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Rasagiline Is Well Tolerated in Elderly Parkinson's Disease Patients

New analysis assessing age-related adverse events of anti-Parkinsonian drugs suggests no need for special precautions in elderly patients taking Azilect

COPENHAGEN, DENMARK, and JERUSALEM, ISRAEL -- May 15 2006 -- Azilect (rasagiline) 1 mg once daily does not increase the risk of adverse events in elderly people with Parkinson's disease (PD) compared to placebo, according to new data published in Neurology. Indeed, Azilect is well tolerated by PD patients regardless of age and requires no special precautions in people over the age of 70.

The analysis is one of the first to compare the adverse event profiles of anti-Parkinsonian drugs in elderly and younger patients.1

The paper is based on an analysis of data from two pivotal trials; TEMPO (TVP-1012 in Early Monotherapy for PD Outpatients) which assessed Azilect as monotherapy2 in early disease and PRESTO (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of "Off") which evaluated Azilect in combination with levodopa.3 TEMPO and PRESTO demonstrated that Azilect was effective and well tolerated in patients with early or moderate to advanced PD respectively.2,3

The new analysis divided patients into two groups: those aged 70 years or older and those under 70 years of age. The analysis included 404 subjects with early PD, who did not yet need dopaminergic therapy (TEMPO), and 472 patients on levodopa with motor fluctuations (PRESTO). Both studies lasted six-months, were double blind and compared Azilect to placebo.1 Adverse events - such as orthostatic hypotension, dyskinesias and hallucinations - were more common among older patients than in younger people with PD. However, Azilect did not increase the rate of these adverse events compared to placebo in elderly people.1

"Elderly patients are particularly vulnerable to the side effects associated with anti-parkinsonian drugs. The challenge for their medical management is maintaining symptomatic control over the motor and non-motor symptoms of PD, while limiting the side effects of treatment," commented lead investigator, Professor Goetz, Rush University Medical Center, Chicago, USA. "This analysis shows that rasagiline does not influence the risk of developing serious adverse events in elderly patients. Based on the previously demonstrated efficacy of rasagiline, and the low prevalence of adverse events in both younger and older patients, rasagiline is a treatment likely to have wide application in PD with no special tolerability or monitoring precautions required."

For all adverse event categories studied, there was no statistical interaction between age and rasagiline use. Dyskinesias and hallucinations pose particular problems in people taking levodopa. Azilect did not further increase the rate of these distressing and debilitating side effects in the elderly.

About Azilect
Azilect is a novel, potent, second-generation, selective, irreversible monoamine oxidase type-B (MAO-B) inhibitor that blocks the breakdown of dopamine, a neurotransmitter that is critical for the regulation and coordination of movement. Azilect received approval from the EMEA in 2005 as both a monotherapy and an adjunct therapy for Parkinson's disease, and is marketed in Europe by Lundbeck and Teva as part of a long-term strategic alliance between the two companies.

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA), headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures, and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90 percent of Teva's sales are in North America and Europe. Teva's innovative R&D focuses on developing novel drugs for diseases of the central nervous system.

About Parkinson's Disease
Parkinson's disease (PD) is a progressive neurodegenerative, chronic disruption of the central nervous system. Symptoms include tremor, slowness of movement, stiffness, gait and posture problems.

As the disease progresses, symptoms worsen and the patient is likely to experience motor complications, including a fluctuating response to treatment.

During "On" states, medication works effectively, but during "Off" states, which correspond to the medication wearing off between doses, patients experience relatively poor function and mobility.

PD affects men and women equally, and the disease, which typically occurs at a late age, affects an estimated four million people worldwide. Approximately 1.6% of the population over the age of 65 suffers from PD. It is estimated that well over one million people in the EU suffer from PD. In 2005, the worldwide market for PD drugs was valued at USD 2.5 billion with approximately 40% of this in Europe.


REFERENCES:
1. Goetz CG, Schwid SR, Eberly SW, Oakes D, Shoulson I. Safety of rasagiline in elderly Parkinson's Disease patients. Neurology 2006.
2. Parkinson Study Group: A controlled trial of rasagiline in early Parkinson disease: the TEMPO Study. Arch Neurol 2002;59:1937-43.
3. Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson's disease and motor fluctuations: the PRESTO study. Arch Neurol 2005;62:241-248.


SOURCE: H. Lundbeck A/S and Teva Pharmaceutical Industries Ltd.

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