Pergolide versus levodopa monotherapy in early Parkinson's disease patients: The PELMOPET study

• Published in: Movement disorders 2006-03, Vol.21 (3), p.343-353
• Main Authors: Oertel, Wolfgang H., Wolters, Erik, Sampaio, Cristina, Gimenez-Roldan, Santiago, Bergamasco, Bruno, Dujardin, Max, Grosset, Donald G., Arnold, Guy, Leenders, Klaus L., Hundemer, Hans-Peter, Lledó, Alberto, Wood, Andrew, Frewer, Paul, Schwarz, Johannes
• Format: Article
• Language: English
• Subjects: Adult; Age of Onset; Aged; Biological and medical sciences; Brain - metabolism; Degenerative and inherited degenerative diseases of the nervous system. Leukodystrophies. Prion diseases; Dopamine Agonists - therapeutic use; Double-Blind Method; dyskinesia; Dyskinesias - diagnostic imaging; Dyskinesias - drug therapy; Dyskinesias - epidemiology; Early Diagnosis; Female; Humans; levodopa; Levodopa - therapeutic use; Male; Medical sciences; Middle Aged; monotherapy; motor complications; Multiple sclerosis and variants. Guillain barré syndrome and other inflammatory polyneuropathies. Leukoencephalitis; Neurology; Parkinson Disease - diagnostic imaging; Parkinson Disease - drug therapy; Parkinson Disease - epidemiology; Parkinson's disease; PELMOPET; pergolide; Pergolide - therapeutic use; Prospective Studies; Radionuclide Imaging; Surveys and Questionnaires; symptomatic effect
• ISSN: 0885-3185; 1531-8257
• DOI: 10.1002/mds.20724

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. © 2005 Movement Disorder Society