Gerència de Prestacions Farmacèutiques i Accés al Medicament, Servei Català de la Salut, Travessera de Les Corts 131-159, Edifici Olimpia, 08028, Barcelona, Spain.
Fundació Institut Català de Farmacologia (FICF), HU Vall d'Hebron, Universitat Autònoma de Barcelona, WHO Collaborating Centre for Research and Training in Pharmacoepidemiology, P Vall d'Hebron 119-129, 08035, Barcelona, Spain.
Drug Saf. 2018 Dec;41(12):1325-1331. doi: 10.1007/s40264-018-0695-6.
Gabapentin and pregabalin are widely prescribed to elderly people, but data on their pharmacokinetics, safety, and efficacy in this population are scarce. Neurological adverse effects are common. Atrial fibrillation (AF) associated with their use has been described in several case reports and case series, but the incidence is unknown.
The aim of this study was to assess the association between exposure to gabapentin or pregabalin and AF in the elderly.
Patients ≥ 65 years of age starting treatment with either gabapentin or pregabalin between January 1 and March 31, 2015, free of cardiovascular disease, and who did not receive the alternate study medications were studied. They were compared with patients who initiated treatment with an analgesic opiate or with alprazolam or diazepam. The two primary outcome variables were a first claim of an oral anticoagulant plus an antiarrhythmic drug (OAC + AA), or of an oral anticoagulant or an antiplatelet agent plus an antiarrhythmic drug (OAC/APA + AA), in the 3 months after treatment initiation.
Compared with opiate analgesics, both gabapentin and pregabalin were associated with an increased risk of initiating OAC/APA + AA. The incidence was 6 of 668 (9.0 per 1000 patients) with gabapentin, versus 12 of 3889 (3.1 per 1000) with opiates, relative risk (RR) 2.91 (95% confidence interval [CI] 1.10-7.73), and for pregabalin it was 6 of 698 (8.6 per 1000) RR 2.79 (95% CI 1.05-7.40). The comparison with alprazolam/diazepam gave similar results. The risks did not vary by age, sex, or co-treatment with NSAIDs, and they increased with dose.
In elderly patients free of cardiovascular disease, an association between new exposure to gabapentin or pregabalin and initiating treatment for AF was found. These results should be confirmed in other studies.
加巴喷丁和普瑞巴林广泛用于老年人,但关于它们在该人群中的药代动力学、安全性和疗效的数据很少。神经不良反应很常见。已在几例病例报告和病例系列中描述了与它们的使用相关的心房颤动(AF),但发病情况尚不清楚。
本研究旨在评估老年患者使用加巴喷丁或普瑞巴林与 AF 之间的关联。
研究纳入了 2015 年 1 月 1 日至 3 月 31 日期间开始接受加巴喷丁或普瑞巴林治疗且无心血管疾病的≥65 岁患者,且他们在治疗期间未使用其他研究药物。将这些患者与开始使用阿片类镇痛药、阿普唑仑或地西泮治疗的患者进行比较。两个主要结局变量为治疗开始后 3 个月内首次使用口服抗凝药加抗心律失常药物(OAC+AA),或使用口服抗凝药或抗血小板药物加抗心律失常药物(OAC/APA+AA)。
与阿片类镇痛药相比,加巴喷丁和普瑞巴林均与 OAC/APA+AA 的起始风险增加相关。加巴喷丁组的发生率为 6/668(9.0/1000 例),阿片类镇痛药组为 12/3889(3.1/1000 例),相对风险(RR)为 2.91(95%置信区间[CI]为 1.10-7.73),普瑞巴林组的发生率为 6/698(8.6/1000 例),RR 为 2.79(95%CI 为 1.05-7.40)。与阿普唑仑/地西泮的比较结果相似。风险与年龄、性别或 NSAIDs 联合治疗无关,且随剂量增加而增加。
在无心血管疾病的老年患者中,新暴露于加巴喷丁或普瑞巴林与开始治疗 AF 之间存在关联。这些结果应在其他研究中得到证实。