Safety and effectiveness of methylphenidate ER multi-unit pellet system in ADHD patients: An open label study.

IF 1 4区医学 Q4 PSYCHIATRY

South African Journal of Psychiatry Pub Date : 2024-11-14 eCollection Date: 2024-01-01 DOI:10.4102/sajpsychiatry.v30i0.2267

Renata Schoeman, Evelyn Y Lai, Anne-Marie Nel, Mashra Gani, Muhammed A Fulat, Akbar A Mahomed

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引用次数: 0

Abstract

Background: 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.

Aim: 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.

Setting: A phase IV, open label, flexible dose, prospective, observational study conducted at six sites covering five provinces of South Africa.

Methods: 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.

Results: In all, 117 participants completed the study (treatment-naïve patients: 46% [n = 55] and switch-over patients: 54% [n = 64]). Mean change from baseline in total WFIRS (95% confidence interval) was -17.7 (-21.1, -14.3; p < 0.001) at week 4 and -29.3 (-33.5, -25.2; p < 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.

Conclusion: 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.

Contribution: 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.

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哌甲酯内啡肽多单位微丸系统治疗ADHD患者的安全性和有效性：一项开放标签研究。

背景：注意缺陷多动障碍（ADHD）是一种发生在儿童和成人中的神经发育障碍。药物治疗仍然是ADHD治疗的基石。像哌醋甲酯这样的兴奋剂是有效的，并且是研究得最好和最常用的治疗多动症的方法之一。然而，不同的输送机制和设备可能会影响患者的体验和现实生活中的结果。目的：本研究在现实环境中评估多单元颗粒系统递送缓释哌甲酯（Contramyl XR）对ADHD患者症状控制和报告结果的有效性。环境：这是一项IV期、开放标签、灵活剂量、前瞻性观察性研究，在南非5个省的6个地点进行。方法：约119名ADHD患者（包括新诊断的[treatment-naïve]和哌甲酯治疗的[切换]患者）入组，开始使用Contramyl XR或从哌甲酯切换到Contramyl XR。12周后，通过Weiss功能损伤评定量表（WFIRS）评估主要疗效。结果：总共有117名参与者完成了研究（treatment-naïve患者：46% [n = 55]，切换患者：54% [n = 64]）。总WFIRS与基线相比的平均变化（95%置信区间）为-17.7 (-21.1,-14.3；P < 0.001)和-29.3 (-33.5,-25.2；P < 0.001)。在第12周，WFIRS评分显著改善，treatment-naïve患者报告治疗满意度。转换患者也显示出相当的有效性。结论：Contramyl XR无论是作为新生治疗还是作为转换治疗，均具有良好的临床疗效。它的耐受性良好，所有患者都选择继续治疗方案。贡献：尽管Contramyl XR的给药机制不同，但本研究为在treatment-naïve和切换型ADHD患者中使用Contramyl XR作为替代治疗选择而不是参考哌甲酯提供了证据。研究参与者在研究结束后愿意继续使用Contramyl XR治疗，进一步增强了Contramyl XR治疗ADHD患者有效性的信心。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

South African Journal of Psychiatry 医学-精神病学

CiteScore

1.60

自引率

10.00%

发文量

审稿时长

>12 weeks

期刊介绍： The journal is the leading psychiatric journal of Africa. It provides open-access scholarly reading for psychiatrists, clinical psychologists and all with an interest in mental health. It carries empirical and conceptual research articles, reviews, editorials, and scientific letters related to psychiatry. It publishes work from various places in the world, and makes special provision for the interests of Africa. It seeks to serve its readership and researchers with the most topical content in psychiatry for clinical practice and academic pursuits, including work in the subspecialty areas of psychiatry.