A Comparative Study of Treatment-Emergent Adverse Events Following Use of Common Bowel Preparations Among a Colonoscopy Screening Population: Results from a Post-Marketing Observational Study.
Colonoscopy may be one of the most frequent elective procedures in older adults and is associated with a low occurrence of complications. However, reduction of risks attributable to the bowel preparation may be achieved with the use of effective and safer products.



The aim of this study was to examine the incidence of treatment-emergent adverse events (TEAEs) associated with SUPREP(®) [oral sulfate solution (OSS)] and other common prescription bowel preparations (non-OSS).



This real-world, observational study used de-identified health insurance claims and laboratory results to identify TEAEs in the 3 months following screening colonoscopy in adults with a prescription for a bowel preparation in the prior 60 days. The unadjusted and adjusted (controlling for patient risk factors) cumulative incidences of TEAEs were estimated using Kaplan-Meier and Poisson regression, respectively.



Among patients ≥45 years, the overall cumulative incidence was significantly lower (p < 0.001) in the OSS cohort than in the non-OSS cohort (unadjusted: 2.31 vs. 2.89 %; adjusted: 1.61 vs. 1.95 %), with significantly lower acute cardiac conditions (1.56 vs. 1.90 %; p < 0.001), renal failure/other serious renal diseases (OSS: 0.21 %, non-OSS: 0.32 %; p < 0.001), and serum electrolyte abnormalities (OSS: 0.39 %, non-OSS: 0.49 %; p = 0.017). There were no significant differences between cohorts in death, seizure disorders, aggravation of gout, and ischemic colitis. Results were similar in the adjusted cumulative incidences.



In actual use, the overall cumulative incidence of TEAEs was significantly lower in the OSS cohort, demonstrating that OSS is as safe as, or possibly safer than, non-OSS prescription bowel preparations.
Health Economics and Outcomes Research, Covance Market Access Services Inc., Gaithersburg, MD, USA.
Kathryn
K
Anastassopoulos
Section of Gastroenterology, Boston Medical Center, Boston University School of Medicine, Boston, MA, USA.
Francis A
FA
Farraye
Health Economics and Outcomes Research, Covance Market Access Services Inc., Gaithersburg, MD, USA.
Tyler
T
Knight
Health Economics and Outcomes Research, Covance Market Access Services Inc., Gaithersburg, MD, USA.
Sam
S
Colman
Braintree Laboratories Inc., Braintree, MA, USA.
Mark vB
MV
Cleveland
Braintree Laboratories Inc., Braintree, MA, USA. RPelham@braintreelabs.com.
Russell W
RW
Pelham
D058186:Acute Kidney Injury / Q000139:chemically induced* / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D001145:Arrhythmias, Cardiac / Q000139:chemically induced* / Q000453:epidemiology; D002400:Cathartics / Q000009:adverse effects*; D017091:Colitis, Ischemic / Q000139:chemically induced / Q000453:epidemiology; D003113:Colonoscopy; D015179:Colorectal Neoplasms / Q000175:diagnosis; D055088:Early Detection of Cancer; D004573:Electrolytes / Q000009:adverse effects*; D006073:Gout / Q000139:chemically induced / Q000453:epidemiology; D006331:Heart Diseases / Q000139:chemically induced / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D007674:Kidney Diseases / Q000139:chemically induced / Q000453:epidemiology; D008875:Middle Aged; D010710:Phosphates / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D012640:Seizures / Q000139:chemically induced / Q000453:epidemiology; D013431:Sulfates / Q000009:adverse effects; D014883:Water-Electrolyte Imbalance / Q000139:chemically induced* / Q000453:epidemiology; D055815:Young Adult
D002400:Cathartics; D004573:Electrolytes; C033608:Golytely; C520497:MoviPrep; D010710:Phosphates; D013431:Sulfates; D011092:Polyethylene Glycols; C018279:sodium phosphate
Adverse event; Bowel preparation; Colonoscopy