Jipan Xie

Patient-Reported Health Status in Coronary Heart Disease in the United States Age, Sex, Racial, and Ethnic Differences

Background— Coronary heart disease (CHD) affects 15.8 million Americans. However, data on the national impact of CHD on health-related quality of life, particularly among people of different age, sex, racial, and ethnic groups, are limited. Methods and Results— Using data from the 2000 and 2002 Medical Expenditure Panel Survey, we examined various measures of patient-reported health status, including health-related quality of life, in the CHD and non-CHD populations and differences in the measures among demographic subgroups. These measures included short-form generic measures (Short Form 12; Mental Component Summary-12 and Physical Component Summary-12) and EuroQol Group measures (EQ-5D index and EQ visual analog scale). Ordinary least-squares regressions were used to adjust for sociodemographic characteristics, risk factors, comorbidities, and proxy report. The adjusted difference between the CHD and non-CHD populations was −1.2 for Mental Component Summary-12 (2.4% of the score in the non-CHD population), −4.6 for Physical Component Summary-12 (9.2%), −0.04 for EQ-5D (4.6%), and −7.3 for EQ visual analog scale (9.0%) (all P<0.05). Differences among demographic subgroups were observed. Particularly, compared with whites, the differences between CHD and non-CHD in blacks were bigger in all measures except Physical Component Summary-12. A significantly bigger difference in Mental Component Summary-12 also was observed among Hispanics compared with non-Hispanics. Conclusions— CHD is associated with significant impairment of health-related quality of life and other patient-reported health status in the US adult population. Differences in the impairment associated with CHD exist across different age, racial, and ethnic groups. In addition to preventing CHD, effective public health interventions should be aimed at improving health-related quality of life and perceived health status in the CHD population, especially the most vulnerable groups.

Impact of Stroke on Health-Related Quality of Life in the Noninstitutionalized Population in the United States

Background and Purpose— Stroke is a major cause of long-term disability in the United States. This study examined the national impact of stroke on health-related quality of life (HRQoL) and disparities in HRQoL across different demographic groups. Methods— Combined 2000 and 2002 Medical Expenditure Panel Survey data were used, which include quality-of-life measures based on the short-form generic measures (SF-12) and the EuroQol Group measures (EQ-5D index and EQ VAS) for 39 680 adults aged >18 years. Stratified analysis and ordinary least square regressions were used to compare HRQoL scores between stroke and nonstroke populations. Results— The study included 1040 noninstitutionalized stroke survivors. After adjustment for sociodemographics, risk factors, and comorbidities, stroke survivors had statistically significantly lower mean scores for mental health (−4.1%), physical health (−7.9%), health utility (−6.9%), and self-rated health (−7.2%) (all P<0.01). In general, stroke did not affect differences in HRQoL among age or gender groups. However, racial and ethnic disparities in HRQoL were greater among stroke survivors than nonstroke individuals, particularly in health utility scores for black vs white participants (−0.06 in stroke survivors and −0.02 in the nonstroke population, P<0.01) and Hispanic versus non-Hispanic participants (−0.11 in stroke survivors and −0.01 in the nonstroke population). Conclusions— Stroke significantly impairs HRQoL in the United States. The findings suggest that racial and ethnic disparities in HRQoL among stroke survivors are more pronounced than in the nonstroke population. The burden of nonfatal stroke, especially among racial and ethnic minorities, should be recognized more widely.

Adherence, persistence, and medication discontinuation in patients with attention-deficit/hyperactivity disorder - a systematic literature review.

Untreated attention-deficit/hyperactivity disorder (ADHD) can lead to substantial adverse social, economic, and emotional outcomes for patients. The effectiveness of current pharmacologic treatments is often reduced, due to low treatment adherence and medication discontinuation. This current systematic literature review analyzes the current state of knowledge surrounding ADHD medication discontinuation, focusing on: 1) the extent of patient persistence; 2) adherence; and 3) the underlying reasons for patients’ treatment discontinuation and how discontinuation rates and reasons vary across patient subgroups. We selected 91 original studies (67 with persistence/discontinuation results, 26 with adherence results, and 41 with reasons for discontinuation, switching, or nonadherence) and 36 expert opinion reviews on ADHD medication discontinuation, published from 1990 to 2013. Treatment persistence on stimulants, measured by treatment duration during the 12-month follow-up periods, averaged 136 days for children and adolescents and 230 days for adults. Owing to substantial study heterogeneity, comparisons across age or medication type subgroups were generally inconclusive; however, long-acting formulations and amphetamines were associated with longer treatment duration than short-acting formulations and methylphenidates. The medication possession ratio, used to measure adherence, was <0.7 for all age groups and medication classes during a 12-month period. Adverse effects were the most commonly cited reason for discontinuation in all studies. Original research studies reported the lack of symptom control as a common discontinuation reason, followed by dosing inconvenience, social stigma associated with ADHD medication, and the patient’s attitude. In summary, although there was a lack of consistency in the measurement of adherence and persistence, these findings indicate that drug adherence and persistence are generally poor among patients with ADHD. Clinicians may be able to help improve adherence and persistence to ADHD treatment by educating caregivers and patients on treatment goals, administering long-acting medications, and following-up with patients to verify if medication is still effective and well-tolerated.

Everolimus-Based Therapy versus Chemotherapy among Patients with HR+/HER2− Metastatic Breast Cancer: Comparative Effectiveness from a Chart Review Study

Objective. To compare the real-world effectiveness of everolimus-based therapy and chemotherapy in postmenopausal women with hormone-receptor-positive/human-epidermal-growth-factor-receptor-2-negative (HR+/HER2−) metastatic breast cancer (mBC). Methods. This retrospective chart review examined a nationwide sample of postmenopausal HR+/HER2− mBC women in community-based oncology practices. Patients received everolimus-based therapy or chemotherapy for mBC between 07/01/2012 and 04/15/2013, after failure of a non-steroidal aromatase inhibitor. Overall survival (OS), progression-free survival (PFS), and time on treatment (TOT) were compared using Kaplan-Meier analysis and Cox proportional hazards models adjusting for line of therapy and baseline characteristics. Results. 234 and 137 patients received everolimus-based therapy and chemotherapy. Patients treated with everolimus-based therapy tended to have less aggressive mBC than patients treated with chemotherapy. Multivariate-adjusted Cox models showed that everolimus-based therapy was associated with significantly longer OS [hazard ratio (HR) = 0.37, 95% confidence interval (CI): 0.22–0.63], PFS (HR = 0.70, 95% CI = 0.50–0.97), and TOT (HR = 0.34, 95% CI: 0.25–0.45) than chemotherapy. Adjusted comparative effectiveness results were generally consistent across lines of therapy. Conclusion. In this retrospective chart review of postmenopausal HR+/HER2− mBC patients, treatment with everolimus-based therapy was associated with longer OS, PFS, and TOT than chemotherapy.

Cost Effectiveness of Guanfacine Extended-Release versus Atomoxetine for the Treatment of Attention-Deficit/Hyperactivity Disorder: Application of a Matching-Adjusted Indirect Comparison

BACKGROUND About 7% of children and adolescents are diagnosed with attention-deficit/hyperactivity disorder (ADHD) in the US. Patients with ADHD who are intolerant of or do not have an optimal response to stimulants often use non-stimulants as alternative therapies. Guanfacine extended-release (GXR) and atomoxetine (ATX) are the only non-stimulants approved by the US Food and Drug Administration for once-daily use in the treatment of children and adolescents with ADHD in the US. ATX has been on the market since 2002 while GXR was recently approved in 2009. To date, there is no comparative effectiveness or cost-effectiveness study comparing the two drugs. OBJECTIVES The aim of this study was to assess the cost effectiveness of GXR versus ATX for the treatment of ADHD in children and adolescents, using the comparative efficacy results from a matching-adjusted indirect comparison (MAIC). METHODS The MAIC method was used to compare the efficacy between GXR (target dose and lower doses) and ATX (target dose) in the absence of head-to-head clinical trials. Individual patients in the GXR trials were weighted such that the summary baseline characteristics and the efficacy of the placebo arm of the GXR trials matched exactly with those from published ATX trials. After weighting, the efficacy (i.e. change in the ADHD rating scale, fourth edition [ADHD-RS-IV] total score from baseline) was compared between each GXR dosing group and the ATX group. The results from the MAIC analyses were used to populate a 1-year Markov model that is used to compare the cost effectiveness of GXR versus ATX from a US third-party payer perspective. Effectiveness outcomes for each treatment group were estimated as the proportion of responders, defined as patients with ≥25% reduction in ADHD-RS-IV total score from baseline, and average quality-adjusted life years (QALYs). Utilities associated with response/non-response and disutilities due to adverse events were applied in the model. Costs included drug and medical service costs and were inflated to 2011 US dollars (

Real-world effectiveness of everolimus-based therapy versus fulvestrant monotherapy in HR(+)/HER2(-) metastatic breast cancer.

US). Incremental cost/QALY and incremental cost/responder were estimated. Univariate sensitivity analyses were conducted by varying all model parameters, including costs, utilities, and response rate. RESULTS The target dose of GXR was 0.12 mg/kg/day. In match-adjusted populations with balanced baseline characteristics, patients receiving GXR at the dose of 0.09-0.12(p = 0.0016) [DOSAGE ERROR CORRECTED] and 0.075-0.09 mg/kg/day (p = 0.0248) had better efficacy, while those receiving GXR at the dose of 0.046-0.075 mg/kg/day had comparable efficacy (p = 0.0699), compared with patients receiving ATX at the target dose of 1.2 mg/kg/day. In the base case of the cost-effectiveness analysis (CEA), GXR had incremental cost-effectiveness ratios of

Matching-adjusted indirect comparisons of efficacy of BAY 81-8973 vs two recombinant factor VIII for the prophylactic treatment of severe hemophilia A

US10 637/QALY and

Economic Evaluation of Denosumab Compared with Zoledronic Acid in Hormone-Refractory Prostate Cancer Patients with Bone Metastases

US853/responder, compared with ATX (incremental costs:

Electrocardiographic Recording and Timeliness of Clinician Evaluation in the Emergency Department in Patients Presenting With Chest Pain

US74; incremental effectiveness: 0.007 QALYs and 86 responders per 1000 patients treated). Results of all univariate sensitivity analyses showed that the model results were robust to changes in model inputs. CONCLUSIONS To our knowledge, this is the first application of the novel comparative efficacy method of MAIC to a CEA model. The MAIC results indicate that GXR (0.075-0.12 mg/kg/day) was more effective than ATX (1.2 mg/kg/day) in the trial population. The CEA results indicate that GXR is cost effective compared with ATX for the treatment of ADHD in children and adolescents.

Impact of atypical antipsychotic use among adolescents with attention-deficit/hyperactivity disorder

AIMS Assessing real-world effectiveness of everolimus-based therapy (EVE) versus fulvestrant monotherapy (FUL) among postmenopausal women with hormone receptor-positive (HR(+))/HER2(-) metastatic breast cancer (mBC) after progression on nonsteroidal aromatase inhibitor (NSAI). DATA & METHODS Medical charts of community-based patients who received EVE or FUL for mBC after NSAI were examined. Progression-free survival (PFS), time on treatment and time to chemotherapy were compared using Kaplan-Meier curves and Cox proportional hazards models adjusting for line of therapy and patient characteristics. RESULTS & CONCLUSION 192 patients received EVE and 156 FUL. After adjusting for patient characteristics, EVE was associated with significantly longer PFS than FUL (hazard ratio: 0.71; p = 0.045). EVE was associated with better PFS than FUL among NSAI-refractory postmenopausal HR(+)/HER2(-) mBC patients.