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Efficacy of combining levodopa with entacapone on quality of life and activities of daily living in patients experiencing wearing-off type fluctuations.
Acta Neurol Scand. 2005 Jan; 111(1):21-8.AN

Abstract

OBJECTIVES

To compare the efficacy of levodopa/dopa decarboxylase inhibitor (DDCI) plus entacapone with levodopa/DDCI plus placebo on measures of parkinsonian disability and health-related quality of life (QoL) in subjects with Parkinson's disease (PD) experiencing motor fluctuations.

MATERIALS AND METHODS

A double-blind, placebo-controlled phase IV study was performed in 270 PD patients randomized to receive either entacapone 200 mg or placebo with each dose of their current levodopa regimen. The primary variables were the Unified Parkinson's Disease Rating Scale (UPDRS) part II activities of daily living (ADL) and the Parkinson's Disease Questionnaire (PDQ)-39 summary index. UPDRS parts I, III-VI, Global Assessment of Change, PDQ-39 subscores, and the Short-Form (SF)-36 and the European Quality of Life five-dimension questionnaire (EQ-5D) were included as secondary variables.

RESULTS

There was a significant improvement in ADL scores with levodopa/DDCI/entacapone compared with levodopa/DDCI/placebo at 5 and 13 weeks (-2.3 vs -0.7, respectively; P = 0.0001). However, no significant differences were observed between treatments using the PDQ-39 summary index. UPDRS part III (motor) scores significantly decreased in the levodopa/DDCI/entacapone group compared with the levodopa/DDCI/placebo group (-5.0 vs -2.9, respectively; P = 0.03). Similarly, the change in the investigators Global Assessment was significantly greater (P = 0.004) in the levodopa/DDCI/entacapone group. There were no significant differences between treatments for any of the PDQ-39 subscores, the SF-36 variables or the EQ-5D utility score.

CONCLUSIONS

Levodopa combined with entacapone demonstrated good efficacy in terms of ADL, global function, motor performance and was well tolerated. However, this short-term study did not generate significant improvements in QoL.

Authors+Show Affiliations

Department of Neurology, Medical Faculty of the Technical University, Dresden, Germany. heinz.reichmann@mailbox.tu-dresden.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

15595934

Citation

Reichmann, H, et al. "Efficacy of Combining Levodopa With Entacapone On Quality of Life and Activities of Daily Living in Patients Experiencing Wearing-off Type Fluctuations." Acta Neurologica Scandinavica, vol. 111, no. 1, 2005, pp. 21-8.
Reichmann H, Boas J, Macmahon D, et al. Efficacy of combining levodopa with entacapone on quality of life and activities of daily living in patients experiencing wearing-off type fluctuations. Acta Neurol Scand. 2005;111(1):21-8.
Reichmann, H., Boas, J., Macmahon, D., Myllyla, V., Hakala, A., & Reinikainen, K. (2005). Efficacy of combining levodopa with entacapone on quality of life and activities of daily living in patients experiencing wearing-off type fluctuations. Acta Neurologica Scandinavica, 111(1), 21-8.
Reichmann H, et al. Efficacy of Combining Levodopa With Entacapone On Quality of Life and Activities of Daily Living in Patients Experiencing Wearing-off Type Fluctuations. Acta Neurol Scand. 2005;111(1):21-8. PubMed PMID: 15595934.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of combining levodopa with entacapone on quality of life and activities of daily living in patients experiencing wearing-off type fluctuations. AU - Reichmann,H, AU - Boas,J, AU - Macmahon,D, AU - Myllyla,V, AU - Hakala,A, AU - Reinikainen,K, AU - ,, PY - 2004/12/15/pubmed PY - 2005/3/24/medline PY - 2004/12/15/entrez SP - 21 EP - 8 JF - Acta neurologica Scandinavica JO - Acta Neurol Scand VL - 111 IS - 1 N2 - OBJECTIVES: To compare the efficacy of levodopa/dopa decarboxylase inhibitor (DDCI) plus entacapone with levodopa/DDCI plus placebo on measures of parkinsonian disability and health-related quality of life (QoL) in subjects with Parkinson's disease (PD) experiencing motor fluctuations. MATERIALS AND METHODS: A double-blind, placebo-controlled phase IV study was performed in 270 PD patients randomized to receive either entacapone 200 mg or placebo with each dose of their current levodopa regimen. The primary variables were the Unified Parkinson's Disease Rating Scale (UPDRS) part II activities of daily living (ADL) and the Parkinson's Disease Questionnaire (PDQ)-39 summary index. UPDRS parts I, III-VI, Global Assessment of Change, PDQ-39 subscores, and the Short-Form (SF)-36 and the European Quality of Life five-dimension questionnaire (EQ-5D) were included as secondary variables. RESULTS: There was a significant improvement in ADL scores with levodopa/DDCI/entacapone compared with levodopa/DDCI/placebo at 5 and 13 weeks (-2.3 vs -0.7, respectively; P = 0.0001). However, no significant differences were observed between treatments using the PDQ-39 summary index. UPDRS part III (motor) scores significantly decreased in the levodopa/DDCI/entacapone group compared with the levodopa/DDCI/placebo group (-5.0 vs -2.9, respectively; P = 0.03). Similarly, the change in the investigators Global Assessment was significantly greater (P = 0.004) in the levodopa/DDCI/entacapone group. There were no significant differences between treatments for any of the PDQ-39 subscores, the SF-36 variables or the EQ-5D utility score. CONCLUSIONS: Levodopa combined with entacapone demonstrated good efficacy in terms of ADL, global function, motor performance and was well tolerated. However, this short-term study did not generate significant improvements in QoL. SN - 0001-6314 UR - https://www.unboundmedicine.com/medline/citation/15595934/Efficacy_of_combining_levodopa_with_entacapone_on_quality_of_life_and_activities_of_daily_living_in_patients_experiencing_wearing_off_type_fluctuations_ L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0001-6314&date=2005&volume=111&issue=1&spage=21 DB - PRIME DP - Unbound Medicine ER -