Efficacy and Safety of Extended- Versus Immediate-Release Pramipexole in Japanese Patients With Advanced and L-dopa–Undertreated Parkinson Disease: A Double-Blind, Randomized Trial
Clinical Neuropharmacology, 08/02/2012
Mizuno Y et al. – In L–dopa–treated patients, pramipexole extended–release (ER) and pramipexole IR demonstrated similar efficacy, safety, tolerability, and trough plasma levels. Patients can be safely switched overnight from pramipexole IR to pramipexole ER with no impact on efficacy.Methods
- After a 1– to 4–week screening/enrollment, 112 patients who had exhibited L–dopa–related problems or were receiving suboptimal L–dopa dosage were randomized in double–blind, double–dummy, 1:1 fashion to pramipexole ER once daily or pramipexole IR 2 to 3 times daily for 12 weeks, both titrated to a maximum daily dose of 4.5 mg.
- Successful completers of double–blind treatment were switched to open–label pramipexole ER, beginning with a 4–week dose–adjustment phase.
- Among the double–blind treatment patients (n=56 in each group), Unified Parkinson’s Disease Rating Scale Parts II+III total scores decreased significantly from baseline and to a similar degree with pramipexole ER and IR formulations.
- In each group, 47 double–blind patients (83.9%) reported adverse events (AEs), requiring withdrawal of 3 ER patients (5.4%) and 2 IR patients (3.6%).
- Trough plasma levels at steady state (at the same doses and dose–normalized concentrations) were also similar with both formulations.
- Among open–label treatment patients (n=53 from IR to ER), 83% were successfully switched (no worsening of PD symptoms) to pramipexole ER.