Gonzalez Pedro Luis, Rappo Urania, Akinapelli Karthik, McGregor Jennifer S, Puttagunta Sailaja, Dunne Michael W
Medical Affairs, Allergan plc, Madison, NJ, USA.
Clinical Development, Allergan plc, Madison, NJ, USA.
Drugs Context. 2018 Dec 11;7:212559. doi: 10.7573/dic.212559. eCollection 2018.
Persons who inject drugs (PWID) are at increased risk of acute bacterial skin and skin structure infections (ABSSSIs), a growing healthcare concern. Multiple medical, social, and economic issues, including adherence and comorbidities, complicate the medical care of the PWID population, adversely affecting patient outcomes.
We assessed demographics and outcomes for the PWID population in a double-blind trial of 698 patients randomized to dalbavancin 1500 mg as a single intravenous (IV) infusion or as a 2-dose regimen (1000 mg IV on day 1; 500 mg IV on day 8) for ABSSSI. The primary endpoint was ≥20% reduction in erythema at 48-72 hours in the intent-to-treat population; clinical status was also assessed at days 14 and 28.
There were 212/698 (30.4%) patients with a history of injection drug use in this clinical trial. Dalbavancin efficacy was similar between the single- and 2-dose therapy groups in the PWID and non-PWID populations at all timepoints. Dalbavancin was well tolerated in the PWID population, with similar rates of adverse events as the non-PWID population.
Dalbavancin as a single-dose or 2-dose regimen had similar efficacy for the treatment of ABSSSI at all timepoints in the PWID and non-PWID populations. A single 30-minute IV infusion would eliminate the need for indwelling IV access. The convenience of a single dose supervised in a health setting may also optimize treatment adherence in the PWID population.
注射吸毒者(PWID)发生急性细菌性皮肤和皮肤结构感染(ABSSSI)的风险增加,这一问题日益受到医疗保健领域的关注。包括依从性和合并症在内的多种医学、社会和经济问题,使PWID人群的医疗护理变得复杂,对患者预后产生不利影响。
在一项双盲试验中,我们评估了698例随机接受达巴万星1500mg单次静脉输注或2剂方案(第1天静脉输注1000mg;第8天静脉输注500mg)治疗ABSSSI的PWID人群的人口统计学特征和预后。主要终点是意向性治疗人群在48 - 72小时内红斑减少≥20%;还在第14天和第28天评估临床状况。
在该临床试验中,有212/698(30.4%)例患者有注射吸毒史。在所有时间点,PWID人群和非PWID人群中,单剂量和2剂量治疗组的达巴万星疗效相似。达巴万星在PWID人群中耐受性良好,不良事件发生率与非PWID人群相似。
在PWID人群和非PWID人群的所有时间点,达巴万星单剂量或2剂量方案治疗ABSSSI的疗效相似。单次30分钟静脉输注将无需留置静脉通路。在医疗机构监督下单次给药的便利性也可能优化PWID人群的治疗依从性。