Associated Gastroenterology Medical Group, Anaheim, California, USA.
Clinical Development, Norgine Ltd, Harefield, United Kingdom.
Gastrointest Endosc. 2018 Mar;87(3):677-687.e3. doi: 10.1016/j.gie.2017.07.047. Epub 2017 Aug 10.
NER1006 is the first 32 fluid ounce (1 L) polyethylene glycol-based bowel preparation. This randomized, multicenter, colonoscopist/central reader-blinded phase 3 non-inferiority trial assessed the efficacy, safety, and tolerability of NER1006 versus trisulfate for bowel cleansing.
Patients undergoing colonoscopy were randomized (1:1) to receive NER1006 or trisulfate, using evening/morning split-dosing administration. Blinded central readers used the validated Harefield Cleansing Scale to evaluate 2 alternative primary endpoints: overall bowel-cleansing success and high-quality cleansing of the ascending colon/cecum. Secondary endpoints included lesion detection, Boston Bowel Preparation Scale (BBPS) assessment, and adherence. The non-inferiority margin was 10% and the significance threshold was P < .025.
Of 621 patients randomized (NER1006, n=310; trisulfate, n=311), 556 were evaluated for efficacy (NER1006, n=276; trisulfate, n=280). NER1006 achieved non-inferiority versus trisulfate for both primary endpoints of overall bowel-cleansing success (85.1% vs 85.0%; difference, 0.14%; one-sided 97.5% lower confidence limit [LCL], -8.15%; P = .528) and high-quality cleansing of the ascending colon/cecum (35.9% versus 29.3%; difference, 6.58%; LCL, -1.69%; P = .059). BBPS assessments supported overall bowel-cleansing success rates. Lesion detection rates were similar between the groups. The percentage of patients with treatment-related adverse events was 14.9% with NER1006 and 9.4% with trisulfate. Both bowel preparations showed similar overall tolerability and safety profiles. Adherence was very high in both arms.
With evening/morning split dosing, NER1006 was as effective as trisulfate for overall bowel and right-sided colon cleansing. Adverse event rates were slightly higher with NER1006 than trisulfate, but did not compromise tolerability, adherence, or efficacy. (Clinical trial registration number: NCT02254486.).
NER1006 是首个 32 液盎司（1 升）聚乙二醇基肠道准备制剂。这是一项随机、多中心、由结肠镜检查医生/中心读片员设盲的 3 期非劣效性试验，旨在评估 NER1006 与三磺酸钠用于肠道清洁的疗效、安全性和耐受性。
接受结肠镜检查的患者按 1:1 随机（双盲）分为 NER1006 组或三磺酸钠组，采用早晚分剂量给药。中心读片员采用经验证的 Harefield 清洁评分量表评估 2 个替代主要终点：总体肠道清洁成功率和升结肠/盲肠的高质量清洁度。次要终点包括病变检出率、波士顿肠道准备量表（BBPS）评分和依从性。非劣效性边界为 10%，显著性阈值为 P<0.025。
在 621 例随机分组（NER1006 组 310 例，三磺酸钠组 311 例）的患者中，556 例接受了疗效评估（NER1006 组 276 例，三磺酸钠组 280 例）。NER1006 与三磺酸钠相比，在总体肠道清洁成功率（85.1% vs 85.0%；差值，0.14%；单侧 97.5%置信下限 [LCL]，-8.15%；P=0.528）和升结肠/盲肠的高质量清洁度（35.9% vs 29.3%；差值，6.58%；LCL，-1.69%；P=0.059）这 2 个主要终点均达到非劣效性。BBPS 评估支持总体肠道清洁成功率。两组的病变检出率相似。NER1006 组和三磺酸钠组治疗相关不良事件的发生率分别为 14.9%和 9.4%。两种肠道准备药物的总体耐受性和安全性相似。两组的依从性均非常高。
采用早晚分剂量给药，NER1006 在总体肠道和右半结肠清洁方面与三磺酸钠同样有效。NER1006 组的不良事件发生率略高于三磺酸钠组，但并未影响耐受性、依从性或疗效。（临床试验注册号：NCT02254486.）
