Electronic Schizophrenia Treatment Adherence Registry Research Articles

Risperidone long-acting injection in the treatment of schizophrenia: 24-month results from the electronic Schizophrenia Treatment Adherence Registry in Canada

ObjectiveTo assess outcomes over 24 months in Canadian patients with schizophrenia initiated on risperidone long-acting injection (RLAI) and participating in the electronic Schizophrenia Treatment Adherence Registry (e-STAR).Materials and methodsPatients with schizophrenia or schizoaffective disorder were enrolled from 24 sites after an independent decision to initiate RLAI. Subsequent patient management was based on usual clinical practice at each site and was not protocol-driven. Relevant data were collected retrospectively by chart review for 12 months prior to RLAI and prospectively for 24 months following RLAI initiation.ResultsPatients (n=188) had a mean age of 39.2 years, were 66.3% male, and 27.7% were inpatients at baseline. Twenty-four months after initiating therapy (initial dose =28.7 mg), 34.1% (95% confidence interval 27.2%–42.2%) of patients had discontinued RLAI with a mean time to discontinuation of 273.4±196 days. Over the treatment period, there were significant (P<0.001) changes from baseline in Clinical Global Impression-Severity (CGI-S; 3.48 versus [vs] 4.31 at baseline), Global Assessment of Functioning (GAF; 56.1 vs 48.1), and Personal and Social Performance (PSP; 59.1 vs 46.9) scale scores. In addition, after 12 months, there were significant (P<0.001) decreases in the percentage of patients hospitalized (23.9% vs 58.5% pre-RLAI), mean length of stay (11.4 vs 30.4 days), and number of hospitalizations (0.32 vs 0.87) compared to the 12-month pre-RLAI period. Reductions in hospitalization continued into the second 12 months of therapy, when only 9% of patients were hospitalized and mean length of stay was 2.0 days.ConclusionIn a routine clinical practice setting, patients switched to RLAI showed significant improvements in clinical outcomes and in global and social functioning, and hospitalization was significantly reduced. The data confirm that RLAI provides effective long-term management of schizophrenia in Canada.

Clinical outcomes of long‐acting risperidone in recent versus long‐term diagnosed Belgian schizophrenic patients: results from electronic Schizophrenia Treatment Adherence Registry (e‐STAR) and Trial for the Initiation and Maintenance Of REmission in Schizophrenia with risperidone (TIMORES)

Potential differences in psychiatric clinical outcomes and hospitalization rates before and after the initiation of long-acting risperidone among recently and long-term diagnosed schizophrenia patients were studied. Data from two observational studies (Trial for the Initiation and Maintenance Of REmission in Schizophrenia with risperidone (TIMORES) and electronic Schizophrenia Treatment Adherence Registry (e-STAR)) were categorized by the recency of their diagnose and compared in several post hoc analyses. Clinical Global Impression of illness Severity (CGI-S) and Global Assessment of Functioning (GAF) scores, as well as symptoms of clinical deterioration (including hospitalization data) at baseline, 12-month (for TIMORES and e-STAR) and 24-month (for e-STAR) follow-up were analysed. Other outcome measures included discontinuation rate, employment status and remission attainment. Statistically significantly differences between recent and long-term diagnosed schizophrenic patients at 12- and 24-month follow-up were found for CGI-S (between P < 0.01 and P ≤ 0.001) and GAF (P < 0.05) scores. Other differences between both schizophrenic patient groups were found for measures of clinical deterioration, employment status and full symptomatic remission rates at 1 year. Although no consistent difference was found between recent and long-term patient groups for hospitalization parameters, the difference in length of full hospitalization days was statistically significantly different (P < 0.01) between e-STAR 'Early' and 'Late' patient groups at both 12- and 24-month endpoints: the mean change from baseline was significantly greater for e-STAR 'Early' at 12 months, but greater for e-STAR 'Late' at 24 months. The findings of the post hoc analyses support the significance of pharmacological interventions, such as long-acting risperidone, in addressing discontinuity issues, especially in recently diagnosed patients.

Registro Electrónico de Adherencia al Tratamiento de Esquizofrenia en Latinoamérica (e-STAR): Resultados clínicos del uso de risperidona inyectable de liberación prolongada a dos años de seguimiento

La esquizofrenia genera elevados costos al sistema de salud. La falta de adherencia al tratamiento es una de las principales causas de recaídas y hospitalizaciones en la esquizofrenia. Lo anterior conduce a un pobre pronóstico y deterioro funcional de los pacientes. La risperidona inyectable de liberación prolongada (RILP) ha demostrado su eficacia en el tratamiento de la esquizofrenia, ofreciendo la posibilidad de que los pacientes tengan una mayor adherencia terapéutica. Objetivo: Determinar la eficacia y efecto sobre la funcionalidad y el uso de recursos hospitalarios de la RILP en una muestra de pacientes con esquizofrenia de América Latina a dos años de seguimiento. Método: El Registro Electrónico de Adherencia al Tratamiento de Esquizofrenia en Latinoamérica (e-STAR) es un estudio observacional del uso de la RILP en la esquizofrenia. Se reclutaron pacientes de México, Colombia y Brasil. Se registró la información clínica del paciente un año previo al inicio del tratamiento con la RILP y de forma prospectiva cada tres meses hasta cumplir los 24 meses de seguimiento. Se registraron las hospitalizaciones y el esquema de tratamiento con la RILP. La escala de Impresión Clínica Global-Gravedad (CGI-S) se utilizó como indicador de eficacia mientras que la Escala Global de Funcionamiento (GAF) y la Escala de Desempeño Personal y Social (PSP) se utilizaron para evaluar el funcionamiento. Resultados: Setenta y tres pacientes completaron los dos años de seguimiento. La proporción de pacientes hospitalizados disminuyó del 16.4 al 4.1% después de dos años de tratamiento con la RILP. El 2.7% descontinuó el tratamiento debido a falta de eficacia. Se observó una mejoría significativa en cuanto a la gravedad del padecimiento y el funcionamiento global. Discusión: En la práctica clínica cotidiana, la RILP resulta ser un tratamiento a largo plazo efectivo para la esquizofrenia con el beneficio adicional de una menor utilización de recursos del sistema de salud.

Importance of Gender in the Treatment of Schizophrenia

To compare male and female patients participating in e-STAR (electronic Schizophrenia Treatment Adherence Registry), an international, prospective, observational study assessing use of risperidone long-acting injection in patients with schizophrenia or schizoaffective disorder in both the Czech and Slovak Republics. The demographic, clinical, and treatment-related data were collected at baseline and then prospectively for 24 months. We focused on gender differences in demographic and clinical data (hospitalizations, concomitant medication, and clinical improvement using Clinical Global Impressions-severity of illness [CGI-S], Global Assessment of Functioning [GAF], and Personal and Social Performance [PSP] scales). All psychiatric diagnoses were made according to International Classification of Diseases, Tenth Revision criteria. Data were collected from September 2006 through September 2009. A total of 868 patients (488 men and 380 women) were included in the assessment. At baseline, the women were significantly older than the men (42.1 ± 12.8 vs 34.8 ± 11.1 years, respectively; P < .0001). The women were also significantly more frequently diagnosed with schizoaffective disorder (P = .0048). There was no difference between men and women in the proportion of patients hospitalized in the retrospective and prospective period (including length of stay). At 24 months, the men were taking fewer antidepressants and benzodiazepines than the women (controlled for baseline values). In men and women, a significant decrease in the CGI-S score (P < .001) and a significant increase in the GAF and PSP scores (P < .001) from baseline were observed. The improvements in CGI-S and PSP scores were similar in both groups (no significant difference between male and female patients). The improvement (increase) in the mean GAF score was significantly higher in women than in men (P = .0317). The treatment with risperidone long-acting injection was associated with clinically significant improvement in both male and female patients with schizophrenia with comparable severity of illness. There were no significant differences in most outcome measures. Gender differences, especially concerning treatment response to individual antipsychotics and their different forms, should be more intensively studied.

THE IMPACT OF TREATMENT WITH RISPERIDONE LONG-ACTING INJECTION ON THE BELGIAN HEALTHCARE SYSTEM: RESULTS FROM A BUDGET IMPACT MODEL

Substantial evidence from randomised clinical trials has demonstrated that long-acting risperidone (RLAI) is efficacious and well tolerated in patients with schizophrenia. Recently, a long-term naturalistic study of treatment practices in Belgium, the electronic Schizophrenia Treatment Adherence Registry (e-STAR), reported that treatment with RLAI is associated with improvements in adherence and long-term outcomes. The present report describes the results of a budget impact model that analysed the Belgian e-STAR data, together with other available data, over a 3-year time horizon, in order to establish the potential impact of treatment with RLAI on total healthcare costs in Belgium. The model framework combined medical resource utilisation with costs of the population of interest in order to quantify the costs, and cost offsets, of RLAI treatment. For the purpose of this budget impact model, it was assumed that among patients who would discontinue their previous antipsychotic medication, 6.7% of patients would be switched to RLAI. The overall cost savings to the Belgian healthcare system were calculated to be € 2.3 million in Year 1, € 3.7 million in Year 2 and € 4.4 million in Year 3. The majority of these cost-savings resulted from the substantial reduction in hospitalisation costs associated with RLAI treatment. This report indicates that improvements in adherence and long-term outcomes previously demonstrated for RLAI treatment in Belgium may result in substantial cost benefits to the country’s healthcare system.

Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database

BackgroundThis observational study was designed to collect treatment outcomes data in patients using the electronic Schizophrenia Treatment Adherence Registry (e-STAR).MethodsPatients with schizophrenia or schizoaffective disorder in Australia who were prescribed risperidone long-acting injection (RLAI) between 2003 and 2007 were assessed 12-months retrospectively, at baseline and 24-months prospectively at 3-monthly intervals. The intent-to-treat population, defined as all patients who received at least one dose of RLAI at baseline, was used for the efficacy and safety analyses.ResultsAt total of 784 patients (74% with schizophrenia, 69.8% male) with a mean age of 37.1 ± 12.5 years and 10.6 ± 9.5 years since diagnosis were included in this Australian cohort. A significant improvement in mean Clinical Global Impression - severity score was observed at 24-months (4.52 ± 1.04 at baseline, 3.56 ± 1.10 at 24-months). Most of this improvement was seen by 3-months and was also reflected in mean Global Assessment of Functioning score, which improved significantly at 24-months (42.9 ± 14.5 at baseline, 59 ± 15.4 at 24-months). For patients still receiving RLAI at 24-months there was an increase from a mean baseline RLAI dose of 26.4 ± 5 mg to 43.4 ± 15.7 mg. Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded.ConclusionOver the 24-month period, initiation of RLAI was associated with improved patient functioning and illness severity in patients with schizophrenia or schizoaffective disorder. Improved outcomes were observed early and sustained throughout the study.Trial RegistrationClinical Trials Registration Number, NCT00283517.

Effectiveness of injectable risperidone long-acting therapy for schizophrenia: data from the US, Spain, Australia, and Belgium

BackgroundBecause wide variations in mental health care utilization exist throughout the world, determining long-term effectiveness of psychotropic medications in a real-world setting would be beneficial to physicians and patients. The purpose of this analysis was to describe the effectiveness of injectable risperidone long-acting therapy (RLAT) for schizophrenia across countries.MethodsThis was a pragmatic analysis of data from two prospective observational studies conducted in the US (Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation [SOURCE]; ClinicalTrials.gov registration number for the SOURCE study: NCT00246194) and Spain, Australia, and Belgium (electronic Schizophrenia Treatment Adherence Registry [eSTAR]). Two separate analyses were performed to assess clinical improvement during the study and estimate psychiatric hospitalization rates before and after RLAT initiation. Clinical improvement was evaluated using the Clinical Global Impressions-Severity (CGI-S) and Global Assessment of Functioning (GAF) scales, and change from baseline was evaluated using paired t tests. Psychiatric hospitalization rates were analyzed using incidence densities, and the bootstrap resampling method was used to examine differences between the pre-baseline and post-baseline periods.ResultsThe initial sample comprised 3,069 patients (US, n = 532; Spain, n = 1,345; Australia, n = 784; and Belgium, n = 408). In all, 24 months of study participation, completed by 39.3% (n = 209), 62.7% (n = 843), 45.8% (n = 359), and 64.2% (n = 262) of patients from the US, Spain, Australia, and Belgium, respectively, were included in the clinical analysis. Improvements compared with baseline were observed on both clinical assessments across countries (P < 0.001 at all post-baseline visits). The mean improvement was approximately 1 point on the CGI-S and 15 points on the GAF. A total of 435 (81.8%), 1,339 (99.6%), 734 (93.6%), and 393 (96.3%) patients from the US, Spain, Australia, and Belgium, respectively, had ≥1 post-baseline visit and were included in the analysis of psychiatric hospitalization rates. Hospitalization rates decreased significantly in all countries regardless of hospitalization status at RLAT initiation (P < 0.0001) and decreased significantly in the US and Spain (P < 0.0001) when the analysis was limited to outpatients only.ConclusionsRLAT in patients with schizophrenia was associated with improvements in clinical and functional outcomes and decreased hospitalization rates in the US, Spain, Australia, and Belgium, despite differences in health care delivery systems.

Clinical outcomes of long-acting injectable risperidone in patients with schizophrenia: six-month follow-up from the Electronic Schizophrenia Treatment Adherence Registry in Latin America

BackgroundRisperidone long-acting injection (RLAI) has been shown to be efficacious, improve compliance, and increase long-term retention rate on therapy. The aim of this work was to determine the effect of RLAI on clinical outcome and hospitalization rate in patients with schizophrenia or schizoaffective disorder enrolled in the electronic Schizophrenia Treatment Adherence Registry in Latin America.MethodsData were collected at baseline, retrospectively for the 12 months prior to baseline, and prospectively every three months for 24 months. Hospitalization prior to therapy was assessed by a retrospective chart review. Efficacy and functioning were evaluated using Clinical Global Impression of Illness Severity (CGI-S), Personal and Social Performance (PSP), and Global Assessment of Functioning (GAF) scores. Relapse and treatment were also registered.ResultsPatients were recruited in Mexico (n = 53), Brazil (n = 11), and Colombia (n = 15). Sixty-five percent (n = 52) were male, and mean age was 32.9 years. Patients were classified as having schizophrenia (n = 73) or schizoaffective disorder (n = 6). The mean dose of RLAI at six months was 34.1 mg (standard deviation = 10.2 mg). The percentage of hospitalized patients before treatment was 28.2% and 5.1% at six months after initiating RLAI (P < 0.001). Significant changes were registered on CGI-S, GAF, and PSP scores.ConclusionsRLAI was associated with an improvement in clinical symptoms and functioning, and a greater reduction in hospitalization.

Treatment retention with risperidone long-acting injection: 24-month results from the Electronic Schizophrenia Treatment Adherence Registry (e-STAR) in six countries

Objective:To assess treatment retention on risperidone long-acting injection (RLAI) and outcomes in schizophrenia patients for whom 24 months of follow-up data in the electronic Schizophrenia Treatment Adherence Registry (e-STAR) were available.Research design and methods:e-STAR is an ongoing, international, multicenter, prospective, observational registry assessing use of antipsychotics in patients with schizophrenia or schizoaffective disorder in a normal clinical practice setting. Parameters were assessed prior to and post-initiation of RLAI. Data presented are from six European countries that enrolled patients in e-STAR after they initiated treatment with RLAI.Main outcome measures:Clinical and demographic information were collected at baseline and treatment-related data, including RLAI discontinuation, psychiatric hospitalization and medication utilization, were collected prospectively every 3 months. Data collection continued for 24 months, even for patients who discontinued RLAI therapy. Hospitalization and medication utilization were also collected retrospectively by chart review for the 12-month period prior to RLAI initiation.Results:A total of 1659 patients (mean age, 39.2; 18.3% inpatients) completed the study. Twenty-four months after initiating therapy (initial RLAI dose = 33.6 mg) 85% of patients (n = 1410) remained on RLAI (completers) while 15% discontinued therapy. The main reasons for discontinuation were insufficient response (28.5%), patient/family choice (26.1%), adverse events (9.6%) and unacceptable tolerability (6.0%). At baseline, compared to completers, discontinuers were younger (37.4 vs. 39.6 years, p = 0.01), had schizophrenia for a shorter time (10.2 vs. 11.9 years, p = 0.02), had lower Global Assessment of Functioning (GAF) scores (43.5 vs. 48.0, p = 0.0001), higher utilization of benzodiazepines (56.5 vs. 43.3%) and more initiated therapy as inpatients (30 vs. 16%). With RLAI therapy GAF scores improved significantly (p < 0.001) for both groups but the 24-month value for discontinuers was lower than that of completers (55.4 vs. 67.2). Compared to the pre-RLAI initiation period, at 12 months post-initiation completers had greater reductions than discontinuers in the percent of patients hospitalized (66.2% reduction vs. 29.2%) and in the length (68% reduction vs. 0%) and number (80.0 vs. 14.3%) of hospital stays, differences that remained at 24 months. The most common adverse events while patients were taking RLAI were nervous system disorders (6.8%), psychiatric disorders (5.6%), weight increase (3.2%), reproductive system and breast disorders (2.5%) and gastrointestinal disorders (2.1%).Conclusions:These observational data confirm that RLAI is an effective treatment in schizophrenia and high levels of adherence to therapy offers an opportunity for effective long-term disease management and significant sustained decreases in hospitalization.

Clinical and resource-use outcomes of risperidone long-acting injection in recent and long-term diagnosed schizophrenia patients: results from a multinational electronic registry

ABSTRACTBackground: Non-adherence to pharmacological treatment leading to frequent relapses and rehospitalizations is a major issue of concern among schizophrenia patients, especially those who are recently diagnosed. Risperidone long-acting injection (RLAI) has been shown to be efficacious, improve compliance, and increase long-term retention rate on therapy.Objective: To determine clinical outcomes and hospitalizations before and after the initiation of RLAI among schizophrenia patients with recent (≤2 years) diagnosis relative to those who had long-term (> 2 years) diagnosis.Research design and methods: The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is an observational study of patients with schizophrenia who start treatment with RLAI. Data were recorded at baseline, retrospectively for the 12 months prior to baseline, and prospectively every 3 months for 24 months. Data on patients with a defined length of diagnosis were pooled from eight countries.Main outcome measures: Clinical Global Impression of Illness Severity (CGI-S), Global Assessment of Functioning (GAF) scores, and hospitalization data were key outcomes.Results: The magnitude of improvement in CGI-S scores was greater in the recent versus long-term diagnosis group [Δ −1.48 vs. Δ −0.95 (12 months); Δ −1.6 vs. Δ −1.09 (24 months)]. There were parallel improvements in GAF scores [Δ 19.4 vs. Δ 13.7 (12 months); Δ 22.3 vs. Δ 16.8 (24 months)]. The decline in the proportion of patients hospitalized from the retrospective to the prospective period was greater in the recent versus long-term diagnosis group (Δ −36.0 vs. Δ −19%, respectively) at 12 months. This was also true for the number of hospital stays (Δ −0.6 vs. Δ −0.3, respectively) and length of stay (days) (Δ −20.9 vs. Δ −6.9, respectively) at 12 months. Common adverse events in both groups included psychiatric, gastrointestinal, musculoskeletal and reproductive system and breast disorders.Conclusions: Treatment with RLAI is associated with improved outcomes in recently diagnosed and chronic patients. However, the magnitude of improvement was higher in recently diagnosed patients.

Long-term outcomes in patients with schizophrenia treated with risperidone long-acting injection or oral antipsychotics in Spain: Results from the electronic Schizophrenia Treatment Adherence Registry (e-STAR)

Background The electronic Schizophrenia Treatment Adherence Registry (e-STAR) is a prospective, observational study of patients with schizophrenia designed to evaluate long-term treatment outcomes in routine clinical practice. Methods Parameters were assessed at baseline and at 3 month intervals for 2 years in patients initiated on risperidone long-acting injection (RLAI) ( n = 1345) or a new oral antipsychotic (AP) ( n = 277; 35.7% and 36.5% on risperidone and olanzapine, respectively) in Spain. Hospitalization prior to therapy was assessed by a retrospective chart review. Results At 24 months, treatment retention (81.8% for RLAI versus 63.4% for oral APs, p < 0.0001) and reduction in Clinical Global Impression Severity scores (−1.14 for RLAI versus −0.94 for APs, p = 0.0165) were significantly higher with RLAI. Compared to the pre-switch period, RLAI patients had greater reductions in the number (reduction of 0.37 stays per patient versus 0.2, p < 0.05) and days (18.74 versus 13.02, p < 0.01) of hospitalizations at 24 months than oral AP patients. Conclusions This 2 year, prospective, observational study showed that, compared to oral antipsychotics, RLAI was associated with better treatment retention, greater improvement in clinical symptoms and functioning, and greater reduction in hospital stays and days in hospital in patients with schizophrenia. Improved treatment adherence, increased efficacy and reduced hospitalization with RLAI offer the opportunity of substantial therapeutic improvement in schizophrenia.

Patient and physician satisfaction with risperidone long-acting injection: 18-month interim results from the electronic schizophrenia treatment adherence registry in Belgium

Patient and physician satisfaction with risperidone long-acting injection: 18-month interim results from the electronic schizophrenia treatment adherence registry in Belgium

Clinical and functional improvements with risperidone long-acting injection treatment: 6-month results from the electronic schizophrenia treatment adherence registry in Sweden

Clinical and functional improvements with risperidone long-acting injection treatment: 6-month results from the electronic schizophrenia treatment adherence registry in Sweden

Remission in patients with schizophrenia treated with risperidone long-acting injection: Results from the e-STAR project in Czech Republic and Slovakia

Objective:Assess illness remission in patients with schizophrenia enrolled in the electronic-Schizophrenia Treatment Adherence Registry (e-STAR) in Czech Republic and Slovakia.Methods:e-STAR is a secure web-based, ongoing, international, long-term observational study of patients with schizophrenia who initiate RLAI during routine clinical management. Data is collected retrospectively (1 year) and prospectively (2 years). Prospectively patients are evaluated for the following symptoms: delusions, conceptual disorganization, hallucinatory behaviour, mannerisms and posturing, unusual thought content, blunted affect, passive/apathetic social withdrawal, and lack of spontaneity and flow of conversation. Patients in whom all of these symptoms are absent, minimal or mild and within normal boundaries, stable, and do not interfere with thinking, social relations, and behaviour or functioning, were considered to be in cross-sectional remission and if this persisted for at least 6 months, they were considered to be in remission.Results:1,068 patients have been enrolled into e-STAR in Czech Republic and Slovakia; 280 patients have been followed for at least 12-months and were included. The majority were male (57.9%) with a diagnosis of schizophrenia or schizoaffective disorder (85.7%, 14.3% respectively) with a mean age of 37±12.1 years and a mean time since diagnosis of 9.2±9 years. The proportion of patients who met the criteria for cross-sectional remission increased from 2.4% at baseline to 37.9% at 12 months. After 12-months, 20.6% of patients met the criteria for illness remission.Conclusions:Based on 12-month interim results, the proportion of patients who met the criteria for illness remission increased after initiating RLAI.

27 – Patient and physician satisfaction with risperidone long-acting injection: 18-Month interim results from the electronic Schizophrenia Treatment Adherence Registry in Belgium

27 – Patient and physician satisfaction with risperidone long-acting injection: 18-Month interim results from the electronic Schizophrenia Treatment Adherence Registry in Belgium

Analisi costo-efficacia dello switch da un trattamento antipsicotico a risperidone iniettabile a rilascio prolungato in pazienti con schizofrenia

The aim of this economic evaluation was 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. 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. 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). Cost effectiveness per month per patient was lower for risperidone than previous antipsychotic medication in the three patient scenarios: without hospitalization (€ 539.82 vs € 982.13), without relapse (€ 519.67 vs € 1242.03) and without hospitalization and without relapse (€ 597.22 vs € 1059.39).

Cost-Effectiveness Analysis of Switching Antipsychotic Medication to Long-Acting Injectable Risperidone in Patients with Schizophrenia

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. 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. 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. 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). 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.