scholarly journals Efficacy and Patient Tolerability of Split-Dose Sodium Picosulfate/Magnesium Citrate (SPMC) Oral Solution Compared to the Polyethylene Glycol (PEG) Solution for Bowel Preparation in Outpatient Colonoscopy: An Evidence-Based Review

2020 ◽  
Vol Volume 13 ◽  
pp. 449-457
Author(s):  
Antonio Afonso de Miranda Neto ◽  
Diogo Turiani Hourneaux de Moura ◽  
Kelly E Hathorn ◽  
Francisco Tustumi ◽  
Eduardo Guimarães Hourneaux de Moura ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Oral Solution ◽  
Evidence Based ◽  
Magnesium Citrate ◽  
Split Dose ◽  
Sodium Picosulfate

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

2020 ◽  
Vol 13 ◽  
pp. 175628482090287
Author(s):  
Lawrence Hookey ◽  
Gerald Bertiger ◽  
Kenneth Lee Johnson ◽  
Mena Boules ◽  
Masakazu Ando ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Age Groups ◽  
Secondary Analysis ◽  
Oral Solution ◽  
Phase Iii ◽  
Age Group ◽  
Split Dose ◽  
Sodium Picosulfate ◽  
The Right ◽  
Post Hoc

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.

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

2019 ◽  
Vol 12 ◽  
pp. 175628481985151 ◽  
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.]

scholarly journals A Randomized, Endoscopist-Blinded, Prospective Trial to Compare the Efficacy and Patient Tolerability between Bowel Preparation Protocols Using Sodium Picosulfate Magnesium Citrate and Polyethylene-Glycol (1 L and 2 L) for Colonoscopy

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Sang Hoon Kim ◽  
Ji Hyeong Kim ◽  
Bora Keum ◽  
Han Jo Jeon ◽  
Se Hyun Jang ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Patient Compliance ◽  
Bowel Preparation ◽  
Prospective Trial ◽  
Liquid Sodium ◽  
Magnesium Citrate ◽  
Patients Satisfaction ◽  
Significant Difference ◽  
Blinded Study ◽  
Sodium Picosulfate

Patient compliance during bowel preparation is important for successful colonoscopy. Bowel preparation with polyethylene glycol (PEG), the most commonly used solution for cleansing, involves the unpleasant ingestion of a large amount of liquid. Sodium picosulfate magnesium citrate (SP-MC) solution is an alternative option with better palatability than PEG. Therefore, in this study, we compared the efficacy and patient tolerability among the following three bowel preparation protocols: 2 L PEG-ascorbic acid (ASc), 1 L PEG-ASc plus bisacodyl, and SP-MC 340 mL plus bisacodyl. We conducted a randomized prospective endoscopist-blinded study between August 2018 and January 2019. A total of 311 patients were randomly classified into three groups according to the above-described bowel preparation protocols. To evaluate the efficacy of bowel cleansing, we used the Boston Bowel Preparation Scale. The degree of symptoms and the patients’ satisfaction with each bowel preparation method were investigated using a questionnaire completed before sedation for colonoscopy. The baseline characteristics were similar among the three groups. There was no significant difference in the bowel preparation quality among the three groups. However, the incidence of symptoms, such as abdominal fullness and pain, was significantly lower (P=0.006 and 0.027, respectively) while the patients’ satisfaction rate was significantly higher (P=0.012) in the SP-MC plus bisacodyl group than in the two PEG groups. In this study, the efficacy of the SP-MC plus bisacodyl solution was similar to that of the PEG solutions. However, patient tolerability and satisfaction were better in the SP-MC plus bisacodyl group than in the other groups. In conclusion, the use of SP-MC plus bisacodyl bowel preparation solution might be a better method for providing good intestinal cleansing and improving patient compliance.

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