Polyethylene glycol 3350 plus electrolytes (PEG3350 + E) is the most commonly used osmotic laxative in Europe. However, prospective data on its long-term (over 6 months) safety and efficacy are not available yet. Therefore, a randomized, double-blind, placebo-controlled study with a 52-week open-label extension was performed. In this study, Japanese patients with chronic constipation were randomized to receive either PEG3350 + E or placebo for 2 weeks orally. Following this, they were administered PEG3350 + E in the 52-week extension study. The starting dose was 13.7 g/day dissolved in 125 mL of water, and dose titration was allowed (upper limit 41.1 g/day) according to the patients bowel condition. Of 204 patients who provided informed consent, 156 were randomized and included in the full analysis. The results showed that the frequency of spontaneous bowel movements was significantly higher with PEG3350 + E [least squares mean (LSM) 4.3, 95% confidence interval (CI): 3.6-4.9] compared to placebo (LSM 1.6, 95% CI: 1.2-2.1; P < 0.0001). A total of 153 patients entered the extension study; use of PEG3350 + E was associated withsustained improvement in bowel function. The common adverse drug reactions were mild gastrointestinal disorders. The researchers concluded that treatment with PEG3350 + E resolved constipation in the short term. Moreover, it was well tolerated and led to sustained improvement in bowel function in long-term treatment of Japanese patients with chronic constipation.

Source: J Gastroenterol. 2019 Sep;54(9):792-803.