my personal edition > parkinson's > news


  E-Mail this DGNews to a colleague

DGNews

Data Support Once-Daily Azilect's Broad Efficacy and Tolerability Profile as Adjunct Therapy in Moderate and More Advanced Parkinson's Disease

GLASGOW, UK -- September 12, 2006 -- New data presented today at the 10th congress of the European Federation of Neurological Societies demonstrate that 1 mg Azilect (rasagiline) once daily is highly efficacious, both as first-line adjunct treatment to levodopa in patients with moderate Parkinson's disease (PD) with mild fluctuations, as well as in addition to concomitant therapies in patients with more advanced PD.1,2

A pooled analysis of patients with moderate PD receiving Azilect as first-line adjunct treatment to levodopa, from the pivotal LARGO and PRESTO trials, demonstrated that Azilect significantly reduced daily "OFF" time (when the effects of medication wear off and PD symptoms return) compared with placebo (P = .0048).1

Azilect also significantly improved Clinical Global Impressions (CGI) measures (P < .0001), UPDRS-Motor scores during "ON" time (P = .0007) (measuring symptoms of tremor, slowness of movement, stability and rigidity), and UPDRS-Activities of Daily Living scores during "OFF" time (P < .01).1

A post-hoc analysis from the PRESTO study, which allowed concomitant treatment with other PD therapies (dopamine agonists, COMT inhibitors, amantadine, anticholinergics), showed that Azilect significantly reduced daily "OFF" time, compared with placebo. These findings were in more advanced PD patients, whether already taking concomitant COMT inhibitor (COMT-I) (-0.91 hours; P < .05), or treated without a concomitant COMT-I (-0.95 hours; P < .001). Improvements in CGI-examiner, UPDRS-Motor while "ON" and UPDRS-ADL while "OFF" scores were also significant and comparable in both groups.2

Furthermore, data presented today also provide additional evidence of the favourable safety and tolerability profile of Azilect.1,2 The incidence of specific dopaminergic adverse events was unaffected when Azilect was added to multiple dopaminergic agents (levodopa/carbidopa, dopamine agonists, COMT-I).2

Professor Werner Poewe, of University Hospital Innsbruck, Austria, commented: "These results show that patients can achieve additional symptom benefits in moderate and advanced Parkinson's disease with Azilect, including as first-line adjunct to levodopa, and regardless of concomitant PD treatments. Azilect can therefore offer benefits to patients with a disease that affects every aspect of their lives, and provides a useful treatment option to their doctors."

These data add to the growing body of evidence for Azilect's benefits in the treatment of Parkinson's disease. Data from the TEMPO trial demonstrated that in early disease, Azilect monotherapy is an effective and well-tolerated treatment, and that early treatment with Azilect is more beneficial to patients in the long term.3,4

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 essential for the regulation and coordination of movement. Azilect is now available in 17 European countries, and has recently been introduced to the market in the US.

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 an estimated four million people worldwide are affected by the disease, which typically occurs at a late age. Approximately 1.6% of the population over the age of 65 suffer 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 2.8 billion with over 40% of this in Europe.

Dopaminergic adverse events are often seen with levodopa and dopamine agonist treatment and include sudden daytime sleepiness, hypotension, vomiting, diarrhoea, constipation and hallucinations.5

Global scales used to measure Parkinson's disease symptoms include:

UPDRS – The Unified Parkinson's Disease Rating Scale, a research tool commonly used to measure a patient's ability to perform mental and motor tasks and activities of daily life
CGI – the Clinical Global Impressions scale, a global measure of function improvement.

REFERENCES:
1. Poewe W, for PRESTO and LARGO investigators. Rasagiline provides significant benefits as adjunct therapy in patients with moderate Parkinson's disease: subgroup analyses. Poster presented at EFNS, September 2-5, 2006
2. Elmer L, for the Parkinson Study Group. Rasagiline is effective and well tolerated in Parkinson's disease (PD) patients with levodopa-related motor fluctuations receiving entacapone. Poster presented at EFNS, September 2-5, 2006
3. Siderowf A, Stern M et al for the Parkinson Study Group. A Controlled Trial of Rasagiline in Early Parkinson's Disease (The TEMPO study). Arch Neurol 2002 December;59(12):1937-1943
4. Parkinson Study Group. A Controlled, Randomised, Delayed-Start Study of Rasagiline in Early Parkinson disease. Arch Neurol 2004 April;61:561-566
5. Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa inpatients with Parkinson's disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. The Lancet 2005 March;365:947-954


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

E-Mail this DGNews to a colleague

To print, use this version