Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis
Treating Opioid Use Disorder With a Monthly Subcutaneous Buprenorphine Depot Injection: 12-Month Safety, Tolerability, and Efficacy Analysis
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DOI：
10.1097/jcp.0000000000001195
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发表时间：
2020-05-01
影响因子：
2.9
通讯作者：
Rutrick, Daniel
中科院分区：
文献类型：
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作者：
Andorn, Anne C.;Haight, Barbara R.;Rutrick, Daniel
背景：bup - xr （RBP-6000或SUBLOCADE）是美国食品和药物管理局批准的首个每月皮下给药的缓释丁丙诺啡药物，用于治疗中度或重度阿片类药物使用障碍。这项III期研究的主要目的是评估BUP-XR的长期安全性、耐受性和有效性。这项开放标签的多中心研究纳入了257名来自先前进行的安慰剂对照、双盲III期研究（翻转组）的成人中度或重度阿片类药物使用障碍患者和412名先前未接受BUP-XR治疗的新患者。参与者最初接受300毫克的BUP-XR注射，随后每月300毫克或100毫克灵活剂量。研究结束时，参与者接受了多达12次注射。结果总体而言，66.8%的参与者报告了1个以上的治疗不良事件（TEAE）。注射部位teae（占参与者的13.2%）的严重程度大多为轻度或中度。安全性评估没有临床意义的变化。一项对双盲和开放标签研究参与者的综合分析显示，在治疗的后6个月，包括注射部位的teae的发生率低于前6个月。经过12个月的治疗，61.5%的对照组和75.8%的新生组戒酒了。在双盲研究中，开始使用BUP-XR的参与者在12个月后的保留率为50.6%，而新参与者的保留率为50.5%。该研究表明，在为期6个月的双盲研究中显示的BUP-XR的临床益处和可接受的安全性在12个月的开放标签研究中得到持续，治疗后6个月的teae发生率较低。
BackgroundBUP-XR (RBP-6000 or SUBLOCADE) is the first Food and Drug Administration-approved subcutaneously administered monthly extended-release buprenorphine medication for the treatment of moderate or severe opioid use disorder. The primary objective of this phase III study was to assess the long-term safety, tolerability, and efficacy of BUP-XR.MethodsThis open-label multicenter study in adults with moderate or severe opioid use disorder enrolled 257 participants from a previously conducted placebo-controlled, double-blind phase III study (rollover group) and 412 de novo participants not previously treated with BUP-XR. Participants received an initial injection of BUP-XR 300 mg and subsequent monthly 300 mg or 100 mg flexible doses. By study end, participants received up to 12 injections.ResultsOverall, 66.8% of participants reported more than 1 treatment-emergent adverse event (TEAE). Injection-site TEAEs (13.2% of participants) were mostly mild or moderate in severity. There were no clinically meaningful changes in safety assessments. An integrated analysis of the double-blind and open-label study participants showed that the incidence of TEAEs, including injection-site TEAEs, was lower in the second 6 months of treatment versus the first 6 months. After 12 months of treatment, 61.5% of the rollover participants and 75.8% of the de novo participants were abstinent. Retention rates after 12 months were 50.6% for the participants who initiated BUP-XR in the double-blind study and 50.5% for de novo participants.ConclusionsThis study demonstrates that the clinical benefits and acceptable safety profile of BUP-XR demonstrated in the 6-month double-blind study are sustained over a 12-month open-label study, with lower incidence of TEAEs in the second 6 months of treatment.