A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-05-30

AUTHORS

Oh Young Lee, Dae-Hwan Kang, Dong Ho Lee, Il-Kwun Chung, Jae-Young Jang, Jin-Il Kim, Jin-Woong Cho, Jong-Sun Rew, Kang-Moon Lee, Kyoung Oh Kim, Myung-Gyu Choi, Sang-Woo Lee, Soo-Teik Lee, Tae-Oh Kim, Yong-Woon Shin, Sang-Yong Seol

ABSTRACT

Misoprostol is reported to prevent non-steroidal anti-inflammatory drug (NSAID)-associated gastroduodenal complications. There is, however, limited information regarding the efficacy of DA-9601 in this context. We performed a comparative study on the relative efficacy of DA-9601 and misoprostol for prevention of NSAID-associated complications. In this multicenter, double-blinded, active-controlled, stratified randomized, parallel group, non-inferiority trial, 520 patients who were to be treated with an NSAID (aceclofenac, 100 mg, twice daily) over a 4-week period were randomly assigned to groups for coincidental treatment with DA-9601 (60 mg, thrice daily) (236 patients for full analysis) or misoprostol (200 μg, thrice daily) (242 patients for full analysis). A total of 236 patients received DA-9601 and 242 received misoprostol. The primary endpoint was the gastric protection rate, and secondary endpoints were the duodenal protection rate and ulcer incidence rate. Endpoints were assessed by endoscopy after the 4-week treatment period. Drug-related adverse effects, including gastrointestinal (GI) symptoms, were also compared. At week 4, the gastric protection rates with DA-9601 and misoprostol were 81.4 % (192/236) and 89.3 % (216/242), respectively. The difference between the groups was −14.2 %, indicating non-inferiority of DA-9601 to misoprostol. Adverse event rates were not different between the two groups; however, the total scores for GI symptoms before and after administration were significantly lower in the DA-9601 group than in the misoprostol group (−0.2 ± 2.8 vs 1.2 ± 3.2; p < 0.0001). DA-9601 is as effective as misoprostol in preventing NSAID-associated gastroduodenal complications, and has a superior adverse GI effect profile. More... »

PAGES

1308-1316

Journal

TITLE

Archives of Pharmacal Research

ISSUE

10

VOLUME

37

Author Affiliations

  • Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea
  • Department of Internal Medicine, Pusan National University Yangsan Hospital, Busan, South Korea
  • Department of Internal Medicine, Seoul National University Hospital of Bundang, Seongnam, South Korea
  • Department of Internal Medicine, Soonchonhyang University Hospital Cheonan, Cheonan, South Korea
  • Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul, South Korea
  • Department of Internal Medicine, The Catholic University of Korea Yeouido St.Mary’s Hospital, Seoul, South Korea
  • Department of Internal Medicine, Presbyterian Medical Center, Jeonju, South Korea
  • Department of Internal Medicine, Chonnam National University College of Medicine, Gwangju, South Korea
  • Department of Internal Medicine, The Catholic University of Korea St.Vincent’s Hospital, Suwon, South Korea
  • Department of Internal Medicine, Gacheon University Gil Medical Center, Incheon, South Korea
  • Department of Internal Medicine, The Catholic University of Korea Seoul St.Mary’s Hospital, Seoul, South Korea
  • Department of Internal Medicine, Korea University Ansan Hospital, Ansan, South Korea
  • Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, South Korea
  • Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, South Korea
  • Department of Internal Medicine, Inha University Hospital, Incheon, South Korea
  • Department of Internal Medicine, Inje University Busan Paik Hospital, 75 Bokji-ro, Busanjin-gu, 614-735, Busan, Korea
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s12272-014-0408-3

    DOI

    http://dx.doi.org/10.1007/s12272-014-0408-3

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1027439333

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/24871787


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