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| |  MDS: Piribedil (Trivastal) Effective in Early Parkinson's Disease as Monotherapy By Paula Moyer ROME, ITALY -- June 21, 2004 -- Monotherapy with the nonergotamine D2/D3 agonist piribedil (Trivastal) significantly reduced the severity of symptoms in patients with early Parkinson's disease compared to placebo and demonstrated a good safety profile, according to findings presented here June 15th at the 8th International Congress of the Movement Disorder Society. Principal investigator Olivier Rascol, MD, PhD, professor of pharmacology, University of Toulouse School of Medicine, Toulouse, France, and coinvestigators planned a 6-month intermediate analysis in a 2-year study to confirm the efficacy and safety of piribedil as single therapy in patients with idiopathic Parkinson's disease who had no or limited exposure to levodopa and dopaminergic agents. Earlier research showed that piribedil is an effective adjunct to levodopa. They conducted a multicenter, randomized, placebo-controlled, double blind, parallel group study with 204 patients in the placebo group and 197 patients treated with piribedil. Patients were an average of 62.3 years old. The initial 6-month trial included an additional 1-month titration phase. Patients had early disease with Hoehn and Yahr stages I to III. After a 30-day run-in period, patients reached the target daily dose of 150 mg by day 28. Their doses could be adjusted afterward up to 300 mg daily in increments of 50 mg. In patients whose disease was not adequately controlled by monotherapy levodopa could be added in an immediate-release formulation after day 42 as a 3-times-daily regimen. The investigators primarily assessed the intent-to-treat group for changes from baseline in Unified Parkinson's Disease Rating Scale III (UPDRS III), motor score, and response rates, which they defined as a 30% decrease. They also assessed changes in the UPDRS II, activities of daily living (ADL) score, time to progression to levodopa treatment, and percentage of patients on levodopa. Of 401 randomized patients, 386 patients were included in the intent-to-treat analysis, consisting of 199 in the placebo group and 187 in the piribedil group. Among these patients, 12.3% of those on placebo and 20.3 of those on piribedil withdrew, with adverse events accounting for 2.5% of placebo withdrawals and 7.6% of piribedil withdrawals. During the study period, the piribedil-treated patient had an average decrease of 4.9 of UPDRS III total score compared with an increase of 2.6 in the placebo group (P <.0001). The investigators found that 42.2% of piribedil patients were defined as responders, compared to 13.6% of those in the placebo group (P <.001). Levodopa therapy was required by 40.2% of the placebo patients and 16.6% of piribedil patients (odds ratio = 3.72, P <.001). Conversely, the relative risk for introducing levodopa was significantly reduced in the treatment group (relative risk = 30.2, P <.001). Study-emergent adverse events were recorded in 57% of placebo patients and 69% of those on piribedil. The most frequent adverse events were nausea, constipation, insomnia, abdominal pain, anxiety, somnolence, and hypertension. Remedial action was taken for 38% of placebo and 50% of piribedil patients. The study drug was stopped in 2.0% of placebo and 7.5% of piribedil patients. The investigators reported 7 cases of hallucinations during the run-in and treatment periods, 4 of which lead to the patient's withdrawal and 1 of which was serious, Dr. Rascol said.
[Presentation title: Piribedil Efficacy in Monotherapy (150 to 300 mg/day) in de Novo Parkinsonian Patients: A 6-Month Planned Intermediate Analysis of the 2-Year Parkinson-Regain Study. Abstract P603]
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