Figura. Estrategia de cambio de la entacapona a la opicapona.
Tabla I. Tolerabilidad de la opicapona 50 mg en los estudios BIPARK-I y BIPARK-II (basada en [20]). |
|||
Placebo |
Opicapona 50 mg |
Frecuencia ajustada |
|
Todos los EAST |
147 (57%) |
170 (64%) |
7% |
EAST graves |
11 (4%) |
13 (5%) |
1% |
Fallecimientos |
1 (0,4%) |
0 (0%) |
–0,4% |
EAST causantes de interrupción del tratamiento |
18 (7%) |
23 (9%) |
2% |
Discinesia |
16 (6%) |
54 (20%) |
14% |
Estreñimiento |
5 (2%) |
17 (6%) |
4% |
Insomnio |
4 (2%) |
9 (3%) |
1% |
Sequedad de boca |
3 (1%) |
8 (3%) |
2% |
Aumento de la creatinfosfocinasa |
5 (2%) |
14 (5%) |
3% |
Mareo |
3 (1%) |
9 (3%) |
2% |
Somnolencia |
5 (2%) |
5 (2%) |
0% |
Infección urinaria |
2 (1%) |
10 (4%) |
3% |
Disminución del peso |
0 |
10 (4%) |
4% |
Alucinaciones |
1 (0,4%) |
3 (1%) |
1% |
Porcentajes redondeados excepto si eran < 0,5%. EAST: efectos adversos surgidos durante el tratamiento. a Frecuencia con opicapona 50 mg menos frecuencia con placebo. |
Tabla II. Posible manejo clínico de los efectos adversos. |
|
Discinesias leves o escasamente molestas |
No modificar tratamiento, tras valoración con el paciente |
Discinesias graves o molestas |
Reducir dosis global de levodopa o incrementar el tiempo entre administraciones |
Hipotensión ortostática |
Si el paciente está recibiendo hipotensores, administrarlos por la noche |
Trastorno del control de impulsos |
Disminuir la dosis del agonista dopaminérgico o de otros fármacos dopaminérgicos |
Mareos, náuseas o vómitos |
Administrar domperidona |
Insomnio |
Valorar la posible administración de opicapona por la mañana |
Alucinaciones |
Reducir la dosis del agonista dopaminérgico y, si se precisa, retirar otros fármacos dopaminérgicos |
Optimized clinical management of Parkinson’s disease with opicapone. Recommendations from Spanish experts Summary. Motor fluctuations are frequently seen in Parkinson disease patients on chronic treatment with levodopa. Management of motor fluctuation includes the addition of catechol-O-methyl transferase (COMT) inhibitors. Opicapone is a recent and selective third-generation COMT inhibitor which achieves marked increase in the bioavailability of levodopa. We present a consensus of a group of Spanish neurologists with extensive experience in the clinical management of motor fluctuations. The clinical experience of this group of experts is in line with clinical trials and confirms that opicapone is an effective drug in the control of motor fluctuations, regardless of the daily levodopa dose, or the use of other antiparkinsonian drugs. However, in the opinion of these experts, the ideal patient with Parkinson’s disease to initiate treatment with opicapone is the one with mild motor fluctuations, since the ratio between clinical efficacy and adverse effects is more favorable. In general, it is an easy-to-use drug both in those first treated with a COMT inhibitor or those already on entacapone. In any case, the secondary side effects are easily managed. Key words. Catechol-O-methyl transferase inhibitors (COMT). Dyskinesias. Motor fluctuation. Opicapone. Parkinson’s disease. |