Safety and efficacy of sodium picosulfate, magnesium oxide, and citric acid bowel preparation in patients with baseline renal impairment or diabetes: subanalysis of a randomized, controlled trial

Gautam N Mankaney, Masakazu Ando, David N Dahdal, Carol A Burke, Gautam N Mankaney, Masakazu Ando, David N Dahdal, Carol A Burke

Abstract

Background: Selecting a bowel preparation for patients with renal impairment or diabetes requires special consideration. We aimed to describe the effect of baseline renal impairment or diabetes on the safety, efficacy, and tolerability of low-volume sodium picosulfate, magnesium oxide, and citric acid (SPMC) ready-to-drink oral solution bowel preparation.

Methods: A post hoc secondary analysis was performed from a randomized, assessor-blinded study of SPMC oral solution bowel preparation in participants with mild or moderate baseline renal impairment or diabetes. 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 ascending colon cleansing from the Boston Bowel Preparation Scale (BBPS), and selected results from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs), adenoma detection, and laboratory evaluations.

Results: Similar overall colon cleansing was demonstrated in the subgroups, with >85% of participants in any subgroup rated as responders by the AS, and >92% of participant responders by the BBPS. Most participants reported a tolerable bowel preparation, regardless of baseline renal impairment or diabetes history. Safety of SPMC oral solution was similar between all subgroups and the overall cohort. For the mild renal impairment, moderate renal impairment, and diabetes subgroups, respectively, commonly reported, drug-related AEs were nausea (2.6%, 5.3%, 1.4%) and headache (2.2%, 2.6%, 4.3%).

Conclusions: Ready-to-drink SPMC oral solution demonstrated efficacious colon cleansing in patients with baseline mild/moderate renal impairment or diabetes, with a tolerable bowel preparation reported by most.

Clinical trial registration: ClinicalTrials.gov identifier: NCT03017235.

Keywords: bowel cleansing; colon cleansing; colonoscopy; diabetes; renal impairment.

Conflict of interest statement

Conflict of interest statement: Dr Burke has received research support and consultant fees from Ferring Pharmaceuticals Inc. Dr Mankaney has received research support from Ferring Pharmaceuticals Inc. Drs Ando and Dahdal are employees of Ferring Pharmaceuticals Inc.

© The Author(s), 2021.

Figures

Figure 1.
Figure 1.
Colon-cleansing efficacy by AS and BBPS was consistent across renal impairment subgroups and the diabetes subgroup relative to the overall SPMC oral solution cohort. Participants considered responders by AS (shown in blue; rating of ‘excellent’ or ‘good’) or BBPS (shown in orange; rating of ‘3’ or ‘2’) were similar across subgroups. The overall cohort represents all participants in the randomized, controlled trial who received SPMC oral solution. AS, Aronchick Scale; BBPS, Boston Bowel Preparation Scale; SPMC, sodium picosulfate, magnesium oxide, and citric acid.
Figure 2.
Figure 2.
Participants in the renal and diabetes subgroups tolerated SPMC oral solution well, similarly to the overall cohort. Participants were asked ‘Was the bowel preparation tolerable?’ The overall cohort represents all participants in the randomized, controlled trial who received SPMC oral solution. SPMC, sodium picosulfate, magnesium oxide, and citric acid.
Figure 3.
Figure 3.
Adenoma detection rate (ADR) was above 28% for female subgroups and 33% for male subgroups. ADR was calculated as the percentage of participants who had at least one adenoma. The overall cohort represents all participants in the randomized, controlled trial who received SPMC oral solution. SPMC, sodium picosulfate, magnesium oxide, and citric acid.

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Source: PubMed

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