Daisy Ng-Mak

Assessment of treatment-seeking behavior and healthcare utilization in an international cohort of subjects with overactive bladder.

Abstract Objective: To assess the association between incontinence severity, treatment-seeking behavior, and healthcare resource utilization (HRU) among participants with overactive bladder (OAB) in eight countries. Research design and methods: A cross-sectional online survey of subjects ≥18 years old in Australia, Europe, and North America, who had a past OAB diagnosis and/or experienced ≥1 urinary incontinence (UI) episode in the preceding 12 months, were eligible to participate. Subjects contacted for the survey were primarily from a voluntary medication monitoring registry, MediGuard. Predominantly stress incontinence subjects were excluded. Incontinence severity was assessed by the number of UI episodes over 3 days and grouped as 0 (‘dry’), 1–2, 3–4, and ≥5 UI episodes/day. Subject demographics, employment status, comorbidities, treatment-seeking behavior (past OAB diagnosis; spoken to healthcare provider [HCP]), and HRU (diagnostic tests; HCP visits in 6 months before screening) were analyzed by incontinence severity. Results: Overall, 1341 subjects with OAB (mean age 54.5 years; 70.7% female) were surveyed; 20.2%, 47.7%, 18.8%, and 13.3% of subjects reported 0, 1–2, 3–4, and ≥5 UI episodes/day, respectively. Employment status and comorbidities were significantly (p < 0.05) associated with incontinence severity. The two measures of treatment-seeking behavior were significantly (p < 0.05) associated with incontinence severity groups; the proportion of subjects with a past diagnosis of OAB were 35.8%, 44.8%, 52.4%, and 64.0% in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively; and 59.0%, 63.6%, 65.9%, and 78.1% of subjects in the respective UI severity groups talked to a HCP about their OAB symptoms. Multivariate linear regression analyses showed a positive and consistent association between incontinence severity and HRU; subjects reported a mean of 2.7, 4.1, 4.4, and 7.7 diagnostic tests overall (p < 0.001), and a mean of 1.4, 2.2, 2.7, and 4.0 HCP visits in the 0, 1–2, 3–4, and ≥5 UI episodes/day groups, respectively (p < 0.001). A potential limitation of the study is the cross-sectional survey methodology which limits the ability to draw causal inferences from the results. Additionally, since this is a web-based survey it is possible respondents who have access to/are familiar with technology were more likely to be enrolled. Conclusions: Incontinence severity was positively associated with both treatment-seeking behavior and HRU among subjects with OAB.

Dosing patterns and medication adherence in bipolar disorder patients treated with lurasidone: a US retrospective claims database analysis

Background: The aim of this study was to describe dosing patterns and medication adherence among bipolar patients who initiated lurasidone in a real-world setting. Methods: Adult bipolar patients who initiated lurasidone between 1 November 2010 and 31 December 2012 (index period) with 6-month pre- and post-index continuous enrollment were identified from the IMS RWD Adjudicated Claims US database. Patients were grouped by starting lurasidone daily dose: 20 mg (7.1%), 40 mg (62.2%), 60–80 mg (28.7%), and 120–160 mg (2.1%). Patient characteristics were compared across doses using Cochran–Armitage trend tests. Multivariable ordinal logistic regression assessed the association between initial lurasidone dose and patient characteristics. Medication adherence was measured using medication possession ratio (MPR). Results: Of 1114 adult bipolar patients (mean age 40.6 years, 70.6% female), 90% initiated lurasidone at 40 mg or 80 mg/day (mean 51.9 mg/day). Of these, 16.2% initiated lurasidone as monotherapy. Mean lurasidone maintenance dose was 55.2 mg/day and mean MPR was 0.53 [standard deviation (SD) = 0.34] over the 6-month follow up. Substance use, hyperglycemia, obesity, and prior antipsychotic use were associated with higher initial lurasidone doses (p < 0.05). Odds of a 20 mg/day increase in initial lurasidone dose was 1.6-times higher for patients with substance use [95% confidence interval (CI): 1.16−2.24], 2.6-times higher with hyperglycemia problems (95% CI: 1.15−5.83), 1.7-times higher with obesity (95% CI: 1.05−2.60), and 1.3 (95% CI: 1.01−1.78) and 1.8-times higher (95% CI: 1.17−2.86) with prior use of second- and first-generation antipsychotics, respectively. Conclusions: This real-world analysis of bipolar patients indicated that 40 mg or 80 mg/day were the most common starting doses of lurasidone. A majority of patients used concomitant psychiatric medications (polypharmacy). Higher doses of lurasidone were prescribed to patients with comorbidities or prior antipsychotic use. Adherence to lurasidone was comparable to or better than antipsychotic adherence reported in bipolar disorder literature.

Major depressive disorder with subthreshold hypomanic (mixed) features: A real-world assessment of treatment patterns and economic burden

BACKGROUND To compare outcomes for individuals with major depressive disorder (MDD) with or without subthreshold hypomania (mixed features) in naturalistic settings. METHODS Using the Optum Research Database (1/1/2009─10/31/2014), a retrospective analysis of individuals newly diagnosed with MDD was conducted. Continuous enrollment for 12-months before and after the initial MDD diagnosis was required. MDD with subthreshold hypomania (mixed features) (MDD-MF) was defined based on ≥1 hypomania diagnosis within 30 days after an MDD diagnosis during the one-year follow-up period, in the absence of bipolar I diagnoses. Psychiatric medication use, healthcare utilization, and costs during the one-year follow-up period were compared using multivariate logistic and gamma regressions, controlling for baseline differences. RESULTS Of 130,626 MDD individuals, 652 (0.5%) met the operational definition of MDD-MF. Compared to the MDD-only group, the MDD-MF group had more suicidality (2.0% vs. 0.5%), anxiety disorders (46.8% vs. 34.0%), and substance use disorders (15.5% vs. 6.1%, all P<0.001). More individuals with MDD-MF were treated with antidepressants (83.6% vs. 71.6%), mood stabilizers (50.5% vs. 2.7%), atypical antipsychotics (39.0% vs. 5.5%), and polypharmacy with multiple drug classes (72.1% vs. 22.7%, all P<0.001). Individuals with MDD-MF had higher hospitalizations rates (24.2% vs. 10.5%) and total healthcare costs (mean:

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

15,660 vs.

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

10,744, all P<0.001). LIMITATIONS The commercial claims data used were not collected for research purposes and may over- or under-represent certain populations. No specific claims-based diagnostic code for MDD with mixed features exists. CONCLUSIONS Greater use of mood stabilizers, atypical antipsychotics, polypharmacy, and healthcare resources provides evidence of the complexity and severity of MDD-MF. Identifying optimal treatment regimens for this population represents a major unmet medical need.

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

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.

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

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.

Socioeconomic Disparities and Metabolic Risk in Veterans with Serious Mental Illness

Abstract 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.

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

Abstract 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.

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

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.