Risk factor assessment and counselling for 12 months reduces metabolic and cardiovascular risk in overweight or obese patients with schizophrenia spectrum disorders: The CRESSOB study.

BACKGROUND: Metabolic syndrome (MS) and cardiovascular risk factors (CRF) have been associated with patients with schizophrenia. The main objective is to assess the evolution of CRF and prevalence of MS for 12 months in a cohort of overweight patients diagnosed with schizophrenia schizophreniform disorder or schizoaffective disorder in which the recommendations for the assessment and control of metabolic and cardiovascular risk were applied. METHODS: The Control of Metabolic and Cardiovascular Risk in Patients with Schizophrenia and Overweight (CRESSOB) study is a 12-month, observational, prospective, open-label, multicentre, naturalistic study including 109 community mental health clinics of Spain. The study included a total of 403 patients, of whom we could collect all variables related to CRF and MS in 366 patients. Of these 366 patients, 286 completed the follow-up, (baseline, months 3, 6 and 12) where they underwent a complete physical examination and a blood test (glucose, cholesterol and triglycerides), they were asked about their health-related habits (smoking, diet and exercise) and they were given a series of recommendations to prevent cardiovascular risk and MS. RESULTS: A total of 403 patients were included, 63% men, mean age (mean; (SD)) 40.5 (10.5) years. After 12 months, the study showed statistically significant decrease in weight (p<0.0001), waist circumference (p<0.0001), BMI (p<0.0001), blood glucose (p=0.0034), total cholesterol (p<0.0001), HDL cholesterol (p=0.02), LDL cholesterol (p=0.0023) and triglycerides (p=0.0005). There was a significant reduction in the percentage of smokers (p=0.0057) and in the risk of heart disease at 10 years (p=0.0353). CONCLUSION: Overweight patients with schizophrenia who receive appropriate medical care, including CRF monitoring and control of health-related habits experience improvements with regard to most CRFs.

La evaluación de factores de riesgo y el asesoramiento durante 12 meses reduce el riesgo metabólico y cardiovascular en pacientes con trastornos del espectro esquizofrénico con sobrepeso u obesidad: Estudio CRESSOB / Risk factor assessment and counselling for 12 months reduces metabolic and cardiovascular risk in overweight or obese patients with schizophrenia spectrum disorders: The CRESSOB study

Introducción. Se ha asociado la presencia del síndrome metabólico (SM) y de factores de riesgo cardiovascular (FRC) a pacientes con esquizofrenia. El principal objetivo es evaluar la evolución de los FRC y la prevalencia del SM durante 12 meses en una cohorte de pacientes con sobrepeso diagnosticados de esquizofrenia esquizofreniforme o de trastorno esquizoafectivo a la que se aplicaron las recomendaciones para la evaluación y control del riesgo cardiovascular. Método. El estudio del control del riesgo metabólico y cardiovascular en pacientes con esquizofrenia y sobrepeso [Control of Metabolic and Cardiovascular Risk in Patients with Schizophrenia and Overweight (CRESSOB)] es un estudio de 12 meses, observacional, prospectivo, abierto, multicéntrico, naturalístico que incluye 109 centros de salud mental en España. El estudio incluyo un total de 403 pacientes, de los cuales se recopilaron todas las variables relacionadas con FRC y SM en 366 pacientes. De esos 366, 286 completaron el seguimiento, (basal, a los 3, 6 y 12 meses) en el que se llevaron a cabo un examen físico completo y una analítica de sangre (glucosa, colesterol y triglicéridos), se les preguntó sobre hábitos de salud (tabaco, dieta y ejercicio) y se les ofreció una serie de recomendaciones para prevenir el riesgo cardiovascular y el SM. Resultados. Un total de 403 pacientes fueron incluidos en el estudio, 63% hombres, de mediana edad [media 40,5 años; DE: (10,5)]. Transcurridos 12 meses, el estudio mostró descensos estadísticamente significativos en el peso

Background. Metabolic syndrome (MS) and cardiovascular risk factors (CRF) have been associated with patients with schizophrenia. The main objective is to assess the evolution of CRF and prevalence of MS for 12 months in a co hort of overweight patients diagnosed with schizophrenia schizophreniform disorder or schizoaffective disorder in which the recommendations for the assessment and control of metabolic and cardiovascular risk were applied. Methods. The Control of Metabolic and Cardiovascular Risk in Patients with Schizophrenia and Overweight (CRESSOB) study is a 12-month, observational, prospective, open-label, multicentre, naturalistic study including 109 community mental health clinics of Spain. The study included a total of 403 patients, of whom we could collect all variables related to CRF and MS in 366 patients. Of these 366 patients, 286 completed the follow-up, (baseline, months 3, 6 and 12) where they underwent a complete physical examination and a blood test (glucose, cholesterol and triglycerides), they were asked about their health-related habits (smoking, diet and exercise) and they were given a series of recommendations to prevent cardiovascular risk and MS. Results. A total of 403 patients were included, 63% men, mean age (mean; (SD)) 40.5 (10.5) years. After 12 months, the study showed statistically significant decrease in weight (p<0.0001) waist circumference (p<0.0001), BMI (p<0.0001), HDL colesterol (p=0.02), LDL colesterol (p=0.0023) and triglycerides (p=0.0005). There was a significant reduction in the percentage of smokers (p=0.0057) and in the risk of heart disease at 10 years (p=0.0353). Conclusion. Overweight patients with schizophrenia who receive appropriate medical care, including CRF monitoring and control of health-related habits experience improvements with regard to most CRFs

[Prevalence of metabolic syndrome in Spanish patients with schizophrenia and overweight. The CRESSOB Study]. / Prevalencia del síndrome metabólico en pacientes españoles con esquizofrenia y sobrepeso. El estudio CRESSOB.

INTRODUCTION: Metabolic syndrome (MS) (visceral obesity, dyslipidemia, hyperglycemia, and hypertension), has become one of the major public-health challenges worldwide. Patients with schizophrenia are more likely to suffer from MS than the general population. OBJECTIVE: The primary aim of this study was to analyze the prevalence of MS in Spanish patients with schizophrenia and overweight and to compare the best method to calculate the MS prevalence in this population. A secondary aim of the CRESSOB study was to determine whether the presence of the metabolic syndrome (MS) is associated or not with clinical remission of schizophrenia. METHODS: The Control of Metabolic and Cardiovascular Risk in Patients with Schizophrenia and Overweight (CRESSOB) study is a 12-month, prospective, naturalistic study including 110 community mental health clinics selected at random. Each site enrolled four consecutive patients with a diagnosis of schizophrenia, according to DSM-IV TR criteria, and who were overweight (Body Mass Index (BMI) >25 kg/m2). To assess the prevalence of MS we analyzed the baseline results of the CRESSOB study. The National Cholesterol Education Program (NCEP-ATP III), the International Diabetes Federation (IDF) and the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) definitions were used to establish the presence of MS. The Positive and Negative Syndrome Scale (PANSS) was used to determine the percentage of patients in remission. Psychosocial functioning was measured by the Global Assessment of Functioning (GAF) scale. RESULTS: A total of 391 patients were enrolled in the study (mean age 40.5 years, 63.8% men). 75.9% of the patients did not meet criteria for remission, using the selected PANSS items. The mean GAF score was 52.7 (Standard Deviation (SD) 15.4). Overall, 59.0% of males and 58.3% of females fulfilled the NCEP-ATP III criteria, 71.1% of males and 65.8% of females fulfilled the IDF criteria and 70.1% of males and 65.1% of females fulfilled the AHA/ NHLBI criteria. The patients who fulfilled remission criteria were younger, had a lower BMI, and a higher GAF score. CONCLUSIONS: MS is highly prevalent in Spanish patients with schizophrenia who are overweight. Given that metabolic syndrome is an important risk factor for cardiovascular disease, these patients should receive appropriate clinical monitoring for this syndrome.

Prevalencia del síndrome metabólico en pacientes españoles con esquizofrenia y sobrepeso. El estudio CRESSOB / Prevalence of Metabolic Syndrome in Spanish Patients with Schizophrenia and Overweight. The CRESSOB Study

Introducción: El síndrome metabólico (SM) (obesidad visceral, dislipemia, hiperglucemia e hipertensión) se ha convertido en uno de los mayores retos de salud pública en todo el mundo. Los pacientes con esquizofrenia son más propensos a sufrir SM que la población general. Objetivos: El objetivo principal de este estudio fue analizarla prevalencia del SM en pacientes españoles con esquizofrenia y sobrepeso y comparar el mejor método para calcular la prevalencia de SM en esta población. Un objetivo secundario del estudio CRESSOB fue determinar si la presencia del síndrome metabólico (SM) está asociada o no con la remisión clínica de la esquizofrenia. Método: El estudio de control del riesgo metabólico y cardiovascular en pacientes con esquizofrenia y sobrepeso (CRESSOB) es un estudio a 12 meses, prospectivo y naturalístico, que incluye 110 centros de salud mental seleccionados al azar. Cada centro seleccionó cuatro pacientes consecutivos con diagnóstico de esquizofrenia, según los criterios DSM-IV TR y que además tuvieran sobrepeso (índice de masa corporal (IMC)> 25 kg/m2). Para evaluar la prevalencia del SM se analizaron los resultados de la línea de base del estudio CRESSOB. Se utilizaron las definiciones del programa Nacional de Educación sobre el Colesterol (NCEP-ATP III), de la Federación Internacional de Diabetes (FID) y de la Asociación Americana del Corazón, el Pulmón y la Sangre (AHA/NHLBI) para establecer la presencia de SM. La escala de los Síndromes Positivo y Negativo (PANSS) se utilizó para determinar el porcentaje de pacientes en remisión. El funcionamiento psicosocial se midió mediante la Evaluación Global de Funcionamiento (GAF). Resultados: Se incluyeron en el estudio un total de391 pacientes (edad media 40,5 años, 63,8% de hombres). El 75,9% de los pacientes no cumplía los criterios de remisión, utilizando los elementos seleccionados de la PANSS. La puntuación media del GAF fue de 52,7 (desviación estándar (DE) de 15,4). En total, el 59,0% de los varones y el 58,3% de las mujeres cumplían los criterios del NCEP-ATP III, el 71,1% de los varones y el 65,8% de las mujeres cumplieron con los criterios de la FID y el 70,1% de los varones y el 65,1% de las mujeres cumplieron con los criterios de la AHA/NHLBI. Los pacientes que cumplieron los criterios de remisión fueron más jóvenes, tenían un índice de masa corporal más bajo y una puntuación superior en el GAF. Conclusiones: El SM es altamente prevalente en pacientes españoles con esquizofrenia que tienen sobrepeso. Dado que el síndrome metabólico es un factor de riesgo importante para la enfermedad cardiovascular, estos pacientes deben recibir una monitorización clínica adecuada para este síndrome

Introduction: Metabolic syndrome (MS) (visceral obesity, dyslipidemia, hyperglycemia, and hypertension), has become one of the major public-health challenges worldwide. Patients with schizophrenia are more likely to suffer from MS than the general population. Objective: The primary aim of this study was to analyze the prevalence of MS in Spanish patients with schizophrenia and overweight and to compare the best method to calculate the MS prevalence in this population. A secondary aim of the CRESSOB study was to determine whether the presence of the metabolic syndrome (MS) is associated or not with clinical remission of schizophrenia. Methods: The Control of Metabolic and Cardiovascular Risk in Patients with Schizophrenia and Overweight (CRESSOB) study is a 12-month, prospective, naturalistic study including 110 community mental health clinics selected at random. Each site enrolled four consecutive patients with a diagnosis of schizophrenia, according to DSM-IV TR criteria, and who were overweight (Body Mass Index (BMI) >25 kg/m2). To assess the prevalence of MS we analyzed the baseline results of the CRESSOB study. The National Cholesterol Education Program (NCEP-ATP III), the International Diabetes Federation (IDF) and the American Heart Association/National Heart, Lung, and Blood Institute (AHA/NHLBI) definitions were used to establish the presence of MS. The Positive and Negative Syndrome Scale (PANSS) was used to determine the percentage of patients in remission. Psychosocial functioning was measured by the Global Assessment of Functioning (GAF) scale. Results: A total of 391 patients were enrolled in the study (mean age 40.5 years, 63.8% men). 75.9% of the patients did not meet criteria for remission, using the selected PANSS items. The mean GAF score was 52.7 (Standard Deviation (SD) 15.4). Overall, 59.0% of males and 58.3% of females fulfilled the NCEP-ATP III criteria, 71.1% of males and 65.8% of females fulfilled the IDF criteria and 70.1% of males and 65.1% of females fulfilled the AHA/NHLBI criteria. The patients who fulfilled remission criteria were younger, had a lower BMI, and a higher GAF score. Conclusions: MS is highly prevalent in Spanish patients with schizophrenia who are overweight. Given that metabolic syndrome is an important risk factor for cardiovascular disease, these patients should receive appropriate clinical monitoring for this syndrome

Randomized crossover pharmacokinetic evaluation of subcutaneous versus intravenous granisetron in cancer patients treated with platinum-based chemotherapy.

BACKGROUND: 5-HT3-receptor antagonists are one of the mainstays of antiemetic treatment, and they are administered either i.v. or orally. Nevertheless, sometimes neither administration route is feasible, such as in patients unable to admit oral intake managed in an outpatient setting. Our objective was to evaluate the bioavailability of s.c. granisetron. PATIENTS AND METHODS: Patients receiving platinum-based chemotherapy were randomized to receive 3 mg of granisetron either s.c. or i.v. in a crossover manner during two cycles. Blood and urine samples were collected after each cycle. Pharmacokinetic parameters observed with each administration route were compared by analysis of variance. RESULTS: From May to November 2005, 31 patients were included and 25 were evaluable. Subcutaneous granisetron resulted in a 27% higher area under the concentration-time curve for 0-12 hours (AUC(0-12h)) and higher levels at 12 hours, with similar values for AUC(0-24h). The maximum concentration was lower with the s.c. than with the i.v. route and was observed 30 minutes following s.c. administration. CONCLUSION: Granisetron administered s.c. achieves complete bioavailability. This is the first study that shows that s.c. granisetron might be a valid alternative to i.v. delivery. Further trials to confirm clinical equivalence are warranted. This new route of administration might be especially relevant for outpatient management of emesis in cancer patients.

A comparative study of the pharmacokinetics of ibuprofen arginate versus dexibuprofen in healthy volunteers.

OBJECTIVE: Ibuprofen arginate is a salt formulation of ibuprofen designed to reach target concentrations rapidly. The primary objective of this study was to compare the 12-h pharmacokinetic profile of S(+)-ibuprofen following administration of single doses of ibuprofen arginate (600 mg) and dexibuprofen (400 mg) in healthy volunteers. METHODS: Twenty-four volunteers were recruited into an open-label, randomised, two-period, single-centre study with crossover design. RESULTS: Both treatments were well tolerated. Ibuprofen arginate and dexibuprofen showed similar bioavailability for S(+)-ibuprofen. Compared with dexibuprofen, ibuprofen arginate demonstrated a 45% higher maximum concentration (C(max)), and a time to peak concentration (T(max)) 2 h sooner. CONCLUSION: Ibuprofen arginate approaches maximum concentrations of S(+)-ibuprofen faster and higher than dexibuprofen.