Department of Gastroenterology, Gandhi Medical College & Hospital, Secunderabad, Telangana, India.
Dr. Reddy's Laboratories Ltd., Greenlands, Hyderabad, Telangana, India.
Adv Ther. 2018 Nov;35(11):1884-1893. doi: 10.1007/s12325-018-0814-x. Epub 2018 Oct 22.
INTRODUCTION: Functional dyspepsia (FD) is a highly prevalent condition which reduces patients' quality of life (QoL) and imparts a significant economic burden on the healthcare system. Acotiamide is a novel prokinetic agent useful in treatment of FD, and this study evaluated the effectiveness of acotiamide hydrochloride hydrate in management of FD over a 4-week period in a real-world setting. METHODS: This study was a prospective, observational, real-world data collection of 132 patients (85 male, 47 female) over 18 years of age diagnosed with FD as per Rome III criteria and treated with acotiamide for 4 weeks at a gastroenterology unit of a medical school in India. Those receiving prokinetics and cholinergic drugs, having any structural lesion on endoscopy, with coexisting irritable bowel syndrome and having heartburn in the past 12 weeks were excluded. Primary outcome was responders based on overall treatment efficacy (OTE) recorded on a seven-point Likert scale for postprandial distress syndrome (PDS; postprandial fullness, early satiety and upper abdominal bloating), epigastric pain syndrome (EPS; upper abdominal pain and upper abdominal discomfort) and associated symptoms (nausea, vomiting and excessive belching) at the end of 2 and 4 weeks. Secondary outcomes were elimination of symptoms of PDS, QoL assessed on the Short-Form Nepean Dyspepsia Index (SFNDI) questionnaire and clinical safety after 2 and 4 weeks. RESULTS: The responder rates with acotiamide at 2 and 4 weeks were 51.5% and 65.9%, respectively, for PDS. Similarly, the responder rates for EPS were 31.8% and 41.7%, respectively, at 2 weeks and 4 weeks. The responder rates for associated symptoms of nausea, vomiting and excessive belching were respectively 18.2%, 17.4% and 16.7% at 2 weeks and 18.2%, 17.4% and 18.2% at 4 weeks. Symptom elimination rates were 9.8% and 18.9% for postprandial fullness, 12.9% and 22.0% for early satiety, and 18.9% and 24.2% for abdominal bloating at 2 and 4 weeks, respectively. Significant improvement (p < 0.0001) in the SFNDI total scores from 25.91 (5.00) at 2 weeks to 23.76 (4.84) at 4 weeks were found at 4 weeks compared to 2 weeks. A total of 7 (5.30%) patients reported mild adverse events which were dizziness (4), headache (3) and nausea (1). CONCLUSION: The current study demonstrates that treatment with acotiamide improves symptoms, QoL and is well tolerated in Indian patients with FD. TRIAL REGISTRATION: Clinical Trial Registry of India, CTRI/2017/11/010421. FUNDING: Dr. Reddy's Laboratories, India.
简介：功能性消化不良（FD）是一种高发疾病，降低了患者的生活质量（QoL），并给医疗保健系统带来了巨大的经济负担。阿考替胺是一种新型的促动力药物，可用于治疗 FD，本研究评估了盐酸阿考替胺水合物在真实世界环境中治疗 FD 的 4 周内的疗效。
方法：这是一项前瞻性、观察性、真实世界数据收集研究，共纳入了 132 名年龄在 18 岁以上的患者（85 名男性，47 名女性），这些患者均根据罗马 III 标准诊断为 FD，并在印度一所医学院的胃肠病学单位接受了 4 周的阿考替胺治疗。排除接受促动力和胆碱能药物治疗、内镜检查有任何结构病变、并存肠易激综合征和过去 12 周有烧心症状的患者。主要结局是根据治疗 2 周和 4 周后餐后不适综合征（PDS；餐后饱胀、早饱和上腹部饱胀）、上腹痛综合征（EPS；上腹痛和上腹部不适）和相关症状（恶心、呕吐和过度嗳气）的总体治疗效果（OTE）记录在 7 分李克特量表上的应答者比例。次要结局是 PDS 症状的消除、使用简短型 Nepean 消化不良指数（SFNDI）问卷评估的生活质量以及治疗 2 周和 4 周后的临床安全性。
结果：在治疗 2 周和 4 周时，阿考替胺治疗 PDS 的应答率分别为 51.5%和 65.9%。同样，EPS 的应答率分别为 31.8%和 41.7%，在 2 周和 4 周时。恶心、呕吐和过度嗳气相关症状的应答率分别为 18.2%、17.4%和 16.7%，在 2 周和 18.2%、17.4%和 18.2%时。在 2 周和 4 周时，餐后饱胀、早饱和上腹部饱胀的症状消除率分别为 9.8%和 18.9%、12.9%和 22.0%以及 18.9%和 24.2%。与治疗 2 周时相比，治疗 4 周时 SFNDI 总分从 25.91（5.00）显著改善（p<0.0001）至 23.76（4.84）。共有 7 名（5.30%）患者报告了轻度不良反应，包括头晕（4 名）、头痛（3 名）和恶心（1 名）。
结论：本研究表明，在印度 FD 患者中，阿考替胺治疗可改善症状、生活质量，且耐受性良好。
试验注册：印度临床试验注册中心，CTRI/2017/11/010421。
资金：印度雷迪博士实验室。
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