Rasagiline Adverse Events

Adverse events were no more common with rasagiline than placebo in the TEMPO study (94) of early patients; the two most common adverse events were infection and headache. In the active treatment phase, there were no significant differences in the most common adverse events occurring in the second six months of the study (infection, headache, unintentional injury, and dizziness). There were eight newly diagnosed malignancies detected over the 12 months of the TEMPO study including six skin cancers (3 squamous cell, 2 melanoma, 1 basal cell carcinoma). Although this may be higher than what would be expected in the general population, it appears that the risk of skin cancers is higher in PD patients in general and does not appear to be specifically related to rasagiline. Given the potential interaction between tyramine and MAO inhibition, a subset of patients on rasagiline also underwent uneventful tyramine challenge tests and blood pressures were generally unchanged after 75 mg of tyramine (99). However, it is recommended that patients should avoid foods and beverages high in tyramine when on rasagiline.

In the PRESTO study of advanced patients (96), balance difficulty was more common with rasagiline 0.5 mg/day than placebo, and weight loss, anorexia, and vomiting were each more common with rasagiline 1 mg/day than placebo (P < 0.05 for each). The safety of rasagiline in elderly (70 years and older) PD patients was reported (100). The authors analyzed the data (including both 1 mg/day and 2 mg/day dosages of rasagiline) from PRESTO (96) and TEMPO (95) studies. They found that older subjects were more prone to develop serious adverse effects than younger subjects, but this was irrespective of treatment with rasagiline or placebo (100). In the PRESTO study, the total number of adverse effects was higher with rasagiline compared to placebo (P=0.03) and more subjects experienced dyskinesia with rasagiline (P = 0.02), but this was seen in both older and younger subjects. Elderly subjects in both TEMPO (P=0.06) and PRESTO (P = 0.01) were more prone to develop hallucinations regardless of treatment. Although the authors acknowledge that this was a secondary analysis and not specifically powered to detect age-rasagiline interactions directly, no significant interaction between age and rasagiline use was identified as a risk factor for adverse effects (100).

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