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.
| Original language | English |
|---|---|
| Pages (from-to) | 1308-1316 |
| Number of pages | 9 |
| Journal | Archives of Pharmacal Research |
| Volume | 37 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2014 Oct 1 |
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Keywords
- DA-9601(Stilen<sup>®</sup>)
- Gastroduodenal injury
- Misoprostol
- NSAID-associated
ASJC Scopus subject areas
- Molecular Medicine
- Drug Discovery
- Organic Chemistry
Cite this
A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment. / Lee, Oh Young; Kang, Dae Hwan; Lee, Dong Ho; Chung, Il Kwun; Jang, Jae Young; Kim, Jin Il; Cho, Jin Woong; Rew, Jong Sun; Lee, Kang Moon; Kim, Kyoung Oh; Choi, Myung Gyu; Lee, Sang Woo; Lee, Soo Teik; Kim, Tae Oh; Shin, Yong Woon; Seol, Sang Yong.
In: Archives of Pharmacal Research, Vol. 37, No. 10, 01.10.2014, p. 1308-1316.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment
AU - Lee, Oh Young
AU - Kang, Dae Hwan
AU - Lee, Dong Ho
AU - Chung, Il Kwun
AU - Jang, Jae Young
AU - Kim, Jin Il
AU - Cho, Jin Woong
AU - Rew, Jong Sun
AU - Lee, Kang Moon
AU - Kim, Kyoung Oh
AU - Choi, Myung Gyu
AU - Lee, Sang Woo
AU - Lee, Soo Teik
AU - Kim, Tae Oh
AU - Shin, Yong Woon
AU - Seol, Sang Yong
PY - 2014/10/1
Y1 - 2014/10/1
N2 - 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.
AB - 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.
KW - DA-9601(Stilen<sup>®</sup>)
KW - Gastroduodenal injury
KW - Misoprostol
KW - NSAID-associated
UR - http://www.scopus.com/inward/record.url?scp=84938877822&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84938877822&partnerID=8YFLogxK
U2 - 10.1007/s12272-014-0408-3
DO - 10.1007/s12272-014-0408-3
M3 - Article
VL - 37
SP - 1308
EP - 1316
JO - Archives of Pharmacal Research
JF - Archives of Pharmacal Research
SN - 0253-6269
IS - 10
ER -