Abstract | INTRODUCTION: A multicentre randomized double-blind parallel group study was carried out on 68 patients suffering from idiopathic Parkinson's disease (PD) treated with L-dopa for at least 1 year with inadequate therapeutic responsiveness. The aim of the study was to compare the efficacy of alpha- dihydroergocryptine (alpha-DHEC) vs lisuride as an adjunct therapy to L-dopa on dyskinesias and clinical fluctuations (Unified Parkinson's Disease Rating Scale [UPDRS] part IV), on the symptoms pattern (Columbia University Rating Scale [CURS]), on disability (Northwestern University Disability Scale [NUDS]), and to evaluate the incidence of adverse events. PATIENTS AND METHODS: Thirty-two patients (18 males, 14 females with a mean age of 64.5+/-1.5 SEM) were randomized to alpha- dihydroergocryptine and 36 (16 males, 20 females with a mean age of 61.8+/-1.4) to lisuride. The treatment lasted 3 months and the dosage was increased until it reached 60 mg/day of alpha- dihydroergocryptine and 1.2 mg/day of lisuride, while the L-dopa dosage was kept constant in both groups. Per protocol and intention to treat analyses were performed on response variables. RESULTS: The adjunctive treatment with the two dopamine agonists determined a significant improvement of PD symptoms in both groups. Alpha- dihydroergocryptine showed a superior efficacy in reducing the clinical complications (P < 0.01 by ANOVA). The number of patients complaining of adverse events was 8 out of 32 (25%) for alpha- dihydroergocryptine and 24/36 (67%) for lisuride (P < 0.05). CONCLUSION: Alpha- dihydroergocryptine effect seems to be superior to that of lisuride both in terms of reduction of L-dopa therapy long term motor complications (UPDRS part IV) as well as in terms of the incidence and severity of adverse events.
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Authors | L Battistin, P G Bardin, F Ferro-Milone, C Ravenna, V Toso, G Reboldi |
Journal | Acta neurologica Scandinavica
(Acta Neurol Scand)
Vol. 99
Issue 1
Pg. 36-42
(Jan 1999)
ISSN: 0001-6314 [Print] Denmark |
PMID | 9925236
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antiparkinson Agents
- Dopamine Agonists
- Dihydroergotoxine
- Levodopa
- Lisuride
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Topics |
- Aged
- Antiparkinson Agents
(therapeutic use)
- Dihydroergotoxine
(adverse effects, therapeutic use)
- Disabled Persons
- Dopamine Agonists
(adverse effects, therapeutic use)
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Levodopa
(therapeutic use)
- Lisuride
(therapeutic use)
- Male
- Middle Aged
- Movement Disorders
(drug therapy)
- Parkinson Disease
(drug therapy)
- Treatment Outcome
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