For the treatment of Covid‐19 patients with remdesivir, poor renal and liver function were both exclusion criteria in randomized clinical trials and contraindication for treatment. Also, nephrotoxicity and hepatotoxicity are reported as adverse events. We retrospectively reviewed renal and liver functions of Covid‐19 103 patients who received remdesivir in the 15 days after treatment initiation. Approximately 20% of the patient population met randomized clinical trial exclusion criteria. In total, 11% of the patients had a decrease in estimated glomerular filtration rate >10 mL/min/1.73m2. Also, 25 and 35% had increased alanine transaminase and aspartate transaminase levels, respectively. However, serious adverse events were limited. Therefore, based on these preliminary results, contraindications based on kidney and liver function should not be absolute for remdesivir treatment in patients with Covid‐19 if these functions are monitored regularly. A larger patient cohort is warranted to confirm our results.
Real‐world evidence can close the inferential gap between marketing authorization studies and clinical practice. However, the current standard for real‐world data extraction from electronic health records (EHRs) for treatment evaluation is manual review (MR), which is time‐consuming and laborious. Clinical Data Collector (CDC) is a novel natural language processing and text mining software tool for both structured and unstructured EHR data and only shows relevant EHR sections improving efficiency. We investigated CDC as a real‐world data (RWD) collection method, through application of CDC queries for patient inclusion and information extraction on a cohort of patients with metastatic renal cell carcinoma (RCC) receiving systemic drug treatment. Baseline patient characteristics, disease characteristics, and treatment outcomes were extracted and these were compared with MR for validation. One hundred patients receiving 175 treatments were included using CDC, which corresponded to 99% with MR. Calculated median overall survival was 21.7 months (95% confidence interval (CI) 18.7–24.8) vs. 21.7 months (95% CI 18.6–24.8) and progression‐free survival 8.9 months (95% CI 5.4–12.4) vs. 7.6 months (95% CI 5.7–9.4) for CDC vs. MR, respectively. Highest F1‐score was found for cancer‐related variables (88.1–100), followed by comorbidities (71.5–90.4) and adverse drug events (53.3–74.5), with most diverse scores on international metastatic RCC database criteria (51.4–100). Mean data collection time was 12 minutes (CDC) vs. 86 minutes (MR). In conclusion, CDC is a promising tool for retrieving RWD from EHRs because the correct patient population can be identified as well as relevant outcome data, such as overall survival and progression‐free survival.
This study showed that decreased renal function (eGFR <50 ml/min) was associated with a fivefold increased risk for hyperkalemia in patients using potassium-influencing drugs. While previous studies showed that hyperkalemia substantially increases below a threshold of eGFR <30 or 40 ml/min, we observed a lower threshold of eGFR <50 ml/min. It is therefore recommended that physicians should be particularly alert while monitoring the use of potassium-influencing drugs in patients with decreased renal function.
In one-third of preoperatively screened patients, an MEA was found. The number of medications and respiratory comorbidities are risk factors for MEA in preoperatively screened patients.
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