Ida Motoko, Nishida Akito, Akiho Hiraku, Nakashima Yoshihiro, Matsueda Kei, Fukudo Shin
Japan-Asia Planning & Administration, Medical & Development, Astellas Pharma Inc., 2-5-1 Nihonbashi-Honcho, Chuo-ku, Tokyo, 103-8411 Japan.
Development Project Management, Astellas Pharma Inc., Tokyo, Japan.
Biopsychosoc Med. 2017 Mar 16;11:8. doi: 10.1186/s13030-017-0093-9. eCollection 2017.
BACKGROUND: Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess "clinically meaningful improvements, focusing on the patient's chief complaint and the severity of major IBS symptoms" in addition to global assessment to show how ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D). METHODS: The same database was used in a previously reported post-marketing phase IV, randomized placebo-controlled pilot trial in male patients with IBS-D. The hypothesis is completely different from that of the other study. Patients with IBS-D diagnosed according to Rome III criteria were given either 5 μg of ramosetron ( = 47) or placebo ( = 51) once daily for 12 weeks after a one-week baseline period. To explore and examine endpoints that allow evaluation of "clinically meaningful improvements focusing on the patient's chief complaint," the chief complaint and its relief by this study drug were assessed in this exploratory study. RESULTS: Rates of patients with abdominal pain/discomfort, stool form and stool frequency which patients had as a chief complaint before administration were 34.0, 19.1 and 25.5%, respectively, in the ramosetron 5 μg group and 42.0, 18.0, and 20.0% in the placebo group. Responder rates for improvement in symptoms of the chief complaint that patients had before administration were 53.2% in the ramosetron 5 μg group and 42.0% in the placebo group at the last point. The greatest symptomatic improvement in the chief complaint in the ramosetron 5 μg group compared to the placebo group was shown with respect to stool consistency. Bristol Stool Form Scale (BSFS) scores were significantly lower in the ramosetron group than in the placebo group (4.36 ± 1.195 vs 4.85 ± 0.890 at the last point, = 0.027) throughout the treatment period, except at week 6. CONCLUSIONS: Ramosetron acted most effectively on stool consistency. Improvement in stool consistency is considered to be a clinically meaningful endpoint in showing how ramosetron was effective for individual IBS symptoms. (Clinicaltrials.gov ID: NCT00918411. Registered 9 June 2009).
背景：整体评估可让患者评估多种肠易激综合征（IBS）症状的改善情况。然而，除整体评估外，评估“具有临床意义的改善，重点关注患者的主要诉求和IBS主要症状的严重程度”也被认为很重要，以此来表明雷莫司琼对个体IBS症状的疗效。这是一项探索性研究，旨在关注腹泻型肠易激综合征（IBS-D）患者的主要诉求，探索临床终点。 方法：在之前一项已发表的上市后IV期随机安慰剂对照试验中，对男性IBS-D患者使用了相同的数据库。本研究的假设与另一项研究完全不同。根据罗马III标准诊断为IBS-D的患者，在为期1周的基线期后，每日给予5μg雷莫司琼（n = 47）或安慰剂（n = 51），持续12周。在这项探索性研究中，为了探索和检验能够评估“关注患者主要诉求的具有临床意义的改善”的终点，对主要诉求以及本研究药物对其的缓解情况进行了评估。 结果：在5μg雷莫司琼组中，给药前作为主要诉求的腹痛/不适、大便形状和大便频率的患者比例分别为34.0%、19.1%和25.5%，在安慰剂组中分别为42.0%、18.0%和20.0%。在最后一个时间点，5μg雷莫司琼组中给药前主要诉求症状改善的有效率为53.2%，安慰剂组为42.0%。与安慰剂组相比，5μg雷莫司琼组在主要诉求方面最大的症状改善体现在大便稠度上。在整个治疗期间，除第6周外，雷莫司琼组的布里斯托大便形状量表（BSFS）评分显著低于安慰剂组（最后一个时间点为4.36 ± 1.195 vs 4.85 ± 0.890，P = 0.027）。 结论：雷莫司琼对大便稠度的作用最为有效。大便稠度的改善被认为是一个具有临床意义的终点，可表明雷莫司琼对个体IBS症状的疗效。（Clinicaltrials.gov标识符：NCT00918411。于2009年6月9日注册）
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