ABSTRACT
Depression is frequent in Parkinson's disease (PD) patients, but the evidence for many antidepressant agents to treat it in PD is insufficient. The aim of the present prospective open-label single-arm study (VOPARK, an open-label study of the effectiveness and safety of VOrtioxetine in PARKinson's disease patients with depression) was to analyze the effectiveness of vortioxetine on depressive symptoms in PD patients with major depression. The primary efficacy outcome was the change from baseline (VB) at the end of the observational period (12 weeks ± 14 days; V12w) in the 17-item Hamilton Depression Rating Scale (HAM-D17) total score. At VB, all patients had a HAM-D17 total score ≥16. A total of 30 patients (age 66.23 ± 10.27; 73.3% males) were included between February 2021 (first patient, 12/FEB/21) and March 2022 (last patient, 14/MAR/22). At 12 weeks, 27 patients completed the follow-up (90%). The total HAM-D17 total score was reduced by 52.7% (from 21.5 ± 4.75 at VB to 10.44 ± 7.54 at V12w; Cohen's effect size = −2.5; p < 0.0001) and the response and remission rates were 50% and 43.3%, respectively. Apathy (Apathy Scale; p < 0.0001), cognition (PD-Cognitive Rating Scale; p = 0.007), fatigue (Fatigue Severity Scale; p = 0.014), and quality of life (PDQ-39 (p = 0.001) and EUROHIS-QOL8 (p < 0.0001)) improved at 3 weeks as well. A total of 11 adverse events in 10 patients (33.3%) were reported, one of which was severe (vomiting related to vortioxetine with full recovery after drug withdrawal). Vortioxetine was safe and well tolerated and improved depressive symptoms and other non-motor symptoms in PD patients.
ABSTRACT
Introducción. Sativex (R) es un fármaco aprobado para el tratamiento de la espasticidad en la esclerosis múltiple. Hemos querido estudiar la tolerabilidad y eficacia de este fármaco en patologías fuera de indicación de ficha técnica, mediante su uso compasivo. Objetivo. Valorar la eficacia y tolerabilidad de Sativex en patologías no incluidas en la ficha técnica, mediante un protocolo de uso compasivo. Pacientes y métodos. Se realizó un estudio observacional, de seis meses de duración, para evaluar la eficacia y tolerabilidad de Sativex en el dolor neuropático y en la espasticidad de causa diferente a la esclerosis múltiple. Resultados. Se incluyó un total de 10 pacientes, seis mujeres y cuatro hombres. Sólo hubo efectos adversos en dos de ellos, y el fármaco se suspendió en un caso. Tras el inicio del tratamiento con Sativex mediante protocolo de uso compasivo, el consumo de fármacos concomitantes se redujo un 34,2% (p = 0,004), y se suspendió la administración de toxina botulínica en siete pacientes (70%). La mejoría de la escala de espasticidad de Ashworth fue del 65,6% (p = 0,004) y la escala visual analógica disminuyó su puntuación un 49,2% (p = 0,026). Conclusión. Sativex puede ser una alternativa terapéutica interesante en pacientes con espasticidad y dolor cuando sehan utilizado los tratamientos habituales disponibles, pero los pacientes continúan con afectación significativa de su calidad de vida (AU)
Introduction. Sativex (R) is a drug approved for use in the treatment of spasticity in multiple sclerosis. We sought to study the tolerability and effectiveness of this drug product in pathologies beyond the scope of the indications of the product data sheet, by means of its compassionate use. Aim. To evaluate the effectiveness and safety of Sativex in pathologies that are not included on the product data sheet, using a compassionate use protocol. Patients and methods. A six-month observational study was conducted to evaluate the effectiveness and safety of Sativex in neuropathic pain and in spasticity from causes other than multiple sclerosis. Results. A total of 10 patients were included: six females and four males. Side effects appeared in only two of them and the drug product was withdrawn in one case. After starting treatment with Sativex by means of a compassionate use protocol, the consumption of concomitant drugs was reduced by 34.2% (p = 0.004), and administration of botulinum toxin was suspended in seven patients (70%). The improvement on the Ashworth spasticity scale was 65.6% (p = 0.004) and the score on the analogical visual scale dropped by 49.2% (p = 0.026). Conclusions. Sativex may be an interesting therapeutic alternative in patients with spasticity and pain when the treatments that are usually available have been employed but patients quality of life continues to be significantly compromised (AU)
Subject(s)
Humans , Male , Female , Adult , Aged , Middle Aged , Compassionate Use Trials , Muscle Spasticity/drug therapy , Plant Extracts/therapeutic use , Muscle Spasticity/etiology , Plant Extracts/adverse effects , Treatment Outcome , Multiple Sclerosis/complicationsABSTRACT
INTRODUCTION: Sativex® is a drug approved for use in the treatment of spasticity in multiple sclerosis. We sought to study the tolerability and effectiveness of this drug product in pathologies beyond the scope of the indications of the product data sheet, by means of its compassionate use. AIM: To evaluate the effectiveness and safety of Sativex in pathologies that are not included on the product data sheet, using a compassionate use protocol. PATIENTS AND METHODS: A six-month observational study was conducted to evaluate the effectiveness and safety of Sativex in neuropathic pain and in spasticity from causes other than multiple sclerosis. RESULTS: A total of 10 patients were included: six females and four males. Side effects appeared in only two of them and the drug product was withdrawn in one case. After starting treatment with Sativex by means of a compassionate use protocol, the consumption of concomitant drugs was reduced by 34.2% (p=0.004), and administration of botulinum toxin was suspended in seven patients (70%). The improvement on the Ashworth spasticity scale was 65.6% (p=0.004) and the score on the analogical visual scale dropped by 49.2% (p=0.026). CONCLUSIONS: Sativex may be an interesting therapeutic alternative in patients with spasticity and pain when the treatments that are usually available have been employed but patients' quality of life continues to be significantly compromised.
TITLE: Evaluacion de eficacia y tolerabilidad de Sativex ® en uso compasivo.Introduccion. Sativex ® es un farmaco aprobado para el tratamiento de la espasticidad en la esclerosis multiple. Hemos querido estudiar la tolerabilidad y eficacia de este farmaco en patologias fuera de indicacion de ficha tecnica, mediante su uso compasivo. Objetivo. Valorar la eficacia y tolerabilidad de Sativex en patologias no incluidas en la ficha tecnica, mediante un protocolo de uso compasivo. Pacientes y metodos. Se realizo un estudio observacional, de seis meses de duracion, para evaluar la eficacia y tolerabilidad de Sativex en el dolor neuropatico y en la espasticidad de causa diferente a la esclerosis multiple. Resultados. Se incluyo un total de 10 pacientes, seis mujeres y cuatro hombres. Solo hubo efectos adversos en dos de ellos, y el farmaco se suspendio en un caso. Tras el inicio del tratamiento con Sativex mediante protocolo de uso compasivo, el consumo de farmacos concomitantes se redujo un 34,2% (p = 0,004), y se suspendio la administracion de toxina botulinica en siete pacientes (70%). La mejoria de la escala de espasticidad de Ashworth fue del 65,6% (p = 0,004) y la escala visual analogica disminuyo su puntuacion un 49,2% (p = 0,026). Conclusion. Sativex puede ser una alternativa terapeutica interesante en pacientes con espasticidad y dolor cuando se han utilizado los tratamientos habituales disponibles, pero los pacientes continuan con afectacion significativa de su calidad de vida.
Subject(s)
Compassionate Use Trials , Muscle Spasticity/drug therapy , Plant Extracts/therapeutic use , Adult , Aged , Cannabidiol , Dronabinol , Drug Combinations , Female , Humans , Male , Middle Aged , Multiple Sclerosis/complications , Muscle Spasticity/etiology , Plant Extracts/adverse effects , Treatment OutcomeABSTRACT
TITLE: Paraparesia espastica tropical: presentacion de un nuevo caso en España.
Subject(s)
Paraparesis, Tropical Spastic/diagnosis , Brain/pathology , Caribbean Region , DNA, Viral/immunology , Diagnosis, Differential , Evoked Potentials, Somatosensory , Female , Human T-lymphotropic virus 1/genetics , Human T-lymphotropic virus 1/immunology , Human T-lymphotropic virus 1/isolation & purification , Humans , Magnetic Resonance Imaging , Middle Aged , Military Personnel , Paraparesis, Tropical Spastic/epidemiology , Paraparesis, Tropical Spastic/immunology , Paraparesis, Tropical Spastic/pathology , Paraparesis, Tropical Spastic/transmission , Proviruses/genetics , Proviruses/immunology , Proviruses/isolation & purification , RNA, Messenger/immunology , RNA, Viral/immunology , Reflex, Abnormal , Spain/epidemiology , Spinal Cord Diseases/diagnosis , Spouses , T-Lymphocytes, Cytotoxic/immunology , TravelABSTRACT
No disponible
Subject(s)
Humans , Paraparesis, Tropical Spastic/diagnosis , Hypertension/complications , HTLV-I Infections/diagnosis , Muscle Weakness/etiology , HTLV-I Antibodies/isolation & purificationABSTRACT
TITLE: Neuropatia optica de Leber, diez años despues: sindrome de Harding.
Subject(s)
Multiple Sclerosis , Optic Atrophy, Hereditary, Leber , Adult , Humans , Male , Multiple Sclerosis/diagnosis , Optic Atrophy, Hereditary, Leber/diagnosis , Syndrome , Time FactorsABSTRACT
No disponible
Subject(s)
Humans , Male , Adult , Optic Atrophy, Hereditary, Leber/complications , Multiple Sclerosis/complications , Visual AcuitySubject(s)
Bone Neoplasms/complications , Chin/innervation , Hypesthesia/etiology , Osteoblasts/pathology , Osteosarcoma/complications , Peripheral Nervous System Diseases/complications , Peripheral Nervous System Diseases/physiopathology , Bone Neoplasms/pathology , Female , Humans , Middle Aged , Osteosarcoma/pathology , SyndromeABSTRACT
No disponible
