Background During the COVID-19 pandemic, the scarcity of resources has necessitated triage of critical care for patients with the disease. In patients aged 65 years and older, triage decisions are regularly based on degree of frailty measured by the Clinical Frailty Scale (CFS). However, the CFS could also be useful in patients younger than 65 years. We aimed to examine the association between CFS score and hospital mortality and between CFS score and admission to intensive care in adult patients of all ages with COVID-19 across Europe. Methods This analysis was part of the COVID Medication (COMET) study, an international, multicentre, retrospective observational cohort study in 63 hospitals in 11 countries in Europe. Eligible patients were aged 18 years and older, had been admitted to hospital, and either tested positive by PCR for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or were judged to have a high clinical likelihood of having SARS-CoV-2 infection by the local COVID-19 expert team. CFS was used to assess level of frailty: fit (CFS 1-3), mildly frail (CFS 4-5), or frail (CFS 6-9). The primary outcome was hospital mortality. The secondary outcome was admission to intensive care. Data were analysed using a multivariable binary logistic regression model adjusted for covariates (age, sex, number of drugs prescribed, and type of drug class as a proxy for comorbidities). Findings Between March 30 and July 15, 2020, 2434 patients (median age 68 years [IQR 55-77]; 1480 [61%] men, 954 [30%] women) had CFS scores available and were included in the analyses. In the total sample and in patients aged 65 years and older, frail patients and mildly frail patients had a significantly higher risk of hospital mortality than fit patients (total sample: CFS 6-9 vs CFS 1-3 odds ratio [OR] 2•71 [95% CI 2•04-3•60], p<0•0001 and CFS 4-5 vs CFS 1-3 OR 1•54 [1•16-2•06], p=0•0030; age ≥65 years: CFS 6-9 vs CFS 1-3 OR 2•90 [2•12-3•97], p<0•0001 and CFS 4-5 vs CFS 1-3 OR 1•64 [1•20-2•25], p=0•0020). In patients younger than 65 years, an increased hospital mortality risk was only observed in frail patients (CFS 6-9 vs CFS 1-3 OR 2•22 [1•08-4•57], p=0•030; CFS 4-5 vs CFS 1-3 OR 1•08 [0•48-2•39], p=0•86). Frail patients had a higher incidence of admission to intensive care than fit patients (CFS 6-9 vs CFS 1-3 OR 1•54 [1•21-1•97], p=0•0010), whereas mildly frail patients had a lower incidence than fit patients (CFS 4-5 vs CFS 1-3 OR 0•71 [0•55-0•92], p=0•0090). Among patients younger than 65 years, frail patients had an increased incidence of admission to intensive care (CFS 6-9 vs CFS 1-3 OR 2•96 [1•98-4•43], p<0•0001), whereas mildly frail patients had no significant difference in incidence compared with fit patients (CFS 4-5 vs CFS 1-3 OR 0•93 [0•63-1•38], p=0•72). Among patients aged 65 years and older, frail patients had no significant difference in the incidence of admission to intensive care compared with fit patients (CFS 6-9 vs CFS 1-3 OR 1•27 [0•92-1•75], p=0•14), whereas mildly frail patients had a lower incide...
Introduction Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK. Methods In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA 1c ) value ≤ 12 weeks before semaglutide initiation were enrolled. The primary endpoint was change in HbA 1c from baseline to end of study (EOS; ~ 30 weeks, although due to the COVID-19 pandemic, visits up to week 52 were permitted). Secondary endpoints included change in body weight, waist circumference and patient-reported outcomes (PROs). Physicians were to report all episodes of documented or severe hypoglycaemia, fatal events, serious adverse drug reactions, pregnancies and adverse events (AEs) in foetuses/newborn infants; other AEs during the study period could be reported on a voluntary basis. Result The estimated mean change in HbA 1c from baseline to EOS was − 16.3 mmol/mol [95% confidence interval (CI): − 18.22, − 14.37] (− 1.5%-points [95% CI − 1.67, − 1.31]; p < 0.0001) among the 171 enrolled patients who completed the study on treatment. Mean body weight change was − 5.8 kg (95% CI − 6.75, − 4.94; p < 0.0001). Sensitivity analyses showed similar results. Improvements were also observed in other secondary endpoints, including PROs. No new safety concerns were identified with semaglutide treatment. Conclusion Patients receiving OW semaglutide experienced statistically significant and clinically relevant reductions from baseline in HbA 1c and body weight. These results are in line with those of the SUSTAIN RCTs and support the use of OW semaglutide in routine clinical practice in adults with T2D in the UK. Trial registration ClinicalTrials.gov Identifier NCT03876015. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-021-01141-8.
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