Neurology Clinical Trial Database
EXPRESS
Bottom Line
Pramipexole ER (extended-release, once daily) was noninferior to pramipexole IR (immediate-release, three times daily) for UPDRS Part II+III improvement in early PD (-7.5 vs -7.4 points; difference -0.1; 95% CI -1.6 to 1.5). Both superior to placebo (-3.4). Similar adverse event profiles. 539 patients, 76 centers. Published Neurology 2010.
Major Points
- ER noninferior to IR: UPDRS II+III -7.5 vs -7.4 (diff -0.1; 95% CI -1.6 to 1.5). Predefined margin ±3.0.
- Both superior to placebo: -7.5/-7.4 vs -3.4 (P<0.0001 for both).
- 539 patients with early PD (Hoehn & Yahr ≤3). 18-week, double-blind, double-dummy.
- ER dose: 0.375-4.5 mg once daily. IR dose: 0.125-1.5 mg TID. 7-week titration.
- CGI-I responder rate: ER 72.3% vs IR 68.4% vs placebo 51.4%.
- AEs similar: somnolence ~11% all active, nausea ~14%, dizziness ~8%.
- Convenience advantage: once-daily dosing with equivalent efficacy and safety.
- 76 centers across 12 countries. Boehringer Ingelheim sponsored.
- Supports switch from IR to ER pramipexole for patient convenience.
- Published Neurology 2010 (Hauser et al.).
Funding
Novartis Pharmaceuticals
Based on: EXPRESS (New England Journal of Medicine, 2004)
Authors: Emre M et al.
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