In hemodialysis patients, withdrawal scores were similar after stopping or continuing difelikefalin, with a placebo-minus-difelikefalin difference of 0.52 (95% CI -0.56, 1.59).
In plain wordsIn hemodialysis patients, withdrawal scores were similar after stopping or continuing difelikefalin.
- Peptide
- Difelikefalin
- Outcome
- No significant changeMaximum COWS withdrawal score
- Study
n = 30
- Comparator
- Switch to placebo after difelikefalin
- Analysis
- Primary
- Outcome group
- Adverse events · Nervous system and cognition
- Studied dose
- Dose not stated · 3 weeks open-label treatment followed by 2 weeks randomized continuation or withdrawalAs given in this study (human).
Measurements
- Least squares mean difference in maximum COWS total score (placebo - difelikefalin)
- 0.52 COWS total score
- double-blind phase, placebo vs continued difelikefalin
- 95% CI of least squares mean difference in maximum COWS total score
- −0.56 to 1.59 COWS total score
- double-blind phase, placebo vs continued difelikefalin
Source sentences
The least squares mean difference in maximum COWS total scores was 0.52 (95% confidence interval [CI]: -0.56, 1.59).
3 context sentences(design, population, supporting numbers)
The upper CI limit (1.59) was below +4, indicating that patients who discontinued difelikefalin (placebo group) had similar withdrawal scores to patients who continued difelikefalin.
Eligible patients received open-label difelikefalin after each dialysis session for 3 weeks before entering a 2-week double-blind phase, when they were randomized to either continue difelikefalin or to switch to receiving placebo.
Signs of physical withdrawal were assessed using the Clinical Opiate Withdrawal Scale (COWS), several patient-reported scales, and physiological measures.