Division of Nephrology and Endocrinology, The University of Tokyo, Tokyo, Japan.
Department of Health Services Research, University of Tsukuba, Tsukuba, Japan.
Pharmacoepidemiol Drug Saf. 2020 May;29(5):558-564. doi: 10.1002/pds.4976. Epub 2020 Feb 21.
This study was performed to investigate the association between the use of pregabalin and injury.
The study was based on a predefined cohort of patients aged ≥20 years who had been registered for ≥6 months and contributed to the Japan Medical Data Center claims database. All patients (cases) had been treated for injuries from January 2014 to December 2016. One-to-four case-control matching was performed for age, sex, calendar day of injury (index date), and follow-up duration. A conditional logistic regression analysis was performed to calculate the odds ratio (OR) for pregabalin use within 180 days prior to the index date between the matched cases and controls, with adjustment for comorbidities and relevant drug categories associated with a risk of injury. To minimize within-individual confounding, we also performed a case-crossover analysis to compare the odds of pregabalin use between a 30-day hazard period immediately before the injury and five consecutive 30-day control periods within individuals with injury.
Among the 2 324 974 people in the nested cohort, we identified 18 084 cases with injury and 71 885 matched controls. The proportion of pregabalin use was 1.7% (304/18 084) and 1.1% (803/71 885), respectively. The adjusted OR for injury was 1.22 (95% confidence interval [CI], 1.06-1.40). In the case-crossover analysis (n = 304), pregabalin use was also significantly associated with an increased risk of injury (adjusted OR, 1.48; 95% CI, 1.10-2.00).
This large database study using two different study designs consistently suggested that the use of pregabalin may be associated with an increased risk of injury.
本研究旨在探讨普瑞巴林的使用与损伤之间的关联。
本研究基于一个预先设定的年龄≥20 岁的患者队列,这些患者已登记至少 6 个月,并为日本医疗数据中心的索赔数据库做出了贡献。所有患者(病例)均在 2014 年 1 月至 2016 年 12 月期间因损伤接受治疗。根据年龄、性别、损伤日期(索引日期)和随访时间,对病例和对照组进行 1:4 病例对照匹配。采用条件逻辑回归分析,在匹配的病例和对照组中,计算损伤前 180 天内使用普瑞巴林的比值比(OR),并对合并症和与损伤风险相关的药物类别进行调整。为了最小化个体内混杂,我们还进行了病例交叉分析,比较个体损伤前 30 天危险期和个体损伤后 5 个连续 30 天对照期内使用普瑞巴林的几率。
在嵌套队列的 2324974 人中,我们共发现 18084 例损伤病例和 71885 例匹配对照组。普瑞巴林使用率分别为 1.7%(304/18084)和 1.1%(803/71885)。损伤的调整 OR 为 1.22(95%置信区间[CI],1.06-1.40)。在病例交叉分析(n=304)中,普瑞巴林的使用也与损伤风险的增加显著相关(调整 OR,1.48;95% CI,1.10-2.00)。
这项使用两种不同研究设计的大型数据库研究一致表明,普瑞巴林的使用可能与损伤风险的增加有关。