title: A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment.
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). [corrected]. 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.
authors.affiliation: Department of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.
authors.forename: Oh Young
authors.initials: OY
authors.lastname: Lee
authors.forename: Dae-Hwan
authors.initials: DH
authors.lastname: Kang
authors.forename: Dong Ho
authors.initials: DH
authors.lastname: Lee
authors.forename: Il-Kwun
authors.initials: IK
authors.lastname: Chung
authors.forename: Jae Young
authors.initials: JY
authors.lastname: Jang
authors.forename: Jae-Young
authors.initials: JY
authors.lastname: Jang
authors.forename: Jin-Il
authors.initials: JI
authors.lastname: Kim
authors.forename: Jin-Woong
authors.initials: JW
authors.lastname: Cho
authors.forename: Jong-Sun
authors.initials: JS
authors.lastname: Rew
authors.forename: Kang-Moon
authors.initials: KM
authors.lastname: Lee
authors.forename: Kyoung Oh
authors.initials: KO
authors.lastname: Kim
authors.forename: Myung-Gyu
authors.initials: MG
authors.lastname: Choi
authors.forename: Sang-Woo
authors.initials: SW
authors.lastname: Lee
authors.forename: Soo-Teik
authors.initials: ST
authors.lastname: Lee
authors.forename: Tae-Oh
authors.initials: TO
authors.lastname: Kim
authors.forename: Yong-Woon
authors.initials: YW
authors.lastname: Shin
authors.forename: Sang-Yong
authors.initials: SY
authors.lastname: Seol
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects* / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004008:Diclofenac / Q000009:adverse effects / Q000031:analogs & derivatives / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D016595:Misoprostol / Q000009:adverse effects / Q000627:therapeutic use*; D010437:Peptic Ulcer / Q000139:chemically induced / Q000188:drug therapy*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D000897:Anti-Ulcer Agents; C116959:DA 9601; D010936:Plant Extracts; D016595:Misoprostol; D004008:Diclofenac; C056498:aceclofenac