Superiority of a Split-dose Regimen of Sodium Picosulfate/ Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study

2016 ◽  
Vol 25 (3) ◽  
pp. 295-302 ◽  
Author(s):  
Christian Schulz ◽  
Joachim Müller ◽  
Joachim Sauter ◽  
Stephan Miehlke ◽  
Christoph Schmöcker ◽  
...  
Keyword(s):  
Adverse Events ◽  
Dose Regimen ◽  
Dose Group ◽  
Magnesium Citrate ◽  
Product Characteristics ◽  
Split Dose ◽  
Summary Of Product Characteristics ◽  
Adenoma Detection ◽  
Bowel Cleansing ◽  
Sodium Picosulfate

Background & Aims: Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM). Methods: Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations. Results: 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events. Conclusion: A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use. Abbreviations: CTCAE: Common Terminology Criteria for Adverse Events; eGFR: Glomerular filtration rate; mITT: modified intent-to-treat; RSS: Residual Stool Score; SA: safety analysis; SAE: serious adverse event; SmPC: summary of product characteristics; SPMC: sodium picosulfate-magnesium citrate.

Comparison of efficacy and tolerance of low-volume preparations prior to colonoscopy a randomized trial.

2019 ◽  
Vol 98 (7) ◽  
pp. 277-281
Keyword(s):  
Single Dose ◽  
Bowel Preparation ◽  
Dose Regimen ◽  
Open Label ◽  
Open Label Study ◽  
Split Dose ◽  
Rate Score ◽  
Bowel Cleansing ◽  
Sodium Picosulfate ◽  
Colonoscopy Quality

Introduction: The aim of the study was to compare the efficacy and tolerability of polyethylene glycol/ascorbic acid (PEGA), sodium picosulfate/ magnesium citrate (SPMC) and the oral sulfate formula (SIR) in a single- or split-dose regimen for bowel preparation prior to colonoscopy. Methods: Randomised, multicentre, open-label study. The subjects received either PEGA, SPMC or SIR in the single- or split-dose regimen before the colonoscopy. Quality and tolerability of the preparation and complaints during preparation were recorded using a 5 point scale. Results: 558 subject were analysed. Preparation quality was comparable in the single-dose regimen. The rate of satisfactory bowel cleansing (Aronchick score 1+2) was higher for split-dose SIR and PEGA compared to SPMC (95.6%, 86.2% vs. 72.5%, p<0.028). The highest tolerance rate (score 1+2) was reported for SPMC (82.3%, p<0.003) and the lowest for single-dose SIR (34.8%, p=0.008). The lowest frequency of nausea (10.4%) was observed for SPMC. The highest prevalence of bloating was linked with the use of PEGA (34.0%). Conclusion: Differences in bowel preparation quality were apparent only in the split-dose regimen, with SIR rated as most efficient. SPMC was the best tolerated formula. The split-dose regimen is more effective than single-dose preparation used in the evening before the examination.

scholarly journals Considering additive effects of polypharmacy

2020 ◽  
Author(s):  
Monika Lexow ◽  
Kathrin Wernecke ◽  
Gordian L. Schmid ◽  
Ralf Sultzer ◽  
Thilo Bertsche ◽  
...  
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Additive Effects ◽  
Product Characteristics ◽  
Cross Sectional ◽  
Term Care ◽  
Event Identification ◽  
Summary Of Product Characteristics ◽  
Naranjo Algorithm

Summary Background Potential additive effects of polypharmacy are rarely considered in adverse events of geriatric patients living in long-term care facilities. Our aim, therefore, was to identify adverse events in this setting and to assess plausible concomitant drug causes. Methods A cross-sectional observational study was performed in three facilities as follows: (i) adverse event identification: we structurally identified adverse events using nurses’ interviews and chart review. (ii) Analysis of the concomitantly administered drugs per patient was performed in two ways: (ii.a) a review of summary of product characteristics for listed adverse drug reactions to identify possible causing drugs and (ii.b) a causality assessment according to Naranjo algorithm. Results (i) We found 424 adverse events with a median of 4 per patient (range 1–14) in 103 of the 104 enrolled patients (99%). (ii.a) We identified a median of 3 drugs (range 0–11) with actually occurring adverse events listed as an adverse drug reaction in the summary of product characteristics. (ii.b) Causality was classified in 198 (46.9%) of adverse events as “doubtful,” in 218 (51.2%) as “possible,” in 7 (1.7%) as “probable,” and in 1 (0.2%) adverse event as a “definitive” cause of the administered drugs. In 340 (80.2%) of all identified adverse events several drugs simultaneously reached the highest respective Naranjo score. Conclusion Patients in long-term facilities frequently suffer from many adverse events. Concomitantly administered drugs have to be frequently considered as plausible causes for adverse events. These additive effects of drugs should be more focused in patient care and research.

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.]

Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial

Endoscopy ◽  
2019 ◽  
Vol 51 (07) ◽  
pp. 628-636 ◽  
Author(s):  
Antonio Z. Gimeno-García ◽  
Raquel de la Barreda Heuser ◽  
Cristina Reygosa ◽  
Alberto Hernandez ◽  
Isabel Mascareño ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Dietary Recommendations ◽  
Detection Rates ◽  
Split Dose ◽  
Intention To Treat ◽  
Level Of Satisfaction ◽  
Adenoma Detection ◽  
Bowel Cleansing ◽  
Low Residue Diet

Abstract Background The aim of this study was to assess whether a 3-day low-residue diet (LRD) improved bowel cleansing quality compared with a 1-day LRD regimen. Methods Consecutive patients scheduled for outpatient colonoscopy were randomized to the 1-day LRD or 3-day LRD groups. All patients received a 2-L split-dose of polyethylene glycol plus ascorbic acid. The primary outcome was bowel cleansing quality as evaluated using the Boston Bowel Preparation Scale (BBPS) (adequate cleansing ≥ 2 points per segment). Secondary outcomes were adherence to and level of satisfaction with the LRD, difficulty following the dietary recommendations, and willingness to repeat the same LRD in the future. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. A superiority analysis was performed to demonstrate that a 3-day LRD regimen was superior to a 1-day LRD regimen with a margin of 10 %. Results 390 patients (1-day LRD group = 196, 3-day LRD = 194) were included. The cleansing quality was not significantly different between the groups: ITT analysis 82.7 % (95 % confidence interval [CI] 77.4 to 88.0) vs. 85.6 % (95 %CI 80.7 to 90.5), with odds ratio (OR) 1.2 (95 %CI 0.72 to 2.15); PP analysis 85.0 % (95 %CI 79.9 to 90.1) vs. 88.6 % (95 %CI 84.0 to 93.2), with OR 1.4 (95 %CI 0.88 to 2.52). No differences were found regarding adherence to the diet or cleansing solution, satisfaction or difficulty with the LRD, and the polyp/adenoma detection rates. Conclusion 3-day LRD did not offer advantages over 1-day LRD in preparation for colonoscopy.

Su1551 Split-Dose Sodium Picosulfate and Magnesium Citrate Preparation for Colonoscopy: Cleansing Effectiveness and Residual Gastric Volume and pH

2014 ◽  
Vol 79 (5) ◽  
pp. AB318
Author(s):  
CéSar Prieto ◽  
RAMóN AngóS ◽  
María Teresa BetéS ◽  
Susana De La Riva ◽  
Iago RodríGuez Lago ◽  
...  
Keyword(s):  
Gastric Volume ◽  
Magnesium Citrate ◽  
Residual Gastric Volume ◽  
Split Dose ◽  
Sodium Picosulfate
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