Lactulose oral solution is suitable for bowel preparation before colonoscopy in elderly patients with chronic constipation

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.

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Bowel Preparation Is Associated with Reduced Morbidity in Elderly Patients Undergoing Elective Colectomy

Journal of Gastrointestinal Surgery ◽

10.1007/s11605-016-3314-9 ◽

2016 ◽

Vol 21 (2) ◽

pp. 372-379 ◽

Cited By ~ 19

Author(s):

Scott C. Dolejs ◽

Michael J. Guzman ◽

Alyssa D. Fajardo ◽

Bruce W. Robb ◽

Bryan K. Holcomb ◽

...

Keyword(s):

Elderly Patients ◽

Bowel Preparation ◽

Elective Colectomy

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The Efficacy of Short-Duration Polyethylene Glycol plus Electrolytes for Improving Bowel Preparation of Colonoscopy in Patients with Chronic Constipation

Gastroenterology Research and Practice ◽

10.1155/2020/8886073 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Naohisa Yoshida ◽

Yoshikazu Inagaki ◽

Kohei Fukumoto ◽

Hiroyuki Yoriki ◽

Yutaka Inada ◽

...

Keyword(s):

Polyethylene Glycol ◽

Adverse Events ◽

Short Duration ◽

Bowel Preparation ◽

Chronic Constipation ◽

Performance Status ◽

Stool Consistency ◽

Related Factors ◽

Improvement Rate ◽

Bowel Movements

Backgrounds and Aims. Sachets of polyethylene glycol plus electrolytes (PEG+E: Movicol: EA Pharma, Tokyo, Japan) are used for chronic constipation, and its efficacy is reported only for female and nonelderly people. Chronic constipation is one of the reasons of poor colonoscopic bowel preparation (BP). We analyzed its efficacy in improving chronic constipation and poor colonoscopic BP related to it, including male and elderly people. Materials and Methods. This multicenter retrospective study was conducted from September 2019 to September 2020 at 5 related institutions among patients ≥ 20 years old diagnosed with chronic constipation whose previous colonoscopic BP had had a fair or poor Aronchick score. Two or four sachets of PEG+E (13.7 or 27.4 g/day) were prescribed for 1 week before colonoscopy. We analyzed the rate of improvement in BP, effect-related factors, spontaneous bowel movements (SBMs), stool consistency, improvement of constipation symptoms, and adverse events. Results. We evaluated 106 cases (56 males) with an average age of 69.5 ± 9.4 years old (≤74 years old: 68 cases, ≥75 years old: 38 cases). The improvement rate of BP was 72.6%, and the insertion time and pain score also improved. A performance status of 1 or 2 was associated with poor BP. SBMs (times/week) increased from 4.0 ± 1.9 to 6.1 ± 2.6 ( p < 0.001 ). The overall improvement rates of SBMs, stool consistency, symptoms of constipation, and rate of adverse events were 58.5%, 90.6%, 59.4%, and 6.6%, respectively, showing no significant differences with regard to age or gender. Conclusions. Short-duration PEG+E was effective for improving poor BP and chronic constipation.

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Sa1721 DISORDERED DEFECATION ASSOCIATED WITH POOR BOWEL PREPARATION IN PATIENTS WITH CHRONIC CONSTIPATION

Gastroenterology ◽

10.1016/s0016-5085(20)31683-8 ◽

2020 ◽

Vol 158 (6) ◽

pp. S-397

Author(s):

Mythili P. Pathipati ◽

Casey J. Silvernale ◽

Kenneth Barshop ◽

Kyle Staller

Keyword(s):

Bowel Preparation ◽

Chronic Constipation

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Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284819851510 ◽

2019 ◽

Vol 12 ◽

pp. 175628481985151 ◽

Cited By ~ 5

Author(s):

Lawrence Hookey ◽

Gerald Bertiger ◽

Kenneth Lee Johnson ◽

Julia Ayala ◽

Yodit Seifu ◽

...

Keyword(s):

Adverse Events ◽

Bowel Preparation ◽

Oral Solution ◽

Right Colon ◽

Split Dose ◽

Colon Cleansing ◽

Randomized Controlled ◽

Secondary Efficacy Endpoint ◽

Sodium Picosulfate ◽

The Right

Background: We performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution. Methods: Eligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint assessed overall colon-cleansing quality with the Aronchick Scale (AS), and the key secondary efficacy endpoint rated quality of right colon cleansing with the Boston Bowel Preparation Scale (BBPS). Assessments were performed by a treatment-blinded endoscopist. Tolerability was assessed using the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events and laboratory evaluations. Results: The study included 901 participants: 448 for SPMC oral solution; 453 for P/MC powder. SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders versus 81.5% (369/453) responders [difference (95% confidence interval): 6.3% (1.8, 10.9)]}. The key secondary efficacy objective assessing the right colon was also met. According to the prespecified hierarchical testing, after meeting the primary and key secondary objectives, SPMC oral solution was tested for superiority to P/MC powder for the primary endpoint ( p = 0.0067). SPMC oral solution was well tolerated. Most common adverse events were nausea (3.1% versus 2.9%), headache (2.7% versus 3.1%), hypermagnesemia (2.0% versus 5.1%), and vomiting (1.3% versus 0.7%) for SPMC oral solution and P/MC powder, respectively. Conclusions: Ready-to-drink SPMC oral solution showed superior efficacy of overall colon cleansing compared with P/MC powder, with similar safety and tolerability. [ClinicalTrials.gov identifier: NCT03017235.]

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