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Azilect offers new hope to levodopa treated patients with moderate to advanced Parkinson’s disease

21.09.2005

Benefits of Azilect seen when given alone or on top of concomitant dopamine agonist therapy

New data presented in an oral presentation session, at the 9th congress of the European Federation of Neurological Societies, showed that treatment with Azilect (rasagiline 1 mg) once daily can provide significant additional benefits to levodopa treated patients with moderate to advanced Parkinson’s disease (PD). These benefits were seen regardless of whether patients were receiving additional, optimized treatment with a dopamine agonist.1

The new sub-analysis of the LARGO trial (Lasting effect in Adjunct therapy with Rasagiline Given Once daily), found that giving Azilect to patients already optimized on levodopa, with or without concomitant dopamine agonist (DA) treatment, significantly reduced daily “OFF” time (when the effects of medication wear off and PD symptoms return) by an average of 1.2 hours when compared to placebo, resulting in a clinically meaningful improvement in daily function for patients, without a related increase in dopaminergic adverse events. Patients experienced a corresponding increase in “ON” time (when medication is working) without troublesome dyskinesias, the involuntary movements characteristic of long-term PD therapy.

Principle investigator, Professor Olivier Rascol, of University Hospital Toulouse, France, commented: “These data show that people with Parkinson’s disease can achieve additional symptom benefits with Azilect, even when already receiving optimized levodopa treatment and irrespective of whether they are also receiving a dopamine agonist.”

The significant improvements in functioning demonstrated by Azilect, on top of DA treatment, were also shown with all additional end points, such as Clinical Global Impressions measures during “ON” time, UPDRS-motor during "ON" time (symptoms of tremor, slowness of movement, stability and rigidity), and UPDRS-Activities of Daily Living scores during “OFF” time, (measuring the ability of patients to walk, speak, swallow, dress and get out of bed.)

The active comparator in the study, entacapone, demonstrated comparable reductions in daily "OFF" time, but results for some of the additional measures mentioned above did not achieve significance.

The LARGO study investigated the response to treatment in 687 levodopa treated patients who were randomized to receive Azilect, entacapone or placebo. Two thirds of patients in each arm were also receiving DA therapy, allowing for comparison of the effectiveness of Azilect given alone or on top of a dopamine agonist.1

These data from the LARGO study add to the growing body of evidence for Azilect as an effective and well-tolerated treatment for Parkinson’s disease. The findings from LARGO are consistent with the recently published study PRESTO, which also demonstrated that once daily Azilect, as an adjunctive therapy, significantly increases daily “ON” time and improves the cardinal symptoms of Parkinson’s disease.2

In addition, data from the TEMPO trial, a study of Azilect as monotherapy, demonstrated that Azilect is an effective and well-tolerated treatment in early disease and can significantly delay the progression of PD symptoms.3,4

References:

1. Rascol O, Brooks, DJ, Melamed E, et al. Rasagiline is effective and well tolerated in the treatment of moderate to advanced Parkinson’s disease patients receiving concomitant dopamine agonist therapy. Oral presentation presented at EFNS, September 17-20, 2005

2. Schwid S, Shoulson I, et al for the Parkinson Study Group. A Randomized Placebo Controlled Trial of Rasagiline in Parkinson’s Disease Patients with Levodopa-Related Motor Fluctuations (The PRESTO Study). Arch Neurol 2005 Feb;62:241-248

3. Siderowf A, Stern M et al for the Parkinson Study Group. A Controlled Trial of Rasagiline in Early Parkinson’ Disease (The TEMPO study). Arch Neurol 2002 Dec;59(12):1937-43

4. Parkinson Study Group. A Controlled, Randomised, Delayed-Start Study of Rasagiline in Early Parkinson disease. Arch Neurol 2004 Apr; 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; 365:947-365