Research Department of Practice and Policy, School of Pharmacy, University College London, London, UK.
Department of Pharmacology and Clinical Pharmacy, Centre of Excellence for Pharmaceutical Care Innovation, Padjadjaran University, Bandung, Indonesia.
Br J Clin Pharmacol. 2022 Nov;88(11):4902-4914. doi: 10.1111/bcp.15438. Epub 2022 Jun 23.
To investigate the risk of cardiovascular disease (CVD) events and all-cause mortality in patients with statin-related adverse drug reaction (ADR) consultation in primary care and examine whether different treatments following the ADR affect subsequent outcomes.
This was a retrospective cohort study of statin users between 2004 and 2019 using IQVIA Medical Research Data (formally known as the THIN database). Patients with statin-related ADR consultation were matched by propensity score (1:1) to statin users without ADR consultation based on demographics, comorbidities and concomitant medication. Cox proportional hazard regression was used to compare the risk of subsequent CVD event and all-cause mortality, stratified by history of CVD. In the secondary analysis among patients with statin-related ADR, treatment changes within a 1-year period following the ADR were examined and the outcomes were compared between different treatment groups.
Among 1 564 687 statin users, 19 035 (1.22%) had a statin-related ADR consultation in primary care. The mean (standard deviation) follow-up time was 6.32 (3.74) years and 5.31 (3.83) years for CVD primary and secondary prevention cohorts, respectively. Statin-related ADR consultation was associated with subsequent CVD events in both cohorts (adjusted hazard ratio [HR] of 1.39 [95% CI 1.23, 1.57] and 1.34 [95% CI 1.25,1.42], respectively). In the secondary analysis among patients with statin-related ADR consultation, we found that (i) continued statin prescription or combination of any statin with additional lipid-lowering treatment (LLT) and (ii) other LLT only were associated with lower risks of CVD event (adjusted HR 0.71 [95% CI 0.64, 0.78] and 0.75 [95% CI 0.62, 0.92], respectively) and all-cause mortality (adjusted HR 0.46 [95% CI 0.42, 0.50] and 0.52 [95% CI, 0.43, 0.64], respectively), compared to discontinuation of all LLT.
Statin-related ADR was associated with an increased risk of subsequent CVD event, indicating that these patients should be monitored more closely. Continued lipid-lowering medication is of importance to protect against CVD events and mortality.
调查初级保健中他汀类药物相关不良反应 (ADR) 咨询患者的心血管疾病 (CVD) 事件和全因死亡率风险，并探讨 ADR 后的不同治疗方法是否会影响后续结局。
这是一项回顾性队列研究，纳入了 2004 年至 2019 年期间使用 IQVIA 医疗研究数据（前身为 THIN 数据库）的他汀类药物使用者。根据人口统计学、合并症和伴随药物，通过倾向评分（1:1）将有他汀类药物相关 ADR 咨询的患者与无 ADR 咨询的他汀类药物使用者相匹配。使用 Cox 比例风险回归比较 CVD 事件和全因死亡率的风险，按 CVD 病史进行分层。在他汀类药物相关 ADR 患者的次要分析中，检查了 ADR 后 1 年内的治疗变化，并比较了不同治疗组之间的结局。
在 1564687 名他汀类药物使用者中，有 19035 名（1.22%）在初级保健中接受了他汀类药物相关 ADR 咨询。平均（标准差）随访时间分别为 CVD 一级和二级预防队列的 6.32（3.74）年和 5.31（3.83）年。他汀类药物相关 ADR 咨询与两个队列中的后续 CVD 事件相关（调整后的危险比 [HR]分别为 1.39 [95% CI 1.23,1.57]和 1.34 [95% CI 1.25,1.42]）。在他汀类药物相关 ADR 咨询患者的次要分析中，我们发现：（i）继续使用他汀类药物或联合使用任何他汀类药物与其他降脂治疗（LLT）；（ii）仅使用其他 LLT，与 CVD 事件风险降低相关（调整后的 HR 分别为 0.71 [95% CI 0.64,0.78]和 0.75 [95% CI 0.62,0.92]）和全因死亡率（调整后的 HR 分别为 0.46 [95% CI 0.42,0.50]和 0.52 [95% CI 0.43,0.64]），与所有 LLT 的停药相比。
他汀类药物相关 ADR 与随后发生 CVD 事件的风险增加相关，表明这些患者应密切监测。继续降脂治疗对于预防 CVD 事件和死亡至关重要。
