IMPORTANT SAFETY INFORMATION
AZILECT® (rasagiline tablets) is contraindicated with meperidine, tramadol, methadone, propoxyphene, dextromethorphan, St. John’s wort, cyclobenzaprine, or another (selective or non-selective) MAOI. Read More Important Safety Information
*The UPDRS (Unified Parkinson's Disease Rating Scale), a commonly used research tool in PD, is a multi-item rating scale that measures the ability of a patient to perform mental and motor tasks as well as activities of daily living. Total UPDRS is measured on a scale of 0-176, with a reduction in score demonstrating improvement.6
AZILECT has a mechanism of action that is complementary to various treatment regimens.4 See how it works in the brain.
Rational polypharmacy is a treatment strategy when monotherapy is suboptimal.7,8
STRIDE-PD post hoc analysis: Blinded assessment of dyskinesia and wearing off in 745 patients performed at 3-month intervals for the randomized, prospective, double-blind, 134- to 208-week STRIDE-PD study comparing the risk of developing dyskinesia in patients receiving either levodopa/carbidopa or levodopa/carbidopa/entacapone.8
PRESTO: 26-week, double-blind, randomized, fixed-dose, parallel-group study of 472 levodopa-treated patients experiencing motor fluctuations.2,4
LARGO: 18-week, double-blind, multicenter study of 687 levodopa-treated patients experiencing motor fluctuations.3,4
†Based on UPDRS Part I (mentation, behavior, and mood).6
By blocking MAO-B, AZILECT preserves dopamine and reduces “off” time.
ANDANTE: 18-week, randomized, double-blind, placebo-controlled study of 328 patients not adequately controlled on dopamine agonist monotherapy. Of the 328 randomized patients, 321 patients were part of the modified intent-to-treat (mITT) population, defined as having taken at least one dose of study medication and completing both baseline and at least one post-baseline efficacy assessment.1,4
|ANDANTE patient demographics at baseline1:|
|Average duration of disease||2 years|
|Average age||63 years|
|Mean total UPDRS score||31|
|Mean ropinirole dose||8 mg/day|
|Mean pramipexole dose||1.5 mg/day|
‡The most commonly observed adverse reactions were those in which the treatment difference for the incidence in AZILECT-treated patients was at least 3% greater than the incidence in placebo-treated patients. Potential dopaminergic AEs include: peripheral edema, somnolence, nausea, and orthostatic hypotension.
Of the 328 randomized patients, 326 were part of the safety population, defined as having taken at least one dose of study medication.
AZILECT's mechanism of action complements DA therapy.
TEMPO: 26-week, double-blind, randomized, fixed-dose, parallel-group study of 404 early patients not yet receiving dopaminergic therapy.4,10 The TEMPO study was conducted by the Parkinson Study Group (PSG).10
Setting treatment expectations for patients when they start AZILECT is important. There is a difference between the onset of action of AZILECT and that of levodopa.
AZILECT® (rasagiline tablets) is indicated for the treatment of Parkinson’s disease (PD).
|1.||Hauser RA, Silver D, Choudhry A, Eyal E, Isaacson S; for the ANDANTE study investigators. Randomized, controlled trial of rasagiline as an add-on to dopamine agonists in Parkinson's disease [published online June 11, 2014]. Mov Disord. doi: 10.1002/mds.25877.|
|2.||The Parkinson Study Group. A randomized, placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: the PRESTO study. Arch Neurol. 2005;62:241-248.|
|3.||Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa in patients 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. Lancet. 2005;365(9463):947-954.|
|4.||AZILECT Prescribing Information, May 2014.|
|5.||Data on file, Teva Pharmaceuticals USA, Inc.|
|6.||Fahn S, Elton RL; UPDRS Development Committee. Unified Parkinson's Disease Rating Scale. In: Fahn S, Marsden CD, Calne DB, Goldstein M, eds. Recent Developments in Parkinson's Disease. Florham Park, NJ: Macmillan; 1987:153-163,293-304.|
|7.||Olanow CW, Stern MB, Sethi K. The scientific and clinical basis for the treatment of Parkinson disease (2009). Neurology. 2009;72(suppl 4):S1-S136.|
|8.||Olanow CW, Kieburtz K, Rascol O, et al, for the Stalevo Reduction in Dyskinesia Evaluation in Parkinson’s Disease (STRIDE-PD) Investigators. Factors predictive of the development of Levodopa-induced dyskinesia and wearing-off in Parkinson’s disease. Mov Disord. 2013;28:1064-1072.|
|9.||Elmer L, Schwid S, Eberly S, et al. Rasagiline-associated motor improvement in PD occurs without worsening of cognitive and behavioral symptoms. J Neurol Sci. 2006;248(1-2):78-83.|
|10.||Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease: the TEMPO study. Arch Neurol. 2002;59(12):1937-1943.|
|11.||Goetz CG, Schwid SR, Eberly SW, et al. Safety of rasagiline in elderly patients with Parkinson disease. Neurology. 2006;66:1427-1429.|