C3749pos1-depression hrqol - ips - oct 2011 (v3.0).pub
Impact on Health-Related Quality of Life of Selecting Aripiprazole for Treatment of Depression:
Results from the National Health and Wellness Survey
Iftekhar Kalsekar, Ph.D.1, Jan-Samuel Wagner, B.S.3, Marco DiBonaventura, Ph.D.3, Jay Bates, Ph.D.1, Robert A. Forbes Ph.D.2, Tony Hebden, Ph.D.1
1Bristol-Myers Squibb, Princeton, NJ, USA; 2Otsuka Pharmaceutical Development and Commercialization Inc., Princeton, NJ, USA; 3Kantar Health, New York, NY, USA
Use of atypical antipsychotics (AA) in combination with an antidepressant is recommended as an
Table 2. Depression Treatment History Differences Between
Comparison between aripiprazole and quetiapine (continued)
augmentation strategy for patients with depression. However, there is a paucity of data comparing aripiprazole and other AAs
Unadjusted differences between groups were examined using chi-square tests and independent-samples t-tests for
When controlling for demographics and health characteristics, aripiprazole users reported significantly higher MCS scores
categorical and continuous variables, respectively.
Patients Taking Aripiprazole or
(33.91 vs. 31.41, p<0.05) and bodily pain (55.06 vs. 46.53, p<0.05), general health (49.89 vs. 43.72, p<0.05), and
emotional role limitation domain scores (49.28 vs. 41.60, p<0.05) (see Figure 2). No differences on health utilities were
To determine if there are differences in health-related quality of life (HRQoL) between those patients who receive
Differences in HRQoL were also examined using General Linear Models (GLM), controlling for the demographics and
Another Atypical to Treat Their Depression
aripiprazole compared to those who receive another AA for treatment of depression.
health characteristics mentioned above. Adjusted means, which provide the mean HRQoL score when all covariates are
set at the sample mean, were obtained through a least-squares algorithm.
Data were obtained from the 2009, 2010, and 2011 National Health and Wellness Survey (NHWS), a
Figure 2. Adjusted HRQoL Scores of Patients Using Aripiprazole Versus Quetiapine
cross-sectional, Internet-based survey that is representative of the adult US population. Only those patients who reported
All analyses were conducted in SAS v9.1 and the a priori cutoff for statistical significance was p<0.05.
being diagnosed with depression by a physician and taking an antidepressant and AA for depression were included. Patients taking AA for less than 2 months or who were diagnosed with bipolar disorder or schizophrenia were excluded. Patients
taking aripiprazole were compared with patients taking another atypical antipsychotic. HRQoL was assessed using the
mental and physical component summaries of the Short Form 12-item (SF-12) health survey and the SF-6D health utility.
Higher scores indicate a better outcome with differences in component summary scores of 3.0 and health utility differences of
Psychiatrist as Prescribing
There were a total of 255 patients taking aripiprazole (59.86%) and 171 patients taking another atypical antipsychotic
0.03 deemed clinical y meaningful. Statistical analyses controlled for demographic and health characteristics using General
(40.14%). Of those taking another atypical antipsychotic, 11.11% were taking olanzapine (n=19), 74.27% were taking
quetiapine (n=127), 8.19% were taking risperidone (n=14), and 6.43% were taking ziprasidone (n=11).
Of the overall sample (n=426) 59.9% took aripiprazole (n=255) and 40.1% (n=171) took another AA [olanzapine
Years Diagnosed with
Compared with other atypical antipsychotic users, patients on aripiprazole were general y similar demographically (see
(n=19), quetiapine (n=127), risperidone (n=14) or ziprasidone (n=11)]. Mean scores for mental component summary (MCS)
Table 1). Patients taking aripiprazole were significantly more likely to be from the South (p<0.05), on disability (p<0.05) or
scores and bodily pain, general health and emotional role limitations (domains of the SF-12) were found to be significantly
retired (p<0.05), and to currently have health insurance (p<0.05). These patients were also less likely to currently smoke
higher (p < 0.05) for patients taking aripiprazole indicating better HRQoL compared to the combined group of other AA. After
1 - 5 years
controlling for demographic and health characteristics, patients taking aripiprazole reported significantly higher mean mental
Patients on aripiprazole were also similar to other atypical antipsychotic users in regards to their prescribing physician
SF-12 component summary (34.1 vs. 31.4, p<0.05), bodily pain (55.2 vs. 49.05, p<0.05), general health (50.1 vs. 43.1,
6 - 10 years
and the number of years they had been diagnosed with depression (see Table 2). However, aripiprazole patients were
p<0.05), emotional role limitations (49.4 vs. 41.8, p<0.05), and SF-6D utility scores (0.59 vs. 0.56, p<0.05).
11 years or more
significantly more likely to be concomitantly treated with an SNRI (p<0.05).
Comparison of patients taking aripiprazole with a cohort of patients using another AA for depression
demonstrated that aripiprazole was independently associated with better (both statistically and clinically) HRQoL and health
Table 1. Demographic and Health Characteristic Differences Between
Patients Taking Aripiprazole or
Another Atypical To Treat Their Depression
Major depressive disorder (MDD) is a mental il ness with a lifetime prevalence of approximately 16% in the United States
Unadjusted health-related quality of life differences
By 2020, it is estimated that depressive disorders will rank as the second most costly set of diseases global y, in terms of
Patients using aripiprazole reported significantly higher mean levels of mental component summary (MCS) scores (34.26
disability adjusted years (DALYs) lost (Donohue & Pincus 2007).
vs. 32.09, p<0.05) though no differences were observed on physical component summary (PCS) scores (42.05 vs. 40.14,
Although many treatments are available, 2 out of 5 patients with clinical depression will not respond to treatment, even
p=0.11). HRQoL was also higher for patients using aripiprazole in the domains of bodily pain scores (56.18 vs. 48.83,
after they have completed a course of fourth-line therapy (Rush et al 2006).
p<0.05), general health (49.92 vs. 42.95, p<0.05), and emotional role limitations (50.05 vs. 42.98, p<0.05). Differences in
mean health utility scores were marginally significant (0.57 vs. 0.54, p=0.06).
A number of randomized clinical trials have demonstrated the beneficial effects of olanzapine, quetiapine, risperidone,
aripiprazole (Komossa et al 2010; Chen et al 2011) as augmentation treatments to current antidepressants. However,
Adjusted health-related quality of life differences
direct comparisons among them are limited, particularly for patient-reported outcomes in a real-world environment (Chen
After controlling for demographics and health characteristic variables, the directionality of the differences were similar to
Married/Living with Partner
the unadjusted analysis, however the effect sizes increased (see Figure 1). Patients using aripiprazole reported significantly higher mean levels of mental component summary (MCS) scores (34.10 vs. 31.43, p<0.05). These patients
also reported significantly greater HRQoL as measured by the bodily pain (55.19 vs. 49.05, p<0.05), general health
(50.05 vs. 43.07, p<0.05), and emotional role limitation domain scores (49.44 vs. 41.83, p<0.05). Differences in mean
health utility scores were also significant (0.59 vs. 0.56, p<0.05).
To examine differences in health-related quality of life (HRQoL) between those patients who receive aripiprazole
All data were self-reported so recall bias may have introduced additional error into the observed associations.
compared to those who receive another AA for treatment of depression.
Figure 1. Adjusted HRQoL Scores of Patients Using Aripiprazole Versus Other
Atypical Antipsychotics for Depression
Given the cross-sectional and non-randomized design of the study, causal inference cannot be determined. Although
factors such as demographics, comorbidities, and health behaviors were controlled through multivariable modeling, it is
Some College Education
possible that other unmeasured variables might explain the relationship between depression treatment and health
This study used data from the 2009, 2010, and 2011 waves of the US National Health and Wellness Survey (NHWS;
Annual Household Income
It should also be emphasized that although the NHWS is demographically representative of the US population, the
sample in the current study of depression patients may differ in meaningful ways that could affect the size and direction
The NHWS is a cross-sectional, internet-based survey of adults (aged 18+) which uses a stratified random sampling
$25K to <$50K
framework to ensure representativeness of the US population (as assessed by the Current Population Survey of the US
$50K to <$75K
$75K or more
Sample and Procedure
This study assessed the relative treatment effects of aripiprazole on HRQoL and health utility scores compared with
All unique respondents who reported being diagnosed with depression by a physician and taking a combination of an
olanzapine, quetiapine, risperidone and ziprasidone, as part of combination therapy with antidepressants among patients
antidepressant and an atypical antipsychotic for at least 2 months were included in the study. Patients experiencing
who self-reported a depression diagnosis.
bipolar disorder or schizophrenia were excluded as were those with missing information regarding weight, income, or time
The results of the current study suggest that patients using aripiprazole have significantly better (both statistically and
clinically) HRQoL and health utilities compared to patients using other atypical antipsychotics in a real-world
The final sample included 426 patients, which included patients who were prescribed either aripiprazole, olanzapine,
quetiapine, risperidone, or ziprasidone.
Have Health Insurance
Type of atypical antipsychotic: Patients taking aripiprazole and an antidepressant were compared with patients taking
another atypical antipsychotic (olanzapine, quetiapine, risperidone, or ziprasidone) and an antidepressant.
Brazier, J., J. Roberts, et al. (2002). "The estimation of a preference-based measure of health from the SF-36." J Health Econ 21
None in Past Month
Health-related quality of life (HRQoL): Version 2 of the Medical Outcomes Study Short Form 12 (SF-12) questionnaire
Charlson, M. E., P. Pompei, et al. (1987). "A new method of classifying prognostic comorbidity in longitudinal studies: development
One to Nine Times a
(Ware et al 1996) was used to measure HRQoL. The SF-12v2 is a generic instrument which includes 8 health domains:
and validation." J Chronic Dis 40
physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social
• Chen, J., K. Gao, et al. (2011). "Second-generation antipsychotics in major depressive disorder: update and clinical perspective." Curr
functioning, role limitations due to emotional problems, and mental health. The health domains are summarized by two
Ten or More Times a
Opin Psychiatry 24
measures: the mental component summary (MCS) and physical component summary (PCS). Higher scores indicate a
• Donohue, J. M. and H. A. Pincus (2007). "Reducing the societal burden of depression: a review of economic costs, quality of care and
better outcome with differences in component summary scores of 3.0 deemed clinically meaningful.
effects of treatment." Pharmacoeconomics 25
Currently Drink Alcohol
Health utility: The SF-6D, which is a preference based health utility index calculated from the SF-12, was also reported
• Kessler, R. C., P. Berglund, et al. (2003). "The epidemiology of major depressive disorder: results from the National Comorbidity
Body Mass Index
(Brazier et al 2002). Scores vary from 0.29-1.00, where 1.00 indicates perfect health. Previous findings indicate the
Survey Replication (NCS-R)." JAMA 289
SF-6D is sensitive to remission of depressive symptoms (Lenert 2000). Health utility differences of 0.03 are deemed
• Komossa, K., A. M. Depping, et al. (2010). "Second-generation antipsychotics for major depressive disorder and dysthymia." Coch-
Comparison between aripiprazole and quetiapine
• Lenert, L. A., C. D. Sherbourne, et al. (2000). "Estimation of utilities for the effects of depression from the SF-12." Med Care 38
As the other AA cohort primarily consisted of patients using quetiapine (74.27%), a sub-analysis comparing aripiprazole
Demographics and health characteristics: Age, gender, ethnicity/race, region of the US, marital status, educational
and quetiapine users was conducted. The unadjusted results were very similar to the overal comparison between
attainment, annual household income, employment status, insurance coverage, BMI, exercise behavior, alcohol
aripiprazole users and atypical users. Significantly higher levels of MCS (34.26 vs. 31.91, p=0.041), bodily pain (56.18
• Rush, A. J., M. H. Trivedi, et al. (2006). "Acute and longer-term outcomes in depressed outpatients requiring one or several treatment
consumption, tobacco smoking behavior, type of antidepressant (selective serotonin reuptake inhibitors (SSRIs),
vs. 46.26, p=0.003), general health (49.92 vs. 43.78, p=0.045), mental health (41.57 vs. 36.81, p=0.048), and emotional
steps: a STAR*D report." Am J Psychiatry 163
serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and other), type of prescriber,
role limitations (50.05 vs. 42.62, p=0.018) were observed for patients using aripiprazole compared with patients using
Charlson Comorbidity Index
Ware, J., Jr., M. Kosinski, et al. (1996). "A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability
year surveyed, time since diagnosis, and the Charlson comorbidity index (Charlson et al., 1987) were assessed.
and validity." Med Care 34
Supported by funding from Bristol-Myers Squibb
63rd Institute on Psychiatric Services (IPS); October 27-30, 2011; San Francisco, CA, USA
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