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Tolevamer, a Novel Nonantibiotic Polymer, Compared with Vancomycin in the Treatment of Mild to Moderately Severe Clostridium difficile–Associated Diarrhea
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Tolevamer, a Novel Nonantibiotic Polymer, Compared with Vancomycin in the Treatment of Mild to Moderately Severe Clostridium difficile–Associated Diarrhea
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Tolevamer, a Novel Nonantibiotic Polymer, Compared with Vancomycin in the Treatment of Mild to Moderately Severe Clostridium difficile–Associated Diarrhea
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Journal Article
Tolevamer, a Novel Nonantibiotic Polymer, Compared with Vancomycin in the Treatment of Mild to Moderately Severe Clostridium difficile–Associated Diarrhea
2006
Overview
Background. Current antibiotic therapies for Clostridium difficile–associated diarrhea have limitations, including progression to severe disease, recurrent C. difficile–associated diarrhea, and selection for nosocomial pathogens. Tolevamer, a soluble, high–molecular weight, anionic polymer that binds C. difficile toxins A and B is a unique nonantibiotic treatment option. Methods. In this 3-arm, multicenter, randomized, double-blind, active-controlled, parallel-design phase II study, patients with mild to moderately severe C. difficile–associated diarrhea were randomized to receive 3 g of tolevamer per day (n = 97), 6 g of tolevamer per day (n = 95), or 500 mg of vancomycin per day (n = 97). The primary efficacy parameter was time to resolution of diarrhea, defined as the first day of 2 consecutive days when the patient had hard or formed stools (any number) or ⩽2 stools of loose or watery consistency. Results. In the per-protocol study population, resolution of diarrhea was achieved in 48 (67%) of 72 patients receiving 3 g of tolevamer per day (median time to resolution of diarrhea, 4.0 days; 95% confidence interval, 2.0–6.0 days), in 58 (83%) of 70 patients receiving 6 g of tolevamer per day (median time to resolution of diarrhea, 2.5 days; 95% confidence interval, 2.0–3.0 days), and in 73 (91%) of 80 patients receiving vancomycin (median time to resolution of diarrhea, 2.0 days; 95% confidence interval, 1.0–3.0 days). Tolevamer administered at a dosage of 6 g per day was found to be noninferior to vancomycin administered at a dosage of 500 mg per day with regard to time to resolution of diarrhea (P = .02) and was associated with a trend toward a lower recurrence rate. Tolevamer was well tolerated but was associated with an increased risk of hypokalemia. Conclusions. Tolevamer, a novel polystyrene binder of C. difficile toxins A and B, effectively treats mild to moderate C. difficile diarrhea and merits further clinical development.
Publisher
The University of Chicago Press,University of Chicago Press,Oxford University Press
Subject
/ Aged
/ Anti-Infective Agents - therapeutic use
/ Antibiotics. Antiinfectious agents. Antiparasitic agents
/ Bacterial Proteins - metabolism
/ Bacterial Toxins - metabolism
/ Biological and medical sciences
/ Colitis
/ Diarrhea
/ Dosage
/ Drugs
/ Enterocolitis, Pseudomembranous - drug therapy
/ Enterocolitis, Pseudomembranous - microbiology
/ Female
/ Humans
/ Kingdoms
/ Male
/ Pharmacology. Drug treatments
/ Placebos
/ Polymers
/ Polystyrenes - therapeutic use
/ Toxins
