Science Links Japan | Post-marketing surveillance of mosapride citrate (Gasmotin) in patients with non-ulcer dyspepsia on long-term administration

Post-marketing surveillance of mosapride citrate (Gasmotin) in patients with non-ulcer dyspepsia on long-term administration

Accession number;05A0742633

Title;Post-marketing surveillance of mosapride citrate (Gasmotin) in patients with non-ulcer dyspepsia on long-term administration

Author; OIKAWA TATSUYA (Dainippon Pharm. Co., Ltd.) TAKEMOTO YUICHI (Dainippon Pharm. Co., Ltd.) HARUMA KEN (Kawasakiidai Naikagaku Shokudoichoka)

Journal Title;Journal of Clinical Therapeutics & Medicines

Journal Code:Y0906A

ISSN:0910-8211

VOL.21;NO.8;PAGE.831-837(2005)

Figure&Table&Reference;FIG.1, TBL.3, REF.13

Pub. Country;Japan

Language;Japanese

Abstract;A post-marketing surveillance was conducted focusing on patients who had been administered Gasmotin (mosapride citrate) for more than 2 weeks. The objective of this surveillance was to confirm the safety and efficacy of Gasmotin in patients who are on long-term medication with the drug and to find any clinical issues related to this drug in the post-marketing stage. 1. From 356 clinical sites across Japan, 966 case report forms of patients with long-term administeration of Gasmotin (i.e., for more than 2 weeks) were collected. The number of cases evaluated for safety was 848 and that for efficacy was 802. 2. The incidence rate of adverse drug reactions was 2.71% (23/848) in the population evaluated for safety. The most frequent adverse drug reactions were abdominal pain and loose stools with a 0.35% incidence for both of them. There were no serious adverse drug reactions reported from this population. 3. The final global improvement rating revealed 85.4% (685/802) improvement in the population for efficacy. The percentage of improvement in each symptom was 86.0% (590/686) for heartburn and 86.2% (579/672) for nausea/vomiting, with no evidence of tachyphylaxis or pharmacological tolerance after long-term use of the drug. 4. The long-term use of Gasmotin in elderly patients or patients with hepatic or renal disorders revealed no evidence for clinically significant issues in these types of patients. Based on the above results, it is concluded that there are no clinically significant issues in safety or efficacy for the long-term use of Gasmotin. (author abst.)

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