Supernus Pharmaceuticals, Inc., Rockville, MD, USA.
Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
Int J Clin Pract. 2021 Aug;75(8):e14330. doi: 10.1111/ijcp.14330. Epub 2021 May 26.
When clinicians evaluate potential medications for their patients, they must weigh the probability of a treatment's benefits against the possible risks. To this end, the present analyses evaluate the novel nonstimulant viloxazine extended-release (viloxazine ER) using measures of effect size to describe the potential benefits of its treatment in children and adolescents with attention-deficit/hyperactivity disorder (ADHD) as well as the risk of discontinuation because of intolerable adverse events.
These post hoc analyses use pooled data from four pivotal Phase 3 trials in paediatric patients treated with viloxazine ER. The Likelihood to be Helped or Harmed (LHH) effect size measure was calculated to describe the probability of patients benefiting from treatment vs discontinuing. The Number Needed to Treat (NNT) was calculated from frequently used thresholds of response. The Number Needed to Harm (NNH) was calculated using discontinuations because of adverse events.
LHH values for viloxazine ER ranged from 5 to 13, suggesting that subjects were 5-13 times more likely to benefit from, rather than discontinue, viloxazine ER treatment. Specifically, NNT values for viloxazine ER treatment ranged from 6 to 7. NNH values for viloxazine ER treatment ranged from 31 to 74. By convention, single-digit NNTs (<10) suggest the intervention is potentially useful, while NNH values ≥10 for adverse events suggest it is potentially safe or tolerable.
These results indicate that patients with ADHD are likely to benefit from treatment with viloxazine ER, and are unlikely to discontinue, as viloxazine ER treatment was associated with favourable LHH, NNT, and NNH values. Clinicaltrials.gov: NCT03247530, NCT03247543, NCT03247517, NCT03247556.
当临床医生为患者评估潜在药物时，他们必须权衡治疗的益处与可能风险的概率。为此，本分析使用效应量来评估新型非兴奋剂维洛沙嗪缓释剂（viloxazine ER），以描述其治疗儿童和青少年注意力缺陷/多动障碍（ADHD）的潜在益处，以及因无法耐受的不良事件而停药的风险。
这些事后分析使用了四项关键性 3 期临床试验中儿科患者接受 viloxazine ER 治疗的汇总数据。使用“受益或伤害的可能性（Likelihood to be Helped or Harmed，LHH）”效应量来描述患者从治疗中获益与停药的可能性。根据常用的反应阈值计算需要治疗的人数（Number Needed to Treat，NNT）。使用因不良事件而停药的人数计算需要治疗的人数（Number Needed to Harm，NNH）。
viloxazine ER 的 LHH 值范围为 5 至 13，表明患者从 viloxazine ER 治疗中获益的可能性是停药的 5 至 13 倍。具体而言，viloxazine ER 治疗的 NNT 值范围为 6 至 7。viloxazine ER 治疗的 NNH 值范围为 31 至 74。根据惯例，小于 10 的单个数字 NNT（<10）表明干预措施可能有用，而大于 10 的 NNH 值（≥10）表明不良事件可能安全或可耐受。
这些结果表明，ADHD 患者可能从 viloxazine ER 治疗中获益，并且不太可能停药，因为 viloxazine ER 治疗与有利的 LHH、NNT 和 NNH 值相关。Clinicaltrials.gov：NCT03247530、NCT03247543、NCT03247517、NCT03247556。
