Estudio de la angina estable en España y su impacto en la calidad de vida del paciente. Registro AVANCE / Stable angina in Spain and its impact on quality of life. The AVANCE registry

Introducción y objetivos. La mortalidad por cardiopatía isquémica aguda se ha reducido, pero los pacientes crónicos persisten sintomáticos en una proporción importante. Se pretende conocer las características clínicas y la terapéutica del paciente con angina estable y el impacto de esta enfermedad en la calidad de vida. Métodos. Estudio observacional, multicéntrico y de corte transversal, sobre 2.039 pacientes con angina estable en control ambulatorio. Además de variables clínicas, el investigador recogió su valoración subjetiva sobre la gravedad de la angina y la limitación causada por ella. Los pacientes contestaron sobre percepción de gravedad y calidad de vida con cuestionarios específicos. Resultados. Se analizó a 2.024 pacientes. El 73% eran varones (media de edad, 68±10 años). El 50,3% estaba asintomático (menos de una crisis de angina por semana en las últimas 4 semanas), el 39,2% había tenido entre una y tres crisis por semana, y el 10,5% declaró más de tres crisis por semana. El 66% había sido revascularizado, y de ellos el 59% volvía a tener angina. Los pacientes puntuaron la gravedad de la enfermedad más que los médicos (4,5±2,5 frente a 4,3±2,3; p=0,002). Las percepciones del médico y del paciente sobre la repercusión de la angina tuvieron poca concordancia (índice kappa<0,3), pues los pacientes consideraron que su enfermedad era más grave, más invalidante y con mayor disminución de la calidad de vida. Conclusiones. Persiste una elevada proporción de pacientes sintomáticos y con reducción de la calidad de vida. La percepción del paciente sobre la enfermedad es peor que la del médico (AU)

Introduction and objectives. Mortality from acute coronary syndrome has fallen but a substantial number of chronic patients remain symptomatic. The present study was designed to determine the clinical characteristics and therapeutic treatment of patients with stable angina and its impact on their quality of life. Methods. A cross-sectional, multicenter, observational study of 2039 patients with stable angina attended in outpatient clinics was performed. Data were collected on clinical variables and on the subjective perception of the severity of angina and the resulting limitations. Patients completed questionnaires on their perception of severity and quality of life. Results. We analyzed data on 2024 patients; 73% were men (mean age 68 [10] years). Some 50.3% were asymptomatic (<1 angina attack per week in the previous 4 weeks), 39.2% reported 1-3 attacks per week and 10.5% reported >3 attacks per week; 66% had previously undergone revascularization, and 59% of these developed recurrent angina. Patients rated the severity of their condition higher than did their physicians (4.5 [2.5] vs 4.3 [2.3]; P=.002). Physicians’ and patients’ perceptions of the repercussions of angina showed little concordance (kappa<0.3). The patients believed their condition was much more severe, more debilitating, and had a greater negative impact on their quality of life. Conclusions. A high proportion of patients with stable angina remains symptomatic and their quality of life is impaired. Their perception of the condition is worse than that of their physicians (AU)

Stable angina in Spain and its impact on quality of life. The AVANCE registry.

INTRODUCTION AND OBJECTIVES: Mortality from acute coronary syndrome has fallen but a substantial number of chronic patients remain symptomatic. The present study was designed to determine the clinical characteristics and therapeutic treatment of patients with stable angina and its impact on their quality of life. METHODS: A cross-sectional, multicenter, observational study of 2039 patients with stable angina attended in outpatient clinics was performed. Data were collected on clinical variables and on the subjective perception of the severity of angina and the resulting limitations. Patients completed questionnaires on their perception of severity and quality of life. RESULTS: We analyzed data on 2024 patients; 73% were men (mean age 68[10] years). Some 50.3% were asymptomatic (<1 angina attack per week in the previous 4 weeks), 39.2% reported 1-3 attacks per week and 10.5% reported >3 attacks per week; 66% had previously undergone revascularization, and 59% of these developed recurrent angina. Patients rated the severity of their condition higher than did their physicians (4.5 [2.5] vs 4.3 [2.3]; P=.002). Physicians' and patients' perceptions of the repercussions of angina showed little concordance (kappa<0.3). The patients believed their condition was much more severe, more debilitating, and had a greater negative impact on their quality of life. CONCLUSIONS: A high proportion of patients with stable angina remains symptomatic and their quality of life is impaired. Their perception of the condition is worse than that of their physicians.

Diferencias en el pronóstico de la insuficiencia cardiaca con función sistólica conservada o deprimida en pacientes mayores de 70 años que toman bloqueadores beta / Differences in outcome of heart failure with preserved or depressed systolic function in patients older than 70 years who receive beta blockers

Introducción y objetivos. La mayoría de los trabajos han puesto de manifiesto que el pronóstico de la insuficiencia cardiaca con función sistólica conservada es tan malo como el de la insuficiencia cardiaca con función sistólica deprimida, aunque estos resultados pueden estar sesgados debido a que estos dos tipos de insuficiencia cardiaca tienen características distintas (edad, comorbilidades, tratamiento) que pueden influir en el pronóstico. Nuestro objetivo es evaluar si la morbimortalidad a corto plazo es distinta en estos dos subgrupos de insuficiencia cardiaca, con pacientes homogéneos en cuanto a edad, comorbilidad y tratamiento recibido. Métodos. Analizamos dos grupos de pacientes mayores de 70 años y que pudieran recibir bloqueadores beta, dados de alta consecutivamente tras un ingreso por insuficiencia cardiaca en 53 hospitales españoles (función sistólica deprimida, 245; función sistólica conservada, 374), y se comparó la morbimortalidad cardiovascular a los 3 meses del alta. Resultados. Las medias de edad fueron similares (77,5±4,8 frente a 78,2±5,5 años). La fracción de eyección ventricular izquierda fue de 56,2±8,1% frente a 33±6,9% (p<0,001). La incidencia del evento combinado (muerte, ingreso por insuficiencia cardiaca, síndrome coronario agudo o ictus) a los 3 meses del alta fue menor en los pacientes con insuficiencia cardiaca y función sistólica conservada (el 13,4 frente al 20,6%; p=0,026). Tener la función sistólica deprimida fue predictor independiente de mayor incidencia de eventos (odds ratio=1,732; p=0,048). Conclusiones. En pacientes de edad similar que reciben el mismo tratamiento, el pronóstico a corto plazo es mejor en los pacientes con insuficiencia cardiaca y función sistólica conservada que en aquellos con función sistólica deprimida (AU)

Introduction and objectives. Most studies have shown that prognosis of heart failure with preserved systolic function is as poor as that of heart failure with depressed systolic function, although these results may be biased by the fact that these types of heart failure have different characteristics (age, comorbidity, treatment), which can influence prognosis. Our aim was to determine whether short-term morbidity and mortality differed in these 2 subgroups of heart failure patients when they were comparable in terms of age, associated comorbidity, and therapy. Methods. We analyzed 2 groups of patients aged >70 years who were candidates to receive beta blockers (preserved systolic function, 245; depressed systolic function, 374), consecutively discharged from 53 participating Spanish hospitals with a diagnosis of heart failure, and compared cardiovascular morbidity and mortality 3 months after discharge. Results. Mean age was similar (77.5±4.8 vs 78.2±5.5 years). Left ventricular ejection fraction was 56.2%±8.1% vs 33%±6.9% (P<.001). The combined event rate (death, hospitalization for heart failure, acute coronary syndrome, or stroke) at 3 months after discharge was lower in patients with heart failure and preserved systolic function (13.4% vs 20.6%; P=.026). Depressed systolic function was an independent predictor of greater incidence of events (odds ratio=1.732; P=.048). Conclusions. In patients of similar age and receiving similar treatment, short-term prognosis is better in patients with heart failure and preserved systolic function than in those with depressed systolic function (AU)

Differences in outcome of heart failure with preserved or depressed systolic function in patients older than 70 years who receive beta blockers.

INTRODUCTION AND OBJECTIVES: Most studies have shown that prognosis of heart failure with preserved systolic function is as poor as that of heart failure with depressed systolic function, although these results may be biased by the fact that these types of heart failure have different characteristics (age, comorbidity, treatment), which can influence prognosis. Our aim was to determine whether short-term morbidity and mortality differed in these 2 subgroups of heart failure patients when they were comparable in terms of age, associated comorbidity, and therapy. METHODS: We analyzed 2 groups of patients aged >70 years who were candidates to receive beta blockers (preserved systolic function, 245; depressed systolic function, 374), consecutively discharged from 53 participating Spanish hospitals with a diagnosis of heart failure, and compared cardiovascular morbidity and mortality 3 months after discharge. RESULTS: Mean age was similar (77.5±4.8 vs 78.2±5.5 years). Left ventricular ejection fraction was 56.2%±8.1% vs 33%±6.9% (P<.001). The combined event rate (death, hospitalization for heart failure, acute coronary syndrome, or stroke) at 3 months after discharge was lower in patients with heart failure and preserved systolic function (13.4% vs 20.6%; P=.026). Depressed systolic function was an independent predictor of greater incidence of events (odds ratio=1.732; P=.048). CONCLUSIONS: In patients of similar age and receiving similar treatment, short-term prognosis is better in patients with heart failure and preserved systolic function than in those with depressed systolic function.

¿Cómo se usan los bloqueadores beta en España? Análisis de las limitaciones para su uso en medicina interna y cardiología: estudio CARACTER-BETA / How Beta-Blockers Are Used in Spain? Analysis of Limitations in Their Use in Internal Medicine and Cardiology: CARACTER-BETA Study

Introducción y objetivos. El tratamiento con bloqueadores beta tiene una indicación de clase I y nivel de evidencia A en las guías de tratamiento de insuficiencia cardiaca, cardiopatía isquémica y fibrilación auricular. A pesar de ello, el uso de bloqueadores beta sigue siendo inferior a lo deseable. El objetivo principal del estudio es analizar el uso de los bloqueadores beta en España en pacientes con cardiopatía isquémica, insuficiencia cardiaca, fibrilación auricular. Métodos. Estudio epidemiológico observacional, transversal y multicéntrico, que incluye a 1.608 pacientes con cardiopatía isquémica, insuficiencia cardiaca y/o fibrilación auricular reclutados en 150 centros sanitarios por cardiólogos y médicos internistas. Resultados. El 78,6% de los pacientes fueron incluidos en cardiología, y el 21,4%, en medicina interna; se recogió al 25,8% en altas hospitalarias y al 74,2%, en consultas externas. El 67% eran varones. La media de edad era 68±12 años. El 73% tenía cardiopatía isquémica; el 42%, insuficiencia cardiaca, y el 36%, fibrilación auricular (variable multirrespuesta). El 82,8% de los tratados en cardiología recibió bloqueadores beta, frente al 71,6% de los tratados en medicina interna (p<0,0001). Por enfermedades, el 85,1% de los pacientes con cardiopatía isquémica, el 77% con insuficiencia cardiaca y el 72,4% con fibrilación auricular. Cardiología prescribió significativamente más bloqueadores beta que medicina interna en cardiopatía isquémica e insuficiencia cardiaca. El análisis multivariable mostró que los bloqueadores beta aumentan si se padece cardiopatía isquémica, se es tratado por un cardiólogo, se tiene dislipemia, accidente cerebrovascular y/o hipertrofia ventricular izquierda. Disminuyen los bloqueadores beta con la edad, el broncospasmo y el asma bronquial, la bradicardia, la enfermedad pulmonar obstructiva crónica y/o la claudicación intermitente. Conclusiones. Todavía existen márgenes de mejora en la prescripción de bloqueadores beta a pacientes con cardiopatía isquémica, insuficiencia cardiaca y/o fibrilación auricular en España (AU)

Introduction and objectives. Beta-blocker treatment has a class I indication, level of evidence A, in guidelines for the treatment of heart failure, ischemic heart disease, and atrial fibrillation. However, beta-blocker use continues to be less than optimal. In this study, beta-blocker use in Spain is analyzed in patients with heart failure, ischemic heart disease, and atrial fibrillation. Methods. Observational, epidemiologic, cross-sectional, multicenter study including 1608 patients with heart failure, ischemic heart disease, and/or atrial fibrillation, recruited in 150 healthcare centers by cardiologists and internal medicine specialists. Results. Cardiologists enrolled 78.6% patients and internal medicine specialists 21.4%; 25.8% were recruited at hospital discharge and 74.2% at outpatient centers. Men accounted for 77% of the sample, and age was 68 (12) years. Of the total, 73% had ischemic heart disease, 42% heart failure, and 36% atrial fibrillation (multiresponse variable). beta-blockers were given to 82.8% of those consulting in cardiology compared to 71.6% of those treated in internal medicine (P<.0001). By pathology, the prescription rate was 85.1% of patients with ischemic heart disease, 77.0% of those with heart failure, and 72.4% of those with atrial fibrillation. Cardiology prescribed significantly more beta-blockers for ischemic heart disease and heart failure than did internal medicine. Multivariate analysis showed that beta-blocker use increased when the patient had ischemic heart disease, was treated by a cardiologist, and had dyslipidemia, stroke, and/or left ventricular hypertrophy. Beta-blocker use decreased with age and with a history of bronchospasm, asthma, bradycardia, chronic obstructive pulmonary disease, and/or intermittent claudication. Conclusions. There is still room for improvement in beta-blocker prescription in Spain for patients with ischemic heart disease, heart failure, and/or atrial fibrillation (AU)

[How beta-blockers are used in Spain? Analysis of limitations in their use in internal medicine and cardiology: CARACTER-BETA study]. / ¿Cómo se usan los bloqueadores beta en España? Análisis de las limitaciones para su uso en medicina interna y cardiología: estudio CARACTER-BETA.

INTRODUCTION AND OBJECTIVES: Beta-blocker treatment has a class I indication, level of evidence A, in guidelines for the treatment of heart failure, ischemic heart disease, and atrial fibrillation. However, beta-blocker use continues to be less than optimal. In this study, beta blocker use in Spain is analyzed in patients with heart failure, ischemic heart disease, and atrial fibrillation. METHODS: Observational, epidemiologic, cross-sectional, multicenter study including 1608 patients with heart failure, ischemic heart disease, and/or atrial fibrillation, recruited in 150 healthcare centers by cardiologists and internal medicine specialists. RESULTS: Cardiologists enrolled 78.6% patients and internal medicine specialists 21.4%; 25.8% were recruited at hospital discharge and 74.2% at outpatient centers. Men accounted for 77% of the sample, and age was 68 (12) years. Of the total, 73% had ischemic heart disease, 42% heart failure, and 36% atrial fibrillation (multiresponse variable). Beta blockers were given to 82.8% of those consulting in cardiology compared to 71.6% of those treated in internal medicine (P<.0001). By pathology, the prescription rate was 85.1% of patients with ischemic heart disease, 77.0% of those with heart failure, and 72.4% of those with atrial fibrillation. Cardiology prescribed significantly more beta blockers for ischemic heart disease and heart failure than did internal medicine. Multivariate analysis showed that beta blocker use increased when the patient had ischemic heart disease, was treated by a cardiologist, and had dyslipidemia, stroke, and/or left ventricular hypertrophy. beta blocker use decreased with age and with a history of bronchospasm, asthma, bradycardia, chronic obstructive pulmonary disease, and/or intermittent claudication. CONCLUSIONS: There is still room for improvement in beta blocker prescription in Spain for patients with ischemic heart disease, heart failure, and/or atrial fibrillation.

Validation of the Spanish version of the Kansas city cardiomyopathy questionnaire.

INTRODUCTION AND OBJECTIVES: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is specifically designed to evaluate quality of life in patients with chronic heart failure (CHF). The purpose of this study was to assess the reliability, validity, and responsiveness to change of the Spanish version of the KCCQ. METHODS: The multicenter study involved 315 patients with CHF. Patients were evaluated at baseline and at weeks 24 and 26. The KCCQ, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Short Form-36 (SF-36) were administered. Reliability was assessed in stable patients (n=163) by examining test-retest and internal consistency measures between weeks 24 and 26. Validity was evaluated at baseline (n=315) by determining how KCCQ scores varied with New York Heart Association functional class and by comparing scores with those on similar domains of the MLHFQ and SF-36. Responsiveness to change was assessed in patients who experienced significant clinical improvement between baseline and week 24 (n=31) by determining the effect size. RESULTS: Reliability coefficients ranged between 0.70 and 0.96 for the different domains. Mean KCCQ scores varied significantly with New York Heart Association functional class (P<.001). Correlations with comparable domains on the other questionnaires were acceptable (e.g. for physical limitation, they were between 0.77 and 0.81). The changes observed at 24 weeks in the majority of KCCQ scores in the subsample that improved corresponded to a moderate effect size (i.e. 0.4-0.6). CONCLUSIONS: The Spanish version of the KCCQ has good metric properties (i.e. validity, reliability and responsiveness), which make it suitable for use in evaluating quality of life in Spanish CHF patients.

Validación de la versión española del Kansas City Cardiomyopathy Questionnaire / Validation of the spanish version of the Kansas City cardiomyopathy questionnaire

Introducción y objetivos. El Kansas City Cardiomyopathy Questionnaire (KCCQ) es un instrumento de calidad de vida específico para insuficiencia cardiaca crónica (ICC). El objetivo es evaluar la fiabilidad, la validez y la sensibilidad al cambio de la versión española del KCCQ. Métodos. Se realizó un estudio multicéntrico con 315 pacientes con ICC. Se realizó una evaluación basal y a las semanas 24 y 26. Se aplicaron el KCCQ, el Minnesota Living with Heart Failure Questionnaire (MLHFQ) y el Short Form 36 (SF-36). La fiabilidad se evaluó mediante test-retest y la consistencia interna en pacientes estables entre las semanas 24 y 26 (n=163). La validez se estudió basalmente (n=315) mediante gradiente de las puntuaciones según la New York Heart Association y las correlaciones, con las dimensiones del MLHFQ y SF-36. La evaluación de la sensibilidad al cambio se analizó en los pacientes (n=31) que habían mejorado significativamente entre la primera y la segunda evaluación mediante el coeficiente de tamaño del efecto. Resultados. Los coeficientes de fiabilidad oscilaron entre 0,7 y 0,96 según las dimensiones. Las medias de las puntuaciones mostraron diferencias significativas según la New York Heart Association (p<0,001). Las correlaciones entre las dimensiones de los diferentes cuestionarios fueron aceptables (por ejemplo, limitación física entre 0,77 y 0,81). El cambio a las 24 semanas en la submuestra de mejoría en la mayoría de las puntuaciones del KCCQ correspondió a tamaños del efecto moderados (0,4-0,6). Conclusiones. La versión española del KCCQ tiene unas adecuadas propiedades métricas (validez, fiabilidad y sensibilidad) como instrumento de valoración de calidad de vida en pacientes españoles con ICC (AU)

Introduction and objectives: The Kansas City Cardiomyopathy Questionnaire (KCCQ) is specifically designed to evaluate quality of life in patients with chronic heart failure (CHF). The purpose of this study was to assess the reliability, validity, and responsiveness to change of the Spanish version of the KCCQ. Methods: The multicenter study involved 315 patients with CHF. Patients were evaluated at baseline and at weeks 24 and 26. The KCCQ, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Short Form-36 (SF-36) were administered. Reliability was assessed in stable patients (n = 163) by examining test–retest and internal consistency measures between weeks 24 and 26. Validity was evaluated at baseline (n = 315) by determining how KCCQ scores varied with NewYork Heart Association functional class and by comparing scores with those on similar domains of the MLHFQ and SF-36. Responsiveness to change was assessed in patients who experienced significant clinical improvement between baseline and week 24 (n = 31) by determining the effect size. Results: Reliability coefficients ranged between 0.70 and 0.96 for the different domains. Mean KCCQ scores varied significantly with New York Heart Association functional class (P < .001). Correlations with comparable domains on the other questionnaires were acceptable (e.g. for physical limitation, they were between 0.77 and 0.81). The changes observed at 24 weeks in the majority of KCCQ scores in the subsample that improved corresponded to a moderate effect size (i.e. 0.4–0.6). Conclusions: The Spanish version of the KCCQ has good metric properties (i.e. validity, reliability and responsiveness), which make it suitable for use in evaluating quality of life in Spanish CHF patients (AU)

Effect of a training program for primary care physicians on the optimization of beta-blocker treatment in elderly patients with heart failure.

INTRODUCTION AND OBJECTIVES: Underuse of betablockers may contribute to elevated mortality in chronic heart failure. The aim of this study was to determine whether a specific interventional training program for primary care physicians would help optimize the use of beta-blockers in elderly chronic heart failure patients. METHODS: This randomized comparative study included 627 patients aged 70 years or more who were discharged consecutively from 53 Spanish hospitals with a principal diagnosis of chronic heart failure. In total, 292 health-care centers in the catchment areas of these hospitals were randomly assigned to two groups: one group of 146 centers carried out an interventional training program on beta-blocker use for primary care physicians belonging to the centers assigned to training, and 146 centers served as a control group. The main outcome variable was the percentage of patients who were receiving a beta-blocker at the maximum or maximum tolerated dose 3 months after hospital discharge. RESULTS: The patients' mean age was 78+/-5 years and 42% were women. There was no difference between the groups in demographic characteristics, clinical care, or treatment at discharge. The percentage of patients who received beta-blockers at the maximum tolerated dose 3 months after discharge was greater in the training group (49% vs. 38%; P=.014). Being treated in the training group was an independent predictor of receiving a beta-blocker at the MTD (odds ratio=2.46; 95% confidence interval, 1.29-4.69; P< .001). CONCLUSIONS: Implementation of an interventional training program on beta-blocker treatment for primary care physicians improved the use of these medications in elderly chronic heart failure patients.

Efecto de un programa de formación en atención primaria sobre la optimización del tratamiento con bloqueadores beta en pacientes ancianos con insuficiencia cardiaca / Effect of a training program for primary care physicians on the optimization of beta-blocker treatment in elderly patients with heart failure

Introducción y objetivos. La infrautilización de bloqueadores beta puede influir en la elevada mortalidad de la insuficiencia cardiaca. El objetivo de nuestro estudio es evaluar si un programa específico de intervención sobre médicos de atención primaria permite optimizar el uso de bloqueadores beta en pacientes ancianos con insuficiencia cardiaca. Métodos. Se diseñó un estudio aleatorizado y comparativo en el que se incluyó a 627 pacientes de 70 o más años, dados de alta de forma consecutiva con el diagnóstico principal de insuficiencia cardiaca en 53 hospitales españoles. Se realizó una asignación aleatoria de los 292 centros de salud de las áreas de esos hospitales a dos grupos (formación, 146 centros, y control, 146 centros), para impartir un programa de intervención y formación sobre bloqueadores beta a los médicos pertenecientes a los centros del grupo formación. La variable principal fue el porcentaje de pacientes que recibían la dosis máxima o máxima tolerada de bloqueadores beta a los 3 meses del alta. Resultados. La edad de los pacientes era de 78 ± 5 años; el 42% eran mujeres. No hubo diferencias entre ambos grupos en sus características demográficas, clínicas o en el tratamiento al alta. El porcentaje de pacientes que recibían la dosis máxima tolerada de bloqueadores beta a los 3 meses del alta fue mayor en el grupo formación (el 49 frente al 38%; p = 0,014); pertenecer al grupo formación fue predictor independiente de recibir la dosis máxima tolerada de bloqueadores beta (odds ratio = 2,46; intervalo de confianza del 95%, 1,29-4,69; p < 0,001). Conclusiones. Un programa de formación sobre bloqueadores beta en atención primaria mejora su uso en pacientes ancianos con insuficiencia cardiaca (AU)

Introduction and objectives. Underuse of betablockers may contribute to elevated mortality in chronic heart failure. The aim of this study was to determine whether a specific interventional training program for primary care physicians would help optimize the use of beta-blockers in elderly chronic heart failure patients. Methods. This randomized comparative study included 627 patients aged 70 years or more who were discharged consecutively from 53 Spanish hospitals with a principal diagnosis of chronic heart failure. In total, 292 health-care centers in the catchment areas of these hospitals were randomly assigned to two groups: one group of 146 centers carried out an interventional training program on beta-blocker use for primary care physicians belonging to the centers assigned to training, and 146 centers served as a control group. The main outcome variable was the percentage of patients who were receiving a beta-blocker at the maximum or maximum tolerated dose 3 months after hospital discharge. Results. The patients’ mean age was 78±5 years and 42% were women. There was no difference between the groups in demographic characteristics, clinical care, or treatment at discharge. The percentage of patients who received beta-blockers at the maximum tolerated dose 3 months after discharge was greater in the training group (49% vs. 38%; P=.014). Being treated in the training group was an independent predictor of receiving a beta-blocker at the MTD (odds ratio=2.46; 95% confidence interval, 1.29-4.69; P < .001). Conclusions. Implementation of an interventional training program on beta-blocker treatment for primary care physicians improved the use of these medications in elderly chronic heart failure patients (AU)

Comparison of dexketoprofen trometamol and dipyrone in the treatment of renal colic.

BACKGROUND: Nonsteroidal anti-inflammatory drugs (NSAIDs) have been widely used for pain relief in patients with renal colic. Dexketoprofen trometamol is an NSAID that has demonstrated good analgesic efficacy and a good safety profile after oral administration in different models of acute and chronic pain. OBJECTIVE: To assess the analgesic efficacy and safety of single intramuscular doses of dexketoprofen trometamol (25 and 50mg) compared with dipyrone (2g) in moderate to severe pain due to renal colic. STUDY DESIGN: Multicentre, randomised, double-blind, parallel-group study. PATIENTS: PATIENTS of both sexes aged 18-70 years with a diagnosis of renal colic were eligible for randomisation if they presented with at least moderate pain as assessed by visual analogue scale (VAS) scoring ≥40mm on a scale of 100mm immediately before study drug administration. METHODS: Assessment of analgesic efficacy was done using standard pain intensity and pain relief scales. Total scores from baseline to 6 hours after study drug administration were calculated for the sum of pain intensity differences relative to baseline (SPID), sum of analogue pain intensity differences relative to baseline (SAPID) and total pain relief scores (TOTPAR) as primary efficacy endpoints. Secondary efficacy and safety variables were also analysed. RESULTS: A total of 333 patients (dexketoprofen 25mg, n = 112; dexketoprofen 50mg, n = 113; dipyrone 2g, n = 108) were included in the study. No significant differences were found between the treatment groups with regard to SPID (p = 0.797), SAPID (p = 0.852) and TOTPAR (p = 0.716). The time-effect course for pain intensity differences and pain relief showed significantly (p < 0.05) higher values for both doses of dexketoprofen trometamol compared with dipyrone during the first hour after treatment administration. More than 90% of the patients in all three groups achieved pain relief of at least 50% as compared with baseline. Similarly, over 70% of the patients in all three groups considered the received treatment as excellent or good in the overall assessment of efficacy at the end of the study. No dose-effect relationship was observed in this pain model between both doses of dexketoprofen trometamol. All three treatments were well tolerated, showing mostly mild to moderate adverse events. CONCLUSION: Dexketoprofen trometamol is a good analgesic for the treatment of moderate to severe pain due to renal colic, with a good safety profile and an efficacy comparable to that of dipyrone. The significantly greater effect of dexketoprofen trometamol early after administration suggests a faster onset of action, which can be of paramount importance in this condition.

The Effect of Food and an Antacid on the Bioavailability of Dexketoprofen Trometamol.

This randomized three-way, crossover pharmacokinetic study was performed to determine whether food or an antacid alters the bioavailability of dexketoprofen trometamol. A total of 24 healthy volunteers received three single 25 mg doses of dexketoprofen trometamol administered either in fasting condition, after an antacid (Maalox® ), or after a high-fat breakfast. Each volunteer received the three treatments in a randomized order, with a 7-day washout period between treatments. Blood samples were taken at regular intervals up to 24 h after dose. Plasma dexketoprofen concentrations were determined by HPLC and the main outcome measures were area under curve of concentration vs. time (AUC0-∞ ), maximal plasma concentration (Cmax .), and time to reach maximal concentration (tmax ). Administration of an antacid 10 min before dexketoprofen trometamol had no clinically relevant effect on any of the pharmacokinetic parameters. Food did not alter the extent of absorption of dexketoprofen trometamol, but tmax was significantly increased and Cmax significantly decreased compared with the fasting state. In conclusion, we can state that neither antacid nor food has a significant effect on the overall bioavailability of dexketoprofen trometamol.

Clinical Comparison of Dexketoprofen Trometamol, Ketoprofen, and Placebo in Dental Pain.

The efficacy and tolerability of single doses of dexketoprofen trometamol12.5 mg, 25 mg, and 50 mg and ketoprofen 50 mg were compared in this double-blind, randomized, placebo-controlled study of 210 patients with moderate to severe pain after removal of one mandibular impacted third molar tooth. Pain intensity and pain relief were monitored for 6 h after administration of medication using visual analogue and verbal rating scales. All four active treatments were significantly more effective than placebo (P < 0.001). Dexketoprofen 25 mg and 50 mg produced an analgesic effect within 30 min of administration and their effect persisted for 6 h. Ketoprofen 50 mg produced a level of analgesia similar to those of the higher doses of dexketoprofen trometamol, but it had a slower onset. The 12.5-mg dose of dexketoprofen trometamol was significantly superior to placebo but produced a lower level and shorter duration of analgesia compared to the other active treatments. There were no significant differences between 25 and 50 mg of dexketoprofen trometamol in any measure of analgesic efficacy. No serious adverse events were observed and there were no significant differences in the incidence of adverse events among treatment groups. These results demonstrate that dexketoprofen trometamol 25 mg is at least as effective as the racemic ketoprofen 50 mg in the treatment of postsurgical dental pain. The more rapid onset of action compared to ketoprofen suggests that dexketoprofen trometamol is more appropriate for treatment of acute pain.

Comparison of Dexketoprofen Trometamol and Ketoprofen in the Treatment of Osteoarthritis of the Knee.

Dexketoprofen, the active enantiomer of the racemic compound ketoprofen, is a new nonsteroidal antiinflammatory drug (NSAID) of the arylpropionate family. The efficacy and safety of dexketoprofen trometamol were compared with the equivalent enantiomeric dose of ketoprofen in a multicenter, randomized, double-blind 3-week trial of adult outpatients with pain due to osteoarthritis of the knee. After a washout period of 7-15 days, patients were randomly assigned to receive either dexketoprofen trometamol 25 mg tid (N = 89) or ketoprofen 50 mg tid (N = 94). Of the 183 patients enrolled, two were lost to follow-up. At the end of treatment (3 weeks), the main efficacy outcome measures were significantly better in the dexketoprofen trometamol group than in the ketoprofen group. In addition, overall physician assessment indicated that 75% of the dexketoprofen group had improved compared with 50% of the ketoprofen patients. There were fewer adverse events in the dexketoprofen treatment group, but the difference did not reach statistical significance. These results demonstrate that dexketoprofen trometamol 25 mg tid is more effective than ketoprofen 50 mg tid in short-term symptomatic treatment of knee osteoarthritis and suggest that the tolerability of dexketoprofen trometamol is more favorable than ketoprofen. Therefore, the substitution of dexketoprofen for racemic ketoprofen may be advantageous in clinical practice.

Pharmacokinetics of Dexketoprofen Trometamol in Healthy Volunteers After Single and Repeated Oral Doses.

The pharmacokinetics of dexketoprofen trometamol were evaluated in two studies using healthy volunteers. In the first study, the relative bioavailability of a single oral capsule of dexketoprofen free acid 25 mg or dexketoprofen trometamol 25 mg (given as 37 mg of the trometamol salt) was compared to ketoprofen 50 mg in 18 healthy volunteers. In the second study, the pharmacokinetics and tolerability of oral dexketoprofen trometamol in tablet form were evaluated after either a single 25 mg dose (24 volunteers) or a repeated dose of 25 mg twice daily for 7 days (12 volunteers). The absorption of dexketoprofen from dexketoprofen trometamol capsules was bioequivalent to that of ketoprofen. On the other hand, the extent of absorption of dexketoprofen free acid was significantly lower than that for ketoprofen. Dexketoprofen trometamol showed the most rapid absorption rate, with highest Cmax and shortest tmax values, whereas dexketoprofen free acid had the slowest absorption rate, and ketoprofen had an intermediate absorption rate. After repeated-dose administration of dexketoprofen trometamol, the pharmacokinetic parameters were similar to those obtained after single doses, indicating that no drug accumulation occurred. Dexketoprofen trometamol was well tolerated, with no clinically relevant adverse events reported.

Clinical Comparison of Dexketoprofen Trometamol and Dipyrone in Postoperative Dental Pain.

A total of 125 outpatients with moderate to severe pain after surgical removal of one impacted third molar were randomly assigned to receive dexketoprofen trometamol 12.5 or 25 mg or dipyrone 575 mg. For first-dose assessments, patients rated their pain intensity and its relief at regular intervals. From 60 min post dose to the end of the 6-h observation period, both doses of dexketoprofen trometamol had higher pain relief scores than dipyrone: Between 3 and 6 h the differences were statistically significant. In addition, peak measures (PIDmax and PARmax ) were statistically superior after both doses of dexketoprofen trometamol compared to dipyrone. The overall efficacy assessed at the end of the first-dose phase was rated as good or excellent by 90%, 83.3%, and 70% of patients receiving dexketoprofen trometamol 25 mg, dexketoprofen trometamol 12.5 mg, and dipyrone, respectively. The number of patients who required remedication during the 6-h period was significantly lower in both dexketoprofen groups. Repeated-dose data were also obtained. No significant differences were found in the efficacy after repeated doses, the number of doses taken, or the mean time elapsed between doses. The overall efficacy at the end of the repeated-dose phase was rated as good or excellent by 84.2%, 66.7%, and 70% of patients receiving dexketoprofen trometamol 25 mg, dexketoprofen trometamol 12.5 mg, and dipyrone, respectively. The frequency of adverse events was similar for all treatments and no serious adverse events were reported during the study.

Comparison of the Efficacy and Tolerability of Dexketoprofen and Ketoprofen in the Treatment of Primary Dysmenorrhea.

Dexketoprofen, the pure S(+)-enantiomer of ketoprofen, is a promising new analgesic, but few clinical trials have yet examined its efficacy and tolerability. In this study, patients with a history of primary dysmenorrhea were treated with dexketoprofen doses of 12.5 and 25 mg, ketoprofen 50 mg, and placebo using a randomized, four-way crossover design. Efficacy analyses showed that dexketoprofen 12.5 and 25 mg and racemic ketoprofen 50 mg significantly reduced pain intensity compared with placebo from 1 h after dose to 4-6 h after dose. Interestingly, dexketoprofen at 12.5 mg was significantly superior to placebo at 30 min after dose. Mean pain relief scores also demonstrated that both doses of dexketoprofen and racemic ketoprofen were significantly superior to placebo at 1-6 h after the first dose. No indices of analgesic efficacy showed any significant differences between the two doses of dexketoprofen or between dexketoprofen and ketoprofen. After repeated dose administration, similar results were obtained. There were no significant effects of any treatment on activities of daily living, menstrual flow, or associated symptoms. Dexketoprofen was effective, well tolerated, and had no difference in the incidence of adverse events compared to ketoprofen or placebo.