Content provided in partnership with

Health Care Industry

Safety and efficacy of sodium phosphate tablets for colon cleansing

AORN Journal, March, 2008 by George Allen

American Journal of Gastroenterology

October 2007

A newly formulated sodium phosphate (NAP) tablet recently was approved by the US Food and Drug Administration for cleansing the colon before colonoscopy. The dosing regimen consists of 32 tablets--20 tablets taken on the evening before the colonoscopy and the remaining 12 tablets taken on the morning of the examination. In a study, the new 32-tablet NaP dosing regimen demonstrated comparable overall colon cleansing and superior ascending colon cleansing compared with a 40-tablet NaP dosing regimen. Additionally, the 32-tablet regimen was better tolerated and was associated with fewer side effects and less pronounced electrolyte changes than the 40-tablet regimen. The safety and efficacy of NaP tablets, however, have not been compared with 2 L polyethylene glycol (PEG) electrolyte lavage solution and bisacodyl tablets. The objective of this randomized, investigator-blinded study were to compare the overall and ascending colon cleansing and safety profile of the new 32-tablet NaP dosing regimen with 2 L PEG solution and bisacodyl tablet bowel preparation kit in adults undergoing colonoscopy.

Most Popular Articles in Health: Fuel your workout: exercisers who eat before they work out have more energy ...; Soothe a dry, itchy scalp: 5 easy expert solutions; Cocktails and calories: Beer, wine and liquor calories can really add up. ...; The sour truth about apple cider vinegar - evaluation of therapeutic use; The, six best supplements you've never heard of: these secret weapons can ...; More »

At 10 sites in the United States from September 2005 through February 2006, men and non-pregnant, non-lactating women who were 18 years of age or older and scheduled for colonoscopy were eligible for participation in the study. Patients were excluded if any one of the following conditions was present:

* renal insufficiency (ie, creatinine > 2 mg/dL);

* serum electrolyte abnormalities at screening;

* uncontrolled congestive heart failure (ie, American Heart Association Classification III or IV);

* unstable angina;

* untreated dysarrhythmia;

* current use of digitalis preparations or medications known to prolong the QT interval;

* myocardial infarction;

* percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within the previous three months;

* ascites;

* current acute exacerbation of chronic inflammatory bowel disease;

* toxic colitis or toxic megacolon;

* severe chronic constipation (ie, less than one bowel movement per week for more than one year);

* ileus and/or 50% or more of the colon removed;

* hypomotility syndrome, megacolon, or idiopathic pseudo-obstruction;

* history of gastric stapling or bypass procedure;

* history of gastric retention;

* impaired gag reflux and/or history of regurgitation or aspiration;

* difficulties swallowing;

* treatment with an investigational medication or product;

* participation in a medication study within 30 days before receiving this study medication or within 60 days for investigational medications with an elimination half-life greater than 15 days;

* previous enrollment in this study;

* treatment with another NaP regimen within 21 days before the colonoscopy;

* known allergy or hypersensitivity to NaP salts and any other constituent of NaP tablets or any constituents of PEG solution and bisacodyl tablets; or

* any other clinically significant disease or finding that, in the opinion of the investigator, would expose the patient to an increased risk of a significant adverse event or would interfere with the assessments of efficacy and safety during the course of treatment.

Patients were randomly assigned to receive either 32 tablets (ie, 48 g) of NaP or 2 L PEG lavage solution and four bisacodyl tablets (ie, 20 mg) and instructed to take them as directed. The endoscopist was blinded to the dosing regimen assigned to each patient. The quality of colon cleansing was assessed using a four-point scale (ie, 1 = excellent, 2 = good, 3 = fair, 4 = inadequate), and the primary efficacy endpoint was a mean overall colon-cleansing score. Adverse events and changes in biochemical tests and vital signs were recorded. Common statistical techniques including the Fisher exact test and analysis of variance techniques were used to analyze the data.

FINDINGS. A total of 404 patients completed the study. There were no significant differences between the treatment groups with respect to age, gender, race, height, weight, or compliance with the regimen as indicated by the number of tablets and volume of fluid taken and returned to the site. The mean overall and ascending colon-cleansing scores for NaP tablets were significantly better than scores for the PEG solution and bisacodyl tablets (overall 1.5 versus 1.8, ascending 1.4 versus 1.8, P < .000 for both).

Patients in the NaP group experienced significantly fewer adverse events (66% versus 82%, P < .000) and gastrointestinal symptoms (64% versus 79%, P = .000) compared to patients receiving PEG solution and bisacodyl tablets. Additionally, patients receiving NaP were significantly less likely to experience abdominal distention, abdominal pain, and vomiting (P < .001). Transient fluctuations in laboratory parameters were observed in both groups; however, fluctuations, particularly in phosphorous, sodium, and potassium, were more common and of greater magnitude in the NaP group.

Health Care Industry

Safety and efficacy of sodium phosphate tablets for colon cleansing

AORN Journal, March, 2008 by George Allen

Find Research Guides for:

Find Featured Titles for: News

Most Popular Articles in Health

Most Popular Publications in Health