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Current Status Of Comorbid Depression Among Japanese Type 2 Diabetes Patients Based On Claims Database Analysis
A182
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
calculated. Finally, we computed the TBI score as the inverse of the overall burden experienced by each patient (ie, higher index score indicates less burden) to derive a score between 0 and 100. TBI score= 100 × [(Maximum burden score – Average burden score)/(Maximum burden score – Minimum burden score)] The mean TBI score for each trial arm represents the average of TBI scores for all patients in that arm. We applied this approach to a randomized, double-blind placebo-controlled trial (~150 patients per arm) from a discontinued development program on the antipsychotic drug bifeprunox, with risperidone included as an active reference. Results: Results demonstrated that TEAE rates varied widely among patients. As expected, the mean TBI, adjusted based on TEAE severity, severity-adjusted duration, and burden weight was higher for bifeprunox and risperidone compared with placebo and increased with dose. Conclusions: This approach will allow comparison of TEAE burden and tolerability between treatments. Further algorithm validation and elicitation of burden weight are ongoing. The approach presented here suggests that such scoring is possible, clinically relevant, and allows standardized comparison of tolerability profiles of antipsychotics. PMH2 Effect Of Psychopharmacotherapy Discontinuation On Body Mass Index Among Bipolar Children And Adolescents Patel A1, Chen H1, Chan W2, Sherer J1, Ochoa-Perez M3, Aparasu R1 of Houston, Houston, TX, USA, 2University of Texas Health Science Center, Houston, TX, USA, 3Legacy Community Health Services, Houston, TX, USA
1University
Objectives: To conduct a one-year comparative effectiveness study assessing the impact of psychotropic medication discontinuation on BMI among pediatric patients with bipolar disorder. Methods: A retrospective study was conducted using the GE-EMR database from 1995 to 2010 to identify individuals with bipolar disorder aged 18 years or less treated with atypical antipsychotics (AT), mood stabilizers (MS) or antidepressants (AD) who discontinued after a minimum of 3 month of the treatment. The date of discontinuation was defined as the index date and patients were followed for up to 3, 6, 9 and 12 months from discontinuation to observe whether BMI increases during treatment were reversible. Individuals without BMI measures prior to, during and post treatment were excluded. Repeated measures models were applied to account for the nesting effect of multiple BMI measures available to each individual, adjusting for the baseline BMI, socio-demographic factors, comorbidities and psychotherapy. Results: The cohort consisted of 1,265 individuals (mean age: 13.67±3.83 years). After discontinuation, most patients’ BMI stayed the same as during treatment and did not return to baseline. The proportion of overweight/obese (≥ 85th percentile) individuals, 12 months after discontinuation, was significantly higher (53.49%) than before treatment (51.03%). The BMI change after discontinuation was not associated with the specific treatment regimen the individuals received in the treatment phase or the amount of time elapsed after discontinuation. Older age and lower BMI at baseline was associated with greater reduction of BMI after treatment discontinuation at all follow-up periods. Conclusions: There was no significant difference between specific treatment regimens on BMI after treatment discontinuation. BMI increases during treatment were not completely reversible after discontinuation of treatment. Bipolar children and adolescents need to be monitored aggressively for height, weight and BMI during and after treatment and should be provided with nutritional and weight management counseling, especially after treatment. PMH3 Effect Of Psychopharmacotherapy Treatment On Body Mass Index Among Bipolar Children And Adolescents Patel A1, Chen H1, Aparasu R1, Chan W2, Sherer J1, Ochoa-Perez M3 of Houston, Houston, TX, USA, 2University of Texas Health Science Center, Houston, TX, USA, 3Legacy Community Health Services, Houston, TX, USA
1University
Objectives: To assess the differential impact of treatment options for bipolar disorders on BMI in children and adolescents. Methods: A retrospective study was conducted using the General Electric EMR database from 1995 to 2010 to identify bipolar individuals’ age 18 years or less who were prescribed atypical antipsychotics (AT), mood stabilizers (MS) or antidepressants (AD). The first bipolar diagnosis available in the data was defined as the index date. After excluding patients with bipolar diagnosis or medication prescription within 6 months pre-index and without at least one BMI measure pre-index and post-index, individuals were followed for up to 3, 6, 9 and 12 months if BMI data were available. Repeated measures models were applied to estimate the effect of treatment regimens on BMI after adjusting for the baseline BMI, socio-demographic factors, comorbidities and psychotherapy. The model helps account for the nesting effect of multiple BMI measures available for each individual. Results: The cohort consisted of 2,299 individuals (mean age: 13.51±3.87 years). Children and adolescents on MS-monotherapy regimens showed a steady increase in BMI over time (3 months: 0.11 kg/m2, 6 months: 0.09 kg/m2, 9 months: 0.09 kg/m2 and 12 months: 0.089 kg/m2.) Compared to individuals on MS monotherapy, individuals on AD monotherapy, AT+MS, AT+AD or MS+AD had similar patterns of change in BMI. AT monotherapy was the only regimen associated with greater BMI increase (3 months: 0.244 kg/m2, 6 months: 0.10 kg/m2, 9 months: 0.07 kg/m2, 12 months: 0.05 kg/m2) at all time points compared to MS monotherapy. A further analysis on AT recipients showed that subjects with a greater baseline BMI and at younger age experienced smaller increases in BMI at all time points. Conclusions: Children and adolescents on all treatment options for bipolar disorder are significantly associated with an increase in BMI and with the greatest increase observed among individuals on AT regimens. PMH4 Current Status Of Comorbid Depression Among Japanese Type 2 Diabetes Patients Based On Claims Database Analysis Takeshima T1, Iwasaki K1, Uda A2, Hiroi S2, Shimasaki Y2 1Milliman, Tokyo, Japan, 2Takeda Pharmaceutical Company Ltd., Tokyo, Japan
Objectives: Depression prevalence among diabetes patients is reported to be relatively high. It is also reported the comorbidity of depression among the diabetes patients might worsen glycemic control. However, the measures against depression for diabetes patients seem to be not enough in Japan. We examined depression prevalence in type 2 diabetes and the association with some factors to help prevent diabetes progression and depression prevalence. Methods: Data source was a Japanese employee based health insurance claims database containing company employees and their families. We used data having HbA1c in annual health checkup in 2014. Patients with type 2 diabetes and depression were identified by ICD10 codes. The patients undergoing diabetes treatment were defined as those prescribed diabetes drugs. The depression prevalence was analyzed in the patients and the others. Since the database contained fewer patients aged > 60, we extracted the type 2 diabetes patients aged ≤ 60, then conducted logistic regression analysis of the association of depression prevalence with HbA1c, age, sex and diabetes treatment. Results: Study population was 347,300 and type 2 diabetes prevalence was 11%. Depression prevalence rates in the patients and the others were 6% and 3%, respectively. The prevalence was higher in the patients than in the others in all age and sex groups. The depression prevalence in type 2 diabetes patients aged ≤ 60 associated with HbA1c [odds ratio (OR) = 1.228, p= 0.0003], age [OR= 1.028, p< 0.0001] and diabetes treatment [OR= 1.263, p= 0.0008], and without sex. Conclusions: We found the depression prevalence among type 2 diabetes patients was higher than in the others. There was positive association between HbA1c and depression prevalence; therefore, poor glycemic control probably may involve in depression prevalence. Because diabetes treatment seems to associate with depression prevalence, some measures considering comorbid depression should be required as well as glycemic control for type 2 diabetes patients. PMH5 Association Of Poor Health Behaviors With Depressive Disorders In Patients With Diabetes: A Composite Score Approach Shrestha S, Rowland AS University of New Mexico, Albuquerque, NM, USA
Objectives: High prevalence of diabetes and the comorbidities associated with it is of great public health concern because of its significant adverse effects on general health. Depressive disorders in diabetes patients are of particular interest because they are common and associated with poor health outcomes. The purpose of this study was to evaluate whether adverse health behaviors (poor nutrition, lack of physical activity, smoking and alcohol consumption) are predictive of presence of depressive disorders with subjects with diabetes. Methods: Using data from the U.S. Behavioral Risk Factor Surveillance System 2013, we identified participants who reported having been diagnosed with diabetes by a health professional. A composite health behavior score with four levels for each of the individual health behaviors (nutrition, physical activity, smoking and alcohol consumption) was created. The resulting composite health score ranging from 0 to 12 (0 being excellent health behavior score and 12 being the worst) was then grouped into quartiles. Multivariate logistic regression was performed to calculate the odds of having a depressive disorder based on calculated composite health behavior score. Results: The prevalence of depressive disorders in the study population was approximately 28%. Females with the poorest health behavior scores had 3.2 (95% CI: 2.9-3.6) times the odds of having depressive disorders while the males with similar score had OR of 1.6 (95% CI: 1.4-1.8) when compared to reference population of males with poorest health behavior scores after adjusting for other covariates. Conclusions: Composite health behaviors score was a strong predictor of depressive disorders in patients with diabetes. Encouraging patients with diabetes to improve health behaviors may be helpful in preventing depressive disorders and the poor health outcomes associated with it. However, because these are cross-sectional data, reverse causation can not be ruled out as an explanation. PMH6 Comparison Of Cardiovascular Risks Following Smoking Cessation Treatments Using Varenicline Versus Nrt Among Schizophrenic Smokers Wang X1, Wu I2, Chen H1, Bordnick P2, Essien EJ1, Johnson ML1, Peters R3, Abughosh SM1 of Houston, Houston, TX, USA, 2University of Houston, houston, TX, USA, 3University of Texas Health Science Center at Houston, houston, TX, USA
1University
Objectives: To compare the likelihood of developing cardiovascular risk factors with different cessation medications among schizophrenia patients. Methods: A retrospective cohort study was conducted using General Electric (GE) medical records database (1995 – 2011). The cohort consisted of patients with diagnosis of schizophrenia newly initiating any cessation medication. Index date was defined as the first day of being prescribed cessation medication. Follow up period was from 12 weeks after index date up to one year. Outcome of interest was cardiovascular risk factors indicated by elevated glucose, cholesterol, and blood pressure. The likelihood of developing cardiovascular risk factors was assessed using Cox proportional hazards regression model after adjusting other covariates. The primary independent variable was cessation medication type received. Other potential confounders included: age, race, gender, region, BMI , payment type , specialty group, nicotine addiction level, received smoking counseling, exposure to medications that may affect smoking status and severity of mental disorder. Results: Of the 580 incident users of cessation medication with diagnosis of schizophrenia, 276 (47.59%) had elevated glucose/cholesterol/blood pressure from week 12 up to one year after the initiation of cessation medications. Cox proportional hazard analysis showed that those initiated with NRT had lower risks in developing cardiovascular risk factors (HR= 0.71, 95% CI= 0.54 –0.94) compared to those who were initiated with Varenicline. Males (HR= 1.47, 95% CI= 1.14 –1.89), obese (HR= 1.63, 95% CI= 1.24 –2.15), and those with high comorbidity indices (HR= 1.17, 95% CI= 1.08 –1.26) had higher risks in developing elevated glucose/cholesterol/blood pressure. Conclusions: Smokers who were prescribed NRT were less likely to develop cardiovascular risk factors compared to those prescribed Varenicline. Other predictors associated with
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
calculated. Finally, we computed the TBI score as the inverse of the overall burden experienced by each patient (ie, higher index score indicates less burden) to derive a score between 0 and 100. TBI score= 100 × [(Maximum burden score – Average burden score)/(Maximum burden score – Minimum burden score)] The mean TBI score for each trial arm represents the average of TBI scores for all patients in that arm. We applied this approach to a randomized, double-blind placebo-controlled trial (~150 patients per arm) from a discontinued development program on the antipsychotic drug bifeprunox, with risperidone included as an active reference. Results: Results demonstrated that TEAE rates varied widely among patients. As expected, the mean TBI, adjusted based on TEAE severity, severity-adjusted duration, and burden weight was higher for bifeprunox and risperidone compared with placebo and increased with dose. Conclusions: This approach will allow comparison of TEAE burden and tolerability between treatments. Further algorithm validation and elicitation of burden weight are ongoing. The approach presented here suggests that such scoring is possible, clinically relevant, and allows standardized comparison of tolerability profiles of antipsychotics. PMH2 Effect Of Psychopharmacotherapy Discontinuation On Body Mass Index Among Bipolar Children And Adolescents Patel A1, Chen H1, Chan W2, Sherer J1, Ochoa-Perez M3, Aparasu R1 of Houston, Houston, TX, USA, 2University of Texas Health Science Center, Houston, TX, USA, 3Legacy Community Health Services, Houston, TX, USA
1University
Objectives: To conduct a one-year comparative effectiveness study assessing the impact of psychotropic medication discontinuation on BMI among pediatric patients with bipolar disorder. Methods: A retrospective study was conducted using the GE-EMR database from 1995 to 2010 to identify individuals with bipolar disorder aged 18 years or less treated with atypical antipsychotics (AT), mood stabilizers (MS) or antidepressants (AD) who discontinued after a minimum of 3 month of the treatment. The date of discontinuation was defined as the index date and patients were followed for up to 3, 6, 9 and 12 months from discontinuation to observe whether BMI increases during treatment were reversible. Individuals without BMI measures prior to, during and post treatment were excluded. Repeated measures models were applied to account for the nesting effect of multiple BMI measures available to each individual, adjusting for the baseline BMI, socio-demographic factors, comorbidities and psychotherapy. Results: The cohort consisted of 1,265 individuals (mean age: 13.67±3.83 years). After discontinuation, most patients’ BMI stayed the same as during treatment and did not return to baseline. The proportion of overweight/obese (≥ 85th percentile) individuals, 12 months after discontinuation, was significantly higher (53.49%) than before treatment (51.03%). The BMI change after discontinuation was not associated with the specific treatment regimen the individuals received in the treatment phase or the amount of time elapsed after discontinuation. Older age and lower BMI at baseline was associated with greater reduction of BMI after treatment discontinuation at all follow-up periods. Conclusions: There was no significant difference between specific treatment regimens on BMI after treatment discontinuation. BMI increases during treatment were not completely reversible after discontinuation of treatment. Bipolar children and adolescents need to be monitored aggressively for height, weight and BMI during and after treatment and should be provided with nutritional and weight management counseling, especially after treatment. PMH3 Effect Of Psychopharmacotherapy Treatment On Body Mass Index Among Bipolar Children And Adolescents Patel A1, Chen H1, Aparasu R1, Chan W2, Sherer J1, Ochoa-Perez M3 of Houston, Houston, TX, USA, 2University of Texas Health Science Center, Houston, TX, USA, 3Legacy Community Health Services, Houston, TX, USA
1University
Objectives: To assess the differential impact of treatment options for bipolar disorders on BMI in children and adolescents. Methods: A retrospective study was conducted using the General Electric EMR database from 1995 to 2010 to identify bipolar individuals’ age 18 years or less who were prescribed atypical antipsychotics (AT), mood stabilizers (MS) or antidepressants (AD). The first bipolar diagnosis available in the data was defined as the index date. After excluding patients with bipolar diagnosis or medication prescription within 6 months pre-index and without at least one BMI measure pre-index and post-index, individuals were followed for up to 3, 6, 9 and 12 months if BMI data were available. Repeated measures models were applied to estimate the effect of treatment regimens on BMI after adjusting for the baseline BMI, socio-demographic factors, comorbidities and psychotherapy. The model helps account for the nesting effect of multiple BMI measures available for each individual. Results: The cohort consisted of 2,299 individuals (mean age: 13.51±3.87 years). Children and adolescents on MS-monotherapy regimens showed a steady increase in BMI over time (3 months: 0.11 kg/m2, 6 months: 0.09 kg/m2, 9 months: 0.09 kg/m2 and 12 months: 0.089 kg/m2.) Compared to individuals on MS monotherapy, individuals on AD monotherapy, AT+MS, AT+AD or MS+AD had similar patterns of change in BMI. AT monotherapy was the only regimen associated with greater BMI increase (3 months: 0.244 kg/m2, 6 months: 0.10 kg/m2, 9 months: 0.07 kg/m2, 12 months: 0.05 kg/m2) at all time points compared to MS monotherapy. A further analysis on AT recipients showed that subjects with a greater baseline BMI and at younger age experienced smaller increases in BMI at all time points. Conclusions: Children and adolescents on all treatment options for bipolar disorder are significantly associated with an increase in BMI and with the greatest increase observed among individuals on AT regimens. PMH4 Current Status Of Comorbid Depression Among Japanese Type 2 Diabetes Patients Based On Claims Database Analysis Takeshima T1, Iwasaki K1, Uda A2, Hiroi S2, Shimasaki Y2 1Milliman, Tokyo, Japan, 2Takeda Pharmaceutical Company Ltd., Tokyo, Japan
Objectives: Depression prevalence among diabetes patients is reported to be relatively high. It is also reported the comorbidity of depression among the diabetes patients might worsen glycemic control. However, the measures against depression for diabetes patients seem to be not enough in Japan. We examined depression prevalence in type 2 diabetes and the association with some factors to help prevent diabetes progression and depression prevalence. Methods: Data source was a Japanese employee based health insurance claims database containing company employees and their families. We used data having HbA1c in annual health checkup in 2014. Patients with type 2 diabetes and depression were identified by ICD10 codes. The patients undergoing diabetes treatment were defined as those prescribed diabetes drugs. The depression prevalence was analyzed in the patients and the others. Since the database contained fewer patients aged > 60, we extracted the type 2 diabetes patients aged ≤ 60, then conducted logistic regression analysis of the association of depression prevalence with HbA1c, age, sex and diabetes treatment. Results: Study population was 347,300 and type 2 diabetes prevalence was 11%. Depression prevalence rates in the patients and the others were 6% and 3%, respectively. The prevalence was higher in the patients than in the others in all age and sex groups. The depression prevalence in type 2 diabetes patients aged ≤ 60 associated with HbA1c [odds ratio (OR) = 1.228, p= 0.0003], age [OR= 1.028, p< 0.0001] and diabetes treatment [OR= 1.263, p= 0.0008], and without sex. Conclusions: We found the depression prevalence among type 2 diabetes patients was higher than in the others. There was positive association between HbA1c and depression prevalence; therefore, poor glycemic control probably may involve in depression prevalence. Because diabetes treatment seems to associate with depression prevalence, some measures considering comorbid depression should be required as well as glycemic control for type 2 diabetes patients. PMH5 Association Of Poor Health Behaviors With Depressive Disorders In Patients With Diabetes: A Composite Score Approach Shrestha S, Rowland AS University of New Mexico, Albuquerque, NM, USA
Objectives: High prevalence of diabetes and the comorbidities associated with it is of great public health concern because of its significant adverse effects on general health. Depressive disorders in diabetes patients are of particular interest because they are common and associated with poor health outcomes. The purpose of this study was to evaluate whether adverse health behaviors (poor nutrition, lack of physical activity, smoking and alcohol consumption) are predictive of presence of depressive disorders with subjects with diabetes. Methods: Using data from the U.S. Behavioral Risk Factor Surveillance System 2013, we identified participants who reported having been diagnosed with diabetes by a health professional. A composite health behavior score with four levels for each of the individual health behaviors (nutrition, physical activity, smoking and alcohol consumption) was created. The resulting composite health score ranging from 0 to 12 (0 being excellent health behavior score and 12 being the worst) was then grouped into quartiles. Multivariate logistic regression was performed to calculate the odds of having a depressive disorder based on calculated composite health behavior score. Results: The prevalence of depressive disorders in the study population was approximately 28%. Females with the poorest health behavior scores had 3.2 (95% CI: 2.9-3.6) times the odds of having depressive disorders while the males with similar score had OR of 1.6 (95% CI: 1.4-1.8) when compared to reference population of males with poorest health behavior scores after adjusting for other covariates. Conclusions: Composite health behaviors score was a strong predictor of depressive disorders in patients with diabetes. Encouraging patients with diabetes to improve health behaviors may be helpful in preventing depressive disorders and the poor health outcomes associated with it. However, because these are cross-sectional data, reverse causation can not be ruled out as an explanation. PMH6 Comparison Of Cardiovascular Risks Following Smoking Cessation Treatments Using Varenicline Versus Nrt Among Schizophrenic Smokers Wang X1, Wu I2, Chen H1, Bordnick P2, Essien EJ1, Johnson ML1, Peters R3, Abughosh SM1 of Houston, Houston, TX, USA, 2University of Houston, houston, TX, USA, 3University of Texas Health Science Center at Houston, houston, TX, USA
1University
Objectives: To compare the likelihood of developing cardiovascular risk factors with different cessation medications among schizophrenia patients. Methods: A retrospective cohort study was conducted using General Electric (GE) medical records database (1995 – 2011). The cohort consisted of patients with diagnosis of schizophrenia newly initiating any cessation medication. Index date was defined as the first day of being prescribed cessation medication. Follow up period was from 12 weeks after index date up to one year. Outcome of interest was cardiovascular risk factors indicated by elevated glucose, cholesterol, and blood pressure. The likelihood of developing cardiovascular risk factors was assessed using Cox proportional hazards regression model after adjusting other covariates. The primary independent variable was cessation medication type received. Other potential confounders included: age, race, gender, region, BMI , payment type , specialty group, nicotine addiction level, received smoking counseling, exposure to medications that may affect smoking status and severity of mental disorder. Results: Of the 580 incident users of cessation medication with diagnosis of schizophrenia, 276 (47.59%) had elevated glucose/cholesterol/blood pressure from week 12 up to one year after the initiation of cessation medications. Cox proportional hazard analysis showed that those initiated with NRT had lower risks in developing cardiovascular risk factors (HR= 0.71, 95% CI= 0.54 –0.94) compared to those who were initiated with Varenicline. Males (HR= 1.47, 95% CI= 1.14 –1.89), obese (HR= 1.63, 95% CI= 1.24 –2.15), and those with high comorbidity indices (HR= 1.17, 95% CI= 1.08 –1.26) had higher risks in developing elevated glucose/cholesterol/blood pressure. Conclusions: Smokers who were prescribed NRT were less likely to develop cardiovascular risk factors compared to those prescribed Varenicline. Other predictors associated with