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Su1542 Polietilenglicol vs Sodium Picosulfate: a Quality Comparison of Colonic Cleansing and Tolerance in Divided Doses
Abstracts
Male: Female Age years* Unpleasant taste Nausea and/or vomiting Bloating Abdominal pain Willing to repeat preparation BBPS*
SP n[25 (Split dose)
Low volume PEG n[25 (Split dose)
P**
12:13 60.6 +/- 13.7 11 8
9:16 54.04 +/-13.8 2 2
10:15 61.7 +/- 10.2 12 9
0.82 0.96 0.0003 0.06
4 2 22
13 8 14
7 4 22
12 5 16
0.02 0.18 0.01
6.8 +/- 1.29
6.52 +/-1.08
6.96 +/- 1.36
7.12 +/- 1.26
0.381
SP n[25 (Day before)
Low volume PEG n[25 (Day Before)
11:14 55.3 +/- 9.34 2 4
*Mean (SD), **Comparisons analyzed using ANOVA test or X2 accordingly.
Su1541 Safety, Efficacy, and Tolerability of a Low-Volume Sodium Picosulfate/Magnesium Citrate Bowel Preparation in Noncaucasian Adult Patients Gerald Bertiger*1, Richard Willey2, Raymond E. Joseph2, Morris Barocas2 1 Hillmont G.I., Flourtown, PA; 2Ferring Pharmaceuticals Inc., Parsippany, NJ Background: Colonoscopy is an important diagnostic tool for colorectal cancer (CRC) screening. Certain ethnic groups show an increased risk for developing CRC. Here, adequate cleansing and a positive bowel preparation experience are critical to maintain detection rates and promote adherence to screening recommendations. We performed a post hoc analysis to evaluate the efficacy, safety, and tolerability of bowel preparation in noncaucasian patients. Methods: Data were obtained from 2 phase 3, randomized, multicenter, assessor-blinded studies that investigated split-dose (Rex DK, et al. Gastrointest Endosc. 2013;78:132) or daybefore (Katz P, et al. Am J Gastroenterol. 2013;108:401) dosing of a nonphosphate, dual-action, low-volume preparation containing sodium picosulfate, magnesium oxide, and anhydrous citric acid (P/MC) compared with per labeled dosing of 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG+bis) in adults preparing for colonoscopy. Efficacy, safety, and tolerability data were analyzed separately for noncaucasian patients. Colon cleansing was rated using a modified Aronchick scale. Patient tolerability was ascertained from a 7-item questionnaire administered on the day of colonoscopy. Safety was assessed by the incidence of adverse events (AEs). Efficacy and tolerability results were analyzed separately for each study, while the safety data was pooled. Results: Across both studies, a total of 62 noncaucasian intent-to-treat (ITT) patients were randomized into P/MC treatment groups and 64 noncaucasian ITT patients were randomized to 2L PEG-bis. Over 90% of noncaucasian patients in both groups identified as Black/African American. Successful cleansing was obtained in 87% and 86% of noncaucasian P/MC patients in the split-dose study and day-before study, respectively. In the 2L PEG+bis arms of both studies there was a O9% reduction in successfully cleansed noncaucasian patients compared to P/MC; however these differences failed to reach statistical significance. A significantly greater proportion of noncaucasians in the P/MC treatment group rated their preparation as “easy”/ “very easy” to consume, compared with the 2L PEG+bis group (split-dose study, 89% vs 42%, P!0.0001; day-before study, 82% vs 52%, PZ0.0026). Preparation taste and overall experience were rated “excellent”/ “good” in a significantly higher proportion of P/MC noncaucasian patients in both studies (P!0.01). AEs in noncacuasain 2L PEG+bis patients included headache (1.6%), nausea (3.1%), and vomiting (4.7%). Headache was reported in 1.6% of noncaucasians in the P/MC groups; however, there were no cases of nausea or vomiting. Conclusion: Split-dose and day-before P/MC provide quality bowel cleansing regardless of ethnicity and were better tolerated than 2L PEG+bis. P/MC provides a safe, low-volume alternative to PEG-based bowel preparations.
Su1542 Polietilenglicol vs Sodium Picosulfate: a Quality Comparison of Colonic Cleansing and Tolerance in Divided Doses Ramón Olavide Aguilar*, Alberto Farca Belsaguy, Diego Angulo- Molina, Juan C. Salceda Otero, Diego Lozoya Gonzalez, Mario Pelaez-Luna, Fausto Romero Vallejo, Eduardo Vazquez Mora, Alfonso Balderas Vazquez Gastroenterology and endoscopy, American British Medical Center, Mexico city, Mexico Background: The preparation with Polietilenglicol (PEG) is the method of choice of colonic cleansing; however, its taste is not so agreeable and has a low acceptance by the patient. The divided doses schemes have proven better tolerance without diminishing quality. There is no ideal scheme of preparation in patients with chronic constipation and the use of laxatives. The combination of sodium picosulfate, citric acid and magnesium oxide represents and effective alternative for the preparation of
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the colon. Objective: To compare the quality of cleansing of the colon and the tolerance of the preparation, using PEG and the combination of sodium picosulfate, citric acid and magnesium oxide as well as to evaluate the efficiency of such combination in patients with chronic constipation and the use of laxatives. Material and Methods: Descriptive, transversal, analytic and comparative study. We include ambulatory patients over 18 years of age who were subject to a colonoscopy from March to October 2014. Four groups where created: Group A. sodium picosulfate treatment. Group B. polietilenglicol. Group C. PEG/ sodium picosulfate and Group D. 3 doses of sodium picosulfate. The cleansing of the colon was evaluated by the Boston and Ottawa scales, then, making a survey for the evaluation of symptoms; and for the inferential statistics chi-cuadrada and U de Mann Whitney were used. Results: a total of 140 patients were included (79 women, 61 men) age media 55.09 +/- 12.63 years. 50 patients in group A and 50 in group B. Patients with chronic constipation and the use of laxatives was of 20 in groups C and D. The findings in the Boston and Ottawa scales for the different groups are shown in table 1. The findings of the study of the variables of tolerance are shown in table 2. The results of the median of the total score of Boston in chronic constipation was 5 in group C and 8 in group D (p Z .01) and Ottawa 5 in group C and 1 in group D (pZ .00) Patients with chronic constipation and preparation bowel with 3 doses of sodium picosulfato (at 11 am, 19 pm and 06 am) showed better cleaning than split doses with Boston and Ottawa scales with statistical difference (p .01 and p .00 respectively). Conclusion: No significant statistic difference was found in global form in the quality of colonic cleansing with the two preparations. There is a better cleansing in the ascending colonic segment with the use of sodium picosulfate. The sodium picosulfate showed significant increased tolerance. The headache was collateral effect shown only by sodium picosulfate. The combination of sodium picosulfate, citric acid and magnesium oxide represent an efficient option and has better tolerance in the colonic preparation and constitutes an ideal therapy (3 doses) for the chronic constipation patients.
Results of the comparison between Groups A and B in the Boston and Ottawa Scales n[100 Ascending Colon Transvers Colon Descending colon Global Results
*p-Boston
*p-Ottawa
0.022 0.393 0.056 0.071
0.027 0.433 0.061 0.075
*p!.05 Chi cuadrada
Table 2. Tolerance variability annalysis. Agreable Taste Abdominal distension Nausea Vomit Headache Abdominal Malaise
Group A
Group B
p*
2 (%) 11 (%) 8 (%) 0 (%) 18 (%) 5 (%)
34 (%) 24 (%) 17 (%) 4 (%) 6 (%) 34 (%)
0.010 0.006 0.001 0.059 0.005 0.013
*p!0.05
Su1543 Long Term Effects of Yoga Based Colon Cleanse on Renal Function Vijay Arya*1,4, Shashank Agarwal2, Ashok Valluri3, Shikha Singh1 1 Gastroenterology, Wyckoff Heights Medical Center, Middle Village, NY; 2 NYU School of Medicine, New York, NY; 3Internal Medicine, Blessing Hospital, Quincy, IL; 4Weill Cornell Medical College, New York, NY Background: A meditation based process known as - ShudhÒ colon cleanse (SCC) has been shown to be non-inferior to Half-LytelyÒ colon prep (HCP) with regards to the quality of bowel preparation. The major advantage with SCC was, bowel preparation time (BPT) of less than 2 hours. The solution drank in SCC was lukewarm normal saline, and no electrolyte imbalance was reported in any patient1. Objective: The primary outcome of this study was to evaluate the long term effects of SCC on the renal function- serum creatinine (sCr) and glomerular filtration rate (GRF) of the patients. Methods: We conducted a retrospective chart review using electronic medical records. Patients’ within 21-70 years of age with good general physical status (American Society of Anesthesiologists (ASA) class 1 or 2) who had used either SCC or HCP for elective colonoscopy in between May 2008 and December 2010 were included in this study. We compared the pre-procedure and follow-up basal metabolic profile (BMP) to look for change in sCr and GRF. The follow up BMP was the earliest BMP that was done after 3 months but before 5 years of the date of the colonoscopy2. GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) since all the patients included in our study were healthy patients3. Results: Out of 133 patients, 65 had
Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB321
Male: Female Age years* Unpleasant taste Nausea and/or vomiting Bloating Abdominal pain Willing to repeat preparation BBPS*
SP n[25 (Split dose)
Low volume PEG n[25 (Split dose)
P**
12:13 60.6 +/- 13.7 11 8
9:16 54.04 +/-13.8 2 2
10:15 61.7 +/- 10.2 12 9
0.82 0.96 0.0003 0.06
4 2 22
13 8 14
7 4 22
12 5 16
0.02 0.18 0.01
6.8 +/- 1.29
6.52 +/-1.08
6.96 +/- 1.36
7.12 +/- 1.26
0.381
SP n[25 (Day before)
Low volume PEG n[25 (Day Before)
11:14 55.3 +/- 9.34 2 4
*Mean (SD), **Comparisons analyzed using ANOVA test or X2 accordingly.
Su1541 Safety, Efficacy, and Tolerability of a Low-Volume Sodium Picosulfate/Magnesium Citrate Bowel Preparation in Noncaucasian Adult Patients Gerald Bertiger*1, Richard Willey2, Raymond E. Joseph2, Morris Barocas2 1 Hillmont G.I., Flourtown, PA; 2Ferring Pharmaceuticals Inc., Parsippany, NJ Background: Colonoscopy is an important diagnostic tool for colorectal cancer (CRC) screening. Certain ethnic groups show an increased risk for developing CRC. Here, adequate cleansing and a positive bowel preparation experience are critical to maintain detection rates and promote adherence to screening recommendations. We performed a post hoc analysis to evaluate the efficacy, safety, and tolerability of bowel preparation in noncaucasian patients. Methods: Data were obtained from 2 phase 3, randomized, multicenter, assessor-blinded studies that investigated split-dose (Rex DK, et al. Gastrointest Endosc. 2013;78:132) or daybefore (Katz P, et al. Am J Gastroenterol. 2013;108:401) dosing of a nonphosphate, dual-action, low-volume preparation containing sodium picosulfate, magnesium oxide, and anhydrous citric acid (P/MC) compared with per labeled dosing of 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG+bis) in adults preparing for colonoscopy. Efficacy, safety, and tolerability data were analyzed separately for noncaucasian patients. Colon cleansing was rated using a modified Aronchick scale. Patient tolerability was ascertained from a 7-item questionnaire administered on the day of colonoscopy. Safety was assessed by the incidence of adverse events (AEs). Efficacy and tolerability results were analyzed separately for each study, while the safety data was pooled. Results: Across both studies, a total of 62 noncaucasian intent-to-treat (ITT) patients were randomized into P/MC treatment groups and 64 noncaucasian ITT patients were randomized to 2L PEG-bis. Over 90% of noncaucasian patients in both groups identified as Black/African American. Successful cleansing was obtained in 87% and 86% of noncaucasian P/MC patients in the split-dose study and day-before study, respectively. In the 2L PEG+bis arms of both studies there was a O9% reduction in successfully cleansed noncaucasian patients compared to P/MC; however these differences failed to reach statistical significance. A significantly greater proportion of noncaucasians in the P/MC treatment group rated their preparation as “easy”/ “very easy” to consume, compared with the 2L PEG+bis group (split-dose study, 89% vs 42%, P!0.0001; day-before study, 82% vs 52%, PZ0.0026). Preparation taste and overall experience were rated “excellent”/ “good” in a significantly higher proportion of P/MC noncaucasian patients in both studies (P!0.01). AEs in noncacuasain 2L PEG+bis patients included headache (1.6%), nausea (3.1%), and vomiting (4.7%). Headache was reported in 1.6% of noncaucasians in the P/MC groups; however, there were no cases of nausea or vomiting. Conclusion: Split-dose and day-before P/MC provide quality bowel cleansing regardless of ethnicity and were better tolerated than 2L PEG+bis. P/MC provides a safe, low-volume alternative to PEG-based bowel preparations.
Su1542 Polietilenglicol vs Sodium Picosulfate: a Quality Comparison of Colonic Cleansing and Tolerance in Divided Doses Ramón Olavide Aguilar*, Alberto Farca Belsaguy, Diego Angulo- Molina, Juan C. Salceda Otero, Diego Lozoya Gonzalez, Mario Pelaez-Luna, Fausto Romero Vallejo, Eduardo Vazquez Mora, Alfonso Balderas Vazquez Gastroenterology and endoscopy, American British Medical Center, Mexico city, Mexico Background: The preparation with Polietilenglicol (PEG) is the method of choice of colonic cleansing; however, its taste is not so agreeable and has a low acceptance by the patient. The divided doses schemes have proven better tolerance without diminishing quality. There is no ideal scheme of preparation in patients with chronic constipation and the use of laxatives. The combination of sodium picosulfate, citric acid and magnesium oxide represents and effective alternative for the preparation of
www.giejournal.org
the colon. Objective: To compare the quality of cleansing of the colon and the tolerance of the preparation, using PEG and the combination of sodium picosulfate, citric acid and magnesium oxide as well as to evaluate the efficiency of such combination in patients with chronic constipation and the use of laxatives. Material and Methods: Descriptive, transversal, analytic and comparative study. We include ambulatory patients over 18 years of age who were subject to a colonoscopy from March to October 2014. Four groups where created: Group A. sodium picosulfate treatment. Group B. polietilenglicol. Group C. PEG/ sodium picosulfate and Group D. 3 doses of sodium picosulfate. The cleansing of the colon was evaluated by the Boston and Ottawa scales, then, making a survey for the evaluation of symptoms; and for the inferential statistics chi-cuadrada and U de Mann Whitney were used. Results: a total of 140 patients were included (79 women, 61 men) age media 55.09 +/- 12.63 years. 50 patients in group A and 50 in group B. Patients with chronic constipation and the use of laxatives was of 20 in groups C and D. The findings in the Boston and Ottawa scales for the different groups are shown in table 1. The findings of the study of the variables of tolerance are shown in table 2. The results of the median of the total score of Boston in chronic constipation was 5 in group C and 8 in group D (p Z .01) and Ottawa 5 in group C and 1 in group D (pZ .00) Patients with chronic constipation and preparation bowel with 3 doses of sodium picosulfato (at 11 am, 19 pm and 06 am) showed better cleaning than split doses with Boston and Ottawa scales with statistical difference (p .01 and p .00 respectively). Conclusion: No significant statistic difference was found in global form in the quality of colonic cleansing with the two preparations. There is a better cleansing in the ascending colonic segment with the use of sodium picosulfate. The sodium picosulfate showed significant increased tolerance. The headache was collateral effect shown only by sodium picosulfate. The combination of sodium picosulfate, citric acid and magnesium oxide represent an efficient option and has better tolerance in the colonic preparation and constitutes an ideal therapy (3 doses) for the chronic constipation patients.
Results of the comparison between Groups A and B in the Boston and Ottawa Scales n[100 Ascending Colon Transvers Colon Descending colon Global Results
*p-Boston
*p-Ottawa
0.022 0.393 0.056 0.071
0.027 0.433 0.061 0.075
*p!.05 Chi cuadrada
Table 2. Tolerance variability annalysis. Agreable Taste Abdominal distension Nausea Vomit Headache Abdominal Malaise
Group A
Group B
p*
2 (%) 11 (%) 8 (%) 0 (%) 18 (%) 5 (%)
34 (%) 24 (%) 17 (%) 4 (%) 6 (%) 34 (%)
0.010 0.006 0.001 0.059 0.005 0.013
*p!0.05
Su1543 Long Term Effects of Yoga Based Colon Cleanse on Renal Function Vijay Arya*1,4, Shashank Agarwal2, Ashok Valluri3, Shikha Singh1 1 Gastroenterology, Wyckoff Heights Medical Center, Middle Village, NY; 2 NYU School of Medicine, New York, NY; 3Internal Medicine, Blessing Hospital, Quincy, IL; 4Weill Cornell Medical College, New York, NY Background: A meditation based process known as - ShudhÒ colon cleanse (SCC) has been shown to be non-inferior to Half-LytelyÒ colon prep (HCP) with regards to the quality of bowel preparation. The major advantage with SCC was, bowel preparation time (BPT) of less than 2 hours. The solution drank in SCC was lukewarm normal saline, and no electrolyte imbalance was reported in any patient1. Objective: The primary outcome of this study was to evaluate the long term effects of SCC on the renal function- serum creatinine (sCr) and glomerular filtration rate (GRF) of the patients. Methods: We conducted a retrospective chart review using electronic medical records. Patients’ within 21-70 years of age with good general physical status (American Society of Anesthesiologists (ASA) class 1 or 2) who had used either SCC or HCP for elective colonoscopy in between May 2008 and December 2010 were included in this study. We compared the pre-procedure and follow-up basal metabolic profile (BMP) to look for change in sCr and GRF. The follow up BMP was the earliest BMP that was done after 3 months but before 5 years of the date of the colonoscopy2. GFR was calculated using the Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI) since all the patients included in our study were healthy patients3. Results: Out of 133 patients, 65 had
Volume 81, No. 5S : 2015 GASTROINTESTINAL ENDOSCOPY AB321