Non-Motor Off Symptoms in Parkinson's Disease

The aim of this study is to elucidate the clinical spectrum and frequency of non-motor symptoms during off periods (NMOS) in Parkinson's disease (PD) patients with motor fluctuation. We compared clinical characteristics between PD patients with motor symptoms only (M-off) and those with both motor and non-motor symptoms (NM-off) during off periods. The association of NMOS with parkinsonian clinical characteristics was also investigated. Sixty-seven consecutive PD patients of both M-off and NM-off groups were included in this study. We reviewed medical records, interviewed the patients, and administered a structured questionnaire. NMOS is classified into three categories: autonomic, neuropsychiatric and sensory. The frequency of NMOS and their individual manifestations were assessed. Of 67 patients with off symptoms, 20 were M-off group and 47 NM-off group. Among NMOS, diffuse pain was the most common manifestation, followed by anxiety and sweating. There were no significant differences between M-off and NM-off groups with regard to age, duration of disease and treatment, interval between onset of parkinsonian symptoms and off symptoms and off periods. Patients taking higher dosage of levodopa had fewer NMOS. NMOS is frequent in PD. Comprehensive recognition of NMOS can avoid unnecessary tests and is important for optimal treatment in PD.

Efficacy and Safety of Entacapone in the Patients with Parkinson's Disease Experiencing Wearing-off Phenomenon: Multicenter Randomized Placebo-controlled Double Blind Study

BACKGROUND: The purpose of this study was to assess the efficacy and safety of entacapone, a catechol-O-methyltransferase (COMT) inhibitor in Parkinson's disease (PD) patients with wearing-off phenomenon. METHODS: A total of 197 PD patients were included in this 2-month multi-center, randomized, placebo-controlled, double blind, parallel-group study. After a 2-week screening period, each patient was randomly allocated to receive either entacapone (n=98) or placebo (n=99) as an adjunct to levodopa. The efficacy was evaluated with the changes of "on" and "off" time percentage while awake, the reduction of the levodopa dose, Unified Parkinson's Disease Rating Scale (UPDRS), and the clinical global impression (CGI) by the examiner. RESULTS: The percentage of "on" time increased by 9.4 +/- 18.0% in the entacapone group, 7.4 +/- 15.6% in the placebo group. The percentage of "off" time was reduced by 8.6 +/- 16.9% in the entacapone group, 6.6 +/- 18.2% in the placebo group. These parameters did not show a statistical significance between the two groups. However, the levodopa dose was significantly reduced in the entacapone group (51.6 +/- 154.5 mg/day) compared with the placebo group (0.7 +/- 130.0 mg/day) (p=0.009). The total and motor scores of the UPDRS were significantly decreased in the entacapone group (p=0.039, p=0.017, respectively). The most common adverse drug reactions in the entacapone group were urine discoloration (22%), dyskinesia (13%), dizziness (7%). CONCLUSIONS: Entacapone was a safe and well-tolerated drug. Although the changes of "on" and "off" time were not significant, entacapone showed an overall significant beneficial effect in the PD patients with wearing-off phenomenon.

Ropinirole as an Adjunct to Levodopa in the Treatment of Parkinson's Disease

BACKGROUND: Ropinirole is a non-ergoline D2 agonist which has a highly selective affinity to D2 receptor. The aim of this study was to evaluate the efficacy and safety of ropinirole in the treatment of Parkinson's disease (PD). METHODS: Seventy-six cases with PD (Hoehn and Yahr stage II to IV) were included in this trial. Each patient was randomly allocated to receive either ropinirole (n=37) or bromocriptine (n=39) over a 16-week period. All subjects were not optimally controlled on levodopa due to motor fluctuations. The response rate was defined as the percentage of patients who had at least 20% reduction of levodopa doses. The clinical status was also assessed using the Unified Parkinson's Disease Rating Scale (UPDRS), Clinical Global Impression (CGI), and reduction of off durations. RESULTS: The end-point analysis, on an intention-to-treat basis, revealed significantly higher response rate in the ropinirole group compared with the bromocriptine group (odds ratio 2.995, 95% C.I. (1.157, 7.751)). A statistically significant improvement in CGI was also observed in the ropinirole group (p=0.046). The mean off duration was significantly reduced in the ropinirole group (p=0.0001). Other parameters using the UPDRS motor score or off duration did not show significant differences between the two groups. The overall incidence of adverse effects was not significantly different between the two groups. The most common side effects were dizziness, dyskinesia, and nausea/vomiting. No subjects were withdrawn from the study due to side effects. CONCLUSION: Ropinirole is a safe and well-tolerated drug and provides superior overall efficacy compared with bromocriptine as an adjunct to levodopa. (J Korean Neurol Assoc 19(2):102~109, 2001)

Ropinirole as an Adjunct to Levodopa in the Treatment of Parkinson's Disease

BACKGROUND: Ropinirole is a non-ergoline D2 agonist which has a highly selective affinity to D2 receptor. The aim of this study was to evaluate the efficacy and safety of ropinirole in the treatment of Parkinson's disease (PD). METHODS: Seventy-six cases with PD (Hoehn and Yahr stage II to IV) were included in this trial. Each patient was randomly allocated to receive either ropinirole (n=37) or bromocriptine (n=39) over a 16-week period. All subjects were not optimally controlled on levodopa due to motor fluctuations. The response rate was defined as the percentage of patients who had at least 20% reduction of levodopa doses. The clinical status was also assessed using the Unified Parkinson's Disease Rating Scale (UPDRS), Clinical Global Impression (CGI), and reduction of off durations. RESULTS: The end-point analysis, on an intention-to-treat basis, revealed significantly higher response rate in the ropinirole group compared with the bromocriptine group (odds ratio 2.995, 95% C.I. (1.157, 7.751)). A statistically significant improvement in CGI was also observed in the ropinirole group (p=0.046). The mean off duration was significantly reduced in the ropinirole group (p=0.0001). Other parameters using the UPDRS motor score or off duration did not show significant differences between the two groups. The overall incidence of adverse effects was not significantly different between the two groups. The most common side effects were dizziness, dyskinesia, and nausea/vomiting. No subjects were withdrawn from the study due to side effects. CONCLUSION: Ropinirole is a safe and well-tolerated drug and provides superior overall efficacy compared with bromocriptine as an adjunct to levodopa. (J Korean Neurol Assoc 19(2):102~109, 2001)