Comparison of Two Dosages of Tolcapone Added to Levodopa in Nonfluctuating Patients with PD
| Autor: | Peter Bailey, Oksana Suchowersky, Giovanni Facciponte, E. Pourcher, Lynne Bulger |
|---|---|
| Rok vydání: | 2001 |
| Předmět: |
Adult
Male Levodopa Dose Nausea Antiparkinson Agents Nitrophenols Benzophenones Double-Blind Method Oral administration Humans Medicine Pharmacology (medical) Adverse effect Aged Pharmacology Cross-Over Studies Tolcapone business.industry Parkinson Disease Middle Aged Crossover study Dyskinesia Anesthesia Drug Therapy Combination Female Neurology (clinical) medicine.symptom business medicine.drug |
| Zdroj: | Clinical Neuropharmacology. 24:214-220 |
| ISSN: | 0362-5664 |
| DOI: | 10.1097/00002826-200107000-00004 |
| Popis: | The efficacy and safety of two dosages of tolcapone were compared in a 12-week crossover trial involving 118 nonfluctuating patients with PD on a stable dose of levodopa (L-Dopa). At trial onset, all patients received open-label tolcapone 100 mg three times daily for 4 weeks. At week 4, 116 eligible patients entered an 8-week double-blind treatment period and were randomized to receive tolcapone three times daily at either 100 mg (group 1; n = 58) or 200 mg (group 2; n = 58) until week 8, followed by the alternative tolcapone dosage until week 12. Ratings included Unified Parkinson's Disease Rating Scale (UPDRS), Schwab & England, and patient diaries, assessed at baseline and at 4, 8, and 12 weeks. At week 4, the investigator's global assessment (IGA) of efficacy showed improvement in 76% of patients. The mean total daily L-Dopa dose and mean UPDRS scores for subscales II and III decreased significantly (p < 0.001). During the double-blind treatment period, IGA showed improvements at either or both dosages in 61% of patients; further changes in other efficacy variables were minimal and were similar with both tolcapone dosages. The most frequent adverse events were dopaminergic (nausea and dyskinesia); the most frequent nondopaminergic adverse event was diarrhea. The incidence of adverse events during double-blind treatment was slightly higher with tolcapone 200 mg three times daily (33%) than with tolcapone 100 mg three times daily (24%). The authors conclude that tolcapone dosages of 100 mg three times daily and 200 mg three times daily are well tolerated and equally effective in improving function in L-Dopa-treated nonfluctuating patients with PD. |
| Databáze: | OpenAIRE |
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