Insani Widya N, Wei Li, Abdulah Rizky, Alfian Sofa D, Ramadhani Nurul A, Andhika Rizky, Zakiyah Neily, Adesuyan Matthew, Pamela Yunisa, Mustafa Rima, Whittlesea Cate
Department of Pharmacology and Clinical Pharmacy, Padjadjaran University, Bandung, Indonesia.
Centre of Excellence for Pharmaceutical Care Innovation, Padjadjaran University, Bandung, Indonesia.
Int J Clin Pharm. 2025 Apr;47(2):354-364. doi: 10.1007/s11096-024-01832-9. Epub 2024 Nov 28.
Effective hypertension management requires medication adherence to prevent complications. However, adverse drug reactions (ADRs) can undermine adherence and negatively affect patients' quality of life. Limited research has explored the association between ADRs, medication adherence, and health-related quality of life (HRQoL) in individuals with hypertension.
To investigate the association between ADRs, medication adherence, and HRQoL among patients with hypertension.
A cross-sectional study using telephone interviews and medical record reviews was conducted in 11 primary care facilities in Indonesia. The causality of reported ADRs was assessed using the Naranjo algorithm, validated by a panel of experts in pharmacy practice and medication safety. The severity of ADRs was classified using the Hartwig scale. Adherence to antihypertensive drugs was estimated using the Medication Adherence Report Scale-5 (MARS-5). The EuroQoL EQ-5D-5L was used to measure HRQoL. The association between ADRs and medication adherence was assessed using multivariate logistic regression, while the association with HRQoL was evaluated through the Tobit regression model.
A total of 507 patients were included in this study. We found that 20.32% (n = 103) of the patients experienced ADRs, with the most commonly reported ADRs being polyuria and urgency, gastrointestinal symptoms, leg swelling, dizziness/hypotension, palpitations, and dry cough. The majority experienced mild ADRs (n = 75, 72.82%), while 27.18% (n = 28) had reactions of moderate severity. Experiencing ADRs was associated with reduced medication adherence (adjusted odds ratio (OR) 7.15, 95% CI 4.07-12.55) and decreased HRQoL (coefficient: - 0.037).
Patients experiencing ADRs were seven times more likely to be non-adherent to their medication regimen and reported a reduced quality of life compared to those without ADRs, placing them at a higher risk of suboptimal treatment outcomes. This finding highlights the need for additional monitoring and education for patients affected by ADRs, particularly through more frequent clinical and laboratory assessments, timely management of ADRs, and personalized education on the importance of adherence to prevent hypertension-related complications.
有效的高血压管理需要坚持服药以预防并发症。然而，药物不良反应（ADR）可能会破坏服药依从性，并对患者的生活质量产生负面影响。关于高血压患者中ADR、服药依从性和健康相关生活质量（HRQoL）之间关联的研究有限。
调查高血压患者中ADR、服药依从性和HRQoL之间的关联。
在印度尼西亚的11个初级保健机构进行了一项横断面研究，采用电话访谈和病历审查。使用Naranjo算法评估报告的ADR的因果关系，并由药学实践和药物安全专家小组进行验证。使用Hartwig量表对ADR的严重程度进行分类。使用药物依从性报告量表-5（MARS-5）评估抗高血压药物的依从性。使用欧洲生活质量量表EQ-5D-5L测量HRQoL。使用多变量逻辑回归评估ADR与服药依从性之间的关联，同时通过Tobit回归模型评估与HRQoL的关联。
本研究共纳入507名患者。我们发现20.32%（n = 103）的患者经历了ADR，最常报告的ADR是多尿和尿急、胃肠道症状、腿部肿胀、头晕/低血压、心悸和干咳。大多数患者经历轻度ADR（n = 75，72.82%），而27.18%（n = 28）有中度严重程度的反应。经历ADR与服药依从性降低（调整后的优势比（OR）7.15，95%置信区间4.07 - 12.55）和HRQoL降低（系数：-0.037）相关。
与未经历ADR的患者相比，经历ADR的患者不遵守药物治疗方案的可能性高7倍，且生活质量降低，这使他们面临治疗效果欠佳的更高风险。这一发现凸显了对受ADR影响的患者进行额外监测和教育的必要性，特别是通过更频繁的临床和实验室评估、及时处理ADR以及就坚持服药以预防高血压相关并发症的重要性进行个性化教育。
