AZILECT As Initial Monotherapy for Parkinson’s Disease

AZILECT has been studied in 2 randomized, placebo-controlled studies as initial monotherapy for the treatment of Parkinson’s disease.1-3 

Once-daily AZILECT 1 mg as initial monotherapy improves total Unified Parkinson’s Disease Rating Scale (UPDRS) scores.1,2*


  • In the TEMPO study, AZILECT treatment improved Parkinson’s disease symptoms at 6 months compared to placebo (-3.8 units, P = 0.0001) assessed as the between-group difference in change from baseline in total UPDRS score.1,2
  • In the ADAGIO study, AZILECT treatment improved Parkinson’s disease symptoms at 9 months compared to placebo (-3.0 units, P<0.0001) assessed as the between-group difference in change from baseline in total UPDRS score.3

*Results from TEMPO, a double-blind, parallel-group, 26-week trial, conducted by the Parkinson Study Group, in early Parkinson's disease patients not yet receiving dopaminergic therapy at the start of the study. The primary measure of effectiveness was the change from baseline in the total UPDRS score.

†Results from ADAGIO, a multicenter, multinational study of 1,176 early patients. Phase I was a 36-week, double-blind, placebo-controlled trial to evaluate total UPDRS scores at week 36 as a secondary endpoint.

UPDRS, a commonly used research tool in Parkinson’s disease, 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. A reduction in the score represents improvement, and a beneficial change from baseline appears as a negative number.4,5

AZILECT may allow early stage patients to stay active longer.1,2,4,6*

AZILECT treatment maintained activities of daily living (ADL) better than placebo (1.2 units vs 0.2 units; P=0.0003) assessed as the change from baseline. ADL measured on a scale from 0-52. Mean baseline score for placebo was 6.2; AZILECT was 5.9. ADL subscale (part II) included, but was not limited to: 

  • Dressing
  • Walking
  • Cutting Food
  • Turning in bed
  • Speech
  • Handwriting

AZILECT improves patients' overall motor symptoms.1-4,6*

  • In the TEMPO study AZILECT treatment had a significant beneficial effect on motor symptoms compared to placebo (-0.4 vs 2.3 units; P<0.0001) assessed as the change from baseline. Motor measured on a scale from 0-108. Mean baseline score for placebo was 17.6; AZILECT was 17.9.
  • UPDRS motor consists of tremor, bradykinesia, rigidity, and postural instability and gait disorder (PIGD).

Please see important safety information and complete prescribing information. 

Learn more about Adjunct therapy with AZILECT.

REFERENCES
1. The Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease. The TEMPO study. Arch Neurol. 2002;59(12):1937-1943.
2. AZILECT Prescribing Information.
3. Rascol O, Olanow CW. Presented at: Movement Disorder Society 13th Annual Conference; June 7-11, 2009; Paris, France.
4. 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.
5. Waters CH. Diagnosis and Management of Parkinson's Disease. 3rd ed. West Islip, NY: Professional Communications, Inc.; 2002.
6. Data on file, Teva Neuroscience, Inc. 


 

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AZILECT (rasagiline tablets) is indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s Disease (PD) as initial monotherapy and as adjunct therapy to levodopa.

IMPORTANT SAFETY INFORMATION ABOUT AZILECT

Azilect is contraindicated with meperidine; the analgesics tramadol, methadone, and propoxyphene; the antitussive agent dextromethorphan; as well as St. John’s wort and cyclobenzaprine. Azilect is also contraindicated with other MAOIs.

In general, the combination of Azilect and antidepressants should be avoided. Caution should be used when giving Azilect concurrently with CYP1A2 inhibitors such as ciprofloxacin. Patients with moderate to severe hepatic impairment should not take Azilect. The daily dose of Azilect should not exceed 1 mg because of the risks associated with nonselective inhibition of MAO. PD patients are advised to monitor for melanoma frequently and see a dermatologist on a regular basis.

The most common side effects as monotherapy include: flu syndrome, arthralgia, depression, and dyspepsia; and as adjunct to levodopa therapy include: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, and fall.

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