Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study.
Dopamine agonists are used as initial treatment in patients with Parkinson's disease (PD) to reduce incidence and severity of motor complications. This paradigm is based on long-term studies, allowing "rescue" therapy with levodopa. The present strict monotherapy study (PELMOPET, the acronym for the pergolide-versus-L-dopa-monotherapy-and-positron-emission-tomography trial) evaluated the efficacy and safety of pergolide versus levodopa without levodopa "rescue" medication. This multicenter, double-blind, randomized, 3-year trial compared pergolide monotherapy (n=148) with levodopa monotherapy (n=146) in dopamine-naive patients with early PD (Hoehn and Yahr stage 1-2.5). Primary efficacy measures were clinical efficacy, severity and time to onset of motor complications, and disease progression. During the 3 years, severity of motor complications was significantly lower and time to onset of dyskinesia was significantly delayed in the group receiving pergolide (3.23 mg/day) compared with those receiving levodopa (504 mg/day). However, time to onset of motor complications was not longer in patients receiving pergolide after 3 years. Symptomatic relief (assessed by Unified Parkinson's Disease Rating Scale [UPDRS], UPDRS II, and III, Clinical Global Impressions [CGI] severity, and CGI and Patient Global Impressions [PGI] improvement) was significantly greater in patients receiving levodopa. Adverse events led to discontinuation of therapy in 17.6% of pergolide patients and 9.6% of levodopa patients. This is the first study comparing strict monotherapy with a dopamine agonist versus levodopa in previously untreated early PD. In principle, both levodopa and a dopamine agonist such as pergolide seem to be suitable options as initial PD therapy. The choice remains with the treating physician based on the different efficacy and adverse event profiles.
Oertel
Wolfgang H
WH
Department of Neurology, Philipps-University, Marburg, Germany. oertelw@med.uni-marburg.de
Wolters
Erik
E
Sampaio
Cristina
C
Gimenez-Roldan
Santiago
S
Bergamasco
Bruno
B
Dujardin
Max
M
Grosset
Donald G
DG
Arnold
Guy
G
Leenders
Klaus L
KL
Hundemer
Hans-Peter
HP
Lledó
Alberto
A
Wood
Andrew
A
Frewer
Paul
P
Schwarz
Johannes
J
D000328:Adult; D017668:Age of Onset; D000368:Aged; D001921:Brain / Q000378:metabolism; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D020820:Dyskinesias / Q000000981:diagnostic imaging / Q000188:drug therapy / Q000453:epidemiology; D042241:Early Diagnosis; D005260:Female; D006801:Humans; D007980:Levodopa / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010300:Parkinson Disease / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D010479:Pergolide / Q000627:therapeutic use*; D011446:Prospective Studies; D011877:Radionuclide Imaging; D011795:Surveys and Questionnaires
D018491:Dopamine Agonists; D010479:Pergolide; D007980:Levodopa