Objectius: Els objectius generals d'aquesta tesi son descriure l'evolucio dels pacients a... more Objectius: Els objectius generals d'aquesta tesi son descriure l'evolucio dels pacients amb esquizofrenia durant tres anys de seguiment i analitzar les diferencies entre regions del mon amb diferents nivells de desenvolupament. Els objectius especifics son: • Descriure la frequencia de resposta al tractament en pacients ambulatoris amb esquizofrenia en diferents regions del mon. • Analitzar les caracteristiques demografiques (edat, sexe, estat civil) i els factors clinics (edat d'inici, temps d'evolucio, gravetat de la malaltia, funcionament) associades a la resposta clinica. • Descriure la frequencia de la remissio clinica i funcional en pacients ambulatoris amb esquizofrenia en diferents regions del mon. • Analitzar les caracteristiques demografiques (edat, sexe, estat civil) i els factors clinics (edat d'inici, temps d'evolucio, gravetat de la malaltia, funcionament) associats a la remissio clinica i funcional. Metodes: La base de dades de l'estudi Wor...
Background: Hospitalization is a costly and distressing event associated with relapse during schi... more Background: Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assess ed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. Methods: This was a post hoc exploratory analysis of data from a randomized, doubleblind study comparing the safety and efficacy of olanzapine-LAI (pooled act ive depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 m...
The number needed to treat (NNT) for all-cause medication discontinuation in large, industry-spon... more The number needed to treat (NNT) for all-cause medication discontinuation in large, industry-sponsored, non-randomized, observational studies conducted across world geographies was compared with NNTs from CATIE, an 18-month, NIMH-sponsored, randomized study. NNTs (with 95% confidence intervals) were calculated using data from 3 large Lilly-sponsored, non-randomized, observational studies (EU-SOHO, IC-SOHO, and US-SCAP, n=20 957). Group differences at medication initiation were adjusted by Cox regression modeling. These NNTs were compared with published NNTs for CATIE (phase 1). NNTs for olanzapine vs. risperidone and for olanzapine vs. quetiapine were similar across the observational studies and similar to those of CATIE. The NNTs for olanzapine vs. oral typical antipsychotics were similar across the observational studies but demonstrated a somewhat stronger effect size than the NNT reported for olanzapine vs. perphenazine in CATIE. NNTs for all-cause treatment discontinuation (a proxy measure of a medication's effectiveness from patients' and clinicians' perspectives) appear to be consistent across study designs (non-interventional, observational vs. RCT), study sponsorship (industry vs. independent), and across world geographies, suggesting that antipsychotics differ in this measure.
Introduction: Medication non-compliance is common in the treatment of depression, particularly in... more Introduction: Medication non-compliance is common in the treatment of depression, particularly in Asia. Objectives: 1) To describe the frequency and factors associated with medication non-compliance. 2) To study the influence of non-compliance on treatment outcomes. Methods: Nine hundred and nine in- and out-patients from Asia presenting with a new or first episode of major depressive disorder were enrolled in a 3-month prospective observational study. Clinical severity and quality of life were assessed, using Hamilton Depression Scale (HAMD-17), Clinical Global Impression Severity (CGI-S), and EuroQoL measures (EQ-5D and EQ-VAS). Medication compliance was also assessed by the investigator and patient. Linear and logistic multiple regression models were used to analyze the consequences of non-compliance. Results: The proportion of non-compliant patients as assessed by the investigator was 16%. Sociodemographic factors and clinical severity were not associated with compliance at baseline. Regression models showed that medication non-compliance was associated with worse depression severity (difference in HAMD-17 -3.98; 95% CI -5.10, -2.87) and overall clinical severity (CGI-S difference -0.46; 95%CI -0.68, -0.24) at three months. Medication non-compliance was also associated with lower quality of life at three months (EQ-VAS difference -7.47; 95%CI -11.13, - 3.82) and EQ-5D score difference -0.08; 95%CI -0.1, -0.04)). Compliant patients had higher odds of response (odds ratio (OR) 3.18; 95% CI 1.98, 5.10) and remission (OR 3.94; 95% CI 2.42, 6.43) compared with non-compliant patients. Conclusions: Patients non-compliant with medication had worse 3-month outcomes in terms of depression severity, quality of life, and response and remission rates, compared with compliant patients.
e13083 Background: To assess how patient characteristics impact treatment patterns and real-world... more e13083 Background: To assess how patient characteristics impact treatment patterns and real-world effectiveness among patients with hormone receptor (HR+)/human epidermal growth receptor 2-negative (HER2-) locally advanced and metastatic breast cancer (ABC) in Korea and Taiwan. Methods: We conducted a retrospective chart review comprising 227 female patients aged ≥ 18 years and diagnosed HR+/HER2- ABC in Korea and Taiwan between 2015-2017. Those having at least one of the following characteristics, shown previously to negatively impact prognosis, formed the poor prognostic cohort (PPC): ECOG PS > 0, not bone-only disease, liver metastases, or negative PgR status. Anonymized data on patient characteristics, treatment pathways, progression-free survival, and grade 3 or higher adverse events (AEs) of interest was abstracted. Descriptive statistics and Kaplan Meier methods were used to assess the outcomes. Results: The mean (range) age was 57.1 (29 - 83) years. A total of 193 (85.0%)...
33 Background: Gastric cancer is one of the leading causes of cancer deaths in both sexes worldwi... more 33 Background: Gastric cancer is one of the leading causes of cancer deaths in both sexes worldwide, especially in East Asia. This study aimed to estimate the economic burden of advanced gastric cancer (AGC) in Taiwan. Methods: The costs of AGC in 2013 were estimated using resource use data from a chart review study (n = 122 with AGC) and national statistics. Annual per-patient costs were estimated from 82 patients who had complete resource use data. The costs were composed of direct medical costs (inpatient, outpatients, and chemotherapy-related costs), direct non-medical costs (healthcare travel and caregiver costs), morbidity costs, and mortality costs. Relevant unit costs were retrieved mainly from literature and national statistics, and applied to the resource use data. Broad definitions of morbidity and mortality costs were employed to value the productivity loss in patients with unpaid employment, economically inactive and unemployed as well as the life years after the age of...
This analysis compared the effectiveness (treatment discontinuation and hospitalization) of depot... more This analysis compared the effectiveness (treatment discontinuation and hospitalization) of depot and oral typical antipsychotics in nonadherent outpatients with schizophrenia. Data from the 3-year, prospective, observational Schizophrenia Outpatient Health Outcome study were used. Time to treatment discontinuation, percentage of patients hospitalized and the mean numbers of hospitalizations were compared for previously nonadherent patients initiating depot typical or oral typical monotherapy. Cox proportional hazards, linear and logistic regression models were used to adjust for differences between the treatment groups at the index visit. Of 1642 nonadherent patients, 431 (26%) started an oral typical (n=169) or depot typical (n=262) antipsychotic and were included in the analysis. After adjusting for index variables, treatment discontinuation was significantly lower in the depot typical cohort (hazard ratio: 0.72, 95% confidence interval: 0.54-0.97, P<0.05). Younger age and more severe positive symptoms were also associated with higher discontinuation. The frequency of hospitalization and the mean number of hospitalizations were both significantly lower for the depot typical cohort at 6 months (P<0.05) compared with oral typicals. In the usual care of outpatients with schizophrenia, treatment continuation among nonadherent patients is longer for depot typicals compared with oral typicals and is accompanied by less hospitalization in the short term.
Background: Little is known about the long-term changes in the functioning of schizophrenia patie... more Background: Little is known about the long-term changes in the functioning of schizophrenia patients receiving maintenance therapy with olanzapine long-acting injection (LAI), and whether observed changes differ from those seen with oral olanzapine. Methods: This study describes changes in the levels of functioning among outpatients with schizophrenia treated with olanzapine-LAI compared with oral olanzapine over 2 years. This was a secondary analysis of data from a multicenter, randomized, open-label, 2-year study comparing the long-term treatment effectiveness of monthly olanzapine-LAI (405 mg/4 weeks; n=264) with daily oral olanzapine (10 mg/day; n=260). Levels of functioning were assessed with the Heinrichs–Carpenter Quality of Life Scale. Functional status was also classified as “good”, “moderate”, or “poor”, using a previous data-driven approach. Changes in functional levels were assessed with McNemar’s test and comparisons between olanzapine-LAI and oral olanzapine employed the Student’s t-test. Results: Over the 2-year study, the patients treated with olanzapine-LAI improved their level of functioning (per Quality of Life total score) from 64.0–70.8 (P0.001). Patients on oral olanzapine also increased their level of functioning from 62.1–70.1 (P0.001). At baseline, 19.2% of the olanzapine-LAI-treated patients had a “good” level of functioning, which increased to 27.5% (P0.05). The figures for oral olanzapine were 14.2% and 24.5%, respectively (P0.001). Results did not significantly differ between olanzapine-LAI and oral olanzapine. Conclusion: In this 2-year, open-label, randomized study of olanzapine-LAI, outpatients with schizophrenia maintained or improved their favorable baseline level of functioning over time.
Objectius: Els objectius generals d'aquesta tesi son descriure l'evolucio dels pacients a... more Objectius: Els objectius generals d'aquesta tesi son descriure l'evolucio dels pacients amb esquizofrenia durant tres anys de seguiment i analitzar les diferencies entre regions del mon amb diferents nivells de desenvolupament. Els objectius especifics son: • Descriure la frequencia de resposta al tractament en pacients ambulatoris amb esquizofrenia en diferents regions del mon. • Analitzar les caracteristiques demografiques (edat, sexe, estat civil) i els factors clinics (edat d'inici, temps d'evolucio, gravetat de la malaltia, funcionament) associades a la resposta clinica. • Descriure la frequencia de la remissio clinica i funcional en pacients ambulatoris amb esquizofrenia en diferents regions del mon. • Analitzar les caracteristiques demografiques (edat, sexe, estat civil) i els factors clinics (edat d'inici, temps d'evolucio, gravetat de la malaltia, funcionament) associats a la remissio clinica i funcional. Metodes: La base de dades de l'estudi Wor...
Background: Hospitalization is a costly and distressing event associated with relapse during schi... more Background: Hospitalization is a costly and distressing event associated with relapse during schizophrenia treatment. No information is available on the predictors of hospitalization during maintenance treatment with olanzapine long-acting injection (olanzapine-LAI) or how the risk of hospitalization differs between olanzapine-LAI and oral olanzapine. This study aimed to identify the predictors of psychiatric hospitalization during maintenance treatment with olanzapine-LAI and assess ed four parameters: hospitalization prevalence, incidence rate, duration, and the time to first hospitalization. Olanzapine-LAI was also compared with a sub-therapeutic dose of olanzapine-LAI and with oral olanzapine. Methods: This was a post hoc exploratory analysis of data from a randomized, doubleblind study comparing the safety and efficacy of olanzapine-LAI (pooled act ive depot groups: 405 mg/4 weeks, 300 mg/2 weeks, and 150 mg/2 weeks) with oral olanzapine and sub-therapeutic olanzapine-LAI (45 m...
The number needed to treat (NNT) for all-cause medication discontinuation in large, industry-spon... more The number needed to treat (NNT) for all-cause medication discontinuation in large, industry-sponsored, non-randomized, observational studies conducted across world geographies was compared with NNTs from CATIE, an 18-month, NIMH-sponsored, randomized study. NNTs (with 95% confidence intervals) were calculated using data from 3 large Lilly-sponsored, non-randomized, observational studies (EU-SOHO, IC-SOHO, and US-SCAP, n=20 957). Group differences at medication initiation were adjusted by Cox regression modeling. These NNTs were compared with published NNTs for CATIE (phase 1). NNTs for olanzapine vs. risperidone and for olanzapine vs. quetiapine were similar across the observational studies and similar to those of CATIE. The NNTs for olanzapine vs. oral typical antipsychotics were similar across the observational studies but demonstrated a somewhat stronger effect size than the NNT reported for olanzapine vs. perphenazine in CATIE. NNTs for all-cause treatment discontinuation (a proxy measure of a medication's effectiveness from patients' and clinicians' perspectives) appear to be consistent across study designs (non-interventional, observational vs. RCT), study sponsorship (industry vs. independent), and across world geographies, suggesting that antipsychotics differ in this measure.
Introduction: Medication non-compliance is common in the treatment of depression, particularly in... more Introduction: Medication non-compliance is common in the treatment of depression, particularly in Asia. Objectives: 1) To describe the frequency and factors associated with medication non-compliance. 2) To study the influence of non-compliance on treatment outcomes. Methods: Nine hundred and nine in- and out-patients from Asia presenting with a new or first episode of major depressive disorder were enrolled in a 3-month prospective observational study. Clinical severity and quality of life were assessed, using Hamilton Depression Scale (HAMD-17), Clinical Global Impression Severity (CGI-S), and EuroQoL measures (EQ-5D and EQ-VAS). Medication compliance was also assessed by the investigator and patient. Linear and logistic multiple regression models were used to analyze the consequences of non-compliance. Results: The proportion of non-compliant patients as assessed by the investigator was 16%. Sociodemographic factors and clinical severity were not associated with compliance at baseline. Regression models showed that medication non-compliance was associated with worse depression severity (difference in HAMD-17 -3.98; 95% CI -5.10, -2.87) and overall clinical severity (CGI-S difference -0.46; 95%CI -0.68, -0.24) at three months. Medication non-compliance was also associated with lower quality of life at three months (EQ-VAS difference -7.47; 95%CI -11.13, - 3.82) and EQ-5D score difference -0.08; 95%CI -0.1, -0.04)). Compliant patients had higher odds of response (odds ratio (OR) 3.18; 95% CI 1.98, 5.10) and remission (OR 3.94; 95% CI 2.42, 6.43) compared with non-compliant patients. Conclusions: Patients non-compliant with medication had worse 3-month outcomes in terms of depression severity, quality of life, and response and remission rates, compared with compliant patients.
e13083 Background: To assess how patient characteristics impact treatment patterns and real-world... more e13083 Background: To assess how patient characteristics impact treatment patterns and real-world effectiveness among patients with hormone receptor (HR+)/human epidermal growth receptor 2-negative (HER2-) locally advanced and metastatic breast cancer (ABC) in Korea and Taiwan. Methods: We conducted a retrospective chart review comprising 227 female patients aged ≥ 18 years and diagnosed HR+/HER2- ABC in Korea and Taiwan between 2015-2017. Those having at least one of the following characteristics, shown previously to negatively impact prognosis, formed the poor prognostic cohort (PPC): ECOG PS > 0, not bone-only disease, liver metastases, or negative PgR status. Anonymized data on patient characteristics, treatment pathways, progression-free survival, and grade 3 or higher adverse events (AEs) of interest was abstracted. Descriptive statistics and Kaplan Meier methods were used to assess the outcomes. Results: The mean (range) age was 57.1 (29 - 83) years. A total of 193 (85.0%)...
33 Background: Gastric cancer is one of the leading causes of cancer deaths in both sexes worldwi... more 33 Background: Gastric cancer is one of the leading causes of cancer deaths in both sexes worldwide, especially in East Asia. This study aimed to estimate the economic burden of advanced gastric cancer (AGC) in Taiwan. Methods: The costs of AGC in 2013 were estimated using resource use data from a chart review study (n = 122 with AGC) and national statistics. Annual per-patient costs were estimated from 82 patients who had complete resource use data. The costs were composed of direct medical costs (inpatient, outpatients, and chemotherapy-related costs), direct non-medical costs (healthcare travel and caregiver costs), morbidity costs, and mortality costs. Relevant unit costs were retrieved mainly from literature and national statistics, and applied to the resource use data. Broad definitions of morbidity and mortality costs were employed to value the productivity loss in patients with unpaid employment, economically inactive and unemployed as well as the life years after the age of...
This analysis compared the effectiveness (treatment discontinuation and hospitalization) of depot... more This analysis compared the effectiveness (treatment discontinuation and hospitalization) of depot and oral typical antipsychotics in nonadherent outpatients with schizophrenia. Data from the 3-year, prospective, observational Schizophrenia Outpatient Health Outcome study were used. Time to treatment discontinuation, percentage of patients hospitalized and the mean numbers of hospitalizations were compared for previously nonadherent patients initiating depot typical or oral typical monotherapy. Cox proportional hazards, linear and logistic regression models were used to adjust for differences between the treatment groups at the index visit. Of 1642 nonadherent patients, 431 (26%) started an oral typical (n=169) or depot typical (n=262) antipsychotic and were included in the analysis. After adjusting for index variables, treatment discontinuation was significantly lower in the depot typical cohort (hazard ratio: 0.72, 95% confidence interval: 0.54-0.97, P<0.05). Younger age and more severe positive symptoms were also associated with higher discontinuation. The frequency of hospitalization and the mean number of hospitalizations were both significantly lower for the depot typical cohort at 6 months (P<0.05) compared with oral typicals. In the usual care of outpatients with schizophrenia, treatment continuation among nonadherent patients is longer for depot typicals compared with oral typicals and is accompanied by less hospitalization in the short term.
Background: Little is known about the long-term changes in the functioning of schizophrenia patie... more Background: Little is known about the long-term changes in the functioning of schizophrenia patients receiving maintenance therapy with olanzapine long-acting injection (LAI), and whether observed changes differ from those seen with oral olanzapine. Methods: This study describes changes in the levels of functioning among outpatients with schizophrenia treated with olanzapine-LAI compared with oral olanzapine over 2 years. This was a secondary analysis of data from a multicenter, randomized, open-label, 2-year study comparing the long-term treatment effectiveness of monthly olanzapine-LAI (405 mg/4 weeks; n=264) with daily oral olanzapine (10 mg/day; n=260). Levels of functioning were assessed with the Heinrichs–Carpenter Quality of Life Scale. Functional status was also classified as “good”, “moderate”, or “poor”, using a previous data-driven approach. Changes in functional levels were assessed with McNemar’s test and comparisons between olanzapine-LAI and oral olanzapine employed the Student’s t-test. Results: Over the 2-year study, the patients treated with olanzapine-LAI improved their level of functioning (per Quality of Life total score) from 64.0–70.8 (P0.001). Patients on oral olanzapine also increased their level of functioning from 62.1–70.1 (P0.001). At baseline, 19.2% of the olanzapine-LAI-treated patients had a “good” level of functioning, which increased to 27.5% (P0.05). The figures for oral olanzapine were 14.2% and 24.5%, respectively (P0.001). Results did not significantly differ between olanzapine-LAI and oral olanzapine. Conclusion: In this 2-year, open-label, randomized study of olanzapine-LAI, outpatients with schizophrenia maintained or improved their favorable baseline level of functioning over time.
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