Influence of type of treatment on the well-being of Spanish patients with schizophrenia and their caregivers.

OBJECTIVE: This study aimed to investigate quality of life and burden on caregivers in Spanish outpatients with schizophrenia, treated with different antipsychotics. METHODS: Sociodemographic and clinical data were collected for 1865 patients diagnosed with schizophrenia. Patients answered the EuroQol-5D questionnaire and caregivers answered questionnaires assessing caregiver burden. Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression of Severity (CGI-S), and clinician's satisfaction were also recorded. The same data were also collected at months 3 and 6. RESULTS: According to EQ-5D results, usual activities (29.6%) and anxiety/depression (31.1%) were the most relevant reported problems. Good overall scores (5-7) on EQ-5D were reported by 47/118 (39.8%) of risperidone long-acting injectable (LAI) patients compared to 52/218 (23.9%) for oral conventional antipsychotics, 51/194 (26.2%) for injectable conventional antipsychotics, and 332/1110 (29.9%) for oral atypical antipsychotics. Significant benefits of risperidone LAI vs. other types of antipsychotic were also found in caregiver burden and clinician-derived outcome measures. At months 3 and 6, retention was > 85%, and score on the EQ5D improved for the overall sample. CONCLUSIONS: In Spanish patients with schizophrenia, activities of daily living and anxiety/depression were more relevant reported problems. Risperidone LAI was associated with better quality-of-life outcomes and lower caregiver burden compared to other types of antipsychotic.

Adherence to treatment and therapeutic strategies in schizophrenic patients: the ADHERE study.

AIM: To assess the degree of compliance and adherence to treatment during the follow-up of schizophrenic outpatients after a new therapeutic strategy had been initiated. METHODS: A multicenter, retrospective, prospective, observational study of 1,848 outpatients with schizophrenia or schizoaffective disorders (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) was conducted. Patients were treated either with oral or injectable conventional or second generation antipsychotics, and were followed up for 3 months at mental health centers. Patient compliance with the pharmacological treatment was assessed by the use of questionnaires, scales, medication accountability, and the Medication Event Monitoring System. Patients were considered compliant if they reported a high compliance rate (> or = 80%). RESULTS: At baseline only 29% of patients on oral medication were compliant compared with 79% of patients on injectable medication (injection counting) (OR= 9.11; 95% CI 6.02-13.77; P<.0001). At the 3 month visit, 84% of patients had changed their treatment and in these, the compliance rate of those on injectable medication was 94% versus 87% of patients taking oral medication (OR= 2.47; 95% CI 1.21-5.05; P=.022). CONCLUSION: The use of long-acting injectable antipsychotics, which improves compliance rates and patient follow-up, should facilitate the management of Spanish patients with schizophrenia in mental health centers.

Cost-effectiveness analysis of switching antipsychotic medication to long-acting injectable risperidone in patients with schizophrenia : a 12- and 24-month follow-up from the e-STAR database in Spain.

BACKGROUND: The availability of long-acting injectable risperidone may increase adherence to antipsychotic treatment and lead to improved clinical and economic outcomes for patients with schizophrenia. OBJECTIVES: To investigate the cost effectiveness of treatment with long-acting injectable risperidone compared with previous antipsychotic regimens in patients with schizophrenia enrolled in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) in Spain. METHODS: e-STAR is an international, long-term, ongoing, observational study of schizophrenia patients who, during their routine course of clinical practice, are started on a new antipsychotic treatment. In e-STAR, data are collected at baseline, retrospectively over a minimum period of 12 months and up to a maximum of 24 months, and prospectively at 3-month intervals for 24 months after the start of a new antipsychotic drug. For the purpose of this study, patients who started treatment with long-acting injectable risperidone during their routine clinical management and were enrolled in the e-STAR study in Spain were eligible. The effectiveness of long-acting injectable risperidone compared with previous antipsychotic treatment, defined as the absence of hospitalizations or relapses, was assessed at 12 and 24 months of treatment. Acquisition costs of antipsychotic drug therapy were based on the official registered price. Drug prices from source were in euro, year 2005 values; hospital costs from source were in euro, year 2001 values, and were inflated to reflect 2005 costs. Complete follow-up data were available for 788 patients at 12 months after starting long-acting injectable risperidone and for 757 patients at 24 months. RESULTS: In terms of effectiveness, at 12 months after switching to long-acting injectable risperidone, there was a higher percentage of patients who did not require hospitalization (89.1%), did not relapse (85.4%) or neither required hospitalization nor relapsed (82.4%) as compared retrospectively with the same period for the previous treatment (67%, 47.8% and 59.8%, respectively). The corresponding figures at 24 months also favoured treatment with long-acting injectable risperidone (85.2% vs 60%, 88.5% vs 47.4% and 77% vs 53.6%, respectively). Treatment with long-acting injectable risperidone was associated with higher medication costs per month compared with previous antipsychotic medication after 12 (euro 405.80 vs euro 128.16) and 24 months (euro 407.33 vs euro 142.77) of follow-up. Cost effectiveness per month per patient was lower for risperidone than previous antipsychotic medication in the three patient scenarios: without hospitalization (euro 539.82 vs euro 982.13), without relapse (euro 519.67 vs euro 1242.03) and without hospitalization and without relapse (euro 597.22 vs euro 1059.39). CONCLUSIONS: Treatment with long-acting injectable risperidone compared with previous antipsychotic medications resulted in a higher number of patients not requiring hospitalization, not relapsing, and not requiring hospitalization and not showing relapse, resulting in risperidone being more cost effective per month per patient.It is important to note that real-world variations in adherence would automatically be controlled from within a randomized control trial, and hence, any evaluation of variations in adherence inevitably requires a real-world focus. On the basis of these findings, which were obtained in real-world clinical practice, long-acting injectable risperidone is predicted to be the dominant strategy because it results in effective symptom control and direct medical cost savings. However, because of limitations in methodology, any conclusions should, at this stage, be treated as tentative, and confirmation in more detailed follow-up studies is required. Cost-effectiveness comparisons based on experimental evaluations of relapse minimization strategies are also required. In order to avoid estimation biases in the future, a prospectively designed study is needed.

[Therapy with antipsychotic drugs as a risk factor for diabetes in schizophrenia: a case-control study]. / Evaluación del tratamiento antipsicótico como factor de riesgo de diabetes en la esquizofrenia: estudio de casos y controles.

BACKGROUND AND OBJECTIVES: Atypical antipsychotics have been related with hyperglycaemia, diabetes mellitus, weight gain and lipid alterations in some patients. This study analyzed whether continuous treatment with risperidone, olanzapine, or clozapine entails a risk of glucose or lipid metabolism alterations in schizophrenic patients. PATIENTS AND METHOD: Patients included in this study were schizophrenics who had received mono-therapeutic with clozapine, olanzapine or risperidone for a period of 1 to 3 years. Those schizophrenic patients who were diagnosed as diabetic during psychiatric treatment and those who showed fasting glycemia greater than or equal to 126 mg/dl in two consecutive measurements were considered cases. The remaining schizophrenic patients who were receiving treatment and did not show these alterations were considered controls. RESULTS: In the adjusted analysis (multivariate logistic regression) of the effect of antipsychotic treatment on the presence of diabetes, which also assessed age and body-mass index, the adjusted odds ratio (OR) for olanzapine relative to risperidone was 2.22 (95% confidence interval [CI], 1.12-4.22), (p = 0.0228); and that for clozapine relative to risperidone was 2.87 (95% CI, 1.19, 6.93), (p = 0.0192). Both results reveal a significantly greater risk for the appearance of diabetes mellitus in patients treated with olanzapine or clozapine than in those treated with risperidone. There were significant differences in the risk of increase in triglycerides in patients receiving olanzapine (OR = 1.34; p = 0.0075) and clozapine (OR = 1.58; p = 0.0028). CONCLUSIONS: The risk of the appearance of diabetes mellitus in patients treated with olanzapine is twice as high as that in patients treated with risperidone, and the risk in patients treated with clozapine is nearly triple as high as that found in patients treated with risperidone. Risperidone appears to be a safer antipsychotic drug in the long term, with regard to the risk of alterations in glucose and lipid metabolism.

Experience with injectable long-acting risperidone in long-term therapy after an acute episode of schizophrenia: the SPHERE Study.

BACKGROUND: Risperidone long-acting injectable (RLAI) is the first long-acting formulation of an atypical antipsychotic introduced into clinical practice. RLAI combines the benefits of atypical antipsychotic agents with an extended duration of activity and is intended for long-term management of schizophrenia. This study evaluated the use of RLAI as part of a long-term management strategy in patients with an acute episode of schizophrenia. OBJECTIVES: The primary objective was to determine clinicians' approaches to the use of RLAI in patients with an acute exacerbation of schizophrenia by examining the prescribing patterns of antipsychotic and other psychotropic medications. Other objectives were to evaluate the overall safety of switching patients to RLAI from previous antipsychotic therapy and to determine patients', caregivers' and relatives' attitudes towards RLAI treatment. METHODS: The Safety and Profile of Handling and Employing of Risperdal Consta in Emergency/Acute Care Settings (SPHERE) study was an observational, non-interventional, multicenter, retrospective study involving a large cohort of patients with acute psychotic exacerbation who attended Spanish emergency/acute care facilities (between August and December 2003) and were treated with RLAI during hospitalization. RESULTS: A total of 1232 patients (70% men; mean age 37 years; median of 8 months since most recent admission) were included in the analyses; 79% had been receiving antipsychotic therapy prior to admission. All patients received RLAI post-stabilization. The main reasons for initiating RLAI were the need for long-term treatment (76%) and a low adherence to previous treatment (71%). RLAI doses administered during hospitalization were: 25 (26%), 37.5 (29%), 50 (42%) and 75-100 mg (3%). The mean number of injections per patient (2 +/- 1) and mean hospitalization time (25 +/- 16 days) indicated that RLAI was administered every 2 weeks as per the manufacturer's recommendations. All patients were discharged on RLAI treatment; 62% were prescribed concomitant therapy, mainly oral risperidone (39%), anxiolytics (25%), antiparkinsonians (15%), hypnotics (11%) and anticonvulsants (11%). Only 5.7% of patients reported adverse events, most commonly extrapyramidal symptoms (1.1%) and somnolence (0.9%). CONCLUSIONS: As part of a long-term management strategy aimed at improving treatment adherence in schizophrenic patients, RLAI was prescribed to a wide spectrum of patients with an acute episode of schizophrenia during hospitalization and at the time of discharge from emergency/acute care facilities. RLAI was well tolerated in the study population and the overall impression of patients, primary caregivers and relatives to RLAI therapy was positive.