Clinical and economic outcomes in patients with chronic obstructive pulmonary disease initiating maintenance therapy with tiotropium bromide/olodaterol or fluticasone furoate/umeclidinium/vilanterol.

BACKGROUND: Clinical practice guidelines recommend dual long-acting muscarinic antagonists (LAMAs)/long-acting ß2agonists (LABAs) as maintenance therapy in patients with chronic obstructive pulmonary disease (COPD) and dyspnea or exercise intolerance. Escalation to triple therapy (TT) (LAMA/LABA/inhaled corticosteroid) is conditionally recommended for patients with continued exacerbations on dual LAMA/LABA therapy. Despite this guidance, TT use is widespread across COPD severities, which could impact clinical and economic outcomes. OBJECTIVE: To compare COPD exacerbations, pneumonia events, and disease-related and all-cause health care resource utilization and costs (in 2020 US dollars) in patients initiating fixed-dose combinations of either LAMA/LABA (tiotropium/olodaterol [TIO + OLO]) or TT (fluticasone furoate/umeclidinium/vilanterol [FF + UMEC + VI]). METHODS: This retrospective observational study of administrative claims included patients with COPD aged 40 years or older initiating TIO + OLO or FF + UMEC + VI from June 2015 to November 2019. TIO + OLO and FF + UMEC + VI cohorts in the overall and maintenance-naive populations were 1:1 propensity score matched on baseline demographics, comorbidities, COPD medications, health care resource utilization, and costs. Multivariable regression compared clinical and economic outcomes up to 12 months in FF + UMEC + VI vs TIO + OLO postmatched cohorts. RESULTS: After matching, there were 5,658 and 3,025 pairs in the overall and maintenance-naive populations, respectively. In the overall population, the risk of any (moderate or severe) exacerbation was 7% lower in FF + UMEC + VI vs TIO + OLO initiators (adjusted hazard ratio [aHR] = 0.93; 95% CI = 0.86-1.0; P = 0.047). There was no difference in the adjusted risk of any exacerbation in the maintenance-naive population (aHR = 0.99; 95% CI = 0.88-1.10). Pneumonia risk was not statistically different between cohorts in the overall (aHR = 1.12; 95% CI = 0.98-1.27) and maintenance-naive (aHR = 1.13; 95% CI = 0.95-1.36) populations. COPD- and/or pneumonia-related adjusted total annualized costs (95% CI) were significantly greater for FF + UMEC + VI vs TIO + OLO in the overall ($17,633 [16,661-18,604] vs $14,558 [13,709-15,407]; P < 0.001; differences [% of relative increase] = $3,075 [21.1%]) and maintenancenaive ($19,032 [17,466-20,598] vs $15,004 [13,786-16,223]; P < 0.001; $4,028 [26.8%]) populations, with significantly higher pharmacy costs with FF + UMEC + VI (overall: $6,567 [6,503-6,632] vs $4,729 [4,676-4,783]; P < 0.001; $1,838 [38.9%]; maintenance-naive: $6,642 [6,560-6,724] vs $4,750 [4,676-4,825]; P < 0.001; $1,892 [39.8%]). CONCLUSIONS: A lower risk of exacerbation was observed with FF + UMEC + VI vs TIO + OLO in the overall population but not among the maintenance-naive population. Patients with COPD initiating TIO + OLO had lower annualized costs than FF + UMEC + VI initiators in the overall and maintenance-naive populations. Thus, in the maintenance-naive population, initiation with dual LAMA/LABA therapy per practice guidelines can improve real-world economic outcomes. Study registration number: ClinicalTrials.gov (identifier: NCT05127304). DISCLOSURES: The study was funded by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI). To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, BIPI grants all external authors access to relevant clinical study data. In adherence with the BIPI Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Dr Sethi has received honoraria/fees for consulting/speaking from Astra-Zeneca, BIPI, and GlaxoSmithKline. He has received consulting fees for serving on data safety monitoring boards from Nuvaira and Pulmotect. He has received consulting fees from Apellis and Aerogen. His institution has received research funds for his participation in clinical trials from Regeneron and AstraZeneca. Ms Palli was an employee of BIPI at the time the study was conducted. Drs Clark and Shaikh are employees of BIPI. Ms Buysman and Mr Sargent are employees and Dr Bengtson was an employee of Optum, which was contracted by BIPI to conduct this study. Dr Ferguson reports grants and personal fees from Boehringer Ingelheim during the conduct of the study; grants from Novartis, Altavant, and Knopp; grants and personal fees from AstraZeneca, Verona, Theravance, Teva, and GlaxoSmithKline; and personal fees from Galderma, Orpheris, Dev.Pro, Syneos, and Ionis outside the submitted work. He was a paid consultant for BIPI for this study. The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

Healthcare Resource Utilization, Cost and Clinical Outcomes in Patients Diagnosed with COPD Initiating Tiotropium Bromide/Olodaterol versus Fluticasone Furoate/Umeclidinium/Vilanterol Based on Exacerbation History.

Background: ATS and GOLD guidelines recommend treating low-exacerbation risk COPD patients with dual (LAMA/LABA) agents and reserving triple therapy (TT; LAMA/LABA and inhaled corticosteroids [ICS]) for severe cases with higher-exacerbation risk. However, TT often is prescribed across the COPD spectrum. This study compared COPD exacerbations, pneumonia diagnosis, healthcare resource utilization, and costs for patients initiating tiotropium bromide/olodaterol (TIO/OLO) and a TT, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), stratified by exacerbation history. Methods: COPD patients who initiated TIO/OLO or FF/UMEC/VI between 06/01/2015-11/30/2019 (index date=first pharmacy fill-date with ≥30 consecutive treatment days) were identified from the Optum Research Database. Patients were ≥40 years old and continuously enrolled for 12 months during the baseline period and ≥30 days during follow-up. Patients were stratified into GOLD A/B (0-1 baseline non-hospitalized exacerbation), No exacerbation (subset of GOLD A/B), and GOLD C/D (≥2 non-hospitalized and/or ≥1 hospitalized baseline exacerbation). Baseline characteristics were balanced with propensity score matching (1:1). Adjusted risks of exacerbation, pneumonia diagnosis, and COPD and/or pneumonia-related utilization and costs were evaluated. Results: Adjusted exacerbation risk was similar in GOLD A/B and No exacerbation subgroups, and lower in GOLD C/D for FF/UMEC/VI versus TIO/OLO initiators (hazard ratio: 0.87; 95% CI: 0.78, 0.98, p=0.020). Adjusted pneumonia risk was similar between cohorts across the GOLD subgroups. Adjusted COPD and/or pneumonia-related population annualized pharmacy costs were significantly higher for FF/UMEC/VI versus TIO/OLO initiators across subgroups, p<0.001. Adjusted COPD and/or pneumonia-related population annualized total healthcare costs were significantly higher for FF/UMEC/VI versus TIO/OLO initiators in the GOLD A/B and No exacerbation, subgroups, p<0.001 (cost ratio [95% CI]: 1.25 [1.13, 1.38] and 1.21 [1.09, 1.36], respectively), but similar in the GOLD C/D subgroup. Conclusion: These real-world results support ATS and GOLD recommendations for treating low-exacerbation risk COPD patients with dual bronchodilators and TT for more severe, higher-exacerbation risk COPD patients.

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.

Sacroiliac joint fusion health care cost comparison prior to and following surgery: an administrative claims analysis.

PURPOSE: To assess real-world expenditures on surgical and non-surgical treatment for sacroiliac joint (SIJ) pain by comparing direct health care costs before and after surgery in patients who underwent an SIJ fusion (SIJF) procedure. MATERIALS AND METHODS: This retrospective observational study examined administrative claims data (January 1, 2010 to February 28, 2017) for adult commercial health plan members with a medical claim for SIJF. Identified patients were included if they had continuous enrollment in the health plan for 12 months pre-SIJF (baseline period) and 12 months post-SIJF (follow-up period). The outcomes of interest were low back pain-related health care costs in the first three quarters of the baseline period (pre-surgery period; excludes the quarter immediately preceding surgery) and last three quarters of the follow-up period (post-surgery period; excludes the quarter in which SIJF was performed). RESULTS: Some 302 patients met inclusion criteria: 159 patients had the index SIJF in an inpatient hospital setting, 122 in an outpatient hospital setting, 18 in a surgery center, and three in other settings. Mean and median costs in the pre-surgery period were US$16,803 and US$5,849, respectively, and US$13,297 and US$2,269 in the post-surgery period. Median costs were significantly different in the pre- and post-surgery periods (P<0.001), while mean costs were not. Median health care costs in the pre-surgery and post-surgery periods were lower than the corresponding means due to the highly skewed nature of the cost data. CONCLUSION: This health care claims data analysis shows the potential for lower post-operative health care costs compared to pre-operative costs in patients undergoing SIJF. Median low back pain-related costs in the post-surgery period were approximately US$400 per quarter overall and US$250 per quarter for those undergoing SIJF in the non-inpatient setting. Future studies with larger sample sizes and longer follow-up will improve the precision of the cost data.

Retrospective Study on the Impact of Adherence in Achieving Glycemic Goals in Type 2 Diabetes Mellitus Patients Receiving Canagliflozin.

INTRODUCTION: Adherence is poor among patients taking antihyperglycemic agents (AHAs) for type 2 diabetes mellitus (T2DM). Inadequate adherence has been linked to decreased glycemic control and increased healthcare costs and hospitalizations. We examined the impact of real-world adherence on glycemic control in T2DM patients treated with canagliflozin. METHODS: This retrospective study used US administrative claims data from commercial and Medicare Advantage healthcare enrollees. Study subjects were adult T2DM patients with baseline HbA1c ≥7.0% and a pharmacy claim for canagliflozin between April 01, 2013 and August 31, 2014. Outcomes included treatment patterns, HbA1c reductions and goal attainment, pharmacy costs, and patient characteristics. Adherence, measured by the proportion of days covered (PDC), was calculated as the number of days of canagliflozin availability divided by the length of the follow-up period. Results were analyzed overall and compared between patients who were highly adherent (HA) (PDC ≥0.8) versus less than highly adherent (LHA) (PDC <0.8). RESULTS: The study population included 2261 patients. At the end of follow-up, patients had an overall mean reduction in HbA1c of 0.97%. Those HA had larger reductions in HbA1c than those LHA (1.17% versus 0.73%, respectively, p < 0.001); 24.6% and 59.4% of patients achieved HbA1c goals of <7.0% and <8.0%, respectively. Highly adherent patients were more likely to achieve goals than those LHA. Less than highly adherent patients increased insulin use by 5.4% in the follow-up period, while HA patients decreased the use of most oral AHAs and had no change in insulin use. CONCLUSIONS: Patients had an HbA1c reduction of 0.97% in the 12 months following the first canagliflozin fill. Highly adherent patients achieved a greater reduction in HbA1c at the end of the follow-up period and were more likely to reach HbA1c goals. Highly adherent patients also had reductions in the use of most oral AHAs, while LHA patients saw a small increase in insulin use.

Serum uric acid levels and the risk of flares among gout patients in a US managed care setting.

OBJECTIVE: Serum uric acid (sUA) levels are causally associated with the risk of gout flares. Our aim was to assess the magnitude of the association and time to first flare among patients in a managed care setting. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study using administrative claims data from a large US health plan. Patients were required to have evidence of gout based on medical and pharmacy claims between January 2009 and April 2012. The 12 months prior to the index gout claim were used to assess baseline sUA levels; risk of gout flares, stratified by baseline sUA levels, was examined for 2 years post-index. Risk of flare was modeled with Cox proportional hazards; time to first flare was assessed by Kaplan-Meier. RESULTS: We identified 18,008 patients with gout and available baseline SUA levels (mg/dL). The hazard ratios for the risk of gout flares compared with sUA <5.0 were: 1.17 for sUA 5.0 to <6.0; 1.69 for sUA 6.0 to <7.0; 2.16 for sUA 7.0 to <8.0; 2.87 for sUA 8.0 to <9.0; and 3.85 for sUA ≥9.0 (all p < .001 except for sUA 5.0 to <6.0 cohort). The time to first flare was shorter for cohorts with higher baseline sUA levels. CONCLUSION: These findings confirm that higher sUA levels are associated with an increased risk of gout flares in a dose-response manner over 2 years. This data supports the need to treat to sUA target levels as recommended by recent gout care guidelines. Claims-based algorithms were used to identify gout flares; although this would not be expected to influence estimates of risk by sUA level, there may have been over- or under-estimation of the incidence of flares.

Flare frequency, healthcare resource utilisation and costs among patients with gout in a managed care setting: a retrospective medical claims-based analysis.

OBJECTIVES: For most gout patients, excruciatingly painful gout attacks are the major clinical burden of the disease. The goal of this study was to assess the association of frequent gout flares with healthcare burden, and to quantify how much lower gout-related costs and resource use are for those with infrequent flares compared to frequent gout flares. DESIGN: Retrospective cohort study. SETTING: Administrative claims data from a large US health plan. PARTICIPANTS: Patients aged 18 years or above, and with evidence of gout based on medical and pharmacy claims between January 2009 and April 2012 were eligible for inclusion. Patient characteristics were assessed during a 12-month baseline period. OUTCOME MEASURES: Frequency of gout flares, healthcare costs and resource utilisation were assessed in the 12 months following the first qualifying gout claim. Generalised linear models were employed to assess the impact of flare frequency on cost outcomes after adjusting for covariates. RESULTS: 102,703 patients with gout met study inclusion criteria; 89,201 had 0-1 gout flares, 9714 had 2 flares, and 3788 had 3+ flares. Average counts of gout-related inpatient stays, emergency room visits and ambulatory visits were higher among patients with 2 or 3+ flares, compared to those with 0-1 flares (all p<0.001). Adjusted annual gout-related costs were $1804, $3014 and $4363 in those with 0-1, 2 and 3+ gout flares, respectively (p<0.001 comparing 0-1 flares to 2 or 3+ flares). CONCLUSIONS: Gout-related costs and resource use were lower for those with infrequent flares, suggesting significant cost benefit to a gout management plan that has a goal of reducing flare frequency.

Impact of medication adherence and persistence on clinical and economic outcomes in patients with type 2 diabetes treated with liraglutide: a retrospective cohort study.

INTRODUCTION: Adherence to diabetes medication has been linked to improved glycemic levels and lower costs, but previous research on adherence has typically involved oral antidiabetic medication or insulin. This study examines how adherence and persistence to once-daily liraglutide impact glycemic control and economic outcomes in a real-world population of adult type 2 diabetes (T2D) patients. METHODS: A retrospective cohort study using administrative claims data from July 2009 through September 2013. Patients aged ≥18 years with T2D treated with liraglutide were identified (index date = first liraglutide prescription). Adherence was based on the proportion of days covered (PDC); with PDC ≥0.80 classified as adherent. Non-persistent patients were those with a gap in therapy of >90 days. Lab results for glycated hemoglobin (A1C) were used to identify whether patients achieved target levels of <7.0% and ≤ 6.5%, or experienced a reduction of ≥1.0% in A1C from pre-index (baseline) to post-index (follow-up). Logistic regression was used to estimate the likelihood of achieving the A1C goals, adjusted for baseline characteristics. Diabetes-related medical, pharmacy, and total costs were modeled and estimated for the adherence and persistence cohorts. RESULTS: A total of 1321 patients were identified. The mean PDC was 0.59 and 34% of patients were classified as adherent, while 60% were persistent over 12 months of follow-up. Adherent and persistent patients were more likely to achieve each of the A1C goals than their non-adherent and non-persistent counterparts after adjusting for patient characteristics. Adherence and persistence were associated with higher adjusted diabetes-related pharmacy and total healthcare costs during follow-up; whereas persistent patients had significantly lower diabetes-related medical costs than non-persistent patients. CONCLUSIONS: Adherence and persistence to liraglutide are associated with improved A1C outcomes. Persistent patients showed significantly lower medical costs versus those discontinuing liraglutide. Total healthcare costs were higher for adherent and persistent cohorts driven by higher pharmacy costs.

Characteristics and short-term outcomes of patients with type 2 diabetes mellitus treated with canagliflozin in a real-world setting.

OBJECTIVE: Canagliflozin is a sodium glucose co-transporter 2 inhibitor that has been shown to improve glycemic control in type 2 diabetes mellitus (T2DM). This study aimed to describe the characteristics, treatment utilization, and outcomes of patients treated with canagliflozin in the real world within the first 6 months of it being commercially available. METHODS: This retrospective cohort study used a large US health plan database for commercial and Medicare Advantage enrollees. Patients aged 18 and over with T2DM who filled a canagliflozin prescription during 1 April 2013 to 30 September 2013 were eligible for inclusion. Patients were required to be enrolled for 6 months before (baseline period) and 3 months after (follow-up period) the first canagliflozin claim. RESULTS: Overall, 3234 patients met study criteria (mean age was 55.7 years; 43.4% were female). Among patients with available lab data at baseline and follow-up, mean HbA1c decreased from 8.54% at baseline to 7.76% at follow-up (p < 0.001); the proportion of patients with HbA1c ≥9.0% decreased by more than half (from 32.0% at baseline to 15.5% at follow-up, p < 0.001). Almost all (94.8%) patients received at least one baseline antihyperglycemic agent; among them, 33.6% received two and 41.5% received three or more agents. Compared to baseline, usage of antihyperglycemic agents during follow-up was lower for metformin, sulfonylureas, insulin, DPP-4 inhibitors, GLP-1 receptor agonists and thiazolidinediones. CONCLUSIONS: Patients treated with canagliflozin when first available in the US typically had poorly controlled HbA1c levels at baseline and had received multiple prior antihyperglycemic agents. Following the first canagliflozin claim, they had an improvement in HbA1c levels and used fewer antihyperglycemic agents. These study results should help clinicians and payers better understand the initial profile of patients receiving canagliflozin and short-term outcomes in the real world. Given the short follow-up time frame and the fact that HbA1c data was not available in all patients, future research on longer term outcomes is warranted.

Impact of initiating insulin glargine disposable pen versus vial/syringe on real-world glycemic outcomes and persistence among patients with type 2 diabetes mellitus in a large managed care plan: a claims database analysis.

BACKGROUND: Diabetes accounts for almost 15% of all direct healthcare expenditures. Managed care organizations try to reduce costs and improve patient outcomes. Increasing patient persistence with antidiabetes treatment could help achieve these goals. SUBJECTS AND METHODS: A retrospective study was conducted using the Optum Research Database (Optum, Eden Prairie, MN) to analyze clinical and economic outcomes associated with initiation of insulin glargine via a disposable pen (GLA-P) or vial and syringe (GLA-V) among adult, insulin-naive patients with type 2 diabetes mellitus (T2DM). Propensity-matched patient cohorts were assessed for persistence with insulin therapy, glycated hemoglobin (A1C), hypoglycemic events (based on diagnosis codes), and healthcare costs (total paid amount of adjudicated claims) after follow-up at 1 year. RESULTS: In 1,308 matched patients, persistence was significantly higher (P=0.011) and longer (P=0.001) with GLA-P. Follow-up A1C values were significantly lower (P=0.038), and decreases in A1C from baseline significantly larger (P=0.043), in GLA-P than in GLA-V. Significantly fewer hypoglycemic events (P=0.042) were experienced, and a lower rate of diabetes-related inpatient admissions (P=0.008) was reported in GLA-P than GLA-V. Despite higher study drug costs with GLA-P than GLA-V, all-cause and diabetes-related healthcare costs were similar. CONCLUSIONS: In insulin-naive patients with T2DM, initiation of insulin glargine using the disposable pen rather than the vial and syringe is associated with higher persistence, better A1C control, and lower rates of hypoglycemia. The higher study drug costs associated with pen use do not increase total all-cause or diabetes-related healthcare costs. This may help treatment selection for patients with T2DM in a managed care setting.

Clinical and economic benefits observed when follow-up triglyceride levels are less than 500 mg/dL in patients with severe hypertriglyceridemia.

BACKGROUND: Increased levels of triglycerides are associated with an increased risk of cardiovascular disease and pancreatitis. In this study we investigated the association between patients with severely increased triglycerides whose follow-up triglyceride levels were <500 mg/dL and reduction of important clinical events and associated health care costs. METHODS: By using two large U.S. health care claims databases, we identified an initial cohort of 41,210 patients with severe hypertriglyceridemia between June 2001 and September 2010 who had a follow-up laboratory test result 6 to <24 weeks after the initial severe hypertriglyceridemia laboratory value. Of these, 8493 patients' follow-up triglyceride levels remained elevated (≥500 mg/dL) whereas 32,717 were <500 mg/dL. After their qualifying follow-up triglyceride level, patients' cardiovascular events, diabetes-related events, pancreatitis episodes, kidney disease, and related costs were identified. Adjusted incidence rate ratios with the use of Cox proportional hazards models were developed for each outcome. RESULTS: Patients whose triglycerides remained ≥500 mg/dL had a greater rate of pancreatitis episodes (hazard ratio [HR]1.79; 95% confidence interval [CI] 1.47-2.18), cardiovascular events (HR1.19; 95% CI 1.10-1.28), diabetes-related events (HR1.42; 95% CI 1.27-1.59), and kidney disease (HR1.13; 95% CI 1.04-1.22) compared with patients whose follow-up triglycerides were <500 mg/dL, after we adjusted for important confounders. Adjusted all-cause total and cardiovascular-related costs were significantly lower in the first 3 years in patients whose follow-up triglyceride levels were <500 mg/dL compared with those whose triglyceride levels remained increased. CONCLUSION: When follow-up triglyceride levels were <500 mg/dL, we observed an associated reduction in the risk of clinical events and decrease in health care resource use and costs.

Hemoglobin A1c outcomes and health care resource use in type 2 diabetes mellitus patients treated with combination oral antidiabetic drugs through step therapy and loose-dose and fixed-dose combinations.

PURPOSE: To compare outcomes of type 2 diabetes mellitus (T2DM) patients initiating therapy with FDC vs. those with loose-dose combination (LDC) or step therapy (ST) in a managed care population. DESIGN: A retrospective claims database analysis. METHODOLOGY: Treatment-naive T2DM patients who were continuously enrolled in a health plan during 2006-2009 were studied. Eligible patients were assigned to FDC, LDC, or ST cohorts. Glycated hemoglobin goal attainment (HbA1c < 7%) was assessed using the American Diabetes Association (ADA) treatment guidelines. Health care resources use and costs, including inpatient, emergency room (ER), and ambulatoryvisits, were measured during the 12 months after therapy initiation. All-cause and diabetes-related use and costs were assessed. PRINCIPAL FINDINGS: 21,048 patients met study criteria (FDC n = 8,416, ST n = 8,407, LDC n = 4,225), and 1,926 of these patients had HbA1c results. FDC patients had lower rates of post-index all-cause inpatient stays and ER visits compared with the other cohorts. FDC patients had lower average counts of diabetes-related ambulatory visits (2.7) compared with ST (3.7; p < 0.001) and LDC (3.2; p < 0.001) and significantly lower average post-index all-cause and diabetes-related costs compared with the other cohorts, with average all-cause costs for FDC, ST, and LDC of $8,445, $10,515, and $9,688, respectively, and diabe-tes-related costs of $1,641, $2,099, and $1,900, respectively. FDC patients had higher rates of achieving HbA1c goal (61%) compared to ST (48%; p < 0.001) or LDC (52%; p = 0.015). Differences in outcomes remained following multivariate analyses. CONCLUSION: Treatment with FDC was associated with lower health care resources use and costs and better likelihood of HbA1c goal attainment.

Costs and clinical outcomes associated with use of ranolazine for treatment of angina.

BACKGROUND: There are 10 million patients with angina in the United States (500,000 new diagnoses annually). Although clinical efficacy of angina treatments is understood, total costs of care and clinical outcomes for patients with chronic angina in different treatment protocols are unknown. OBJECTIVE: Our objective was to estimate total costs of care and revascularization rates for patients with poorly controlled angina who added either (1) long-acting nitrates, (2) beta blockers or calcium channel blockers, or (3) ranolazine to their therapy. STUDY DESIGN: We performed retrospective claims analysis using an index event involving change of therapy in which a new antiangina drug was added. METHODS: Using a large commercial insurance claims database, 4545 patients with angina with an index event (ie, change of antiangina therapy) and 6 months of continuous enrollment pre- and postindex event were identified. Using total cost of care and revascularization rates, we first compared preindex disease burden, medical care use, and total cost of care and components of total cost. We then compared unadjusted use and cost of care across treatment groups. Finally, we estimated regression models to predict postindex event total costs of care and revascularization rates. RESULTS: During the preindex period, the 3 comparison groups had similar health measures, medical care use, and total costs of care. During the postindex period, ranolazine users had lower revascularization rates (9.9%) than comparison patient groups (15.4%-20.4%, both Ps < 0.001). Ranolazine users had lower total costs of care ($13,961) than the nitrate group ($18,166, 30.0% higher; P < 0.001) and the beta blockers/calcium channel blockers group ($17,612, 26.6% higher; P = 0.002). CONCLUSIONS: Adding ranolazine to the treatment regimen of patients with poorly controlled angina was associated with lower rates of revascularization and lower total costs of care than for comparable patients, differences both statistically and clinically relevant.

Total healthcare costs in the US for preterm infants with respiratory syncytial virus lower respiratory infection in the first year of life requiring medical attention.

BACKGROUND: Respiratory syncytial virus (RSV) lower respiratory infection (LRI) is the most common cause of hospitalization among infants <1 year of age. The healthcare costs of preterm infants with RSV LRI were compared with those without RSV LRI in the first year of life. METHODS: This retrospective cohort study propensity-matched premature infants < or =36 weeks' gestational age (wGA) and/or < or =2499 g birth weight, born May 1, 2001 through April 30, 2006 (five RSV seasons) with RSV LRI to those without RSV LRI in a national United States health plan. The primary outcome was first-year healthcare costs and utilization excluding the birth hospitalization compared between the study cohorts. Subgroup analysis evaluated costs and healthcare resource utilization by GA (< or =32 wGA and 33-36 wGA) and hospitalization status (hospitalized and outpatient). RESULTS: A total of 2995 infants with RSV LRI were matched to 2995 controls. Infants with RSV LRI had $9115 higher healthcare costs (RSV LRI group: $19 559; control group: $10 444; p < 0.001) in the first year of life. Late preterm infants (33-36 wGA) with an RSV hospitalization incurred $21 977 higher costs (p < 0.001) and those with an outpatient RSV LRI incurred $3898 higher costs (p < 0.001) compared to corresponding controls. Similar results were found among infants < or =32 wGA with higher costs in the RSV LRI group. Rates of all-cause hospitalizations, emergency department visits, and ambulatory visits were significantly higher among infants with RSV LRI compared to controls. CONCLUSION: Development of RSV LRI among preterm and late preterm infants is associated with significantly higher healthcare costs in the first year of life. These findings must be considered in the context of potential study limitations that may have over- or underestimated costs, such as unconfirmed RSV infection, unintentional omission of fatal cases, and unobserved imbalances between groups.