| アブストラクト | Background/Objectives: The global rise in obesity-related hypertension, metabolic syndrome, and chronic inflammation calls for a precise characterization of the safety profiles of first-line therapies. While amlodipine is considered metabolically neutral, its real-world impact on dysglycemia and inflammatory biomarkers remains incompletely defined. This study aims to characterize the metabolic and inflammatory adverse drug reaction profile of amlodipine, using the EudraVigilance database. Methods: Descriptive and disproportionality analyses were performed on 41,872 Individual Case Safety Reports recorded prior to 17 May 2026. Amlodipine was compared against major antihypertensive classes (beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, sartans, and diuretics), calculating reporting odds ratios (ROR) and 95% confidence intervals. Results: "Hyperglycaemia" could be considered a safety signal for amlodipine, compared to beta-blockers (e.g., bisoprolol-ROR: 2.56), ACE inhibitors (e.g., ramipril-ROR: 2.82), and sartans (e.g., candesartan-ROR: 3.85). "Metabolic syndrome" was reported for amlodipine with a lower probability than for hydrochlorothiazide (ROR: 0.35). Inflammatory signals (e.g., increased C-reactive protein) appeared less frequently for amlodipine than for certain renin-angiotensin-aldosterone system inhibitors (e.g., perindopril-ROR: 0.53). Conclusions: The disproportionality analysis identified relatively lower reporting frequencies for several metabolic and inflammatory adverse drug reactions, compared with selected antihypertensive agents. These findings represent pharmacovigilance signals that warrant further investigation in analytical epidemiological and clinical studies. Although hyperglycemia was reported disproportionally relative to several comparator drugs, reports of T2DM were less frequently reported for amlodipine. However, these observations should not be interpreted as evidence of differences in clinical risk, because disproportionality analyses cannot establish incidence or causality. Reports of inflammation likely reflect patient comorbidities rather than a direct drug effect. These findings demonstrate that post-marketing surveillance remains essential, even when accounting for the methodological limitations of spontaneous reporting. |
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| ジャーナル名 | Pharmaceuticals (Basel, Switzerland) |
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| Pubmed追加日 | 2026/8/27 |
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| 投稿者 | Solomon, Crina Cristina; Butuca, Anca; Frum, Adina; Dobrea, Carmen Maximiliana; Morgovan, Claudiu; Palade, Nastaca Alina; Pintea, Alina Liliana; Dadarlat, Dragos Anton; Ghibu, Steliana; Batar, Florina; Tilinca, Mariana Cornelia; Gligor, Felicia Gabriela |
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| 組織名 | Preclinical Department, Faculty of Medicine, "Lucian Blaga" University of Sibiu,;550169 Sibiu, Romania.;County Emergency Clinical Hospital Sibiu, 550025 Sibiu, Romania.;Department of Dental Medicine and Nursing, Faculty of Medicine, "Lucian Blaga";University of Sibiu, 550169 Sibiu, Romania.;Department of Pharmacology, Physiology and Pathophysiology, Faculty of Pharmacy,;"Iuliu Hatieganu" University of Medicine and Pharmacy, 6A Louis Pasteur Street,;400349 Cluj-Napoca, Romania.;Department of Internal Medicine I, Faculty of Medicine in English, "George Emil;Palade" University of Medicine, Pharmacy, Science and Technology, 540142 Targu;Mures, Romania.;Clinical Compartment of Diabetes Mellitus, Nutrition and Metabolic Diseases,;Emergency Clinical County Hospital of Targu Mures, 540136 Targu Mures, Romania. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42653674/ |
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