Session Information
Date: Thursday, June 23, 2016
Session Title: Parkinsons's Disease: Clinical Trials I
Session Time: 12:00pm-1:30pm
Objective: The PD MED trial aimed to determine which class of drug provides the best patient-rated quality of life (QoL) when used as adjuvant therapy to levodopa.
Background: It is uncertain which class of drug should be added when motor complications of Parkinson’s disease (PD) are poorly controlled by levodopa.
Methods: In this pragmatic, open-label randomised trial, 500 PD patients receiving levodopa (LD) and experiencing uncontrolled motor complications were randomised 1:1:1 between dopamine degradation inhibitors (DDI; COMTI or MAOBI) and dopamine agonist (DA). Primary (mobility dimension on the PDQ-39 QoL scale) and secondary outcomes (other dimensions of PDQ-39, EQ-5D, dementia and mortality) were analysed using repeated measures regression and logrank methods.
Results: Compliance with COMTI, MAOBI and DA allocation at 2 years was 42%, 48% and 43%, respectively. PDQ-39 mobility scores were not significantly different in patients randomised to DA and DDI (difference: 2.2, 95% CI -0.4 to 4.7; p=0.09). Likewise, there were no significant differences between DDI and DA in secondary outcome measures. However over the 5-year follow-up period, PDQ-39 mobility scores averaged 3.3 (95% CI 0.7 to 5.9; p=0.01) points better in participants randomised to MAOBI than COMTI, with similar differences seen in PDQ-39 summary index and EQ-5D (table). Rates of dementia (HR = 0.69; 95% CI 0.47 to 1.03), and mortality (HR = 0.76; 95% CI 0.56 to 1.02) also favoured MAOBI over COMTI, albeit non-significantly.
| DA vs. DDI Estimate (95% CI) | MAOBI vs. COMTi Estimate (95% CI) | |
| PDQ-39: Mobility | 2.2 (-0.4 to 4.7), P=0.09 | 3.3 (0.7 to 5.9), p=0.01 |
| PDQ-39: Summary Index | 0.8 (-0.8 to 2.5), p=0.3 | 1.8 (0.2 to 3.4), p=0.03 |
| EQ-5D: Utility Score | 0.01 (-0.02 to 0.30), p=0.6 | 0.04 (0.01 to 0.07), p=0.009 |
Conclusions: Despite poor compliance with treatment allocation, patient-rated QoL was slightly better with MAOBI than COMTI therapy, and the risk of dementia, institutionalisation and death may also be reduced though longer follow-up is needed for confirmation. Taken together, there was no difference in patient reported QoL between DDIs and DA.
To cite this abstract in AMA style:
C.E. Clarke, S. Patel, N. Ives, C. Rick, A. Gray, C. Jenkinson, E. McIntosh, K. Wheatley, A. Williams, R. Gray. Randomised trial comparing dopamine agonist, MAOB inhibitor and COMT inhibitor as adjuvant therapy in later Parkinson’s disease (PD) [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/randomised-trial-comparing-dopamine-agonist-maob-inhibitor-and-comt-inhibitor-as-adjuvant-therapy-in-later-parkinsons-disease-pd/. Accessed November 22, 2024.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/randomised-trial-comparing-dopamine-agonist-maob-inhibitor-and-comt-inhibitor-as-adjuvant-therapy-in-later-parkinsons-disease-pd/