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PURPOSE: For controlling symptoms in Parkinson's disease (PD) together with treating additional comorbidities, patients often face complex medication regimens, with suboptimal adherence, drug-related problems, and diminished therapy efficacy as a common consequence. A medication review could potentially tackle these issues, among others by optimizing drug treatment. Even if no change in clinical outcomes is observed, this intervention might decrease health care costs by reducing drug-related problems and hospital admissions. This study aimed to gain more insight in the health benefits and costs of a structured medication review (SMR) in PD. METHODS: A cost-utility analysis was performed, based on a multicenter randomized controlled trial with 202 PD patients with polypharmacy. The intervention group received an SMR, whereas the control group received usual care. The intervention effect after 6 months of follow-up was presented as incremental quality-adjusted life years (QALY) using the EQ-5D-5L questionnaire. Costs were based on real-world data. Missing data was imputed using multiple imputation techniques. Bootstrapping was used to estimate the uncertainty in all health and economic outcomes. RESULTS: The QALY gain in the intervention group compared to the control group was - 0.011 (95% CI - 0.043; 0.020). Incremental costs were 433 (95% CI - 873; 1687). When adapting a willingness-to-pay threshold of 20,000/QALY and 80,000/QALY, the probability of SMRs being cost-effective was 18% and 30%, respectively. CONCLUSION: A community pharmacist-led SMR in PD patients in the current setting shows no apparent benefit and is not cost-effective after 6 months, compared to usual care. TRIAL REGISTRATION: Netherlands Trial Register, NL4360. Registered 17 March 2014.
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Enfermedad de Parkinson , Humanos , Análisis Costo-Beneficio , Enfermedad de Parkinson/tratamiento farmacológico , Revisión de Medicamentos , Costos de la Atención en Salud , Farmacéuticos , Años de Vida Ajustados por Calidad de Vida , Calidad de VidaRESUMEN
PURPOSE: Potential drug-drug interactions (pDDIs) may harm patients admitted to the Intensive Care Unit (ICU). Due to the patient's critical condition and continuous monitoring on the ICU, not all pDDIs are clinically relevant. Clinical decision support systems (CDSSs) warning for irrelevant pDDIs could result in alert fatigue and overlooking important signals. Therefore, our aim was to describe the frequency of clinically relevant pDDIs (crpDDIs) to enable tailoring of CDSSs to the ICU setting. MATERIALS & METHODS: In this multicenter retrospective observational study, we used medication administration data to identify pDDIs in ICU admissions from 13 ICUs. Clinical relevance was based on a Delphi study in which intensivists and hospital pharmacists assessed the clinical relevance of pDDIs for the ICU setting. RESULTS: The mean number of pDDIs per 1000 medication administrations was 70.1, dropping to 31.0 when considering only crpDDIs. Of 103,871 ICU patients, 38% was exposed to a crpDDI. The most frequently occurring crpDDIs involve QT-prolonging agents, digoxin, or NSAIDs. CONCLUSIONS: Considering clinical relevance of pDDIs in the ICU setting is important, as only half of the detected pDDIs were crpDDIs. Therefore, tailoring CDSSs to the ICU may reduce alert fatigue and improve medication safety in ICU patients.
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Cuidados Críticos , Preparaciones Farmacéuticas , Interacciones Farmacológicas , Humanos , Unidades de Cuidados Intensivos , Estudios RetrospectivosRESUMEN
BACKGROUND: Treatment of Parkinson's disease (PD) is symptomatic and frequently consists of complicated medication regimes. This negatively influences therapy adherence, resulting in lower benefit of treatment, drug related problems and decreased quality of life (QoL). A potential effective intervention strategy is a structured medication review, executed by community pharmacists. However, little is known about the effects on clinical endpoints like QoL, as well as on feasibility and cost-effectiveness in PD patients. OBJECTIVES: To assess the effect of a structured medication review on QoL in PD patients. Secondary objectives are measurements of physical disability, activities in daily life, non-motor symptoms, health state, personal carers' QoL and cost-effectiveness. Furthermore, a better insight in the process of performing medication reviews will be obtained from the perspective of community pharmacists. METHODS: In this multicenter randomized controlled trial we aim to enroll 200 PD patients from the outpatient clinic of three Dutch hospitals. Community pharmacists will perform a structured medication review in half of the assigned patients; the other half will receive usual care. Data obtained by use of six validated questionnaires will be collected at baseline and after 3 and 6 months of follow-up. Semi-structured interviews with community pharmacists will be conducted till data saturation has been reached. DISCUSSION: This trial targets a high-risk patient group for whom optimizing therapy by a structured medication review might be of added value. If effectiveness is proven, this could further promote the implementation of pharmaceutical care in a primary care setting.
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The safety and tolerability of nebulized amoxicillin clavulanic acid were determined in patients with stable COPD and during severe exacerbations of COPD. Nine stable COPD patients received doses ranging from 50:10 mg up to 300:60 mg amoxicillin clavulanic acid and eight patients hospitalised for a COPD exacerbation received fixed doses 200/40 mg twice daily. Safety was evaluated by spirometry before and after inhalation. Tolerability was evaluated by questionnaire. Plasma and expectorated sputum samples were assayed for amoxicillin content. Seventeen patients underwent in total 100 nebulizations with amoxicillin clavulanic acid. In this safety and tolerability study no clinically relevant deteriorations in FEV1 were observed. Nebulized amoxicillin clavulanic acid produces sputum concentrations well above the Minimal Inhibiting Concentration of 90% for potential pathogenic micro-organisms, with low concentrations in the central compartment (low systemic exposure). Based on spirometry and reported side effects, inhalation of nebulized amoxicillin clavulanic acid seems to be safe and well tolerated, both in stable patients with COPD as in those experiencing a severe exacerbation. Levels of amoxicillin were adequate.
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Combinación Amoxicilina-Clavulanato de Potasio/administración & dosificación , Antibacterianos/administración & dosificación , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Inhibidores de beta-Lactamasas/administración & dosificación , Administración por Inhalación , Anciano , Anciano de 80 o más Años , Combinación Amoxicilina-Clavulanato de Potasio/análisis , Antibacterianos/análisis , Progresión de la Enfermedad , Femenino , Volumen Espiratorio Forzado , Humanos , Masculino , Pruebas de Sensibilidad Microbiana , Persona de Mediana Edad , Nebulizadores y Vaporizadores , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Esputo/química , Encuestas y Cuestionarios , Inhibidores de beta-Lactamasas/análisisRESUMEN
Lack of response to monoclonal antibodies (mAbs) has been associated with inadequate mAb serum concentrations. Therapeutic drug monitoring (TDM) of mAbs has the potential to guide to more effective dosing in individual patients. This review discusses the mechanisms responsible for interpatient variability of mAb pharmacokinetics, summarizes exposure-response data of mAbs used in inflammatory and malignant disease, presents current evidence of mAb-TDM in inflammatory disease, and provides hurdles and required future steps for further implementing mAb-TDM.
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Antiinflamatorios/farmacocinética , Anticuerpos Monoclonales/farmacocinética , Antineoplásicos/farmacocinética , Monitoreo de Drogas/métodos , Factor de Necrosis Tumoral alfa/antagonistas & inhibidores , Antiinflamatorios/administración & dosificación , Antiinflamatorios/efectos adversos , Antiinflamatorios/sangre , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/efectos adversos , Anticuerpos Monoclonales/sangre , Antineoplásicos/administración & dosificación , Antineoplásicos/efectos adversos , Antineoplásicos/sangre , Cálculo de Dosificación de Drogas , Humanos , Terapia Molecular Dirigida , Factor de Necrosis Tumoral alfa/inmunologíaRESUMEN
PURPOSE: Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetylsalicylic acid (ASA) are often prescribed concurrently in patients with nociceptive pain and cardiovascular comorbidity. NSAIDs and ASA inhibit the same COX-enzymes, and thus may interact. ASA's cardioprotective antiplatelet effect is entirely COX-1 dependent. NSAIDs can be either non-COX-1 and COX-2 selective or COX-2 selective. The aim of this study was to examine the interaction between ASA and different selective and nonselective NSAIDs on thrombocyte function. METHODS: Single-blind, prospective, placebo-controlled, ex vivo, serial crossover trial of 3-day cycles separated by washout periods of at least 12 days in 30 healthy volunteers, evaluating interaction on ASA's antithrombocyte effect by naproxen, ibuprofen, meloxicam, or etoricoxib taken 2 h before ASA. Ex vivo thrombocyte function, closure time (CT) in seconds, was measured using the Platelet Function Analyzer 100 (PFA-100). CT prolongation during a cycle reflects thrombocyte inhibitory effect. ASA nonresponse was defined as CT prolongation <40 % in the placebo cycle. ASA nonresponders were excluded. Wilcoxon signed-rank was used to evaluate NSAID effect on ASA-induced CT prolongation. RESULTS: Ibuprofen and naproxen inhibit ASA's antithrombocyte effect below the nonresponse threshold. Etoricoxib and meloxicam do not cause relevant change in ASA thrombocyte inhibition. Naproxen has an inherent weak thrombocyte inhibitory action below the ASA response threshold. CONCLUSIONS: COX-1 affinity determines the interaction between NSAIDs and ASA on thrombocyte adhesion and aggregation. Ibuprofen and naproxen, but not etoricoxib or meloxicam, taken 2 h before ASA, significantly inhibit ASA's antithrombocyte effect.
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Antiinflamatorios no Esteroideos/efectos adversos , Aspirina/administración & dosificación , Plaquetas/efectos de los fármacos , Inhibidores de la Ciclooxigenasa/administración & dosificación , Inhibidores de la Ciclooxigenasa/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Adulto , Antiinflamatorios no Esteroideos/administración & dosificación , Plaquetas/enzimología , Estudios Cruzados , Ciclooxigenasa 1/metabolismo , Ciclooxigenasa 2/metabolismo , Esquema de Medicación , Interacciones Farmacológicas , Etoricoxib , Femenino , Humanos , Ibuprofeno/efectos adversos , Masculino , Meloxicam , Persona de Mediana Edad , Naproxeno/efectos adversos , Países Bajos , Pruebas de Función Plaquetaria , Estudios Prospectivos , Piridinas/efectos adversos , Medición de Riesgo , Sulfonas/efectos adversos , Tiazinas/efectos adversos , Tiazoles/efectos adversos , Factores de Tiempo , Adulto JovenRESUMEN
SUMMARY: The effect of dopaminergic medication on the risk of hip/femur fractures is not clear. Our results showed a nearly twofold increased risk of hip/femur fractures in current dopaminergic drug users. Concomitant use of antidepressants further increased this risk. Fracture risk assessment may be warranted in elderly users of dopaminergic drugs. INTRODUCTION: Dopaminergic drugs, often used in the treatment of Parkinson's disease, have several pharmacological effects that may increase or decrease the risk of falling and fractures. Thus, the effect of dopaminergic medication on the risk of hip/femur fractures is not clear. The objective of the study was to examine the effect of dopaminergic medication and concomitant use of psychotropics on the risk of hip/femur fractures taking into account the timing of dopaminergic drug use. METHODS: A population-based case-control study in the PHARMO database was conducted for the period 1991 to 2002. Cases were patients aged 18 years and older with a first hip or femur fracture and matched to four control patients by year of birth, sex and geographical region. RESULTS: The study population included 6,763 cases and 26,341 controls. Current use of dopaminergic drugs (1-30 days before the index date) was associated with an increased risk of hip/femur fractures compared to never use (OR(adj) 1.76, 95% CI = 1.39-2.22), but this excess risk rapidly dropped to baseline levels when treatment had been discontinued >1 year ago. Concomitant use of antidepressants among current dopaminergic drug users further increased the risk of hip/femur fractures (OR(adj) 3.51, 95% CI = 2.10-5.87) while there was no additional risk with concomitant use of other psychotropics. CONCLUSIONS: Although the observed association between dopaminergic drugs and fracture risk may not be entirely causal, due to absence of information on the (severity of the) underlying disease, fracture risk assessment may be warranted in elderly users of dopaminergic drugs.
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Dopaminérgicos/efectos adversos , Fracturas del Fémur/inducido químicamente , Psicotrópicos/efectos adversos , Adolescente , Adulto , Anciano , Antidepresivos/efectos adversos , Estudios de Casos y Controles , Dopaminérgicos/administración & dosificación , Femenino , Fracturas del Fémur/epidemiología , Estudios de Seguimiento , Fracturas de Cadera/inducido químicamente , Fracturas de Cadera/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Sialorrhea affects approximately 75% of patients with Parkinson disease (PD). Sialorrhea is often treated with anticholinergics, but central side effects limit their usefulness. Glycopyrrolate (glycopyrronium bromide) is an anticholinergic drug with a quaternary ammonium structure not able to cross the blood-brain barrier in considerable amounts. Therefore, glycopyrrolate exhibits minimal central side effects, which may be an advantage in patients with PD, of whom a significant portion already experience cognitive deficits. OBJECTIVE: To determine the efficacy and safety of glycopyrrolate in the treatment of sialorrhea in patients with PD. METHODS: We conducted a 4-week, randomized, double-blind, placebo-controlled, crossover trial with oral glycopyrrolate 1 mg 3 times daily in 23 patients with PD. The severity of the sialorrhea was scored on a daily basis by the patients or a caregiver with a sialorrhea scoring scale ranging from 1 (no sialorrhea) to 9 (profuse sialorrhea). RESULTS: The mean (SD) sialorrhea score improved from 4.6 (1.7) with placebo to 3.8 (1.6) with glycopyrrolate (p = 0.011). Nine patients (39.1%) with glycopyrrolate had a clinically relevant improvement of at least 30% vs 1 patient (4.3%) with placebo (p = 0.021). There were no significant differences in adverse events between glycopyrrolate and placebo treatment. CONCLUSIONS: Oral glycopyrrolate 1 mg 3 times daily is an effective and safe therapy for sialorrhea in Parkinson disease. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that glycopyrrolate 1 mg 3 times daily is more effective than placebo in reducing sialorrhea in patients with Parkinson disease during a 4-week study.
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Glicopirrolato/administración & dosificación , Enfermedad de Parkinson/complicaciones , Sialorrea/tratamiento farmacológico , Sialorrea/etiología , Anciano , Método Doble Ciego , Esquema de Medicación , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Antagonistas Muscarínicos/administración & dosificación , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
The objective of this review was to compare and to discuss the results of studies that investigated the ability of drugs to improve motor recovery after stroke by influencing dopamine, norepinephrine, or serotonin concentrations in the brain. A systematic literature search up to January 2009 was conducted in MEDLINE, Pubmed, EMBASE and in the database of the Cochrane Stroke Group Trial Register. In addition, the literature reference lists of the relevant publications were checked. The literature search was conducted in order to identify randomized controlled trials focusing on the effects of drugs on motor recovery after stroke. In order to structure the data, motor recovery was sub-divided into motor control and motor function. The methodological quality of the studies was also assessed. Six studies, investigating the effects of 7 different kinds of drugs were included. Methodological scores varied between 10 and 14 (max 19). Motor control was not influenced by any of the drugs. Motor function improved in patients treated with methylphenidate, trazodone, and nortriptyline. Results for fluoxetine and levodopa were contradicting. There is insufficient evidence to conclude that neuromodulating drugs targeting serotonin, norepinephrine, or dopamine influence motor recovery after stroke.
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Actividad Motora/fisiología , Neurotransmisores/uso terapéutico , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/fisiopatología , Humanos , Recuperación de la Función , Accidente Cerebrovascular/psicologíaRESUMEN
BACKGROUND: A previous study aimed at revealing the prevalence and determinants of lithium induced polyuria suggested an increased risk of polyuria (urine volume > or =3 L/24 h) in those using serotonergic antidepressants next to lithium. OBJECTIVE: The objective of our study was to re-evaluate this secondary finding in another study population. METHODS: We performed a multicenter medical chart review study in patients using lithium in whom a 24-hour urine volume had been determined. RESULTS: We included 116 patients, twelve (26%)of the 46 patients with polyuria used serotonergic antidepressants compared to ten (14%) of the 70 patients without polyuria. We found an increased risk of polyuria in lithium users concurrently using serotonergic antidepressants (oddsratio 2.86; 95% confidence interval 1.00-8.21), adjusted for age, gender, use of antiepileptics and thyreomimetics. CONCLUSION: Our results confirm the previous secondary finding of an increased risk of polyuria in patients using serotonergic antidepressants next to lithium. Physicians should take this into account when evaluating polyuria in patients using lithium and when choosing an antidepressant in patients using lithium.
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Antidepresivos/efectos adversos , Cloruro de Litio/efectos adversos , Poliuria/inducido químicamente , Adolescente , Adulto , Asociación , Estudios Transversales , Trastorno Depresivo/tratamiento farmacológico , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Oportunidad Relativa , Poliuria/epidemiología , Resultado del TratamientoRESUMEN
OBJECTIVE: There is much evidence that driving under the influence of alcohol and/or drugs of abuse is related to an increased accident risk. A remaining question is whether the use of psychoactive substances is also related to clinically more severe accidents. The aim of this study is to explore the relationship between the use of psychoactive substances and the injury severity in a group of crash-involved drivers. METHODS: The study group included all injured car drivers, admitted to the regional trauma center, in the period from May 2000 until August 2001. The outcome of interest was the severity of injury, measured by using the Injury Severity Score (ISS). The determinant was the presence of psychoactive substances in blood and urine samples. Psychoactive substances tested for were alcohol, amphetamines, barbiturates, benzodiazepines, cannabis, methadone, opiates, and tricyclic antidepressants in blood and urine. RESULTS: The number of injured car drivers included in this study was 106. Overall, 43% (46/106) of the drivers tested positive for at least one psychoactive substance. Comparison of the means of the log ISS suggests that there is no significant difference between drivers who tested positive for alcohol and/or drugs, compared to drivers tested negative. CONCLUSION: The results of this study support the hypothesis that there is no clear association between use of psychoactive substances and the severity of crash-related injury.
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Accidentes de Tránsito , Psicotrópicos/aislamiento & purificación , Índices de Gravedad del Trauma , Heridas y Lesiones/patología , Adolescente , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Psicotrópicos/sangre , Psicotrópicos/orina , Estudios Retrospectivos , Centros Traumatológicos , Heridas y Lesiones/clasificaciónRESUMEN
The driving performance is easily impaired as a consequence of the use of alcohol and/or licit and illicit drugs. However, the role of drugs other than alcohol in motor vehicle accidents has not been well established. The objective of this study was to estimate the association between psychoactive drug use and motor vehicle accidents requiring hospitalisation. A prospective observational case-control study was conducted in the Tilburg region of The Netherlands from May 2000 to August 2001. Cases were car or van drivers involved in road crashes needing hospitalisation. Demographic and trauma related data was collected from hospital and ambulance records. Urine and/or blood samples were collected on admission. Controls were drivers recruited at random while driving on public roads. Sampling was conducted by researchers, in close collaboration with the Tilburg police, covering different days of the week and times of the day. Respondents were interviewed and asked for a urine sample. If no urine sample could be collected, a blood sample was requested. All blood and urine samples were tested for alcohol and a number of licit and illicit drugs. The main outcome measures were odds ratios (OR) for injury crash associated with single or multiple use of several drugs by drivers. The risk for road trauma was increased for single use of benzodiazepines (adjusted OR 5.1 (95% Cl: 1.8-14.0)) and alcohol (blood alcohol concentrations of 0.50-0.79 g/l, adjusted OR 5.5 (95% Cl: 1.3-23.2) and >or=0.8 g/l, adjusted OR 15.5 (95% Cl: 7.1-33.9)). High relative risks were estimated for drivers using combinations of drugs (adjusted OR 6.1 (95% Cl: 2.6-14.1)) and those using a combination of drugs and alcohol (OR 112.2 (95% Cl: 14.1-892)). Increased risks, although not statistically significantly, were assessed for drivers using amphetamines, cocaine, or opiates. No increased risk for road trauma was found for drivers exposed to cannabis. The study concludes that drug use, especially alcohol, benzodiazepines and multiple drug use and drug-alcohol combinations, among vehicle drivers increases the risk for a road trauma accident requiring hospitalisation.
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Accidentes de Tránsito/estadística & datos numéricos , Psicotrópicos/efectos adversos , Heridas y Lesiones/epidemiología , Adolescente , Adulto , Consumo de Bebidas Alcohólicas/efectos adversos , Estudios de Casos y Controles , Interacciones Farmacológicas , Femenino , Hospitalización/estadística & datos numéricos , Humanos , Drogas Ilícitas/efectos adversos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Países Bajos/epidemiología , Estudios Prospectivos , Psicotrópicos/farmacología , RiesgoRESUMEN
BACKGROUND: Some patients with multiple sclerosis (MS) do not show a clear improvement of acute relapses after treatment with intravenous methylprednisolone (IVMP). We compared the efficacy of the combination of intravenous immunoglobulins (IVIg) and IVMP with the standard treatment of IVMP alone in promoting recovery from moderate to severe acute relapses in MS. METHODS: Patients with clinically definite MS having a relapse with at least a one point increase in Kurtzke's expanded disability status scale (EDSS) in comparison to the preattack EDSS were randomized to IVMP-IVIg or IVMP-placebo treatment. The primary outcome criterion was the EDSS grade at four weeks. A preplanned interim analysis was performed after inclusion of 19 consecutive MS patients to evaluate the sample size necessary for a larger trial. FINDINGS: Both groups had improved one point on the EDSS four weeks after start of treatment (P = 0.81) and one of the stopping rules of the interim analysis was fulfilled. There were also no differences in secondary outcomes: EDSS at eight and 12 weeks, time to improve > or = 1 EDSS points, difference in Scripps score and ambulation index. Five patients in the IVMP-IVIg group and two in the IVMP group had a new relapse in the six month follow-up. INTERPRETATION: Our study could not show superiority of IVMP-IVIg in the treatment of moderate to severe acute relapses in MS.
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Inmunoglobulinas Intravenosas/uso terapéutico , Metilprednisolona/administración & dosificación , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Fármacos Neuroprotectores/administración & dosificación , Adulto , Evaluación de la Discapacidad , Método Doble Ciego , Femenino , Humanos , Inyecciones Intravenosas , Masculino , Esclerosis Múltiple Recurrente-Remitente/inmunología , Esclerosis Múltiple Recurrente-Remitente/fisiopatología , Proyectos Piloto , Resultado del TratamientoRESUMEN
Medical diagnosis can be studied using various sources of information, such as medical and hospital discharge records and laboratory measurements. These sources do not always concur. The objective of the present study was to assess the sensitivity, specificity, and positive and negative predictive values of hospital discharge diagnosis compared with clinical laboratory data for the identification of hyponatremia. Patients with hyponatremia were selected from a hospital information system determined by the International Classification of Diseases, 9th edition (ICD-9). The validity parameters for hyponatremia (ICD code 276.1) were estimated by comparison with accurate serum sodium (Na+) levels. A total of 2632 cases of hyponatremia were identified using laboratory measurements (Na+ < or =135 mmol/L). The sensitivity of ICD coding for hyponatremia was maximally about 30% for patients with very severe hyponatremia (Na+ < or =115 mmol/L). Corresponding specificities were high (>99%). In 87% of the cases with severe hyponatremia (Na+ < or =125 mmol/L), other discharge ICD codes reflecting severe morbidity were found. This study suggests that ICD codes for hyponatremia represent only one third of the patients admitted to the hospital and experiencing hyponatremia. About two thirds of the patients with hyponatremia were classified as hospitalized for other reasons. To assess the validity of case finding of patients with hyponatremia, the use of analytical techniques, such as certain laboratory measurements, is advisable.
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Hiponatremia/diagnóstico , Clasificación Internacional de Enfermedades/normas , Sistemas de Registros Médicos Computarizados/normas , Femenino , Hospitalización , Hospitales de Enseñanza , Humanos , Hiponatremia/epidemiología , Modelos Logísticos , Masculino , Registro Médico Coordinado , Países Bajos/epidemiología , Alta del Paciente , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Polyuria is common in patients with bipolar disorder treated with lithium. However, the risk factors for polyuria in these patients have not been established. AIMS: To estimate the prevalence of polyuria associated with the use of lithium and to identify additional risk factors. METHOD: A 4-month prospective follow-up study in an out-patient lithium clinic. The 75 participants were asked to provide 24-h urine samples; polyuria was defined as a urine volume greater than 3 litres per 24 h. Risk factors examined included demographic variables, medications and medical comorbidities. RESULTS: The prevalence of polyuria among lithium users was 37%. Concomitant use of serotonergic antidepressants was strongly associated with polyuria (odds ratio 4.25, 95% CI 1.15-15.68) compared with patients not using these agents. CONCLUSIONS: Our data confirm the high prevalence of lithium-induced polyuria. Physicians should be aware that concurrent use of serotonergic antidepressants and lithium significantly enhances the risk of its occurrence. Although limited polyuria is not harmful, it may be troublesome for the patient. In many cases cessation of lithium therapy is not an option because of difficulty in controlling the manic or depressive symptoms.
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Antipsicóticos/efectos adversos , Litio/efectos adversos , Poliuria/inducido químicamente , Adulto , Antidepresivos/uso terapéutico , Trastorno Bipolar/tratamiento farmacológico , Trastorno Depresivo/tratamiento farmacológico , Quimioterapia Combinada , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Serotoninérgicos/uso terapéutico , Resultado del TratamientoRESUMEN
PURPOSE: Irrespective of its cause, urinary incontinence is a medical condition seriously affecting quality of life and is increasingly recognized. In this study, we examined the association between the use of selective serotonin reuptake inhibitors (SSRIs) and urinary incontinence. METHODS: A retrospective follow-up study among starters with an SSRI was performed to estimate the relative and absolute risk for urinary incontinence associated with SSRI use. Data came from the PHARMO database, which includes information on drug dispensing for approximately 450,000 residents living in eight Dutch cities. All patients initially using an SSRI between 1994 and 1998 were selected. The frequency measures for urinary incontinence were estimated by using prescription sequence analysis, where initiation of spasmolytic drugs or absorbent products was used as a measure for urinary incontinence. Besides crude incidence density calculations, Andersen-Gill's model was used in order to control for possible confounding factors and time varying covariates. RESULTS: A total of 13,531 were identified as first time users of an SSRI. Compared to non-exposure, the incidence density ratio for urinary incontinence during SSRI exposure was 1.75 (95% CI 1.56-1.97). Overall, compared to baseline, SSRI use caused 14 extra cases of urinary incontinence per 1000 patients treated per year; the elderly were more at risk resulting in 60 extra cases per 1000 patients per year. The adjusted relative risk for urinary incontinence due to SSRI use was 1.61 (95% CI 1.42-1.82); the risk for sertraline users was 2.76; 95% CI 1.47-5.21). CONCLUSIONS: Exposure to SSRIs is associated with an increased risk for developing urinary incontinence, which can be explained pharmacologically. Approximately 15 out of 1000 patients treated per year with an SSRI developed urinary incontinence. The elderly and users of sertraline are at the highest risk.
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Inhibidores Selectivos de la Recaptación de Serotonina/efectos adversos , Sertralina/efectos adversos , Incontinencia Urinaria/inducido químicamente , Adulto , Distribución por Edad , Anciano , Bases de Datos Factuales , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Modelos de Riesgos Proporcionales , Estudios Retrospectivos , Factores de Riesgo , Distribución por Sexo , Incontinencia Urinaria/epidemiologíaRESUMEN
BACKGROUND: Hyponatraemia may have serious clinical consequences. Several reports of hyponatraemia associated with the use of antidepressants have been published. However, it remains unclear whether a specific class or individual antidepressants are associated with an increased risk for hyponatraemia. OBJECTIVES: To investigate the association between the use of serotonergic antidepressant drugs and the occurrence of hyponatraemia compared with non-users of these agents and to determine the time-to-admission rate after initiation of these drugs. METHOD: A matched case-control study was conducted. Data were obtained from the PHARMO database including information on drug dispensing and hospital admission indications for 320,000 inhabitants of eight Dutch cities. Data from 1990 to 1998 were used. Case patients ( n=203) were all patients who were admitted to a hospital for hyponatraemia. Community controls ( n=608), matched by age and gender, were sampled within the same living area and calendar (index) date as the case patients. All patients were 18 years of age or older. Exposure to antidepressant drugs, classified as serotonergic versus non-serotonergic agents, and potential confounding factors were determined on the index date. Time-to-admission was defined as the period between start of the antidepressant drug and hospital admission. Conditional logistic regression model was used to estimate odds ratios (ORs) and to adjust for potential confounding factors. RESULTS: Ten (5%) case patients used serotonergic antidepressants compared with eight (1%) in the control group; compared with non-use, the risk for hyponatraemia was fourfold higher [OR 3.96; 95% confidence interval (CI) 1.33, 11.83] due to serotonergic antidepressant drug use. Risk for developing hyponatraemia was greatest in the first 2 weeks of serotonergic drug therapy. CONCLUSION: Use of serotonergic antidepressants is associated with the development of hyponatraemia. Hyponatraemia occurred during the first 2 weeks of treatment, which justifies blood-sodium monitoring during the first weeks after initial treatment with a serotonergic antidepressant.