title: Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study.
abstract: 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.
authors.affiliation: Department of Neurology, Philipps-University, Marburg, Germany. oertelw@med.uni-marburg.de
authors.forename: Wolfgang H
authors.initials: WH
authors.lastname: Oertel
authors.forename: Erik
authors.initials: E
authors.lastname: Wolters
authors.forename: Cristina
authors.initials: C
authors.lastname: Sampaio
authors.forename: Santiago
authors.initials: S
authors.lastname: Gimenez-Roldan
authors.forename: Bruno
authors.initials: B
authors.lastname: Bergamasco
authors.forename: Max
authors.initials: M
authors.lastname: Dujardin
authors.forename: Donald G
authors.initials: DG
authors.lastname: Grosset
authors.forename: Guy
authors.initials: G
authors.lastname: Arnold
authors.forename: Klaus L
authors.initials: KL
authors.lastname: Leenders
authors.forename: Hans-Peter
authors.initials: HP
authors.lastname: Hundemer
authors.forename: Alberto
authors.initials: A
authors.lastname: Lledó
authors.forename: Andrew
authors.initials: A
authors.lastname: Wood
authors.forename: Paul
authors.initials: P
authors.lastname: Frewer
authors.forename: Johannes
authors.initials: J
authors.lastname: Schwarz
mesh_terms: 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
chemical_list: D018491:Dopamine Agonists; D010479:Pergolide; D007980:Levodopa