These data provide no evidence of a beneficial effect of gabapentin on disease progression or symptoms in patients with ALS.

Introduction SARS-CoV-2 pneumonia is often associated with hyper-inflammation. The cytokine-storm-like is one of the targets of current therapies for coronavirus disease 2019 (COVID-19). High Interleukin-6 (IL6) blood levels have been identified in severe COVID-19 disease, but there are still uncertainties regarding the actual role of anti-IL6 antagonists in COVID-19 management. Our hypothesis was that the use of sarilumab plus corticosteroids at an early stage of the hyper-inflammatory syndrome would be beneficial and prevent progression to acute respiratory distress syndrome (ARDS). Methods We randomly assigned (in a 1:1 ratio) COVID-19 pneumonia hospitalized patients under standard oxygen therapy and laboratory evidence of hyper-inflammation to receive sarilumab plus usual care (experimental group) or usual care alone (control group). Corticosteroids were given to all patients at a 1 mg/kg/day of methylprednisolone for at least 3 days. The primary outcome was the proportion of patients progressing to severe respiratory failure (defined as a score in the Brescia-COVID19 scale ≥ 3) up to day 15. Results A total of 201 patients underwent randomization: 99 patients in the sarilumab group and 102 patients in the control group. The rate of patients progressing to severe respiratory failure (Brescia-COVID scale score ≥ 3) up to day 15 was 16.16% in the Sarilumab group versus 15.69% in the control group (RR 1.03; 95% CI 0.48–2.20). No relevant safety issues were identified. Conclusions In hospitalized patients with Covid-19 pneumonia, who were under standard oxygen therapy and who presented analytical inflammatory parameters, an early therapeutic intervention with sarilumab plus standard of care (including corticosteroids) was not shown to be more effective than current standard of care alone. The study was registered at EudraCT with number: 2020-002037-15. Supplementary Information The online version contains supplementary material available at 10.1007/s40121-021-00543-2.

Impact of findings on practicei. There is a lack on drug safety in patients with HI.ii. ACP is an effective and reproducible pre-screening score to assess the prevalence of prescriptions susceptible to be adjusted in patients with HI.iii. The pharmacist plays an important role implementing programs to stratify patients and recommending appropriate dose in HI.

BackgroundMore and thermolabile drugs are becoming available, and in most cases, these medications are dispensed to ambulatory patients. However, there is no regulation once medications are dispensed to patients and little is known with regard to what happens during transport and home storage. Previous studies suggest that these drugs are improperly stored. The present study was designed to determine the storage conditions of thermolabile drugs once they are dispensed to the patient in the Hospital Pharmacy Department.MethodsThis is a prospective observational study to assess the temperature profile of 7 thermolabile drugs once they are dispensed to ambulatory patients at a tertiary care hospital. A data logger was added to the medication packaging. Temperature was considered inappropriate if one of the following circumstances were met: any temperature record less than or equal to 0ºC or over 25ºC; temperatures between 0-2ºC or 8ºC-25ºC for a continuous period over 30 minutes. The time series of temperature measurements obtained from each data logger were analyzed as statistically independent variables. The data shown did not undergo any statistical treatment and must be considered directly related to thermal measurements.ResultsOne hundred and fourteen patients were included and 107 patients were available for the analysis. On the whole, a mean of 50.6 days (SD 18.3) were measured and the mean temperature was 6.88ºC (SD 2.93). Three data loggers (2.8%) maintained all the measurements between 2ºC and 8ºC with less than 3 continuous data (< 30 minutes) out of this range but no data over 25ºC or below or equal to 0ºC. 28 (26.2%) data loggers had at least one measurement below zero, 1 data logger had a measurement greater than 25ºC and 75 (70.1%) were between 0ºC and 2ºC and/or between 8º and 25ºC for more than 30 minutes.ConclusionsOnce dispensed to patients, most thermolabile drugs are improperly stored. Future studies should focus on clinical consequences and possible solutions.

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