RESUMEN
Objectives: This study was designed to assess the disproportionality analyses of adverse drug reactions (ADRs) related to hydroxychloroquine and remdesivir and how ADR reporting fluctuated during the COVID-19 pandemic. Methods: A retrospective observational study was conducted utilizing the Food and Drug Administration's Adverse Event Reporting System (FAERS) data between 2019 and 2021. The study was conducted in two phases. In the first phase, all reports associated with the drugs of interest were evaluated to assess all related adverse drug reactions. In the second phase, specific outcomes of interest (i.e., QT prolongation and renal and hepatic events) were determined to study their association with the drugs of interest. A descriptive analysis was conducted for all adverse reactions related to the drugs being studied. In addition, disproportionality analyses were conducted to compute the reporting odds ratio, the proportional reporting ratio, the information component, and the empirical Bayes geometric mean. All analyses were conducted using RStudio. Results: A total of 9,443 ADR reports related to hydroxychloroquine; 6,160 (71.49) patients were female, and higher percentage of patients of both sexes were over the age of 65 years. QT prolongation (1.48%), pain (1.38%), and arthralgia (1.25%) were most frequently reported ADRs during the COVID-19 pandemic. The association of QT prolongation with use of hydroxychloroquine was statistically significant (ROR 47.28 [95% CI 35.95-62.18]; PRR 42.41 [95% CI 32.25-55.78]; EBGM 16.08; IC 4.95) compared with fluoroquinolone. The outcome was serious medical events in 48.01% of ADR reports; 27.42% required hospitalization and 8.61% resulted in death. Of 6,673 ADR reports related to remdesivir, 3,928 (61.13%) patients were male. During 2020, the top three ADR reports were elevated liver function tests (17.26%), acute kidney injury (5.95%) and death (2.84%). Additionally, 42.71% of ADR reports indicated serious medical events; 19.69% resulted in death and 11.71% indicated hospitalization. The ROR and PRR of hepatic and renal events associated with remdesivir were statistically significant, (4.81 [95% CI 4.46-5.19] and 2.96 [95% CI 2.66-3.29], respectively. Conclusion: Our study showed that several serious ADRs were reported with the use of hydroxychloroquine, which resulted in hospitalization and death. Trends with the use of remdesivir were similar, but to a lesser extent. Therefore, this study showed us that off-label use should be based on thorough evidence-based evaluation.
RESUMEN
Background: On March 11th, 2020, The World Health Organization (WHO) declared that the COVID-19 is a pandemic due to its worldwide spread. The COVID-19 pandemic has extended its impact to Saudi Arabia. By mid-February 2021, The Kingdom of Saudi Arabia has reported more than 373,000 COVID-19 cases impacting different population categories (i.e., male, female, different age groups, comorbidities status). The objective of this nationwide study was to describe and explore the characteristics of hospitalized patients diagnosed with COVID-19 in Saudi Arabia. Methods: This study was an observational epidemiological study based on collected clinical data from ten health institutions across all regions in Saudi Arabia. The study was conducted during the period from March 2nd, 2020, to January 31st, 2021. The data were collected included demographics, medical information, medications, and laboratory and diagnostic. More detailed information on usually missing factors such as smoking status, comorbidities, length of hospital stay were also collected. Both descriptive and inferential analyses were conducted using the statistical analysis software "SAS®" version 9.4. Results: During the study period, 5286 patients were included in this study. Of these, (79.15%) were male. Of all 5286 patients, quite a high number of the studied population 2010 (38.02%) were smokers. The majority of the patients 3436 (65%) were reported to have comorbidities, with hypertension being the most common disease 1725 (32.6%), followed by diabetes 1641(31.04%). A high proportion of the patients, 2220 patients (41.99%), were admitted to the intensive care unit; of these, (33.52%) were on mechanical ventilation. Most patients received anticoagulant prophylaxis medications (n = 4414, 83.5%). All patients were given more than one antibiotic prophylaxis. Overall, the median hospital stay was 5.5 days, and the median length in the intensive care unit was 4.26 days. Around (89.14%) of patients were discharged from the hospital, and (10.8%) died. Conclusion: In this real-world study utilizing a large sample size, this study provides confirmatory results on the COVID-19 patients characteristics that are similar to other populations. Healthcare professionals need to give COVID-19 patients with specific characteristics including smoking, diabetes mellitus and cardiac disease more care to avoid losing these patients.