Validation of the Italian Version of the Test of Adherence to Inhalers

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COVID-19 in Severe Asthma Network in Italy (SANI) patients: Clinical features, impact of comorbidities and treatments

none17noNo abstract availablenoneHeffler, Enrico; Detoraki, Aikaterini; Contoli, Marco; Papi, Alberto; Paoletti, Giovanni; Malipiero, Giacomo; Brussino, Luisa; Crimi, Claudia; Morrone, Daniela; Padovani, Marianna; Guida, Giuseppe; Gerli, Alberto Giovanni; Centanni, Stefano; Senna, Gianenrico; Paggiaro, Pierluigi; Blasi, Francesco; Canonica, Giorgio WalterHeffler, Enrico; Detoraki, Aikaterini; Contoli, Marco; Papi, Alberto; Paoletti, Giovanni; Malipiero, Giacomo; Brussino, Luisa; Crimi, Claudia; Morrone, Daniela; Padovani, Marianna; Guida, Giuseppe; Gerli, Alberto Giovanni; Centanni, Stefano; Senna, Gianenrico; Paggiaro, Pierluigi; Blasi, Francesco; Canonica, Giorgio Walte

COVID-19 in Severe Asthma Network in Italy (SANI) patients: Clinical features, impact of comorbidities and treatments

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Sarilumab in patients admitted to hospital with severe or critical COVID-19: a randomised, double-blind, placebo-controlled, phase 3 trial

Background: Elevated proinflammatory cytokines are associated with greater COVID-19 severity. We aimed to assess safety and efficacy of sarilumab, an interleukin-6 receptor inhibitor, in patients with severe (requiring supplemental oxygen by nasal cannula or face mask) or critical (requiring greater supplemental oxygen, mechanical ventilation, or extracorporeal support) COVID-19. Methods: We did a 60-day, randomised, double-blind, placebo-controlled, multinational phase 3 trial at 45 hospitals in Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia, and Spain. We included adults (≥18 years) admitted to hospital with laboratory-confirmed SARS-CoV-2 infection and pneumonia, who required oxygen supplementation or intensive care. Patients were randomly assigned (2:2:1 with permuted blocks of five) to receive intravenous sarilumab 400 mg, sarilumab 200 mg, or placebo. Patients, care providers, outcome assessors, and investigators remained masked to assigned intervention throughout the course of the study. The primary endpoint was time to clinical improvement of two or more points (seven point scale ranging from 1 [death] to 7 [discharged from hospital]) in the modified intention-to-treat population. The key secondary endpoint was proportion of patients alive at day 29. Safety outcomes included adverse events and laboratory assessments. This study is registered with ClinicalTrials.gov, NCT04327388; EudraCT, 2020-001162-12; and WHO, U1111-1249-6021. Findings: Between March 28 and July 3, 2020, of 431 patients who were screened, 420 patients were randomly assigned and 416 received placebo (n=84 [20%]), sarilumab 200 mg (n=159 [38%]), or sarilumab 400 mg (n=173 [42%]). At day 29, no significant differences were seen in median time to an improvement of two or more points between placebo (12·0 days [95% CI 9·0 to 15·0]) and sarilumab 200 mg (10·0 days [9·0 to 12·0]; hazard ratio [HR] 1·03 [95% CI 0·75 to 1·40]; log-rank p=0·96) or sarilumab 400 mg (10·0 days [9·0 to 13·0]; HR 1·14 [95% CI 0·84 to 1·54]; log-rank p=0·34), or in proportions of patients alive (77 [92%] of 84 patients in the placebo group; 143 [90%] of 159 patients in the sarilumab 200 mg group; difference −1·7 [−9·3 to 5·8]; p=0·63 vs placebo; and 159 [92%] of 173 patients in the sarilumab 400 mg group; difference 0·2 [−6·9 to 7·4]; p=0·85 vs placebo). At day 29, there were numerical, non-significant survival differences between sarilumab 400 mg (88%) and placebo (79%; difference +8·9% [95% CI −7·7 to 25·5]; p=0·25) for patients who had critical disease. No unexpected safety signals were seen. The rates of treatment-emergent adverse events were 65% (55 of 84) in the placebo group, 65% (103 of 159) in the sarilumab 200 mg group, and 70% (121 of 173) in the sarilumab 400 mg group, and of those leading to death 11% (nine of 84) were in the placebo group, 11% (17 of 159) were in the sarilumab 200 mg group, and 10% (18 of 173) were in the sarilumab 400 mg group. Interpretation: This trial did not show efficacy of sarilumab in patients admitted to hospital with COVID-19 and receiving supplemental oxygen. Adequately powered trials of targeted immunomodulatory therapies assessing survival as a primary endpoint are suggested in patients with critical COVID-19. Funding: Sanofi and Regeneron Pharmaceuticals

Immunoglobulin replacement therapy in secondary hypogammaglobulinemia.

Immunoglobulin (Ig) replacement therapy dramatically changed the clinical course of primary hypogammaglobulinemias, significantly reducing the incidence of infectious events. Over the last two decades its use has been extended to secondary antibody deficiencies, particularly those related to hematological disorders as lymphoproliferative diseases (LPDs) and multiple myeloma. In these malignancies, hypogammaglobulinemia can be an intrinsic aspect of the disease or follow chemo-immunotherapy regimens, including anti-CD20 treatment. Other than in LPDs the broadening use of immunotherapy (e.g., rituximab) and immune-suppressive therapy (steroids, sulfasalazine, and mycophenolate mofetil) has extended the occurrence of iatrogenic hypogammaglobulinemia. In particular, in both autoimmune diseases and solid organ transplantation Ig replacement therapy has been shown to reduce the rate of infectious events. Here, we review the existing literature about Ig replacement therapy in secondary hypogammaglobulinemia, with special regard for subcutaneous administration route, a safe, effective, and well-tolerated treatment approach, currently well established in primary immunodeficiencies and secondary hypogammaglobulinemias

Rectangular cuffs may overestimate blood pressure in individuals with large conical arms.

OBJECTIVES: : Although the upper arm has the shape of a truncated cone, cylindrical cuffs and bladders are currently used for blood pressure (BP) measurement. The aim of this study was to ascertain whether cylindrical and tronco-conical cuffs provide different readings according to arm size and shape. DESIGN: : We studied 220 individuals with arm circumference ranging from 22 to 42.5\u200acm. Four different cylindrical and four different tronco-conical bladders of appropriate size were used. Sequential same-arm measurements were performed in triplicate by two observers using the two cuffs in a random order. In 100 individuals, the actual pressure transmitted to the arm surface by the two cuffs at the central point was also measured. RESULTS: : Upper arm shape was tronco-conical in all of the individuals. In a multiple regression, conicity was related to arm circumference (P\u200a<\u200a0.001) and length (P\u200a=\u200a0.001). Arm conicity and size were independently related to the between-cuff SBP (P\u200a=\u200a0.001 and 0.002, respectively) and DBP (P\u200a=\u200a0.001 and <0.001, respectively) discrepancies. In the group with arm circumference of 37.5-42.5\u200acm, the cylindrical cuff overestimated BP measured with the tronco-conical cuff by 2.0\u200a\ub1\u200a0.4/1.8\u200a\ub1\u200a0.3\u200ammHg (P\u200a=\u200a0.001 and <0.001). In this group, 15% of individuals found hypertensive with the cylindrical cuff were normotensive when assessed with the conical cuff. Differences as great as 9.7/7.8\u200ammHg were found in individuals with large arms and slant angle equal to or less than 83\ub0. CONCLUSION: : In obese people, the upper arm may have a pronounced tronco-conical shape and cylindrical cuffs may overestimate BP. Tronco-conical cuffs should be used for BP measurement in individuals with large arms

Myocarditis: A Clinical Overview

none4nononeCaforio, A.L.P; Malipiero, G.; Marcolongo, R.; Iliceto, S.Caforio, ALIDA LINDA PATRIZIA; Malipiero, Giacomo; Marcolongo, Renzo; Iliceto, Sabin

Does home blood pressure allow for a better assessment of the white-coat effect than ambulatory blood pressure?

BACKGROUND: The difference between clinic and ambulatory blood pressure (BP) is a poor estimate of the true white-coat effect (WCE) measured with beat-to-beat recording. METHOD: We investigated whether the difference between clinic and home BP (home WCE) was a better estimate of true WCE than ambulatory WCE. In 73 young hypertensives, ambulatory WCE was calculated as the difference between clinic BP and the mean of two 24-h BP recordings, and home WCE as the difference between clinic and home BP (HBP) measured over 6 months. All individuals underwent beat-to-beat BP monitoring with the Finometer. During the recording, a white-coat test (true WCE) and a public speaking test were performed. RESULTS: Ambulatory WCE correlated with home WCE (P\u200a \u200a0.21). Individuals were divided into two groups according to whether BP response to the doctor's visit was above (WCH+) or below (WCH-) the median. WCH+ patients had similar clinic and ambulatory BPs to WCH- but showed a higher BP response to public speaking. CONCLUSION: As previously observed for ambulatory WCE, home WCE does not reflect the true BP reaction to doctor's visit. BP response to psychosocial stressors is increased in individuals with hyperreactivity to doctor's measurement but not in individuals with white-coat hypertension identified with either ambulatory or HBP measurement