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A 57-year-old man developed a locked-in state due to a brain stem stroke. He communicated through eye movements. The team suggested treatment should be discontinued, as there was no perspective of improvement. The family was very upset because they experienced sufficient quality of life. We investigated what 'quality of life' means. The literature shows that severely ill and completely care-dependent patients may experience high quality of life; this is called the disability paradox. Patients and families evaluate quality of life by looking for positive things to live for. Some quality-of-life tests, however, understand quality of life as 'functionality'. Healthy people evaluate the situation of people living with handicaps more negatively than the handicapped themselves do. Practitioners may overlook the instability of patients' evaluations: responses and situations may shift. Quality of life as an outcome in clinical trials may be different for individual patients. These insights may improve communication.
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Personas con Discapacidad/psicología , Cuadriplejía/psicología , Calidad de Vida , Comunicación , Evaluación de la Discapacidad , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Intravenous thrombolytic therapy after ischaemic stroke significantly reduces mortality and morbidity. Actual thrombolysis rates are disappointingly low in many western countries. It has been suggested that higher patient volume is related to shorter door-to-needle-time (DNT) and increased thrombolysis rates. We address a twofold research question: a) What are trends in national thrombolysis rates and door-to-needle times in the Netherlands between 2005-2012? and b) Is there a relationship between stroke patient volume per hospital, thrombolysis rates and DNT? METHODS: We used data from the Stroke Knowledge Network Netherlands dataset. Information on volume, intravenous thrombolysis rates, and admission characteristics per hospital is acquired through yearly surveys, in up to 65 hospitals between January 2005 and December 2012. We used linear regression to determine a possible relationship between hospital stroke admission volume, hospital thrombolysis rates and mean hospital DNT, adjusted for patient characteristics. RESULTS: Information on 121.887 stroke admissions was available, ranging from 7.393 admissions in 2005 to 24.067 admissions in 2012. Mean national thrombolysis rate increased from 6.4% in 2005 to 14.6% in 2012. Patient characteristics (mean age, gender, type of stroke) remained stable. Mean DNT decreased from 72.7 min in 2005 to 41.4 min in 2012. Volume of stroke admissions was not an independent predictor for mean thrombolysis rate nor for mean DNT. CONCLUSION: Intravenous thrombolysis rates in the Netherlands more than doubled between 2005 and 2012, in parallel with a large decline in mean DNT. We found no convincing evidence for a relationship between stroke patient volume per hospital and thrombolysis rate or DNT.
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Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular/tratamiento farmacológico , Terapia Trombolítica/métodos , Administración Intravenosa , Anciano , Femenino , Hospitalización , Hospitales , Humanos , Masculino , Países BajosRESUMEN
BACKGROUND: Cognitive and emotional sequellae are commonly observed in stroke patients and these symptoms often co-occur. Diagnosis can be difficult since symptoms of depression and executive dysfunction overlap. OBJECTIVE: To study the longitudinal relationship between depressive symptoms and executive dysfunction in stroke patients. METHODS: The study comprises of 116 first-ever stroke patients who were followed-up for 2 years and who were assessed for emotional and cognitive sequellae after 1, 6, 12, and 24 months. Emotional disturbances were evaluated using the SCL-90 depression subscale. Executive functions were assessed using compound scores of a combination of the interference scores of the Stroop Colour Word Test and the Concept Shifting Test. RESULTS: Twenty-five patients suffered from both depressive symptoms and executive dysfunction, 28 patients were depressed with no signs of executive dysfunction, and 13 patients showed executive dysfunction with no depressive symptoms. Patients with executive dysfunction had higher mean SCL-90-D scores compared to patients with no executive dysfunction (30.9 (SD 11.7) versus 26.2 (SD 11.1, p = 0.037). Depressive symptoms were predictive for executive dysfunction in a regression analysis corrected for age, sex, and diabetes mellitus but not after additional correction for pre-existent brain damage and other vascular risk factors. After 2 years 66.6 and 53.3% of patients with both depressive symptoms and executive dysfunction at baseline still had depressive symptoms and executive dysfunctions respectively and had worse prognostic outcome than patients with depressive symptoms or executive dysfunction alone. CONCLUSIONS: Symptoms of depression and executive dysfunction are highly prevalent in stroke patients and often co-occur. These patients are more at risk for poor stroke outcome, chronic depression, and cognitive deterioration.
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Trastornos del Conocimiento/diagnóstico , Trastorno Depresivo/diagnóstico , Función Ejecutiva/fisiología , Accidente Cerebrovascular/psicología , Anciano , Trastornos del Conocimiento/epidemiología , Trastorno Depresivo/epidemiología , Femenino , Estudios de Seguimiento , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Pronóstico , Análisis de Regresión , Accidente Cerebrovascular/fisiopatologíaRESUMEN
BACKGROUND: Cognitive impairment is commonly observed after stroke and has a negative impact on survival and rehabilitation. Some stroke patients deteriorate in cognitive functioning whereas others do not. Environmental and demographic risk factors cannot fully explain this. There is growing evidence that a genetic predisposition plays a role in the pathogenesis of post-stroke cognitive decline. OBJECTIVE: To study the influence of the APOE-epsilon4 allele and the ACE-I/D polymorphism on cognitive functioning after stroke. METHODS: We included 194 first-ever stroke patients of whom information about APOE genotyping and ACE-I/D polymorphism was available in 92 and 129 patients, respectively. Patients were cognitively assessed at 1, 6, 12 and 24 months after the event. Linear mixed models with slope estimates were used to study the influence of the APOE-epsilon4 allele and the ACE-I/D polymorphism on the MMSE score, CAMCOG, executive functioning, psychomotor speed, and verbal memory function during follow-up. RESULTS: Patients carrying the APOE-epsilon4 allele more often suffered a lacunar infarction than non-carriers. The APOE-epsilon4 allele had no effect on cognitive functioning during the follow-up. ACE-DD homozygosity was associated with a worse performance in executive functioning compared to patients with neither an APOE-epsilon4 allele nor the ACE-DD genotype. There was no interaction between the APOE-epsilon4 allele and the ACE-DD phenotype in the prediction of cognitive decline. CONCLUSION: The ACE-DD genotype may be associated with post-stroke cognitive decline while the APOE-epsilon4 allele is not. Further research is needed to examine the role of genetic risk factors for post-stroke cognitive decline and to determine why some patients deteriorate cognitively after stroke but others do not.
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Apolipoproteína E4/genética , Trastornos del Conocimiento/genética , Predisposición Genética a la Enfermedad , Peptidil-Dipeptidasa A/genética , Accidente Cerebrovascular/genética , Anciano , Anciano de 80 o más Años , Distribución de Chi-Cuadrado , Cognición/fisiología , Trastornos del Conocimiento/etiología , Femenino , Estudios de Seguimiento , Humanos , Mutación INDEL/genética , Modelos Lineales , Masculino , Persona de Mediana Edad , Factores de Riesgo , Accidente Cerebrovascular/complicacionesRESUMEN
BACKGROUND: Stroke patients commonly suffer from neuropsychiatric disorders, such as depression, that negatively influence stroke outcome. Diagnosis, treatment and prevention of post-stroke psychiatric disorders including depression are under debate. OBJECTIVE: To study the course of depression after stroke. METHODS: One hundred and ninety first-ever stroke patients were screened for depressive symptoms at 1, 3, 6, 9, and 12 months after stroke. Diagnosis of depression was made according to the DSM-IV criteria of major and minor depression. RESULTS: Follow-up was completed in 138 patients. The cumulative incidence of post-stroke depression (PSD) in 1 year was 36.2%. One month after stroke the prevalence of PSD was 18.8%. Thirty percent of patients who were depressed in the first three months did not reach cut-off levels on depression screening instruments at the following assessments. In 44% of these patients symptoms recurred. Recurrent cases were older than patients with limited disease. In 40% of PSD patients depression persisted for at least two consecutive following follow-up visits. Persistent cases were more disabled and suffered more often from major depression. CONCLUSION: Half of PSD patients become depressed within the first month after stroke. Although most patients recover, a clinician has to be aware that symptoms can recur especially in older patients and that in patients with major depression symptoms may be persistent. In these patients treatment should be considered, whereas in patients with limited disease an observational approach may suffice.
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Depresión/epidemiología , Depresión/etiología , Accidente Cerebrovascular/psicología , Anciano , Análisis de Varianza , Estudios de Cohortes , Depresión/diagnóstico , Depresión/prevención & control , Manual Diagnóstico y Estadístico de los Trastornos Mentales , Femenino , Estudios de Seguimiento , Humanos , Incidencia , Masculino , Países Bajos/epidemiología , Psicometría , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/complicaciones , Factores de TiempoRESUMEN
BACKGROUND: Depression is a frequent problem in stroke patients but, all too often, the problem goes unrecognized. How depression-like symptoms in post-stroke depression (PSD) should be interpreted is still subject to debate. If PSD has a distinct symptom profile of depression accompanying other chronic vascular somatic conditions then this could imply that PSD is a specific disease entity. OBJECTIVE: To study whether depressed stroke patients exhibit other signs and symptoms than patients suffering from depression after myocardial infarction (MI). METHODS: Depressive signs and symptoms were measured using the Hospital Anxiety and Depression Scale and the 17-item Hamilton Depression Rating Scale. The results of 190 stroke patients were compared with the results of 198 MI patients every 3 months during the first year after the event. RESULTS: Depressed stroke patients exhibited more loss of interest, psychomotor retardation, and gastro-intestinal complaints as compared to depressed MI patients. However, in multivariate analyses including both depressed and non-depressed stroke and MI patients, no specific symptom profile was found to differentiate between the two depressive syndromes by looking at the modifying effect of stroke vs MI on the occurrence of specific symptoms in depression. CONCLUSION: Although in their clinical presentation, depressed stroke patients exhibit a symptom profile different from depressed MI patients, this is not due to differences in the depressive syndrome in these two patient groups but it reflects differences between stroke and MI patients in general.
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Depresión/psicología , Infarto del Miocardio/psicología , Accidente Cerebrovascular/psicología , Anciano , Ansiedad/epidemiología , Estudios de Cohortes , Estudios Transversales , Depresión/epidemiología , Fatiga/epidemiología , Femenino , Enfermedades Gastrointestinales/epidemiología , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Motivación , Análisis Multivariante , Escalas de Valoración Psiquiátrica , Psicometría , Trastornos Psicomotores/epidemiologíaRESUMEN
INTRODUCTION: Several risk factors for sudden unexplained death in epilepsy patients (SUDEP) have been proposed, but subsequent work has yielded conflicting data. The relative importance of various risk factors for SUDEP was never explored. The aim of this study is to review systematically risk factors for SUDEP and also to determine their relevance for SUDEP by calculating relative risk factor ratios. METHODS AND MATERIALS: Authors performed a literature-search on "SUDEP" in Medline, the Cochrane Library and EMBASE. Studies with unknown number of SUDEP cases or with less than five SUDEP cases and reviews were excluded from further analysis. The value of each paper was assessed, based on the quality of the study and the reliability of the diagnosis of SUDEP. This value ranged from 1 (low quality) to 10 (high quality). Papers with a value below 7 were eliminated for further analysis. For each analysed factor, a risk factor ratio was determined, with a higher ratio for a stronger risk factor. RESULTS: A number of strong risk factors for SUDEP: young age, early onset of seizures, the presence of generalized tonic clonic seizures, male sex and being in bed. Weak risk factors for SUDEP: prone position, one or more subtherapeutic bloodlevels, being in the bedroom, a strucural brain lesion and sleeping. CONCLUSIONS: In this study, authors have designed a quality scale to select papers. The relative importance of risk factors for SUDEP is demonstrated.
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Muerte Súbita/etiología , Epilepsia Tónico-Clónica/epidemiología , Epilepsia/complicaciones , Factores de Edad , Edad de Inicio , Femenino , Humanos , Masculino , Factores de Riesgo , Factores Sexuales , SueñoRESUMEN
PURPOSE: Business process redesign (BPR) is used to implement organizational transformations towards more customer-focused and cost-effective care. Ideally, these innovations should be carefully described and evaluated so that "best practices" can be re-applied. To investigate this, available evidence was collected on patient care redesign projects. DESIGN/METHODOLOGY/APPROACH: The Ebsco Business Source Premier, Embase and Medline databases were searched. Studies on innovations related to re-engineering patient care that used before-after design as minimum prerequisites were selected. General characteristics, logistic parameters and other outcome measures to determine the objectives and results and interventions used were looked at. FINDINGS: A total of 86 studies that conformed to the criteria were found: a minority mentioned measurable parameters in their objectives. In the majority of studies, multiple interventions were combined within single studies, making it impossible to compare the effects of individual interventions. Only three randomized controlled trials were found. Furthermore, inconsistencies were noted between the study objectives and the reported results. Many more issues were reported in the results than were mentioned in the study aims. It would appear that publications were hard to find owing to a lack of specific MeSH headings. Nearly 7,500 abstracts were scanned and from these it was concluded that clear and univocal research methods, terms and reporting guidelines are advisable and must be developed in order to learn and benefit from BPR innovations in health care organizations. ORIGINALITY/VALUE: This appears to be the first time available evidence about redesign projects in hospitals has been systematically collected and assessed.
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Medicina Basada en la Evidencia , Administración Hospitalaria , Atención Dirigida al Paciente , Programas Nacionales de Salud , Países Bajos , Innovación OrganizacionalAsunto(s)
Antihipertensivos/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Accidente Cerebrovascular/prevención & control , Anticolesterolemiantes/uso terapéutico , Antihipertensivos/efectos adversos , Bloqueadores de los Canales de Calcio/efectos adversos , Humanos , Hipercolesterolemia/complicaciones , Hipercolesterolemia/tratamiento farmacológico , Hipertensión/complicaciones , Hipertensión/tratamiento farmacológico , Accidente Cerebrovascular/etiologíaRESUMEN
BACKGROUND AND PURPOSE: Familial occurrence of intracranial aneurysms suggests a genetic factor in the development of these aneurysms. In this study, we present the identification of a susceptibility locus for the development of intracranial aneurysms detected by a genome-wide linkage approach in a large consanguineous pedigree. METHODS: Patients with clinical signs and symptoms of intracranial aneurysms, confirmed by radiological, surgical, or postmortem investigations, were included in the study. Magnetic resonance angiography was used to detect asymptomatic aneurysms in relatives. RESULTS: Seven out of 20 siblings had an intracranial aneurysm. Genome-wide multipoint linkage analysis showed a significant logarithm of the odds score of 3.55. CONCLUSIONS: In a large consanguineous pedigree intracranial aneurysms are linked to chromosome 2p13 in a region between markers D2S2206 and D2S2977.
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Cromosomas Humanos Par 2 , Ligamiento Genético , Aneurisma Intracraneal/genética , Mapeo Cromosómico , Consanguinidad , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico , Angiografía por Resonancia Magnética , Masculino , Países Bajos , LinajeRESUMEN
Master Classes arose within the performing arts and are now being offered in system sciences. The IPhiE group of faculty from six universities in Europe and the United States has offered Master Classes in health informatics to provide an integrative forum for honors students. Featured are international views of health systems, varied opportunities for student interaction and promotion of informatics professionalism. Five years of experience indicate the success of this concept and suggest changes that will be considered for the future.
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Educación de Postgrado , Informática Médica/educación , Curriculum , Europa (Continente) , Humanos , Cooperación Internacional , Estados Unidos , UniversidadesRESUMEN
OBJECTIVE: (a) To describe trends in the number of heart interventions performed over time, (b) to determine the length of waiting lists for elective heart interventions in the Netherlands according to the monthly survey of the Supervisory Committee for Heart Interventions in the Netherlands [Begeleidingscommissie Hartinterventies Nederland (BHN)], (c) to compare the length of the waiting lists with existing standards, and (d) to determine the reliability of the waiting list survey. DESIGN: Prospective. METHOD: Data were obtained from the monthly waiting list survey of the 13 heart centres in the Netherlands (1 January 1999-30 November 2002) and from the intervention registry (1 January 1999-30 June 2001), which was complete for 10 centres. Both the survey and the maintenance of the registry are carried out by the Supervisory Committee for Heart Interventions in the Netherlands. RESULTS: (a) The number of percutaneous coronary interventions performed in the Netherlands has increased. The number of cardiothoracic interventions remained stable. (b) The number of patients waiting for a percutaneous coronary intervention is increasing by 16% per annum. In November 2002 there were 751 patients on the waiting list. The number of patients waiting for a cardiothoracic intervention increased by 20% per annum until August 2001 and since then there has been a decrease of 21% per annum. In November 2002, 1557 patients were on the waiting list. (c) The percentage of patients treated within existing standards has fallen to 78% for percutaneous coronary interventions and to 53% for cardiothoracic interventions. (d) The length of the waiting list and the waiting times obtained in the survey concurred with the data taken from the intervention registry. CONCLUSIONS: The length of the waiting list for heart interventions has increased and complies increasingly less with existing standards. The monthly waiting-list survey was a reliable method of determining the length of waiting lists for elective heart interventions.
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Procedimientos Quirúrgicos Cardíacos/estadística & datos numéricos , Listas de Espera , Angioplastia Coronaria con Balón/estadística & datos numéricos , Puente de Arteria Coronaria/estadística & datos numéricos , Procedimientos Quirúrgicos Electivos/estadística & datos numéricos , Humanos , Países Bajos , Estudios Prospectivos , Factores de TiempoRESUMEN
Intracranial aneurysms (IA) are the major cause of subarachnoid haemorrhages (SAH). A positive family history for SAH is reported in 5-10% of the patients. The mode of inheritance is not unambiguously established; both autosomal dominant and recessive modes have been reported. In sporadic as well as in familial SAH, approximately 60% of the SAH patients are female. Recently, anticipation has been described in familial SAH. Since up to 15% of the SAHs are not caused by an IA, we have analysed anticipation, sex ratio and mode of inheritance only in families with patients with a proven IA in two consecutive generations. A total of 10 families were studied in which at least two persons in consecutive generations were affected by SAH, a symptomatic IA (SIA) or a presymptomatic IA (PIA). We also analysed published data from families with a proven IA in two consecutive generations on age of SIA onset and sex ratios among affected family members (both SIA and PIA). The age of SIA onset in the parental generation (mean 55.5 years) differed significantly from the age of onset in their children (mean 32.4 years). In the parental generation 11 men and 37 women were affected (both SIA and PIA), in the consecutive generation these numbers were 28 men and 32 women. There is a significant difference in sex ratio of affected family members when the generations are compared (P<0.02). No family could be found in which three consecutive generations were affected by an IA (SIA or PIA).
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Anticipación Genética , Aneurisma Intracraneal/genética , Adulto , Anciano , Salud de la Familia , Femenino , Genes Dominantes , Genes Recesivos , Predisposición Genética a la Enfermedad , Humanos , Aneurisma Intracraneal/mortalidad , Masculino , Persona de Mediana Edad , Linaje , Factores Sexuales , Hemorragia Subaracnoidea/genética , Hemorragia Subaracnoidea/mortalidadRESUMEN
The medical information sciences program of Amsterdam has been in existence for 15 years now. Starting in 1987, the program has been modified several times. Now a full-fledged 4 years master program exists. Students are taught skills to adequately and systematically apply information and communication technologies in order to optimize health care information processing. The program is offered within the Faculty of Medicine of the University of Amsterdam. The structure and contents of the current program will be described.
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Informática Médica/educación , Curriculum , Países BajosRESUMEN
Twenty-five healthy and thirty-one preeclamptic pregnant women were assessed by means of transcranial Doppler sonography. Resting cerebral blood flow velocities in the middle cerebral arteries were measured followed by a repeat measurement 30 s after breath holding. Absolute blood flow velocities and per cent changes after breath holding procedure were compared between the groups. Absolute blood flow velocities were higher in preeclamptic pregnant women both at rest and after breath holding. The percent increase in cerebral blood flow velocity after breath holding (cerebral vascular reactivity) was similar in the two groups. Our data suggest that cerebral vascular reactivity is preserved in pregnant women with preeclampsia.
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BACKGROUND AND PURPOSE: Based on the results of animal experiments, clinical trials were performed with nimodipine, which did not demonstrate a beneficial effect on outcome after stroke. The aim of this study was to determine whether the evidence from animal experiments with nimodipine supported the use of nimodipine in clinical trials. METHODS: - We performed a systematic review of animal experiments with nimodipine in focal cerebral ischemia. Studies were identified by searching Medline and Embase. We assessed whether these studies showed a beneficial effect of active treatment. In-depth analyses were performed on infarct size and amount of edema, and subgroup analyses were performed on the length of the time window to the initiation of treatment and the methodological quality of the studies. RESULTS: - Of 225 identified articles, 20 studies were included. The methodological quality of the studies was poor. Of the included studies, 50% were in favor of nimodipine. In-depth analyses showed statistically significant effects in favor of treatment (10 studies). No influence of the length of time to the initiation of treatment or of the methodological quality on the results was found. CONCLUSIONS: - We conclude that the results of this review did not show convincing evidence to substantiate the decision to perform trials with nimodipine in large numbers of patients. There were no differences between the results of the animal experiments and clinical studies. Surprisingly, we found that animal experiments and clinical studies ran simultaneously.
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Isquemia Encefálica/tratamiento farmacológico , Bloqueadores de los Canales de Calcio/uso terapéutico , Fármacos Neuroprotectores/uso terapéutico , Nimodipina/uso terapéutico , Animales , Ensayos Clínicos como Asunto/estadística & datos numéricos , Modelos Animales de Enfermedad , Humanos , Reproducibilidad de los Resultados , Proyectos de Investigación/estadística & datos numéricos , Resultado del TratamientoRESUMEN
In a cohort 760 consecutive stroke patients (23 hospitals in the Netherlands), we studied prognosis in relation to stroke type and focused on (a) short-term and long-term mortality, and (b) long-term functional health. Based on clinical and CT data, we distinguished infratentorial strokes from supratentorial strokes (lacunar infarctions, (sub)cortical infarctions and intracerebral hemorrhages). Cumulative mortality for all stroke patients was 34% at 6 months, 51% at 3 years, and 62% at 5 years. Short-term mortality could be explained by stroke type, whereas long-term mortality could not. Of all survivors, 55% were in poor functional health at 6 months, 49% at 3 years and 42% at 5 years. Long-term functional health outcomes were associated with stroke type. We conclude that the impact of stroke type on mortality is limited to the first 6 months, whereas the type of stroke influences the long-term functional health.
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Estado de Salud , Accidente Cerebrovascular/clasificación , Accidente Cerebrovascular/mortalidad , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Pronóstico , Radiografía , Accidente Cerebrovascular/diagnóstico por imagen , Tasa de Supervivencia , Factores de TiempoRESUMEN
OBJECTIVE: To compare cerebral autoregulatory responses obtained during roll over tests in healthy pregnant women and those with pre-eclampsia in order to assess the middle cerebral artery velocity changes in relation to the roll over test in normotensive and pre-eclamptic women. PARTICIPANTS: Twenty-two healthy pregnant women and 26 with pre-eclampsia underwent transcranial Doppler measurements of the middle cerebral artery. METHODS: Systolic, mean and diastolic blood flow velocities and mean arterial blood pressures were recorded in the left lateral position and five minutes after turning to the supine position. Absolute values of mean blood flow velocities, mean arterial blood pressure values and calculated cerebral blood flow indices as well as cerebrovascular resistance area products were compared at different positions among the groups. RESULTS: Mean arterial blood pressure increased in both groups while turning from the left lateral to the supine position. In women with pre-eclampsia both mean arterial blood pressure and absolute values of mean blood flow velocity values were higher in both positions, compared with healthy pregnant women. In both groups, changing the position resulted in a decrease of absolute values of mean blood flow velocities. Calculated cerebral blood flow indices did not change, while cerebrovascular resistance area products increased significantly in the groups during roll over testing. In women with pre-eclampsia, the increase of cerebrovascular resistance area products was more pronounced as compared with healthy pregnant women. CONCLUSIONS: In women with pre-eclampsia roll over test results in an increase of the mean arterial blood pressure, which is accompanied by a decreased mean blood flow velocity in the middle cerebral artery. Further studies are needed to clarify the pathophysiological background of cerebral haemodynamic changes in pre-eclampsia.
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Arteria Cerebral Media/fisiología , Preeclampsia/fisiopatología , Embarazo/fisiología , Adulto , Velocidad del Flujo Sanguíneo/fisiología , Presión Sanguínea/fisiología , Femenino , Hemodinámica/fisiología , Humanos , Movimiento/fisiologíaRESUMEN
BACKGROUND AND PURPOSE: The Very Early Nimodipine Use in Stroke (VENUS) trial was designed to test the hypothesis that early treatment with nimodipine has a positive effect on survival and functional outcome after stroke. This was suggested in a previous meta-analysis on the use of nimodipine in stroke. However, in a recent Cochrane review we were unable to reproduce these positive results. This led to the early termination of VENUS after an interim analysis. METHODS: In this randomized, double-blind, placebo-controlled trial, treatment was started by general practitioners or neurologists within 6 hours after stroke onset (oral nimodipine 30 mg QID or identical placebo, for 10 days). Main analyses included comparisons of the primary end point (poor outcome, defined as death or dependency after 3 months) and secondary end points (neurological status and blood pressure 24 hours after inclusion, mortality after 10 days, and adverse events) between treatment groups. Subgroup analyses (on final diagnosis and based on the per-protocol data set) were performed. RESULTS: At trial termination, after inclusion of 454 patients (225 nimodipine, 229 placebo), no effect of nimodipine was found. After 3 months of follow-up, 32% (n=71) of patients in the nimodipine group had a poor outcome compared with 27% (n=62) in the placebo group (relative risk, 1.2; 95% CI, 0.9 to 1.6). A treatment effect was not found for secondary outcomes and in the subgroup analyses. CONCLUSIONS: The results of VENUS do not support the hypothesis of a beneficial effect of early nimodipine in stroke patients.
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Bloqueadores de los Canales de Calcio/administración & dosificación , Nimodipina/administración & dosificación , Accidente Cerebrovascular/tratamiento farmacológico , Enfermedad Aguda , Administración Oral , Adulto , Anciano , Anciano de 80 o más Años , Isquemia Encefálica/prevención & control , Bloqueadores de los Canales de Calcio/efectos adversos , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Nimodipina/efectos adversos , Variaciones Dependientes del Observador , Paresia/etiología , Estudios Prospectivos , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Accidente Cerebrovascular/complicaciones , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
BACKGROUND AND PURPOSE: Stroke is a common disease, and many trials with calcium antagonists as possible neuroprotective agents have been conducted. The aim of this review is to determine whether calcium antagonists reduce the risk of death or dependency after acute ischemic stroke. METHODS: Acute stroke trials were identified with help of the Cochrane Collaboration Stroke Group and personal contacts. All randomized trials (published and unpublished) investigating a calcium antagonist (acting on voltage-sensitive calcium channels) were included. Poor outcome, defined as death or dependency in activities of daily living, was used as main outcome. Analyses were, if possible, "intention-to-treat"; pooled relative risks with 95% CIs were calculated. RESULTS: Forty-seven trials were identified, of which 29 were included (7665 patients). No effect of calcium antagonists on poor outcome at the end of follow-up (relative risk, 1.04; 95% CI, 0.98 to 1.09) or on death at end of follow-up (relative risk, 1.07; 95% CI, 0.98 to 1.17) was found. Sensitivity analyses on route of administration and time interval between stroke and start of treatment showed no effect on outcome. In subgroups of unpublished and methodologically sound trials, a statistically significant negative effect for calcium antagonists was found. This contrasts with results of published trials and trials of moderate or poor methodological quality. CONCLUSIONS: The presented evidence rules out a clinically important effect of calcium antagonists after ischemic stroke. The large amount of data leads to narrow CIs with no significant heterogeneity, and the overall results are therefore likely to be statistically robust.