Sun Ju Chung, Matilde Calopa, Maria G Ceravolo, Nicola Tambasco, Angelo Antonini, K Ray Chaudhuri, Weining Z Robieson, Olga Sánchez-Soliño, Cindy Zadikoff, Man Jin, Luigi M Barbato
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Key secondary outcomes included the Unified PD Rating Scale (UPDRS) Part II, Clinical Global Impression of Change (CGI-C), and PD Questionnaire-8 (PDQ-8). Additional secondary measures of Patient Global Impression of Change (PGIC), King's PD Pain Scale (KPPS), and Parkinson Anxiety Scale (PAS) also were evaluated. Finally, safety was assessed.</p><p><strong>Results: </strong>Out of 89 patients randomized, 87 were included in the analysis (LCIG, <i>n</i> = 43; OMT, <i>n</i> = 44). There were no significant differences in NMSS or PDSS-2 total score changes (baseline to Week 26) between LCIG and OMT; within-group changes were significant for NMSS (LCIG, <i>p</i> < 0.001; OMT, <i>p</i> = 0.005) and PDSS-2 (LCIG, <i>p</i> < 0.001; OMT, <i>p</i> < 0.001). Between-group treatment differences were nominally significant for UPDRS Part II (<i>p</i> = 0.006) and CGI-C (<i>p</i> < 0.001) at Week 26 in favor of LCIG; however, statistical significance could not be claimed in light of primary efficacy outcomes. PGIC (Week 26) and KPPS (Week 12) scores were nominally significantly reduced with LCIG versus OMT (<i>p</i> < 0.001; <i>p</i> < 0.05). There were no significant differences in PDQ-8 or PAS. Adverse events (AEs) were mostly mild to moderate; common serious AEs were pneumoperitoneum (<i>n</i> = 2) and stoma-site infection (<i>n</i> = 2) (LCIG).</p><p><strong>Conclusions: </strong>There were no significant differences between LCIG versus OMT in NMSS or PDSS-2; both LCIG and OMT groups significantly improved from baseline. 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Primary outcomes assessed were total NMS (NMS scale (NMSS) and PD sleep scale (PDSS-2)). Key secondary outcomes included the Unified PD Rating Scale (UPDRS) Part II, Clinical Global Impression of Change (CGI-C), and PD Questionnaire-8 (PDQ-8). Additional secondary measures of Patient Global Impression of Change (PGIC), King's PD Pain Scale (KPPS), and Parkinson Anxiety Scale (PAS) also were evaluated. Finally, safety was assessed.</p><p><strong>Results: </strong>Out of 89 patients randomized, 87 were included in the analysis (LCIG, <i>n</i> = 43; OMT, <i>n</i> = 44). There were no significant differences in NMSS or PDSS-2 total score changes (baseline to Week 26) between LCIG and OMT; within-group changes were significant for NMSS (LCIG, <i>p</i> < 0.001; OMT, <i>p</i> = 0.005) and PDSS-2 (LCIG, <i>p</i> < 0.001; OMT, <i>p</i> < 0.001). 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引用次数: 0
摘要
背景:非运动症状(NMS)在晚期帕金森病(APD)中很常见，并降低与健康相关的生活质量。目的:评价左旋多巴-卡比多巴肠道凝胶(LCIG)与优化药物治疗(OMT)对APD NMS的影响。方法:INSIGHTS是一项3b期、开放标签、随机、多中心研究，研究对象是APD患者(LCIG或OMT, 26周)(NCT02549092)。主要评价指标为总NMS (NMS量表(NMSS)和PD睡眠量表(PDSS-2))。主要次要结局包括统一PD评定量表(UPDRS)第二部分、临床总体变化印象(CGI-C)和PD问卷-8 (PDQ-8)。另外还评估了患者总体变化印象(PGIC)、King’s PD疼痛量表(KPPS)和帕金森焦虑量表(PAS)。最后进行安全性评价。结果:89例随机患者中，87例纳入分析(LCIG, n = 43;OMT, n = 44)。LCIG和OMT在NMSS或PDSS-2总分变化(基线至第26周)方面无显著差异;NMSS组内变化显著(LCIG, p < 0.001;OMT, p = 0.005)和PDSS-2 (LCIG, p < 0.001;OMT, p < 0.001)。在第26周，UPDRS第二部分(p = 0.006)和CGI-C (p < 0.001)的组间治疗差异名义上显著，有利于LCIG;然而，根据主要疗效结果，不能声称具有统计学意义。LCIG与OMT相比，PGIC(第26周)和KPPS(第12周)得分名义上显著降低(p < 0.001;P < 0.05)。PDQ-8和PAS无显著差异。不良事件(ae)多为轻至中度;常见的严重ae有气腹(n = 2)和口部感染(n = 2) (LCIG)。结论:lcigg与OMT在NMSS或PDSS-2方面无显著差异;LCIG组和OMT组均较基线有显著改善。ae符合已知的安全概况。
Effects of Levodopa-Carbidopa Intestinal Gel Compared with Optimized Medical Treatment on Nonmotor Symptoms in Advanced Parkinson's Disease: INSIGHTS Study.
Background: Nonmotor symptoms (NMS) are common in advanced Parkinson's disease (APD) and reduce health-related quality of life.
Objective: The aim of the study was to evaluate levodopa-carbidopa intestinal gel (LCIG) versus optimized medical treatment (OMT) on NMS in APD.
Methods: INSIGHTS was a phase 3b, open-label, randomized, multicenter study in patients with APD (LCIG or OMT, 26 weeks) (NCT02549092). Primary outcomes assessed were total NMS (NMS scale (NMSS) and PD sleep scale (PDSS-2)). Key secondary outcomes included the Unified PD Rating Scale (UPDRS) Part II, Clinical Global Impression of Change (CGI-C), and PD Questionnaire-8 (PDQ-8). Additional secondary measures of Patient Global Impression of Change (PGIC), King's PD Pain Scale (KPPS), and Parkinson Anxiety Scale (PAS) also were evaluated. Finally, safety was assessed.
Results: Out of 89 patients randomized, 87 were included in the analysis (LCIG, n = 43; OMT, n = 44). There were no significant differences in NMSS or PDSS-2 total score changes (baseline to Week 26) between LCIG and OMT; within-group changes were significant for NMSS (LCIG, p < 0.001; OMT, p = 0.005) and PDSS-2 (LCIG, p < 0.001; OMT, p < 0.001). Between-group treatment differences were nominally significant for UPDRS Part II (p = 0.006) and CGI-C (p < 0.001) at Week 26 in favor of LCIG; however, statistical significance could not be claimed in light of primary efficacy outcomes. PGIC (Week 26) and KPPS (Week 12) scores were nominally significantly reduced with LCIG versus OMT (p < 0.001; p < 0.05). There were no significant differences in PDQ-8 or PAS. Adverse events (AEs) were mostly mild to moderate; common serious AEs were pneumoperitoneum (n = 2) and stoma-site infection (n = 2) (LCIG).
Conclusions: There were no significant differences between LCIG versus OMT in NMSS or PDSS-2; both LCIG and OMT groups significantly improved from baseline. AEs were consistent with the known safety profile.
期刊介绍：
Parkinson’s Disease is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to the epidemiology, etiology, pathogenesis, genetics, cellular, molecular and neurophysiology, as well as the diagnosis and treatment of Parkinson’s disease.
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