OBJECTIVE The objective of this study was to ascertain to what extent adults with migraine value ... more OBJECTIVE The objective of this study was to ascertain to what extent adults with migraine value an early onset of efficacy for preventive migraine treatments. BACKGROUND In placebo-controlled clinical trials, treatment with eptinezumab resulted in a lower proportion of adults with migraine on the first day following infusion (day 1; 14% point-reduction for chronic migraine [CM] in PROMISE-2 and 8% point-reduction for episodic migraine [EM] in PROMISE-1). METHODS Adults with migraine completed an online preference-elicitation thresholding exercise to ascertain to what extent they value not having a migraine on day 1 postdosing relative to a clinically relevant reduction in number of migraine days during the first month postdosing (≥2 migraine-free days for CM and ≥1 migraine-free days for EM). RESULTS One hundred and one participants (mean age, 50.6 ± 12.4 years; 81 [80%] women) were included. In participants with CM, 29 of 50 (58%) considered the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing to be at least as important as a clinically relevant reduction in number of migraine days the first month postdosing, whereas 37 of 50 (74%) considered a clinically relevant reduction of migraine days the first month postdosing to have a value equivalent to the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing. In participants with EM, 18 of 35 (51%) considered the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing to be at least as important as a clinically relevant reduction in migraine days the first month postdosing, whereas 24 of 35 (69%) considered a clinically relevant reduction of migraine days the first month postdosing to have a value equivalent to the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing. CONCLUSION Most participants considered the reduction in the likelihood of migraine offered by eptinezumab on day 1 postdosing to be at least as important as a clinically relevant reduction in migraine days the first month postdosing.
TableS1. Individual medical comorbidities collected for patients with and without BD. This table ... more TableS1. Individual medical comorbidities collected for patients with and without BD. This table lists all of the ICD-9-CM diagnostic codes for the comorbid medical disorders observed in the study population. (DOCX 13 kb)
ClinicoEconomics and Outcomes Research, Dec 1, 2019
PurposeMajor depressive disorder (MDD) is a chronic mental disorder with a substantial clinical a... more PurposeMajor depressive disorder (MDD) is a chronic mental disorder with a substantial clinical and economic burden. Despite the efficacy of adjunctive atypical antipsychotics (AAP) for augmentation in patients with major depressive disorder (MDD) who failed first-line antidepressant therapy (ADT), little is known of the impact of AAP choices on healthcare resource use and costs in real-world practice. Therefore, this study compared real-world healthcare utilization and costs in patients with MDD treated with brexpiprazole or extended-release (XR) quetiapine as adjunctive treatment to ADT.Patients and methodsAdults with MDD starting adjunctive treatment with brexpiprazole (n=844) or extended-release (XR) quetiapine (n=688) were identified in the adjudicated health plan claims data (07/2014 – 09/2016). Resource use and healthcare costs in the 6 months following treatment initiation were compared between non-matched populations, and between propensity score-matched groups, and by multivariable regression analyses.ResultsDuring follow-up, unadjusted all-cause hospitalization (6.6% vs 12.5%) and ED visits (17.0% vs 27.5%) were lower with brexpiprazole compared to quetiapine XR (both p<0.001). Brexpiprazole-treated patients had significantly lower mean medical costs (US$6,421 vs US$8,545, p=0.0123) but higher mean pharmacy costs (US$7,401 vs US$4,691, p<0.0001) than quetiapine XR-treated patients did. Total healthcare costs were not significantly different between the two cohorts. Propensity score-matched comparisons of 397 patients in each cohort showed no statistically significant difference in all-cause hospitalization, ED visits, and total healthcare costs; and significantly lower medical costs (US$5,719 vs US$8,602, p=0.0092) but higher pharmacy costs (US$7,091 vs US$5,091, p=0.0007) in brexpiprazole compared to quetiapine XR. In multivariable regressions, brexpiprazole was associated with 16.1% lower medical costs (p=0.0186) and 9.4% higher total healthcare costs (p=0.0463) as compared to quetiapine XR.ConclusionSignificantly lower medical costs were observed in patients with MDD treated with brexpiprazole vs quetiapine XR.
Journal of Comparative Effectiveness Research, 2018
Aim: To examine hospitalization risk factors in antipsychotic-treated patients with schizophrenia... more Aim: To examine hospitalization risk factors in antipsychotic-treated patients with schizophrenia, bipolar I disorder (BD-I) or major depressive disorder (MDD). Patients & methods: Using Truven Health MarketScan® Commercial, Medicaid and Medicare Supplemental data (01/01/2012–06/30/2016), logistic regression models were performed to identify risk factors for both psychiatric and all-cause hospitalization in three separate analyses. Results: Significant risk factors included prior hospitalization (schizophrenia: odds ratio [95% CI]: 2.83 [2.50–3.21; psychiatric]; 2.58 [2.31–2.87; all-cause]; BD-I: 2.42 [2.23–2.63]; 2.09 [1.96–2.23]; MDD: 2.81 [2.49–3.16]; 2.21 [2.03–2.40]), previous antipsychotic treatment (schizophrenia: 1.71 [1.52–1.93]; 1.31 [1.18–1.46]; BD-I: 1.33 [1.23–1.44]; 1.22 [1.14–1.30]; MDD: 1.31 (1.11–1.54); 1.17 (1.04–1.32) and substance abuse (schizophrenia: 1.42 [1.27–1.60]; 1.37 [1.23–1.53]; BD-I: 1.72 [1.58–1.86]; 1.61 [1.50–1.72]; MDD: 1.90 [1.68–2.15] and 1.55 [1....
Alzheimer's disease (AD) is the most common neurodegenerative form of dementia. Pharmacologic... more Alzheimer's disease (AD) is the most common neurodegenerative form of dementia. Pharmacological therapies for symptomatic treatment, such as acetylcholinesterase inhibitors (AChEIs) and memantine, have been available in the USA since 2000. Over the past decade, few studies have analyzed real-world anti-dementia treatment patterns in the USA. This study evaluated monotherapy AChEIs and memantine treatment patterns among newly diagnosed AD patients. A retrospective cohort study was conducted using Medicare data and the Minimum Data Set from 2008 to 2012. Patients aged 65-100 years with newly diagnosed AD (ICD-9 code: 331.0) and monotherapy AChEI or memantine treatment initiated after diagnosis were included. Descriptive treatment pattern analyses, including discontinuation and switch, were undertaken. Kaplan-Meier curves were developed to examine the treatment duration. A total of 9812 newly diagnosed AD patients were identified, with 56.7% (n = 5567) first receiving anti-dementia...
Treatment of schizophrenia and major depressive disorder (MDD) with atypical antipsychotics (AAPs... more Treatment of schizophrenia and major depressive disorder (MDD) with atypical antipsychotics (AAPs) show improved efficacy and reduced side effect burden compared with older antipsychotic medications. However, a risk of treatment-emergent adverse events (TEAEs) remains. TEAEs are hard to quantify and perspectives on the importance of TEAEs differ across patients and between patients and physicians. The current study is a qualitative assessment that investigates TEAEs of AAPs from both patient and physician perspectives to provide better understanding of the occurrence and burden of TEAEs associated with these medications. Focus groups comprised of patients with MDD and interviews with patients with schizophrenia were conducted at two qualitative research facilities, along with a physician focus group at one of the facilities. Information collected from patients included an exhaustive list of TEAEs experienced, and the frequency and level of bother of each TEAE; from psychiatrists, in...
Electroencephalography and Clinical Neurophysiology, 1998
High spatial density recording and better topographic mapping algorithms have improved the spatia... more High spatial density recording and better topographic mapping algorithms have improved the spatial resolving power of the event-related potential (ERP), adding to its already excellent temporal resolution. This study used a 64 channel recording array and spherical spline interpolation to create topographic descriptions of the voltage and current density scalp distributions of the ERP in an auditory oddball paradigm. Frequent (standard) and infrequent (target) tones were presented at a rate of one every approximately 2500 ms to a group of 20 college undergraduates in passive listening and active (count the infrequent tones) task blocks. ANOVAs and topographic analyses were performed on the primary deflections in the &amp;amp;#39;late&amp;amp;#39; portion of the ERP: the P1, N1, P2, N2 and P3. A target minus standard difference wave was also created for each task. The difference wave contained a mismatch negativity (MMN), an N2b and a P3d. The MMN did not differ between the passive and active tasks and had a topography similar to the N1; also the difference wave P3d was topographically similar to the target P3. The N2b, which occurred only to targets in the active condition, and was the first index of target detection, had a scalp distribution consistent with generation in frontal and superior temporal cortex, suggesting activity in cortical areas of selective attention and auditory stimulus representation.
Background Although patients with dementia frequently experience neuropsychological symptoms (NPS... more Background Although patients with dementia frequently experience neuropsychological symptoms (NPS) such as agitation, which profoundly impacts patients, caregivers, and the healthcare system, few studies have evaluated the associated burden of agitation or agitation-related symptoms in dementia. Methods This retrospective analysis of claims data from the Truven Health MarketScan® database (2012–2015) compared clinical characteristics, treatment patterns, healthcare resource utilization, and costs among patients with dementia with behavioral disturbances (BD) versus patients with dementia without BD. Existing BD diagnosis codes 294.11 or 294.21 were used as a means to identify patients with agitation/agitation-related symptoms. Results From a starting sample of 6.4 million beneficiaries, 103,402 patients with dementia were identified, of whom 16,440 (16%) had BD during an average of 17 months of follow-up. Patients with BD had significantly more medical and psychiatric comorbidities ...
The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identi... more The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identify and measure treatment‐related needs, preferences, and priorities of individuals with or at risk for Alzheimer’s disease (AD) and care partners across the continuum of AD. First, the What Matters Most (WMM) study assessed needs, preferences and priorities of individuals in these populations. The next work will compare the WMM results to concepts in existing clinical outcome assessments (COAs) used in AD trials. This study identifies the most commonly used measures in AD research throughout the disease continuum.
Background: Few studies have examined patient characteristics and treatment patterns among patien... more Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%)...
The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identi... more The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identify and measure treatment‐related needs, preferences, and priorities of individuals across the continuum of AD. In the What Matters Most (WMM) study, we identified concepts of interest among patients and care partners and derived 42 items from these concepts.
Background: Few studies have examined patient characteristics and treatment patterns among patien... more Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%)...
OBJECTIVE The objective of this study was to ascertain to what extent adults with migraine value ... more OBJECTIVE The objective of this study was to ascertain to what extent adults with migraine value an early onset of efficacy for preventive migraine treatments. BACKGROUND In placebo-controlled clinical trials, treatment with eptinezumab resulted in a lower proportion of adults with migraine on the first day following infusion (day 1; 14% point-reduction for chronic migraine [CM] in PROMISE-2 and 8% point-reduction for episodic migraine [EM] in PROMISE-1). METHODS Adults with migraine completed an online preference-elicitation thresholding exercise to ascertain to what extent they value not having a migraine on day 1 postdosing relative to a clinically relevant reduction in number of migraine days during the first month postdosing (≥2 migraine-free days for CM and ≥1 migraine-free days for EM). RESULTS One hundred and one participants (mean age, 50.6 ± 12.4 years; 81 [80%] women) were included. In participants with CM, 29 of 50 (58%) considered the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing to be at least as important as a clinically relevant reduction in number of migraine days the first month postdosing, whereas 37 of 50 (74%) considered a clinically relevant reduction of migraine days the first month postdosing to have a value equivalent to the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing. In participants with EM, 18 of 35 (51%) considered the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing to be at least as important as a clinically relevant reduction in migraine days the first month postdosing, whereas 24 of 35 (69%) considered a clinically relevant reduction of migraine days the first month postdosing to have a value equivalent to the eptinezumab-generated reduction in the likelihood of migraine on day 1 postdosing. CONCLUSION Most participants considered the reduction in the likelihood of migraine offered by eptinezumab on day 1 postdosing to be at least as important as a clinically relevant reduction in migraine days the first month postdosing.
TableS1. Individual medical comorbidities collected for patients with and without BD. This table ... more TableS1. Individual medical comorbidities collected for patients with and without BD. This table lists all of the ICD-9-CM diagnostic codes for the comorbid medical disorders observed in the study population. (DOCX 13 kb)
ClinicoEconomics and Outcomes Research, Dec 1, 2019
PurposeMajor depressive disorder (MDD) is a chronic mental disorder with a substantial clinical a... more PurposeMajor depressive disorder (MDD) is a chronic mental disorder with a substantial clinical and economic burden. Despite the efficacy of adjunctive atypical antipsychotics (AAP) for augmentation in patients with major depressive disorder (MDD) who failed first-line antidepressant therapy (ADT), little is known of the impact of AAP choices on healthcare resource use and costs in real-world practice. Therefore, this study compared real-world healthcare utilization and costs in patients with MDD treated with brexpiprazole or extended-release (XR) quetiapine as adjunctive treatment to ADT.Patients and methodsAdults with MDD starting adjunctive treatment with brexpiprazole (n=844) or extended-release (XR) quetiapine (n=688) were identified in the adjudicated health plan claims data (07/2014 – 09/2016). Resource use and healthcare costs in the 6 months following treatment initiation were compared between non-matched populations, and between propensity score-matched groups, and by multivariable regression analyses.ResultsDuring follow-up, unadjusted all-cause hospitalization (6.6% vs 12.5%) and ED visits (17.0% vs 27.5%) were lower with brexpiprazole compared to quetiapine XR (both p<0.001). Brexpiprazole-treated patients had significantly lower mean medical costs (US$6,421 vs US$8,545, p=0.0123) but higher mean pharmacy costs (US$7,401 vs US$4,691, p<0.0001) than quetiapine XR-treated patients did. Total healthcare costs were not significantly different between the two cohorts. Propensity score-matched comparisons of 397 patients in each cohort showed no statistically significant difference in all-cause hospitalization, ED visits, and total healthcare costs; and significantly lower medical costs (US$5,719 vs US$8,602, p=0.0092) but higher pharmacy costs (US$7,091 vs US$5,091, p=0.0007) in brexpiprazole compared to quetiapine XR. In multivariable regressions, brexpiprazole was associated with 16.1% lower medical costs (p=0.0186) and 9.4% higher total healthcare costs (p=0.0463) as compared to quetiapine XR.ConclusionSignificantly lower medical costs were observed in patients with MDD treated with brexpiprazole vs quetiapine XR.
Journal of Comparative Effectiveness Research, 2018
Aim: To examine hospitalization risk factors in antipsychotic-treated patients with schizophrenia... more Aim: To examine hospitalization risk factors in antipsychotic-treated patients with schizophrenia, bipolar I disorder (BD-I) or major depressive disorder (MDD). Patients & methods: Using Truven Health MarketScan® Commercial, Medicaid and Medicare Supplemental data (01/01/2012–06/30/2016), logistic regression models were performed to identify risk factors for both psychiatric and all-cause hospitalization in three separate analyses. Results: Significant risk factors included prior hospitalization (schizophrenia: odds ratio [95% CI]: 2.83 [2.50–3.21; psychiatric]; 2.58 [2.31–2.87; all-cause]; BD-I: 2.42 [2.23–2.63]; 2.09 [1.96–2.23]; MDD: 2.81 [2.49–3.16]; 2.21 [2.03–2.40]), previous antipsychotic treatment (schizophrenia: 1.71 [1.52–1.93]; 1.31 [1.18–1.46]; BD-I: 1.33 [1.23–1.44]; 1.22 [1.14–1.30]; MDD: 1.31 (1.11–1.54); 1.17 (1.04–1.32) and substance abuse (schizophrenia: 1.42 [1.27–1.60]; 1.37 [1.23–1.53]; BD-I: 1.72 [1.58–1.86]; 1.61 [1.50–1.72]; MDD: 1.90 [1.68–2.15] and 1.55 [1....
Alzheimer's disease (AD) is the most common neurodegenerative form of dementia. Pharmacologic... more Alzheimer's disease (AD) is the most common neurodegenerative form of dementia. Pharmacological therapies for symptomatic treatment, such as acetylcholinesterase inhibitors (AChEIs) and memantine, have been available in the USA since 2000. Over the past decade, few studies have analyzed real-world anti-dementia treatment patterns in the USA. This study evaluated monotherapy AChEIs and memantine treatment patterns among newly diagnosed AD patients. A retrospective cohort study was conducted using Medicare data and the Minimum Data Set from 2008 to 2012. Patients aged 65-100 years with newly diagnosed AD (ICD-9 code: 331.0) and monotherapy AChEI or memantine treatment initiated after diagnosis were included. Descriptive treatment pattern analyses, including discontinuation and switch, were undertaken. Kaplan-Meier curves were developed to examine the treatment duration. A total of 9812 newly diagnosed AD patients were identified, with 56.7% (n = 5567) first receiving anti-dementia...
Treatment of schizophrenia and major depressive disorder (MDD) with atypical antipsychotics (AAPs... more Treatment of schizophrenia and major depressive disorder (MDD) with atypical antipsychotics (AAPs) show improved efficacy and reduced side effect burden compared with older antipsychotic medications. However, a risk of treatment-emergent adverse events (TEAEs) remains. TEAEs are hard to quantify and perspectives on the importance of TEAEs differ across patients and between patients and physicians. The current study is a qualitative assessment that investigates TEAEs of AAPs from both patient and physician perspectives to provide better understanding of the occurrence and burden of TEAEs associated with these medications. Focus groups comprised of patients with MDD and interviews with patients with schizophrenia were conducted at two qualitative research facilities, along with a physician focus group at one of the facilities. Information collected from patients included an exhaustive list of TEAEs experienced, and the frequency and level of bother of each TEAE; from psychiatrists, in...
Electroencephalography and Clinical Neurophysiology, 1998
High spatial density recording and better topographic mapping algorithms have improved the spatia... more High spatial density recording and better topographic mapping algorithms have improved the spatial resolving power of the event-related potential (ERP), adding to its already excellent temporal resolution. This study used a 64 channel recording array and spherical spline interpolation to create topographic descriptions of the voltage and current density scalp distributions of the ERP in an auditory oddball paradigm. Frequent (standard) and infrequent (target) tones were presented at a rate of one every approximately 2500 ms to a group of 20 college undergraduates in passive listening and active (count the infrequent tones) task blocks. ANOVAs and topographic analyses were performed on the primary deflections in the &amp;amp;#39;late&amp;amp;#39; portion of the ERP: the P1, N1, P2, N2 and P3. A target minus standard difference wave was also created for each task. The difference wave contained a mismatch negativity (MMN), an N2b and a P3d. The MMN did not differ between the passive and active tasks and had a topography similar to the N1; also the difference wave P3d was topographically similar to the target P3. The N2b, which occurred only to targets in the active condition, and was the first index of target detection, had a scalp distribution consistent with generation in frontal and superior temporal cortex, suggesting activity in cortical areas of selective attention and auditory stimulus representation.
Background Although patients with dementia frequently experience neuropsychological symptoms (NPS... more Background Although patients with dementia frequently experience neuropsychological symptoms (NPS) such as agitation, which profoundly impacts patients, caregivers, and the healthcare system, few studies have evaluated the associated burden of agitation or agitation-related symptoms in dementia. Methods This retrospective analysis of claims data from the Truven Health MarketScan® database (2012–2015) compared clinical characteristics, treatment patterns, healthcare resource utilization, and costs among patients with dementia with behavioral disturbances (BD) versus patients with dementia without BD. Existing BD diagnosis codes 294.11 or 294.21 were used as a means to identify patients with agitation/agitation-related symptoms. Results From a starting sample of 6.4 million beneficiaries, 103,402 patients with dementia were identified, of whom 16,440 (16%) had BD during an average of 17 months of follow-up. Patients with BD had significantly more medical and psychiatric comorbidities ...
The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identi... more The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identify and measure treatment‐related needs, preferences, and priorities of individuals with or at risk for Alzheimer’s disease (AD) and care partners across the continuum of AD. First, the What Matters Most (WMM) study assessed needs, preferences and priorities of individuals in these populations. The next work will compare the WMM results to concepts in existing clinical outcome assessments (COAs) used in AD trials. This study identifies the most commonly used measures in AD research throughout the disease continuum.
Background: Few studies have examined patient characteristics and treatment patterns among patien... more Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%)...
The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identi... more The Alzheimer's Disease Patient and Caregiver Engagement (AD PACE) Initiative works to identify and measure treatment‐related needs, preferences, and priorities of individuals across the continuum of AD. In the What Matters Most (WMM) study, we identified concepts of interest among patients and care partners and derived 42 items from these concepts.
Background: Few studies have examined patient characteristics and treatment patterns among patien... more Background: Few studies have examined patient characteristics and treatment patterns among patients with dementia and agitation in the United States (US). Objective: To examine real-world treatment patterns and characteristics of patients with agitation related to dementia who were treated with antipsychotics in US residential care and community-based settings. Methods: This retrospective chart review collected US physician-level data from patients 55 to 90 years old initiated on an antipsychotic medication for the treatment of agitation related to dementia from January 2018 to May 2018. Clinical characteristics and treatment patterns were assessed overall and stratified by residential care and community-based settings. Results: A total of 313 participating physicians, 59.5% of whom were primary care physicians, abstracted 801 patient charts (residential care: n = 312; community-based: n = 489). Of patients with agitation who were initiated on an antipsychotic, most patients (74.5%)...
Uploads