Real-world treatment utilization and economic implications of lupus nephritis disease activity in the United States.

BACKGROUND: Lupus nephritis (LN) is a common and severe complication of systemic lupus erythematosus (SLE), with approximately 40% of patients with SLE developing LN. Even with treatment, 10%-30% of patients will progress to end-stage renal disease (ESRD). Although many studies have assessed the clinical value of low disease activity in LN, the economic implications are less defined. OBJECTIVE: To evaluate treatment utilization and health care costs associated with active disease, low disease activity, and ESRD in patients with LN. METHODS: A retrospective analysis of Optum pharmacy and medical claims data from 2015 to 2019 was performed and included patients with a diagnosis of SLE (International Classification of Diseases, Ninth Revision or Tenth Revision codes 710.0 or M32, respectively) and additional prespecified criteria for LN. Total health care payer costs for medical and pharmacy services and treatment utilization for commonly prescribed medications were determined for periods of low disease activity, active disease, or ESRD. RESULTS: A total of 21,251 patients (mean age 60.3 years; 87% female; 55% White patients and 18% Black patients) with a mean follow-up period of 30.6 months were included; the majority of patients had active disease (67.3%), followed by low disease activity (51.3%), and ESRD (10.5%). Glucocorticoids were used 2 times more often and mycophenolate mofetil was used 4 times more often in patients with active disease vs low disease activity. Glucocorticoids, mycophenolate mofetil, and tacrolimus were more commonly used in patients with ESRD vs those with low disease activity. Mean medical costs were $4,777 per month in active disease and $18,084 per month in ESRD vs $2,523 per month in low disease activity. CONCLUSIONS: Treatment burden and costs are high for patients with active disease and ESRD in LN. Treatments that allow patients to achieve and maintain low disease activity may help improve patient outcomes and reduce medication use and overall health care costs. DISCLOSURES: Maria Dall'Era and Kenneth Kalunian are consultants of Aurinia Pharmaceuticals. Eric Turowski, Vanessa Birardi, Neil Solomons, Simrat Randhawa, and Paola Mina-Osorio are employees and stockholders of Aurinia Pharmaceuticals. Michael Eaddy is a former employee of Xcenda, LLC. Augustina Ogbonnaya and Eileen Farrelly are employees of Xcenda, LLC, which was contracted by Aurinia Pharmaceuticals to assist in the conduct of this study and the writing of this manuscript. Aurinia Pharmaceuticals provided funding for this study and the preparation of the manuscript. Aurinia Pharmaceuticals had a role in writing the report and decision to submit for publication.

Economic Impact of Transformation to Acute Myeloid Leukemia Among Actively Managed Patients with Higher-Risk Myelodysplastic Syndromes in the United States.

INTRODUCTION: Transformation of higher-risk myelodysplastic syndromes (MDS) to acute myeloid leukemia (AML) may be associated with increased healthcare resource utilization (HCRU) and costs. To describe this economic impact, HCRU and costs were compared between US patients who experienced transformation to AML and those who did not. METHODS: Using the Optum administrative claims data, this retrospective matched cohort study identified patients (≥ 18 years old) with higher-risk MDS who initiated first-line therapy between January 1, 2008, and June 30, 2019. Patients whose disease transformed to AML were matched 1:1 to patients whose disease did not transform, based on the duration of follow-up. The follow-up period was divided into two periods: pre- (before transformation to AML) and post-AML (after transformation to AML). For patients who did not transform to AML, pre- and post-AML periods were determined using the transformation date of their matched pair. HCRU and total adjusted costs (2019 US dollars, $) were compared between patients who transformed to AML and those who did not. RESULTS: A total of 118 matched patient pairs were included in the study. The hospitalization rate was significantly higher in patients who transformed than in those who did not during the entire follow-up (58.8% vs. 44.1%; P = 0.0295) and post-AML (47.5% vs. 28.0%; P = 0.0028) periods. Across all periods, supportive care use was significantly higher among patients who transformed to AML vs. patients who did not transform. Adjusted mean monthly costs for patients with higher-risk MDS who transformed to AML were higher than those who did not transform ($25,964 vs. $19,150; P < 0.0001). The observed total cost difference was more notable in the post-AML period ($36,424 vs. $14,860; P < 0.0001). CONCLUSIONS: Patients with higher-risk MDS whose disease transformed to AML incurred significantly higher healthcare costs compared to those whose disease did not transform, highlighting the important need for treatments that prevent or delay transformation.

Health Care Resource Utilization and Costs for Metastatic Breast Cancer Patients Newly Treated with Human Epidermal Growth Factor Receptor 2 (HER2)-Targeted Agents.

INTRODUCTION: HER2-positive metastatic breast cancer (mBC) is an incurable disease associated with years of chronic therapy and excess cost. HER2-targeted therapies have shown survival benefit for early-stage and mBC; however, the economic impact of these therapies has not been fully assessed. We evaluated health care resource use (HCRU) and costs of mBC patients treated with HER2-targeted therapy. METHODS: This was a retrospective cohort study using the IQVIA Real-World Data Adjudicated Claims Database (July 1, 2014 to July 31, 2019). Female patients aged ≥18 years with mBC who initiated HER2-targeted therapy in the prior year were identified. The index date was the initiation date of the HER2-targeted agent, after which patients were required to have ≥12 months of follow-up. Annual and cumulative all-cause and BC-related costs (2019 USD) and annual BC-related HCRU were computed in years 1, 2, and 3 following the index date. RESULTS: Following the initiation of HER2-targeted therapy, the mean annual total all-cause costs per patient in years 1 (n = 423), 2 (n = 357), and 3 (n = 166) were $320,892 (SD: $224,343), $235,159 (SD: $185,287), and $226,254 (SD: $197,901), respectively. The mean annual total BC-related costs were $240,048 (SD: $151,230), $175,631 (SD: $148,058), and $165,506 (SD: $159,374) in years 1, 2, and 3, respectively. A major portion of BC-related costs were costs associated with HER2-targeted treatment. The 3-year cumulative all-cause and BC-related total costs were $769,573 (SD: $456,920) and $624,455 (SD: $401,319), respectively. CONCLUSION: Treatment of HER2-positive mBC is a substantial economic burden. A potential approach to minimizing cost and HCRU is to prevent recurrence.

Economic Burden of Patients Treated for Higher-Risk Myelodysplastic Syndromes (HR-MDS) in Routine Clinical Care in the United States.

BACKGROUND AND OBJECTIVE: Significant clinical burden is associated with higher-risk myelodysplastic syndromes (HR-MDS); however, the economic burden has not been fully examined. We examined cost of care and healthcare utilization (HCU) in HR-MDS patients engaged in routine care in the United States (US). METHODS: Adult US patients diagnosed with HR-MDS from 1/1/2008 to 10/31/2015 were identified from the Optum database. Patients were followed until death, progression to acute myeloid leukemia (AML), end of enrollment, or end of study (12/31/2015). Myelodysplastic syndrome (MDS)-related costs/HCU (including medical/pharmacy claims with a primary diagnosis of MDS, MDS-related treatment, or supportive care) and non-MDS-related costs/HCU were evaluated. Costs were calculated as per-patient per-month (PPPM) costs adjusted to 2015 US dollars. RESULTS: Of the 209 HR-MDS patients included, median follow-up was 9.9 months (interquartile range 4.6-17.9), and 69.4% had at least one inpatient admission, 56.9% had at least one emergency department visit, and nearly all patients had at least one outpatient visit. Average PPPM costs over follow-up were $17,361; year 1 versus year 2 costs were higher ($17,337 vs $12,976) following HR-MDS diagnosis. The majority of costs were for MDS-related medical services ($10,327 PPPM). MDS-related medical PPPM costs decreased from $10,557 (year 1) to $6530 (year 2). The main drivers of MDS-related medical costs and the decrease in year 2 were chemotherapy and supportive care costs. CONCLUSIONS: The economic burden of HR-MDS is considerable, particularly within the first year of diagnosis. Treatment/supportive care costs accounted for a significant portion of MDS-related costs. As HR-MDS treatment evolves, the economic impact and HCU need to be further investigated.

Economic burden of elderly patients with acute myeloid leukemia treated in routine clinical care in the United States.

This retrospective claims database study examined healthcare utilization (HCU) and costs associated with acute myeloid leukemia (AML) in 237 elderly patients who received chemotherapy or a stem cell transplant (SCT) following AML diagnosis. Patients with secondary AML were excluded. Over the entire follow-up period, 92.0% of patients had ≥1 inpatient admission; 85.7% had ≥1 AML-related admission, and 42.6% had ≥1 non-AML-related admission. During inpatient admissions, 39.2% of patients had ≥1 intensive care unit (ICU) admission, with 20.7% having ≥1 AML-related ICU admission, and 27.8% having ≥1 non-AML-related ICU admission. Total mean per-patient per-month (PPPM) costs over the follow-up period were $25,243 (SD: $21,909), with costs from Year 1 ($27,756 [SD: $22,121]) more than double those in Year 2 ($12,953 [SD: $26,334]) following AML diagnosis. The majority of total costs were medical ($24,512 PPPM [SD: $21,704]), which included inpatient admissions ($6548 PPPM [SD: $10,777]), other outpatient visits ($5021 PPPM [SD: $7997]), supportive care ($3640 PPPM [SD: $5589], and chemotherapy administration ($2029 PPPM [SD: $2345]). Healthcare costs of treated elderly AML patients are substantial, particularly in the first year following diagnosis. Further research is needed to understand factors contributing to high costs in various settings of care for elderly AML patients.

Economic burden of patients with diffuse large B-cell and follicular lymphoma treated in the USA.

AIM: Evaluate healthcare costs and utilization of treated diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) patients. MATERIALS & METHODS: Adults with newly diagnosed DLBCL and FL between 1 January 2008 and 31 October 2015 were identified in the Optum™ claims database. Healthcare costs and utilization were assessed from diagnosis date until end of follow-up. RESULTS: A total of 1267 DLBCL- and 1595 FL-treated patients were identified. Mean per-patient, per-month cost during follow-up was US$11,890 for DLBCL and US$10,460 for FL. Healthcare costs and utilization decreased from year 1 to 2 following diagnosis, due to a decrease in chemotherapy services, inpatient admissions and other outpatient services. CONCLUSION: The economic burden of treated DLBCL and FL is considerable, especially in the first year following diagnosis.

Use and cost comparison of clobazam to other antiepileptic drugs for treatment of Lennox-Gastaut syndrome.

Background: Lennox-Gastaut syndrome (LGS) is a severe form of childhood-onset epilepsy associated with serious injuries due to frequent and severe seizures. Of the antiepileptic drugs (AEDs) approved for LGS, clobazam is a more recent market entrant, having been approved in October 2011. Recent AED budget impact and cost-effectiveness analyses for LGS suggest that adding clobazam to a health plan formulary may result in decreased medical costs; however, research on clinical and economic outcomes and treatment patterns with these AED treatments in LGS is limited. Objectives: To compare the baseline characteristics and treatment patterns of new initiators of clobazam and other AEDs among LGS patients and compare healthcare utilization and costs before and after clobazam initiation among LGS patients. Methods: A retrospective study of probable LGS patients was conducted using the MarketScan® Commercial, Medicare Supplemental, and Medicaid databases (10/1/2010-3/31/2014). Results: In the Commercial/Medicare Supplemental population, clobazam users were younger, had fewer comorbidities, and more prior AED use than non-clobazam users. In the 12 months pre-treatment initiation, clobazam users had significantly more seizure-related inpatient stays and outpatient visits and higher total seizure-related (P < 0.001) and all-cause (P < 0.001) costs than non-clobazam users. Among clobazam users, when compared to the 12 months pre-clobazam initiation, seizure-related medical utilization and costs were lower in the 12 months post-clobazam initiation (P = 0.004). Total all-cause (P < 0.001) and seizure-related (P = 0.029) costs increased post-clobazam initiation mainly due to the increase in outpatient pharmacy costs. Similar results were observed in the Medicaid population. Conclusions: Baseline results suggest a prescribing preference for clobazam in severe LGS patients. Clobazam users had a reduction in seizure-related medical utilization and costs after clobazam initiation. The improvement in medical costs mostly offset the higher prescription costs following clobazam initiation.

Rate of Adverse Events and Healthcare Costs Associated with the Topical Treatment of Rosacea.

BACKGROUND: Rosacea is a condition more common in women than in men, and in people aged ≥30 years than in younger patients. Adverse events associated with the use of topical medications for rosacea may lead to a lack of treatment adherence. Previous studies have reported low treatment adherence rates among patients with rosacea. OBJECTIVE: To describe the rate of treatment discontinuation resulting from adverse events and the associated healthcare costs among patients with rosacea who are receiving a topical medication. METHODS: We conducted a retrospective cohort study of patients diagnosed with rosacea based on International Classification of Diseases, Ninth Revision, Clinical Modification code 695.3 who were newly initiating topical treatment with metronidazole, azelaic acid, sodium sulfacetamide/sulfur, or benzoyl peroxide between January 1, 2009, and September 30, 2013. Patients were identified from the MarketScan Commercial Claims and Encounters database and the Medicare Supplemental database and had to be aged ≥30 years, have continuous coverage with medical and pharmacy benefits ≥12 months before treatment and ≥3 months after treatment inititation, and have no evidence of oral antibiotic use or ocular rosacea during the study period. The 3-month period immediately after the index date (ie, first topical rosacea treatment) was defined as the postindex period and was used to evaluate the outcome measures, which included the rate of adverse events, treatment patterns, and healthcare costs. RESULTS: The final cohort included 49,351 patients, with a mean age of 54 years, and 74.5% of the patients were female. Metronidazole was the most common (72.7%) treatment, followed by azelaic acid (21.7%), sodium sulfacetamide/sulfur (3.4%), and benzoyl peroxide (2.2%). A total of 6270 (12.7%) patients had a coded adverse event, of whom 199 (3.2%) continued treatment despite the adverse event, 466 (7.4%) switched to another treatment within 8.8 days, and 5605 (89.4%) discontinued therapy within 31.1 days. Patients with adverse events incurred, on average, a cost of $325 (medical, $143; pharmacy, $182) in rosacea-related costs; patients without adverse events incurred, on average, a cost of $172 (medical, $14; pharmacy, $157) in rosacea-related costs. CONCLUSIONS: The majority of adverse events associated with current topical drugs for rosacea resulted in treatment switch or discontinuation. Drugs with a different mechanism of action or new formulations of existing drugs may provide additional treatment options for patients and may lead to improved adherence and better symptom control.

Impact of adherence to antidepressants on healthcare outcomes and costs among patients with type 2 diabetes and comorbid major depressive disorder.

OBJECTIVE: To evaluate the association between adherence to antidepressants and an effect on clinical outcomes and healthcare costs in patients with major depressive disorder (MDD) and comorbid type 2 diabetes (T2D). METHODS: This retrospective study used MarketScan claims data from January 2012 to March 2014. Study entry was the first claim for an antidepressant and a diagnosis code for MDD and T2D in the prior 6 months. Adherence and persistence with antidepressant therapy in the first 180 days were defined as medication possession ratio (MPR) ≥ 80% and length of therapy (LOT), with no treatment gap of >15 days, respectively. T2D control (HbA1c <7%), oral diabetes medication adherence, and healthcare costs were measured in the 12 month post-index period. The impact of antidepressant adherence and persistence on outcomes was assessed using multivariable analyses. RESULTS: Among the 1361 patients included, the mean age was 59 years and 55% were women. About one-third of the patients were adherent (35.9%, mean MPR = 40%), persistent (32.0%, average LOT = 100 days), and adherent/persistent (31.2%) on antidepressants. Being adherent, persistent, or adherent/persistent to antidepressants was associated with a two-fold improvement in adherence to oral diabetes medications. Of those with HbA1c data (n = 121), adherence or adherence/persistence to antidepressants was associated with patients being five times more likely to have T2D control (odds ratio [OR]: 4.95; 95% confidence interval [CI]: 1.39, 17.59, p = .0134). Comparison between antidepressant-persistent and non-persistent patients was not significant. Mean difference in adjusted all-cause annual costs showed lower costs among antidepressant-adherent and adherent/persistent patients (adherent: -$350, 95% CI: -$462, -$247; adherent/persistent: -$1165; 95% CI: -$1280, -$1060). CONCLUSIONS: Patients with better antidepressant adherence and adherence/persistence demonstrated better HbA1c control, with lower all-cause total and medical costs. Adherence, persistence, or adherence/persistence to antidepressants was associated with improved adherence to oral diabetes medications.

Fall-related healthcare use and costs in neurogenic orthostatic hypotension with Parkinson's disease.

AIMS: To compare patient characteristics, rates, and costs of medically attended falls among patients with Parkinson's disease (PD) and probable PD plus neurogenic orthostatic hypotension (PD + nOH). MATERIALS AND METHODS: MarketScan Commercial and Medicare Supplemental databases (January 1, 2009-December 31, 2013) were used to identify PD and probable PD + nOH patients. The first medical or prescription claim suggesting these diagnoses served as the index date. Baseline characteristics and post-index all-cause and fall-related healthcare utilization and costs were compared between patient groups. RESULTS: A total of 17,421 PD and 281 PD + nOH patients were identified. Compared with PD patients, PD + nOH patients were older (77 vs 74 years; p < .0001) and had more comorbidities. Pre- and post-index date, more PD + nOH patients had a medically attended fall than PD patients (25% vs 20% [p = .0159] and 30% vs 21% [p = 0.0002], respectively). Fallers in both groups had similar numbers of medically attended falls 12-months pre-index (mean =1.9), but PD + nOH fallers had more falls post-index (2.5 vs 2.0; p = .0176). Compared with PD patients, more PD + nOH patients (all p < .01) had fall-related emergency department (ED) visits (18% vs 10%), hospitalizations (7% vs 3%), and non-office visit outpatient services (15% vs 10%). Adjusted total post-index medical costs for falls ($2,260 vs $1,049; p = .0002) and total all-cause costs ($31,260 vs $20,910; p < .0001) were higher for PD + nOH vs PD patients. LIMITATIONS: This study had some limitations. There is no ICD-9-CM diagnosis code for nOH, so a combination of PD and OH diagnoses (with confounding conditions excluded) served as a proxy for an nOH diagnosis. Also, the rate of falls and associated costs in these cohorts might be under-reported because only medically attended falls were evaluated. CONCLUSIONS: PD + nOH patients had a higher prevalence of pre-existing comorbidities and a higher rate of medically attended falls than those with PD alone, leading to increased costs of care.

Opioid Use Among Metastatic Prostate Cancer Patients With Skeletal-related Events.

PURPOSE: The development of skeletal-related events (SREs) (pathologic fracture, need for surgery and/or radiation to bone, spinal cord compression, and hypercalcemia of malignancy) in metastatic prostate cancer (MPC) is associated with worsened pain and compromised quality of life. Opioids are frequently used throughout the course of SRE treatment. This study describes the treatment patterns and incremental use of opioids in MPC patients diagnosed with SREs. METHODS: PC patients with bone metastases newly diagnosed with an SRE between January 1, 2005, and September 30, 2014, were identified using MarketScan Commercial and Medicare databases. Included patients were aged ≥40 years, had medical/pharmacy benefits for ≥12 months before (preindex) and ≥6 months after (postindex) diagnosis, and were without evidence of other primary cancers. Patients were categorized as nonusers of opioids (<10 days), short-term users (≥10 and <60 days), or long-term users (≥60 days) and further by SRE type. Opioid type, proportion of time on opioids, morphine-equivalent dose, adjuvant medications, and radiation use before and after SRE diagnosis were evaluated. FINDINGS: A total of 1071 eligible patients were identified (mean age, 71 years; 10.8% had chronic pain at baseline). The most common SRE types present were radiation (60.2%), radiation and bone surgery (15.0%), pathologic fracture (7.2%), and bone surgery (6.5%). Opioid use increased from 49.9% preindex to 53.3% postindex (P < 0.0001). The proportion of time on opioids doubled after SRE (pre, 0.3 vs post, 0.6; P < 0.0001). A greater percentage of patients used only opioids after an SRE (pre, 11.0%; post, 46.1% [P < 0.0001]), while a lesser percentage of patients used only radiation after an SRE (pre, 36.0%; post, 4.7% [P < 0.0001]). An increase was observed in patients using neither radiation nor opioids (pre, 14.5%; post, 42.0% [P < 0.0001]). An increase of ~50% was noted in long-term opioid users (from 22.1% to 32.1%). The use of monotherapy with a short-acting opioid decreased (pre, 35.1%; post, 32.5% [P < 0.0001]), while use of mixed opioids increased (pre, 13.7%; post, 19.1% [P < 0.0001]). Mean morphine-equivalent dose increased from pre- to post-SRE (9.1 vs 13.1 mg). Bisphosphonate and NSAID users decreased from before to after an SRE diagnosis (bisphosphonates, 40.2% vs 8.6%; NSAIDs, 26.7% vs 17.5% [both, P < 0.0001]). IMPLICATIONS: Long-term opioid use and dose were significantly increased after SRE development in MPC. The high percentage of patients not treated with an opioid or radiation potentially supports the need for additional treatment options for controlling pain if medically necessary and/or to prevent SREs.

Bivalirudin therapy is associated with improved clinical and economic outcomes in ST-elevation myocardial infarction patients undergoing percutaneous coronary intervention: results from an observational database.

BACKGROUND: Randomized trials show improved outcomes among acute coronary syndrome patients treated with bivalirudin. The objective of this analysis was to compare clinical and economic outcomes in ST-elevation myocardial infarction (STEMI) patients encountered in routine clinical practice undergoing primary percutaneous coronary intervention (PPCI), treated with bivalirudin or heparin+GP IIb/IIIa receptor inhibitor (heparin+GPI). METHODS AND RESULTS: STEMI admissions from January 1, 2004 through March 31, 2008 among patients receiving PPCI and bivalirudin or heparin+GPI in the Premier hospital database were identified. The probability of receiving bivalirudin was estimated using individual and hospital variables; using propensity scores, each bivalirudin patient was matched to 3 heparin+GPI treated patients. The primary outcome was in-hospital death. Rates of bleeding, transfusion, length of stay, and in-hospital cost were secondary outcomes. There were 59,917 STEMI PPCIs receiving bivalirudin (n=6735) or heparin+GPI (n=53,182). Seventy-nine percent of bivalirudin patients matched, resulting in 21,316 STEMI PPCIs for analysis. Compared with heparin+GPI patients, bivalirudin patients had fewer deaths (3.2% versus 4.0%; P=0.011) and less inpatient bleeding (clinically apparent bleeding [6.9% versus 10.5%, P<0.0001], clinically apparent bleeding with transfusion [1.6% versus 3.0%, P<0.0001], and transfusion [5.9% versus 7.6%, P<0.0001]). Patients receiving bivalirudin had shorter average length of stay (mean 4.3 versus 4.5 days; P<0.0001), with lower in-hospital cost (mean $18,640 versus $19,967 [median $14,462 versus $16,003], P<0.0001). CONCLUSIONS: This large "real-world" retrospective analysis demonstrates that bivalirudin therapy compared with heparin+GPI is associated with a lower rate of inpatient death, inpatient bleeding, and decreased overall in-hospital cost in STEMI patients undergoing PPCI.

Prevalence of stroke/transient ischemic attack among patients with acute coronary syndromes in a real-world setting.

BACKGROUND: Atherothrombosis is a systemic disease that may manifest as acute ischemic events in multiple vascular beds. Patients who have experienced an atherothrombosis-related ischemic event in 1 vascular bed are at risk for developing ischemic events in other vascular beds. Antiplatelet therapy demands an understanding of the balance between arterial thrombosis benefit and adverse event risk. Clinical trials indicate that dual antiplatelet therapy with aspirin and the newer thienopyridines increases the risk of bleeding in patients with acute coronary syndromes (ACS) with prior cerebrovascular events. Informed clinical decision making requires a better understanding of the real-world prevalence of cerebrovascular events. OBJECTIVE AND PURPOSE: To estimate the prevalence of stroke and/or transient ischemic attack (TIA) among patients with ACS within US health plan populations. METHODS: A retrospective, observational cohort study was conducted of patients with ACS in 5 health care claims databases. The index event was defined as the first documented inpatient health care claim for myocardial infarction or unstable angina. Patients with ≥12 months of pre-index medical care encounter information were included. Stroke/TIA was identified by the first health care claim for these conditions any time prior to or within 90 days following the index ACS event. RESULTS: Across all databases, between 3.8% and 15.7% of patients with ACS had prior stroke/TIA and between 3.4% and 11.7% of patients with ACS with no history of cerebrovascular events had documented stroke/TIA following the index ACS hospitalization. CONCLUSION: Despite important differences between the various database populations, there is a high prevalence of documented stroke/TIA in patients with ACS both prior to and following the ACS event. These real-world findings, set within the context of the increased bleeding risk observed with the newer thienopyridines, are important considerations when selecting antiplatelet therapy for patients with ACS.

Economic consequences of ACS-related rehospitalizations in the US.

OBJECTIVE: To examine economic consequences related to rehospitalization following initial acute coronary syndrome (ACS) treatment in United States managed care settings. STUDY DESIGN: Retrospective observational studies. RESEARCH DESIGN AND METHODS: Retrospective observational studies were conducted on two managed care populations to examine medical encounter insurance claims and charges for ACS-related rehospitalizations following an index hospitalization for new onset ACS (2002-2007). All charges were adjusted to year 2007 United States Dollars (USDs). MAIN OUTCOME MEASURES: The main outcomes for this study were the direct charges related to ACS rehospitalizations as captured in two separate medical encounter claims databases. RESULTS: Of the 11,266 ACS patients identified for analysis in the health system plan, 3588 (32%) had at least one ACS rehospitalization. Of the 97,177 ACS patients enrolled in the nationally representative managed care database, 32,578 (34%) had at least one ACS-related rehospitalization. Multivariate analyses demonstrated that coronary artery bypass graft (CABG) was the strongest predictor of increased charges during the recurrence in both populations (p < 0.0001). When controlling for length of stay (LOS) in the model, CABG remained a significant predictor of increased charges, while percutaneous coronary intervention (PCI) and stent insertion became even stronger predictors of increased charges. CONCLUSIONS: The costs associated with ACS-related rehospitalizations in a real-world setting are high, even when controlling for known cost drivers such as length of stay.

Clinical impact of early clopidogrel discontinuation following acute myocardial infarction hospitalization or stent implantation: analysis in a nationally representative managed-care population.

OBJECTIVES: To evaluate the association between discontinuation of clopidogrel therapy and risk of acute myocardial infarction (AMI) hospitalization or cardiac revascularization in a nationally-representative patient population following hospitalization for an AMI or coronary stent insertion. RESEARCH DESIGN AND METHODS: This observational cohort study was performed using data on patients from the PharMetrics Anonymous Patient-Centric Database who were hospitalized for an AMI or coronary stent insertion and subsequently treated with clopidogrel. Cox proportional hazard modeling was used to evaluate the association between clopidogrel discontinuation prior to 1 year post-initial AMI hospitalization and the primary endpoint of repeat AMI hospitalization or coronary intervention defined as percutaneous coronary intervention (PCI) with or without stent, or coronary artery bypass graft (CABG). MAIN OUTCOME MEASURES: The main outcome for this study was AMI hospitalization or coronary intervention defined as PCI with or without stent placement or CABG. RESULTS: A total of 31 835 patients were included in the analyses. Patients were predominantly male and the average patient age was approximately 60 years. After controlling for baseline patient characteristics and follow-up time, discontinuation of clopidogrel was associated with a significantly higher rate of hospitalization for AMI or coronary intervention (HR 1.34, 95% CI 1.22-1.44). CONCLUSION: Within a population of ACS patients drawn from a database of 85 US health plans, clopidogrel discontinuation within 1 year following hospitalization for AMI or stent placement is associated with an increased risk of AMI hospitalization or coronary intervention. The results of this study should be interpreted within the context of observational research, which does not address cause and effect relationships.