| アブストラクト | Background Angiotensin receptor blockers (ARBs) are pivotal in hypertension management. Despite sharing a common mechanism of blocking angiotensin II receptors, ARBs exhibit varying pharmacokinetic and pharmacodynamic properties that influence safety profiles. ARBs have been linked to adverse events (AEs) across multiple organ systems, including skin (e.g., angioedema), neurological (e.g., dizziness), and cardiovascular disorders (e.g., hypotension). Understanding these differences is essential for optimizing clinical decision-making. Objectives This study compared AE profiles of seven ARBs in patients with hypertension using data from the United States Food and Drug Administration Adverse Event Reporting System (FAERS). To enhance result reliability and control for confounding factors, only cases where ARBs were explicitly indicated for hypertension treatment were included. FAERS is a valuable post-marketing surveillance tool that captures spontaneous AE reports, although it has limitations such as reporting bias. The findings aim to generate hypotheses regarding ARB-associated AEs for future research using robust study designs. Methods A retrospective analysis of FAERS data between 2004 and 2024 was conducted. Patients prescribed ARBs for hypertension were included, while those with missing prescription indications or alternative uses were excluded. Reporting odds ratio (ROR) and adjusted ROR (aROR) were calculated to compare reporting proportions (RPs) among ARBs, with each ARB sequentially used as the reference in pairwise comparisons. The Bonferroni correction addressed multiple comparisons, with an adjusted significance level of 0.05/21=0.0024. For aROR calculations, cases with unknown values in adjustment variables were excluded. To enhance robustness, results were considered significant only when both ROR and aROR showed significance. Results Using losartan as the reference, valsartan, irbesartan, candesartan, telmisartan, and olmesartan demonstrated significantly lower RPs for skin disorders. For instance, the RP for skin disorders was 10.6 for losartan compared to 6.1 for valsartan (ROR: 0.545, p<0.0001; aROR: 0.648, p<0.0001) and 4.2 for olmesartan (ROR: 0.368, p<0.0001; aROR: 0.412, p<0.0001). Conversely, valsartan and olmesartan exhibited significantly higher RPs for cardiovascular disorders, with 23.7 for valsartan (ROR: 1.574, p<0.0001; aROR: 1.570, p<0.0001) and 19.0 for olmesartan (ROR: 1.186, p<0.0001; aROR: 1.278, p<0.0001) compared to 16.5 for losartan. Similar trends were observed when other ARBs were used as references, revealing a heterogeneous distribution of AE profiles among the seven ARBs. Conclusions This study reveals distinct AE patterns among ARBs in hypertension management. No single ARB exhibited universally favorable safety profiles across all AE categories, emphasizing the need for personalized prescribing. When selecting an ARB, prescribers should consider patient-specific risk factors and comorbidities. For instance, patients with a history of skin disorders may benefit from ARBs other than losartan. Conversely, patients with elevated cardiovascular risk may require closer monitoring when prescribed valsartan, including more frequent follow-up visits or additional cardiovascular diagnostics to detect early AEs. These findings enable healthcare providers to tailor ARB selection and monitoring strategies to optimize efficacy and safety in hypertension treatment. |
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| 組織名 | Department of Biostatistics, Clinical Research Support Center, Mie University;Hospital, Tsu, JPN.;Department of Emergency and Disaster Medical Pharmacy, Fukuoka University,;Fukuoka, JPN. |
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