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.

[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.

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.