A prep is considered successful if it is good or excellent 3,4
- 97% agreement was seen between central and local readers4
SUTAB Split-Dose Regimen†
Excellent
Good
Fair
Poor
Efficacy
92%
of patients IN TWO PIVOTAL TRIALS achieved successful bowel cleansing with sutab3,4*
Study Design4: 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.
92%–95%
of patients IN ONE PIVOTAL
TRIAL achieved successful cleansing in all segments of the colon, including the proximal colon4
90%–96%
OF HARD-TO-PREP PATIENTS IN ONE PIVOTAL TRIAL ACHIEVED SUCCESSFUL CLEANSING4*
Subgroup of Patients (n=164)
| Hard-to-Prep Patients (n=115) | Successful Cleansing Rate |
Excellent Cleansing Rate |
|---|---|---|
|
History of constipation Opioid use Failed colonoscopy BMI ≥35 |
90% | 61% |
| Afternoon colonoscopy (n=49) | 96% | 74% |
- 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.
>98%
OF EXAMS REACHED THE CECUM IN ONE PIVOTAL TRIAL, WITH 97% DEEMED ADEQUATE
BY ENDOSCOPISTS4
Secondary Endpoints4
| Endpoint | SUTAB Result |
|---|---|
| Cecal intubation rate | 98% |
| Preparation adequacy | 97% |
| Procedure duration (median) | 13.5 minutes |
| Intraprocedural water volume (median) | 30 mL |
Recommended Cecal Intubation Rate: >95%
- US Multi-Society Task Force on Colorectal Cancer recommends a cecal intubation rate of at least 95% for screening colonoscopy and 90% for all colonoscopies6
- ASGE/ACG Task Force on Quality Indicators targets >85% adequate bowel preps to allow the use of recommended surveillance or screening intervals7
- Adenoma detection success rate was 33% in patients taking SUTAB (n=278)4
ACG=American College of Gastroenterology
ASGE=American Society for Gastrointestinal Endoscopy
IMPORTANT SAFETY INFORMATION
INDICATION
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.
CONTRAINDICATIONS
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. Each SUTAB bottle contains a desiccant. Remove and discard the desiccant from both bottles the evening prior to the colonoscopy. 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. Risk of Gastrointestinal Complications with Ingestion of Desiccant: Postmarketing reports of ingestion of the desiccant along with SUTAB tablets has been reported and may be associated with risk of gastrointestinal complications and/or choking.
ADVERSE REACTIONS
Most common gastrointestinal adverse reactions are: nausea, abdominal distension, vomiting, and upper abdominal pain.
DRUG INTERACTIONS
Drugs that increase risk of fluid and electrolyte imbalance.
View the Full Prescribing Information and Medication Guide.
References:
1. Data on file. Breakaway Partners, LLC.
2. IQVIA, National Prescription Audit Report. December 2023.
3. SUTAB [package insert]. Braintree, MA: Braintree Laboratories, Inc.
4. 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.
5. 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.
6. Rex DK, Boland CR, Dominitz JA, et al. Colorectal cancer screening: recommendations for physicians and patients from the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2017;112(7):1016-1030. doi:10.1038/ajg.2017.174.
7. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):
