ABSTRACT
Opicapone is a catechol-O-methyl-transferase (iCOMT) inhibitor authorized in Europe in 2016 and indicated as adjunctive therapy to preparations of levodopa/ DOPA decarboxylase inhibitors in adult patients with Parkinson's disease and end-of-dose motor fluctuations who cannot be stabilised on those combinations. The efficacy of opicapone in these patients has been demonstrated in two pivotal randomized clinical trials, BIPARK I and BIPARK II, in which it has demonstrated its superiority versus placebo and non-inferiority versus entacapone. Although they constitute the gold standard for the evaluation of interventions, randomized clinical trials present limitations of external validity due to the use of strict eligibility criteria. Therefore, it is considered necessary to have a more comprehensive evaluation of the efficacy of the drug, complementing the information obtained from randomized clinical trials with that of "real world or real clinical practice" studies. The objective of this review has been to collect and put into perspective the information available on opicapone coming from real clinical practice studies in Spain. The data from Spain with opicapone in 18 series with more than 1,000 patients in total, confirm the safety and efficacy previously reported with this iCOMT. Furthermore, they show that opicapone is especially useful in patients with a less advanced stage of the disease and mild motor fluctuations, which would suggest that the earlier its introduction in the therapeutic scheme for the management of motor fluctuations, the better is the benefit-risk ratio for the drug.
TITLE: Opicapona para el tratamiento de la enfermedad de Parkinson: datos de vida real en España.Resumen. La opicapona es un inhibidor de la catecol-O-metiltransferasa (iCOMT) autorizado en Europa en 2016 como terapia adyuvante a las preparaciones de levodopa/inhibidores de la dopa descarboxilasa en pacientes adultos con enfermedad de Parkinson y fluctuaciones motoras de final de dosis que no puedan ser estabilizados con esas combinaciones. La eficacia de la opicapona en estos pacientes ha sido demostrada en dos ensayos clínicos pivotales, BIPARK I y BIPARK II, en los que se ha demostrado la superioridad frente al placebo y la no inferioridad frente a la entacapona. A pesar de que constituyen el estándar para la evaluación de intervenciones, los ensayos clínicos aleatorizados presentan limitaciones de validez externa debidas a la utilización de criterios estrictos de elegibilidad. Por tanto, se considera necesario disponer de una evaluación más amplia de la eficacia general del fármaco, complementando la información de los ensayos clínicos aleatorizados con estudios de 'vida real o práctica clínica real'. El objetivo de esta revisión ha sido recopilar y poner en perspectiva la información disponible sobre los resultados de la opicapona en estudios de práctica clínica real en España. Los datos acumulados en España con opicapona en 18 series con más de 1.000 pacientes confirman la seguridad y la eficacia de este iCOMT comunicadas previamente. Además, muestran que la opicapona es especialmente útil en pacientes en un estadio de la enfermedad menos avanzado y fluctuaciones motores leves, lo que sugeriría una mejor relación beneficio-riesgo cuanto más temprana sea su introducción en el esquema terapéutico para el tratamiento de las fluctuaciones motoras.
Subject(s)
Antiparkinson Agents/therapeutic use , Catechol O-Methyltransferase Inhibitors/therapeutic use , Oxadiazoles/therapeutic use , Parkinson Disease/drug therapy , Antiparkinson Agents/administration & dosage , Antiparkinson Agents/adverse effects , Combined Modality Therapy , Deep Brain Stimulation , Drug Therapy, Combination , Humans , Levodopa/administration & dosage , Levodopa/therapeutic use , Oxadiazoles/administration & dosage , Oxadiazoles/adverse effects , Parkinson Disease/therapy , Quality of Life , Randomized Controlled Trials as Topic , Retrospective Studies , Risk Assessment , Spain , Treatment OutcomeABSTRACT
No disponible
Subject(s)
Humans , Male , Middle Aged , Glymphatic System/physiopathology , Parkinsonian Disorders/physiopathology , Parkinsonian Disorders/diagnostic imaging , Glymphatic System/diagnostic imaging , Magnetic Resonance ImagingABSTRACT
OBJECTIVE: To assess the effect on cognition of a controlled intervention testing Mediterranean diets (MedDiet). DESIGN: Randomized trial after 6.5 years of nutritional intervention. SETTING: Eight primary care centers affiliated to the University of Navarra. PARTICIPANTS: A random subsample of 285 participants (95 randomly allocated to each of 3 groups) of the PREDIMED-NAVARRA trial. All of them were at high vascular risk (44.8% men, 74.1±5.7 years at cognitive evaluation). INTERVENTIONS: Nutritional intervention comparing two MedDiets (supplemented with extra-virgin olive oil [EVOO] or mixed nuts) versus a low-fat control diet. Participants received intensive education to increase adherence to the intended intervention. Participants allocated to the MedDiet groups received EVOO (1 l/week) or 30 g/day of mixed nuts. Dietary habits were evaluated using a validated 137-item food frequency questionnaire (FFQ). Additionally, adherence to MedDiet was appraised using a 14-item questionnaire both at baseline and yearly thereafter. MEASUREMENTS: Cognitive performance as a main outcome and cognitive status (normal, mild cognitive impairment [MCI] or dementia) as a secondary outcome were evaluated by two neurologists blinded to group assignment after 6.5 years of nutritional intervention. RESULTS: Better post-trial cognitive performance versus control in all cognitive domains and significantly better performance across fluency and memory tasks were observed for participants allocated to the MedDiet+EVOO group. After adjustment for sex, age, education, apolipoprotein E genotype, family history of cognitive impairment/dementia, smoking, physical activity, body mass index, hypertension, dyslipidaemia, diabetes, alcohol and total energy intake, this group also showed lower MCI (OR=0.34 95% CI: 0.12-0.97) compared with control group. Participants assigned to MedDiet+Nuts group did not differ from controls. CONCLUSION: A long-term intervention with an EVOO-rich MedDiet resulted in a better cognitive function in comparison with a control diet. However, non-significant differences were found for most cognitive domains. Participants allocated to an EVOO-rich MedDiet had less MCI than controls.
Subject(s)
Cognition/drug effects , Dietary Supplements , Plant Oils/administration & dosage , Aged , Aged, 80 and over , Body Mass Index , Cognitive Dysfunction/diet therapy , Dementia/diet therapy , Diet, Fat-Restricted , Diet, Mediterranean , Energy Intake , Feeding Behavior , Female , Follow-Up Studies , Humans , Logistic Models , Male , Middle Aged , Motor Activity , Multivariate Analysis , Nutrition Assessment , Nuts , Olive Oil , Patient Compliance , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Se comunica la experiencia y los resultados obtenidos de 110 casos de histerectomía total laparoscópica asistida por robot entre junio de 2010 y abril de 2013 en Clínica Indisa. Parámetros evaluados: diagnóstico, edad, índice de masa corporal (IMC), tiempo de instalación de trócares (TT), tiempo operatorio (TO), conversión a laparotomía, sangrado, dolor postoperatorio, estadía hospitalaria y complicaciones postoperatorias. Los diagnósticos preoperatorios más frecuentes fueron: miomatosis y adenomiosis. El promedio de edad fue de 45 años y de IMC 25,8 kg/m2, 7 por ciento de las pacientes con IMC mayor de 35. TT promedio de 14 min y TO fue de 81 min. No hubo conversión a laparotomía. Sangrado promedio de 17 ml. A las 48 horas pos intervención el 100 por ciento de las pacientes presentó un test de EVA de 0-2. Promedio de estadía hospitalaria fue 1,6 días. Hubo tres complicaciones postoperatorias: una neumonía, un desgarro vulvar y una dehiscencia de la cúpula vaginal. Conclusión: La histerectomía total laparoscópica asistida por robot es una técnica segura y ofrece ventajas al paciente y cirujano...
We reports the experience and results obtained after 110 total robot assisted laparoscopic hysterectomy from June 2010 to April 2013 at Indisa Clinic. Parameters evaluated: diagnostic, age, body mass index (BMI), trocars installation time (TT), intervention time (TO), conversion to laparotomy, bleeding, post operatory pain, hospital stay, and post operatory complications. The most frequent preoperatory diagnostic were uterine fibroid and adenomyosis. The age average was 45 years and BMI 25.8 Kg/m2 and 7 percent was over 35. TT average 14 min and TO 81 min. There were no conversions to laparotomy. Bleeding average was 17 ml. At 48 hours, 100 percent of patients had an EVA test of 0-2. The average of hospital stay was 1.6 days. Only three complications occurred: one pneumonia, one vulvar tear and one vaginal cuff dehiscence. Conclusion: robot assisted laparoscopy hysterectomy appears to be a safe surgical technique that offers benefits to the patient and also to the surgeon...
Subject(s)
Humans , Adult , Female , Middle Aged , Aged, 80 and over , Hysterectomy/methods , Laparoscopy , Robotics , Hysterectomy/instrumentation , Length of Stay , Postoperative Complications , Treatment OutcomeABSTRACT
BACKGROUND AND PURPOSE: White matter hyperintensities (WMHs) detected by magnetic resonance imaging (MRI) of the brain are associated with dementia and cognitive impairment in the general population and in Alzheimer's disease. Their effect in cognitive decline and dementia associated with Parkinson's disease (PD) is still unclear. METHODS: We studied the relationship between WMHs and cognitive state in 111 patients with PD classified as cognitively normal (n = 39), with a mild cognitive impairment (MCI) (n = 46) or dementia (n = 26), in a cross-sectional and follow-up study. Cognitive state was evaluated with a comprehensive neuropsychological battery, and WMHs were identified in FLAIR and T2-weighted MRI. The burden of WMHs was rated using the Scheltens scale. RESULTS: No differences in WMHs were found between the three groups in the cross-sectional study. A negative correlation was observed between semantic fluency and the subscore for WMHs in the frontal lobe. Of the 36 non-demented patients re-evaluated after a mean follow-up of 30 months, three patients converted into MCI and 5 into dementia. Progression of periventricular WMHs was associated with an increased conversion to dementia. A marginal association between the increase in total WMHs burden and worsening in the Mini Mental State Examination was encountered. CONCLUSIONS: White matter hyperintensities do not influence the cognitive status of patients with PD. Frontal WMHs have a negative impact on semantic fluency. Brain vascular burden may have an effect on cognitive impairment in patients with PD as WMHs increase overtime might increase the risk of conversion to dementia. This finding needs further confirmation in larger prospective studies.
Subject(s)
Brain/pathology , Cognition Disorders/etiology , Cognition Disorders/pathology , Parkinson Disease/complications , Parkinson Disease/pathology , Aged , Brain/blood supply , Cognitive Dysfunction/pathology , Cross-Sectional Studies , Dementia/pathology , Disease Progression , Female , Follow-Up Studies , Humans , Magnetic Resonance Imaging , Male , Neuropsychological TestsABSTRACT
The authors critically review subthalamic nucleus (STN) stimulation for Parkinson's disease (PD) at long follow-up (3-5 years). Subthalamic stimulation induce a significant improvement during the "off" medication in the assessment motor score UPDRS (Unified Parkinson Disease Rating Scale) 3-5 years after surgery. Results show that the benefits obtained in tremor, rigidity, bradykinesia, dyskinesias induced by medication and levodopa reduction are significantly maintained during long term. The improvement in other clinical signs as gait and postural stability at long follow-up are not maintained comparing with the benefits obtained one year after surgery. A high percentage of patients show a cognitive disturbance during the follow-up period that may be correlated with the disease progression. The conclusion is that bilateral STN stimulation is an effective treatment for PD patients at long term but it should be considered earlier in the course of PD.
Subject(s)
Deep Brain Stimulation , Parkinson Disease/surgery , Subthalamic Nucleus , Antiparkinson Agents/therapeutic use , Deep Brain Stimulation/adverse effects , Deep Brain Stimulation/methods , Follow-Up Studies , Humans , Motor Activity/physiology , Parkinson Disease/drug therapy , Subthalamic Nucleus/physiology , Subthalamic Nucleus/surgeryABSTRACT
Los autores realizan una revisión crítica de laestimulación del núcleo subtalámico (NST) en laenfermedad de Parkinson (EP) a largo plazo (3-5años). La estimulación del NST produce una mejoríasignificativa de la parte motora de la escala UPDRS(Unified Parkinson Disease Rating Scale) sin medicacióna los 3-5 años de la cirugía. Los resultadosmuestran que los beneficios obtenidos tanto en eltemblor, la rigidez, la bradicinesia y las disquinesias,así como la reducción de la medicación están mantenidossignificativamente a largo plazo. Otros signosde la enfermedad como la marcha y la estabilidadpostural no se mantienen al comparar los beneficiosal año de la cirugía. Un porcentaje alto de pacientesintervenidos muestra un deterioro cognitivo duranteel seguimiento que puede estar relacionado con lapropia evolución de la enfermedad. La conclusión esque la estimulación bilateral del NST continúa siendoefectiva a largo plazo pero debería considerarse lacirugía en un momento más precoz de la evolución dela enfermedad (AU)
The authors critically review subthalamic nucleus(STN) stimulation for Parkinson´s disease (PD) at longfollow-up (3-5 years). Subthalamic stimulation induce asignificant improvement during the off medication inthe assessment motor score UPDRS (Unified ParkinsonDisease Rating Scale) 3-5 years after surgery. Resultsshow that the benefits obtained in tremor, rigidity,bradykinesia, dyskinesias induced by medication andlevodopa reduction are significantly maintained duringlong term. The improvement in other clinical signs asgait and postural stability at long follow-up are notmaintained comparing with the benefits obtained oneyear after surgery. A high percentage of patients show acognitive disturbance during the follow-up period thatmay be correlated with the disease progression. Theconclusion is that bilateral STN stimulation is an effectivetreatment for PD patients at long term but it shouldbe considered earlier in the course of PD (AU)
Subject(s)
Humans , Parkinson Disease/surgery , Subthalamic Nucleus , Antiparkinson Agents/therapeutic use , Deep Brain Stimulation/adverse effects , Deep Brain Stimulation/methods , Follow-Up Studies , Motor Activity/physiology , Parkinson Disease/drug therapy , Subthalamic Nucleus/physiology , Subthalamic Nucleus/surgeryABSTRACT
Neurodegenerative processes with movement disorders is predominant features show a high incidence of sleep alterations at some point in their evolution. The degeneration of structures responsible for maintaining the sleep-wakefulness cycles and the architecture of sleep could be at their root. Other factors like the drugs employed in the treatment of motor problems, the limitations to movement, etc., aggravate the problem. Although, at present, there is no medical therapy able to restore the defects derived from the degeneration of the key structures of sleep, an individual analysis of the coadyuvant factors in each patient could help to improve these problems. In this article we describe the main sleep disorders in Parkinson's disease and other degenerative diseases such as multi-system atrophies or progressive supranuclear paralysis.
Subject(s)
Parkinson Disease/complications , Sleep Wake Disorders/etiology , Humans , Movement Disorders/complications , Sleep Wake Disorders/therapyABSTRACT
La práctica totalidad de los procesos neurodegenerativos cuyos principales síntomas son motores y que se incluyen bajo el epígrafe de trastornos del movimiento, presentan una alta incidencia de alteraciones del sueño en algún momento de su evolución. La degeneración de estructuras responsables del mantenimiento de los ciclos sueño-vigilia y de la arquitectura del sueño puede ser la base de los mismos. Otros factores como los fármacos empleados en el tratamiento de los problemas motores, las limitaciones del movimiento etc., agravan el problema. Aunque en el momento actual no disponemos de fármacos que puedan reponer los defectos derivados de la degeneración de las estructuras claves del sueño, el análisis individual de los factores que concurren en cada paciente puede ayudar a mejorar estos problemas. En este capítulo se describen los principales trastornos del sueño en la enfermedad de Parkinson y otras enfermedades degenerativas como las atrofias multisistema o la parálisis supranuclear progresiva
Neurodegenerative processes with movement disorders is predominant features show a high incidence of sleep alterations at some point in their evolution. The degeneration of structures responsible for maintaining the sleep-wakefulness cycles and the architecture of sleep could be at their root. Other factors like the drugs employed in the treatment of motor problems, the limitations to movement, etc., aggravate the problem. Although, at present, there is no medical therapy able to restore the defects derived from the degeneration of the key structures of sleep, an individual analysis of the coadyuvant factors in each patient could help to improve these problems. In this article we describe the main sleep disorders in Parkinsons disease and other degenerative diseases such as multi-system atrophies or progressive supranuclear paralysis
Subject(s)
Humans , Parkinson Disease/complications , Sleep Wake Disorders/complications , Movement Disorders/complications , REM Sleep Behavior Disorder/complications , PolysomnographyABSTRACT
Introducción: en la práctica obstétrica hay un aumento en el número de pacientes con cicatriz de cesárea anterior CCA, en trabajo de parto, T de P. Objetivos: 1) Describir la evolución de pacientes con CCA y con posibilidad de parto vaginal. 2) Comparar en las que inician trabajo de parto espontáneo, los resultados del manejo con intervención farmacológica, conducción ocitócica y anestesia peridural continua, y la evolución espontánea de éste. Método: estudio clínico, prospectivo, aleatorio. Se analizaron: edad, paridad, causa de CCA, condiciones obstétricas al ingreso, vía del parto, complicaciones maternas y neonatales y días de hospitalización. Análisis: univariado con frecuencias simples y bivariable con tabla de contingencia, chi² y comparación de promedios, T test. Resultados: ingresaron 81 casos. 16 por ciento fueron cesarizadas sin iniciar su T de P. 84 por ciento restante, n=68 se separó aleatoriamente en 2 grupos: 26, manejadas farmacológicamente. El 84,6 por ciento tuvieron un parto vaginal; y 42, manejadas espontáneamente, con 88,1 por ciento de partos vaginales. La única variable con diferencia estadísticamente significativa fue la mayor dilatación cervical en el grupo de evolución espontánea al ingreso. Conclusión: la posibilidad de parto vaginal en pacientes con CCA, es de 72,8 por ciento que aumenta a 86,7 por ciento cuando inician trabajo de parto. El manejo activo no difiere de la evolución espontánea en este estudio que cuenta con un poder de 10 por ciento para afirmarlo
Subject(s)
Humans , Female , Pregnancy , Adolescent , Adult , Labor, Induced , Labor, Obstetric/physiology , Vaginal Birth after Cesarean/methods , Cesarean Section, Repeat , Clinical Evolution , Fetal Monitoring , Oxytocics/therapeutic useABSTRACT
A case of a 42-year-old woman with peritoneal leiomyomatosis (PL) unrelated to pregnancy or any other obvious hormonal source is presented. After treatment with leuprolide acetate for six months, a second-look operation revealed that the majority of the nodules totally regressed. The few remaining ones were substantially reduced in size and exhibited histopathologic evidence of fibrotic change. This response to treatment is documented here for the first time. Since this case was not associated with initial abnormally raised hormonal levels, the regression was caused solely by the treatment and not by the removal of any hormonal stimulus. The usefulness of GnRH analogues in the treatment of PL is proposed.
