Park-Wyllie Laura, Van Stralen Judy, Almagor Doron, Dobson-Belaire Wendy, Charland Katia, Smith Andrew, Le Lorier Jacques
Janssen Inc., Toronto, Ontario, Canada.
Center for Pediatric Excellence, Ottawa, Ontario, Canada.
Clin Ther. 2016 Aug;38(8):1789-802. doi: 10.1016/j.clinthera.2016.07.001. Epub 2016 Jul 29.
We conducted a retrospective cohort study to compare medication use patterns of a long-acting extended-release methylphenidate (Osmotic Release Oral System [OROS(®)] methylphenidate, CONCERTA(®)) and Teva-methylphenidate (methylphenidate ER-C), a generic drug determined by the Canadian regulatory authority, Health Canada, to be bioequivalent to OROS(®) methylphenidate.
We established an OROS(®) methylphenidate-experienced and new-user population cohort to compare medication use patterns, including medication persistence, duration of therapy, and treatment-switching patterns. Multivariable log-binomial regression was used to adjust for confounders of the associations with persistence.
In the OROS(®) methylphenidate-experienced cohort (n = 21,940), OROS(®) methylphenidate was associated with a 70% higher rate of medication persistence at 12 months relative to methylphenidate ER-C (adjusted relative risk = 1.70; 95% CI, 1.64-1.77). In the new-user cohort (n = 20,410), OROS(®) methylphenidate had a 58% higher rate of medication persistence relative to methylphenidate ER-C (adjusted relative risk = 1.58; 95% CI, 1.51-1.65). Median duration of therapy was significantly longer in patients taking OROS(®) methylphenidate compared with those taking methylphenidate ER-C, and treatment-switching occurred significantly more frequently in patients taking methylphenidate ER-C compared with those taking OROS(®) methylphenidate.
Significant differences were observed in how the medications were used by patients in the real-world setting. Because the data sources were administrative databases, it was not possible to control for all potentially important confounding variables. Although differences in medication persistence may not directly reflect differences in treatment efficacy, the findings are important because these products are used interchangeably in a number of Canadian provinces.
我们进行了一项回顾性队列研究,以比较长效缓释哌醋甲酯(渗透泵控释口服系统[OROS(®)]哌醋甲酯,CONCERTA(®))与特瓦哌醋甲酯(哌醋甲酯缓释胶囊,ER-C)的用药模式。特瓦哌醋甲酯是一种由加拿大监管机构加拿大卫生部认定与OROS(®)哌醋甲酯生物等效的仿制药。
我们建立了一个使用过OROS(®)哌醋甲酯的人群队列和新用户人群队列,以比较用药模式,包括用药持续性、治疗持续时间和治疗转换模式。采用多变量对数二项回归对与持续性相关的混杂因素进行调整。
在使用过OROS(®)哌醋甲酯的队列(n = 21,940)中,与哌醋甲酯缓释胶囊相比,OROS(®)哌醋甲酯在12个月时的用药持续性率高70%(调整后的相对风险 = 1.70;95%置信区间,1.64 - 1.77)。在新用户队列(n = 20,410)中,与哌醋甲酯缓释胶囊相比,OROS(®)哌醋甲酯的用药持续性率高58%(调整后的相对风险 = 1.58;95%置信区间,1.51 - 1.65)。与服用哌醋甲酯缓释胶囊的患者相比,服用OROS(®)哌醋甲酯的患者治疗持续时间中位数显著更长,并且与服用OROS(®)哌醋甲酯的患者相比,服用哌醋甲酯缓释胶囊的患者治疗转换更为频繁。
在现实环境中,患者使用这些药物的方式存在显著差异。由于数据来源是行政数据库,无法控制所有潜在的重要混杂变量。尽管用药持续性的差异可能无法直接反映治疗效果的差异,但这些发现很重要,因为这些产品在加拿大的多个省份可互换使用。