The Unified Parkinson's Disease Rating Scale (UPDRS) is the main outcome measure in clinical trials of Parkinson's disease (PD). The minimal change that represents a clinically meaningful improvement is unknown. The objective of this study was to determine the minimal change on the UPDRS that represents a clinically meaningful improvement in early PD after 6 months of treatment. Data from two independent randomized treatment trials over 6 months involving 603 patients with de novo PD were analyzed to determine the minimal clinically important change (MCIC), referred to the status before treatment, for the UPDRS motor, activities of daily living (ADL), and total scores. An anchor-based method using ratings on a seven-point global clinical improvement was used. A change of five points on the UPDRS motor part was found to be the most appropriate cutoff score for all Hoehn and Yahr stages I to III, and a change of eight points for the UDPRS total score. For the UDPRS ADL score, an MCIC of two points for Hoehn and Yahr stages I/I.5 and II and of three points for Hoehn and Yahr stage II.5/III was the most appropriate cutoff score. These data give the first estimate for cutoffs defining clinically important changes in UPDRS ADL and motor scores. Further studies using larger databases from more diverse study populations are encouraged to better define and solidify the MCIC for the UPDRS.
"There is a paucity of MCID data based on a patient-rated tool, such as the Patient-rated Global Impression of Improvement (PGI-I). Most of the published MCID data focus on patients with early PD and come from clinical trials of ropinirole or rasagiline  , but not pramipexole. Using both PGI-I and CGI-I as anchors, we describe MCID data from two placebo-controlled studies of pramipexole extended release (ER) in patients with early PD (EPD) and advanced PD (APD). "
[Show abstract][Hide abstract] ABSTRACT: Background. The minimal clinically important difference (MCID) is the smallest change in an outcome measure that is meaningful for patients. Objectives. To calculate the MCID for Unified Parkinson's Disease Rating Scale (UPDRS) scores in early Parkinson's disease (EPD) and for UPDRS scores and "OFF" time in advanced Parkinson's disease (APD). Methods. We analyzed data from two pivotal, double-blind, parallel-group trials of pramipexole ER that included pramipexole immediate release (IR) as an active comparator. We calculated MCID as the mean change in subjects who received active treatment and rated themselves "a little better" on patient global impression of improvement (PGI-I) minus the mean change in subjects who received placebo and rated themselves unchanged. Results. MCIDs in EPD (pramipexole ER, pramipexole IR) for UPDRS II were -1.8 and -2.0, for UPDRS III -6.2 and -6.1, and for UPDRS II + III -8.0 and -8.1. MCIDs in APD for UPDRS II were -1.8 and -2.3, for UPDRS III -5.2 and -6.5, and for UPDRS II + III -7.1 and -8.8. MCID for "OFF" time (pramipexole ER, pramipexole IR) was -1.0 and -1.3 hours. Conclusions. A range of MCIDs is emerging in the PD literature that provides the basis for power calculations and interpretation of clinical trials.
"Recent studies regarding minimal clinically important change (MCIC), which was to assess therapeutic interventions for Parkinson's disease, suggested that cutoffs for a MCIC are scores of 2.5–5 points on UPDRS part III and 5–8 points on combined UPDRS parts II þ III   . "
"Relatively large differences are often required as minimal (significant) changes in UPDRS scores are generally not considered to have much clinical value. For instance, Schrag et al.  found that a change of 8 points in the overall UPDRS score was required to be considered clinically significant. Shulman et al.  found that a difference of 4.1–4.5 points for the overall UPDRS score had clinical value. "
[Show abstract][Hide abstract] ABSTRACT: Rasagiline (Azilect®) is a selective and irreversible monoamine oxidase B inhibitor, which is well tolerated, safe, improves motor symptoms, and prevents motor complications in Parkinson's disease (PD). Rasagiline is effective in monotherapy and as an adjunct to levodopa-therapy, with beneficial effects on quality-of-life parameters in early and late stages of PD. In this review, we compare the efficacy of rasagiline versus placebo for decreasing PD symptoms. Major databases (Medline, the Cochrane Library) were systematically searched to identify and select clinical randomized control trials of rasagiline. The Unified Parkinson Disease Rating Scale (UPDRS) for rasagiline monotherapy and reduction in off-time for combined treatment were the outcomes assessed. Rasagiline monotherapy, in early stages of the disease, reduces the UPDRS score [-3.06 (95% CI -3.81 to -2.31, p<0.00001) with rasagiline 1mg/day]. In combination with levodopa, 1mg/day of rasagiline reduced off-time [-0.93h (95% CI -1.17 to -0.69, p<0.00001)]. However, although rasagiline reduces the UPDRS score [-0.89 (95% CI from -1.78 to 0, p=0.05)] in trials with a delayed-start design, we found a disagreement between studies and doses, making it difficult to interpret this result. In conclusion, our results confirm the efficacy of rasagiline in PD, but the clinical significance of these data remains to be established. Furthermore, the delayed-start study design did not establish with certainty the neuroprotective effect of rasagiline. It is advisable to carry out comparative trials with other drugs used in Parkinson's disease.
Pharmacological Research 06/2013; 74. DOI:10.1016/j.phrs.2013.05.005 · 4.41 Impact Factor
Chenhui Ji, Guo-Fang Xue, Cao Lijun, Peng Feng, Dongfang Li, Lin Li, Guanglai Li, Christian Hölscher
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