INVESTIGADORES
PEREZ LLORET Santiago
congresos y reuniones científicas
Título:
Adverse Drug Reactions with Selegiline and Rasagiline compared to Levodopa and Ropinirole: a study in the French Pharmacovigilance Database
Autor/es:
SANTIAGO PEREZ LLORET; MARIA VERÓNICA REY; JEAN-LOUIS MONTASTRUC; OLIVIER RASCOL
Reunión:
Congreso; 17th International Congress of Parkinsons Disease and Movement Disorders; 2013
Institución organizadora:
Movement Disorders Society
Resumen:
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.