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Ready-to-drink Solution Superior to Powder for Colonoscopy Bowel Prep
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WASHINGTON — Clenpiq showed efficacy and safety for patients who undergo colonoscopy, according to research presented at Digestive Disease Week. Additionally, study data revealed the ready-to-drink solution was superior to a powder solution.
“Many patients see colonoscopies as an ordeal they must endure for their overall health,” Lawrence Hookey, MD, of the department of medicine at Queen’s University in Ontario, Canada, said in a press release. “An effective bowel preparation is essential for a successful screening colonoscopy.”
Hookey and colleagues conducted a phase 3, randomized, assessor-blind study to test the non-inferiority and safety of split-dose Clenpiq (sodium picosulfate, magnesium oxide, and citric acid oral solution [SPMC oral solution], Ferring Pharmaceuticals) to a powder solution (P/MC) for colon cleansing in adults.
Investigators randomly assigned 901 patients to receive either the ready-to-drink SPMC oral solution (n = 448) or P/MC powder (n = 453). They assessed overall colon cleansing using the Aronchick scale, and they based efficacy on the proportion of patients with “excellent” or “good” ratings.
The efficacy rate of SPMC oral solution was 87.7% (95% CI, 84.3–90.6), and for P/MC powder it was 81.5% (95% CI, 77.6–84.9; P = .0067).
Regarding safety, no deaths or serious treatment emergent adverse events related to the drug were reported. The adverse event rate for the SPMC solution was 13.2% compared with 16.8% for P/MC powder.
Hookey said their findings showed that the SPMC solution is not only non-inferior to P/MC powder, but superior.
“The data from this study confirm the efficacy of a ready-to-drink treatment option that can help adult patients prepare for their colonoscopy,” he said.
The FDA approved Clenpiq for colonoscopy preparation in December 2017, and it is currently available by prescription. - by Alex Young
Reference:
Hookey L, et al. Poster Tu2010. Presented at: Digestive Disease Week; June 2-5, 2018; Washington, D.C.
Disclosures: Hookey reports financial ties to Ferring Pharmaceuticals and Pentax Medical. Please see the DDW faculty disclosure index for a list of all other authors’ relevant financial disclosures.
Perspective
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Carol Burke, MD
The key to the effectiveness of colonoscopy is the ability to detect and remove colon polyps. Adequate colon cleansing is a requisite for adenoma and sessile serrated polyp detection. Unfortunately, a patient barrier to colonoscopy is the fear or intolerability of large volume and poor tasting bowel cleansing agents. Over the last decade the taste of bowel cleansing agents has improved and the effectiveness of less than 4 L bowel purgatives has been shown. The U.S. Multi-Society Task Force on Colorectal Cancer and the European Society of Gastrointestinal Endoscopy have consistent statements on the proper dosing of bowel preparation to attain high quality colon cleansing – split the dose of the bowel preparation. That means having patients ingest at least 50% of the bowel preparation on the day of the exam to clean the right colon from bile stained residue. Right colon cleansing is paramount to high quality colonoscopy as the right colon is the area in the colon where sessile serrated polyps, flat adenomas and interval cancers are likely to occur. The trial by Hookey, et al, demonstrated the premixed, ready to drink formulation (SPMC) was non-inferior to the mix-your-own powder version (PMC powder) of the prep in terms of overall colon cleansing. On the Aronchik cleansing scale, only 4% of patients in the premixed arm had an inadequate prep vs. 10% in the mix-your-own arm. Excellent right colon cleansing as identified as Boston Bowel Preparation Scale of 3 was noted in 51.6% and 44.4% of the SPMC arm and PMC powder arm, respectively. As an endoscopist, I would like to have over 90% of my patients having a squeaky-clean right colon and thus more work needs to be done to attain that level of right colon cleanliness.
Reference: Johnson DA, et al. Am J Gastroenterol 2014;109:1528-45.
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