Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial
2
조회
0
다운로드
4
인용
0
참고문헌
키워드
초록
Background/Aims: Polyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG. Methods: Patients undergoing colonoscopy were randomized (1:1:1) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per protocol set (PPS) analyses were performed. Results: Of the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS): total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008- 2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP- 008-2 83.2% vs 2LPEG 62.5%; p=0.005). Conclusions: TJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability.
Abstract
Background/Aims: Polyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG. Methods: Patients undergoing colonoscopy were randomized (1:1:1) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per protocol set (PPS) analyses were performed. Results: Of the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS): total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008- 2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP- 008-2 83.2% vs 2LPEG 62.5%; p=0.005). Conclusions: TJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability.
참고문헌 (23)
- Levin B, "Screening and surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008 : a joint guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology", Gastroenterology, 134, pp.1570~1595 (2008)
- Belsey J, "Systematic review : oral bowel preparation for colonoscopy", Aliment Pharmacol Ther, 25, pp.373~384 (2007)
- Menees SB, "The impact of bowel cleansing on follow-up recommendations in average-risk patients with a normal colonoscopy", Am J Gastroenterol, 109, pp.148~154 (2014)
- Hassan C, "Bowel preparation for colonoscopy : European Society of Gastrointestinal Endoscopy(ESGE)Guideline. Update 2019", Endoscopy, 51, pp.775~794 (2019)
- Clark BT, "High-quality bowel preparation is required for detection of sessile serrated polyps", Clin Gastroenterol Hepatol, 14, pp.1155~1162 (2016)
- Rex DK, "Serrated lesions of the colorectum : review and recommendations from an expert panel", Am J Gastroenterol, 107, pp.1315~1329 (2012)
- Bechtold ML, "Optimizing bowel preparation for colonoscopy : a guide to enhance quality of visualization", Ann Gastroenterol, 29, pp.137~146 (2016)
- Belsey J, "Meta-analysis : the relative efficacy of oral bowel preparations for colonoscopy 1985-2010", Aliment Pharmacol Ther, 35, pp.222~237 (2012)
- Ell C, "Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy", Am J Gastroenterol, 103, pp.883~893 (2008)
- Worthington J, "A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy", Curr Med Res Opin, 24, pp.481~488 (2008)
- Fayad NF, "Association between body mass index and quality of split bowel preparation", Clin Gastroenterol Hepatol, 11, pp.1478~1485 (2013)
- Halphen M, "Validation of the Harefield Cleansing Scale : a tool for the evaluation of bowel cleansing quality in both research and clinical practice", Gastrointest Endosc, 78, pp.121~131 (2013)
- Parmar R, "Validated scales for colon cleansing : a systematic review", Am J Gastroenterol, 111, pp.197~204 (2016)
- Bisschops R, "Colon cleansing efficacy and safety with 1 L NER1006 versus 2 L polyethylene glycol + ascorbate : a randomized phase 3 trial", Endoscopy, 51, pp.60~72 (2019)
- Schreiber S, "Colon cleansing efficacy and safety with 1 L NER1006 versus sodium picosulfate with magnesium citrate : a randomized phase 3trial", Endoscopy, 51, pp.73~84 (2019)
- Matro R, "Efficacy of morningonly compared with split-dose polyethylene glycol electrolyte solution for afternoon colonoscopy : a randomized controlled single-blind study", Am J Gastroenterol, 105, pp.1954~1961 (2010)
- Rex DK, "A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy", Gastrointest Endosc, 72, pp.328~336 (2010)
- Kaminski MF, "Performance measures for lower gastrointestinal endoscopy : a European Society of Gastrointestinal Endoscopy(ESGE)Quality Improvement Initiative", Endoscopy, 49, pp.378~397 (2017)
- Corley DA, "Adenoma detection rate and risk of colorectal cancer and death", N Engl J Med, 370, pp.1298~1306 (2014)
- Kaminski MF, "Increased rate of adenoma detection associates with reduced risk of colorectal cancer and death", Gastroenterology, 153, pp.98~105 (2017)
- Lasisi F, "Improving protection against proximal colon cancer by colonoscopy", Expert Rev Gastroenterol Hepatol, 5, pp.745~754 (2011)
- Pontone S, "Multiple, zonal and multi-zone adenoma detection rates according to quality of cleansing during colonoscopy", United European Gastroenterol J, 4, pp.778~783 (2016)
- Adamcewicz M, "Mechanism of action and toxicities of purgatives used for colonoscopy preparation", Expert Opin Drug Metab Toxicol, 7, pp.89~101 (2011)