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Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease.
J Neurol Sci. 2003 Dec 15; 216(1):81-7.JN

Abstract

OBJECTIVE

To evaluate the efficacy and safety of the non-ergot dopamine agonist pramipexole in untreated and levodopa-treated Chinese patients with early or advanced Parkinson's disease.

METHODS

This randomized, double-blind, placebo-controlled, parallel-group study, which was conducted in Hong Kong and Taiwan, comprised a screening period of at least 1 week, a dose-escalation period of 7 weeks, and a maintenance period of 8 weeks (total duration of treatment: 15 weeks). During the dose-escalation period, the dose of pramipexole (or number of placebo tablets) was escalated in a blinded fashion according to a predetermined schedule to the optimum tolerated dose of pramipexole, administered three times a day (minimum dose=0.375 mg/day; maximum dose=4.5 mg/day). This dose was then maintained for the duration of the maintenance period. Efficacy was primarily assessed by the Unified Parkinson's Disease Rating Scale (UPDRS). Safety and tolerability were evaluated by treatment-emergent adverse event reports, clinical laboratory test results (blood chemistry, hematology, and urinalysis), vital signs, and electrocardiograms.

RESULTS

Pramipexole was significantly more effective than placebo in reducing the total scores of the UPDRS Part II, Part III, and Parts II and III combined. Approximately 70% of both the placebo- and pramipexole-treated patients evaluated in this analysis were on levodopa. Regardless of levodopa use, the mean UPDRS total scores showed a consistently greater improvement in pramipexole patients than in placebo patients. Mean scores for pramipexole patients not on levodopa showed a greater improvement than did pramipexole patients on levodopa. The mean improvement for the pramipexole/no levodopa group relative to the placebo/no levodopa group at week 15 was 10.93 points (i.e., -14.43 points minus -3.50 points). The mean improvement for the pramipexole/levodopa group relative to the placebo/levodopa group at week 15 was 9.04 points (i.e., -10.26 points minus -1.22 points). Pramipexole was also superior to placebo as measured by improvement in the modified Hoehn and Yahr Scale and a reduction in the number of "off" hours for patients on concomitant levodopa therapy.

CONCLUSIONS

Pramipexole is an effective and well-tolerated therapy, with or without concomitant levodopa, for Chinese patients with Parkinson's disease.

Authors+Show Affiliations

Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

14607306

Citation

Wong, Ka Sing, et al. "Efficacy, Safety, and Tolerability of Pramipexole in Untreated and Levodopa-treated Patients With Parkinson's Disease." Journal of the Neurological Sciences, vol. 216, no. 1, 2003, pp. 81-7.
Wong KS, Lu CS, Shan DE, et al. Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease. J Neurol Sci. 2003;216(1):81-7.
Wong, K. S., Lu, C. S., Shan, D. E., Yang, C. C., Tsoi, T. H., & Mok, V. (2003). Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease. Journal of the Neurological Sciences, 216(1), 81-7.
Wong KS, et al. Efficacy, Safety, and Tolerability of Pramipexole in Untreated and Levodopa-treated Patients With Parkinson's Disease. J Neurol Sci. 2003 Dec 15;216(1):81-7. PubMed PMID: 14607306.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy, safety, and tolerability of pramipexole in untreated and levodopa-treated patients with Parkinson's disease. AU - Wong,Ka Sing, AU - Lu,Chin-Song, AU - Shan,Din-E, AU - Yang,Chih-Chao, AU - Tsoi,Tak Hong, AU - Mok,Vincent, PY - 2003/11/11/pubmed PY - 2004/2/27/medline PY - 2003/11/11/entrez SP - 81 EP - 7 JF - Journal of the neurological sciences JO - J Neurol Sci VL - 216 IS - 1 N2 - OBJECTIVE: To evaluate the efficacy and safety of the non-ergot dopamine agonist pramipexole in untreated and levodopa-treated Chinese patients with early or advanced Parkinson's disease. METHODS: This randomized, double-blind, placebo-controlled, parallel-group study, which was conducted in Hong Kong and Taiwan, comprised a screening period of at least 1 week, a dose-escalation period of 7 weeks, and a maintenance period of 8 weeks (total duration of treatment: 15 weeks). During the dose-escalation period, the dose of pramipexole (or number of placebo tablets) was escalated in a blinded fashion according to a predetermined schedule to the optimum tolerated dose of pramipexole, administered three times a day (minimum dose=0.375 mg/day; maximum dose=4.5 mg/day). This dose was then maintained for the duration of the maintenance period. Efficacy was primarily assessed by the Unified Parkinson's Disease Rating Scale (UPDRS). Safety and tolerability were evaluated by treatment-emergent adverse event reports, clinical laboratory test results (blood chemistry, hematology, and urinalysis), vital signs, and electrocardiograms. RESULTS: Pramipexole was significantly more effective than placebo in reducing the total scores of the UPDRS Part II, Part III, and Parts II and III combined. Approximately 70% of both the placebo- and pramipexole-treated patients evaluated in this analysis were on levodopa. Regardless of levodopa use, the mean UPDRS total scores showed a consistently greater improvement in pramipexole patients than in placebo patients. Mean scores for pramipexole patients not on levodopa showed a greater improvement than did pramipexole patients on levodopa. The mean improvement for the pramipexole/no levodopa group relative to the placebo/no levodopa group at week 15 was 10.93 points (i.e., -14.43 points minus -3.50 points). The mean improvement for the pramipexole/levodopa group relative to the placebo/levodopa group at week 15 was 9.04 points (i.e., -10.26 points minus -1.22 points). Pramipexole was also superior to placebo as measured by improvement in the modified Hoehn and Yahr Scale and a reduction in the number of "off" hours for patients on concomitant levodopa therapy. CONCLUSIONS: Pramipexole is an effective and well-tolerated therapy, with or without concomitant levodopa, for Chinese patients with Parkinson's disease. SN - 0022-510X UR - https://www.unboundmedicine.com/medline/citation/14607306/Efficacy_safety_and_tolerability_of_pramipexole_in_untreated_and_levodopa_treated_patients_with_Parkinson's_disease_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022510X0300217X DB - PRIME DP - Unbound Medicine ER -