Adverse Drug Reactions with Selegiline and Rasagiline compared to Levodopa and Ropinirole: a study in the French Pharmacovigilance Database

SANTIAGO PEREZ LLORET; MARIA VERÓNICA REY; JEAN-LOUIS MONTASTRUC; OLIVIER RASCOL

Congreso; 17th International Congress of Parkinson’s Disease and Movement Disorders; 2013

Movement Disorders Society

Objective: To compare spontaneous Adverse Drug Reaction (ADR) reports to the French PharmacoVigilance Database (FPVD) between Selegiline and Rasagiline, taking Levodopa and Ropinirole as references. PharmacoVigilance Database (FPVD) between Selegiline and Rasagiline, taking Levodopa and Ropinirole as references. To compare spontaneous Adverse Drug Reaction (ADR) reports to the French PharmacoVigilance Database (FPVD) between Selegiline and Rasagiline, taking Levodopa and Ropinirole as references. Background: Selegiline and Rasagiline are Monoaminooxidase B enzyme inhibitors, being the main difference that Selegiline is metabolized into a metanphetaminic compound. difference that Selegiline is metabolized into a metanphetaminic compound. Selegiline and Rasagiline are Monoaminooxidase B enzyme inhibitors, being the main difference that Selegiline is metabolized into a metanphetaminic compound. Methods: Reporting of “Serious” and “Unexpected” ADR is mandatory in France since 1996. The FPVDReporting of “Serious” and “Unexpected” ADR is mandatory in France since 1996. The FPVD Selegiline, Rasagiline, Levodopa or Ropinirole were considered as “suspected” drugs. ADRs were classified according to System-Organ Class (Medical Dictionary for Regulatory Activities). Frequency of ADRs was compared by Chi-Sq test. Results: We retrieved 199 ADR reports for Selegiline, 132 for Rasagiline, 1851 for Levodopa and 432 for Ropinirole. “Serious” ADR were less frequent with Selegiline as compared to the rest of the drugs (31% vs 45%). Confusion, Hallucination or Agitation, were more frequent with Selegiline compared to the rest of the drugs (respectively, 19% vs 10%, 12% vs 8% and 6% vs 2%). Impulse control disorders were more frequent with Ropinirole vs Rasagiline (12% vs 4%) and less frequent with Selegiline (1%). Somnolence was less frequent with Selegiline and Rasagiline vs Ropinirole (1% and 4% vs 16%). Headache was more frequent with Rasagiline compared to rest of the drugs (5% vs 1%). Orthostatic Hypotension was less frequent with Rasagiline vs Selegiline (1% vs 9%). Weight loss was more frequent with Rasagiline or Selegiline. Renal ADRs, including imperious micturition and incontienence, were more frequent with Rasagiline compared to Selegiline, Levodopa and Ropinirole (6% vs 1%, 1% and 3%). Musculosqueletal ADRs, including arthralgias and myalgias, were more frequent with Rasagiline compared to Selegiline, Levodopa and Ropinirole (11% vs 2%, 3% and 2%). Ropinirole. “Serious” ADR were less frequent with Selegiline as compared to the rest of the drugs (31% vs 45%). Confusion, Hallucination or Agitation, were more frequent with Selegiline compared to the rest of the drugs (respectively, 19% vs 10%, 12% vs 8% and 6% vs 2%). Impulse control disorders were more frequent with Ropinirole vs Rasagiline (12% vs 4%) and less frequent with Selegiline (1%). Somnolence was less frequent with Selegiline and Rasagiline vs Ropinirole (1% and 4% vs 16%). Headache was more frequent with Rasagiline compared to rest of the drugs (5% vs 1%). Orthostatic Hypotension was less frequent with Rasagiline vs Selegiline (1% vs 9%). Weight loss was more frequent with Rasagiline or Selegiline. Renal ADRs, including imperious micturition and incontienence, were more frequent with Rasagiline compared to Selegiline, Levodopa and Ropinirole (6% vs 1%, 1% and 3%). Musculosqueletal ADRs, including arthralgias and myalgias, were more frequent with Rasagiline compared to Selegiline, Levodopa and Ropinirole (11% vs 2%, 3% and 2%). We retrieved 199 ADR reports for Selegiline, 132 for Rasagiline, 1851 for Levodopa and 432 for Ropinirole. “Serious” ADR were less frequent with Selegiline as compared to the rest of the drugs (31% vs 45%). Confusion, Hallucination or Agitation, were more frequent with Selegiline compared to the rest of the drugs (respectively, 19% vs 10%, 12% vs 8% and 6% vs 2%). Impulse control disorders were more frequent with Ropinirole vs Rasagiline (12% vs 4%) and less frequent with Selegiline (1%). Somnolence was less frequent with Selegiline and Rasagiline vs Ropinirole (1% and 4% vs 16%). Headache was more frequent with Rasagiline compared to rest of the drugs (5% vs 1%). Orthostatic Hypotension was less frequent with Rasagiline vs Selegiline (1% vs 9%). Weight loss was more frequent with Rasagiline or Selegiline. Renal ADRs, including imperious micturition and incontienence, were more frequent with Rasagiline compared to Selegiline, Levodopa and Ropinirole (6% vs 1%, 1% and 3%). Musculosqueletal ADRs, including arthralgias and myalgias, were more frequent with Rasagiline compared to Selegiline, Levodopa and Ropinirole (11% vs 2%, 3% and 2%). Conclusions: Compared to Selegiline, Rasagiline was associated with a higher risk of renal or musculoesqueletal ADRs, headaches or impulse control disorders. Conversely, the risk of orthostatic hypotension, confusion, hallucinations or agitation was higher with Selegiline. musculoesqueletal ADRs, headaches or impulse control disorders. Conversely, the risk of orthostatic hypotension, confusion, hallucinations or agitation was higher with Selegiline. Compared to Selegiline, Rasagiline was associated with a higher risk of renal or musculoesqueletal ADRs, headaches or impulse control disorders. Conversely, the risk of orthostatic hypotension, confusion, hallucinations or agitation was higher with Selegiline.