Agilect Shows Positive Long-Term Effects When Used Early in PD Patients

New long-term data suggest that, when initial monotherapy treatment with once-daily Agilect tablets is started early in the course of Parkinson's disease (PD), positive effects on functional impairments at one year can be maintained up to 6.5 years.

The data were presented at the Ninth International Congress of Parkinson's Disease and Movement Disorders. These new data are from an open-label, follow-up extension of patients originally enrolled in the TEMPO trial [(TVP-1012) in Early Monotherapy for Parkinson's disease Outpatients], a 12-month, double-blind, parallel-group, randomized, delayed-start study conducted in 32 centers in the U.S. and Canada.

TEMPO evaluated the effects of once-daily Agilect (rasagiline) as initial monotherapy in early stage disease. Outcomes from the initial 12-month TEMPO study included a beneficial effect on the total UPDRS score (Parts I, II and III combined) for those treated initially with Agilect compared to those patients who received Agilect after a delayed start (placebo during the first six-month period followed by Agilect during the second six-month period). UPDRS is a research tool commonly used to measure a patient's ability to perform mental and motor tasks and activities of daily life.

Approximately half of the patients who received Agilect in the original TEMPO trial and were still in the study after two years (121 out of 266) were adequately maintained without additional dopaminergic therapy. In this long-term extension study of up to 6.5 years, the mean annual UPDRS decline for patients treated with Agilect only was 2 to 3 units compared with reported historical rates of 8 to 11 units in placebo-treated patients. The most commonly reported adverse events observed over this long-term treatment period were infection, accidental injury, nausea and joint pain.