Search

Diego Novick,1 William Montgomery,2 Ellen Vorstenbosch,3 Maria Victoria Moneta,3 Héctor Dueñas,4 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly de Mexico, Mexico City, Mexico Abstract: Not all individuals treated for major depressive disorder (MDD) achieve recovery. This observational study examined the recovery rates in MDD patients and the patient characteristics associated with achieving recovery in a naturalistic clinical setting. Recovery was defined as having both clinical and functional remission. Data for this post hoc analysis were taken from a 24-week prospective, observational study that involved 1,549 MDD patients. Clinical remission was assessed using the 16-item Quick Inventory of Depressive Symptomatology Self-Report and functional remission through the Sheehan Disability Scale and no days of reduced productivity in the previous week. Generalized estimating equation regression models were used to examine the baseline factors associated with recovery during follow-up. Clinical and functional remission was achieved in 70.6% and 56.1% of the MDD patients, respectively. MDD patients who achieved recovery (52.1%) were significantly less likely to have impaired levels of functioning, concurrent medical or psychiatric conditions, low levels of education, or nonadherence to therapy at follow-up. The level of functioning during the index episode seems to be a better predictor of recovery than symptom severity. Therefore, the level of functioning should be considered while determining recovery from depression. Keywords: remission, functional impairment, clinical remission, course of illness, disability, predictors

Diego Novick,1 William Montgomery,2 Tamas Treuer,3 Ai Koyanagi,4 Jaume Aguado,4 Susanne Kraemer,5 Josep Maria Haro4 1Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly and Company, Windlesham, Surrey, UK; 2Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly Australia Pty Ltd, West Ryde, Australia; 3Global Patient Outcomes and Real World Evidence (GPORWE), Eli Lilly and Company, Budapest, Hungary; 4Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 5Medical Department, Eli Lilly and Company, Bad Homburg, Germany Purpose: Medication nonadherence is common in the treatment of patients with severe mental illness and is a frequent cause of relapse. Different formulations have been developed in an effort to improve medication adherence. The aim of this study was to explore whether there are differential clinical outcomes between two different formulations of olanzapine (orodispersible tablets [ODTs] vs standard oral tablets [SOT]) for the treatment of nonadherent patients with schizophrenia or bipolar disorder.Methods: Data for this analysis were from an observational study conducted in Europe (N=903). Adult schizophrenia and bipolar disorder patients in outpatient settings who initiated or changed to either olanzapine ODT or SOT according to physician decision within the last 45 days were eligible for enrollment. The follow-up period was 1 year. Of the 903 participants, 266 nonadherent patients (Medication Adherence Rating Scale score 0–4 at baseline) were included in the analysis. Clinical outcomes of interest were: 1) hospitalization and 2) relapse identified by the participating psychiatrist or hospitalization. An adjusted logistic regression model was fitted.Results: Patients taking ODT had more severe illness at baseline (P

Jihyung Hong,1 Diego Novick,1 William Montgomery,2 Maria Victoria Moneta,3 Héctor Dueñas,4 Xiaomei Peng,5 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, Sydney, NSW, Australia; 3Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly de Mexico, Mexico City, Mexico; 5Eli Lilly and Company, Indianapolis, IN, USA Purpose: To assess the levels of quality of life (QoL) in major depressive disorder (MDD) patients treated with either duloxetine or a selective serotonin reuptake inhibitor (SSRI) as monotherapy for up to 6 months in a naturalistic clinical setting mostly in the Middle East, East Asia, and Mexico.Patients and methods: Data for this post hoc analysis were taken from a 6-month prospective observational study involving 1,549 MDD patients without sexual dysfunction. QoL was measured using the EQ-5D instrument. Depression severity was measured using the Clinical Global Impression of Severity and the 16-item Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16), while pain severity was measured using the pain items of the Somatic Symptom Inventory. Regression analyses were performed to compare the levels of QoL between duloxetine-treated (n=556) and SSRI-treated (n=776) patients, adjusting for baseline patient characteristics.Results: These MDD patients, on average, had moderately impaired QoL at baseline, and the level of QoL impairment was similar between the duloxetine and SSRI groups (EQ-5D score of 0.46 [SD =0.32] in the former and 0.47 [SD =0.33] in the latter, P=0.066). Both descriptive and regression analyses confirmed QoL improvements in both groups during follow-up, but duloxetine-treated patients achieved higher QoL. At 24 weeks, the estimated mean EQ-5D score was 0.90 in the duloxetine cohort, which was statistically significantly higher than that of 0.83 in the SSRI cohort (P

Diego Novick,1 William Montgomery,2 Victoria Moneta,3 Xiaomei Peng,4 Roberto Brugnoli,5 Josep Maria Haro3 1Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, Australia; 3Parc Sanitari Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 4Eli Lilly and Company, Indianapolis, IN, USA; 5Department of Neuroscience, School of Medicine, Sapienza University of Rome, Rome, Italy Purpose: To describe pharmacological treatment patterns in Asian patients with major depressive disorder (MDD), including duration of treatment, reasons for medication discontinuation, rate of medication nonadherence, factors associated with medication nonadherence, and impact of medication nonadherence on depression outcomes.Patients and methods: Data were from a prospective, observational 3-month study of East Asian MDD inpatients from 40 sites in six East Asian countries who initiated antidepressant treatment at baseline (n=569). Assessments included the Clinical Global Impression-Severity scale (CGI-S), 17-item Hamilton Depression Rating Scale (HAMD-17), painful physical symptoms, response and remission, employment status, quality of life (QoL) (EuroQOL Questionnaire-5 Dimensions [EQ-5D]) and health state using the visual analog scale, adherence by clinician opinion, and patient self-report. Cox proportional hazards modeling, Kaplan–Meier survival analysis, and regression modeling were employed.Results: Median time to discontinuation for any reason was 70 days (95% confidence interval: 47; 95). Reasons for discontinuation were inadequate response in 64.1%, nonadherence in 6.2%, and adverse events in 4.1%; 25.6% who discontinued experienced an adequate response to treatment. In those patients who had an adequate response, age and country were significantly associated with time to medication discontinuation. Patient-reported nonadherence was 57.5% and clinician-reported nonadherence was 14.6% (62/426). At 3 months, nonadherent patients had significantly higher disease severity (CGI-S, P=0.0001; HAMD-17, P

Jihyung Hong,1 Diego Novick,1 Tamás Treuer,2 William Montgomery,3 Virginia S Haynes,4 Shenghu Wu,5 Josep Maria Haro61Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly and Company, Neuroscience Research, Budapest, Hungary; 3Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 4Eli Lilly and Company, Indianapolis, IN, US; 5Eli Lilly China, Shanghai, People's Republic of China; 6Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, SpainPurpose: To assess baseline predictors and consequences of medication non-adherence in the treatment of pediatric patients with attention-deficit/hyperactivity disorder (ADHD) from Central Europe and East Asia.Patients and methods: Data for this post-hoc analysis were taken from a 1-year prospective, observational study that included a total of 1,068 newly-diagnosed pediatric patients with ADHD symptoms from Central Europe and East Asia. Medication adherence during the week prior to each visit was assessed by treating physicians using a 5-point Likert scale, and then dichotomized into either adherent or non-adherent. Clinical severity was measured by the Clinical Global Impressions-ADHD-Severity (CGI-ADHD) scale and the Child Symptom Inventory-4 (CSI-4) Checklist. Health-Related Quality of Life (HRQoL) was measured using the Child Health and Illness Profile-Child Edition (CHIP-CE). Regression analyses were used to assess baseline predictors of overall adherence during follow-up, and the impact of time-varying adherence on subsequent outcomes: response (defined as a decrease of at least 1 point in CGI), changes in CGI-ADHD, CSI-4, and the five dimensions of CHIP-CE.Results: Of the 860 patients analyzed, 64.5% (71.6% in Central Europe and 55.5% in East Asia) were rated as adherent and 35.5% as non-adherent during follow-up. Being from East Asia was found to be a strong predictor of non-adherence. In East Asia, a family history of ADHD and parental emotional distress were associated with non-adherence, while having no other children living at home was associated with non-adherence in Central Europe as well as in the overall sample. Non-adherence was associated with poorer response and less improvement on CGI-ADHD and CSI-4, but not on CHIP-CE.Conclusion: Non-adherence to medication is common in the treatment of ADHD, particularly in East Asia. Non-adherence was associated with poorer response and less improvement in clinical severity. A limitation of this study is that medication adherence was assessed by the treating clinician using a single item question.Keywords: ADHD, non-adherence, response, effectiveness, Asia, Central Europe

Diego Novick,1 William Montgomery,2 Zbigniew Kadziola,3 Victoria Moneta,4 Xiaomei Peng,5 Roberto Brugnoli,6 Josep Maria Haro41Eli Lilly and Company, Windlesham, Surrey, UK; 2Eli Lilly Australia Pty Ltd, West Ryde, NSW, Australia; 3Eli Lilly Austria GmbH, Vienna, Austria; 4Parc Sanitari Sant Joan de Déu, Fundació Sant Joan de Déu, CIBERSAM, Universitat de Barcelona, Barcelona, Spain; 5Eli Lilly and Company, Indianapolis, IN, USA; 6Università di Roma, “Sapienza,” Rome, ItalyBackground: Patients with major depressive disorder (MDD) may suffer from concomitant pain symptoms. The aim of this study is to determine whether the presence of painful physical symptoms (PPS) influences quality of life when taking into account baseline depression severity.Methods: Patients with a new or first episode of MDD (n = 909) were enrolled in a 3-month prospective observational study in East Asia. The Hamilton Depression Rating Scale, Clinical Global Impression-Severity score, Somatic Symptom Inventory, and EuroQoL questionnaire-5 Dimensions (EQ-5D) and EQ-Visual Analogue Scale (EQ-VAS) were assessed at baseline and 3 months’ follow-up. The presence of PPS was defined as a mean score of ≥2 on the Somatic Symptom Inventory pain-related items. Regression analyses determined predictors of quality of life at 3 months, adjusting for age, sex, depressive symptoms, overall severity, and quality of life at baseline.Results: PPS were present (PPS+) at baseline in 52% of patients. During the 3-month follow-up, EQ-VAS scores improved from 47.7 (standard deviation [SD] 20.6) to 72.5 (SD 20.4), and EQ-5D improved from 0.48 (SD 0.34) to 0.80 (SD 0.26). At 3 months, mean EQ-VAS was 66.4 (SD 21.2) for baseline PPS+ patients versus 78.5 (SD 17.6) for baseline PPS- patients, and mean EQ-5D was 0.71 (SD 0.29) versus 0.89 (SD 0.18). PPS+ at baseline was a significant predictor of quality of life at 3 months after adjusting for sociodemographic and baseline clinical variables.Conclusion: The presence of painful physical symptoms is associated with less improvement in quality of life in patients receiving treatment for major depression, even when adjusting for depression severity.Keywords: pain, depression, quality of life, treatment, Asia, course

William Montgomery1, Tamas Treuer2, Jamie Karagianis3, Haya Ascher-Svanum4, Gavan Harrison51Global Health Outcomes, Eli Lilly and Company, Sydney, Australia; 2Emerging Markets Business Unit (Neuroscience), Eli Lilly and Company, Budapest, Hungary; 3Eli Lilly and Company, Indianapolis, IN, USA; 4Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 5Asia-Pacific Medical Communications, Eli Lilly and Company, Sydney, AustraliaAbstract: Orally disintegrating olanzapine (ODO) is a rapid-dissolving formulation of olanzapine which disintegrates in saliva almost immediately, developed as a convenient and adherence-enhancing alternative to the standard olanzapine-coated tablet (SOT). Clinical studies, which form the basis of this review, have shown ODO and SOT to have similar efficacy and tolerability profiles. However, ODO appears to have a number of advantages over SOT in terms of adherence, patient preference, and reduction in nursing burden. Overall, the existing clinical data suggests that compared to SOT, ODO is not only well-suited for difficult-to-treat, agitated, and/or nonadherent patients but, due to its potential ability to improve adherence and greater patient preference, may also be an appropriate formulation for the majority of patients for which olanzapine is the antipsychotic of choice.Keywords: orodispersible formulation, orally disintegrating, olanzapine, atypical antipsychotics, patient adherence, preference, schizophrenia, bipolar disorder

Background: This study aimed to improve physicians' understanding of the treatment circumstances and needs of outpatients with schizophrenia at risk of nonadherence, by naturalistically assessing antipsychotic treatment patterns, clinical outcomes, and health care service use in this little-studied patient population., Methods: In this one-year, prospective, multicenter, noninterventional, observational study, patients considered at risk of nonadherence by their physicians were switched from their primary oral antipsychotic to another oral or a depot antipsychotic at study entry. All cause treatment discontinuation (antipsychotic switch, augmentation, or discontinuation) during the study was assessed using Kaplan-Meier survival analyses and descriptive statistics. Patients' illness severity, quality of life, attitude towards medication, patient-reported adherence, and health care resource utilization were assessed during the study., Results: Of the 406 enrolled patients, 43 (10.6%) were switched to depot and 363 (89.4%) were switched to oral antipsychotics at study entry. During the study, 99 (24.4%) patients switched, augmented, or discontinued their antipsychotic (all cause treatment discontinuation). Of the 99 patients who switched, augmented, or discontinued their antipsychotic, 8 (18.6%) were taking depot and 91 (25.0%) were taking oral antipsychotics. These patients were switched to either depot (n = 15) or oral (n = 78) antipsychotics, or discontinued their antipsychotic medication (n = 6). Inadequate response was the most frequently reported reason for medication discontinuation. During the study, patients' clinical and functional status improved significantly and service use was low. Most patients considered themselves to be adherent at study entry, and this favorable self-perception increased during the study (from 68.5% to 88.1%)., Conclusion: Although identified as at risk of nonadherence, few patients in this naturalistic study discontinued their prescribed antipsychotic medication during the study. The discrepancy between the physicians' perception of their patient's medication adherence and the patients' self-perceived adherence highlights the need to better understand the underlying reasons for this phenomenon.

In this year-long, prospective observational study, sociodemographic, clinical, and functional characteristics were assessed in outpatients with schizophrenia from Australia, Mexico, Romania, and Taiwan who were switched from their primary oral antipsychotic to another oral or depot antipsychotic at study entry because of physician-perceived nonadherence risks. Patients (N = 406) rated their quality of life and functioning level as low. Few patients (10.6%, 43/406) were switched to depot antipsychotics, with country-specific differences (P < 0.001). Although illness severity was similar between subgroups, the depot switch subgroup had: a documented history of nonadherence (32.6% versus oral: 4.7%); recent alcohol (48.8% versus 23.2%; P < 0.001) or illicit drug use (16.3% versus 5.0%; P = 0.010); recent depot antipsychotic (20.7% versus 7.5%; P = 0.030) and mood stabilizer use (51.7% versus 26.3%; P = 0.008); poorer attitudes towards medication (P = 0.004); and poorer illness awareness (P = 0.041). Findings indicate that even when a risk of nonadherence has been identified, few patients with schizophrenia receive depot antipsychotics, despite being prime candidates for depot therapy. Findings suggest physicians may select depot therapy based on previous nonadherence, substance use, recent depot antipsychotic and mood stabilizer use, poor attitudes towards medications, and poor illness awareness.