Dataset Information

Effects of rasagiline on Parkinson's Disease Questionnaire (PDQ-39) emotional well-being domain in patients with Parkinson's disease: A post-hoc analysis of clinical trials in Japan.

ABSTRACT:

Background

Identifying the factors that influence health-related quality of life (HRQoL) is of great scientific interest, but a potential causal relationship between treatment and HRQoL has yet to be fully elucidated. Japanese patients reported better HRQoL outcomes on the Parkinson's Disease Questionnaire (PDQ-39) emotional well-being domain, a 6-question subset of the PDQ-39 which is considered to reflect the emotional aspects of the disease-specific HRQoL, when treated with rasagiline, than placebo, in both a monotherapy clinical trial (NCT02337725) and an adjunctive therapy clinical trial in patients with wearing-off phenomena (NCT02337738).

Objective

To investigate how rasagiline exerts its effect on the PDQ-39 emotional well-being domain in Japanese patients with Parkinson's disease.

Methods

A path analysis was performed to assess the direct treatment effects of rasagiline on the PDQ-39 emotional well-being domain and the effects mediated indirectly through the influence on items related to motor symptoms by a post-hoc analysis of two clinical trials in Japan.

Results

In the monotherapy trial, the PDQ-39 emotional well-being domain was mainly affected indirectly through items related to motor symptoms (80.7%) composed of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (67.2%) and Part III (13.5%). In the adjunctive therapy trial, the PDQ-39 emotional well-being domain was also mainly influenced indirectly through effects on items related to motor symptoms (1 mg/day: 54.7%, 0.5 mg/day: 57.6%) composed of MDS-UPDRS Part II (1 mg/day: 35.6%, 0.5 mg/day: 40.9%), Part III (1 mg/day: 8.0%, 0.5 mg/day: 8.3%) and mean daily OFF-time (1 mg/day: 11.1%, 0.5 mg/day: 8.4%).

Conclusions

The effects of rasagiline on the PDQ-39 emotional well-being domain were mediated primarily by influence on the subjective aspects of motor experiences of daily living.

PROVIDER: S-EPMC8789184 | BioStudies |

REPOSITORIES: biostudies

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Project description:Background:Parkinson's disease impacts health-related quality of life (HRQoL), however no studies inquired on predictors of HRQoL changes after rehabilitation. This study assessed the relationship between mobility domain of HRQoL measured by Parkinson's Disease Questionnaires-39 (PDQ-39) and clinical-demographic characteristics and developed a model predicting changes after rehabilitation. Methods:Subjects with Parkinson's disease underwent rehabilitation treatment and completed the following predictors: 10-m walking test (10MWT), Timed Up and Go (TUG), Berg Balance scale (BBS), Activities-specific Balance Confidence scales (ABC), Freezing of Gait (FOGQ) and PDQ-39. Two general linear models were calculated to predict the relationship between HRQoL at baseline and to predict HRQoL changes after rehabilitation. Results:Forty-two subjects (age 74.9?±?7.3?years, Hoehn&Yahr 2.8?±?0.6) completed the baseline evaluation. The first model (multiple R2?=?0.59, F?=?5.86, P?<?0.001) showed that ABC (B?=?-?0.51, CI?=?-?0.86 to 0.15, R2?=?0.41, P?=?0.005) and FOGQ (B?=?2.38, CI?=?1.03 to 3.73, R2?=?0.07, P?=?0.001) were statistically significant predictors of mobility aspect of HRQoL at baseline. Thirty seven subjects completed the rehabilitation sessions, data were entered in the second model (multiple R2?=?0.40, F?=?4.24, P?<?0.004) showing that gender (B?=?-?5.12, CI?=?-?9.86 to -?0.39, R2?=?0.23, P?=?0.034), Hoehn&Yahr (B?=?10.93, CI?=?+?3.27 to +?18.61, R2?=?0.22, P?=?0.006) and PDQ-39 mobility at baseline (B?=?-?0.38, CI?=?-?0.63 to -?0.14, R2?=?0.55, P?=?0.002) were statistically significant predictors of changes of the mobility aspect of HRQoL. Conclusions:Balance confidence and Freezing of Gait are associated with the mobility aspect of HRQoL. Changes in mobility domain of HRQoL (as assessed by PDQ-39) are likely to be greater in males, in people at higher stages of the disease and in people with more severe limitation in mobility domain of HRQoL (as assessed by PDQ-39) before rehabilitation. Results might be different when considering different outcomes or different measures for the same outcome (performance mobility test instead of self-report questionnaires). Further investigations are needed to better understand other components of HRQoL in addition to mobility. Trial registration:NCT02713971 registered March 8, 2016.