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An acute and long‐term study with a dispersible formulation of levodopa/benserazide (Madopar®) in Parkinson's disease
Author(s) -
Monge A.,
Barbato L.,
Nordera G.,
Stocchi F.
Publication year - 1997
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/j.1468-1331.1997.tb00388.x
Subject(s) - medicine , levodopa , morning , benserazide , tolerability , adverse effect , evening , parkinson's disease , anesthesia , disease , astronomy , physics
The clinical efficacy, tolerability and administration regimens of a dispersible formulation of levodopa/benserazide (DM) were investigated in 30 patients with idiopathic Parkinson's disease, complicated by motor fluctuations. All 30 patients showed delayed‐ “on” phenomenon after administration of the first morning dose of standard levodopa (SM), and 20 showed delayed‐ “on” phenomenon after the first afternoon dose. Patients were receiving standard formulations of levodopa as monotherapy or in combination. A double‐dose study of the dispersible vs the standard formulation was performed in 30 patients, 24 of whom participated in a 36‐month, follow‐up clinical study. In the long‐term study, SM was replaced with DM by substituting the first morning dose or the first morning and first afternoon doses. In the double‐dose study, mean latency to “on” after the first morning dose was significantly shorter with DM than with SM ( p < 0.001), whereas the duration of “on” was similar with the two preparations. The post‐prandial delayed‐ “on” in the 14 patients who responded to therapy was significantly shorter for DM than for SM ( p < 0.001). In the long‐term study, the mean latency to “on” in all patients was significantly shorter than at baseline ( p < 0.001). Time spent in “on” during the active day increased significantly, and remained stable during the 36‐month study. No changes were apparent in the mean dosage of levodopa/day or the number of doses/day, and no acute or long‐term adverse events were reported. In conclusion, these results confirm the long‐term safety of the dispersible formulation, and its improved efficacy compared with standard levodopa formulations, as monotherapy and in association with slow‐release formulations.