Department of Neurology, Neurological Institute, Taipei Veterans General Hospital, No. 201, Sec. 2, Shi-Pai Road, Bei-Tou District, Taipei City, Taiwan, 11217.
Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.
J Headache Pain. 2020 May 19;21(1):54. doi: 10.1186/s10194-020-01123-4.
Pregabalin is approved for the treatment of neuropathic pain, fibromyalgia, and seizure disorders, although the pivotal trials were mostly carried out in Europe or North America. The prescribing patterns among different indications in Asia have rarely been explored.
This was a population-based retrospective cohort study based on the National Health Insurance Research Database in Taiwan. Prescriptions of pregabalin were identified, and data regarding demographics, indications, co-existing diagnoses, and concomitant medications were extracted. Pregabalin users were followed for at least one year, and factors associated with persistence at one year were determined by using multivariate logistic regression analysis.
Between June 2012 and December 2016, 114,437 pregabalin users (mean age 60.7 ± 15.4 years, 57.8% female) were identified. The indications included post-herpetic neuralgia (PHN) (30.5%), musculoskeletal diseases other than fibromyalgia (21.2%), fibromyalgia (18.4%), diabetic peripheral neuropathic pain (DPNP) (11.7%) and epilepsy (2.9%). Overall, 62.5% and 6.4% of patients achieved a maximum dose of ≥150 and ≥ 300 mg/day, respectively. The median duration of persistent pregabalin use was 28 days (interquartile range 14-118 days). The one-year persistence rate was 12.1%, and the indications associated with the highest and lowest persistence rates were epilepsy (42.4%) and PHN (6.1%), respectively. Male gender (odds ratio [OR] 1.14, 95% confidence interval [CI] 1.09-1.18), older age (OR 1.01 per year, 95% CI 1.01-1.01), indications other than PHN, especially epilepsy (OR 8.04, 95% CI 7.33-8.81, PHN as reference), and a higher initial dose (OR 1.12 per 75 mg, 95% CI = 1.10-1.15) were associated with persistence at one year, whereas the initial concomitant use of antiviral agents decreased the likelihood (OR 0.41, 95% CI 0.35-0.47).
Pregabalin prescriptions for pain disorders were limited to short-term use, which is consistent around the world. However, the average prescribed dose in Taiwan was lower than those in Western countries, and was frequently below the recommended ranges. Potential causes included the duration of natural history of PHN, and off-label prescriptions for pain in acute herpes zoster, rather than PHN, as well as intolerance to the side effects.
普瑞巴林获批用于治疗神经病理性疼痛、纤维肌痛和癫痫发作性疾病，但关键性试验大多在欧洲或北美进行。亚洲不同适应证的处方模式鲜有研究。
这是一项基于台湾全民健康保险研究数据库的基于人群的回顾性队列研究。确定了普瑞巴林的处方，并提取了人口统计学、适应证、并存诊断和伴随药物的数据。对普瑞巴林使用者进行了至少一年的随访，并使用多变量逻辑回归分析确定了一年时持续使用的相关因素。
2012 年 6 月至 2016 年 12 月，共确定了 114437 名普瑞巴林使用者（平均年龄 60.7±15.4 岁，57.8%为女性）。适应证包括带状疱疹后神经痛（PHN）（30.5%）、非纤维肌痛性肌肉骨骼疾病（21.2%）、纤维肌痛（18.4%）、糖尿病周围神经病理性疼痛（DPNP）（11.7%）和癫痫（2.9%）。总体而言，62.5%和 6.4%的患者达到了≥150 和≥300mg/天的最大剂量。普瑞巴林持续使用的中位时间为 28 天（四分位距 14-118 天）。一年的持续使用率为 12.1%，癫痫（42.4%）和 PHN（6.1%）是与最高和最低持续使用率相关的适应证。男性（比值比[OR]1.14，95%置信区间[CI]1.09-1.18）、年龄较大（OR 每年 1.01，95%CI 1.01-1.01）、PHN 以外的适应证，特别是癫痫（OR 8.04，95%CI 7.33-8.81，PHN 为参照）和较高的起始剂量（OR 每 75mg 增加 1.12，95%CI=1.10-1.15）与一年时的持续使用相关，而初始伴随使用抗病毒药物会降低可能性（OR 0.41，95%CI 0.35-0.47）。
疼痛障碍的普瑞巴林处方仅限于短期使用，这与全球一致。然而，台湾的平均处方剂量低于西方国家，且经常低于推荐范围。潜在原因包括 PHN 的自然病史持续时间，以及急性带状疱疹疼痛而非 PHN 的非适应证处方，以及对副作用的不耐受。
