Idioma:

Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial

Schapira, Anthony HV, Prof ; McDermott, Michael P, Prof ; Barone, Paolo, Prof ; Comella, Cynthia L, Prof ; Albrecht, Stefan, MD ; Hsu, Helen H, MD ; Massey, Daniel H, MSc ; Mizuno, Yoshikuni, Prof ; Poewe, Werner, Prof ; Rascol, Olivier, Prof ; Marek, Kenneth, MD

Lancet neurology, 2013-08, Vol.12 (8), p.747-755 [Revista revisada por pares]

England: Elsevier Ltd

Texto completo disponible

Citas Citado por

Acciones

Título:
Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial
Autor: Schapira, Anthony HV, Prof ; McDermott, Michael P, Prof ; Barone, Paolo, Prof ; Comella, Cynthia L, Prof ; Albrecht, Stefan, MD ; Hsu, Helen H, MD ; Massey, Daniel H, MSc ; Mizuno, Yoshikuni, Prof ; Poewe, Werner, Prof ; Rascol, Olivier, Prof ; Marek, Kenneth, MD
Materias: Adult ; Aged ; Analysis of covariance ; Analysis of Variance ; Antiparkinson Agents - therapeutic use ; Benzothiazoles - therapeutic use ; Consent ; Dopamine ; Double-Blind Method ; Drug Administration Schedule ; Drug withdrawal ; Female ; Humans ; Male ; Medical imaging ; Middle Aged ; Neuroimaging ; Neurology ; Parkinson Disease - diagnostic imaging ; Parkinson Disease - drug therapy ; Parkinson Disease - psychology ; Parkinson's disease ; Patients ; Pramipexole ; Quality of Life ; Questionnaires ; Retrospective Studies ; Severity of Illness Index ; Tomography, Emission-Computed, Single-Photon
Es parte de: Lancet neurology, 2013-08, Vol.12 (8), p.747-755
Notas: ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
Descripción: Summary Background In models of dopaminergic neuronal loss, the dopamine agonist pramipexole has exhibited neuroprotective properties. The Pramipexole On Underlying Disease (PROUD) study was designed to identify whether early versus delayed pramipexole initiation has clinical and neuroimaging benefits in patients with Parkinson's disease (PD). Methods Between May 24, 2006, and April 22, 2009, at 98 centres, we recruited patients with PD diagnosed within 2 years and aged 30–79 years. We randomly assigned eligible patients (ratio 1:1), by a centralised, computerised randomisation schedule, to receive double-blind either placebo or pramipexole (1·5 mg a day) and followed them up for 15 months. At 9 months, or as early as 6 months if considered necessary, placebo recipients were assigned to pramipexole. In a neuroimaging substudy, striatal dopamine-transporter binding was assessed by SPECT. All patients, investigators, and independent raters were masked to study treatment. The primary endpoint was the 15-month change from baseline in total score on the unified Parkinson's disease rating scale (UPDRS). This trial is registered with ClinicalTrials.gov , number NCT00321854. Findings Of 535 patients, 261 were randomly assigned to receive pramipexole and 274 to receive placebo. At 15 months (n=411), adjusted mean change in UPDRS total score showed no significant difference between early and delayed pramipexole (−0·4 points, 95% CI −2·2 to 1·4, p=0·65). 62 patients in the early pramipexole group and 61 patients in the delayed pramipexole group were included in the neuroimaging substudy, for which the adjusted mean 15-month change in striatal123 I-FP-CIT binding was −15·1% (SE 2·1) for early and −14·6% (2·0) for delayed pramipexole (difference −0·5 percentage points, 95% CI −5·4 to 4·4, p=0·84). Overall, 180 (81%) of patients given early pramipexole and 179 (84%) patients given delayed pramipexole reported adverse events (most frequently nausea), and 22 (10%) patients in the early pramipexole group and 17 (8%) in the delayed pramipexole group had serious events, two of which (hallucinations and orthostatic hypotension) were deemed related to study drug. Interpretation By clinical and neuroimaging measures, pramipexole showed little evidence differentiating 15-month usage from usage delayed for 6–9 months. The results do not support the hypothesis that pramipexole has disease-modifying effects. Funding Boehringer Ingelheim GmbH.
Editor: England: Elsevier Ltd
Idioma: Inglés

Enlaces

View this record in MEDLINE/PubMed

Volver a la lista de resultados

Anterior Resultado 10 Siguiente Ir a la siguiente página

Realización: Logos de Redes Sociales:

Pramipexole in patients with early Parkinson's disease (PROUD): a randomised delayed-start trial

Schapira, Anthony HV, Prof ; McDermott, Michael P, Prof ; Barone, Paolo, Prof ; Comella, Cynthia L, Prof ; Albrecht, Stefan, MD ; Hsu, Helen H, MD ; Massey, Daniel H, MSc ; Mizuno, Yoshikuni, Prof ; Poewe, Werner, Prof ; Rascol, Olivier, Prof ; Marek, Kenneth, MD

England: Elsevier Ltd

Buscando en bases de datos remotas, por favor espere