JPERM

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Hyponatremia is the most common electrolyte imbalance and usually induced by renal water retention due to the presence of factors contributing to increased antidiuretic hormone, low glomerular filtration rate and poor intake of salt and protein in the elderly population. Although symptom severity varies according to the severity, duration and rapidity of hyponatremia, mild chronic hyponatremia is associated with frailty, osteoporosis, cognitive impairment and gait disturbance. The syndrome of inappropriate antidiuretic hormone secretion and endocrinopathies such as hypothyroidism and adrenal insufficiency are major causes of hyponatremia, but medications have been considered as an important factor of water imbalance, and thiazide diuretics, psychotropic agents, anticancer chemotherapeutic drugs and vasopressin analogues are major hyponatremia-inducing drugs in clinical practice. Syndrome of inappropriate anti-diuresis (SIAD) is a main pathogenesis of drug-induced hyponatremia, but multifactorial factors are associated with hyponatremia in old patients. Clinicians should prescribe these potential drugs with caution, especially in those with risk factors for SIAD. The treatment of hyponatremia depends on the severity and type of hyponatremia, and all offending drugs should be discontinued and re-administration of these drugs is strongly discouraged.

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Reproducibility and transparency are fundamental scientific principles that enhance research efficiency, facilitate corrections, and strengthen the reliability of published literature. The clearer each stage of the research process is, the easier it is for reviewers to understand how evidence was obtained and to evaluate the validity of the methods used. This also helps in understanding differences between studies addressing similar topics. A recent evaluation has revealed significant discrepancies in the transparency of real-world evidence (RWE) studies, emphasizing the need for rigorous and internationally agreed-upon guidelines. To address this issue, the International Society for Pharmacoepidemiology (ISPE) and the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) have formed a joint task force with key stakeholders to develop a harmonized protocol template for RWE studies, aimed at assessing treatment effects and guiding decision-making. The HARmonized Protocol Template to Enhance Reproducibility (HARPER) incorporates various sections, guidelines, and structures from four protocol templates developed by multiple stakeholders and international organizations for RWE studies, which have been thoroughly evaluated, integrated, and updated. HARPER assists in building a common understanding of intended scientific decisions through a unified format of text, tables, and visuals. To assist Korean researchers in developing clearer and more reproducible research designs, we present the development process and usage guidelines of the HARPER format, along with the final version template, all translated into Korean from the original English publication.

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The increasing development of new drugs for rare diseases has posed challenges to the use of randomization in clinical trials. Therefore, the importance of regulatory decision-making utilizing real-world data (RWD) and real-world evidence (RWE) to complementary and alternative clinical trials has become a focal point. The United States, Europe, and Japan have implemented relevant laws and regulations and are continuously developing guidelines in this field. In response to this trend, South Korea is also advancing its research on regulatory decision-making using RWD/ RWE. This study aimed to explore the current utilization status of RWD/RWE for complementing and alternating clinical trials by examining guidelines from the United States, Europe, Japan, and South Korea. Through a comparative analysis of guidelines from various countries, we have developed recommendations for essential guidelines tailored to South Korea. We expect this study to enhance rational and efficient decision-making in regulatory processes and lay the groundwork for establishing clinical research that utilizes RWD/RWE.

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Tuberculosis remains a significant public health issue globally despite being preventable and treatable. This study reviews domestic and international tuberculosis treatment guidelines, focusing on recommendations for preventing ethambutol-induced optic neuropathy, a serious side effect of a key anti-tuberculosis drug. This study reviews tuberculosis treatment guidelines published between January 2015 and June 2024, focusing on recommendations for managing ethambutol-induced optic neuropathy. A systematic search was conducted using major databases and health organization websites. Guidelines were selected based on specific criteria and evaluated using the AGREE II instrument, with strengths and limitations analyzed to identify potential improvements in monitoring strategies. This study analyzed six international and one domestic tuberculosis treatment guideline using the AGREE II instrument. Guidelines varied in development rigor and transparency, with WHO and ATS/CDC/IDSA guidelines demonstrating the most comprehensive methodologies. Four guidelines, including the domestic one, addressed ethambutol-induced visual impairment, recommending baseline and periodic vision assessments. Recommendations for monitoring and managing ocular side effects varied across guidelines, emphasizing the importance of patient education and prompt reporting of visual changes. Out of seven guidelines examined, only four, including the domestic guideline, provided specific recommendations. The study emphasizes the importance of early detection and prevention of permanent visual impairment, suggesting the need for more detailed criteria, monitoring frequencies, and advanced diagnostic methods, particularly for high-risk patients. Selective use of optical coherence tomography and angiography is recommended for early diagnosis and prevention of irreversible disability.

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Objective: 3-Hydroxy-3-methylglutaryl coenzyme A reductase inhibitors (i.e., statins) are widely used to treat dyslipidemia. Several studies indicate that statin users have greater bone mineral density and a lower risk of fractures than non-users. However, a recent study indicated that high-dose statin use increased the risk of osteoporosis. Thus, we assessed the risk of osteoporosis of statin users compared with nonusers. Methods: This was a retrospective cohort study using the National Health Insurance Service database in Korea from 2011 to 2019. Patients aged ≥ 40 years and diagnosed with dyslipidemia (ICD-10, E78) between January 1, 2014 and December 31, 2015 were enrolled. Statin users were defined as patients with at least one statin prescription. The outcome was osteoporosis. Primary analysis was performed using Cox’s proportional hazard model after 1:1 exact matching and 1:1 propensity score (PS) matching (462,900 patients per group) to calculate the hazard ratio (HR) and 95% confidence interval (CI). Results: Statin users had a lower risk of osteoporosis versus non-users (HR: 0.92, 95% CI: 0.91-0.93); the subgroup analyses were consistent. In the subgroup analysis, the risk of osteoporosis in statin users versus non-users was 0.96 (95% CI: 0.95-0.97), 0.88 (95% CI: 0.87-0.89), and 0.75 (95% CI: 0.72-0.79) in the low, moderate, and high dose groups, respectively; the results were statistically significant at all doses. Conclusion: Statin use is significantly associated with a lower risk of osteoporosis compared to non-use of statins. In particular, as the dose increased, the risk of osteoporosis decreased, confirming a dose-response relationship.

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Objective: Ammonia generated during breakdown of L-asparaginase is elevated due to excessive production or hindrance of ammonia conversion to urea. While children are in condition of growth and have faster metabolic rate compared to adults, hyperammonemia is more critical and can potentially lead to neurotoxicity. We aimed to assess the incidence and risk factors of hyperammonemia in pediatric patients with leukemia or lymphoma during hospitalization after L-asparaginase administration. Methods: Electronic medical records of pediatric patients with leukemia or lymphoma who were hospitalized at Seoul National University Children's Hospital and received L-asparaginase between 2013 and 2022, were retrospectively reviewed. Ammonia level ≥ 200 μmol/L were defined as hyperammonemia. Risk factors for hyperammonemia were analyzed using chi-square tests. Results: Among 110 patients whose ammonia levels were measured after L-asparaginase administration, hyperammonemia was observed in 70 patients (63.6%). Among them, 32 patients (45.7%) experienced neurological symptoms including nausea, vomiting, dizziness, confusion, seizure. Ideal body weight percentage, acute lymphoblastic leukemia (ALL) standard risk group and 1952 induction regimen (p = 0.019, 0.018, 0.038) were found as risk factors. Patients classified as high-risk for leukemia treatment had a higher risk of neurological symptoms (p = 0.005). Conclusion: Hyperammonemia occurred in 63.6% of pediatric hospitalized patients administered L-asparaginase. Patients with overweight or in the standard risk group for ALL were more likely to develop hyperammonemia. The risk of developing neurological symptoms in the high-risk group for ALL was higher and treatment was necessary. Thus, consistent monitoring of ammonia levels in pediatric patients administered L-asparaginase is necessary to detect hyperammonemia.

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Objective: Real-World Data (RWD) and Real-World Evidence (RWE) complement the limitations of clinical trials and play a crucial role in drug development and approval processes. This study assesses the awareness of RWD/RWE in the Korean drug approval process, and investigates practical experiences and challenges. Methods: The survey collected 113 responses through both offline and online methods. The respondents were broadly classified into two groups: those utilizing it for academic purposes and those for profitgeneration purposes. Data were analyzed using SAS 9.4 software. Results: Data revealed that only 26% of respondents felt they could fully utilize RWD/RWE currently, while 40% believed they could do so within 12 years. Both groups recognized the importance of RWD/RWE, but there were significant differences in utilization perceptions. 80% of academic respondents positively evaluated RWD/RWE, while 48% of respondents from the pharmaceutical industry indicated that more time was needed (p-value=0.011). In academia, the proportion of those with and without RWD/RWE experts was similar. However, the pharmaceutical industry showed 1.75 times higher rate of lacking such experts (p-value=0.173). Major challenges identified included data accessibility and quality issues, with the industry particularly concerned about costs. Among those without plans to utilize RWD/RWE, the main obstacles cited were the absence of experts within research teams and inadequate laws and regulations. Conclusion: This study highlights the necessity of addressing data accessibility and quality issues, training specialized experts, and providing clear regulatory guidelines and support. Bridging the perception gap between academia and the industry requires solutions to improve data accessibility and reduce cost burdens. Regulatory agencies should strengthen the legal framework for RWD/RWE utilization and establish systems and guidelines to ensure data quality and consistency. By systematically investigating the awareness and utilization of RWD/RWE in the domestic drug approval process, this study identifies key barriers and proposes solutions to overcome them. Effective utilization of RWD/RWE is expected to significantly enhance the efficiency and safety of drug development and approval processes, driving innovation.

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Objective: This study aimed to classify medication errors during clinical trials by stage of medication use, identify error types, and analyze associated factors at a single institution. Methods: Data were collected from medication errorrelated reports, including ‘protocol violation reports’ and ‘near miss reports,’ from January 1, 2018, to December 31, 2022. Errors were categorized by severity using the Medication Error Index and classified by error type using the Sheikhtaheri and psychological classification methods. Contributing factors were analyzed in terms of human, organizational, investigational product, and clinical trial design factors. Results: A total of 62 medication errors from 46 reports were identified. Errors occurred across various stages: prescribing (19.4%), preparation (46.8%), administration (1.6%), site management (9.7%), and sponsor management (22.6%). Common errors included ‘wrong dose’ in prescribing (58.3%) and ‘wrong medication’ in preparation (31.0%). Severity classification showed that most errors were in categories B (45.7%) and C (52.2%). Near miss analysis revealed that 45.6% of errors were intercepted before reaching the patient. Contributing factors were primarily human (52.9%), followed by organizational (16.1%), investigational product (16.1%), and clinical trial design factors (14.9%). Psychological classification indicated 34.8% rule-based, 30.4% knowledge-based, 21.7% action-based, and 13.0% memorybased errors. Conclusion: Understanding medication errors and their contributing factors in clinical trials can provide valuable insights for improving medication safety strategies in the planning and execution of clinical trials.

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Objective: The clinical outcome of mycophenolate (MPA) combined with tacrolimus in pediatric liver transplantation (LT) are not well understood. This study aimed to evaluate the effectiveness and safety of MPA and tacrolimus combination therapy compared to tacrolimus monotherapy in this population. Methods: This retrospective cohort study included pediatric LT patients who received at least 30 consecutive days of either tacrolimus and MPA (± steroid) combination therapy and their propensity score matched patients on tacrolimus (± steroid) monotherapy between 2010 and 2021. Incidence of acute rejection and immunosuppressantrelated adverse events (AEs) were compared between the two groups. Results: Among 130 pediatric LT patients, 32 were assigned to each group. Within one-year post-transplant, there were no statistically significant differences in acute rejection (9.4% vs. 12.5%; p = 0.502) or overall AEs (84.4% vs. 65.6%; p = 0.149) between the combination and control groups. However, a significantly higher rate of AEs leading to immunosuppressant discontinuation was observed in the combination group (62.5% vs. 3.1%; p < 0.001). No significant differences were found in severe infections, cytomegalovirus infections, post-transplant lymphoproliferative disease, or renal dysfunction. Although tacrolimus exposure was similar, the concentration/dose ratio was lower in the combination group at 1 month (1.8 ± 5.4 vs. 3.4 ± 3.8, p = 0.040). Conclusion: While acute rejection and overall AE rates did not differ significantly between the two groups, the MPA combination group had a higher rate of therapy discontinuation due to AEs. Further studies with larger populations are needed to confirm these findings.

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Objective: Acid-suppressive therapy is commonly used for stress ulcers; however, concerns have been raised regarding its potential to increase the risk of Clostridioides difficile infection (CDI). This study aimed to compare the risk of CDI associated with proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) among acid-suppressive agents. Methods: We conducted a meta-analysis to systematically evaluate the risk of CDI associated with PPIs compared to H2RAs. We searched 3 major databases up to April 30, 2024. The primary outcome was the incidence of CDI. Results: The meta-analysis of 14 articles involving 160,085 patients showed PPIs were associated with a 1.50-fold increase in the risk of CDI compared to H2RAs [95% CI: 1.22–1.85, I² = 39%]. In a subgroup analysis of 8 out of 14 studies, which included 88,393 critically ill patients, PPIs were linked to a 1.58-fold increase in the risk of CDI compared to H2RAs [95% CI: 1.10–2.27, I² = 61%]. In observational studies, PPIs were associated with a 1.55-fold increase in the risk of CDI [95% CI: 1.26–1.91, I² = 33%]. In randomized trials, PPIs were not significantly associated with an increased risk of CDI compared to H2RAs [OR 1.92, 95% CI: 0.51–7.25, I² = 41%]. Conclusion: Our findings indicate that PPIs are associated with a higher risk of CDI compared to H2RAs. Further well-controlled clinical trials are necessary to confirm these results.

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While health insurance claims data in Korea have the potential as evidence for drug regulatory decision-making, its effective utilization remains limited. This study aims to identify the challenges encountered by researchers in utilizing claims data and discuss improvement strategies. We summarized practical difficulties encountered by researchers who have experience using claims data from the National Health Insurance Service and the Health Insurance Review and Assessment Service. Challenges encountered by researchers included difficulties in acquiring drug data, delays in data provision, limited provision of information on specific conditions, drugs, and treatments, small data capacity, short data usage periods, and spatiotemporal considerations when accessing data. To maximize the utility of claims data in drug regulatory decision-making, continuous communication between researchers and data providers is necessary for addressing these challenges.

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Globally, advanced therapy medicinal products (ATMP) such as stem cell therapies and gene therapies have become the focal point of the pharmaceutical market. In response to this trend, Korea, like the United States and Europe, has established various regulations and systems pertaining to ATMP. The Ministry of Food and Drug Safety enacted the ‘Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Therapy Medicinal Products,’ restructuring the existing approval system from one centered around synthetic drugs and conventional biopharmaceuticals to one tailored to the characteristics of ATMP. While this regulatory framework allows for consideration of the unique attributes of ATMP, standardized safety measures specific to each product category are currently lacking. To address this gap, we provided foundational data for the safety and effective management of ATMP. This was accomplished by comparing and analyzing the mechanisms of gene therapy products, which are central to ATMP. Additionally, we conducted an analysis of indications and potential adverse events. Based on our research, we anticipate that our study will serve as foundational data for the safety and effective management of gene therapy.

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Penicillin allergy labels are associated with significant challenges, including antimicrobial resistance, restricted prescribing options, and negative outcomes for both patients and health care systems. However, only 10% of individuals labeled as penicillin allergic are found to be truly allergic after formal assessment. The evaluation process for a penicillin allergy encompasses a detailed allergy history, often followed by skin testing, and drug challenge. Researchers have suggested assessment tools and clinical decision rules for risk stratification for efficient and precise removal of incorrect penicillin allergy labels. In particular, patients categorized as low risk based on the assessment may undergo direct challenge test with penicillin, a practice supported by accumulating evidence. This comprehensive approach, emphasizing history taking and risk stratification, highlights the important role of healthcare providers in reducing the burden related to penicillin allergy labels. This review aims to understand the process of penicillin allergy evaluation and potential benefits of delabeling.

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Objective: We aimed to identify factors associated with adverse event (AE) reports in statin-associated muscle symptoms (SAMS) using hierarchical clustering of patients in the Korea Institute of Drug Safety and Risk Management - Korea Adverse Event Reporting System database (KIDS-KAERS DB) (2105A0027). Methods: To explore the characteristics and risk factors of SAMS reports, we analysed the KIDSKAERS DB from 2016 to 2020. We included reports with a causality category level of “possible” or higher. Hierarchical clustering analysis was used to identify distinctive patterns within the dataset, with a particular focus on variables such as sex, age, statin type, contraindicated drugs and concomitant drugs. The reporting characteristics were described according to the cluster. Results: Four clusters of AE reports were distinguished by hierarchical clustering: atorvastatin- and rosuvastatinassociated AE (cluster 1), pitavastatin- and simvastatin-associated AE (cluster 2), rosuvastatin-associated AE (cluster 3), and atorvastatin-associated AE (cluster 4). Cluster 1 had a relatively higher proportion of men (57 cases, 50.9%) and a higher mean age (64.8 years) than the other clusters. Concomitant drug use was more common in cluster 1 (56 cases, 50.0%) than in other clusters (33.5%–46.2%), and all serious AEs were observed in cluster 1. Conclusion: Using hierarchical clustering, we found four distinct clusters based on SAMS report characteristics. Our findings further emphasize that patients prescribed statins, especially elderly male patients taking rosuvastatin and atorvastatin concomitantly with other medications, should be closely monitored for the development of rhabdomyolysis

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Objective: This study aimed to assess diabetes medication intensification at discharge in older adults hospitalized for non-glycemic reasons, examining its shortterm benefits and risks. Methods: A retrospective review of electronic medical records from Boramae Medical Center (September 1, 2020, to August 31, 2022) was conducted. Medication intensification was defined as either increasing the dosage of existing diabetes medications, adding insulin or initiating new medications. We compared glycated hemoglobin (HbA1c) levels 90 days post-discharge and the incidence of blood glucose-related emergency department visits or diabetesrelated unplanned readmission within 90 days post-discharge between patients with and without medication intensification. Results: Out of 1,278 patients, 480 (37.6%) underwent medication intensification at discharge. Factors associated with intensification included longer hospital stays, consultations with endocrinologist, higher HbA1c at admission, frequent hyperglycemic events, and changes in steroid or immunosuppressant use. The intensification group showed a significant reduction (8.6% to 7.0%) in HbA1c 90 days post-discharge compared to the non-intensification group (6.9% to 6.9%, p < 0.001). However, there was no significant impact on postdischarge emergency visits or unplanned readmissions related to blood glucose (aOR 0.34; 95% CI 0.07–1.53). Conclusion: A third of older adults admitted for nonglycemic issues was discharged with intensified diabetes medications, leading to improved short-term glycemic control but did not significantly affect diabetesrelated unplanned readmissions or emergency visits.

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Objective: This study aimed to examine the causality of hepatotoxicity related to sulfamethoxazole/trimethoprim (SMX/TMP) in pediatric patients with acute lymphoblastic leukemia (ALL). Methods: We retrospectively analyzed medical records of pediatric ALL patients, who were transitioned from SMX/TMP to aerosolized pentamidine (AP) for Pneumocystis jirovecii pneumonia prevention due to suspected hepatotoxicity between 2010 and 2023. The Roussel Uclaf causality assessment method (RUCAM) was used to assess hepatotoxicity due to SMX/ TMP, emphasizing cases considered “high probability” (RUCAM ≥ 6). Results: Of the 176 pediatric ALL patients who switched from SMX/TMP to AP, 112 did so due to elevated liver enzyme levels, and 38 of these (33.9%) were classified as “high probability” for hepatotoxicity according to RUCAM. Hepatotoxicity induced by SMX/TMP is characterised by an average ALT level of 430.6 IU/L, a total bilirubin level of 1.2 mg/dL at onset, typically manifesting after 223.1 days and resolving within 110.7 days. Multivariable analysis identified significant factors such as age (1–5 years), obesity, onset time (≤ 20 days), recovery time (≤ 20 days), and treatments with L-asparaginase and 6-mercaptopurine as associated with an increased risk of hepatotoxicity. Conclusion: This study found that 21.6% of pediatric ALL patients who discontinued SMX/TMP for prophylaxis had hepatotoxicity with a ‘probable or higher’ causality due to SMX/TMP. Identifying factors associated with ‘probable or higher’ causality for SMX/TMP-induced hepatotoxicity in these patients may be valuable for future research in this domain.

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Objective: The importance of effective adverse drug reaction (ADR) management in local clinics is increasing. This study investigates the current status of ADR management and reporting system use in local clinics, and opinions on development directions for effective ADR prevention. Methods: From January 11th to January 17th, 2022, an online survey was conducted targeting physicians working at local clinics regarding ADR management, use of reporting systems, and development of ADR prevention systems. Results: The awareness of the ADR reporting system was 54.50%, and 22.07% of respondents actually reported ADR incidents. The primary reasons for not reporting were ‘lack of time and unfamiliarity with the process,’ accounting for the highest percentage at 36.62%. Regarding sharing ADR information with other healthcare institutions, 88.56% responded that it would be helpful, and 66.49% indicated they could trust such information. The most crucial areas for improvement identified from the survey were the sharing of ADR records and national-level management. Conclusion: Creating an environment where local clinics can diligently report ADRs and establishing a system to share verified ADR information with other clinics will be a great help to national drug safety.

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Objective: This study aimed to evaluate the association between nirmatrelvir/ritonavir, molnupiravir and adverse events and identify safety signals not previously known. Methods: To identify major adverse events and safety signals associated with nirmatrelvir/ritonavir and molnupiravir, we conducted pharmacovigilance study using drug-related adverse events reported to KIDS KAERS DB (2305A0011). Disproportionality analysis were performed using reporting odds ratio (ROR) and information component (IC) method to detected new safety signals not listed in drug label. Results: Adverse events related to nirmatrelvir/ritonavir and molnupiravir were frequently reported in women and person aged ≥ 65, and mostly reported as not serious. Following nirmatrelvir/ritonavir administration, ‘sensory abnormalities’ (20.18%), ‘diarrhoea’ (13.76%), and ‘nausea and vomiting symptoms’ (9.87%) were most commonly reported, while for molnupiravir, ‘nausea and vomiting symptoms’ (15.92%), ‘neurological signs and symptoms’ (15.92%), ‘urticarias’ (10.45%) were predominantly reported. Disproportionality analysis revealed a significant association of nirmatrelvir/ritonavir with ‘sensory abnormalities’ (ROR [95% CI] = 223.74 [207.24–241.55]), ‘interactions’ (ROR [95% CI] = 37.35 [15.10–92.35]), ‘faecal abnormalities’ (ROR [95% CI] = 32.33 [18.68–56.36]). Adverse events not listed on drug label included ‘olfactory nerve disorders’, ‘appitite disorder’, ‘hallucinations’ and urinary adverse events. For molnupiravir, strong association were observed with cardiovascular adverse events such as ‘heart rate and pulse investigations’ (ROR [95% CI] = 58.60 [18.96–181.16]) and ‘vascular tests’ (ROR [95% CI] = 10.97 [4.09–29.47]), which were not included in drug label. Conclusion: Adverse events following the use of nirmatrelvir/ritonavir and molnupiravir were generally not serious, but some safety signals not listed on drug label were newly detected and warranted attention. We expected this study to provide basic data of safety for oral antivirals of COVID-19 and may contribute to the development of future drug safety guidelines.

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Objective: Fimasartan, an angiotensin II receptor blocker (ARB) with superior potency and longer-lasting effects than losartan, demonstrates a good safety profile. However, recent case reports have emerged, linking fimasartan to hepatotoxicity. The aim of the study is to compare the occurrence of liver injury induced by fimasartan. Methods: Patients prescribed with fimasartan and losartan from 2011 to 2021 were identified from electronic health recordbased Common Data Model (CDM) of Seoul National University Hospital. Using clinical data warehouse, clinical information was collected and employed to cross-reference the results retrieved from the CDM. To assess causality and compare the incidence of drug-induced liver injury (DILI), 100 randomly selected patients with liver function abnormalities were evaluated. Results: The CDM analysis included 3,063 patients on fimasartan and 9,688 patients on losartan, among which 302 patients (2.37%) exhibited liver function abnormalities within the first year of ARB therapy. Specifically, 107 (3.49%) patients on fimasartan showed elevated serum alanine aminotransferase or aspartate aminotransferase, compared to 195 (2.01%) patients on losartan. However, when causality was assessed, patients with causality graded as probable or certain did not show any significant difference between the two medications. Conclusion: Although patients taking fimasartan exhibited a slightly higher incidence of mild liver enzyme elevations, this study did not find a significant difference in the occurrence of DILI. Consequently, fimasartan is less safe than losartan in terms of hepatotoxicity cannot be asserted. However, similar to other ARBs, fimasartan poses a risk of DILI, underscoring the importance of monitoring liver function tests to promote safer use of the medication.