Delving into the Latest Updates on Sodium Picosulfate Hydrate with Synapse

Author: Anderloni, Andrea ; Di Sabatino, Antonio ; Biagi, Federico ; Fazzino, Erica ; Schiepatti, Annalisa ; Agazzi, Simona ; Lusetti, Francesca ; Mazza, Stefano ; Lenti, Marco Vincenzo ; Maimaris, Stiliano ; Alimenti, Eleonora ; Mauro, Aurelio ; Strada, Elena ; Pozzi, Lodovica ; Bardone, Marco ; Scalvini, Davide ; Rovedatti, Laura

BACKGROUND:

Several randomized clinical trials comparing different bowel preparations (BP) have shown similar efficacy; however, there is a lack of real-world studies on this topic.

AIMS:

This study aims to identify the most effective BP regimen in a real-world setting and any predictors of inadequate BP.

METHODS:

A retrospective single-center study was conducted over 14 months at an academic hospital including outpatient colonoscopies in which adult patients did not teach on how to perform BP before colonoscopy. Colonoscopies with 1L-PEG, 2L-PEG and picosulphate mixtures were considered. A multivariable analysis for factors associated to poor BP was fitted.

RESULTS:

Overall, 1779 patients (51 %F, 60±14) years were included. The 1L-PEG regimen provided a higher rate of BP adequacy at multivariate analysis (adjusted OR 2.30, 95 %CI 1.67-3.16,p < 0.001) and was associated with higher median Boston Bowel Preparation Scale score (p < 0.001), higher rate of right-colon cleansing (p < 0.001) and exam completion (p = 0.04). Furthermore, we identified male sex, history of constipation, active smoking, previous pelvic surgery, concomitant psychiatric/neurological or chronic kidney diseases as predictors of inadequate BP.

CONCLUSIONS:

This is the largest real-world study comparing 1L-PEG to other BP regimens. Our results suggest 1L-PEG provides better BP in a non-controlled setting, improving clinical practice quality and minimizing the need for repeated colonoscopies and saving healthcare resources.

01 Oct 2024·JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY

Efficacy and safety of same‐day preparation with sodium picosulfate plus magnesium citrate on the day of colonoscopy for bowel preparation: Multicenter, single‐arm, open‐label study

Article

Author: Tanabe, Hiroshi ; Hori, Hitomi ; Hoki, Shinya ; Yoshizaki, Tetsuya ; Ooi, Makoto ; Takao, Madoka ; Morita, Yoshinori ; Ikezawa, Nobuaki ; Kinoshita, Masato ; Okamoto, Norihiro ; Ueda, Chise ; Ishida, Ryosuke ; Sakaguchi, Hiroya ; Toyonaga, Takashi ; Tanaka, Shinwa ; Kodama, Yuzo ; Abe, Hirofumi ; Takayama, Hiroshi ; Fujisawa, Mizuho ; Miyazaki, Haruka

Abstract:

Background and Aim:

Sodium picosulfate plus magnesium citrate (SP + MC) is a well‐tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP + MC: the day‐before and split‐dose preparation, without approval of same‐day preparations. This study aimed to evaluate the efficacy and safety of same‐day SP + MC preparations.

Methods:

This was a multicenter, single‐arm, nonrandomized, open‐label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP + MC dissolved in 300 ml of water and 1200 mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated.

Results:

Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3 ± 1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP + MC. Regarding patient satisfaction, all patients were able to take SP + MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies.

Conclusion:

The same‐day SP + MC preparation showed high bowel‐cleansing efficacy and satisfaction in Japanese patients without serious AEs.

01 Sep 2024·SCANDINAVIAN JOURNAL OF GASTROENTEROLOGY

A randomized prospective study comparing the effect of low-volume bowel preparations for colonoscopy preparation in China

Article

Author: Zhao, Qiang ; Zhu, Xianjie ; Shao, Xiaona ; Sheng, Hong ; Shen, Jianwei ; Yang, Nuonan ; Sun, Changbo ; Shen, Ruiwei ; He, Hui ; Lu, Ting ; Chen, Dawei ; Lin, Jieqiong ; Wang, Jiaqi ; Yuan, Xiaogang ; Han, Xufeng ; Chen, Dahua ; Ye, Qunqun ; Wang, Chunwei

AIM:

To evaluate the effect of sodium picosulfate/magnesium citrate (SPMC) and 3 L split-dose polyethylene glycol (PEG) with or without dimethicone on bowel preparation before colonoscopy.

METHODS:

In this multicenter, prospective, randomized, controlled study conducted from April 2021 to December 2021, consecutive adult patients scheduled for colonoscopy were prospectively randomized into four groups: SPMC, SPMC plus dimethicone, 3 L PEG, and 3 L PEG plus dimethicone. Primary endpoint was colon cleansing based on Boston Bowel Preparation Scale (BBPS). Secondary endpoints were bubble score, time to cecal intubation, adenoma detection rate (ADR), patient safety and compliance, and adverse events.

RESULTS:

We enrolled 223 and 291 patients in SPMC and 3 L PEG group, respectively. The proportion with acceptable bowel cleansing, total BBPS score and cecal intubation time were similar in all four subgroups (p > 0.05). Patient-reported acceptability and tolerability was significantly greater in SPMC than 3 L PEG group (p < 0.001); adverse events were significantly lower in SPMC than latter group (p < 0.001). ADR in both groups was greater than 30%.

CONCLUSION:

SPMC had significantly higher acceptability and tolerability than 3 L PEG, however, was similar in terms of bowel-cleansing effect and cecal intubation time and hence can be used before colonoscopy preparation.

1

News (Medical) associated with Sodium Picosulfate Hydrate

25 May 2023

·www.drugs.com

Guidelines Developed for Treating Chronic Idiopathic Constipation

THURSDAY, May 25, 2023 -- In a clinical practice guideline issued by the American Gastroenterological Association and the American College of Gastroenterology, and published online May 19 in the American Journal of Gastroenterology and Gastroenterology , recommendations are presented for the pharmacologic treatment of chronic idiopathic constipation (CIC) in adults. Lin Chang, M.D., from the David Geffen School of Medicine at the University of California in Los Angeles, and colleagues conducted systematic reviews relating to use of fiber, osmotic laxatives, stimulant laxatives, secretagogues, and serotonin type 4 agonists to provide evidence-based practice recommendations for treatment of CIC in adults. The multidisciplinary guideline panel agreed on 10 recommendations for pharmacological management of CIC. These included strong recommendations for use of polyethylene glycol, sodium picosulfate, linaclotide, plecanatide, and prucalopride, based on moderate certainty of evidence. Conditional recommendations, based on low or very low certainty of evidence, were made for fiber supplementation, lactulose, senna, magnesium oxide, and lubiprostone. "The guidelines are meant to provide a framework for approaching the management of CIC," the authors write. "Clinical providers should engage in shared decision-making based on patient preferences as well as medication cost and availability." Several authors disclosed ties to the pharmaceutical, medical device, and other industries. Several authors hold patents, including for a rectal expulsion device. Abstract/Full Text Posted May 2023

100 Deals associated with Sodium Picosulfate Hydrate

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KEGG	Wiki	ATC	Drug Bank
D01612	Sodium Picosulfate Hydrate	A06AB08	DB09268

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Contrast agents	JP	Viatris Healthcare GmbH	01 Jul 1992
Intestinal preparation	JP	Teijin Pharma Ltd.	27 Mar 1992
Constipation	JP	Sanofi	27 Aug 1979
Constipation	JP	Teijin Pharma Ltd.	27 Aug 1979

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Gastrointestinal Diseases	Phase 3	FR	Ferring BV	01 Nov 2014
Gastrointestinal Diseases	Phase 3	DE	Ferring BV	01 Nov 2014
Gastrointestinal Diseases	Phase 3	NL	Ferring BV	01 Nov 2014
Diffuse Large B-Cell Lymphoma	Phase 3	JP	Ferring BV	01 Sep 2014
Constipation - functional	Phase 3	CN	Chongqing Lummy Pharmaceutical Co., Ltd.	16 Sep 2011
Pharmaceutical aids	Phase 3	US	Ferring BV	01 May 2010