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James F Donohue,1 Vamsi K Bollu,2 Donald E Stull,3 Lauren M Nelson,4 Valerie SL Williams,4 Michael D Stensland,5 Nicola A Hanania6 1Department of Pulmonary Diseases and Critical Care Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, NC, 2Worldwide Health Economics and Outcomes Research, Bristol-Myers Squibb, Princeton, NJ, 3Data Analytics and Design Strategy, 4Psychometrics, RTI Health Solutions, Research Triangle Park, NC, 5Agile Outcomes Research, Inc., Rochester, MN, 6Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, TX, USA Background: Symptom severity is the largest factor in determining subjective health in COPD. Symptoms (eg, chronic cough, dyspnea) are associated with decreased health-related quality of life (HRQoL). We evaluated the impact of arformoterol on HRQoL in COPD patients, measured by St George’s Respiratory Questionnaire (SGRQ). Post hoc growth mixture model (GMM) analysis examined symptom response profiles. Methods: We examined data from a randomized, double-blind, parallel-group, 12-month safety trial of twice-daily nebulized arformoterol 15 µg (n=420) versus placebo (n=421). COPD severity was assessed by Global Initiative for Chronic Obstructive Lung Disease (GOLD) status. GMM analysis identified previously unknown patient subgroups and examined the heterogeneity in response to SGRQ Symptoms scores. Results: SGRQ Total score improved by 4.24 points with arformoterol and 2.02 points with placebo (P=0.006). Significantly greater improvements occurred for arformoterol versus placebo in SGRQ Symptoms (6.34 vs 4.25, P=0.031) and Impacts (3.91 vs 0.97, P=0.001) scores, but not in Activity score (3.57 vs 1.75, P=0.057). GMM identified responders and nonresponders based on the SGRQ Symptoms score. End-of-study mean difference in SGRQ Symptoms scores between these latent classes was 20.7 points (P

Vaidyanathan Ganapathy,1 Michael D Stensland2 1Sunovion Pharmaceuticals Inc., Marlborough, MA, 2Agile Outcomes Research, Inc., Rochester, MN, USA Objective: Arformoterol is the (R,R)-enantiomer of formoterol. Preclinical studies suggest that it is a stronger bronchodilator than the racemic (R,R/S,S)-formoterol; however, its potential clinical advantages have not been demonstrated. This study compared the length of stay (LOS), 30-day readmission rates, and doses of rescue medication administered in hospitalized patients with COPD who were treated with nebulized arformoterol or nebulized formoterol. Methods: This retrospective analysis utilized data from Premier, Inc. (Charlotte, NC, USA), the largest nationwide hospital-based administrative database. COPD patients ≥40 years of age were included if they were hospitalized between January 2011 and July 2014, had no asthma diagnoses, and were treated with nebulized arformoterol or nebulized formoterol. LOS was measured from the day the patients initiated the study medication (index day). Rescue medications were defined as short-acting bronchodilators used from the index day onward. Multivariate statistical models included a random effect for hospital and controlled for patient demographics, hospital characteristics, admission characteristics, prior hospitalizations, comorbidities, pre-index service use, and pre-index medication use. Results: A total of 7,876 patients received arformoterol, and 3,612 patients received nebulized formoterol. There was no significant difference in 30-day all-cause (arformoterol =11.9%, formoterol =12.1%, odds ratio [OR] =0.981, P=0.82) or COPD-related hospital readmission rates (arformoterol =8.0%, formoterol =8.0%, OR =1.002, P=0.98) after adjusting for covariates. The adjusted mean LOS was significantly shorter for arformoterol-treated vs formoterol-treated patients (4.6 vs 4.9 days, P=0.039), and arformoterol-treated patients used significantly fewer doses of rescue medications vs formoterol-treated patients (5.9 vs 6.6 doses, P=0.006). Conclusion: During inpatient stays, treating with arformoterol instead of nebulized formoterol may lead to shorter LOS and lower rescue medication use. Keywords: nebulized long-acting bronchodilator agents, patient readmission, length of stay

Objective: Atypical antipsychotics are playing an increasing role in the treatment of bipolar disorder. The objective of this study was to assess the medication treatment patterns and costs associated with different atypical antipsychotics.Methods: PharMetrics Integrated Database for medical and pharmacy claims was used to assess medication patterns and healthcare costs associated with atypical antipsychotics in the treatment of bipolar disorder. Patients who initiated on olanzapine, risperidone, quetiapine or ziprasidone as monotherapy or in combination with other bipolar medications between 01/2003 and 01/2004 were followed for 1 year. Pair-wise group comparisons were made between olanzapine and other atypical antipsychotics using Wilcoxon without adjustment, log linear regression model with adjustment, and propensity score-adjusted bootstrapping methods.Results: Among 1516 patients with bipolar disorder, olanzapine (n = 507, 51%) was significantly (p < 0.01) more likely to be initiated as the mono-bipolar medication than risperidone (n = 424, 40%), quetiapine (n = 463, 36%) or ziprasidone (n = 122, 25%). Post-initiation, olanzapine was used as the mono-bipolar medication for significantly (p < 0.01) more days (73.4) than risperidone (52.9), quetiapine (56.2) and ziprasidone (36.6). Annual healthcare costs incurred by patients with bipolar disorder varied from $14,216 for risperidone, $15,208 for olanzapine, $18,087 for quetiapine to $18,729 for ziprasidone treatments. No statistically significant differences in the annual healthcare costs were observed between olanzapine and risperidone treatments. Statistically significant differences between olanzapine and quetiapine were observed in two of the three models compared (p < 0.01, Wilcoxon; p = 0.024, log linear; p = 0.390, propensity score-adjusted bootstrapping) and between olanzapine and ziprasidone in one of the three models (p < 0.01, Wilcoxon; p = 0.068, log linear; p = 0.394, propensity score-adjusted bootstrapping).Limitations: Those arising from the data source and nature of retrospective assessments. Potential bias may also exist due to the presence of confounding factors and unobserved conditions and characteristics. As such, results of this study need to be considered in the context of its limitations and generalizability should be reserved to similar patient populations.Conclusions: Antipsychotic medication use patterns were statistically significantly different among atypical antipsychotics in the usual treatment of bipolar disorder. Olanzapine appears to be more likely used as a monobipolar medication compared with risperidone, quetiapine, and ziprasidone. The annual healthcare costs associated with the treatment of bipolar disorder by olanzapine and risperidone were similar, and the costs of these treatments were lower than with quetiapine or ziprasidone. [ABSTRACT FROM AUTHOR]

Objectives: During a schizophrenia treatment episode, persistence with the initial antipsychotic may indicate optimal pharmacotherapy and be a precursor to longer-term effectiveness and other positive outcomes. The objective of this study was to examine the ability of selected variables to predict antipsychotic persistence among patients receiving olanzapine or risperidone as initial treatment.Research Design and Methods: Data for this analysis, which was not defined in the original study protocol, came from a naturalistic, randomized, open-label trial comparing costs and effectiveness of first-line antipsychotic treatment options in schizophrenia. Predictor variables were as follows: (1) patients' initial antipsychotic (olanzapine [n = 222] or risperidone [n = 218]); (2) current (within 30 days) comorbid diagnosis of substance abuse; and (3) nine self-report items from the Rating of Medication Influence (ROMI) scale, including an item assessing patients' perceptions of the role of their therapeutic alliance in their adherence.Main Outcome Measures: For the primary analysis, a stepwise logistic regression was used in predicting antipsychotic persistence of at least 180 days. Variables found to be significantly predictive were included in a second analysis that assessed persistence at additional thresholds (> 90 days, > 270 days, and completion of the 1-year study).Results: Four variables predicted longer antipsychotic persistence; olanzapine as initial antipsychotic (p = 0.004), absence of comorbid substance abuse (p = 0.025), and two of the ROMI items representing patients' subjective response to treatment--positive relationship with clinical staff (p = 0.048) and fulfillment of life goals (p = 0.050).Conclusions: Within a randomized trial design, this study corroborated the influence of several factors on antipsychotic persistence in schizophrenia. Results support the importance of the initial antipsychotic treatment option, presence of a comorbid substance abuse diagnosis, and the role of patients' subjective responses. Additional research is needed to further explore these and other factors as predictors of antipsychotic persistence, and of subsequent treatment outcomes. [ABSTRACT FROM AUTHOR]

Purpose: Medication treatment patterns for chronic obstructive pulmonary disease (COPD) in inpatient settings were examined, as were the characteristics of patients treated with long-acting bronchodilators (LABDs) during hospitalization., Methods: This retrospective study was conducted using inpatient administrative data from hospitals and medical centers nationwide. All patients discharged from the hospital from January 1, 2010, through December 31, 2012, who were at least 40 years of age, had a primary discharge diagnosis of COPD or a secondary diagnosis of COPD with a primary diagnosis of a respiratory condition, and treatment with a bronchodilator were included. Treatment patterns were described for inpatient use of medications, including short-acting β-agonists (SABAs), long-acting β-agonists (LABAs), short-acting muscarinic antagonists (SAMAs), and long-acting muscarinic antagonists. Logistic regression predicted characteristics of patients receiving LABDs., Results: Only 5.5% of patients did not receive an SABA during the hospitalization: 71.7% received a single-product SABA, and 46.4% received an SABA-SAMA combination product, with some patients switching between or using SABA and SABA-SAMA combinations concurrently. Most patients (80.9%) received systemic corticosteroids, and nearly all (91.6%) were treated with antibiotics. Only 52.2% of patients received LABDs (39.3% LABAs). Patients treated with LABDs were more likely to have a primary COPD diagnosis, prior hospitalizations, spirometry use, and fewer comorbidities., Conclusion: A review of COPD-related inpatient admissions found that the majority of patients received the primary recommended treatments for acute exacerbations of COPD (SABAs, systemic corticosteroids, and antibiotics). However, maintenance therapy had been initiated for only about half of patients before discharge., (Copyright © 2018 by the American Society of Health-System Pharmacists, Inc. All rights reserved.)

Purpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease that impairs both objectively measured lung function and patient-reported health status. In a randomized clinical trial of patients with moderate to severe COPD, we compared changes in health status after adding arformoterol tartrate or placebo to patients' treatment regimens., Methods: In this multicenter, double-blind trial, patients were randomized to receive nebulized arformoterol 15 µg BID (n = 420) or matched placebo (n = 421). Treatment with other COPD medications was permitted, except for long-acting β 2 -agonists. Inclusion criteria were a forced expiratory volume in 1 second (FEV 1 ) ≤65% of predicted, FEV 1 >0.50 L, age ≥40 years, smoking history ≥15 pack-years, and a baseline breathlessness severity grade ≥2. The Clinical COPD Questionnaire (CCQ) was used to measure health status at randomization and at months 3, 6, and 12. CCQ scores range from 0 to 6, with higher scores indicating worse health status, and a decrease from baseline in total score by 0.4 point is considered clinically significant. Outcomes were analyzed by using mixed models for repeated measures., Findings: At baseline, patients' mean age was 63.8 years; 42.9% of patients were female, and 51.4% were current smokers. The mean baseline CCQ total scores were 2.88 and 2.91 for the arformoterol and placebo groups, respectively. A total of 841 patients were randomized to receive either arformoterol (n = 420) or placebo (n = 421); among them, 211 (50.1%) who received placebo and 255 (60.7%) who received arformoterol completed the trial. Arformoterol-treated patients had greater mean improvement from baseline in CCQ total score (-0.18 vs 0.02; P = 0.001), symptoms (-0.21 vs 0.01; P = 0.002), functional state (-0.15 vs 0.02; P = 0.018), and mental state (-0.18 vs 0.02; P = 0.023) than patients receiving placebo. At study end, 38.3% of the arformoterol-treated patients and 30.8% of patients receiving placebo reported clinically significant improvements on the CCQ (P = 0.026). These improvements were only modestly correlated with improvements in FEV 1 (r = -0.15; P < 0.01)., Implications: In this 52-week trial, arformoterol-treated patients had greater improvements in health status than patients receiving placebo. Assessing health status along with lung function seems to provide additional information regarding the effectiveness of COPD maintenance treatments. ClinicalTrials.gov identifier: NCT00909779., (Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.)

Objectives: This study examined whether participation in a weight control program (WCP) by patients with schizophrenia treated with olanzapine was also associated with improvements in clinical and functional outcomes., Methods: A post-hoc analysis was conducted using data from the Chinese subgroup (n=330) of a multi-country, 6-month, prospective, observational study of outpatients with schizophrenia who initiated or switched to oral olanzapine. At study entry and monthly visits, participants were assessed with the Clinical Global Impression of Severity, and measures of patient insight, social activities, and work impairment. The primary comparison was between the 153 patients who participated in a WCP at study entry (n=93) or during the study (n=60) and the 177 patients who did not participate in a weight control program (non-WCP). Mixed Models for Repeated Measures with baseline covariates were used to compare outcomes over time. Kaplan-Meier survival analysis was used to assess time to response., Results: Participants had a mean age of 29.0 years and 29.3 years, and 51.0% and 57.6% were female for WCP and non-WCP groups, respectively. Average initiated daily dose for olanzapine was 9.5±5.4 mg. WCP participants gained less weight than non-participants (3.9 kg vs 4.9 kg, P=0.03) and showed statistically significant better clinical and functional outcomes: greater improvement in illness severity (-2.8 vs -2.1, P<0.001), higher treatment response rates (94.1% vs 80.9%, P<0.001), shorter time to response (P<0.001), and greater improvement in patients' insight (P<0.001). Patients who enrolled in a WCP during the study had greater initial weight gain than those who enrolled at baseline (P<0.05), but similar total weight gain., Conclusion: Participation in a WCP may not only lower the risk of clinically significant weight gain in olanzapine-treated patients, but may also be associated with additional clinical and functional benefits.

Background: The aims of this analysis were to identify factors associated with early response (at 4 weeks) to olanzapine treatment and to assess whether early response is associated with better longer-term outcomes for patients with schizophrenia in the People's Republic of China., Methods: A post hoc analysis of a multi-country, 6-month, prospective, observational study of outpatients with schizophrenia or bipolar mania who initiated or switched to treatment with oral olanzapine was conducted using data from the Chinese schizophrenia subgroup (n=330). Factors associated with early response were identified using a stepwise logistic regression with baseline clinical characteristics, baseline participation in a weight control program, and adherence with antipsychotics during the first 4 weeks of treatment. Mixed models for repeated measures with baseline covariates were used to compare outcomes over time between early responders and early nonresponders to olanzapine., Results: One hundred and thirty patients (40%) achieved an early response. Early response was independently predicted by higher baseline Clinical Global Impressions-Severity score (odds ratio [OR] 1.51, 95% confidence interval [CI] 1.15-1.97), fewer years since first diagnosis (OR 0.94, CI 0.90-0.98), a greater number of social activities (OR 1.22, CI 1.05-1.40), participation in a weight control program (OR 1.81, CI 1.04-3.15), and high adherence with antipsychotics during the first 4 weeks of treatment (OR 2.98, CI 1.59-5.58). Relative to early nonresponders, early responders were significantly more likely to meet treatment response criteria at endpoint, had significantly greater symptom improvement (Clinical Global Impressions-Severity), and had significantly greater improvement in functional outcomes (all P<0.05)., Conclusion: High levels of adherence to prescribed antipsychotics and participation in a weight control program were associated with early response to olanzapine in Chinese patients with schizophrenia. Early response was associated with greater improvement in symptomatic, functional, and quality of life outcomes at 6 months compared with early nonresponse. Current findings are consistent with previous research outside of the People's Republic of China.

Background: This article describes the personal, societal, and economic burden attributable to schizophrenia in the People's Republic of China and highlights the potential for effective outpatient treatment to reduce this burden given recent changes in the Chinese health care system. The importance of effective antipsychotic therapy in reducing the burden of schizophrenia is also examined., Methods: Published research on the burden, disability, management, and economic costs of schizophrenia in the People's Republic of China was examined in the context of the larger body of global research. Research written in English or Chinese and published before June 2012 was identified using PubMed, CNKI, and Wanfang Med database searches. The contribution of effective antipsychotic therapy in reducing the risk for relapse and hospitalization and improving patients' functioning is described., Results: Schizophrenia imposes a substantial burden on Chinese society, with indirect costs accounting for the majority of the total cost. Functional impairment is high, leading to lost wages and work impairment. In the People's Republic of China, schizophrenia is the most common diagnosis among hospitalized psychiatric patients. Ongoing changes in the Chinese health care system may reduce some barriers to effective relapse prevention in schizophrenia and potentially reduce hospitalizations. The use of antipsychotics for acute episodes and maintenance treatment has been shown to decrease symptom severity and reduce the risk for relapse and hospitalization. However, discontinuing antipsychotic medication appears common and is a strong predictor of relapse. Cost-effectiveness research in the People's Republic of China is needed to examine the potential gains from improved outpatient antipsychotic treatment., Conclusion: Schizophrenia is a very costly mental illness in terms of personal, economic, and societal burden, both in the People's Republic of China and globally. When treated effectively, patients tend to persist longer with antipsychotic treatment, have fewer costly relapses, and have improved functioning. Further research examining the long-term effects of reducing barriers to effective treatments on the societal burden of schizophrenia in the People's Republic of China is needed.

Background: Little is known about the long-term outcomes for patients with schizophrenia who fail to achieve symptomatic remission. This post-hoc analysis of a 3-year study compared the costs of mental health services and functional outcomes between individuals with schizophrenia who met or did not meet cross-sectional symptom remission at study enrollment., Methods: This post-hoc analysis used data from a large, 3-year prospective, non-interventional observational study of individuals treated for schizophrenia in the United States conducted between July 1997 and September 2003. At study enrollment, individuals were classified as non-remitted or remitted using the Schizophrenia Working Group Definition of symptom remission (8 core symptoms rated as mild or less). Mental health service use was measured using medical records. Costs were based on the sites' medical information systems. Functional outcomes were measured with multiple patient-reported measures and the clinician-rated Quality of Life Scale (QLS). Symptoms were measured using the Positive and Negative Syndrome Scale (PANSS). Outcomes for non-remitted and remitted patients were compared over time using mixed effects models for repeated measures or generalized estimating equations after adjusting for multiple baseline characteristics., Results: At enrollment, most of the 2,284 study participants (76.1%) did not meet remission criteria. Non-remitted patients had significantly higher PANSS total scores at baseline, a lower likelihood of being Caucasian, a higher likelihood of hospitalization in the previous year, and a greater likelihood of a substance use diagnosis (all p < 0.05). Total mental health costs were significantly higher for non-remitted patients over the 3-year study (p = 0.008). Non-remitted patients were significantly more likely to be victims of crime, exhibit violent behavior, require emergency services, and lack paid employment during the 3-year study (all p < 0.05). Non-remitted patients also had significantly lower scores on the QLS, SF-12 Mental Component Summary Score, and Global Assessment of Functioning during the 3-year study., Conclusions: In this post-hoc analysis of a 3-year prospective observational study, the failure to achieve symptomatic remission at enrollment was associated with higher subsequent healthcare costs and worse functional outcomes. Further examination of outcomes for schizophrenia patients who fail to achieve remission at initial assessment by their subsequent clinical status is warranted.

Objective: Information about the cost-effectiveness of aripiprazole relative to other atypical antipsychotics in the treatment of patients with schizophrenia is limited. This information is needed to better inform drug formulary managers and population-based health care decision makers. The objective of this study was to compare the cost-effectiveness of olanzapine to aripiprazole in the treatment of schizophrenia from the perspective of public payers in the United States., Methods: Data for this post-hoc analysis came from a 28-week double-blind, randomized trial of individuals with schizophrenia who were treated with olanzapine or aripiprazole (clinicaltrial.gov identifier NCT00088049). Two-thirds (67.7%) of the patients were male and the patients' mean age was 37.6 years. Utilities were calculated based on previously published methods using the Positive and Negative Syndrome Scale (PANSS) and treatment-emergent adverse events. Treatment costs were calculated based on previously published methods and were inflated to 2008 US dollars. A mixed model was used to compare outcomes on utilities. Propensity score-adjusted analysis of covariance was used for the cost analysis., Results: Olanzapine treatment was associated with statistically significantly greater total utility scores relative to aripiprazole (0.78 vs. 0.76; p = 0.024) and lower total treatment costs ($22,831 vs. $24,749; p = 0.013), although medication acquisition cost was significantly higher for olanzapine than aripiprazole ($3524 vs. $2637; p < 0.001). An incremental cost-effectiveness ratio was not calculated because olanzapine was found to be the dominant choice (i.e., greater effectiveness and lower total costs)., Conclusions: This cost-effectiveness analysis is the first to use patient-level data from a randomized, double-blind study comparing olanzapine and aripiprazole in the treatment of patients with schizophrenia. Olanzapine was found to be a dominant cost-effective choice, as it was associated with greater effectiveness at lower total costs relative to aripiprazole.

Objective: Treatment-resistant depression (TRD) imposes substantial cost from the perspective of employers. The objective of this study was to assess direct healthcare costs and indirect (disability and medical-related absenteeism) costs associated with TRD compared with non-treatment-resistant major depressive disorder (MDD)., Methods: Employees with one or more inpatient, or two or more outpatient/other MDD diagnoses (ICD-9-CM: 296.2x, 296.3x) from 2004 through 2007, ages 18-63 years, were selected from a claims database. Employees who initiated a third antidepressant following two antidepressant treatments of adequate dose and duration or who met published TRD criteria were classified as TRD likely (N = 2312). The index date was the date of the first antidepressant, starting 1/1/2004. The control group was an age- and sex-matched cohort of employees with MDD but without TRD. All had continuous eligibility during the 6-month pre-index (baseline) and 24-month post-index (study) period. McNemar tests were used to compare baseline comorbidities. Wilcoxon signed-rank tests were used to compare costs from employer perspective., Results: TRD-likely employees were on average 48 years old, and 64.8% were women. Compared with MDD controls, TRD-likely employees had significantly higher rates of mental-health disorders, chronic pain, fibromyalgia, and higher Charlson Comorbidity Index. Average direct 2-year costs were significantly higher for TRD-likely employees ($22,784) compared with MDD controls ($11,733), p < 0.0001. Average indirect costs were also higher among TRD-likely employees ($12,765) compared with MDD controls ($6885), p < 0.0001., Limitations: Limitations of claims data related to accuracy of diagnosis coding and lack of clinical information apply to this study., Conclusions: Based on comorbidities and healthcare resources used, patients with TRD appeared to represent a clinically complex subgroup of individuals with MDD. TRD was associated with significant cost burden.

Background: Previous research has documented that the symptoms of bipolar disorder are often mistaken for unipolar depression prior to a patient's first bipolar diagnosis. The assumption has been that once a patient receives a bipolar diagnosis they will no longer be given a misdiagnosis of depression. The objectives of this study were 1) to assess the rate of subsequent unipolar depression diagnosis in individuals with a history of bipolar disorder and 2) to assess the increased cost associated with this potential misdiagnosis., Methods: This study utilized a retrospective cohort design using administrative claims data from 2002 and 2003. Patient inclusion criteria for the study were 1) at least 2 bipolar diagnoses in 2002, 2) continuous enrollment during 2002 and 2003, 3) a pharmacy benefit, and 4) age 18 to 64. Patients with at least 2 unipolar depression diagnoses in 2003 were categorized as having an incongruent diagnosis of unipolar depression. We used propensity scoring to control for selection bias. Utilization was evaluated using negative binomial models. We evaluated cost differences between patient cohorts using generalized linear models., Results: Of the 7981 patients who met all inclusion criteria for the analysis, 17.5% (1400) had an incongruent depression diagnosis (IDD). After controlling for background differences, individuals who received an IDD had higher rates of inpatient and outpatient psychiatric utilization and cost, on average, an additional $1641 per year compared to individuals without an IDD., Conclusions: A strikingly high proportion of bipolar patients are given the differential diagnosis of unipolar depression after being identified as having bipolar disorder. Individuals with an IDD had increased acute psychiatric care services, suggesting higher levels of relapses, and were at risk for inappropriate treatment, as antidepressant therapy without a concomitant mood-stabilizing medication is contraindicated in bipolar disorder. Further prospective research is needed to validate the findings from this retrospective administrative claims-based analysis.

Background: Bipolar disorder is a chronic mood disorder associated with a high risk for suicide attempts, which carry personal, societal, and economical consequences. No information is available on the economic costs associated with suicide attempts among patients with bipolar disorder or the change in economic costs from before to following the suicide attempt., Aims of the Study: The primary objective of this study was to estimate the total health care costs and cost components (inpatient, outpatient, emergency services, and medication) incurred by patients diagnosed with bipolar disorder who attempt suicide. Cost data included psychiatric and non-psychiatric costs. A secondary objective was to compare patients with and without attempted suicide on demographic and clinical characteristics., Methods: Data for this retrospective study were obtained from the PharMetrics Integrated Outcomes Database (1995-2005). Patients diagnosed with bipolar disorder with (N = 352) and without (N = 15,102) a suicide attempt were identified and compared on demographics and psychiatric and medical comorbidities. T-tests and chi-square tests were used for group comparisons of patient characteristics. Among patients who attempted suicide and were continuously enrolled in the year before and following the suicide attempt (N = 352), Wilcoxon signed-rank tests were used to compare health care costs between the year prior and the year following the first suicide attempt., Results: The average total health care cost for the year following the suicide attempt (N = 352) was $25,012, which was more than 2 times higher than the $11,476 incurred in the prior 1-year period (p. < 001). The total health care cost in the first month following the suicide attempt accounted for 28.9% of the total annual cost. The cost distribution over time showed a large spike for inpatient and emergency services costs in the month following the attempt with sustained increases in medication and outpatient costs. Patients with suicide attempt (N = 1,147) were significantly more likely than patients without (N = 15,102) to be younger, female, and to have comorbid psychiatric and medical diagnoses, especially depressive and substance use disorders., Discussion: The substantial economic costs incurred by patients with bipolar disorder who attempt suicide are marked by an increase in costs of crisis services during the first month following the suicide attempt, along with sustained increases in medication and outpatient costs during the year following the suicide attempt. Limitations of the study include reliance on claims data and potential lack of generalizability beyond private payer data., Implications for Health Care Provision and Use: Interventions designed to reduce the risk of suicide attempts among patients diagnosed with bipolar disorder may help decrease the related high economic costs, in addition to helping decrease adverse personal and societal consequences., Implications for Health Policies: Cost-benefit analyses of treatment methods for bipolar disorder need to include the considerable expenses associated with suicide attempts. Current findings may also be of value for modeling the cost-effectiveness of treatment for bipolar disorder and of interest to payers and other health care decision makers, especially those involved in developing Medicare capitation models for patients with chronic conditions such as bipolar disorder., Implications for Further Research: Additional research is needed on the cost of attempted suicide in the treatment of patients with bipolar disorder, especially studies that capture societal costs.

Objective: Compare annual health-care costs and resource utilization associated with olanzapine versus quetiapine for treating schizophrenia in a Medicaid population., Methods: Adult schizophrenia patients were selected from deidentified Pennsylvania Medicaid claims database (1999–2003). Included patients were continuously enrolled and initiated with olanzapine or quetiapine monotherapy after a 90-day washout period. Treatment costs were calculated for 1-year post-therapy initiation and inflation adjusted to year 2003. To control for selection bias, olanzapine and quetiapine patients were 1:1 matched using an optimal matching algorithm on propensity score, which was generated using logistic regression controlling for demographics, prior drug therapy, utilization, and costs. Treatment costs for the matched cohorts were compared directly, as well as using a difference-in-difference analysis., Results: A total of 6929 patients treated with olanzapine and 2321 with quetiapine met inclusion criteria. Quetiapine patients appeared more severe at baseline. After propensity score matching, 2321 patient pairs had similar baseline characteristics, including total costs. Compared with matched quetiapine patients, for the 1-year postindex period, olanzapine patients had similar drug costs ($6131 vs. $6014, P = 0.326), lower medical costs ($9897 vs. $11,218, P = 0.0128), and lower total health-care costs ($16,028 vs. $17,232, P = 0.0279). Lower psychiatric hospitalization costs account for most of the total cost difference. Difference-in-difference regression analysis confirmed olanzapine's economic advantage. Further adjusting for baseline variations, the total cost advantage of olanzapine patients was $962 (P = 0.032), and was mostly because of reduced psychiatric hospitalization costs of $992 (P = 0.004)., Conclusion: Schizophrenia patients treated with olanzapine had lower total costs than quetiapine patients, mostly attributable to reductions in psychiatric hospitalization costs.

Objective: Compare treatment patterns for patients with schizophrenia treated with olanzapine versus quetiapine in the Pennsylvania Medicaid population., Methods: Patients (18-64 years) with a diagnosis of schizophrenia (ICD-9-CM: 295.xx) and treated with olanzapine or quetiapine were identified from the Pennsylvania Medicaid claims database (1999-2003). Patients were continuously enrolled in the 12-month pre- and 12-month post-initiation periods. To control for selection bias, propensity score method with optimal matching algorithm was used to match patients from the two treatment groups. The key study outcomes including rates of augmentation, polypharmacy, discontinuation, and switching were analyzed using Kaplan-Meier survival analysis. Medication possession ratio and use of concurrent psychotropic drugs were also compared between the two groups., Results: A total of 2321 quetiapine and 6929 olanzapine patients were identified. In all, 2321 pairs of patients were matched between the two groups and they had similar baseline characteristics. Over the 12-month study period, olanzapine patients had a better medication adherence (0.47 vs. 0.43; p < 0.0001), and were less likely to use other psychotropic medications concomitantly (all p < 0.05). Olanzapine patients had a significantly lower risk of augmentation and polypharmacy with other antipsychotics. The 6-month augmentation rates with antipsychotics were 12.9% and 16.7% for olanzapine and quetiapine, respectively (p < 0.05); the polypharmacy rates with any antipsychotics were 12.5% and 18.6% for olanzapine and quetiapine, respectively (p < 0.001). No significant differences were observed for discontinuation and switching between the two treatment groups. Sensitivity analysis with a 60-day minimum monotherapy requirement showed similar results., Limitations: This study's limitations include the analysis of a single Medicaid state, which may limit the generalizability to the entire Medicaid population with schizophrenia or to all patients with schizophrenia., Conclusion: This large Medicaid claims database analysis showed that olanzapine patients were significantly more compliant to treatment and less likely to augment or have polypharmacy with antipsychotics during the course of treatment compared to quetiapine patients.

Background: Bipolar disorder is challenging to diagnose in medical practice., Objectives: Our objectives were (1) to determine the rate of depression misdiagnosis in patients previously diagnosed with bipolar disorder in administrative claims, (2) to determine the resulting increased treatment costs, and (3) to verify the misdiagnoses in the medical charts for a subset of patients., Method: We employed cohort analysis using claims from a large, commercial, U.S. health plan from January 2001 through December 2003. Inclusion criteria included 2 bipolar disorder diagnoses (ICD-9-CM criteria), continuous enrollment for 1 year before and after initial bipolar disorder diagnosis, age 18-64 years, and a pharmacy benefit. Propensity scoring was used to control for differences between patients with and without 2 depression diagnoses in the year following their bipolar disorder diagnosis. Medical charts were obtained for 100 patients, including 76 with a bipolar disorder diagnosis chart from one provider and a depression diagnosis chart from a second provider., Results: Of 3119 bipolar disorder patients meeting inclusion criteria, 857 (27.5%) had subsequent depression misdiagnoses during the follow-up year. These patients had 1.82 times more psychiatric hospitalizations and 2.47 times more psychiatric emergency room visits. For 673 patients (78.5%), a different provider gave the depression misdiagnosis. Annual per-patient treatment costs were significantly higher (p < .001) for those diagnosed with depression ($12,594) than for those not ($9405). In the chart review, both the bipolar disorder and subsequent depression diagnoses were confirmed for 65.8% (50/76) of the patients who had charts from 2 different providers., Conclusions: More than one quarter of individuals diagnosed with bipolar disorder received an ostensible depression misdiagnosis during the follow-up period. Significant (p = .001) increases in psychiatric inpatient hospitalization suggest that improvements in the continuity of care could improve outcomes and reduce costs.

Background: Bipolar disorder is a chronic and costly condition. This analysis examines health care costs associated with bipolar disorder in 2004 and contrasts them with those for depression, a better understood mental illness., Methods: Health care costs associated with bipolar disorder and non-bipolar depression were determined using private payer administrative claims. Individuals having 2 claims with a primary ICD-9-CM code for bipolar disorder or depression were categorized as bipolar disorder or non-bipolar depression patients, respectively. Comparisons between patient groups were adjusted for demographic differences and comorbid diagnoses., Results: On average, bipolar patients (n=6072) used significantly more psychiatric resources per person than depression patients (n=60,643), and had more mean psychiatric hospital days, psychiatric and medical emergency room visits, and psychiatric office visits (p<.001 for all). Bipolar patients were slightly less likely to be treated with antidepressants, but substantially more likely to be treated with antipsychotics, anticonvulsants, lithium, and benzodiazepines (p<.001 for all). Mean direct per-patient costs were $10,402 for bipolar patients and $7494 for depression patients (p<.001), with the primary differences observed for psychiatric medication ($1641 vs. $507) and psychiatric hospitalization ($1187 vs. $241)., Limitations: Patients were categorized based on diagnostic codes in administrative claims data, which may not always be accurate. Results may not generalize beyond private payer populations in the US., Conclusions: Bipolar disorder is associated with significantly greater per-patient total annual health care costs than non-bipolar depression, as well as significantly greater psychiatric costs. Bipolar disorder, a chronic condition often suboptimally treated, may represent a good target for disease-management programs.

Treatment-emergent weight gain may be a general marker of therapeutic improvement, even when improvements occur in the absence of active antipsychotic treatment. To investigate the association between treatment-emergent weight gain and therapeutic improvement across placebo and active treatments, and to examine the association between reported treatment-emergent weight changes and the treatments' reported efficacy. Data from a randomized, double-blind trial comparing treatment of schizophrenia with placebo and olanzapine were used to correlate weight change and change in psychopathology. Additionally, we correlated effect sizes of the efficacy of clozapine, olanzapine, risperidone, haloperidol and placebo (reported in meta-analytical reviews), with their reported weight changes. Weight gain significantly correlated with clinical improvements for placebo and olanzapine. The correlation between treatments' efficacy and corresponding weight changes was high (r 0.88, p 0.05). Treatment-emergent weight gain appears to be an important marker of symptom reduction, and may not be exclusively attributable to pharmacological perturbations.

Differences between public mental health delivery systems do not permit generalizing most research findings from one service system to another. Under certain circumstances, generalizing psychopharmacological research findings may be feasible when patients served at these health care systems share a similar illness severity profile. This study compared the illness severity of schizophrenia patients served at the Veterans Healthcare Administration (VA) with that for Non-VA Medicaid patients served at state facilities. Findings demonstrate remarkable clinical comparability and suggest the potential for generalizing psychopharmacological research findings from one health care delivery system to the other, after adjustments for relevant background characteristics.