Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation
Polyethylene Glycol Laxative for Chronic Treatment of Chronic Constipation
Objectives: Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.
Methods: Study subjects who met defined criteria for chronic constipation were randomized in this double-blind, placebo-controlled, parallel, multicenter study to receive PEG laxative as a single daily dose of 17 g or placebo for 6 months. Baseline constipation status was confirmed during a 14-day observation period. As a primary efficacy variable, treatment success was defined as relief of modified ROME criteria for constipation for 50% or more of their treatment weeks. Various secondary measures were assessed. An Interactive Voice Response System (IVRS) recorded daily bowel movement experience and study efficacy and safety information. Laboratory testing at baseline and monthly for the study duration was analyzed for hematology, blood chemistry including amylase, GGT, uric acid, lipids, and urinalysis.
Results: A total of 304 patients were enrolled and received treatment at one of 50 centers. Successful treatment according to the primary efficacy variable was seen in 52.0% of PEG and 11% of placebo subjects (P < 0.001). Similar efficacy was seen in a subgroup of 75 elderly subjects. According to the primary efficacy definition (based on individual treatment weeks), 61% of PEG treatment weeks versus 22% of the placebo weeks were successful (P < 0.001). There were no significant differences in laboratory findings or adverse events except for the gastrointestinal category where diarrhea, flatulence, and nausea were the most frequent with PEG although they were not individually statistically significant compared with placebo. Similar results were observed when analyzed for differences due to gender, race, or age.
Conclusions: PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.
Until recently, few data have been available about chronic treatment of chronic constipation. Of the various constipation regimens, only tegaserod, a serotonin subtype 4 receptor partial agonist (Zelnorm, Novartis Pharmaceutical Corporation, East Hannover, NJ), and lubiprostone, a selective chloride channel activator (Amitiza, Takeda Pharmaceuticals, Lincolnshire, IL), have FDA approval for treatment of chronic idiopathic constipation. Polyethylene glycol 3350 (PEG) (MiraLAX, Braintree Laboratories, Inc, Braintree, MA) has proven safety and efficacy for short-term treatment of occasional constipation. This present investigation was designed to evaluate the safety and efficacy of PEG for extended (6 month) use in patients with chronic constipation, including a subgroup of elderly patients.
Abstract and Introduction
Abstract
Objectives: Polyethylene glycol (PEG) 3350 (MiraLAX) is currently approved for the short-term treatment of occasional constipation. This study was designed to compare the safety and efficacy of PEG laxative versus placebo over a 6-month treatment period in patients with chronic constipation.
Methods: Study subjects who met defined criteria for chronic constipation were randomized in this double-blind, placebo-controlled, parallel, multicenter study to receive PEG laxative as a single daily dose of 17 g or placebo for 6 months. Baseline constipation status was confirmed during a 14-day observation period. As a primary efficacy variable, treatment success was defined as relief of modified ROME criteria for constipation for 50% or more of their treatment weeks. Various secondary measures were assessed. An Interactive Voice Response System (IVRS) recorded daily bowel movement experience and study efficacy and safety information. Laboratory testing at baseline and monthly for the study duration was analyzed for hematology, blood chemistry including amylase, GGT, uric acid, lipids, and urinalysis.
Results: A total of 304 patients were enrolled and received treatment at one of 50 centers. Successful treatment according to the primary efficacy variable was seen in 52.0% of PEG and 11% of placebo subjects (P < 0.001). Similar efficacy was seen in a subgroup of 75 elderly subjects. According to the primary efficacy definition (based on individual treatment weeks), 61% of PEG treatment weeks versus 22% of the placebo weeks were successful (P < 0.001). There were no significant differences in laboratory findings or adverse events except for the gastrointestinal category where diarrhea, flatulence, and nausea were the most frequent with PEG although they were not individually statistically significant compared with placebo. Similar results were observed when analyzed for differences due to gender, race, or age.
Conclusions: PEG laxative is safe and effective for use in patients with chronic constipation for 6 months.
Introduction
Until recently, few data have been available about chronic treatment of chronic constipation. Of the various constipation regimens, only tegaserod, a serotonin subtype 4 receptor partial agonist (Zelnorm, Novartis Pharmaceutical Corporation, East Hannover, NJ), and lubiprostone, a selective chloride channel activator (Amitiza, Takeda Pharmaceuticals, Lincolnshire, IL), have FDA approval for treatment of chronic idiopathic constipation. Polyethylene glycol 3350 (PEG) (MiraLAX, Braintree Laboratories, Inc, Braintree, MA) has proven safety and efficacy for short-term treatment of occasional constipation. This present investigation was designed to evaluate the safety and efficacy of PEG for extended (6 month) use in patients with chronic constipation, including a subgroup of elderly patients.
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