs their absence in a non-nested population was investigated. RESULTS: A total of 1275 patients hospitalized due to COVID-19 were matched to 12 734 controls. Compared with recent use of MTX, no association between HCQ/CLQ monotherapy and COVID-19 hospitalization [odds ratio (OR) 0.83 (95% CI 0.69, 1.00)] or mortality [OR 1.19 (95% CI 0.85, 1.67)] was observed. A lower risk was found when comparing HCQ/CLQ use with the concomitant use of other cDMARDs and glucocorticoids. HCQ/CLQ was not associated with COVID-19 hospitalization as compared with non-use. An increased risk for recent use of either MTX monotherapy [OR 1.19 (95% CI 1.05, 1.34)] or other cDMARDs [OR 1.21 (95% CI 1.08, 1.36)] vs non-use was found. Rheumatic diseases were not associated with COVID-19-related outcomes. CONCLUSION: HCQ/CLQ use in rheumatic patients was not associated with a protective effect against COVID-19-related outcomes. The use of other cDMARDs was associated with an increased risk when compared with non-use and, if concomitantly used with glucocorticoids, also vs HCQ/CLQ, probably due to immunosuppressive action.


Subject(s)
Antirheumatic Agents/therapeutic use , COVID-19/drug therapy , Hospitalization/statistics & numerical data , Hydroxychloroquine/therapeutic use , Rheumatic Diseases/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/mortality , Case-Control Studies , Drug Therapy, Combination , Female , Glucocorticoids/therapeutic use , Humans , Italy , Male , Middle Aged , Odds Ratio , Population Surveillance , Rheumatic Diseases/virology , SARS-CoV-2 , Young Adult
12.
BioDrugs ; 35(6): 749-764, 2021 Nov.
Article in English | MEDLINE | ID: covidwho-1460522

ABSTRACT

BACKGROUND: Biological drugs have improved the management of immune-mediated inflammatory diseases (IMIDs) despite being associated with important safety issues such as immunogenicity, infections, and malignancies in real-world settings. OBJECTIVE: The aim of this study was to explore the potential of a large Italian multi-database distributed network for use in the postmarketing surveillance of biological drugs, including biosimilars, in patients with IMID. METHODS: A retrospective cohort study was conducted using 13 Italian regional claims databases during 2010-2019. A tailor-made R-based tool developed for distributed analysis of claims data using a study-specific common data model was customized for this study. We measured the yearly prevalence of biological drug users and the frequency of switches between originator and biosimilars for infliximab, etanercept, and adalimumab separately and stratified them by calendar year and region. We then calculated the cumulative number of users and person-years (PYs) of exposure to individual biological drugs approved for IMIDs. For a number of safety outcomes (e.g., severe acute respiratory syndrome coronavirus 2 [SARS-COV-2] infection), we conducted a sample power calculation to estimate the PYs of exposure required to investigate their association with individual biological drugs approved for IMIDs, considering different strengths of association. RESULTS: From a total underlying population of almost 50 million inhabitants from 13 Italian regions, we identified 143,602 (0.3%) biological drug users, with a cumulative exposure of 507,745 PYs during the entire follow-up. The mean age ± standard deviation of biological drug users was 49.3 ± 16.3, with a female-to-male ratio of 1.2. The age-adjusted yearly prevalence of biological drug users increased threefold from 0.7 per 1000 in 2010 to 2.1 per 1000 in 2019. Overall, we identified 40,996 users of biosimilars of tumor necrosis factor (TNF)-α inhibitors (i.e., etanercept, adalimumab, and infliximab) in the years 2015-2019. Of these, 46% (N = 18,845) switched at any time between originator and biosimilars or vice versa. To investigate a moderate association (incidence rate ratio 2) between biological drugs approved for IMIDs and safety events of interest, such as optic neuritis (lowest background incidence rate 10.4/100,000 PYs) or severe infection (highest background incidence rate 4312/100,000 PYs), a total of 43,311 PYs and 104 PYs of exposure to individual biological drugs, respectively, would be required. As such, using this network, of 15 individual biological drugs approved for IMIDs, the association with those adverse events could be investigated for four (27%) and 14 (93%), respectively. CONCLUSION: The VALORE project multi-database network has access to data on more than 140,000 biological drug users (and > 0.5 million PYs) from 13 Italian regions during the years 2010-2019, which will be further expanded with the inclusion of data from other regions and more recent calendar years. Overall, the cumulated amount of person-time of exposure to biological drugs approved for IMIDs provides enough statistical power to investigate weak/moderate associations of almost all individual compounds and the most relevant safety outcomes. Moreover, this network may offer the opportunity to investigate the interchangeability of originator and biosimilars of several TNFα inhibitors in different therapeutic areas in real-world settings.


Subject(s)
Biosimilar Pharmaceuticals , COVID-19 , Delivery of Health Care , Female , Humans , Infliximab/adverse effects , Italy/epidemiology , Male , Retrospective Studies , SARS-CoV-2
13.
Vaccines (Basel) ; 9(7)2021 Jul 01.
Article in English | MEDLINE | ID: covidwho-1317265

ABSTRACT

To investigate the association of the 2019-2020 influenza vaccine with prognosis of patients positive for SARS-CoV-2A, a large multi-database cohort study was conducted in four Italian regions (i.e., Lazio, Lombardy, Veneto, and Tuscany) and the Reggio Emilia province (Emilia-Romagna). More than 21 million adults were residing in the study area (42% of the population). We included 115,945 COVID-19 cases diagnosed during the first wave of the pandemic (February-May, 2020); 34.6% of these had been vaccinated against influenza. Three outcomes were considered: hospitalization, death, and intensive care unit (ICU) admission/death. The adjusted relative risk (RR) of being hospitalized in the vaccinated group when compared with the non-vaccinated group was 0.87 (95% CI: 0.86-0.88). This reduction in risk was not confirmed for death (RR = 1.04; 95% CI: 1.01-1.06), or for the combined outcome of ICU admission or death. In conclusion, our study, conducted on the vast majority of the population during the first wave of the pandemic in Italy, showed a 13% statistically significant reduction in the risk of hospitalization in some geographical areas and in the younger population. No impact of seasonal influenza vaccination on COVID-19 prognosis in terms of death and death or ICU admission was estimated.

14.
Rheumatology (Oxford) ; 60(SI): SI25-SI36, 2021 10 09.
Article in English | MEDLINE | ID: covidwho-1185985

ABSTRACT

OBJECTIVES: To ascertain if the use of hydroxychloroquine(HCQ)/cloroquine(CLQ) and other conventional DMARDs (cDMARDs) and rheumatic diseases per se may be associated with COVID-19-related risk of hospitalization and mortality. METHODS: This case-control study nested within a cohort of cDMARD users was conducted in the Lombardy, Veneto, Tuscany and Lazio regions and Reggio Emilia province. Claims databases were linked to COVID-19 surveillance registries. The risk of COVID-19-related outcomes was estimated using a multivariate conditional logistic regression analysis comparing HCQ/CLQ vs MTX, vs other cDMARDs and vs non-use of these drugs. The presence of rheumatic diseases vs their absence in a non-nested population was investigated. RESULTS: A total of 1275 patients hospitalized due to COVID-19 were matched to 12 734 controls. Compared with recent use of MTX, no association between HCQ/CLQ monotherapy and COVID-19 hospitalization [odds ratio (OR) 0.83 (95% CI 0.69, 1.00)] or mortality [OR 1.19 (95% CI 0.85, 1.67)] was observed. A lower risk was found when comparing HCQ/CLQ use with the concomitant use of other cDMARDs and glucocorticoids. HCQ/CLQ was not associated with COVID-19 hospitalization as compared with non-use. An increased risk for recent use of either MTX monotherapy [OR 1.19 (95% CI 1.05, 1.34)] or other cDMARDs [OR 1.21 (95% CI 1.08, 1.36)] vs non-use was found. Rheumatic diseases were not associated with COVID-19-related outcomes. CONCLUSION: HCQ/CLQ use in rheumatic patients was not associated with a protective effect against COVID-19-related outcomes. The use of other cDMARDs was associated with an increased risk when compared with non-use and, if concomitantly used with glucocorticoids, also vs HCQ/CLQ, probably due to immunosuppressive action.


Subject(s)
Antirheumatic Agents/therapeutic use , COVID-19/drug therapy , Hospitalization/statistics & numerical data , Hydroxychloroquine/therapeutic use , Rheumatic Diseases/drug therapy , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/mortality , Case-Control Studies , Drug Therapy, Combination , Female , Glucocorticoids/therapeutic use , Humans , Italy , Male , Middle Aged , Odds Ratio , Population Surveillance , Rheumatic Diseases/virology , SARS-CoV-2 , Young Adult
16.
Drug Saf ; 43(12): 1297-1308, 2020 12.
Article in English | MEDLINE | ID: covidwho-1092868

ABSTRACT

INTRODUCTION: The epidemic due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection has been spreading globally, raising increasing concerns. There are several controversial hypotheses on the potentially harmful or beneficial effects of antihypertensive drugs acting on the renin-angiotensin-aldosterone system (RAAS) in coronavirus disease 2019 (COVID-19). Furthermore, there is accumulating evidence, based on several observational studies, that angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) do not increase the risk of contracting SARS-CoV-2 infection. On the other hand, conflicting findings regarding the role of ACEIs/ARBs as prognosis modifiers in COVID-19 hospitalised patients have been reported. OBJECTIVE: The aim of this large-scale, retrospective cohort study was to investigate whether prior exposure to ACEIs and/or ARBs was associated with all-cause mortality among over 40,000 hospitalised COVID-19 patients compared with calcium channel blockers (CCBs), a potential therapeutic alternative. METHODS: This study was conducted using COVID-19 registries linked to claims databases from Lombardy, Veneto and Reggio Emilia (overall, 25% of Italian population). Overall, 42,926 patients hospitalised between 21 February and 21 April 2020 with a diagnosis of COVID-19 confirmed by real-time polymerase chain reaction tests were included in this study. All-cause mortality occurring in or out of hospital, as reported in the COVID-19 registry, was estimated. Using Cox models, adjusted hazard ratios (HRs) of all-cause mortality (along with 95% confidence intervals [CIs]) were estimated separately for ACEIs/ARBs and other antihypertensives versus CCBs and non-use. RESULTS: Overall, 11,205 in- and out-of-hospital deaths occurred over a median of 24 days of follow-up after hospital admission due to COVID-19. Compared with CCBs, adjusted analyses showed no difference in the risk of death among ACEI (HR 0.97, 95% CI 0.89-1.06) or ARB (HR 0.98, 95% CI 0.89-1.06) users. When non-use of antihypertensives was considered as a comparator, a modest statistically significant increase in mortality risk was observed for any antihypertensive use. However, when restricting to drugs with antihypertensive indications only, these marginal increases disappeared. Sensitivity and subgroup analyses confirmed our main findings. CONCLUSIONS: ACEI/ARB use is not associated with either an increased or decreased risk of all-cause mortality, compared with CCB use, in the largest cohort of hospitalised COVID-19 patients exposed to these drugs studied to date. The use of these drugs therefore does not affect the prognosis of COVID-19. This finding strengthens recommendations of international regulatory agencies about not withdrawing/switching ACEI/ARB treatments to modify COVID-19 prognosis.


Subject(s)
Angiotensin Receptor Antagonists/therapeutic use , Angiotensin-Converting Enzyme Inhibitors/therapeutic use , COVID-19/mortality , Hospitalization , Renin-Angiotensin System , Adolescent , Adult , Aged , Aged, 80 and over , Calcium Channel Blockers/therapeutic use , Case-Control Studies , Cohort Studies , Female , Humans , Intensive Care Units , Italy , Male , Middle Aged , Prognosis , Proportional Hazards Models , Retrospective Studies , Risk Factors , Young Adult
17.
Clin Epidemiol ; 12: 1337-1346, 2020.
Article in English | MEDLINE | ID: covidwho-992953

ABSTRACT

INTRODUCTION: COVID-19 case fatality rate in hospitalized patients varies across countries and studies. Reliable estimates, specific for age, sex, and comorbidities, are needed to monitor the epidemic, to compare the outcome in different settings, and to correctly design trials for COVID-19 interventions. The aim of this study was to provide population-based survival curves of hospitalized COVID-19 patients. MATERIALS AND METHODS: A cohort study was conducted in three areas of Northern Italy, heavily affected by SARS-CoV-2 infection (Lombardy and Veneto Regions, and Reggio Emilia province), using a loco-regional COVID-19 surveillance system, linked to hospital discharge databases. We included all patients testing positive for SARS-CoV-2 RNA by RT-PCR on nasopharyngeal/throat swab samples who were hospitalized from 21 February to 21 April 2020. Kaplan-Meier survival estimates were calculated at 14 and 30 days for death in any setting, stratifying by age, sex, and the Charlson Index. RESULTS: Overall, 42,926 hospitalized COVID-19 patients were identified. Patients' median age was 69 years (IQR: 57-79), 62.6% were males, and 6.0% had a Charlson Index ≥3. Survival curves showed that 22.0% (95% CI 21.6-22.4) of patients died within 14 days and 27.6% (95% CI 27.2-28.1) within 30 days from hospitalization. Survival was higher in younger patients and in females. The negative impact of comorbidities on survival was more pronounced in younger age groups. CONCLUSION: The high fatality rate observed in the study (28% at 30 days) suggests that studies should focus on death as primary endpoint during a follow-up of at least one month.

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