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疾病领域	数量

内分泌与代谢疾病	1
感染	1
免疫系统疾病	1
神经系统疾病	1

排名前五的药物类型	数量

小分子化药	1

排名前五的靶点	数量

COX(环氧化酶)	1

关联

1

项与 PPD Pharmaceutical Development (Beijing) Co. Ltd. 相关的药物

Diclofenac Sodium

双氯芬酸钠

靶点

COX

作用机制

COX抑制剂

在研机构

Hisamitsu Pharmaceutical Co., Inc. [+13]

原研机构

Novartis Pharma AG

在研适应症

滑囊炎 [+21]

非在研适应症

光化性角化病 [+9]

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期1973-08-08

100 项与 PPD Pharmaceutical Development (Beijing) Co. Ltd. 相关的临床结果

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0 项与 PPD Pharmaceutical Development (Beijing) Co. Ltd. 相关的专利（医药）

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1

项与 PPD Pharmaceutical Development (Beijing) Co. Ltd. 相关的文献（医药）

2016-07-01·Diabetes & Metabolic Syndrome: Clinical Research & Reviews

Effects of body mass index or dosage on gastrointestinal disorders associated with extended-release metformin in type 2 diabetes: Sub-analysis of a Phase IV open-label trial in Chinese patients

Article

作者: Zhao, Dong ; Li, Yan ; Ji, Linong ; Wu, Xiaojing ; Guo, Xiaohui ; Jiang, Xiaozhen ; Su, Qing ; Guo, Lixin ; Hong, Xu

AIMTo determine whether gastrointestinal (GI) tolerability of metformin monotherapy varies according to baseline BMI or at doses >1500mg/day in patients newly diagnosed with type 2 diabetes.METHODSWe performed a sub-analysis of the safety population from a prospective, multicenter, Phase IV open-label study in which 371 Chinese patients with type 2 diabetes received extended-release metformin monotherapy for 16 weeks. The incidence, severity and duration of GI adverse events (AEs) were compared between normal-weight (BMI<25kg/m(2), n=155) and overweight/obese (BMI≥25kg/m(2), n=216) patients. The primary objective was to determine whether baseline BMI affect the incidence, severity and duration of GI AEs, using Fisher's exact test and Student's t-test. Secondary objectives were to compare these factors according to final metformin dose (≤1500mg/day versus 2000mg/day).RESULTSThe proportion of patients who reported ≥1 GI AE did not differ significantly between BMI groups (25.2% of the normal-weight group versus 21.3% of the overweight/obese group; p=0.3840). Patients who reported GI AEs in the two BMI groups experienced similar GI AE severity (p=0.5410), mean duration (p=0.3572) and duration distribution (p=0.1347). There was no significant difference in GI AE severity and duration between metformin dosage groups (≤1500mg/day versus 2000mg/day).CONCLUSIONSNewly-diagnosed Chinese type 2 diabetes patients of normal weight are no more likely than overweight/obese patients to suffer from increased incidence rates, severity or duration of GI AEs when treated with first-line extended-release metformin monotherapy. Doses of 2000mg/day did not increase the severity or duration of GI AEs.

100 项与 PPD Pharmaceutical Development (Beijing) Co. Ltd. 相关的药物交易

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100 项与 PPD Pharmaceutical Development (Beijing) Co. Ltd. 相关的转化医学

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