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Summary Background Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. Methods This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov , NCT04352556 , and the prospective part of the study is ongoing. Findings We enrolled 536 patients with a median follow-up of 20 days (IQR 10–34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77–2·34) in our whole study cohort and 3·72 (2·86–4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1–44·9). Older age (hazard ratio 1·03, 95% CI 1·01–1·05); progressive disease status (2·10, 1·41–3·12); diagnosis of acute myeloid leukaemia (3·49, 1·56–7·81), indolent non-Hodgin lymphoma (2·19, 1·07–4·48), aggressive non-Hodgkin lymphoma (2·56, 1·34–4·89), or plasma cell neoplasms (2·48, 1·31–4·69), and severe or critical COVID-19 (4·08, 2·73–6·09) were associated with worse overall survival. Interpretation This study adds to the evidence that patients with haematological malignancies have worse outcomes than both the general population with COVID-19 and patients with haematological malignancies without COVID-19. The high mortality among patients with haematological malignancies hospitalised with COVID-19 highlights the need for aggressive infection prevention strategies, at least until effective vaccination or treatment strategies are available. Funding Associazione italiana contro le leucemie, linfomi e mieloma–Varese Onlus.

Background Recent meta-analyses suggested that screening program for abdominal aortic aneurysms (AAA) in 65-year old males is cost-effective at prevalence of about 1%. Since some events occur also in females and among the youngers, screening could be feasible among those at higher risk, such as smokers or individuals with a family history of AAA. The RoCAV (Risk of Cardiovascular diseases and abdominal aortic Aneurysms in Varese) Project is a population-based study aimed to evaluate AAA prevalence in Northern Italy in males over-65 years as well as among females and younger males, and to identify new markers for risk stratification by collecting a large set of CVD risk factors. The aims of the project are: (i) cross-sectional evaluation of AAA prevalence (ii); evaluation of standard CVD risk score as criteria for selecting subgroup at higher risk to be included in a screening program; (iii) identification of new risk markers and risk score algorithm for AAA and CVD risk stratification; (iv) cost-effective evaluation during the follow-up. Methods Males aged 50–75 years and females aged 60–75 years, resident in the city of Varese (Lombardy Region), were randomly selected from the civil registry. Among 5198 successfully invited, 3777 subjects accepted to participate and were finally recruited (participation rate 63.8%) from June 2013 to May 2016. Trained operators administered a computerized anamnestic questionnaire, measured anthropometric parameters (BMI, body circumferences, skinfolds), blood pressure, ankle-brachial index, pulse wave velocity and performed abdominal aortic ultrasound scan, ECG and spirometry. All methods were internationally validated. A blood sample was collected and stored in biobank. A follow-up will be carried out through linkage with electronic records. Discussion Participation rate and data quality assessment were as expected and will reasonably allow to reach the project aims. The expected impact in public health of the RoCAV project will be the potential implementation of a AAA screening program to the whole region as well as the formulation of new criteria for risk assessment of AAA and CVD.

Objective We examined the prospective associations of sleep disturbances and sleep duration with the long-term incidence of major cardiovascular disease (CVD) events, in a large cohort of Italian adult men. Methods A total of 2277 men aged 35–74 years of age and CVD free at baseline from the MONICA-Brianza and PAMELA population-based cohorts were followed up for a median of 17 years, for first coronary heart disease (CHD) or ischemic stroke events (fatal or nonfatal; n = 293). Sleep disturbances, based on the Jenkins Sleep Questionnaire, were categorized as none/some, moderate, or severe. Sleep durations were ≤6 hours (short), seven to eight hours, and ≥9 hours (long) per night. Results At baseline, 855 men (38%) either reported sleep disturbances or were short or long sleepers. The presence of severe sleep disturbances increased the risk of first CVD (hazard ratio [HR] = 1.80, 95% confidence interval [CI] = 1.07–3.03) and CHD events (HR = 1.97, 95% CI = 1.09–3.56), in particular from the age of 48 years onward. In comparison to men sleeping seven to eight hours, long sleepers experienced a higher CVD risk (HR = 1.56, 95% CI = 1.10–2.22), due mainly to ischemic strokes, and starting at older ages (≥60 years). A joint effect between disturbed sleep and short sleep duration on CVD and CHD events was also observed. Adjustments for physical activity and depression did not substantially modify these associations. Conclusion Severe sleep disturbances and long sleep duration were associated with specific CVD endpoints and age at onset, potentially suggesting distinct underlying mechanisms. A short questionnaire discriminating different levels of sleep disturbances and sleep duration should be routinely adopted in CVD prevention programs to identify men at increased risk for early-onset events.

Objective: To investigate the association between the use of fluoroquinolone agents and the risk of tendinitis in a large population-based case-control study. Methods: The study was performed by linking automated health databases from the Region of Lombardia, Italy. Cases were patients aged ≥18 years who had a hospital discharge diagnosis of non-traumatic tendinitis in 2002–3. For each case, up to five controls were randomly selected among those eligible for inclusion in the study. A conditional logistic regression model was used to estimate the odds ratio of tendinitis associated with the current, recent and past use of fluoroquinolones. Odds ratios were adjusted for exposure to other antibacterials and other drugs. Results: 22 194 cases and 104 906 controls met the inclusion criteria. Current use of fluoroquinolones significantly increased the risk of tendon disorders as a whole (odds ratio [OR] = 1.7; 95% CI 1.4, 2.0), tendon rupture (OR = 1.3; 95% CI 1.0, 1.8) and rupture of the Achilles’ tendon (OR = 4.1; 95% CI 1.8, 9.6). Concomitant use of corticosteroids and fluoroquinolones increased the risk of both tendon rupture (OR = 3.1; 95% CI 1.5, 6.3) and rupture of the Achilles’ tendon (OR = 43.2; 95% CI 5.5, 341.1). Discussion: Evidence that exposure to fluoroquinolones is associated with the sudden occurrence of tendinitis is supported by this large population-based study. We can estimate that a single case of rupture of the Achilles’ tendon would occur for every 5958 persons treated with fluoroquinolones (95% CI 2148, 23 085). The corresponding number needed to harm is 979 (95% CI 122, 9172) for patients who concomitantly use corticosteroids and 1638 (95% CI 351, 8843) for those aged >60 years. Conclusion: Clinicians should be aware of this adverse effect, and the increased risk for fluoroquinolone-associated tendinitis in elderly patients with corticosteroid use must be considered when these agents are prescribed.

Purpose To compare different strategies in allocating time-window at risk and in choosing optimal comparator in the setting of proarrhythmic effects of antibacterial fluoroquinolones. Design A population-based cohort study. Setting Resident population of a Northern Italian Province. Participants The study cohort comprised 75 226 patients who received at least one prescription for fluoroquinolone from 1997 to 1999. Cohort members who experienced at least an antiarrhythmic drug prescription and/or hospitalisation with diagnosis of arrhythmia during the follow-up were identified. Analysis Trends in incidence rates of arrhythmia according to different strategies in allocating time-windows at risk were calculated. Standardised incidence ratios were obtained by comparing arrhythmic events experienced by the study cohort during the time-windows at risk with those expected from both external (unexposed target population) and internal (study cohort during reference time-windows) comparators. Results The rate of arrhythmia was 21.0 per 100 000 person-weeks during the in-treatment period, remained stable during the following week, and progressively decreased until to converge to 7.7 per 100 000 person-weeks from 16th weeks after stop of exposure. Standardised incidence ratios were 2.35 (95%CI: 1.82, 2.99) and 1.86 (1.44, 2.37) according to external and internal comparators respectively. Evidence of linear increasing of proarrhythmic effect with the length of the antibacterial therapy appeared from every approaches, but it was stronger by using internal comparator. Conclusions Time-windows designs should be performed by allocating the time-windows at risk and comparing outcome events observed in the cohort during these periods with those experienced by the same cohort during an adequate reference period. Copyright © 2005 John Wiley & Sons, Ltd.

Study objective: Although lipid lowering drugs are effective in preventing morbidity and mortality from cardiovascular events, the extent of their adverse effects is not clear. This study explored the association between prescription of lipid lowering drugs and the risk of peripheral neuropathy. Design: A population based case-control study was carried out by linkage of several automated databases. Setting: Resident population of a northern Italian Province aged 40 years or more. Participants: Cases were patients discharged for peripheral neuropathy in 1998–1999. For each case up to 20 controls were randomly selected among those eligible. Altogether 2040 case patients and 36 041 controls were included in the study. Exposure ascertainment: Prescription drug database was used to assess exposure to lipid lowering drugs at any time in the one year period preceding the index date. Analysis: Conditional logistic regression model for matched data was used to estimate the risk of peripheral neuropathy associated with exposure to statins, fibrates, and other lipid lowering drugs. Main results: Weak but significant effects of lipid lowering drugs as a whole (matched odds ratio: 1.27; 95% confidence intervals: 1.05 to 1.55), statins (1.19; 1.00 to 1.40), and fibrates (1.49; 1.03 to 2.17) were observed. Significant linear trends towards increased risk at increased exposure to both statins and fibrates were observed. Conclusions: The use of both statins and fibrates was associated with the risk of peripheral neuropathy. The primary purpose of this exploratory study is signal generation. This requires further investigations to evaluate the causal role of lipid lowering drugs on the onset of peripheral neuropathy.