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One factor greatly influencing the prognosis and progression of the Schizophrenia is compliance and it is essential to find new drugs which carry minimal side effects.
To identify the profile of patients who are treated with aAripiprazole and to assess the effectiveness, tolerability and treatment adherence.
Patients and Methods:
This was a multicentre, observational, retrospective study with participation of 200 psychiatrists. Data from the medical records of patients treated with aAripiprazole with at least two months were collected between October and December 2005.
A total of 997 patients were included. 95% of patients had been treated with another drug prior to receiving aAripiprazole. The pattern for switching from the previous treatment was substitution in 75% of cases and addition in 25%. Reasons for switching were: 56,6% lack of efficacy and 35,6% adverse reactions. The investigator's assessment of aAripiprazole's effectiveness and tolerability showed these was very good or good in 76% and 90% of cases respectively. Around 87.6% showed good treatment compliance. Efficacy of treatment was correlated with duration of the disease: the proportion of patients with good efficacy is greater in patients who had suffered the disease for less than ten years (78.7 vs. 73.8%) (p=0.01).
aAripiprazole was considered to have a good effectiveness and tolerability in most patients. Effectiveness was greater in the acute phase of the disease, in patients with shorter duration of the disease and in those only taking full dose aAripiprazole
Prevalence of cardiovascular disease is high in schizophrenia. Our aim is to estimate the prevalence of cardiovascular risk factors (CVRF) among schizophrenia patients.
National cross-sectional study in patients diagnosed with schizophrenia under treatment with second generation antipsychotics and admitted to short-stay hospitalisation units.
A sample of 733 consecutively admitted patients was enrolled; the most prevalent CVRFs were smoking 71% (95% CI: 67–74%) and hypercholesterolemia 66% (61–70%) followed by hypertriglyceridemia 26% (26–32%), hypertension 18% (15–21%) and diabetes 5% (4–7%). Metabolic syndrome showed 19% (95% CI: 16–23%) prevalence or, according to updated definitions (Clin Cornerstone 7  36–45), 24% (95% CI: 20–28%). The rate of patients within the high-risk range of a 10-year fatal cardiovascular event was 6.5%. CVRFs under routine management were diabetes (60%), hypertension (28%) and, to a lesser extent, dyslipemia (14%). Treatment for CVRFs was associated to gender, men for hypertension OR = 25.34, p < 0.03 and women for diabetes OR = 0.02, p < 0.03.
We found that CVRFs in schizophrenia were prevalent and under-diagnosed, and thus with insufficient therapeutic management.
Antipsychotic treatment is known to be associated with secondary sexual dysfunction (SD). Recognition and treatment of this adverse effect has received growing attention. Until now, all antipsychotic agents were thought to potentially cause SD mediated by increased prolactin. Our aim was to observe whether aripiprazole modifies SD in patients with schizophrenia after 3 months of treatment.
Material and Methods:
Multicenter, observational, open-label, prospective, three-month study with single group of aripiprazole treated patients. Sexual activity was assessed using CGI-S and CGI-I for SD; SALSEX scale, validated for Spanish, 3 times after initiating study drug. Patient's clinical status was evaluated by CGI-S and CGI-I for psychotic disorders, and by BPRS Scale.
Result: 42 patients (70% men), 38 completed the study. Incidence of SD at 3 months was null for all patients studied. As period of treatment advanced, the Salsex score decreased, showing a mean overall reduction of –5 points (SD 3.6). Largest reduction was observed in subgroup of patients with SD in baseline visit, who exhibited a mean reduction of –6 points (SD 3.1).
Men with SD in baseline evaluation showed more marked improvement than women at 40 days of treatment (p=0.0447). However, recovery was similar for both groups at 90 days of treatment.
In schizophrenia, SD secondary studies to antipsychotics are important in establishing effectiveness of these agents in chronic treatment. After 3 months of aripiprazole treatment, no SD was observed in patients. Patients who presented SD at study initiation improved over course of 3 months treatment with aripiprazole.
Prevalence data of aggressive behavior and its management in schizophrenia during acute episodes is scarce in Europe. The available data comes from studies conducted in small samples from single centers and do focus on pharmacological interventions.
To document the prevalence of agitation-hostility among patients and management strategies in Spain.
Cross-sectional survey during an hospital admission at specialized acute units. Selection criteria included patients with a diagnosis of Schizophrenia according to DSM-IV-TR criteria, attending the hospital for admission. Information regarding clinical profile, sociodemographic data, work status, severity of the disease by using the Clinical Impression of Severity Scale disease-specific (CGI-SCH) was collected. Aggression and hostility were recorded at admission by using the PANSS-EC subscore, and aggressive behaviors during the hospitalization period by the Overt Aggression Scale (OAS). Therapeutical management was also recorded at three time points, at admission during hospitalization and at discharge.
800 patients were recruited by 200 clinicians from 120 specialized psychiatric units across the country. Prevalence data for agitation-hostility in Spain is provided. For those patients showing aggressive behaviors during the hospitalization period, information concerning intensity and type of aggression is also described. Its associated management strategies are provided.
Prevalence data of agitation-hostility in patients in acute settings is valuable as well as understanding the routine practice applied to its management. This comprehensive work could represent a basis for the development of a consensus guideline for clinical practice at specialized acute units.
Epidemiological study of schizophrenia in Spain with a focus on clinical, diagnostic and treatment trends along the year 2005 compared with those observed in ACE 2004 study;
617 psychiatrists from public and private Spanish clinics registered the first four patients with schizophrenia seen at their offices.
A total of 2,430 patients were entered in the study (70% males, 79% unmarried; median age, 37 years) of which, 1,113 had participated in the ACE 2004 study. Twelve percent of patients had a history of illegal drug abuse, 59% had paranoid schizophrenia, 11% had residual schizophrenia, and 6% showed undifferentiated schizophrenia, with a significant skewing to a greater proportion (71% vs. 47%) of the paranoid subtype among “de novo” patients. On inclusion, 9% were suffering an acute exacerbation, 72% showed a stable disorder, and 18% had active symptoms. Up to 96% of patients included “de novo” had been previously treated with antipsychotic drugs, mainly risperidone (27%), and olanzapine (17%). After inclusion in the study, the antipsychotic drugs most frequentely prescribed were aripiprazole (25%), risperidone (18%), olanzapine (10%), and amisulpiride (8%). Training for psychosocial functioning, and occupational therapy (about 15% each) were the most frequent non-pharmacologic interventions (44% of all patients) used before entering in the study.
Patients observed were predominantly unmarried young males with paranoid schizophrenia. The proportion of patients with this subtype was greater than that recorded for patients who previously participated in ACE 2004 study. A trend towards treatment with aripiprazole or risperidone was observed.
Akathisia remains a challenge in routine psychiatric practice, despite the widespread use of second generation antipsychotics (SGAs). This analysis was performed to quantify and qualify clinical characteristics of akathisia in schizophrenia or schizoaffective disorder patients experiencing an acute relapse who were randomized to receive aripiprazole, or placebo in 5 pooled short term trials.
A post hoc analysis of the safety dataset was conducted to assess clinical aspects of akathisia in five 4- or 6-week, double-blind, randomized trials comparing aripiprazole (2, 5, 10, 15, 20, 30 mg/day) to placebo.
A total of 1,635 patients was included in this analysis (aripiprazole: n=1170; placebo: n=465). Akathisia was reported by 9% of the aripiprazole-treated patients and 6% of those receiving placebo. Among those reporting akathisia, more patients receiving aripiprazole (83%, n=86) reported this AE within the first 2 weeks of the trials when compared to placebo (69%, n=20). The mean and median duration of akathisia was generally low in both groups (Mean: aripiprazole=12.5 days and placebo=4.2 days; Median, aripiprazole=5.0 days and placebo=1.5 days). The percentage of patients reporting akathisia at endpoint (BARS Item 4≥2) was similar between aripiprazole- (16%) and placebo-treated patients (14%).
In the aripiprazole and placebo groups, akathisia appeared to occur early in treatment, was time-limited, and was associated with high rates of concomitant benzodiazepine usage. Additionally, most cases of akathisia were reported as mild to moderate and rarely associated with treatment discontinuation.
Six hundred psychiatrists from private and public Spanish clinics registered the first four patients with schizophrenia seen at their offices during 2004. Sociodemographic characteristics, diagnostic criteria, clinical features, and therapy patterns, including adherence to treatment, were recorded.
A total of 2,154 patients were included in the study (86% ≤50 years old; 69% males; 79% unmarried), half of them had elementary school studies only while a 28% had a university degree. Male to female significant differences were observed regarding patterns of cigarette, alcohol, and illegal substance comsumption. A 69% of patients had paranoid schizophrenia, 13% presented with residual schizophrenia, and the remaining 18% had other types. The paranoid and hebephrenic types were the predominant types seen in patients ≤50 years old, while residual schizophrenia was most frequently seen in patients >50. When admitted into the study, 10% of patients were in an acute phase, 19% showed active symptoms, and the remaining 71% showed a stable disorder. Antipsychotic medications more frequently prescribed before enrolment were risperidone (29%), olanzapine (19%), and clozapine, quietapine, amisulpiride and haloperidol (7% each). The most common non-pharmacologic therapy prescribed to patients before entering the study was occupational therapy.
Patients included in this observational study were predominantly males <50 year old who presented with paranoid schizophrenia. Almost all patients had received antipsychotic medication before entering the study, mainly risperidone and olanzapine.
After the commercialization of Aripiprazole in Spain, two observational studies were proposed, one was conducted when the drug was first launched, and the other when the starting dose of Aripiprazole was modified, in order to understand the switching strategies, the effectiveness, tolerability and adherence to treatment in standard use conditions.
Patients and Methods:
Two multicenter, retrospective, observational studies were carried out involving 200 psychiatrists throughout Spain with approximate 1000 patients treated with Aripiprazole during the previous four months in each one of the studies during 2005 and 2006 respectively.
Both groups of patients had a very similar demographic profile that matches with the general schizophrenic population. In the first study, the main reasons for switching medication were low efficacy (56% of cases) and intolerance (35%), and 44% and 43% respectively in the second study. Despite the poor response to previous treatment, clinical evaluation of effectiveness and tolerability with Aripiprazole was very positive: In the first study, 76% of patients had very good or good effectiveness and tolerability was very good or good in 90%. In the second study, these values were 75% and 93%, respectively. Patterns of change from the previous treatment were switching in 75% of cases in the first study and in 60% in the second study.
Effectiveness of treatment with Aripiprazole is good in patients who had a poor response to their previous antipsychotic treatments. The most frequent and effective pattern for change patients to Aripiprazole treatments is switching.
The conditions for the use of study medications are different in a clinical trial than when the same drugs are marketed and administered to larger population groups. This study was proposed after the recent change in the range of doses marketing of Aripiprazole in our country and following a change in the range of doses used.
To identify the type of patients treated with aAripiprazole during 4 months (May 06) after the change in the SmPC (10-30 mg dose) and to establish the doses used. To identify the proportion of patients switching to aAripiprazole from previous antipsychotic treatments due to reduced efficacy or low tolerance to the previous drugs.
Patients and Methods:
This is a retrospective, observational, multicenter study. Data will be collected from the medical records of 1000 patients treated with aAripiprazole during the four months prior to the study initiation, with a minimum of 1 month treatment. The information will be gathered by 200 psychiatrists each one providing 5 cases. Data collection was initiated in October 2006 and is expected to last two months. The sample size based on the primary objective obtained will enable a 95% confidence interval with a maximum acceptable error of 3% to estimate the proportion based on the primary objective.
The collection of data will enable us to know how psychiatrists prescribe aAripiprazole, considering the type of patient, dosage regime, switching strategy of antipsychotic treatment (by identifying the ratios of treatment switches) under standard conditions of use.
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