Division of Metabolism and Endocrinology, Department of Internal Medicine, St. Marianna University School of Medicine, 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
Department of Diabetes and Endocrinology, Kanto Rosai Hospital, 1-1, Kizukisumiyoshi, Nakahara, Kawasaki, Kanagawa, 211-8510, Japan.
Adv Ther. 2022 Sep;39(9):4205-4217. doi: 10.1007/s12325-022-02243-w. Epub 2022 Jul 22.
To evaluate the efficacy and safety of elobixibat in patients with diabetes and concomitant chronic constipation.
This was a single-center, single-arm study. Thirty-three patients with diabetes and chronic constipation, as defined by the Rome IV criteria, were treated with elobixibat (10 mg/day) for 8 weeks. Patients recorded stool properties, including spontaneous bowel movements (SBMs) and stool consistency, according to the Bristol Stool Form Scale (BSFS). Quality of life for constipation was evaluated with the Japanese version of the Patient Assessment of Constipation Quality of Life (JPAC-QOL).
Of the 33 eligible patients, 30 completed the study. Elobixibat significantly increased the median (interquartile range) frequency of SBMs per week, from 5.0 (3.0-7.0) at baseline to 6.0 (4.0-7.0] at week 8 (p = 0.030). After 8 weeks, the BSFS score approached 4; the score for normal stool consistency and the JPAC-QOL score significantly improved from 1.05 ± 0.40 at baseline to 0.94 ± 0.53 (p = 0.048); and glycated albumin and serum lipid profiles significantly improved. Stratified analysis revealed that SBMs increased especially in patients with low SBM frequency, in particular in women, older adults, patients without overweight, patients with a long duration of constipation, and patients with diabetic neuropathy. No serious adverse events occurred.
Among patients with diabetes who met the Rome IV criteria for constipation, elobixibat was effective, especially in those with few SBMs at baseline. Improvements in lipid profiles could be an advantage of elobixibat compared with other laxatives.
Japan Registry of Clinical Trials registration number: jRCTs031190092.
评估依洛利昔单抗在合并慢性便秘的糖尿病患者中的疗效和安全性。
这是一项单中心、单臂研究。33 名符合罗马 IV 标准的糖尿病合并慢性便秘患者接受依洛利昔单抗（10 mg/天）治疗 8 周。患者根据布里斯托粪便形状量表（BSFS）记录粪便特性，包括自发性排便（SBM）和粪便稠度。采用日本版便秘患者生活质量量表（JPAC-QOL）评估便秘患者的生活质量。
在 33 名符合条件的患者中，有 30 名完成了研究。依洛利昔单抗显著增加了每周 SBM 的中位数（四分位距），从基线时的 5.0（3.0-7.0）增加到第 8 周的 6.0（4.0-7.0）（p=0.030）。8 周后，BSFS 评分接近 4；正常粪便稠度评分和 JPAC-QOL 评分从基线时的 1.05±0.40显著改善至 0.94±0.53（p=0.048）；糖化白蛋白和血清脂质谱也显著改善。分层分析显示，SBM 增加尤其见于 SBM 频率较低的患者，尤其是女性、老年人、无超重患者、便秘病程较长的患者和糖尿病神经病变患者。未发生严重不良事件。
在符合罗马 IV 标准的糖尿病患者中，依洛利昔单抗有效，尤其对基线 SBM 较少的患者效果更好。与其他泻药相比，依洛利昔单抗改善血脂谱可能是其优势。
日本临床试验注册编号：jRCTs031190092。
