Psychiatrist and Psychiatric Pharmacists Beliefs and Preferences for Atypical Antipsychotic Treatments in Patients With Schizophrenia and Bipolar Disorders.

BACKGROUND: Selection of schizophrenia or bipolar disorder treatments is complicated by treatment-effect heterogeneity. OBJECTIVES: This study assessed how clinicians' beliefs and health system/ insurace policies impact choice of atypical antipsychotic agent in schizophrenia and bipolar disorder. METHODS: A cross-sectional survey was conducted of members of the American College of Clinical Pharmacy and College of Psychiatric & Neurologic Pharmacists. Beliefs regarding atypical antipsychotic effectiveness and safety, impact of comorbidity on drug selection, and factors influencing atypical antipsychotic therapy selection were assessed. RESULTS: Twenty-four psychiatric pharmacists and 18 psychiatrists participated. Mean age was 39.6 years, 57.1% were female. Most clinicians (64.3%) believed medication effectiveness and safety equally important, while 26.2% believed safety and 9.4% believed effectiveness more important. The most important medication properties for schizophrenia were reducing positive symptoms (92.7%) and hospitalizations (87.8%) and for bipolar disorder were reducing manic episodes (87.8%), episode relapse (53.7%), and hospitalizations (53.7%). Agranulocytosis (78.1%), arrhythmias (70.7%), and extrapyramidal side effects (68.3%) were most concerning. Restrictions affected antipsychotic choice at 80.5% of sites and were believed to affect medication adherence (55.0%) and outcomes (53.4%). CONCLUSION: Efficacy and safety were considered equally important when choosing atypical antipsychotics. Formulary restrictions were perceived as impacting treatment choice and outcomes.

Lurasidone compared to other atypical antipsychotic monotherapies for adolescent schizophrenia: a systematic literature review and network meta-analysis.

This network meta-analysis assessed the efficacy and tolerability of lurasidone versus other oral atypical antipsychotic monotherapies in adolescent schizophrenia. A systematic literature review identified 13 randomized controlled trials of antipsychotics in adolescents with schizophrenia-spectrum disorders. A Bayesian network meta-analysis compared lurasidone to aripiprazole, asenapine, clozapine, olanzapine, paliperidone extended-release (ER), quetiapine, risperidone, and ziprasidone. Outcomes included Positive and Negative Syndrome Scale (PANSS), Clinical Global Impressions-Severity (CGI-S), weight gain, all-cause discontinuation, extrapyramidal symptoms (EPS), and akathisia. Results were reported as median differences for continuous outcomes and odds ratios (ORs) for binary outcomes, along with 95% credible intervals (95% CrI). Lurasidone was significantly more efficacious than placebo on the PANSS (- 7.95, 95% CrI - 11.76 to - 4.16) and CGI-S (- 0.44, 95% CrI - 0.67 to - 0.22) scores. Lurasidone was associated with similar weight gain to placebo and statistically significantly less weight gain versus olanzapine (- 3.62 kg, 95% CrI - 4.84 kg to - 2.41 kg), quetiapine (- 2.13 kg, 95% CrI - 3.20 kg to - 1.08 kg), risperidone (- 1.16 kg, 95% CrI - 2.14 kg to - 0.17 kg), asenapine (- 0.98 kg, 95% CrI - 1.71 kg to - 0.24 kg), and paliperidone ER (- 0.85 kg, 95% CrI - 1.57 kg to - 0.14 kg). The odds of all-cause discontinuation were significantly lower for lurasidone than aripiprazole (OR = 0.28, 95% CrI 0.10-0.76) and paliperidone ER (OR = 0.25, 95% CrI 0.08-0.81) and comparable to other antipsychotics. Rates of EPS and akathisia were similar for lurasidone and other atypical antipsychotics. In this network meta-analysis of atypical antipsychotics in adolescent schizophrenia, lurasidone was associated with similar efficacy, less weight gain, and lower risk of all-cause discontinuation compared to other oral atypical antipsychotics.

Hospitalization risk in patients with schizophrenia treated with dose-equivalent antipsychotics.

This study compared the risk of hospitalization among adults with schizophrenia being treated with equivalent dose ranges of lurasidone versus aripiprazole, olanzapine, quetiapine, or risperidone. Administrative claims data for this analysis came from the IBM MarketScan Commercial, Medicare Supplemental, and Multi-State Medicaid databases between January 2011 and June 2017. The study included adults with schizophrenia who initiated treatment with an antipsychotic and were continuously enrolled for 360 days prior to and following the date of the initial antipsychotic prescription. Risk of all-cause and schizophrenia-related hospitalization among patients who received lurasidone monotherapy versus aripiprazole, olanzapine, quetiapine, or risperidone in equivalent dose ranges were assessed. Marginal structural models that accounted for preindex characteristics, changes in antipsychotic treatment, and time-varying covariates assessed differences between lurasidone and other second-generation antipsychotics on all-cause and schizophrenia-related hospitalizations. A sensitivity analysis was conducted without the dose-equivalence requirement. A total of 20,212 patients met the study inclusion criteria. Compared with those treated with lurasidone monotherapy, the adjusted risk of all-cause hospitalization was significantly higher among patients treated with olanzapine (adjusted rate ratio [aRR], 1.49; P = .04), quetiapine (aRR, 1.64; P = .01), or risperidone (aRR, 1.47; P = .04), but not aripiprazole (aRR, 1.24; P = .28). A similar, non-statistically significant pattern of adjusted risks of schizophrenia-related hospitalizations was observed. A sensitivity analysis without the dose-equivalence requirement produced consistent results. As hospitalization is a major cost driver of direct healthcare cost, lurasidone may be a cost-saving treatment option for patients with schizophrenia.

Association between meaningful use of electronic health records and patient health outcomes in schizophrenia: a retrospective database analysis.

Improvements in patient outcomes from the meaningful use of electronic health records (EHRs) have not been extensively studied among patients with schizophrenia. This study assessed the association between EHR use, provision of quality care, and patient outcomes. Providers who were at least 50% compliant with current requirements for the CMS Electronic Health Records Incentive Program were classified as EHR providers. Quality of mental health care was assessed using 4 Healthcare Effectiveness Data and Information Set indicators. Patient outcomes included inpatient admissions and emergency department visits. A total of 18,305 providers (EHR: 16.6%; non-EHR: 83.3%) treated 27,153 patients with schizophrenia. EHR use was associated with improved rates of diabetes screening (77.9% vs 72.4%; P <.001), diabetes monitoring (72.1% vs 61.4%; P <.001), and better antipsychotic adherence (54.7% vs 36.6%; P <.001). EHR use was also associated with fewer inpatient admissions (15.9% vs 25.2%; P <.001) and emergency department visits (32.2% vs 49.3%; P <.001). These data suggest that EHR use may have a positive influence on the process and outcomes of psychiatric care when treating patients with schizophrenia. More research is needed to identify the drivers of the influence of EHRs and to develop programs that ensure all EHR users enjoy the same potential benefits as demonstrated here.

Hospitalization risk in bipolar disorder patients treated with lurasidone versus other atypical antipsychotics.

OBJECTIVE: This observational study compared the risk of hospitalization for patients with bipolar disorder when treated with lurasidone versus other oral atypical antipsychotics. METHODS: This US commercial claims analysis (4 April 2010 through 24 September 2014) used the Optum Research Database to identify adult patients with bipolar disorder treated with oral atypical antipsychotics (N = 11,132). The first claim for an atypical antipsychotic defined the index date, with pre-index and post-index periods of 180 and 360 days, respectively. Every month of the post-index period was categorized as monotherapy treatment with lurasidone, aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone, no/minimal treatment or other. Starting with the initial month of treatment, the risk of psychiatric or all-cause hospitalization in the subsequent month was examined based on treatment in the current month and pre-index covariates (age, gender, hospitalizations, emergency room visits, diagnoses for anxiety, alcohol abuse, substance abuse, hypertension, type 2 diabetes and obesity) and time-varying versions of the pre-index covariates using a marginal structural model. RESULTS: After controlling for covariates, relative to lurasidone, the odds of psychiatric and all-cause hospitalization, respectively, were 2-3 times higher for olanzapine (odds ratio [OR] = 2.78, CI 1.09, 7.08, p = .032; OR = 3.20, CI 1.24, 8.26, p = .016), quetiapine (OR = 2.80, CI 1.13, 6.95, p = .026; OR = 3.23, CI 1.29, 8.11, p = .013), risperidone (OR = 2.50, CI 1.01, 6.21, p = .048; OR = 2.79, CI 1.11, 7.02, p = .029), aripiprazole (OR = 2.13, CI 0.87, 5.20, p = .097; OR = 2.57, CI 1.04, 6.37, p = .041) and ziprasidone (OR =2.31, CI 0.91, 5.85, p = .079; OR = 2.49, CI 0.97, 6.40, p = .058). CONCLUSIONS: In this claims database analysis, lurasidone-treated patients with bipolar disorder had a significantly lower risk of psychiatric hospitalization compared to quetiapine, olanzapine and risperidone, but not aripiprazole or ziprasidone. Lurasidone-treated patients had a significantly lower risk of all-cause hospitalization compared to quetiapine, olanzapine, risperidone and aripiprazole, but not ziprasidone.

Examining quality of care for individuals treated for mental health using the HEDIS mental health quality measures.

Objective: This descriptive study examined the quality of care received by individuals with serious mental illness observed in clinical care using established Healthcare Effectiveness Data and Information Set (HEDIS) measures for individuals with serious mental illness.Methods: Administrative claims (Medicaid, Medicare, and commercial) from a national health and well-being company were used to identify adults with schizophrenia or bipolar disorder. Performance rates for five HEDIS mental health quality measures were computed. Sub-group analyses examined each HEDIS measure by those who were medication adherent vs non-adherent, and by typical vs atypical antipsychotics.Results: Eighty-nine percent of the Medicaid population received a diabetes screening (vs 79% for national benchmark Medicaid rates), 81% (vs 69%) received monitoring for diabetes, 88% (vs 79%) received monitoring for cardiovascular disease, 63% (vs 60%) were adherent with antipsychotic medication, and 34% (vs 61%) had a follow-up visit with a mental health practitioner within 30 days of a discharge. The rates for individuals with Medicare coverage were similar or marginally higher than those reported for those with Medicaid coverage, while rates for the commercially insured population were lower than the other groups.Conclusions: Most (>65%) individuals with serious mental illness received the recommended screening and monitoring for diabetes and cardiovascular disease. Barriers to and reasons for lack of follow-up should be investigated to guide future interventions to improve follow-up after hospitalization for individuals with serious mental illness.

Implementation and Use of a Client-Facing Web-Based Shared Decision-Making System (MyCHOIS-CommonGround) in Two Specialty Mental Health Clinics.

Electronic shared-decision making programs may provide an assistive technology to support physician-patient communication. This mixed methods study examined use of a web-based shared decision-making program (MyCHOIS-CommonGround) by individuals receiving specialty mental health services, and identified qualitative factors influencing adoption during the first 18 months of implementation in two Medicaid mental health clinics. T-tests and χ2 analyses were conducted to assess differences in patient use between sites. Approximately 80% of patients in both clinics created a MyCHOIS-CommonGround user profile, but marked differences emerged between clinics in patients completing shared decision-making reports (79% vs. 28%, χ2(1) = 109.92, p < .01) and average number of reports (7.20 vs. 3.60, t = - 3.64, p < .01). Results suggest high penetration of computer-based programs in specialty mental health services is possible, but clinic implementation factors can influence patient use including leadership commitment, peer staff funding to support the program, and implementation strategy, most notably integration of the program within routine clinical workflow.

Use of a Web-Based Shared Decision-Making Program: Impact on Ongoing Treatment Engagement and Antipsychotic Adherence.

OBJECTIVE: The authors examined the impact of a Web-based shared decision-making application, MyCHOIS-CommonGround, on ongoing outpatient mental health treatment engagement (all users) and antipsychotic medication adherence (users with schizophrenia). METHODS: An intervention study was conducted by comparing Medicaid-enrolled MyCHOIS-CommonGround users in 12 participating mental health clinics (N=472) with propensity score-matched adults receiving services in nonparticipating clinics (N=944). Medicaid claims were used to assess ongoing treatment engagement and antipsychotic adherence (among individuals with schizophrenia) one year prior to and after entry into the cohort. Multilevel linear models were conducted to estimate the effects of the MyCHOIS-CommonGround program over time. RESULTS: No differences during the baseline year were found between the MyCHOIS-CommonGround group and the matched control group on demographic, diagnostic, or service use characteristics. At one-year follow-up, engagement in outpatient mental health services was significantly higher for MyCHOIS-CommonGround users than for the control group (months with a service, 8.54±.22 versus 6.95±.15; ß=1.40, p<.001). Among individuals with schizophrenia, antipsychotic medication adherence was also higher during the follow-up year among MyCHOIS-CommonGround users compared with the control group (proportion of days covered by medication, .78±.04 versus .69±.03; ß=.06, p<.01). CONCLUSIONS: These findings provide new evidence that shared decision-making tools may promote ongoing mental health treatment engagement for individuals with serious mental illness and improved antipsychotic medication adherence for those with schizophrenia.

Hospitalization outcomes in patients with schizophrenia after switching to lurasidone or quetiapine: a US claims database analysis.

BACKGROUND: This study compared hospital admission rates among adult patients with schizophrenia who switched to antipsychotic monotherapy with lurasidone or quetiapine. METHODS: This retrospective cohort study used U.S.-based Truven Health MarketScan® Medicaid Multi-State Database (April 2010 through December 2012) and MarketScan® Commercial Claims and Encounters Database (April 2010 through October 2013). Continuous enrollment for 6-months before and after medication initiation was required. Treatment episodes ended after 6-months post lurasidone or quetiapine initiation, a 60-day treatment gap, or initiation of another antipsychotic. Length of treatment episodes (i.e., treatment duration) was compared using a t-test. All-cause, mental-health, and schizophrenia-related hospitalization rates, as well as costs, were compared between lurasidone- and quetiapine-treated patients using multivariable generalized linear models that adjusted for background characteristics. RESULTS: Quetiapine (n = 435) compared to lurasidone (n = 238) treatment was associated with increased all-cause (21% vs 13%, p < 0.05) and mental health-related hospitalizations (20% vs 12%, p < 0.05), but similar rates of schizophrenia-related hospitalizations (14% vs. 10%, p = 0.14). After adjusting for baseline covariates, quetiapine had 64% higher likelihood of all-cause hospitalizations (OR [odds ratio] = 1.64, 95% confidence interval [CI] 1.05-2.57, p = 0.03), 74% higher likelihood of mental health-related hospitalizations (OR = 1.74, 95% CI 1.11-2.75, p = 0.02), and a similar likelihood of schizophrenia-related hospitalization (OR = 1.35, 95% CI 0.82-2.22, p = 0.24). For those with hospital admissions, adjusted all-cause admission costs were higher for quetiapine when compared with lurasidone in both the Medicaid ($22,036 vs. $15,424, p = 0.17) and commercial populations ($23,490 vs. $20,049, p = 0.61). These differences were not significant. The length of treatment episodes was significantly shorter for quetiapine than lurasidone (115.4 vs 123.1 days, p < 0.05). CONCLUSIONS: In this retrospective claims database study, patients with schizophrenia who were switched to lurasidone had significantly fewer all-cause and mental health-related hospitalizations and similar rates of schizophrenia-related hospitalization compared with those switched to quetiapine. Patients switching to lurasidone had a significantly longer treatment duration rate than those switching to quetiapine. These results may reflect differences in efficacy or tolerability between lurasidone and quetiapine.

Efficacy and metabolic effects of lurasidone versus brexpiprazole in schizophrenia: a network meta-analysis.

Aim: To assess the relative efficacy and metabolic effects of lurasidone and brexpiprazole in the acute treatment of schizophrenia. Methods: Five lurasidone and three brexpiprazole trials were identified. In the absence of head-to-head trials, a Bayesian network meta-analysis comparing lurasidone and brexpiprazole was performed. Results: Nonstatistically significant differences in efficacy measures were observed between lurasidone and brexpiprazole. Significant differences favoring lurasidone for weight change (-0.69 kg; 95% CrI: -1.22 to -0.15), total cholesterol (-7.60 mg/dl; 95% CrI: -13.94 to -1.22), and low-density lipoprotein (-6.58 mg/dl; 95% CrI: -12.11 to -1.04) were observed, with a trend indicating half the risk of experiencing ≥7% weight gain. Conclusion: This network meta-analysis suggested that lurasidone had similar efficacy and fewer metabolic effects than brexpiprazole in patients with acute schizophrenia.

Patient preferences for important attributes of bipolar depression treatments: a discrete choice experiment.

PURPOSE: The purpose of this study was to assess patient preferences regarding pharmacological treatment attributes for bipolar depression using a discrete choice experiment (DCE). METHODS: Adult members of an Internet survey panel with a self-reported diagnosis of bipolar depression were invited via e-mail to participate in a web-based DCE survey. Participants were asked to choose between hypothetical medication alternatives defined by attributes and levels that were varied systematically. The six treatment attributes included in the DCE were time to improvement, risk of becoming manic, weight gain, risk of sedation, increased blood sugar, and increased cholesterol. Attributes were supported by literature review, expert input, and results of focus groups with patients. Sawtooth CBC System for Choice-Based Conjoint Analysis was used to estimate the part-worth utilities for the DCE analyses. RESULTS: The analytical sample included 185 participants (50.8% females) from a total of 200 participants. The DCE analyses found weight gain to be the most important treatment attribute (relative importance =49.6%), followed by risk of sedation (20.2%), risk of mania (13.0%), increased blood sugar (8.3%), increased cholesterol (5.2%), and time to improvement (3.7%). CONCLUSION: Results from this DCE suggest that adults with bipolar depression considered risks of weight gain and sedation associated with pharmacotherapy as the most important attributes for the treatment of bipolar depression. Incorporating patient preferences in the treatment decision-making process may potentially have an impact on treatment adherence and satisfaction and, ultimately, patient outcomes.

Socioeconomic Disparities and Metabolic Risk in Veterans with Serious Mental Illness.

Socioeconomic disparities were assessed in predicting metabolic risk among veterans with serious mental illness. Veterans with schizophrenia, schizoaffective, or bipolar disorders were identified in VISN 4 facilities from 10/1/2010 to 9/30/2012. Differences between patients with and without metabolic syndrome were compared using t-tests, Chi square tests and multivariate logistic regressions. Among 10,132 veterans with mental illness, 48.8% had metabolic syndrome. Multivariate logistic regression analysis confirmed that patients with metabolic syndrome were significantly more likely to be older, male, African-American, married, and receiving disability pensions but less likely to be homeless. They were more likely to receive antipsychotics, antidepressants, or anticonvulsants. Bivariate cross-sectional analysis revealed that patients with metabolic syndrome had higher rates of coronary artery disease, cerebrovascular disease, and mortality, and that metabolic syndrome was more often associated with emergency visits and psychiatric or medical hospitalizations. Demographics, socioeconomic status and medications are independent predictors of metabolic syndrome and should be considered in broader screening of risk factors in order to provide preventive interventions for metabolic syndrome.

Lurasidone compared to other atypical antipsychotic monotherapies for bipolar depression: A systematic review and network meta-analysis.

OBJECTIVES: To assess the efficacy and tolerability of lurasidone versus other atypical antipsychotic monotherapy agents in patients with bipolar depression, using a Bayesian network meta-analysis. METHODS: Fourteen randomised clinical trials (6221 patients) of lurasidone, quetiapine (extended release and immediate release), aripiprazole, olanzapine, and ziprasidone for bipolar depression were included. Efficacy assessments included change in the Montgomery-Åsberg Depression Rating Scale (MADRS), rates of response (≥50% improvement in MADRS) and remission (MADRS ≤12 at study endpoint), and change in the Clinical Global Impressions-Bipolar Disorder-Severity (CGI-BP-S) scale. Tolerability outcomes included weight, somnolence, extrapyramidal symptoms (EPS), and all-cause discontinuation. Changes from baseline or odds ratios (OR) with 95% credible intervals (CrI) were evaluated. RESULTS: Improvement in the MADRS associated with lurasidone treatment was significantly greater than placebo (-4.70, 95%CrI: -7.20, -2.21), aripiprazole (-3.62, 95%CrI: -7.04, -0.20), and ziprasidone (-3.38, 95%CrI: -6.68, -0.11), but not olanzapine (-0.15, 95%CrI: -3.12, 2.74) or quetiapine (0.10, 95%CrI: -2.68, 2.84). Results for improvement in the CGI-BP-S, and for response and remission were similar. Lurasidone was associated with less weight gain than olanzapine (-2.54 kg, 95%CrI: -3.42, -1.67) and quetiapine (-0.83kg, 95%CrI: -1.59, -0.08); and with lower rates of somnolence than quetiapine (OR: 0.33, 95%CrI: 0.11, 0.82) and ziprasidone (OR: 0.34, 95%CrI: 0.09, 0.93). No significant differences among atypical antipsychotic agents were observed in rates of discontinuation or in rates of EPS. CONCLUSIONS: In this network meta-analysis, lurasidone was found to be more efficacious than aripiprazole and ziprasidone, and was associated with less weight gain than quetiapine and olanzapine and less somnolence than quetiapine and ziprasidone.

Weight changes before and after lurasidone treatment: a real-world analysis using electronic health records.

BACKGROUND: Severe and persistent mental illnesses, such as schizophrenia and bipolar disorder, are associated with increased risk of obesity compared to the general population. While the association of lurasidone and lower risk of weight gain has been established in short and longer-term clinical trial settings, information about lurasidone's association with weight gain in usual clinical care is limited. This analysis of usual clinical care evaluated weight changes associated with lurasidone treatment in patients with schizophrenia or bipolar disorder. METHODS: A retrospective, longitudinal analysis was conducted using de-identified electronic health records from the Humedica database for patients who initiated lurasidone monotherapy between February 2011 and November 2013. Weight data were analyzed using longitudinal mixed-effects models to estimate the impact of lurasidone on patient weight trajectories over time. Patients' weight data (kg) were tracked for 12-months prior to and up to 12-months following lurasidone initiation. Stratified analyses were conducted based on prior use of second-generation antipsychotics with medium/high risk (clozapine, olanzapine, quetiapine, or risperidone) versus low risk (aripiprazole, ziprasidone, first-generation antipsychotics, or no prior antipsychotics) for weight gain. RESULTS: Among the 439 included patients, the mean age was 42.2 years, and 69.7% were female. The average duration of lurasidone treatment across all patients was 55.2 days and follow-up duration after the index date was 225.1 days. The estimated impact of lurasidone on weight was - 0.77 kg at the end of the 1-year follow-up. Patients who had received a prior second-generation antipsychotic with medium/high risk for weight gain were estimated to lose an average of 1.68 kg at the end of the 1-year follow-up. CONCLUSIONS: Lurasidone was associated with a reduction in weight at 1 year following its initiation in patients with schizophrenia or bipolar disorder. Stratified analyses indicated that weight reduction was more pronounced among patients who had received second-generation antipsychotics associated with a higher risk of weight gain prior to lurasidone treatment. These findings are consistent with the results of prior short- and long-term prospective studies and suggest that lurasidone is associated with low risk for weight gain in patients with schizophrenia or bipolar disorder.

Outpatient Follow-Up Care and Risk of Hospital Readmission in Schizophrenia and Bipolar Disorder.

OBJECTIVE: Although outpatient care within 30 days of mental health hospital discharge is an established quality indicator, little is known about the clinical implications of not receiving such care. This study evaluated whether receipt of outpatient care within 30 days of discharge was associated with a reduced risk of readmission during days 31-120 postdischarge among adult inpatients with schizophrenia or bipolar disorder. METHODS: Retrospective longitudinal cohort analyses were performed with Truven MarketScan Commercial (2010-2014) and Medicaid (2010-2013) databases. Among inpatients with schizophrenia (N=25,401) or bipolar disorder (N=46,375), overall and stratified associations were examined between receipt of an outpatient follow-up visit in the 30 days postdischarge and hospital readmission during days 31-120 postdischarge. RESULTS: Receipt of a follow-up visit within 30 days of discharge was associated with a slightly lower adjusted odds ratio (AOR) of hospital readmission during days 31-120 postdischarge (schizophrenia, AOR=.88, 95% confidence interval [CI]=.81-.96; bipolar disorder, AOR=.91, CI=.85-.98). For patients with schizophrenia, the strongest observed inverse association of follow-up care with readmission risk was among inpatients whose index admissions were 13 to 30 days long (AOR=.73, CI=.61-.89). For patients with bipolar disorder, the strongest corresponding inverse association was among those in the manic phase of illness at the index discharge (AOR=.73, CI=.63-.86). CONCLUSIONS: Outpatient visits during the 30 days after discharge were associated with a lower hospital readmission risk during the following 90 days. Assertive hospital discharge planning to secure outpatient visits after hospital discharge is needed for these patient populations.

Patient Characteristics Associated With Use of Lurasidone Versus Other Atypical Antipsychotics in Patients With Bipolar Disorder: Analysis From a Claims Database in the United States.

OBJECTIVE: To compare patient characteristics, medical comorbidities, health care utilization, and health care costs among patients with bipolar disorder who initiated lurasidone versus other atypical antipsychotics in usual clinical practice. METHODS: A retrospective analysis of administrative claims data was conducted using the US Optum Research Database (December 30, 2012, through February 27, 2014). Adult, commercially insured patients with bipolar disorder with an atypical antipsychotic prescription between June 28, 2013, and November 30, 2013, were included. The lurasidone cohort first included any patients with a lurasidone prescription; remaining patients were assigned to their first atypical antipsychotic (aripiprazole, olanzapine, quetiapine, risperidone, ziprasidone). Preindex patient characteristics comparisons to lurasidone were conducted with t tests (continuous variables) and χ² or Fisher exact tests (categorical variables). RESULTS: A total of 3,329 patients were included in this database analysis. A higher percentage of the lurasidone cohort (31.1%) had bipolar depression compared with the other cohorts (23.5%-28.0%). The lurasidone cohort had a statistically significantly higher percentage of patients with prior diabetes mellitus (13.3%) and lipid metabolism disorders (23.2%) than did the quetiapine cohort (8.4% and 16.3%, P < .01). In addition, the lurasidone cohort had significantly more prior antipsychotic polypharmacy (23.0% vs 6.7%-12.9%, P < .01) and atypical antipsychotic use (55.6% vs 11.8%-26.3%, P < .01) than other cohorts. The lurasidone cohort had a statistically significantly higher mean number of prior all-cause and mental health office visits (P < .001) and higher mean prior pharmacy costs than most cohorts (P < .01). CONCLUSIONS: Lurasidone-treated patients with bipolar disorder tended to have a more complex clinical profile, comorbidities, and prior treatment history compared to patients initiated with other atypical antipsychotics in this claims database study. This pattern of treatment may have reflected the overall clinical profile of lurasidone, the role perceived for lurasidone in the therapeutic armamentarium by practitioners, and the recent introduction of lurasidone into clinical practice during the study period.

Remission and recovery associated with lurasidone in the treatment of major depressive disorder with subthreshold hypomanic symptoms (mixed features): post-hoc analysis of a randomized, placebo-controlled study with longer-term extension.

OBJECTIVE: This post-hoc analysis assessed rates of symptomatic and functional remission, as well as recovery (combination of symptomatic and functional remission), in patients treated with lurasidone for major depressive disorder (MDD) associated with subthreshold hypomanic symptoms (mixed features). METHOD: Patients with MDD plus two or three manic symptoms (defined as per the DSM-5 mixed-features specifier) were randomly assigned to flexible-dose lurasidone 20-60 mg/day (n=109) or placebo (n=100) for 6 weeks, followed by a 3-month open-label, flexible-dose extension study for U.S. sites only (n=48). Cross-sectional recovery was defined as the presence of both symptomatic remission (Montgomery-Åsberg Depression Rating Scale score ≤ 12) and functional remission (all Sheehan Disability Scale [SDS] domain scores ≤3) at week 6, and at both months 1 and 3 of the extension study ("sustained recovery"). RESULTS: A significantly higher proportion of lurasidone-treated patients (31.3%) achieved recovery (assessed cross-sectionally) compared to placebo (12.2%, p=0.002) at week 6. The number of manic symptoms at baseline moderated the effect size for attaining cross-sectional recovery for lurasidone treatment (vs. placebo) (p=0.028). Sustained recovery rates were higher in patients initially treated with lurasidone (20.8%) versus placebo (12.5%). CONCLUSIONS: In this post-hoc analysis of a placebo-controlled study with open-label extension that involved patients with MDD and mixed features, lurasidone was found to significantly improve the rate of recovery at 6 weeks (vs. placebo) that was sustained at month 3 of the extension study. The presence of two (as opposed to three) manic symptoms moderated recovery at the acute study endpoint.

Lurasidone for major depressive disorder with mixed features and anxiety: a post-hoc analysis of a randomized, placebo-controlled study.

OBJECTIVE: The aim of this post-hoc analysis was to evaluate the efficacy of lurasidone in treating patients with major depressive disorder (MDD) with mixed features who present with mild and moderate-to-severe levels of anxiety. METHODS: The data in this analysis were derived from a study of patients meeting the DSM-IV-TR criteria for unipolar MDD, with a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥26, presenting with two or three protocol-defined manic symptoms, who were randomized to 6 weeks of double-blind treatment with either lurasidone 20-60 mg/day (n=109) or placebo (n=100). Anxiety severity was evaluated using the Hamilton Anxiety Rating Scale (HAM-A). To evaluate the effect of baseline anxiety on response to lurasidone, the following two anxiety groups were defined: mild anxiety (HAM-A≤14) and moderate-to-severe anxiety (HAM-A≥15). Change from baseline in MADRS total score was analyzed for each group using a mixed model for repeated measures. RESULTS: Treatment with lurasidone was associated with a significant week 6 change versus placebo in MADRS total score for patients with both mild anxiety (-18.4 vs. -12.8, p<0.01, effect size [ES]=0.59) and moderate-to-severe anxiety (-22.0 vs. -13.0, p<0.001, ES=0.95). Treatment with lurasidone was associated with a significant week 6 change versus placebo in HAM-A total score for patients with both mild anxiety (-7.6 vs. -4.0, p<0.01, ES=0.62), and moderate-to-severe anxiety (-11.4 vs. -6.1, p<0.0001, ES=0.91). CONCLUSIONS: In this post-hoc analysis of an MDD with mixed features and anxiety population, treatment with lurasidone was associated with significant improvement in both depressive and anxiety symptoms in subgroups with mild and moderate-to-severe levels of anxiety at baseline.

Cardiometabolic comorbidities, readmission, and costs in schizophrenia and bipolar disorder: a real-world analysis.

BACKGROUND: Serious mental illnesses are associated with increased risk of cardiometabolic comorbidities. The objective of this study was to evaluate the prevalence of cardiometabolic comorbidity and its association with hospitalization outcomes and costs among inpatients with schizophrenia or bipolar disorder. METHODS: This retrospective database analysis reviewed patients with an inpatient diagnosis of schizophrenia or bipolar disorder from the Premier Perspective® Database (4/1/2010-6/30/2012). Patients were categorized into 4 cohorts based on the number of ICD-9-CM cardiometabolic comorbidities (i.e., 0, 1, 2, or 3+). Outcomes included length of stay, mortality during the index hospitalization, healthcare costs, and 30-day all-cause readmission rates. RESULTS: Of 57,506 patients with schizophrenia, 66.1% had at least one cardiometabolic comorbidity; 39.3% had two or more comorbidities. Of 124,803 patients with bipolar disorder, 60.5% had at least one cardiometabolic comorbidity; 33.4% had two or more. Average length of stay was 8.5 (for patients with schizophrenia) and 5.2 (for patients with bipolar disorder) days. Each additional cardiometabolic comorbidity was associated with an increase in length of stay for patients with bipolar disorder (p < .001) but not for patients with schizophrenia. Mortality rates during the index hospitalization were 1.2% (schizophrenia) and .7% (bipolar disorder). Each additional cardiometabolic comorbidity was associated with a significant increase in mortality for patients with bipolar disorder (OR 1.218, p < .001), and a numerical increase in mortality for patients with schizophrenia (OR 1.014, p = .727). Patients with more cardiometabolic comorbidities were more likely to have a 30-day readmission (schizophrenia = 9-13%; bipolar disorder = 7-12%), and to incur higher costs (schizophrenia = $10,606-15,355; bipolar disorder = $7126-13,523) (all p < .01). CONCLUSIONS: Over 60% of inpatients with schizophrenia or bipolar disorder had cardiometabolic comorbidities. Greater cardiometabolic comorbidity burden was associated with an increased likelihood of readmission and higher costs among patients with schizophrenia or bipolar disorder, and an increase in length of stay and mortality for patients with bipolar disorder.