Publications : 2018

Sacks NC, Sharma A, Cyr PL, Bertiger G, Dahdal DN, Brogadir S. 2018. Real-world evidence comparison of the efficacy and safety of different bowel preparation agents in a high-risk population. Gastroenterol 154(6) S632-S633; doi: 10.1016/S0016-5085(18)32266-2.

Abstract

Background: Individuals with inflammatory bowel disease (IBD) require regular screening colonoscopy. The tolerability of bowel preparation agents may deter these individuals fromcompleting the screenings as needed, which may have negative consequences for long-termdisease management. Aims: To evaluate rates of incomplete screening colonoscopies, repeat screenings, and adverse events of various bowel preparation agents in patients with IBD in a real-world setting. Methods: Data from the Truven Health Analytics Commercial and Medicare Supplemental MarketScan databases were extracted for patients who had at least one screening colonoscopy between July 1, 2012 – June 30, 2015, were $18 years of age, could be observed in the database $6 months before and $3 months after the index screening (first screening colonoscopy in the study period), and had a confirmed diagnosis of IBD (identified by ICD-9-CM diagnosis codes for Crohn’s disease or ulcerative colitis). Data were stratified by bowel preparation class, including over-the-counter (OTC), low volume (LV), high volume (HV) and other prescription agents. The proportions of individuals with an incomplete screening (identified by screening colonoscopy claim with modifier code 22, 52, 53, 73, or 74), repeat screening within 30 or 90 days of the index event (a measure of bowel preparation tolerability), or hospitalization for hyponatremia (ICD-9 codes: 276.0, 276.1) or dehydration (ICD-9 codes: 276.50, 276.51, 276.52) within 10 days of the index event were reported. Multivariate logistic regression was conducted, adjusting for age, sex, illness burden, and medication use. Results: Of 125,981 individuals with IBD, 58.9% used an OTC agent, 2.9% used sodium picosulfate, magnesium oxide, and citric acid (P/MC), 28.5% used another LV agent, and 7.9% an HV prescription agent. Mean age was 50.0 years, and 55.7% were female. P/MC had a lower rate of incomplete screening (0.74%) than LV, HV, and OTC agents (1.35%, 1.35%, and 1.50%, respectively) (Table 1). P/MC patients had significantly lower odds of incomplete screening than patients using LV, HV, or OTC agents (0.54, 0.48, 0.55, respectively; all P<0.01). Patients using P/MC who had an incomplete screening had 2.3 to 3.1 times the odds of returning for repeat screening compared to patients using other agents, though these results did not achieve statistical significance. There were no reports of hospitalizations due to hyponatremia or dehydration in the P/MC group and 1 hospitalization with one other LV agent. Use of an OTC bowel preparation was associated with higher rates of hospitalization. Tests of significance were not conducted because there were no hospitalizations for P/MC. Conclusions: P/MC was associated with lower rates of incomplete colonoscopy in individuals with IBD. The safety profile of P/MC was comparable to other prescription agents.