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A Comparative Study of DA-9601 and Misoprostol for Prevention of NSAID-Associated Gastroduodenal Injury in Patients Undergoing Chronic NSAID Treatment

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A Comparative Study of DA-9601 and Misoprostol for Prevention of NSAID-Associated Gastroduodenal Injury in Patients Undergoing Chronic NSAID Treatment View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Arch. Pharm. Res. (2014) 37:1308–1316 DOI 10.1007/s12272-014-0408-3 RESEARCH ARTICLE A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment 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 Received: 25 April 2014 / Accepted: 2 May 2014 / Published online: 30 May 2014 Ó The Author(s) 2014. This article is published with open access at Springerlink.com Abstract Misoprostol is reported to prevent non-steroidal The primary endpoint was the gastric protection rate, and anti-inflammatory drug (NSAID)-associated gastroduode- secondary endpoints were the duodenal protection rate and nal complications. There is, however, limited information ulcer incidence rate. Endpoints were assessed by endos- regarding the efficacy of DA-9601 in this context. We copy after the 4-week treatment period. Drug-related performed a comparative study on the relative efficacy of adverse effects, including gastrointestinal (GI) symptoms, DA-9601 and misoprostol for prevention of NSAID-asso- were also compared. At week 4, the gastric protection rates ciated complications. In this multicenter, double-blinded, with DA-9601 and misoprostol were 81.4 % (192/236) and active-controlled, stratified randomized, parallel group, 89.3 % (216/242), respectively. The difference between the non-inferiority trial, 520 patients who were to be treated groups was -14.2 %, indicating non-inferiority of DA- with an NSAID (aceclofenac, 100 mg, twice daily) over a 9601 to misoprostol. Adverse event rates were not different 4-week period were randomly assigned to groups for between the two groups; however, the total scores for GI coincidental treatment with DA-9601 (60 mg, thrice daily) symptoms before and after administration were signifi- (236 patients for full analysis) or misoprostol (200 lg, cantly lower in the DA-9601 group than in the misoprostol thrice daily) (242 patients for full analysis). A total of 236 group (-0.2 ± 2.8 vs 1.2 ± 3.2; p \ 0.0001). DA-9601 is patients received DA-9601 and 242 received misoprostol. as effective as misoprostol in preventing NSAID- O. Y. Lee J.-W. Cho Department of Internal Medicine, Hanyang University College Department of Internal Medicine, Presbyterian Medical Center, of Medicine, Seoul, South Korea Jeonju, South Korea D.-H. Kang J.-S. Rew Department of Internal Medicine, Pusan National University Department of Internal Medicine, Chonnam National University Yangsan Hospital, Busan, South Korea College of Medicine, Gwangju, South Korea D. H. Lee K.-M. Lee Department of Internal Medicine, Seoul National University Department of Internal Medicine, The Catholic University of Hospital of Bundang, Seongnam, South Korea Korea St.Vincent’s Hospital, Suwon, South Korea I.-K. Chung K. O. Kim Department of Internal Medicine, Soonchonhyang University Department of Internal Medicine, Gacheon University Gil Hospital Cheonan, Cheonan, South Korea Medical Center, Incheon, South Korea J.-Y. Jang M.-G. Choi Department of Internal Medicine, Kyung Hee University College Department of Internal Medicine, The Catholic University of of Medicine, Seoul, South Korea Korea Seoul St.Mary’s Hospital, Seoul, South Korea J.-I. Kim S.-W. Lee Department of Internal Medicine, The Catholic University of Department of Internal Medicine, Korea University Ansan Korea Yeouido St.Mary’s Hospital, Seoul, South Korea Hospital, Ansan, South Korea 123 A comparative study of DA-9601 1309 associated gastroduodenal complications, and has a supe- Table 1 Endoscopic scoring of gastric mucosal lesions rior adverse GI effect profile. Score Gastric mucosal lesion status Keywords DA-9601(StilenÒ) Á Misoprostol Á NSAID- 0 No visible lesions associated Á Gastroduodenal injury 1 Mucosal hemorrhages only 2 1 or 2 erosions 3 Numerous (3–10) areas of erosions Introduction 4 Large number ([10) of erosions 5 Ulcer Despite the various gastroduodenal complications associ- ated with non-steroidal anti-inflammatory drugs (NSAIDs), they remain a desirable treatment for patients with mus- be efficacious in preventing NSAID-associated gastroduo- culoskeletal pain or other inflammatory conditions. denal complications. Administration of misoprostol is NSAID-associated gastroduodenal complications include associated with side effects including diarrhea, nausea, and mild forms of gastropathy such as erosive gastritis and abdominal pain. Studies comparing misoprostol with a dyspepsia, in addition to more serious gastric or duodenal H2RA or PPI have reported lower compliance in the case of ulcers. Moreover, life-threatening gastrointestinal (GI) misoprostol, preventing accurate assessment of drug bleeding may be caused by chronic NSAID use (Garcı´a efficacy. Rodrı´guez and Jick 1994). These NSAID-associated gas- In addition to COX inhibition and resultant prostaglan- troduodenal complications are attributable to the depletion din depletion, NSAIDs may cause leukocyte recruitment of prostaglandin in the gastroduodenal mucosa, by inhibi- and generation of reactive oxygen species (ROS), which tion of cyclooxygenase (COX), which is known to play an may contribute towards gastroduodenal injury (Hussain essential role in maintaining mucosal integrity (Schoen and et al. 2012). Inhibiting the development of ROS using Vender 1989). Replenishment of prostaglandin with antioxidants, such as DA-9601, may therefore represent a misoprostol has, therefore, been used to prevent NSAID- different modality for prevention of NSAID-associated GI associated gastroduodenal complications (Silverstein et al. complications. DA-9601 (Stillen) is a phytopharmaceutical 1995). In comparison with a placebo, misoprostol was derived from Artemisia asiatica, which has antioxidative shown to significantly reduce the incidence of gastroduo- and anti-inflammatory actions in the context of experi- denal ulcers in chronic NSAID users (Graham et al. 2002; mentally induced GI mucosal damage (Kim et al. 2004). In Hawkey et al. 1998). former double-blinded cetraxate-controlled phase III clin- Because NSAID-associated gastroduodenal injury can ical studies, administration of DA-9601 was effective for be facilitated by low intragastric pH, antisecretory agents treatment of erosive gastritis of various etiologies, and was such as H2 receptor antagonists (H2RAs) and proton pump well tolerated. inhibitors (PPIs) are commonly prescribed to reduce the In a previous report, the preventive effect of DA-9601 risk of NSAID-associated gastroduodenal injury in patients and misoprostol on NSAID-associated gastroduodenal being treated with NSAIDs (Agrawal et al. 2000). injury was established in healthy volunteers using a ran- Administration of antisecretory agents is recommended for domized, double-blinded, multicenter study. DA-9601 was chronic NSAID users (Weaver and Gitlin 2002). When shown to not be inferior to misoprostol in terms of endo- compared with PPIs, misoprostol has been demonstrated to scopic gastroduodenal protection rates. The study also indicated that the side-effect profile of DA-9601 was S.-T. Lee superior to that of misoprostol (Lee et al. 2011). However, Department of Internal Medicine, Chonbuk National University compared with healthy volunteers, patients with arthritis Hospital, Jeonju, South Korea are more susceptible to developing NSAID-associated T.-O. Kim gastropathies (McCafferty et al. 1995; Kato and Takeuchi Department of Internal Medicine, Inje University Haeundae Paik 2002). Furthermore, the risk of development of a serious Hospital, Busan, South Korea NSAID-associated peptic ulcer is increased in the elderly Y.-W. Shin (Griffin et al. 1988, 1991; Hong et al. 2013). Department of Internal Medicine, Inha University Hospital, We, therefore, conducted a multicenter, double-blinded, Incheon, South Korea stratified randomized, active-controlled, parallel group, non-inferiority study to investigate whether DA-9601 is S.-Y. Seol (&) Department of Internal Medicine, Inje University Busan Paik comparable to misoprostol in reducing NSAID-associated Hospital, 75 Bokji-ro, Busanjin-gu, Busan 614-735, Korea gastroduodenal complications. Both drug efficacy and e-mail: [email protected] safety were assessed. 123 1310 O. Y. Lee et al. Materials and methods placebo, in order to maintain the double blind condition. The subjects visited each center for follow-up endoscopy at Study participants week 4. Eligible patients were 20–65 years of age, on a course of Study assessments NSAIDs for more than 4 weeks, experiencing pain due to rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, Efficacy frozen shoulders, toothache, trauma-associated inflamma- tion, lumbar pain, ischialgia, or nonarthritic rheumatism, Each subject underwent an upper GI endoscopy to establish and had normal baseline endoscopic findings with no ero- a baseline, and again after the 4-week treatment period. sion or ulcer (i.e., grading scores of 0–1 based on gastric The primary endpoint was the gastric mucosa protection mucosal lesions, irrespectively of duodenal mucosal rate at week 4, based on endoscopy scores ranging from 0 lesions) (Table 1). to 5 (0, no visible lesion; 1, mucosal hemorrhage only; 2, Exclusion criteria were a history of gastric or duodenal one or two erosions;
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