Placebo-controlled trial of lubiprostone for constipation associated with Parkinson disease
Ondo WG et al. – In this randomized controlled trial, lubiprostone seemed to be well tolerated and effective for the short–term treatment of constipation in Parkinson disease (PD).Methods
- Patients with PD and clinically meaningful constipation (constipation rating scale score >10 [range: 0-28]) were recruited from 2 academic movement disorder centers to participate in the study.
- After enrollment, patients were initially followed for 2 weeks and then were randomly assigned 1:1 to lubiprostone, and the dose was titrated up to 48 μg/day.
- They returned 4 weeks later for a final assessment.
- Data included stool diaries and global impressions (coprimary endpoints), demographics, Unified Parkinson's Disease Rating Scale scores, constipation scale scores, visual analog scale (VAS) scores, a stool diary, and adverse events.
- Fifty-four subjects (39 male, mean age 67.0 ± 10.1 years, and mean duration of PD 8.3 ± 5.4 years) were randomly assigned to lubiprostone or placebo.
- One patient in the drug group discontinued the study because of logistics, and one patient in the placebo group discontinued the study because of lack of efficacy.
- A marked or very marked clinical global improvement was reported by 16 of 25 (64.0%) subjects receiving drug vs 5 of 27 (18.5%) subjects receiving placebo (p=0.001).
- The constipation rating scale (p<0.05), VAS (p=0.001), and stools per day in the diary (p<0.001) all improved with drug compared with placebo.
- Adverse events with drug were mild, most commonly intermittent loose stools.