Javier Rejas

Cardiovascular and metabolic risk in outpatients with schizophrenia treated with antipsychotics: Results of the CLAMORS Study

AIM To assess the prevalence of Coronary Heart Disease (CHD) and Metabolic Syndrome (MS) in patients treated with antipsychotics. METHODS Retrospective, cross-sectional, multicenter study in which 117 Spanish psychiatrists (the CLAMORS Study Collaborative Group) recruited consecutive outpatients meeting DSM-IV criteria for Schizophrenia, Schizophreniform or Schizoaffective Disorder, receiving antipsychotic treatment for at least 12 weeks. CHD risk was assessed by SCORE (10-year CV death) and Framingham (10-year all CHD events) function. MS was defined by at least 3 of the following components: waist circumference >102 (men)/>88 (women) cm; triglycerides > or =150 mg/dl; HDL-cholesterol <40 mg/dl (men)/<50 mg/dl (women); blood pressure > or =130/85; fasting glucose > or =110 mg/dl. RESULTS 1452 evaluable patients (863 men, 60.9%), aged 40.7+/-12.2 years (mean+/-SD) were included. MS was present in 24.6% [23.6% (men), 27.2% (women); p=0.130)]. The overall 10-year risks were 0.9+/-1.9 (SCORE) and 7.2+/-7.6 (Framingham). 8% (95%CI: 6.5-9.5) and 22.1% (95%CI: 20.0-24.3) of patients showed a high/very high risk according to SCORE (> or =3%) and Framingham (> or =10%) function. Abdominal obesity and low HDL-cholesterol were more prevalent in women: 54.5% (95%CI: 50.2-58.9) versus 34.3% (95%CI: 31.0-37.7), and 46.1% (95%CI: 41.4) versus 28.5 (95%CI: 50.8), p<0.001 in both cases. Hypertension and hypertriglyceridemia were more prevalent in men: 59.0% (95%CI: 55.7-62.3) versus 46.0% (95%CI: 41.8-50.2), and 40.7% (95%CI: 37.2-44.2) versus 32.4 (95%CI: 28.3-36.5), p<0.01 in both cases. CONCLUSIONS CHD risk and MS prevalences among patients with schizophrenia treated with antipsychotics were in the same range as the Spanish general population 10 to 15 years older.

Healthy lifestyle habits and 10-year cardiovascular risk in schizophrenia spectrum disorders: an analysis of the impact of smoking tobacco in the CLAMORS schizophrenia cohort.

AIM We analysed the impact of tobacco smoking over several healthy lifestyle habits along with the impact on 10-years cardiovascular event (CVE) risk in the CLAMORS schizophrenia cohort. METHODS This analysis was performed within the scope of the CLAMORS study which included consecutive outpatients meeting DSM-IV criteria for schizophrenia spectrum disorder. Beside smoking history, data on usual healthy lifestyle habits included current exercise, saturated fat sparing diet, low-caloric diet, and daily dietary fibre, salt, caffeine and alcohol consumption were recorded. The 10-year CVE risk was calculated with Framingham function. RESULTS 1704 patients (61.1% male), 18 to 74 years were examined. Prevalence of smoking was 54.54% (95% CI: 52.16%-56.90%) significantly higher than in age and sex matched general population subjects, 31.51% (31.49%-31.52%); OR=2.61 (2.37-2.87, p<0.0001). After controlling by confounders smokers showed a 10-year CVE risk excess versus non-smokers of 2.63 (2.16-3.09), p<0.001. Smoking cessation would reduce the likely of high/very high 10-year CVE risk (above 10%) by near 90% [OR=0.10 (0.06-0.18), p<0.0001]. Also, smokers were more likely to consume alcohol daily [4.13 (3.07-5.54), p<0.0001] and caffeine [3.39 (2.72-4.23), p<0.0001] than non-smoker patients with schizophrenia, and less likely to avoid daily consumption of salt [0.58 (0.43-0.78), p<0.0001], saturated fat [0.71 (0.56-0.91), p=0.006], high fibre diet [0.67 (0.53-0.84), p=0.001], or to follow a low-caloric diet [0.63 (0.48-0.81), p<0.0001]. Smokers also were less likely to do exercise habitually [0.62 (0.48-0.82, p=0.001]. CONCLUSION Compared with the general population, patients with schizophrenia showed significant higher prevalence of smoking. Smokers who stop smoking would benefit by a near 90% reduction in the likely of 10-year cardiovascular event risk above 10%.

Validity and reliability of the Spanish version of the DN4 (Douleur Neuropathique 4 questions) questionnaire for differential diagnosis of pain syndromes associated to a neuropathic or somatic component.

BackgroundThis study assesses the validity and reliability of the Spanish version of DN4 questionnaire as a tool for differential diagnosis of pain syndromes associated to a neuropathic (NP) or somatic component (non-neuropathic pain, NNP).MethodsA study was conducted consisting of two phases: cultural adaptation into the Spanish language by means of conceptual equivalence, including forward and backward translations in duplicate and cognitive debriefing, and testing of psychometric properties in patients with NP (peripheral, central and mixed) and NNP. The analysis of psychometric properties included reliability (internal consistency, inter-rater agreement and test-retest reliability) and validity (ROC curve analysis, agreement with the reference diagnosis and determination of sensitivity, specificity, and positive and negative predictive values in different subsamples according to type of NP).ResultsA sample of 164 subjects (99 women, 60.4%; age: 60.4 ± 16.0 years), 94 (57.3%) with NP (36 with peripheral, 32 with central, and 26 with mixed pain) and 70 with NNP was enrolled. The questionnaire was reliable [Cronbachs alpha coefficient: 0.71, inter-rater agreement coefficient: 0.80 (0.71–0.89), and test-retest intra-class correlation coefficient: 0.95 (0.92–0.97)] and valid for a cut-off value ≥ 4 points, which was the best value to discriminate between NP and NNP subjects.DiscussionThis study, representing the first validation of the DN4 questionnaire into another language different than the original, not only supported its high discriminatory value for identification of neuropathic pain, but also provided supplemental psychometric validation (i.e. test-retest reliability, influence of educational level and pain intensity) and showed its validity in mixed pain syndromes.

Weight gain in patients with schizophrenia treated with risperidone, olanzapine, quetiapine or haloperidol: results of the EIRE study

OBJECTIVES The aim of this cross-sectional study, the EIRE study, was to assess the frequency of several side effects with antipsychotics in the clinical setting. This paper addresses the adverse effect of weight gain. METHOD Outpatients diagnosed of schizophrenia according to DSM-IV criteria and receiving a single antipsychotic (risperidone, olanzapine, quetiapine or haloperidol) for at least 4 weeks were consecutively recruited. Data were collected in a single visit, including data on demographic, clinical and treatment characteristics. Mean weight change was evaluated retrospectively by means of clinical charts and the weight at the time of the visit; in addition, the corresponding item of a modified version of the UKU, a Scandinavian side-effect rating scale, was used. Chi-squared test and logistic regression methods were used to analyze frequency of weight gain between treatments. RESULTS Out of 669 recruited, 636 evaluable patients were assessed. The treatment with the highest number of patients with weight gain as an adverse reaction on the UKU scale was olanzapine (74.5%), followed by risperidone (53.4%) and haloperidol (40.0%). The proportion of patients with clinically relevant weight gain (>or=7% increase versus initial weight) was also higher with olanzapine (45.7%) than with risperidone (30.6%) and haloperidol (22.4%). Five patients (13.5%) treated with quetiapine had some degree of weight gain according to the UKU scale, although no patient showed a clinically relevant weight gain (>or=7%). Treatment with olanzapine and risperidone were identified as risk factors of weight gain versus haloperidol. The risk of weight gain was higher in women (OR: 4.4), overweight patients (OR: 3.0) and in patients with <or=1 year of treatment (OR: 6.3) in the olanzapine group. A higher risk of weight gain in women (OR: 2.6) was also seen with risperidone. CONCLUSION Clinically relevant weight gain is clearly associated with olanzapine, and to lesser extent, with haloperidol and risperidone. Data for quetiapine were not conclusive because of the short duration of treatment.

Prevalence of Negative Symptoms in Outpatients With Schizophrenia Spectrum Disorders Treated With Antipsychotics in Routine Clinical Practice: Findings From the CLAMORS Study

OBJECTIVE To analyze the prevalence of negative symptoms in antipsychotic-treated outpatients with schizophrenia spectrum disorders. METHOD A cross-sectional, retrospective multicenter study was carried out between May 2004 and April 2005 in 1,704 adult psychiatric outpatients meeting DSM-IV criteria for schizophrenia, schizophreniform, or schizoaffective disorder. We used 5 items of the Positive and Negative Syndrome Scale (PANSS) negative symptoms subscale to individually determine the presence of a negative symptom when the score on the item was > 3. Primary negative symptoms were considered present when patients fulfilled all of the following: > 3 score on the corresponding item; < 3 score on any positive item; no extrapyramidal symptoms; <or= 3 score on anxiety and depression items; dose of haloperidol, when applicable, <or= 15 mg/d; and no antiparkinsonian treatment. RESULTS A total of 1,452 evaluable patients (863 men, 60.9%), 40.7 +/- 12.2 (mean +/- SD) years of age, were included. One or more negative symptoms were present in 57.6% of patients, with primary negative symptoms in 12.9% of subjects. The most frequent negative symptom items were social withdrawal (45.8%), emotional withdrawal (39.1%), poor rapport (35.8%), and blunted affect (33.1%). Negative symptoms (1-blunted affect, 2-emotional withdrawal, 3-poor rapport, 4-social withdrawal, 5-verbal fluency) were most associated with maleness (symptom 4); age > 40/45 years (men/women; symptoms 1,2,4); single/unmarried status (symptoms 2-4); unemployment (symptoms 3,4); higher score on the Clinical Global Impressions (CGI) scale and PANSS total score (symptoms 1-5); lower score on the PANSS positive symptoms subscale (symptoms 1,3); more than 52 weeks of treatment (symptoms 1-3,5); and high antipsychotic dose (symptom 2). CONCLUSIONS The prevalence of negative symptoms in patients with schizophrenia spectrum disorders treated with antipsychotics in routine clinical practice not only is still considerably high but also seems to be related to poorer functioning, unemployment, greater severity, and less positive symptomatology and higher antipsychotic dose.

Metabolic syndrome in bipolar disorder: a cross-sectional assessment of a Health Management Organization database

OBJECTIVE To estimate the prevalence of metabolic syndrome (MS) in patients with bipolar disorder (BD) included in a Health Management Organization (HMO) database. METHODS A cross-sectional analysis of the administrative claim database of Badalona Serveis Assistencials (BSA) was performed. All patients of either sex over 16 years of age and receiving treatment for BD for more than three weeks were included in the study group. The reference group comprised the rest of patients in the BSA database without BD. MS was defined according to the National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III modified criteria and required fulfillment of at least three of the following five components: body mass index (BMI) >or=28.8 kg/m(2), triglycerides >or=150 mg/dL, high-density lipoprotein (HDL) cholesterol <40 mg/dL (males)/<50 mg/dL (females), blood pressure >or=130/85 mmHg, and fasting glucose >or=110 mg/dL. Descriptive statistics, bivariate analysis, and logistic regression models were applied. RESULTS We identified 178 patients with BD out of 86,028 subjects (50.5% women; 45.5 +/- 17.8 years, mean +/- SD) included in the BSA database. MS prevalence was significantly higher in BD: 24.7% [95% confidence interval (CI): 18.6-31.7] versus 14.4% (CI: 14.2-14.7) with no statistically significant differences between genders; age-adjusted odds ratio (OR) = 1.65 (1.11-2.44, p = 0.013). All MS components were higher in the BD group, particularly BMI >28.8 kg/m(2) [33.1% (26.3-40.6) versus 17.9% (17.7-18.2), adjusted OR = 2.05 (1.46-2.87, p < 0.001)], high triglyceride levels [23.0% (17.1-29.9) versus 11.3% (11.1-11.5), adjusted OR = 2.09 (1.45-3.02, p < 0.001)], and low HDL cholesterol levels [54.5% (46.9-62.0) versus 29.4% (29.1-29.7), adjusted OR = 2.77 (2.02-3.80, p < 0.001)]. Furthermore, patients with BD showed a significantly higher frequency of obesity [41.4% (32.3-50.9) versus 27.1% (26.6-27.5); adjusted OR = 1.83 (1.24-2.68, p = 0.002)]. CONCLUSIONS Compared with the general population managed by the BSA, the prevalence of MS was significantly higher in patients with BD, mainly due to a higher prevalence of obesity, high triglyceride levels, and low HDL cholesterol levels. These findings strongly support the development of health policies addressing this problem in BD patients.

Treating patients with fibromyalgia in primary care settings under routine medical practice: a claim database cost and burden of illness study

IntroductionThe objective of this study was to analyze health care and non-health care resource utilization under routine medical practice in a primary care setting claims database and to estimate the incremental average cost per patient per year of fibromyalgia syndrome (FMS) compared with a reference population.MethodsA 12-month cross-sectional and retrospective study was completed using computerized medical records from a health provider database. Analyses were conducted from the perspective of the provider and from the viewpoint of society. Health care and non-health care resource utilization included drugs, complementary tests, all types of medical visits, referrals, hospitalizations, sick leave, and early retirement because of disability due to FMS. Patients with a diagnosis of FMS in accordance with ICD-10 (International Statistical Classification of Diseases and Related Health Problems, 10th revision) criteria were included in the analysis if they had at least one claim for FMS during the 12 months prior to the end of May 2007. A non-FMS comparison group was also created with the remaining subjects.ResultsOf the 63,526 patients recruited for the study, 1,081 (1.7%) (96.7% of whom were women, 54.2 [10.1] years old) met the criteria for FMS. After an adjustment for age and gender, FMS subjects used significantly more health care resources than the reference population and had more sick leave and the percentage of subjects with premature retirement was also significantly higher (P < 0.001 in all cases). As a result, FMS subjects showed an incremental adjusted per-patient per-year total cost of €5,010 (95% confidence interval [CI] 3,494 to 6,076, +153%, P < 0.001) on average compared with non-FMS subjects. Significantly higher differences were observed in both health care and non-health care adjusted costs: €614 (404 to 823, +66%) and €4,394 (3,373 to 5,420, +189%), respectively (P < 0.001 in both cases). Annual drug expenditure per patient on average was considerably higher in FMS patients, €230 (124 to 335, +64%, P < 0.001), than the reference group.ConclusionsUnder routine medical practice, patients with FMS were associated with considerably higher annual total costs in the primary care setting compared with the reference population.

Psychometric properties of the MOS (Medical Outcomes Study) Sleep Scale in patients with neuropathic pain.

Objective: This study assessed the psychometric properties of the MOS Sleep Scale in neuropathic pain (NeP).

Development and Validation of the “Treatment Satisfaction with Medicines Questionnaire” (SATMED‐Q)©

OBJECTIVE To develop and validate a multidimensional generic questionnaire measuring satisfaction with treatment with medicines. The questionnaire was designed to be used in chronic patients undergoing pharmacological treatment for any disease. METHODS After a literature review and cognitive debriefing process with an expert panel of six members and 21 chronic patients in four focus groups, a preliminary instrument with 36 items grouped into six dimensions was developed. Three samples of patients were enrolled during the whole process: 1) 12 patients to assess feasibility and pertinence of items; 2) 150 patients for item reduction; and 3) 455 patients for psychometric properties assessment of the instrument. The latter two were stratified by gender, age, and main disease (type 2 diabetes, hypertension, osteoarthritis, benign prostate hyperplasia, chronic obstructive pulmonary disease/asthma, depression, and migraine). Additional measures were gathered for concept validity: clinical and treatment information, patient and clinician assessment of treatment tolerability and effectiveness, treatment satisfaction (Treatment Satisfaction Questionnaire for Medication [TSQM]), and therapeutic compliance (Morisky-Green). Feasibility, reliability, and validity (content, discriminant, construct, and concurrent) were assessed. RESULTS Factor analysis item reduction resulted in a 17-item questionnaire with six dimensions: treatment effectiveness, convenience of use, impact on daily activities, medical care, global satisfaction, and undesirable side effects. Unidimensional scales (Cronbachs alpha ranging 0.813-0.912) were correlated, and allowed computation of a summary composite score (alpha = 0.890). SATMED-Q dimensions showed moderate but significant correlations with TSQM dimensions (0.577-0.680). Differences between tolerability and effectiveness groups were found, depending on dimension and whether the clinician or the patient were informing. Therapeutic compliance groups showed differences in some treatment satisfaction dimensions. CONCLUSIONS The SATMED-Q is a reliable and valid measure of treatment satisfaction, structured in six dimensions, and a summary composite score. Additional work is needed to assess sensitivity to change.

A comparison of schizophrenia outpatients treated with antipsychotics with and without metabolic syndrome: Findings from the CLAMORS study

OBJECTIVE To compare clinical, laboratory, lifestyle, and sociodemographic parameters and cardiac risk in antipsychotic-treated patients with and without metabolic syndrome (MS). METHODS A multicenter cross-sectional study in which 117 psychiatrists recruited antipsychotic-treated outpatients meeting DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder. MS was diagnosed when 3 or more of the following criteria were met: waist circumference > 102 cm (men)/> 88 cm (women); serum triglycerides > or = 150 mg/dl; HDL cholesterol < 40 mg/dl (men)/< 50 mg/dl (women); blood pressure > or = 130/85 mmHg; fasting blood glucose > or = 110 mg/dl. The 10-year cardiovascular (CV) risk was assessed by the Systematic COronary Risk Evaluation (SCORE) function (CV mortality) and the Framingham function (any-CV-event). RESULTS 1452 evaluable patients (863 men, 60.9%), aged 40.7+/-12.2 years and with a mean duration of illness of 15.5+/-10.8 years (mean+/-SD), were included. MS was present in 24.6% [23.6% (men), 27.2% (women); p=0.130]. Overall 10-year risks were 0.9+/-1.9 (SCORE) and 7.2+/-7.6 (Framingham). Coronary heart disease (CHD) 10-year risk was higher in MS patients: 6.6% vs 2.8% showed high/very-high CV mortality risk (SCORE > or = 3%), and 44.2% vs 12.9% high/very-high CV event risk (Framingham > or = 10%) (p<0.001). MS patients also had more psychopathology (PANSS) and greater severity (CGI). CONCLUSIONS MS is highly prevalent in antipsychotic-treated patients and is associated with increased cardiovascular risk and psychopathology.