ADAGIO Analysis Demonstrates That the Natural Progression of Clinical Symptoms in Parkinson's Disease May Be Slower in Earlier Stages
JERUSALEM, Israel--(BUSINESS WIRE)--Apr 19, 2010 - Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results from the placebo group analyses of the ADAGIO study (Attenuation of Disease progression with AZILECT® GIven Once-daily) that were presented at the 62nd Annual Meeting of the American Academy of Neurology (AAN). The ADAGIO study stands out from other Parkinson's disease (PD) trials as it is the largest clinical study conducted in patients who were still in the very early stages of their disease course (average time from PD diagnosis of 4.5 months).
The placebo analyses demonstrated that the natural progression of clinical symptoms in PD may be slower in the earlier stages of disease development than was expected from previous findings. These results may have implications for the overall interpretation of the ADAGIO results. Specifically, the clinical significance of the 1.7 UPDRS (Unified Parkinson's Disease Rating Scale) units seen between the AZILECT® (rasagiline tablets) 1 mg/day early and delayed-start groups during the nine month time period represents, on average, a 40 percent reduction from baseline in the early group when compared to the delayed group.
The results of the subgroup analysis showed faster progression in placebo patients with the highest baseline UPDRS scores (upper quartile), which may provide an explanation for the reported ability to detect a larger magnitude of disease-modifying effect with AZILECT® in ADAGIO patients in this subgroup.
“One interpretation about what was found in the subgroup analyses of placebo patients with the highest UPDRS scores is that the faster progression of these patients may explain the previously reported ability to detect a larger magnitude of disease modifying effect in this population, as well as a significant effect for the 2 mg dose,” said Olivier Rascol, MD, University UPS, Toulouse, France, the co-principal investigator of the ADAGIO study.
About the Study
The Natural Progression of Clinical Symptoms in Parkinson's Disease may Not Be Faster in the Earlier Stages: Results From the ADAGIO Delayed-Start Study
The ADAGIO study was an 18-month, placebo-controlled, double-blind, multicenter trial using a delayed-start design, involving patients with early, previously untreated Parkinson's disease (PD) (n=1176). Subsequent analyses were performed on placebo subjects (n=588), including a subgroup analysis of those with high (>25.5) and low (‰¤14) baseline total UPDRS scores. Overall, the rate of progression for subjects on placebo was slower than anticipated (~6 UPDRS units/year), despite the fact that subjects were recruited at an earlier stage of disease progression than other trials as well as the belief that dopaminergic cell loss is thought to progress faster in the earlier stages of the disease.
Patients on placebo with more advanced PD (higher UPDRS baseline scores; n=145) showed faster disease progression (change from baseline extrapolated to 9 units/year as measured by Total-UPDRS). In contrast, patients with less advanced disease (lower UPDRS baseline scores; n=160) deteriorated at a slower pace (by 4 units/year as measured by Total-UPDRS).
Azilect® 1mg tablets are indicated for the treatment of the signs and symptoms of Parkinson's disease both as initial monotherapy and as adjunct to levodopa later in the disease. Azilect® 1mg tablets are currently available in 39 countries, including the US, Canada, Israel, Mexico, and all EU countries.
Teva has a long-term agreement for the joint development and marketing of Azilect® in Europe and some additional markets with H. Lundbeck A/S. In North America, Azilect® is marketed by Teva's wholly-owned subsidiary Teva Neuroscience (www.tevaneuro.com).
See additional important information at http://www.azilect.com/PrescribingInformation.pdf.ashx. For hardcopy releases, please see enclosed full prescribing information.
About Parkinson's disease
Parkinson's disease is an age-related degenerative disorder of the brain. Symptoms can include: tremor, stiffness, slowness of movement, and impaired balance. An estimated five million people worldwide suffer from the disease, with an average age of onset of about 60 years.
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 15 pharmaceutical companies in the world and is the leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients. Over 80 percent of Teva's sales are in North America and Western Europe.
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Contact: Teva Pharmaceutical Industries Ltd.
Elana Holzman, +972 (3) 9267554
Teva North America
Kevin Mannix, +1 215-591-8912
Posted: April 2010