Abstract: TH-PO981
DIalysis Symptom COntrol-Restless Legs Syndrome (DISCO-RLS): A Multicenter, Randomized, Double Blinded, Placebo Controlled 4x Crossover Trial
Session Information
- Late-Breaking Clinical Trials (Posters)
November 03, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 701 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Collister, David Thomas, University of Alberta Faculty of Medicine & Dentistry, Edmonton, Alberta, Canada
- Hardy, Colin Scott William, Population Health Research Institute, Hamilton, Ontario, Canada
- Rabbat, Christian G., McMaster University, Hamilton, Ontario, Canada
- Tennankore, Karthik K., Dalhousie University Faculty of Medicine, Halifax, Nova Scotia, Canada
- Zimmerman, Deborah Lynn, University of Ottawa Faculty of Medicine, Ottawa, Ontario, Canada
- Tangri, Navdeep, University of Manitoba Max Rady College of Medicine, Winnipeg, Manitoba, Canada
- Wald, Ron, University of Toronto, Toronto, Ontario, Canada
- Manns, Braden J., University of Calgary Cumming School of Medicine, Calgary, Alberta, Canada
- Nadeau-Fredette, Annie-Claire, Universite de Montreal, Montreal, Quebec, Canada
- Goupil, Remi, Universite de Montreal, Montreal, Quebec, Canada
- Silver, Samuel A., Queen's University, Kingston, Ontario, Canada
- Walsh, Michael, McMaster University, Hamilton, Ontario, Canada
Group or Team Name
- DISCO-RLS investigators
Background
Restless legs syndrome (RLS) affects 30% of patients with kidney failure and reduces quality of life. Commonly used pharmacologic treatments may reduce RLS severity but residual symptoms are common as are side effects at higher doses.
Methods
Potential participants were adults receiving in-center hemodialysis at least 3x weekly with at least moderate RLS symptoms after a 2-week placebo run-in period off their baseline RLS medications. Eligible participants were randomly allocated to the four weeks each of the four following treatments in random order: 1) gabapentin 100mg + ropinirole 0.5mg, 2) gabapentin 100mg + ropinirole placebo, 3) gabapentin placebo + ropinirole 0.5mg, 4) gabapentin placebo + ropinirole placebo, each taken once daily. In each treatment period, participants were seen weekly. The primary outcome was the International Restless Legs Study Group Rating Scale (IRLS) score at 3 and 4 weeks of each treatment period.
Results
Of the 52 participants randomized, the mean (SD) age was 58.5 (13.6) years, 21 (40.4%) were female, 30 (57.7%) had diabetes, and the mean (SD) baseline IRLS was 23.8 (8.6). No treatment group reduced estimated IRLS to a greater extent than placebo (Figure 1). There were no significant effects of either treatment on other measures of RLS severity, quality of life or serious adverse effects.
Conclusion
Neither gabapentin 100 mg daily, ropinirole 0.5 mg daily or the combination reduced RLS symptoms in this trial of adults receiving hemodialysis. New approaches to treating RLS in patients receiving dialysis are needed. (ClinicalTrials.gov NCT03806530)