Schoeman Renata, Lai Evelyn Y, Nel Anne-Marie, Gani Mashra, Fulat Muhammed A, Mahomed Akbar A
Stellenbosch Business School, Stellenbosch University, Stellenbosch, South Africa.
Department of Medical Affairs, Mylan (Pty) Ltd, Johannesburg, South Africa.
S Afr J Psychiatr. 2024 Nov 14;30:2267. doi: 10.4102/sajpsychiatry.v30i0.2267. eCollection 2024.
Attention deficit hyperactive disorder (ADHD) is a neurodevelopmental disorder occurring in children and adults. Pharmacotherapy remains the cornerstone of ADHD treatment. Stimulants such as methylphenidate are effective and have been one of the best studied and most frequently used treatment for ADHD. However, different delivery mechanisms and devices may potentially impact patient experience and real-life outcomes.
This study evaluated the effectiveness of Multiple-Unit Pellet System Delivered Extended-Release Methylphenidate (Contramyl XR) on symptom control and reported outcomes in ADHD patients, in a real-world setting.
A phase IV, open label, flexible dose, prospective, observational study conducted at six sites covering five provinces of South Africa.
About 119 participants with ADHD (both newly diagnosed [treatment-naïve] and methylphenidate-treated [switch-over] patients) were enrolled and initiated either on Contramyl XR or switched over from methylphenidate to Contramyl XR. Primary efficacy was assessed by Weiss Functional Impairment Rating Scale (WFIRS) over 12 weeks.
In all, 117 participants completed the study (treatment-naïve patients: 46% [ = 55] and switch-over patients: 54% [ = 64]). Mean change from baseline in total WFIRS (95% confidence interval) was -17.7 (-21.1, -14.3; < 0.001) at week 4 and -29.3 (-33.5, -25.2; < 0.001) at week 12. At week 12, there was significant improvement in WFIRS scores, with treatment satisfaction reported by treatment-naïve patients. Switch-over patients also demonstrated comparable effectiveness.
Contramyl XR was found to be clinically effective either as de novo or as switch therapy. It was well tolerated, and all patients chose to continue with the treatment option.
Despite distinct and different delivery mechanism of Contramyl XR, this study provides evidence for using it as an alternate treatment option versus reference methylphenidate, in both treatment-naïve and switch-over ADHD patients. Study participants willingness to continue Contramyl XR therapy post study, further strengthens the confidence on the effectiveness of Contramyl XR in managing ADHD patients.
注意力缺陷多动障碍（ADHD）是一种发生于儿童和成人的神经发育障碍。药物治疗仍然是ADHD治疗的基石。诸如哌甲酯之类的兴奋剂是有效的，并且一直是针对ADHD研究最为深入且使用最为频繁的治疗方法之一。然而，不同的给药机制和装置可能会对患者体验和实际生活结局产生潜在影响。
本研究在现实环境中评估了多单元微丸系统缓释哌甲酯（康达明长效型）对ADHD患者症状控制及报告结局的有效性。
在南非五个省份的六个地点开展的一项IV期、开放标签、灵活剂量、前瞻性观察性研究。
招募了约119例ADHD患者（包括新诊断的[未接受过治疗的]和接受过哌甲酯治疗的[换药的]患者），并开始使用康达明长效型进行治疗，或从哌甲酯换用康达明长效型。通过韦斯功能损害评定量表（WFIRS）在12周内评估主要疗效。
共有117例参与者完成了研究（未接受过治疗的患者：46%[ = 55]，换药的患者：54%[ = 64]）。在第4周时，WFIRS总分相对于基线的平均变化（95%置信区间）为-17.7（-21.1，-14.3；<0.001），在第12周时为-29.3（-33.5，-25.2；<0.001）。在第12周时，WFIRS评分有显著改善，未接受过治疗的患者报告了治疗满意度。换药的患者也显示出了相当的有效性。
发现康达明长效型作为起始治疗或换药治疗均具有临床有效性。其耐受性良好，所有患者都选择继续使用该治疗方案。
尽管康达明长效型具有独特且不同的给药机制，但本研究为其在未接受过治疗的和换药的ADHD患者中作为替代哌甲酯的治疗选择提供了证据。研究参与者在研究结束后愿意继续使用康达明长效型治疗，进一步增强了对康达明长效型治疗ADHD患者有效性的信心。
