Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study

Abstract

Background: The incidence and mortality of colorectal cancer (CRC) increase with age and, therefore, it is recommended that adults undergo regular CRC screening, ideally by colonoscopy, with some new guidelines recommending screening begin at 45 years. Effective bowel preparation is a critical step to a successful colonoscopy. Of concern is that older adults may have poorer quality of bowel preparation or reduced tolerability for the bowel preparation. Here, we performed a post hoc secondary analysis for the effect of age 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, non-inferiority study was conducted comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A post hoc secondary analysis was performed to assess efficacy, safety, and tolerability of SPMC oral solution by age group (<50 years, 50-64 years, ⩾65 years). The 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: Within age groups, at least 83.9% of participants were responders by the AS, and at least 91.1% of participants were responders by the BBPS in the right colon. On both scales, responder rates were highest in the youngest age group and decreased with increasing age. Greater than 88% of participants in any age group found the preparation 'easy' or 'acceptable' to ingest, with rates of 'easy' being highest in the oldest age group. No new safety signals were seen in any age group. The most commonly reported drug-related, treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%).

Conclusion: Ready-to-drink SPMC oral solution showed good efficacy of overall colon cleansing and tolerability in adults across different age groups, including those ⩾65 years.ClinicalTrials.gov identifier: NCT03017235.

Keywords: bowel preparation; colon cleansing; elderly; inadequate bowel preparation; older adults; oral solution; screening colonoscopy.

Conflict of interest statement

Conflict of interest statement: Dr Hookey has participated in the speaker’s bureau for Ferring Pharmaceuticals Inc. Dr Bertiger 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. Dr Johnson was an investigator on clinical trials sponsored by Ferring Pharmaceuticals Inc. Drs Boules, Ando, and Dahdal are employees of Ferring Pharmaceuticals Inc.

© The Author(s), 2020.

Figures

Figure 1.

Rates of participants who were responders by the modified AS or had a BBPS score of ‘2’ or ‘3’ in all three colon segments. Numerically, the rates were highest in the youngest age group and lowest in the oldest group. Colon cleansing was rated by an endoscopist blinded to the treatment group. AS, Aronchick scale; BBPS, Boston Bowel Preparation Scale; SPMC, sodium picosulfate, magnesium oxide, and citric acid.

Figure 2.

Participant tolerability by age group. Participants were asked, ‘Was the bowel preparation tolerable?’ on the Mayo Clinic Bowel Prep Tolerability Questionnaire. At least 88% of the participants in each age group of the SPMC oral solution arm reported it was ‘easy’ or ‘acceptable’ to ingest, with ‘easy’ rates increasing with age. SPMC, sodium picosulfate, magnesium oxide, and citric acid.

Figure 3.

Tolerability of SPMC oral solution compared with a previous preparation. Most participants who had experience with a prior colonoscopy rated SPMC oral solution as ‘better’ than the previous preparation, especially in the youngest group. As expected, the highest rates of prior colonoscopy experience were in the oldest age group and lowest rates of experience were in the youngest age group. Participants with no response are not shown on the graph and, therefore, numbers may not total 100%. SPMC, sodium picosulfate, magnesium oxide, and citric acid.

Figure 4.

Rates of polyp detection and adenoma detection versusage group for participants receiving SPMC oral solution. PDR and ADR increased with increasing age group for those who received SPMC oral solution. ADR was above guideline-recommended target for the relevant age groups, 50–64 years and ⩾65 years. Any polyps found during the colonoscopy were removed, recorded as adverse events, and sent for histological analysis. PDR and ADR were calculated as the percentage of participants who had at least one polyp or adenoma, respectively. ADR, adenoma detection rate; PDR, polyp detection rate; SPMC, sodium picosulfate, magnesium oxide, and citric acid.