Resource utilization in patients with schizophrenia who initiated risperidone long-acting therapy: results from the Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE)

<p>Abstract</p> <p>Background</p> <p>Schizophrenia is a chronic mental health disorder associated with increased hospital admissions and excessive utilization of outpatient services and long-term care. This analysis examined health care resource utilization from a 24-month observational study of patients with schizophrenia initiated on risperidone long-acting therapy (RLAT).</p> <p>Methods</p> <p>Schizophrenia Outcomes Utilization Relapse and Clinical Evaluation (SOURCE) was a 24-month observational study designed to examine real-world treatment outcomes by prospectively following patients with schizophrenia initiated on RLAT. At baseline visit, prior hospitalization and ER visit dates were obtained for the previous 12 months and subsequent hospitalization visit dates were obtained at 3-month visits, if available. The health care resource utilization outcomes measures observed in this analysis were hospitalizations for any reason, psychiatric-related hospitalizations, and emergency room (ER) visits. Incidence density analysis was used to assess pre-event and postevent rates per person-year (PY).</p> <p>Results</p> <p>The primary medical resource utilization analysis included 435 patients who had a baseline visit, ≥1 postbaseline visits after RLAT initiation, and valid hospitalization dates. The number of hospitalizations and ER visits per PY declined significantly (<it>p </it>< .0001) after initiation with RLAT. A 41% decrease (difference of -0.29 hospitalizations per PY [95% CI: -0.39 to -0.18] from baseline) in hospitalizations for any reason, a 56% decrease (a difference of -0.35 hospitalizations per PY [95% CI: -0.44 to -0.26] from baseline) in psychiatric-related hospitalizations, and a 40% decrease (-0.26 hospitalizations per PY [95% CI: -0.44 to -0.10] from baseline) in ER visits were observed after the baseline period. The percentage of psychiatric-related hospitalizations decreased significantly after RLAT initiation, and patients had fewer inpatient hospitalizations and ER visits (all <it>p </it>< .0001).</p> <p>Conclusion</p> <p>The results suggest that treatment with RLAT may result in decreased hospitalizations for patients with schizophrenia.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00246194">NCT00246194</a></p

Assessment of effectiveness measures in patients with schizophrenia initiated on risperidone long-acting therapy: the SOURCE study results

<p>Abstract</p> <p>Background</p> <p>To evaluate effectiveness outcomes in a real-world setting in patients with schizophrenia initiating risperidone long-acting therapy (RLAT).</p> <p>Methods</p> <p>This was a 24-month, multicenter, prospective, longitudinal, observational study in patients with schizophrenia who were initiated on RLAT. Physicians could change treatment during the study as clinically warranted. Data were collected at baseline and subsequently every 3 months up to 24 months. Effectiveness outcomes included changes in illness severity as measured by Clinical Global Impression-Severity (CGI-S) scale; functional scores as measured by Personal and Social Performance (PSP) scale, Global Assessment of Functioning (GAF), and Strauss-Carpenter Levels of Functioning (LOF); and health status (Medical Outcomes Survey Short Form-36 [SF-36]). Life-table methodology was used to estimate the cumulative probability of relapse over time. Adverse events were evaluated for safety.</p> <p>Results</p> <p>532 patients were enrolled in the study; 209 (39.3%) completed the 24-month study and 305 (57.3%) had at least 12 months of follow-up data. The mean (SD) age of patients was 42.3 (12.8) years. Most patients were male (66.4%) and either Caucasian (60.3%) or African American (23.7%). All changes in CGI-S from baseline at each subsequent 3-month follow-up visit were statistically significant (<it>p </it>< .0001), indicating improvement in disease severity. Improvements were also noted for the PSP, GAF, and total LOF, indicating improvement in daily functioning and health outcome.</p> <p>Conclusions</p> <p>Patients with schizophrenia who were initiated on RLAT demonstrated improvements in measures of effectiveness within 3 months, which persisted over 24 months.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov: <a href="http://www.clinicaltrials.gov/ct2/show/NCT00246194">NCT00246194</a></p

Attitudes toward anticoagulant treatment among nonvalvular atrial fibrillation patients at high risk of stroke and low risk of bleed

Concetta Crivera,1 Winnie W Nelson,1 Jeff R Schein,1 Edward A Witt2 1Janssen Scientific Affairs, LLC, Raritan, 2Kantar Health, Princeton, NJ, USA Background: Atrial fibrillation (AF) is associated with an increased risk of stroke. Anticoagulant (AC) therapies are effective at treating AF, but carry with them an increased risk of bleed. Research suggests that a large proportion of AF patients who have high risk of stroke and low risk of bleeding are not currently receiving AC treatment. The goal of this study was to understand the reasons why these patients do not engage in this potentially life-saving treatment.Method: Through a self-report online survey, using validated instruments, 1,184 US adults who self-reported a diagnosis of AF were screened for the risk of stroke and bleed. Of these patients, 230 (19.4%) were at high risk of stroke, low risk of bleed, and not currently using an AC treatment, and were asked follow-up questions to assess their reasons for nontreatment, attitudes toward treatment, and attitudes toward dosing regimens.Results: The most common reasons patients stopped AC treatment were concerns regarding bleeding (27.8%) and other medical concerns (26.6%), whereas the most common reason cited for not being prescribed an AC in the first place was the use of antiplatelet therapy as an alternative (57.1%). In both cases, potentially erroneous decisions regarding perceived stoke and/or bleeding risk were also a factor. Finally, the largest factors regarding attitudes toward treatment and dosing regimen were instructions from an authority figure (eg, physician, pharmacist) and ease of use, respectively.Conclusion: Results suggest that many AF patients who are at high risk of stroke but at low risk of bleed may not be receiving AC due to potentially inaccurate beliefs about risk. This study also found that AF patients place trust in physicians above other factors such as cost when making treatment decisions. Increased education of patients by physicians on the risks and benefits may be a simple strategy to improve outcomes. Keywords: atrial fibrillation, anticoagulants, stroke risk, bleeding risk, treatmen

Clinical and economic outcomes among hospitalized patients with acute coronary syndrome: an analysis of a national representative Medicare population

Shih-Yin Chen,1 Concetta Crivera,2 Michael Stokes,1 Luke Boulanger,1 Jeffrey Schein2 1United BioSource Corporation, Lexington, MA, USA; 2Janssen Scientific Affairs, LLC, Raritan, NJ, USA Objective: To evaluate the clinical and economic burden of acute coronary syndrome (ACS), a common cardiovascular illness, in the Medicare population. Methods: Data from the Medicare Current Beneficiary Survey were analyzed. Patients with incident hospitalization for ACS without similar events during the 6 months prior were included. Outcomes evaluated included inpatient mortality, 30-day mortality and readmission, subsequent hospitalization events, and total direct health care costs. Sample population weights were applied, accounting for multistage sampling design to obtain nationally representative estimates for the US Medicare population. Results: Between March 1, 2002 and December 31, 2006, we identified 795 incident ACS patients (mean age 76 years; 49% male) representing 2,542,211 Medicare beneficiaries. The inpatient mortality rate was 9.71% and the 30-day mortality ranged from 10.96% to 13.93%. The 30-day readmission rate for surviving patients was 18.56% for all causes and 17.90% for cardiovascular disease (CVD)-related diagnoses. The incidence of death since admission was 309 cases per 1000 person&ndash;years. Among patients discharged alive, the incidence was 197 for death, 847 for CVD-related admission, and 906 for all-cause admission. During the year when the ACS event occurred, mean annual total direct health care costs per person were US$50,458, with more than half attributable to inpatient hospitalization ($27,609). Conclusion: In this national representative Medicare population, we found a substantial clinical and economic burden for ACS. These findings suggest a continuing unmet medical need for more effective management of patients with ACS. The continuous burden underscores the importance of development of new interventions and/or strategies to improve long-term outcomes. Keywords: acute coronary syndromes, economic burden, cardiovascular events, Medicar