Colesevelam, Ezetimibe, and Patients With Type 2 Diabetes Mellitus: Characteristics and Clinical Outcomes From a Health Care Database.

BACKGROUND: Despite the prevalence of therapies available to patients at highest coronary heart disease risk, only a minority of type 2 diabetes mellitus (T2DM) patients reach desired cholesterol treatment levels, with limited data regarding their outcomes. OBJECTIVE: To examine "real-world" effectiveness of initiating treatment with either colesevelam or ezetimibe among individuals with evidence of T2DM and hypercholesterolemia (HCh). Key outcomes included treatment patterns and cardiovascular (CV) events. METHODS: This retrospective administrative claims-based study utilized medical, pharmacy, and enrollment data linked to laboratory results information from a large United States health plan (January 1, 2006, to March 31, 2011) and included individuals with recorded evidence of T2DM and HCh. The index date was the date of first pharmacy claim for colesevelam or ezetimibe, with cohort assignment based on index medication. Assessments included baseline characteristics, follow-up treatment patterns, and composite CV event, with propensity score matching to correct for sample selection bias. RESULTS: In total, 4231 individuals were identified with evidence of HCh and T2DM (ezetimibe n = 3384; colesevelam n = 847). After matching, the baseline characteristics between cohorts were rendered to be similar. Mean days of persistent medication use was lower with colesevelam compared with ezetimibe (P < 0.001). Compared with ezetimibe, a smaller percentage of individuals in the colesevelam cohort experienced a follow-up composite CV event, and adjusted Cox model results suggested decreased risk (hazard ratio = 0.58; P = 0.004) of a follow-up composite CV event. CONCLUSION: In this health care database analysis among patients with HCh and T2DM, colesevelam was associated with decreased risk of a composite CV event compared with ezetimibe, despite lower persistence.

Real-world primary nonadherence to antiobesity medications.

BACKGROUND: Primary nonadherence (PNA), when a medication is newly prescribed but not filled, has been identified as a major research gap potentially impacting the optimal treatment of patients with overweight and obesity who are newly prescribed antiobesity medications (AOMs). OBJECTIVES: To assess PNA among patients with newly prescribed AOMs and to examine factors associated with PNA to AOMs. METHODS: This was a retrospective study that used the Optum Integrated Clinical plus Claims database to identify individuals who had at least 1 prescription order for an AOM the US Food and Drug Administration approved for long-term use. Individuals with prescription orders between January 1, 2012, and February 28, 2019, were identified, and patient demographics, clinical characteristics, medication prescribed, baseline health care utilization, and obesity-related complications were described by PNA status. PNA was defined as no pharmacy claim for the AOM within 60 days of the date of the new prescription order as identified in electronic health record data. A multivariable logistic regression model was used to examine factors associated with PNA. RESULTS: The study sample included a total of 1,563 patients. The mean body mass index was 38.4 kg/m2; 10.7% were prescribed liraglutide 3.0 mg, 26.0% were prescribed lorcaserin, 36.3% of patients were prescribed naltrexone-bupropion, 5.4% were prescribed orlistat, and 21.6% were prescribed phentermine-topiramate. Most patients (91.1%) exhibited PNA, with only 8.9% filling their newly prescribed AOM within 60 days. Both the adherent and nonadherent groups were predominately female sex, White, and covered by commercial insurance. The mean age was similar between the 2 groups. Most obesity-related complications were less prevalent in the adherent group, although the Charlson comorbidity index score was similar between the 2 groups. After adjustment for patient demographics and clinical characteristics, there was not a statistically significant association between the specific AOM and PNA (P = 0.299). Patients with depression or living in the Midwest or South regions were at significantly increased risk of PNA. CONCLUSIONS: The rate of PNA to AOMs was very high, suggesting barriers in effective medical management of patients with overweight and obesity. Future research is warranted to understand reasons for PNA to AOMs and how to address these barriers. DISCLOSURES: Dr Kan, Dr Bae, Dr Dunn, and Dr Ahmad are employees of Eli Lilly and Company. Ms Buysman and Dr Gronroos are employees of Optum. Dr Swindle was an employee of Optum at the time the study was conducted and is currently employed at Evidera. Dr Bengtson is employed at Boehringer Ingelheim Pharmaceuticals, Inc. (Boehringer Ingelheim has no connection to this study), and during the conduct of this study was employed at Optum.

Weight management treatment modalities in patients with overweight or obesity: A retrospective cohort study of administrative claims data.

Background: The purpose of this study was to describe demographic and clinical characteristics among patients who have medical encounters for weight management treatments and to investigate the association of those characteristics with treatment modality. Methods: This was a retrospective database study using medical claims, pharmacy claims, and enrollment information from commercial and Medicare Advantage with Part D members in the Optum Research Database from 01/01/2011-2/29/2020. Adult patients with a claim for a weight management treatment from 01/01/2012-2/28/2019 were categorized into cohorts according to the highest intensity intervention received. To examine the association between patient characteristics and treatment modality received, a multinomial logit model was performed. Results: Cohorts by increasing intensity included lifestyle intervention (LSI, n = 67,679), weight reduction pharmacotherapy (WRRx) with an anti-obesity medication (AOM, n = 6,905), weight reduction procedure (WRP, n = 1,172), and weight reduction surgery (WRS, n = 18,036). Approximately 32.1% and 16.6% of patients who received WRS or WRP had an LSI during the 12-month baseline, and only 0.6% and 0.4% had treatment with long-term AOMs. In a multinomial logit model, patients with type 2 diabetes (not including WRRx cohort), respiratory disorders, cardiovascular risk factors, pain disorders, and mental health conditions had increased odds of treatment with higher intensity intervention versus LSI. Patients who were male, received an intervention more recently (2016-2019), or had a Charlson comorbidity score of 1 (compared to 0) had decreased odds of treatment with higher intensity interventions. Conclusion: In this study, age, sex, body mass index, obesity-related complications, and Charlson comorbidity score appeared to influence the type of weight management treatment modality received. This study improves understanding of weight management treatment utilization and identifies gaps and opportunities to improve obesity care with the appropriate use of different treatment modalities.

Retrospective Real-World Evaluation of Outcomes in Patients with Skin and Soft Structure Infections Treated with Tedizolid in an Outpatient Setting.

INTRODUCTION: Outcomes data for patients who received tedizolid for acute bacterial skin and skin-structure infections (ABSSSIs) are scant. We provide a real-world analysis of economic and clinical outcomes following tedizolid use in the outpatient setting. METHODS: This retrospective study of adults with skin infections treated with tedizolid (index period: 1 July 2014-31 May 2016) used data from the Optum Research and Impact National Benchmark databases. RESULTS: Ninety-one patients received tedizolid for the treatment of skin infections (with complications, n = 18; without complications, n = 73). Some patients had > 1 complication and infection site. Among patients with complications, pre-index complications during the [index date - 30] through [index date + 1] period included osteomyelitis (44.4%), septicemia (44.4%), and prosthetic joint/device/graft infection (16.7%). For the [index date - 7] through [index date + 1] period, the infection site included abscesses (55.6%) and chronic ulcers (38.9%). Mean (standard deviation [SD]) days supplied for the index tedizolid claim was 6.8 (2.3) days. Healthcare resource utilization (HCRU) during the 30-day post-index period included ≥ 1 ambulatory visit (100.0%), ≥ 1 emergency department (ED) visit (16.7%), and ≥ 1 hospitalization (22.2%). Median 30-day post-index all-cause costs were $11,098 [lower quartile (Q1), $5688; upper quartile (Q3), $16,246; mean (SD), $14,637 ($11,435)]. Among patients without complications, the pre-index infection site from ([index date - 7] through [index date + 1]) included abscesses (60.3%), chronic ulcers (37.0%), and cellulitis (2.7%). Mean (SD) days supplied for the index tedizolid claim was 6.6 (2.5) days. Thirty-day post-index HCRU included ≥ 1 ambulatory visit (91.8%), ≥ 1 ED visit (17.8%), and ≥ 1 hospitalization (5.5%). Median 30-day post-index all-cause costs were $3230 (Q1, $2345; Q3, $6847; mean [SD], $6898 [$11,129]). CONCLUSIONS: Patients treated with tedizolid in the outpatient setting experienced a short duration of therapy, low hospital admission, and modest post-index HCRU indicators, suggesting its utility for outpatient therapy of ABSSSIs.

Healthcare costs among patients with hemophilia A treated with factor replacement or bypassing agents.

Objective: To assess real-world costs for patients with hemophilia A treated with bypassing agents versus factor VIII (FVIII) replacement. Methods: Claims data from a large US health insurer during 1 January 2006-30 September 2014 were used for analysis. Treated patients with hemophilia A were identified based on ≥1 medical claim with a diagnosis code for hemophilia A (ICD-9-CM 286.0) and ≥1 medical or pharmacy claim for bypassing therapy and/or FVIII replacement during 1 January 2007-31 August 2014. The bypassing therapy cohort comprised patients with ≥1 claim for bypassing therapy; all others were assigned to the factor replacement therapy cohort. Post-index hemophilia-related costs were computed as combined health plan plus patient paid amounts for medical claims with hemophilia A diagnosis code or hemophilia therapy procedure code (bypassing therapy, FVIII replacement therapy, desmopressin, antifibrinolytic therapy), as well as pharmacy claims for hemophilia therapy. Results: The study sample represented 580 patients: 50 (8.6%) in the bypassing therapy cohort (mean age: 38.5 years; mean post-index period: 2.1 years) and 530 (91.4%) in the factor replacement therapy cohort (mean age: 29.3 years; mean post-index period: 2.7 years). Compared with the factor replacement therapy cohort, mean per-patient-per-month hemophilia-related total costs were 4.8-fold higher in the bypassing therapy cohort ($57,232 vs. $11,899), comprising 4.4-fold higher medical costs ($45,911 vs. $10,352) and 7.3-fold higher outpatient pharmacy costs ($11,321 vs. $1547). Conclusions: Patients with hemophilia A treated with bypassing agents between 2007 and 2014 incurred substantially higher monthly hemophilia-related medical and pharmacy costs than patients treated only with FVIII replacement.

Lower Hospitalization and Healthcare Costs With Sacubitril/Valsartan Versus Angiotensin-Converting Enzyme Inhibitor or Angiotensin-Receptor Blocker in a Retrospective Analysis of Patients With Heart Failure.

Background Outcomes data among patients with heart failure (HF) with reduced ejection fraction treated with sacubitril/valsartan ( SAC / VAL ) are largely limited to clinical trial results. We compared hospitalization and healthcare costs among real-world patients with HF with reduced ejection fraction treated with SAC / VAL versus angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker ( ACEI / ARB ). Methods and Results Using retrospective administrative claims data, stable patients with HF with reduced ejection fraction treated with SAC / VAL or ACEI / ARB from October 2015 to June 2016 were identified. Postindex hospitalization and healthcare costs were assessed in propensity-matched cohorts using robust variance estimation. Time to first hospitalization was modeled using unadjusted Kaplan-Meier estimates and multivariable models. Postindex all-cause healthcare costs were modeled using an adjusted multivariable model. Among 279 patients per matched cohort, postindex hospitalization risk was lower for SAC / VAL compared with ACEI / ARB using Kaplan-Meier estimation and unadjusted Cox models. For HF hospitalization, the hazard ratio (95% CI) was 0.56 (0.33-0.94; P=0.030). Adjusted results were similar to unadjusted. Mean ( SD ) monthly healthcare costs were lower for SAC / VAL versus ACEI / ARB for all categories except pharmacy, with hospital costs being particularly disparate between cohorts: for HF hospitalization, $248 ($1588) for SAC / VAL versus $1122 ($7290) for ACEI / ARB . The adjusted risk of incurring increased all-cause postindex costs was lower for SAC / VAL versus ACEI / ARB (cost ratio [95% CI] 0.74 [0.59-0.94]; P=0.013). Conclusions In clinical practice, patients with HF with reduced ejection fraction treated with SAC / VAL were less likely to be hospitalized than matched patients treated with ACEI / ARB . Despite higher pharmacy costs, SAC / VAL -treated patients incurred lower monthly medical and total healthcare costs.

Healthcare Costs Among Patients with Heart Failure: A Comparison of Costs between Matched Decedent and Survivor Cohorts.

INTRODUCTION: Prior research suggests increased costs during the final months of life, yet little is known about healthcare cost differences between patients with heart failure (HF) who die or survive. METHODS: A retrospective claims study from a large US health plan [commercial and Medicare Advantage with Part D (MAPD)] was conducted. Patients were ≥18 years old with two non-inpatient or one inpatient claim(s) with HF diagnosis code(s). The earliest HF claim date during 1 January 2010-31 December 2011 was the index date. Cohort assignment was based on evidence of death within 1 year (decedents) or survival for >1 year (survivors) post-index. Per-patient-per-month (PPPM) and 1-year (variable decedent follow-up) costs (all-cause and HF-related) were calculated up to 1 year post-index. Cohorts were matched on demographic and clinical characteristics. Independent samples t tests and Pearson's chi-square tests were used to examine cohort differences. RESULTS: Among patients with HF, 8344 survivors were 1:1 matched to decedents [mean age 75 years, 50% female, 88% MAPD; mean time to decedents' death: 150 (SD 105) days]. Compared to survivors, more decedents had no pharmacy claims for HF-related outpatient pharmacotherapy within 60 days post-index (42.1% vs. 27.1%; p < 0.001). Decedents also incurred higher all-cause medical costs (PPPM: $21,400 vs. $2663; 1 year: $60,048 vs. $32,394; both p < 0.001) and higher HF-related medical costs (PPPM: $16,477 vs. $1358; 1 year: $39,052 vs. $16,519; both p < 0.001). Hospitalizations accounted for more than half of all-cause PPPM medical costs (54.6% for survivors, 84.3% for decedents). CONCLUSION: Patients with HF who died within 1 year after an index HF encounter incurred markedly higher costs within 1 year (despite the much shorter post-index period) and PPPM costs than those who survived, with the majority of costs attributable to hospitalizations for both patient cohorts. There may be opportunities for improving outcomes in HF, considering higher use of pharmacotherapy and lower costs were seen among survivors.

Health Care Resource Utilization, Costs, and Persistence in Patients Newly Diagnosed as Having Nonvalvular Atrial Fibrillation and Newly Treated With Dabigatran versus Warfarin in the United States.

PURPOSE: This study compared health care resource utilization (HCRU), costs, and persistence among patients newly diagnosed as having nonvalvular atrial fibrillation (NVAF) and newly treated with dabigatran versus warfarin. METHODS: This retrospective claims-based study used data from a large US managed care organization. The earliest claim for dabigatran or warfarin during October 1, 2010 through October 31, 2011 was the index date, with cohort assignment based on index medication. Evidence of newly diagnosed NVAF within 30 days before the index date and no claims for oral anticoagulants during the 12-month preindex period were required. Cohorts were matched using propensity scores. Per-patient-per-month HCRU, costs, and persistence were calculated during the variable follow-up period of up to 12 months after the index date. Descriptive and multivariable analyses were used to examine differences in outcomes. FINDINGS: After matching, 869 patients per cohort were identified (mean age, 67.8 years; 40.4% female). Compared with warfarin, dabigatran had fewer per-patient-per-month emergency department (0.10 vs 0.13, P = 0.010), office (1.98 vs 2.96, P < 0.001), and outpatient (1.05 vs 1.48, P < 0.001) visits. Despite higher mean pharmacy costs for dabigatran (P < 0.001), mean total health care (P = 0.309) and medical costs (P = 0.568) were similar to warfarin. Persistence was higher with dabigatran versus warfarin (median, 204 vs 161 days; mean, 213.7 vs 195.5 days, P = 0.001). IMPLICATIONS: Among patients newly diagnosed as having NVAF, those newly treated with dabigatran had lower HCRU, higher persistence, and similar total health care costs compared with those treated with warfarin.

Evaluation of mortality and readmissions following hospitalization with heart failure.

OBJECTIVE: To examine the association of patient/clinical characteristics with mortality and readmission following a heart failure (HF)-related hospitalization. RESEARCH DESIGN AND METHODS: Claims data, linked to laboratory, race/ethnicity, and mortality data, from a large US health plan were utilized to identify individuals with ≥1 inpatient claim with a diagnosis code for HF (1 January 2008-30 September 2012). Study variables were analyzed using descriptive and multivariable approaches to identify patient/clinical characteristics associated with post-discharge outcomes. MAIN OUTCOME MEASURES: Primary outcomes included post-discharge mortality and readmission. RESULTS: A total of 126,214 individuals were identified with a HF-related hospitalization; 19.1% with data to calculate chronic kidney disease (CKD) stage. For the overall sample, mortality probability was 4.9% and 13.4% at 1 and 6 months post-discharge, respectively (4.5% and 12.4% for subset with calculated CKD stage), while readmission (all-cause) probability was 14.8% and 39.6% at 1 and 6 months post-discharge, respectively (18.4% and 44.5% for subset with calculated CKD stage). Within the subset with calculated CKD stage, mortality and readmission probabilities differed by CKD stage (p < 0.001), with decreased renal function corresponding with increased risk of mortality and readmission. After multivariable adjustment, increasing age was associated with increased risk of mortality, while advancing CKD stage, various index hospitalization variables (i.e., pre-admission emergency room visit, intensive care unit during hospitalization), and baseline all-cause hospitalization were associated with both increased risk of mortality and all-cause 1 month readmission. CONCLUSIONS: Calculated CKD, various index hospitalization variables, and baseline all-cause hospitalization were associated with increased risk of mortality and all-cause 1 month readmission among patients hospitalized with HF. Risk of post-discharge readmission and mortality increased with worse renal function, suggesting that improved management of this subset may reduce the burden and cost of this disease. Key study limitations include those related to retrospective claims-based studies and that renal function data were available for a subset of study patients.

Health Care Costs for Patients with Heart Failure Escalate Nearly 3-Fold in Final Months of Life.

BACKGROUND: Heart failure (HF) is a severe chronic disease with growing prevalence and health care burden as well as high mortality. End-of-life cost data for patients with HF may inform disease and medication therapy management. OBJECTIVES: To (a) characterize a real-world sample of patients with HF who died; (b) estimate health care costs for 6 months and semiannually for 24 months, before death; and (c) examine associations between patient characteristics and predeath health care costs. METHODS: This was a retrospective study of commercial and Medicare Advantage with Part D (MAPD) enrollees (aged ≥ 18 years), using data from a large national health plan. Included patients had evidence of HF during January 1, 2009-December 31, 2013, based on ≥ 1 inpatient hospitalization or ≥ 2 noninpatient encounters with diagnosis code for HF and evidence of mortality during July 1, 2009-December 31, 2013. Demographic data, comorbidities, guideline-directed HF-related outpatient pharmacotherapy (HFRx), and predeath health care costs (all-cause and HF-related) were described. A generalized linear model examined associations between all-cause health care costs (months 6 and 1 previous to death) and specific patient characteristics. RESULTS: Of 48,026 identified patients, mean age was 77.9 years; 52.8% were female; 93.0% were MAPD enrolled; 92.5% had Quan-Charlson comor-bidity score ≥ 3; and about one quarter (26.0%) had no evidence of HFRx. Over the last 6 months of life, monthly all-cause total cost increased 3.2-fold for MAPD enrollees and 2.8-fold for commercial enrollees, although pharmacy cost decreased slightly (0.8-fold for both plan types). Cumulative 6-month all-cause medical cost was $37,186 for MAPD enrollees and $143,363 for commercial enrollees (68.8% and 73.2% due to hospitalization, respectively), and cumulative HF-related medical cost was $20,794 for MAPD enrollees and $78,440 for commercial enrollees (88.8% and 95.3% due to hospitaliza-tion, respectively). Over the last 24 months, semiannual all-cause total cost increased 3.2-fold for MAPD enrollees and 4.5-fold for commercial enroll-ees, although pharmacy cost increased only slightly (1.1-fold and 1.3-fold, respectively). Based on multivariable analysis, factors associated with higher risk of incurring a cost increase between month 6 and month 1 before death included older age (75-84 years: cost ratio [CR] = 1.33, P < 0.001; 226585 years: CR = 1.43, P < 0.001), comorbid coronary heart disease (CR = 1.12, P = 0.003), and no evidence of HFRx (CR = 1.48, P < 0.001). CONCLUSIONS: Patients with HF experienced ≥ 2.8-fold increase in monthly all-cause total cost over the last 6 months of life, which was driven by hospitalization. Although MAPD enrollees incurred greater cost increases, cumulative costs were higher for commercial enrollees. After multivariable adjustment, older age, comorbid coronary heart disease, and no evidence of HFRx were among factors associated with higher risk of cost increase over the last 6 months of life. Study findings provide predeath cost information that should be useful in value assessments of innovative HF interventions and highlight impact of HFRx on predeath health care costs.

Reviewing a clinical decision aid for the selection of anticoagulation treatment in patients with nonvalvular atrial fibrillation: applications in a US managed care health plan database.

PURPOSE: The Clinical Decision Aid was created to assist in selecting anticoagulant therapies for patients with nonvalvular atrial fibrillation. The aid incorporates a patient's absolute risk for stroke and bleeding, relative stroke risk reduction, and increase in relative bleeding risk to identify the agent with the lowest net risk. We describe theoretical implications of utilizing the aid at a US managed care population level. METHODS: This retrospective study used claims data from a large US managed care database including enrollees in commercial and Medicare Advantage plans. The distribution of patients across each possible combination of scores on the HAS-BLED scale (evidence of hypertension, abnormal renal or liver function, stroke, bleeding, labile INR, age >65 years, and drugs or alcohol abuse or dependence) and the CHA2DS2-VASc scale (CHADS2 [congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism] with additional nonmajor stroke risk factors, including age 65-74 years, female sex, and vascular disease) was generated. We assessed the correlation between the HAS-BLED and CHA2DS2-VASc scores and derived the optimal treatment options based on various bleeding ratios. FINDINGS: Data from 48,260 patients were included in the analysis. The MAPD subset had a higher mean HAS-BLED score (2.17 vs 1.39; P < 0.001) and a higher mean CHA2DS2-VASc score (3.35 vs 2.05; P < 0.001) than did the commercial subset. Pearson coefficients suggested a moderate to strong positive correlation between the HAS-BLED and CHA2DS2-VASc scores among the commercial (0.730; P < 0.001) and MAPD (0.568; P < 0.001) enrollees. Based on a 2:1 bleeding-to-stroke risk ratio, 70.50% of patients would be recommended treatment with apixaban; 25.86%, no treatment; 3.62%, acetylsalicylic acid; and 0.01%, dabigatran 150 mg, if the Clinical Decision Aid were to be used for anticoagulant treatment selection. IMPLICATIONS: Evidence-based clinical decision-making tools utilizing risk assessment for recommending a treatment may be valuable for not only health care providers but also health care payers in optimizing care at the population level.

Clinical and economic outcomes associated with amlodipine/renin-angiotensin system blocker combinations.

OBJECTIVES: Since treatment regimen type can influence adherence and other outcomes, this study examined adherence, cardiovascular events, and economic outcomes in patients with hypertension treated with fixed-dose combination (FDC) amlodipine/olmesartan (AML/OM), FDC AML/benazepril (AML/BEN), and loose-dose combination AML plus angiotensin II receptor blockers (LDC AML/ARBs). METHODS: Commercial health plan enrollees aged at least 18 years with index claim(s) for AML/OM, AML/BEN, or LDC AML/ARB were identified. Absence of study drug 6 months pre index, and continuous enrollment for at least 12 months post index were required. Descriptive analyses were executed to make comparisons between treatments, as well as multivariate models adjusting for baseline demographic and clinical characteristics, including propensity for assignment to study drug. RESULTS: Descriptive results suggested mean follow-up adherence was higher in the AML/OM cohort [proportion of days covered (PDC) = 0.63] compared with the AML/BEN (PDC = 0.55; p < 0.001) and LDC AML/ARB cohorts (PDC = 0.34; p < 0.001). The proportion of individuals with an incident follow-up cardiovascular event composite was lower in the AML/OM cohort versus the AML/BEN and LDC AML/ARB cohorts (5.94% versus 7.85% and 16.89% respectively). Adjusted Cox models suggested that patients initiated on LDC AML/ARB (hazard ratio 1.35; p < 0.001), but not on AML/BEN, were at greater risk of a follow-up cardiovascular event (composite) compared with AML/OM. Adjusted generalized linear models suggested that mean follow-up per-member-per-month overall costs were higher in the AML/BEN (cost ratio = 1.169; p < 0.001; unadjusted mean cost US$780) and LDC AML/ARB cohorts (cost ratio = 1.286; p < 0.001; unadjusted mean cost US $1394) compared with the AML/OM cohort (unadjusted mean cost US $740). CONCLUSION: The results suggested that treatment with FDC AML/OM was associated with greater likelihood of adherence and lower overall costs than with FDC AML/BEN and LDC AML/ARB, and lower risk of cardiovascular event composite versus LDC AML/ARB.

Long-term clinical and economic outcomes associated with angiotensin II receptor blocker use in hypertensive patients.

OBJECTIVE: To examine clinical and economic outcomes associated with angiotensin II receptor blockers (ARB). METHODS: Retrospective claims data were analyzed for hypertensive adults with ≥1 year follow-up from first ARB claim. Subjects were stratified into four cohorts: olmesartan (OM); valsartan (VAL); losartan (LOS); and irbesartan (IRB), which represented the full sample. Analyses were also conducted with the "limited sample," which excluded subjects with pre-existing conditions in the period before first ARB. Time to follow-up cardiac event was modeled using Cox proportional hazards regression; follow-up healthcare resource utilization and costs were examined using generalized linear models. RESULTS: The full and limited samples consisted of 118,700 and 65,579 subjects, respectively. Mean follow-up ranged from 861 to 933 days. Baseline characteristics including the Quan-Charlson comorbidity score differed by cohort. In both the full and limited samples, respectively, multivariate models predicted a higher adjusted risk of follow-up cardiac event for VAL cohort (hazard ratio [HR] = 1.261 and 1.242, p < 0.001), LOS cohort (HR = 1.307 and 1.178, p < 0.01), and IRB cohort (HR = 1.222 and 1.179, p ≤ 0.016) compared to OM cohort. Adjusted risk (full sample) of follow-up ambulatory and inpatient visits (all-cause and hypertension-attributable) was higher in VAL, LOS, and IRB cohorts compared to OM. Adjusted risk (limited sample) of follow-up ambulatory visits (all-cause and hypertension-attributable) was greater for VAL, LOS and IRB cohorts relative to OM, but inpatient visit risk was greater only in VAL and LOS cohorts. Compared to the OM cohort, follow-up all-cause adjusted healthcare costs (limited sample) were higher in VAL (cost ratio [CR] = 1.067, p = 0.001) and IRB cohorts (CR = 1.062, p = 0.045). CONCLUSIONS: In this large national US health plan, treatment with OM was associated with lower risk of cardiac events and lower healthcare resource utilization and costs versus VAL, LOS, and IRB over a mean follow-up of 2.5 years. Association, rather than causality, to cardiac outcomes may be inferred from these observational claims data.

Drug utilization patterns and cardiovascular outcomes in elderly patients newly initiated on atorvastatin or simvastatin.

BACKGROUND: Hydroxymethylglutaryl coenzyme-A reductase inhibitors simvastatin and atorvastatin are effective at lowering LDL-C levels and reducing the risk of cardiovascular (CV) events. OBJECTIVE: The objective of this study was to examine differences in drug utilization and CV event risk among elderly patients newly initiated on simvastatin versus atorvastatin. METHODS: This was a retrospective analysis using pharmacy and medical claims from a US health plan database. Enrollees aged ≥65 years, newly initiated on simvastatin or atorvastatin (index drugs) from July 1, 2006 to November 30, 2008 were identified for study inclusion. Patients were excluded if they had any prescriptions for clopidogrel, nitrates, or other dyslipidemia medication, or any CV events before index drug initiation. Adherence was calculated by proportion of days covered with index medication. CV events (myocardial infarction, ischemic heart disease, cerebrovascular disease, peripheral vascular disease, aortic aneurysm, revascularization, or heart failure) were identified from medical claims. RESULTS: There were 11,470 atorvastatin initiators and 20,132 simvastatin initiators identified. Mean age of these patients was 72 years; 40% were male; nearly half had hypertension; and more than a quarter had diabetes. The majority of statin therapy (77%) was prescribed by primary care physicians. Forty-nine percent of atorvastatin patients were initiated on a 10 mg-dose and 61% of simvastatin patients on 5-, 10-, or 20-mg doses. A larger percentage of patients in the simvastatin cohort were adherent to index therapy than patients in the atorvastatin cohort (43% vs 36%, respectively). Multivariate regression adjusting for patient characteristics revealed no significant difference in CV events between patients receiving atorvastatin versus simvastatin. CONCLUSIONS: In this study of elderly statin patients without recent evidence of CV events, the majority of patients started on low-dose therapy and did not achieve sufficient adherence. After controlling for patient and clinical characteristics, no statistically significant difference in risk of CV event was observed based on initiation with atorvastatin versus simvastatin.

Relationship between physician specialty and allopurinol prescribing patterns: a study of patients with gout in managed care settings.

OBJECTIVE: Allopurinol is used to lower serum uric acid (sUA) levels in gout patients. The objective of this study was to investigate the influence of physician specialty on allopurinol treatment patterns and sUA control. DESIGN AND METHODS: This was a retrospective study using claims from a managed care database of US health plan enrollees. Gout patients at least 18 years of age who received allopurinol were identified from the database between January 1, 2002 and April 30, 2007. The index date was defined as the date of the earliest allopurinol claim, and patients were required to have health plan enrollment for at least 365 days prior to and following the index date for inclusion. Physician specialty was determined using the index allopurinol claim. Dosage of allopurinol prescription(s) and number of gout flares were determined from claims data. sUA measurements were used to assess goal attainment over a period of at least one year following the index allopurinol prescription. RESULTS: There were 3363 patients with gout of whom 69.9% received an index allopurinol prescription from a generalist/internist, 5.7% from a rheumatologist, 2.6% from a nephrologist, and 21.8% from a physician with other specialty. Of patients receiving their index prescription from a nephrologist, 38.7% reached the sUA goal of <6 mg/dL (357 µmol/L), as compared to patients prescribed by a rheumatologist, generalist/internist, or other physician (35.4%, 31.4%, and 39.4%, respectively; P = 0.015). When controlling for patient characteristics, multivariate analysis did not reveal statistically significant different odds of sUA goal attainment based on prescribing physician specialty, though separate analyses indicated that patients prescribed by a nephrologist had fewer gout flares. Change in allopurinol dosage from initial to final dose was more frequent among patients prescribed by rheumatologists and nephrologists. CONCLUSION: There is significant heterogeneity in the specialists' management of sUA levels in patients with gout, possibly reflecting differences in case mix and treatment approaches. Limitations related to the use of claims data, such as inability to observe medications filled over-the-counter, should be considered when interpreting study results.

Underutilization of beta-blockers in patients undergoing implantable cardioverter-defibrillator and cardiac resynchronization procedures.

BACKGROUND: Current guidelines emphasize the need for optimal medical therapy before implantation of cardiac devices (implantable cardioverter-defibrillator, cardiac resynchronization therapy). Our objective was to evaluate use of beta-blockers (BB) among patients with heart failure undergoing a cardiac device procedure. METHODS AND RESULTS: We used a large, multistate, managed-care database (January 2003 to December 2006) to identify adults admitted with an International Classification of Diseases, Ninth Revision (ICD-9) procedure code for cardiac device, continuous enrollment for 180 days before and 180 days after device procedure, and a primary or secondary ICD-9 diagnosis code for heart failure during that period. Our primary measures were use of BB before device procedure and changes after discharge. A total of 2766 beneficiaries (78.8% men; median age, 61 years) underwent a device procedure for primary prevention. The median number of days on BB therapy in the 90 days before device procedure was 46. Beneficiaries who did not have a pharmacy fill for BB during that time (n=925, 33.4%) were more elderly and had fewer antecedent outpatient visits with a cardiologist. There was a shift toward greater use of BB after device procedure; 83.4% had at least 1 pharmacy fill for a BB during follow-up. CONCLUSIONS: BB are underused before and after cardiac device procedures. There is a modest increase in use after the procedure. Strategies are required to ensure that patients are on optimal medical therapy before device therapy is selected.

Implantable cardiac device procedures in older patients: use and in-hospital outcomes.

BACKGROUND: Although the effectiveness of implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) alone or in combination is well established, limited data are available on device use and short-term outcomes in older patients. We sought to characterize age-specific practices and outcomes among patients with heart failure undergoing device implantation using a large nationally representative administrative database. METHODS: The cohort comprised patients older than 18 years with a diagnosis of heart failure who underwent implantation of an ICD or CRT between January 1, 2004, and December 31, 2005. Data included patient demographics, comorbidities, type of device, procedural complications, length of stay, total cost of hospitalization, and hospital characteristics. Multivariate stepwise logistic regression analysis was used to identify risk factors for in-hospital mortality. RESULTS: We identified 26 887 patients who received an implantable device. The median age was 70.0 years (17.5% were > or =80 years), 72.6% were male, and 31.3% were of nonwhite race/ethnicity. Compared with younger patients, those 80 years or older were more likely to receive CRT alone. In-hospital mortality increased from 0.7% among patients younger than 80 years to 1.2% among those aged 80 to 85 years and 2.2% among those older than 85 years (P < .001). Independent predictors of in-hospital mortality included age 80 years or older, elevated comorbidity score, inotrope use, and procedure-related complications. CONCLUSIONS: Despite the fact that most device trials have excluded patients 80 years or older, more than one-fifth of ICD and CRT devices are implanted in this age group. Advanced age is an independent predictor of in-hospital mortality following device implantation, suggesting that additional study is needed to define criteria for appropriate device use in older patients.

Increasing incidence of new-onset diabetes after transplant among pediatric renal transplant patients.

BACKGROUND: Risk of new-onset diabetes after transplant (NODAT) is well characterized for adults but much less understood in pediatric transplant. This study examines the incidence and risk factors of NODAT in pediatric renal transplant patients. METHODS: The incidence of NODAT over the first 3 years after transplant was examined with the United States Renal Data System data for primary renal transplant recipients (ages 0-21 years, transplanted between 1995 and 2004) with Medicare primary. Patients had no evidence of diabetes before transplant. We estimated the cumulative incidence rate and used Cox proportional hazards regression to identify the risk factors for NODAT. Propensity scores were calculated for immunosuppression choice to adjust for potential confounding factors. RESULTS: Two thousand one hundred sixty-eight recipients with valid immunosuppression records and without pretransplant evidence of diabetes were included. Unadjusted, cumulative NODAT incidence at 3 years posttransplant was 7.1%. Significant factors for increased risk of NODAT included cytomegalovirus D+/R- serostatus (adjusted hazard ratio [aHR]=1.60), age 13 to 18 years (aHR=2.18), age 19 to 21 years (aHR=2.60), body mass index more than or equal to 30 kg/m (aHR=2.17), and use of tacrolimus (aHR=1.51). We failed to find any significant relationships between NODAT and graft failure or death. CONCLUSIONS: Although the incidence of NODAT among patients aged 0 to 21 years is lower than that for adult patients, it is higher than suggested by earlier research and may represent an increase over time. The lack of association between NODAT and graft or failure death has important implications for posttransplant care. A clearer understanding of risk factors can help guide posttransplant monitoring and clinical decision making.