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Gartlehner G, Jonas DE, Morgan LC, et al. Drug Class Review: Constipation Drugs: Final Report [Internet]. Portland (OR): Oregon Health & Science University; 2007 Sep.

Addendum

As this report was going to press, the first full text study on lubiprostone was published.76 In this RCT, 129 patients with chronic constipation were randomized to lubiprostone (24, 48, or 72 mcg/day) or placebo. During the 21 days of follow-up, lubiprostone improved spontaneous bowel movement (SBM) rates in a dose-dependent manner. Mean SBM frequencies per week ranged from 5.1 to 6.1 in the lubiprostione groups compared with 3.8 in the placebo group (P = 0.046). The most common adverse events were nausea (33%), headache (11%), and diarrhea (11%). Adverse events also occurred in a dose-dependent manner. Overall, 62% – 70% of patients in the lubiprostone groups experienced at least one adverse event (compared with 39% in the placebo group).

Because lubiprostone 72 mcg/d led to higher rates of adverse events, the authors concluded that no clear risk-to-benefit advantage existed compared with lubiprostone 48 mcg/d.

Copyright © 2007, Oregon Health & Science University, Portland, Oregon.
Cover of Drug Class Review: Constipation Drugs
Drug Class Review: Constipation Drugs: Final Report [Internet].
Gartlehner G, Jonas DE, Morgan LC, et al.
Portland (OR): Oregon Health & Science University; 2007 Sep.

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