Efficacy

REX 20105: 98% “GOOD” OR “EXCELLENT” CLEANSING5*†

  • Excellent
  • Good
  • Fair
percentage

Results from Rex 2010

  • 71% of patients receiving SUPREP had “excellent” bowel cleansing5

    Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies7

  • >90% of patients had no residual stool in all colon segments5
*Based on investigator grading. This clinical trial was not included in the product labeling. SUPREP Bowel Prep Kit has been FDA approved as a split-dose oral regimen.

Di PALMA 20093: 97% “GOOD” OR “EXCELLENT” CLEANSING3*

  • Excellent
  • Good
  • Fair
  • Poor
percentage

Results from Di Palma 2009

  • 63% of patients receiving SUPREP had “excellent” bowel cleansing3*

    Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies7

  • A high percentage of elderly patients (≥65 years of age) had successful cleansing (”good” or “excellent”) with SUPREP3
  • The degree of cleansing was the same between the two split-dose preparations3
A prep is considered successful if it is “good” or “excellent”3
*Based on investigator grading. SUPREP Bowel Prep Kit has been FDA approved as a split-dose oral regimen.

REX 20144: 94% “GOOD” OR “EXCELLENT” CLEANSING4*†¶#

  • Excellent
  • Good
  • Fair
  • Poor
percentage

Results from Rex 2014

  • 54% of patients receiving SUPREP had “excellent” bowel cleansing4

    Aligned with Gastrointestinal Quality Improvement Consortium (GIQuIC) performance target of ≥85% quality cleansing for outpatient colonoscopies7

  • Segmental evaluation also demonstrated ≥77% absence of residual stool in all five colon segments4
  • Protocol for the split-dose comparator was amended shortly after the study began to reflect comparator’s approved label4
*Based on investigator grading. This clinical trial was not included in the product labeling. SUPREP Bowel Prep Kit has been FDA approved as a split-dose oral regimen. Failures included those patients who were discontinued because additional preparation was required to attempt colonoscopy. #One patient was excluded as nonevaluable for efficacy analysis.

INTRAPROCEDURAL ASSESSMENTS FOR SUPREP4†

  • There were no statistically significant differences between SUPREP Bowel Prep Kit and the comparator in lesion detection rates4†

    This clinical trial was not included in the product labeling.

SUPREP (%)4†
Irrigation water volume, mL
54.2
Procedure duration, min
16.5 (7)
Polyp detection rate, %
50.9
Adenoma detection rate, %
26.0
Flat lesion detection rate, %
9.5

COMPETITIVE STUDY FINDINGS

MiraLAX§ (polyethylene glycol 3350) and a sports drink such as Gatorade®|| (PEG-SD) were compared to SUPREP®8

Results related to stool quality8
  • PEG-SD produced smaller stool volumes and higher residual stool solids than SUPREP8
  • Patients receiving PEG-SD absorbed more water. Gastric absorption of water poses a higher risk of hypervolemia8
graph

Summary8

  • Onset of bowel movements was twice as fast with SUPREP—40 minutes versus 83 minutes with PEG-SD8
  • PEG-SD lower stool output poses a risk of suboptimal bowel cleansing8

Results related to electrolyte imbalance8

  • PEG-SD patients lost statistically significant electrolyte levels, especially sodium, increasing the risk of hyponatremia8
chart

Negative value, loss; positive value, gain; SD, standard deviation.

Summary8

  • PEG-SD electrolyte imbalances pose a higher risk of hyponatremia8

§MiraLAX is a registered trademark of Bayer AG. ||Gatorade is a registered trademark of PepsiCo.

IMPORTANT SAFETY INFORMATION

SUPREP® Bowel Prep Kit (sodium sulfate, potassium sulfate and magnesium sulfate) Oral Solution is an osmotic laxative indicated for cleansing of the colon as a preparation for colonoscopy in adults. Most common adverse reactions (>2%) are overall discomfort, abdominal distention, abdominal pain, nausea, vomiting and headache.

Use is contraindicated in the following conditions: gastrointestinal (GI) obstruction, bowel perforation, toxic colitis and toxic megacolon, gastric retention, ileus, known allergies to components of the kit. Use caution when prescribing for patients with a history of seizures, arrhythmias, impaired gag reflex, regurgitation or aspiration, severe active ulcerative colitis, impaired renal function or patients taking medications that may affect renal function or electrolytes. Use can cause temporary elevations in uric acid. Uric acid fluctuations in patients with gout may precipitate an acute flare. Administration of osmotic laxative products may produce mucosal aphthous ulcerations, and there have been reports of more serious cases of ischemic colitis requiring hospitalization. Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes. Advise all patients to hydrate adequately before, during, and after use. Each bottle must be diluted with water to a final volume of 16 ounces and ingestion of additional water as recommended is important to patient tolerance.

View the Full Prescribing Information and Medication Guide.

References: 1. IQVIA. National Prescription Audit Report. June 2019. 2. SUPREP Bowel Prep Kit [package insert]. Braintree, MA: Braintree Laboratories, Inc; 2017. 3. Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume, oral sulfate colon-cleansing preparation for colonoscopy. Am J Gastroenterol. 2009;104(9):2275-2284. 4. Rex DK, Di Palma JA, McGowan J, Cleveland M. A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy. Gastrointest Endosc. 2014;80(6):1113-1123. 5. Rex DK, Di Palma JA, McGowan J, Cleveland M. 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. 6. Rex DK, Johnson DA, Anderson JC, Schoenfeld PS, Burke CA, Inadomi JM; American College of Gastroenterology. American College of Gastroenterology guidelines for colorectal cancer screening 2009 [corrected]. Am J Gastroenterol. 2009;104(3):739-750. 7. Rex DK, Schoenfeld PS, Cohen J, et al. Quality indicators for colonoscopy. Gastrointest Endosc. 2015;81(1):31-53. 8. Cleveland M, Zamora C, Pelham R. PEG-sports drink bowel prep: physiology of electrolyte imbalance. Poster presented at: American College of Gastroenterology Annual Meeting; October 16-21, 2015; Honolulu, Hawaii. Abstract 1482. 9. Patel V, Nicar M, Emmett M, et al. Intestinal and renal effects of low-volume phosphate and sulfate cathartic solutions designed for cleansing the colon: pathophysiological studies in five normal subjects. Am J Gastroenterol. 2009;104(4):953-965. 10. Pelham RW, Alcorn H Jr, Cleveland M. A pharmacokinetics evaluation of a new, low-volume, oral sulfate colon cleansing preparation in patients with renal or hepatic impairment and healthy volunteers. J Clin Pharmacol. 2010;50(3):350-354. 11. Plenvu [package insert]. Amsterdam, the Netherlands: Norgrine B.V.; 2018. 12. Clenpiq [package insert]. Parsippany, NJ: Ferring Pharmaceuticals Inc; 2018. 13. 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. 14. Data on file. Braintree Laboratories, Inc. Braintree, MA.