of patients IN TWO PIVOTAL TRIALS achieved successful bowel cleansing with sutab1,2*
A prep is considered successful if it is good or excellent 1,2
97% agreement was seen between central and local readers2
SUTAB Split-Dose Regimen†
Study Design2: Study 1 was a phase 3 trial that was conducted in 22 US sites. Of the 620 subjects who enrolled, 548 patients were evaluable for efficacy analyses. The primary endpoint was the percentage of subjects with successful cleansing, which was based on the US FDA Bowel Prep Scoring Scale, the goal of which was to determine non-inferiority against MoviPrep®. Safety follow-up visits were required 24-48 hours after colonoscopy and on days 7 and 30 if adverse events or lab abnormalities were indicated. A subset of colonoscopies was
graded by central readers (exploratory). The primary endpoint of non-inferiority was met.
*Success was the primary efficacy endpoint and defined in non-inferiority trials as an overall cleansing assessment of 3 (good) or 4 (excellent) by the blinded endoscopist; scores were assigned following completion of the colonoscopy.
†Two patients (0.7%) were unable to complete their preparation and are included as missing.
MoviPrep is a registered trademark of Velinor AG.
of patients IN ONE PIVOTAL
TRIAL achieved successful cleansing in all segments of the colon, including the proximal colon2
OF HARD-TO-PREP PATIENTS IN ONE PIVOTAL TRIAL ACHIEVED SUCCESSFUL CLEANSING2*
Subgroup of Patients (n=164)
Hard-to-Prep Patients (n=115)
History of constipation
Afternoon colonoscopy (n=49)
A subgroup of patients with known predictors of suboptimal preparation were analyzed
Hard-to-prep patients included those with history of constipation, current opioid users, BMI ≥35,
those who failed previous preparation; and those who had a planned afternoon colonoscopy
SUTAB achieved high rates of success in both subgroups
BMI=body mass index
*Success was defined as cleansing graded either excellent or good.
OF EXAMS REACHED THE CECUM IN ONE PIVOTAL TRIAL, WITH 97% DEEMED ADEQUATE
Cecal intubation rate
Procedure duration (median)
Intraprocedural water volume (median)
Adenoma detection success rate was 33% in patients taking SUTAB (n=278)2
ASGE/ACG Task Force on Quality Indicators targets ≥85% adequate bowel preps to allow
the use of recommended surveillance or screening intervals4
ACG=American College of Gastroenterology
ASGE=American Society for Gastrointestinal Endoscopy
IMPORTANT SAFETY INFORMATION
SUTAB® (sodium sulfate, magnesium sulfate, potassium chloride) tablets for oral use is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults.
Use is contraindicated in the following conditions: gastrointestinal obstruction or ileus, bowel perforation, toxic colitis or toxic megacolon, gastric retention, hypersensitivity to any ingredient in SUTAB.
DOSAGE AND ADMINISTRATION
A low residue breakfast may be consumed. After breakfast, only clear liquids may be consumed until after the colonoscopy. Administration of two doses of SUTAB (24 tablets) are required for a complete preparation for colonoscopy. Twelve (12) tablets are equivalent to one dose. Water must be consumed with each dose of SUTAB and additional water must be consumed after each dose. Complete all SUTAB tablets and required water at least 2 hours before colonoscopy.
WARNINGS AND PRECAUTIONS Risk of fluid and electrolyte abnormalities: Encourage adequate hydration, assess concurrent medications and consider laboratory assessments prior to and after each use; Cardiac arrhythmias: Consider pre-dose and post-colonoscopy ECGs in patients at increased risk; Seizures: Use caution in patients with a history of seizures and patients at increased risk of seizures, including medications that lower the seizure threshold; Patients with renal impairment or taking concomitant medications that affect renal function: Use caution, ensure adequate hydration and consider laboratory testing; Colonic mucosal ulcerations: Consider potential for mucosal ulcerations when interpreting colonoscopy findings in patients with known or suspected inflammatory bowel disease. Suspected GI obstruction or perforation: Rule out the diagnosis before administration. Hypersensitivity reactions, including anaphylaxis: Inform patients to seek immediate medical care if symptoms occur.
Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting, and upper abdominal pain.
Drugs that increase risk of fluid and electrolyte imbalance.
References: 1. SUTAB® [package insert]. Braintree, MA: Braintree Laboratories, Inc.
2. Di Palma JA, Bhandari R, Cleveland M, et al. A safety and efficacy comparison of a new sulfate-based tablet bowel preparation versus a PEG and ascorbate comparator in adult subjects undergoing colonoscopy. Am J Gastroenterol. 2021;116(2):319-328. doi: 10.14309/ajg.0000000000001020.
3. Rex DK, Johnson DA, Anderson JC, et al; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750.
4. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53.
5. Data on file. Braintree Laboratories, Inc. Braintree, MA.
6. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc.
7. Plenvu [package insert]. Bridgewater, NJ: Bausch Health LLC.
8. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals, Inc.
9. Rex DK, Di Palma JA, Rodriguez R, et al. 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. 2010;72(2):328-336.
10. Matro R, Daskalakis C, Negoianu D, et al. Randomised clinical trial: polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy – the incidence of hyponatraemia. Aliment Pharmacol Ther. 2014;40(6):610-619.