September 29, 2010International Clinical Psychopharmacology
Evaluation of the effect of paliperidone extended release and quetiapine on corrected QT intervals
Key result
Paliperidone ER 12 mg/day was noninferior to quetiapine 800 mg/day for QTc interval change (mean difference -5.1 ms; 90% CI -9.2 to -0.9) based on a 10-ms noninferiority margin.
Why the study?
Does paliperidone ER compared to quetiapine prolong the QTc interval in patients with schizophrenia or schizoaffective disorder?
Population
109 patients with schizophrenia (79%) or schizoaffective disorder (21%)
Comparison
Paliperidone extended release 12 mg/day and 18… vs Quetiapine 800 mg/day and placebo
Design
RCT, randomly assigned in 2 : 2 : 1 ratio
Follow-up
11-12 days
Authors
Discussion
Loading...
Member takes
Implication
Supports similar QTc safety for paliperidone and quetiapine at high doses; extends comparative cardiac safety data for antipsychotic selection.
Study Design
Type
RCT (n=109)
Randomization
2:2:1 ratio
Structured PICO
Does paliperidone ER compared to quetiapine prolong the QTc interval in patients with schizophrenia or schizoaffective disorder?
P
Population
109 patients with schizophrenia or schizoaffective disorder.
I
Intervention
Paliperidone extended release (ER) 12 mg/day and 18 mg/day
C
Comparator
Quetiapine 800 mg/day and placebo
O
Outcome
Least-squares mean change from baseline in population-specific linear-derived correction method (QTc) from baseline to days 6-7 at individual tmaxsurrogate
Main Result
Mean Difference: -5.1 (95% CI -9.2–-0.9)
Paliperidone ER at doses up to 18 mg/day is noninferior to quetiapine 800 mg/day regarding QTc prolongation in patients with schizophrenia or schizoaffective disorder.
Cite This Study
Hough et al. (2010) conducted an RCT in Schizophrenia or schizoaffective disorder (n=109). Paliperidone extended release vs. Quetiapine 800 mg/day and placebo was evaluated on Least-squares mean change from baseline in population-specific linear-derived QTc interval to days 6-7 at individual tmax (MD -5.1 ms, 95% CI -9.2 to -0.9). Paliperidone ER 12 mg/day was noninferior to quetiapine 800 mg/day for QTc interval change (mean difference -5.1 ms; 90% CI -9.2 to -0.9) based on a 10-ms noninferiority margin.