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Early treatment of Parkinson's disease with cabergoline delays the onset of motor complications. Results of a double-blind levodopa controlled trial. The PKDS009 Study Group.
Drugs. 1998; 55 Suppl 1:23-30.D

Abstract

This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4 mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34%; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline vs levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications.

Authors+Show Affiliations

Department of Neurology, University of Turku, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

9483167

Citation

Rinne, U K., et al. "Early Treatment of Parkinson's Disease With Cabergoline Delays the Onset of Motor Complications. Results of a Double-blind Levodopa Controlled Trial. the PKDS009 Study Group." Drugs, vol. 55 Suppl 1, 1998, pp. 23-30.
Rinne UK, Bracco F, Chouza C, et al. Early treatment of Parkinson's disease with cabergoline delays the onset of motor complications. Results of a double-blind levodopa controlled trial. The PKDS009 Study Group. Drugs. 1998;55 Suppl 1:23-30.
Rinne, U. K., Bracco, F., Chouza, C., Dupont, E., Gershanik, O., Marti Masso, J. F., Montastruc, J. L., & Marsden, C. D. (1998). Early treatment of Parkinson's disease with cabergoline delays the onset of motor complications. Results of a double-blind levodopa controlled trial. The PKDS009 Study Group. Drugs, 55 Suppl 1, 23-30.
Rinne UK, et al. Early Treatment of Parkinson's Disease With Cabergoline Delays the Onset of Motor Complications. Results of a Double-blind Levodopa Controlled Trial. the PKDS009 Study Group. Drugs. 1998;55 Suppl 1:23-30. PubMed PMID: 9483167.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Early treatment of Parkinson's disease with cabergoline delays the onset of motor complications. Results of a double-blind levodopa controlled trial. The PKDS009 Study Group. AU - Rinne,U K, AU - Bracco,F, AU - Chouza,C, AU - Dupont,E, AU - Gershanik,O, AU - Marti Masso,J F, AU - Montastruc,J L, AU - Marsden,C D, PY - 1998/3/4/pubmed PY - 1998/3/4/medline PY - 1998/3/4/entrez SP - 23 EP - 30 JF - Drugs JO - Drugs VL - 55 Suppl 1 N2 - This multicentre randomised double-blind 3- to 5-year trial was designed to assess whether initial therapy with cabergoline alone or in combination with levodopa prevents or delays the occurrence of long term motor complications in patients with early Parkinson's disease. Patients eligible for study inclusion (n = 412) had early idiopathic Parkinson's disease (Hoehn and Yahr stages 1 to 3) and had received no previous treatment with levodopa, selegiline or dopamine agonists. Patients were randomised to receive either cabergoline (0.25 to 4 mg once daily) or levodopa (100 to 600 mg/day) titrated over a maximum period of 24 weeks. Once the optimum or maximum tolerated dose was achieved, it was maintained up to the end-point (development of motor complications confirmed at 2 consecutive 3-month visits) or up to a minimum of 3 years' treatment. Open labelled levodopa was added in both treatment arms when the improvement in motor disability [Unified Parkinson's Disease Rating Scale (UPDRS) factor III] decreased below 30% vs baseline. Both treatments improved motor disability, decreasing UPDRS factor III scores and factor II scores for activities of daily living. The development of motor complications (end-point) was significantly less frequent in patients treated with cabergoline than in levodopa recipients (22% vs 34%; p < 0.02). The relative risk of developing motor complications during treatment with cabergoline was more than 50% lower than with levodopa. Serious adverse events, either drug related or not, were slightly more frequent in cabergoline-treated patients (31%) than in those treated with levodopa (25%). The withdrawal rate in the cabergoline vs levodopa group was 16 vs 13%. In conclusion, the study shows that, in patients with early Parkinson's disease, cabergoline is effective either as monotherapy or combined with levodopa. Moreover, starting treatment with cabergoline significantly delays the development of motor complications. SN - 0012-6667 UR - https://www.unboundmedicine.com/medline/citation/9483167/Early_treatment_of_Parkinson's_disease_with_cabergoline_delays_the_onset_of_motor_complications__Results_of_a_double_blind_levodopa_controlled_trial__The_PKDS009_Study_Group_ L2 - https://dx.doi.org/10.2165/00003495-199855001-00004 DB - PRIME DP - Unbound Medicine ER -