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Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria ; 46(3):166-172, 2022.
Article in English | Scopus | ID: covidwho-2072713

ABSTRACT

OBJECTIVE: One year after the declaration of the SARS-CoV-2 pandemic, only  dexamethasone has clearly shown a reduction in mortality for COVID-19  hospitalized patients. For interleukin-6 inhibitors, results are variable and  nclear. The objective was to review and analyze the effect of tocilizumab and  sarilumab on survival in this setting. METHOD: The PRISMA statements were fulfilled for the systematic review. A  systematic search in Medline, Embase and medRxiv was conducted to identify  randomized controlled trials with tocilizumab or sarilumab in hospitalized  patients with COVID-19. Mortality data from non-critical and critical patients  were extracted. A random-effects (DerSimonian-Laird) meta-analysis was  performed for both subgroups and the whole population using MAVIS software  v. 1.1.3. Similarity and homogeneity among trials were assessed. RESULTS: Twenty-five and 23 articles were identified in Medline and Embase,  respectively, five were trials with tocilizumab and/or sarilumab; two more were  identified at medRxiv. Seven randomized clinical trials fulfilled the  inclusion criteria. Another trial was pre-published and included post-hoc. The  meta-analysis, with eight randomized clinical trials and 6,340 patients, showed  a benefit on mortality for interleukin-6  heterogeneity (I2 = 7%), but  a low similarity among studies. The results showed no differences among  critical and non-critical patients. A sensitivity analysis excluding non-similar or  heterogeneous studies showed different results, without benefit and with low  precision of the result in non-critical patients. CONCLUSIONS: A benefit in mortality for interleukine-6 inhibitors was found, but  with important differences among the scenarios analyzed in the clinical  trials. Positive results are mainly caused by two randomized clinical trials which  are similar in concomitant use of steroids and veryhigh mortality in  critical patents. Sarilumab was poorly represented in the meta-analysis.  Nevertheless, an association between the benefit and the critical/non-critical  condition was not found. More randomized clinical trials, mainly focused in  atients at high mortality risk, are needed to confirm the benefit of interleukine- 6 inhibitors for COVID-19. Sarilumab was underrepresented in the meta- analysis. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved. OBJETIVO: Un año después de la declaración de la pandemia por SARS‑CoV-2,  solo dexametasona había mostrado claramente una reducción de la mortalidad  en pacientes hospitalizados por COVID-19. Los resultados de los inhibidores de  interleucina 6 son diversos y poco claros. El objetivo de este trabajo es  revisar y analizar el efecto de tocilizumab y sarilumab sobre la supervivencia  de los pacientes en este escenario.Método: La revisión sistemática siguió las recomendaciones de PRISMA. Se  realizó una búsqueda sistemática en Medline, Embase y medRxiv para identificar ensayos controlados aleatorizados con tocilizumab o sarilumab  en pacientes hospitalizados con COVID-19. Se recopilaron los datos de mortalidad de pacientes críticos y no críticos y se llevó a cabo un metaanálisis de efectos aleatorios (Der Simonian-Laird) para ambos  subgrupos y para toda la población, usando el software MAVIS v. 1.1.3. La similitud y homogeneidad entre los ensayos fue evaluada. RESULTADOS: Se identificaron 25 y 23 artículos en Medline y Embase, respectivamente;cinco eran ensayos con tocilizumab y/o sarilumab;  se identificaron dos más en medRxiv. En total, siete ensayos clínicos  aleatorizados cumplieron los criterios de inclusión. Posteriormente, se  prepublicó otro ensayo que cumplía los criterios de inclusión y se incorporó al  análisis. El metaanálisis, con ocho ensayos clínicos aleatorizados y 6.340  pacientes, mostró un beneficio sobre la mortalidad para los inhibidores de  interleucina-6 (hazard ratio 0,85;intervalo de confianza al 95% 0,74-0,99),  con baja h terogeneidad (I2 = 7%), pero reducida similitud entre los estudios.  Los resultados no mostraron diferencias entre pacientes críticos y no  críticos. Un análisis de sensibilidad excluyendo estudios heterogéneos o no  similares mostró resultados diferentes, sin beneficio y con baja precisión del  resultado en pacientes no críticos. CONCLUSIONES: Se encontró un beneficio en la mortalidad de los inhibidores de  la interleucina 6, pero con importantes diferencias entre los escenarios analizados en los ensayos clínicos. Los resultados positivos se  eben principalmente a dos ensayos que son similares en el uso concomitante  de esteroides y una mortalidad muy alta en pacientes críticos. Sarilumab estuvo escasamente representado en el metaanálisis. Sin embargo, el metaanálisis por subescenarios no encontró una relación entre  el beneficio y la condición de pacientes críticos/no críticos. Se necesitan más ensayos clínicos aleatorizados, principalmente enfocados en  pacientes con alto riesgo de mortalidad, para confirmar el beneficio de los  inhibidores de interleucina-6 en COVID-19.

3.
Farmacia Hospitalaria ; 46(3):166-172, 2022.
Article in Spanish | Web of Science Web of Science | ID: covidwho-1884660

ABSTRACT

Objective: One year after the declaration of the SARS-CoV-2 pandemic, only dexamethasone has clearly shown a reduction in mortality for COVID-19 hospitalized patients. For interleukin-6 inhibitors, results are variable and unclear. The objective was to review and analyze the effect of tocilizumab and sarilumab on survival in this setting. Method: The PRISMA statements were fulfilled for the systematic review. A systematic search in Medline, Embase and medRxiv was conducted to identify randomized controlled trials with tocilizumab or sarilumab in hospitalized patients with COVID-19. Mortality data from non-critical and critical patients were extracted. A random-effects (DerSimonian-Laird) meta-analysis was performed for both subgroups and the whole population using MAVIS software v. 1.1.3. Similarity and homogeneity among trials were assessed. Results: Twenty- five and 23 articles were identified in Medline and Embase, respectively, five were trials with tocilizumab and/or sarilumab;two more were identified at medRxiv. Seven randomized clinical trials fulfilled the inclusion criteria. Another trial was pre-published and included post-hoc. The meta-analysis, with eight randomized clinical trials and 6,340 patients, showed a benefit on mortality for interleukin-6 inhibitor (hazard ratio 0.85;confidence interval 95% 0.74-0.99), low heterogeneity (I-2 = 7%), but a low similarity among studies. The results showed no differences among critical and non- critical patients. A sensitivity analysis excluding non-similar or heterogeneous studies showed different results, without benefit and with low precision of the result in non- critical patients. Conclusions: A benefit in mortality for interleukine- 6 inhibitors was found, but with important differences among the scenarios analyzed in the clinical trials. Positive results are mainly caused by two randomized clinical trials which are similar in concomitant use of steroids and veryhigh mortality in critical patents. Sarilumab was poorly represented in the meta-analysis. Nevertheless, an association between the benefit and the critical/non-critical condition was not found. More randomized clinical trials, mainly focused in patients at high mortality risk, are needed to confirm the benefit of interleukine-6 inhibitors for COVID-19. Sarilumab was underrepresented in the meta-analysis.

4.
European Journal of Hospital Pharmacy ; 28(SUPPL 1):A63, 2021.
Article in English | EMBASE | ID: covidwho-1186314

ABSTRACT

Background and importance The SARS-CoV-2 pandemic could have changed the clinical management of cancer patients because of travel restrictions, overloading of hospital systems and disruption of treatment. Lung cancer patients constitute a vulnerable population due to the particular risk of their disease, chemotherapy or immunotherapy. Aim and objectives To analyse disease management and the clinical impact of the COVID-19 pandemic on non-small cell lung cancer (NSCLC) patients receiving intravenous treatment during the social isolation period compared with the normal situation. Material and methods This retrospective observational cohort study included a 2:1 random sample of NSCLC patients in the 'COVID cohort' (patients in isolation February 2020 to June 2020) and the 'no COVID cohort' (patients treated between February 2019 and June 2019). Collected variables from digital clinical history were age, sex, stage, previous lines, type of treatment, number of medical visits and telephone consults, cycles received, worsening of performance status (PS), respiratory infection (COVID-19 and others), delays, therapeutic rest break, disease progression and deaths. Results COVID cohort (CC): 40 patients, 31 (78%) men;mean 67 years (59-84). Cancer stage: IV (69%), IIIB (28%), IIIA (2%) and IIIC (1%). 12 (30%) patients had not received lines previously. 38% of the population received immunotherapy. Median number of medical visits was 3 (14-1) and median number of telephone consults was 3 (1-8). Median number of cycles was 4 (1-16). PS 0 (58%) and PS 1 (42%). No patient had COVID-19. No COVID cohort' (NCC): 20 patients, 15 (75%) men, mean 67 years (54-85). Cancer stage: stage IV (75%), IIIB (25%). All patients had received lines previously and none had received immunotherapy. Median medical visits was 7 (3- 11) with no telephone consults. Median number of cycles was 3 (1-11). PS 0 (70%) and PS1-2 (30%). The rest of the variables are shown in table 1. Conclusion and relevance In spite of the limitations of the study, the new strategies of clinical management during the COVID-19 pandemic (telephone consults and therapeutic tire) did not appear to affect disease progression and NSCLC patient survival although worsening of performance status was observed.

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