Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study

Lawrence Hookey, Gerald Bertiger, Kenneth Lee Johnson 2nd, Mena Boules, Masakazu Ando, David N Dahdal, Lawrence Hookey, Gerald Bertiger, Kenneth Lee Johnson 2nd, Mena Boules, Masakazu Ando, David N Dahdal

Abstract

Background: We performed a post hoc secondary analysis for the effect of body mass index (BMI) on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation.

Methods: A phase III, randomized, assessor-blinded, multicenter, noninferiority study was conducted comparing split-dose, low-volume SPMC oral solution with a powder formulation for oral solution. A post hoc secondary analysis assessed efficacy, safety, and tolerability of SPMC oral solution stratified by BMI. BMI was classified by Centers for Disease Control and Prevention definitions (underweight and normal weight: BMI < 25 kg/m2; overweight: BMI 25-29.9 kg/m2; class I obesity: BMI 30-34.9 kg/m2; class II obesity: BMI 35-39.9 kg/m2; class III/severe obesity: BMI ⩾40 kg/m2). Prespecified primary efficacy endpoint ('responders') was the proportion of participants with 'excellent' or 'good' ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations.

Results: Between 82.8% and 92.5% of participants in any BMI group were responders by AS, and between 91.3% and 100% were responders by BBPS in the right colon. Efficacy was consistent across BMI groups, with no clear trends. Greater than 83% of participants in any BMI group found the preparation 'easy' or 'acceptable' to ingest, and the majority (>58%) rated SPMC oral solution as 'better' than a prior bowel preparation. In all BMI groups, safety data were similar to the overall cohort. Commonly reported, drug-related, treatment-emergent AEs were, by ascending BMI group, nausea (1.1%, 5.3%, 1.0%, 5.7%, and 0%) and headache (1.1%, 4.1%, 1.0%, 5.7%, and 0%).

Conclusions: Ready-to-drink SPMC oral solution had consistent, good quality colon cleansing, and favorable tolerability among participants of all BMI groups.

Clinicaltrialsgov registration: NCT03017235.

Keywords: BMI; bowel preparation; colon cleansing; inadequate bowel preparation; obesity; oral solution; overweight; screening colonoscopy.

Conflict of interest statement

Conflict of interest statement: LH has participated in the speaker’s bureau for Ferring Pharmaceuticals Inc. GB was an investigator for clinical trials sponsored by Ferring Pharmaceuticals Inc. and has served as a consultant and has participated in the speaker’s bureau for Ferring Pharmaceuticals Inc. KLJ is an investigator on clinical trials sponsored by Ferring Pharmaceuticals Inc. MB, MA, and DND are employees of Ferring Pharmaceuticals Inc.

© The Author(s), 2020.

Figures

Figure 1.
Figure 1.
In the SPMC oral solution treatment arm, a substantial majority of participants in each BMI group were responders on the modified AS, rated by a treatment-blinded endoscopist. Likewise, at least 87% of participants had a BBPS score of 2 or better in all 3 colon segments. The efficacy ratings were consistent across BMI groups. AS, Aronchick scale; BBPS, Boston Bowel Preparation Scale, BMI, body mass index; SPMC, sodium picosulfate, magnesium oxide, and citric acid.
Figure 2.
Figure 2.
Participants were asked ‘Was the bowel preparation tolerable?’ on the Mayo Clinic Bowel Prep Tolerability Questionnaire. At least 83% of participants in each BMI group indicated that SPMC oral solution was ‘easy’ or ‘acceptable’ to ingest. BMI, body mass index; SPMC, sodium picosulfate, magnesium oxide, and citric acid.
Figure 3.
Figure 3.
Participants who had experience with a prior colonoscopy (51–64% of each BMI cohort) were asked to rate the tolerability of the study bowel preparation compared with the previous preparation. The majority of participants rated SPMC oral solution bowel preparation as ‘better’ than a previous preparation. No consistent trend of responses was seen across BMI groups. Participants with no response are not shown on the graph and, therefore, numbers may not add to 100%. BMI, body mass index; SPMC, sodium picosulfate, magnesium oxide, and citric acid.
Figure 4.
Figure 4.
The PDR varied by BMI, with no consistent trend. ADR was above the guideline-recommended target for all BMI groups. Any polyps found during the colonoscopy were removed, recorded as AEs, and sent for histological analysis. PDR and ADR were calculated as the percentage of any participants who had at least one polyp or adenoma, respectively. ADR, adenoma detection rate; AE, adverse event; BMI, body mass index; PDR, polyp detection rate.

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