A systematic literature review of frequency of vaso-occlusive crises in sickle cell disease.

BACKGROUND AND PURPOSE: Sickle cell disease (SCD) is a collection of rare inherited blood disorders affecting approximately 100,000 people in the U.S. and 20-25 million people globally. Individuals with SCD experience recurrent episodes of severe and unpredictable pain that are caused by vaso-occlusive crises (VOCs), a hallmark of the disease. VOCs are the primary cause of hospitalization in SCD, result in missed workdays and school days, and decrease quality of life (QoL). Although VOCs cause significant burden in the lives of individuals with SCD, there is no synthesis on the frequency of VOCs in the real world. This systematic literature review sought to identify literature describing the frequency of VOCs experienced by individuals with SCD in real-world settings. METHODS: MEDLINE and 6 congresses were searched (date range: January 1, 2000 to June 30, 2020). Studies were reviewed independently by two researchers. Studies assessing frequency or prevalence of VOCs or VOC-related outcomes were included. RESULTS: Of 1438 studies identified in the search, 52 met pre-specified inclusion and exclusion criteria. Reported frequency of VOCs varied widely ranging from a mean or median of 0 VOCs/year to 18.2 VOCs/year. The proportion of patients experiencing ≥ 3 VOCs/year ranged from 4 to 67% and the proportion of patients experiencing ≥ 5 VOCs/year ranged from 18 to 59%. Measures of VOC severity were limited, with 13 studies considering frequency of complicated VOCs and only 1 study reporting duration of VOC episodes. CONCLUSIONS: This is the first study to systematically assess published evidence pertaining to VOCs in real-world settings. Reported VOC frequency in real-world settings varied widely, with a majority of studies only considering VOCs managed in an inpatient or outpatient setting. Studies that considered VOCs managed at home reported a higher frequency of VOCs, suggesting that many studies may underestimate the frequency of VOCs. This systematic literature review (SLR) highlights the need for consistent reporting of (1) self-reported VOCs, including those managed at home, (2) definitions of VOCs, (3) complicated VOCs, and (4) duration of VOC episodes in literature.

Erratum to 'Lipid Treatment and Goal Attainment Characteristics among Persons with Atherosclerotic Cardiovascular Disease in the United States' [American Journal of Preventive Cardiology 1C (2020) 100010].

[This corrects the article DOI: 10.1016/j.ajpc.2020.100010.].

Lifetime Costs for Treated Follicular Lymphoma Patients in the US.

BACKGROUND AND OBJECTIVE: The objective of this study was to estimate the lifetime costs of patients receiving treatment for follicular lymphoma (FL) in the United States. METHODS: A Markov model was programmed in heRo3 with a 6-month cycle length, 35-year time horizon (lifetime projection), and health states for line of treatment, response, receipt of maintenance therapy among responders, transformation to diffuse large B-cell lymphoma (DLBCL), development of second primary malignancy (SPM), and death. The model was used to estimate the expected lifetime costs of FL (in 2019 USD), including costs of drug acquisition and administration, transplant procedures, radiotherapy, adverse events, follow-up, DLBCL, SPM, end-of-life care, and indirect costs. Model inputs were based on published sources. RESULTS: In the US, patients with FL receiving treatment have a life expectancy of approximately 14.5 years from initiation of treatment and expected lifetime direct and indirect costs of US$515,884. Costs of drugs for induction therapy represent the largest expenditure (US$233,174), followed by maintenance therapy costs (US$88,971) and terminal care costs (US$57,065). Despite the relatively advanced age of these patients, indirect costs (due to patient morbidity and mortality and caregiver lost work time) represent a substantial share of total costs (US$40,280). Treated FL patients spend approximately 6.9 years in the health states associated with first-line therapy. Approximately 66 and 46% continue to second- and third-line therapies, respectively. The mean (95% credible interval) of expected lifetime costs based on the probabilistic sensitivity analyses was US$559,202 (421,997-762,553). CONCLUSIONS: In the US, the expected lifetime costs of care for FL patients who receive treatment is high. The results highlight the potential economic benefits that might be achieved by treatments for FL that prevent or delay disease progression.

Statin utilization and low-density lipoprotein cholesterol in statin-treated patients with atherosclerotic cardiovascular disease: Trends from a community-based health care delivery system, 2002-2016.

BACKGROUND: A better understanding of patterns in statin utilization and low-density lipoprotein cholesterol (LDL-C) among patients with atherosclerotic cardiovascular disease (ASCVD) in a clinical practice setting is needed. OBJECTIVES: The objective of this study was to examine statin utilization and LDL-C among new statin users with ASCVD. METHODS: This retrospective study used an electronic health record database from a community-based health care system. We identified ASCVD patients ≥21 years of age with a new statin prescription during the study period (2002-2016). Outcomes included high-intensity statin therapy (HIST) prescribing at treatment initiation, medication adherence (defined as proportion of days covered ≥0.80), statin therapy titrations rates, and changes in LDL-C during follow-up. RESULTS: Among 6199 eligible patients, mean follow-up was 16.8 months. At treatment initiation, 16.6% of patients received HIST. Approximately 53% of patients were adherent to statin regimens. Mean percent reduction in LDL-c was 25% during follow-up; 18% of patients, overall, and 30% of those initiating on HIST attained LDL-C reductions >50%. Rates of statin intensity-level increases were 8.4 per 100 person-years. HIST prescribing increased over time, beginning after generic atorvastatin availability and preceded treatment guidelines by two years. Initiation on HIST, higher adherence, and treatment intensification during follow-up were independent predictors of attaining LDL-C goals of <70 mg/dL or <100 mg/dL. CONCLUSIONS: In a community-based health care system, modest LDL-C lowering for secondary ASCVD prevention is likely driven by suboptimal adherence and low HIST prescribing and treatment intensification rates. Clinician and patient education are needed to reduce clinical inertia and improve medication adherence to better manage ASCVD.

Lipid treatment and goal attainment characteristics among persons with atherosclerotic cardiovascular disease in the United States.

OBJECTIVE: National estimates of atherosclerotic cardiovascular disease (ASCVD) in the United States (US) are scarce, especially for patients grouped by cardiovascular risk, lipid-lowering therapy use, and low-density lipoprotein cholesterol (LDL-C) levels. The objective of this study was to estimate the size of the ASCVD population, including the subgroup at very high risk for recurrent events as defined by the 2018 Multi-Society Cholesterol Guidelines. METHODS: Patient-level data from the Truven MarketScan Research Database were used and extrapolated to approximate national figures based on known national demographic and ASCVD prevalence numbers. Demographic and clinical characteristics, including LDL-C levels and lipid-lowering therapy use, were captured. RESULTS: The extrapolated prevalence of ASCVD in 2014 was 18.3 million, of whom 690,524 had an acute coronary syndrome event in the past year. An estimated 41.4% of patients with ASCVD had diabetes, 44.9% had polyvascular disease, and 23.8% had multiple cardiovascular events. A third of those with ASCVD were estimated to be at very high risk for subsequent events per the 2018 Multi-Society Cholesterol Guidelines. Of those with ASCVD, 74.2% were estimated to have an LDL-C level of ≥70 â€‹md/dL, and more than half of these patients were neither on statins nor ezetimibe. Only 9.2% of patients with ASCVD and LDL-C ≥70 â€‹mg/dL were on a high-intensity statin. CONCLUSIONS: The underutilization of lipid-lowering therapies in general, and in particular the relatively low usage of high-intensity statins among patients with uncontrolled LDL-C (including those at very high risk), suggests that eligible patients for proprotein convertase subtilisin/kexin type 9 inhibitor therapy may not be as numerous as previously estimated.

Lipid-lowering Therapy and Goal Achievement in High-risk Patients From French General Practice.

PURPOSE: The goal of this study was to summarize patterns of lipid-lowering therapy (LLT) usage and achievement of guideline-identified lipid goals in a 2015 general practice cohort of French patients with atherosclerotic cardiovascular disease (ASCVD) and/or diabetes mellitus (DM). METHODS: From the IMS Health Real-World Data database, patients aged ≥18years were classified hierarchically into mutually exclusive categories of ASCVD subgroups and DM. LLT use and lipid goal achievement were assessed on the date of lipid measurement. The data were compared with previously published results of LLT use and lipid goal achievement in a 2014 UK population. FINDINGS: Of 32,924 patients meeting the inclusion criteria, only 47.5% were prescribed a statin as of the index date. Hierarchically, the highest rates of use of any statin (73.3%) and high-intensity statins (43.3%) were among patients with recent acute coronary syndrome; rates in DM without ASCVD were 38.7% and 2.3%, respectively. Overall, achievement of LDL-C levels <1.8 mmol/L (<70 mg/dL) was only 13.9% for patients with ASCVD and 10.7% with DM. Relative to a 2014 UK population, the 2015 French cohort (data reanalyzed according to the UK statin categorization) were prescribed "high-dose statins" less frequently (31.4% vs 20.9%, and 18.7% vs 7.2%, for ASCVD and DM). Similarly, the proportion of patients with high-dose statins achieving LDL-C levels <1.8mmol/L was higher in the 2014 UK population than in the 2015 French population (37.3% vs 22.2%, and 36.8% vs 20.3%, for ASCVD and DM). IMPLICATIONS: In a large cohort of French patients with ASCVD and/or DM, LLT usage and LDL-C goal achievement were suboptimal, relative to current guidelines.

Statin utilization and lipid goal attainment in high or very-high cardiovascular risk patients: Insights from Italian general practice.

BACKGROUND AND AIMS: Statin utilization and lipid goal achievement were estimated in a large sample of Italian patients at high/very-high cardiovascular (CV) risk. METHODS: Patients aged ≥18 years with a valid low-density lipoprotein cholesterol (LDL-C) measurement in 2015 were selected from the IMS Health Real World Data database; non-high-density lipoprotein cholesterol (non-HDL-C) was assessed in those with available total cholesterol measurements. Index dates were defined as the last valid lipid measurement in 2015. Patients were hierarchically classified into mutually exclusive risk categories: heterozygous familial hypercholesterolemia (primary and secondary prevention), atherosclerotic CV disease (including recent acute coronary syndrome [ACS], chronic coronary heart disease, stroke, and peripheral arterial disease), and diabetes mellitus (DM) alone. Statin and non-statin lipid-modifying therapy (LMT) use, and European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guideline-recommended goal attainment, were assessed. RESULTS: Among 66,158 patients meeting selection criteria, the overall rate of LMT prescriptions was 53.3%, including 7.7% on high-intensity statin therapy. Statin use was highest for recent ACS and lowest for DM alone. LDL-C goal attainment was 16.0% for <1.8 mmol/l and 45.0% for <2.5 mmol/l; 24.3% reached non-HDL-C <2.6 mmol/l and 52.2% were at <3.3 mmol/l. Goal achievement was greatest with high-intensity statin use. CONCLUSIONS: Statin use in this cohort was consistent with previous reports in Italian patients at high/very-high CV risk, and low relative to statin use in other European countries. The low rate of ESC/EAS lipid goal attainment observed was consistent with outcomes of other European studies.

Utilization of lipid-modifying therapy and low-density lipoprotein cholesterol goal attainment in patients at high and very-high cardiovascular risk: Real-world evidence from Germany.

BACKGROUND AND AIMS: Elevated low-density lipoprotein cholesterol (LDL-C) is a causal risk factor for cardiovascular (CV) events. European guidelines recommend reducing LDL-C as the primary lipid target to reduce CV risk, using lifestyle modifications and lipid-lowering therapy (LLT). Many European patients do not achieve guideline-recommended LDL-C levels. The present database analysis aimed to assess LLT treatment patterns and LDL-C threshold attainment in Germany in a large, real-world cohort of patients. METHODS: Patients from the Cegedim Longitudinal Practice Database in Germany who met selection criteria were included: (a) LDL-C measurement in 2013; (b) ≥20 years of age; (c) high or very-high CV risk conditions: recent acute coronary syndrome (ACS), other coronary heart disease (CHD), ischemic stroke, peripheral arterial disease (PAD) (atherosclerotic cardiovascular disease [ASCVD]) or diabetes mellitus (DM) (non-ASCVD). LDL-C threshold attainment was assessed based on LDL-C targets from 2011 European guidelines. RESULTS: 42,767 patients met the inclusion criteria; 35% received current statin treatment, and 30% achieved guideline-recommended LDL-C targets. Attainment of LDL-C goals among ASCVD hierarchical categories was 46.7% for recent ACS, 35.8% for ischemic stroke, 34.9% for other CHD, and 26.9% for PAD. Among patients in the non-ASCVD group with DM, 23.6% achieved LDL-C goals. Similar results were observed when patients were grouped by prevalence (patients assigned to every risk group for which they qualified). CONCLUSIONS: In this high/very-high CV risk population in Germany, statin utilization was low; suggesting that LLTs are not prescribed as per European guidelines. These results highlight the need to increase LLT use among high-risk patients.

The economic burden of pulmonary arterial hypertension (PAH) in the US on payers and patients.

BACKGROUND: Pulmonary arterial hypertension (PAH) is a rare condition that can ultimately lead to right heart failure and death. In this study we estimated the health care costs and resource utilization associated with PAH in a large US managed care health plan. METHODS: Subjects with claims-based evidence of PAH from 1/1/2004 to 6/30/2010 (identification period) were selected. To be included in the final PAH study sample, subjects were required to have ≥2 claims with a primary PH diagnosis; ≥2 claims with a PAH related-diagnosis (connective tissue diseases, congenital heart diseases, portal hypertension); and ≥1 claim with evidence of a PAH-indicated medication. The earliest date of a claim with evidence of PAH-indicated medication during the identification period was set as the index date. Health care costs and resource utilization were compared between an annualized baseline period and a 12 month follow-up period. RESULTS: 504 PAH subjects were selected for the final study cohort. Estimated average total health care costs were approximately 16% lower in the follow-up period compared to the baseline period (follow-up costs = $98,243 [SD = 110,615] vs. baseline costs = $116,681 [SD = 368,094], p < 0.001), but substantively high in each period relative to costs reported for other chronic diseases. Pharmacy costs were significantly higher in the follow-up period vs. the baseline period, ($38,514 [SD = 34,817] vs. $6,440 [SD = 12,186], p < 0.001) but medical costs were significantly lower in the follow-up vs. baseline ($59,729 [SD = 106,683] vs. $110,241 [SD = 368,725], p < 0.001). These costs were mirrored in health-care resource utilization estimates. The average counts of ambulatory visits and inpatient stays were lower in the follow-up vs. the baseline (both p < 0.001). Results varied in exploratory analyses when less restrictive subject identification algorithms were used. CONCLUSIONS: Subjects with evidence of PAH had substantively high health care costs. Medical costs appeared to decrease following PAH medication use, but with a concomitant increase in pharmacy costs.

Healthcare Resource Utilization and Costs Associated with Autosomal Dominant Polycystic Kidney Disease.

Background: Autosomal dominant polycystic kidney disease (ADPKD), a hereditary nephropathy, eventually leads to end-stage renal disease (ESRD), typically by mid-life. Objectives: The objective of this study was to assess real-world healthcare resource utilization and cost among commercially insured (COM) and Medicare Advantage (MAPD) ADPKD patients in addition to the cost profile by chronic kidney disease (CKD) stage. Methods: Patients diagnosed with ADPKD (two or more claims) with ≥30 days of continuous medical and pharmacy benefits and no evidence of autosomal recessive polycystic kidney disease were selected (Optum Research Database and Impact National Benchmarking Database: 1/1/06-8/31/12). Plan and patient paid healthcare costs and resource utilization per patient per month (PPPM) were described in total and by insurance type. CKD stage was established based on serum creatinine laboratory values or dialysis-related codes. Adjusted, CKD stage-specific costs were predicted for 4 years using regression models. Results: Of the 36,253,096 patients in the databases (1/1/06-8/31/12), 5,051 had evidence of ADPKD. Following exclusion criteria, 4,356 COM and 468 MAPD ADPKD patients remained. Total healthcare resource utilization and costs were high, and costs increased substantially from CKD stage 1-5. PPPM healthcare costs were 37% for ADPKD management and 52% for dialysis services. Predicted 4-year healthcare costs by CKD stage were $40,164 (stage 1), $33,397 (stage 2), $42,686 (stage 3), $148,402 (stage 4), and $207,548 (stage 5). Conclusions: Healthcare resource utilization and costs associated with ADPKD were substantial, irrespective of payer type, and primarily driven by CKD stage. Of the total healthcare costs, 88% were ADPKD- and dialysis-related. Most impactful was the spike in predicted cost when patients progressed from CKD stage 3 to stage 4 (by 348%) after multivariate adjustment. These stage 4-associated costs are primarily due to ultimate progression into stage 5 and ESRD within the 4-year time frame.

Medical costs and healthcare resource use in patients with lupus nephritis and neuropsychiatric lupus in an insured population.

OBJECTIVE: Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organ systems, including the kidneys (lupus nephritis) and the central nervous system (neuropsychiatric lupus, or NPSLE). The healthcare costs and resource utilization associated with treating lupus nephritis and NPSLE in a large US managed care plan were studied. METHODS: SLE subjects ≥18 years of age and with claims-based evidence of nephritis or neuropsychiatric conditions were identified from a health plan database. An index date was set as a randomly drawn date from all qualifying claims during 2003-2008 for study subjects. Subjects were matched on the basis of demographic and clinical characteristics to unaffected controls. Costs and resource use were determined during a fixed 12-month post-index period. RESULTS: Nine hundred and seven lupus nephritis subjects were matched to controls, and 1062 subjects with NPSLE were matched to controls. Mean overall post-index healthcare costs were significantly higher among subjects with lupus nephritis in comparison to matched controls ($33,472 vs $5347, p < 0.001). Similarly, mean overall post-index healthcare costs were significantly higher among subjects with NPSLE compared to controls ($30,341 vs $4646, p < 0.001). Subjects with lupus nephritis or NPSLE had higher mean post-index numbers of ambulatory visits, specialist visits, emergency department visits and inpatient hospital stays, compared to controls (all p < 0.001). LIMITATIONS: Additional research, such as medical chart review, could provide validation for the claims-based identification of lupus nephritis and NPSLE subjects. Also, indirect costs were not evaluated in this study. CONCLUSION: Subjects with lupus nephritis or NPSLE have high costs and resource use, compared to unaffected controls.

Annual medical costs and healthcare resource use in patients with systemic sclerosis in an insured population.

OBJECTIVE: Systemic sclerosis (SSc) is a chronic autoimmune disease. The objective of our study was to estimate the medical costs and healthcare resource use of subjects with SSc in a large US managed care plan. METHODS: Subjects at least 18 years of age and with claims-based evidence of SSc (ICD-9-CM code 710.1x) were identified from a health plan database from 2003 through 2008. Subjects were matched to unaffected controls, based on index date, age, sex, geographic region, time on insurance, and comorbidity score. Costs and resource use were identified during the 12-month postindex period. A generalized linear model (GLM) was used to estimate costs, controlling for demographic and clinical characteristics. RESULTS: In this study, 1648 subjects with SSc were matched to 4944 controls. Mean overall annual medical costs were higher among SSc subjects than controls ($17,365 vs $5,508; p < 0.001). A GLM model supported these results. Evidence of lung disease, gastrointestinal bleeding, or renal disease increased costs (all p < 0.001). Compared to controls, significantly higher proportions of SSc subjects had postindex ambulatory visits, emergency department visits, and inpatient hospital stays (all p < 0.001). CONCLUSION: Our findings suggest that the medical costs and resource use associated with treating SSc are high (compared to matched controls), and as expected, subjects with serious disease complications experience the highest costs.

Medical costs and health-care resource use in patients with inflammatory myopathies in an insured population.

INTRODUCTION: In this study we determined the health-care costs and resource utilization associated with idiopathic inflammatory myopathies (IIMs) in a large managed care plan in the USA. METHODS: Myositis subjects ≥18 years of age with claims-based evidence of IIMs were identified from a health plan database. Subjects were matched with unaffected controls, and costs and resource use were determined during a 12-month period. RESULTS: A total of 1781 newly diagnosed IIM subjects were matched to 5343 controls, and 2697 subjects with existing disease were matched to 8091 controls. Mean overall annual medical costs were higher among newly diagnosed subjects ($16,319 vs. $4926, P < 0.001) and subjects with an existing IIM ($15,539 vs. $5210, P < 0.001) in comparison to controls. IIM subjects had significantly higher mean counts of ambulatory visits, specialist visits, and inpatient hospital stays compared with controls (all P < 0.001). CONCLUSION: Our analysis suggests that IIMs have increased medical costs and resource use.

Preadmission glycemic control and changes to diabetes mellitus treatment regimen after hospitalization.

OBJECTIVE: To evaluate treatment patterns associated with diabetes medication regimen changes after hospitalization on the basis on preadmission hemoglobin A1c levels. METHODS: In this retrospective database analysis, patients with a diabetes diagnosis, hospitalization, and documented hemoglobin A1c level within the 90 days leading up to hospital admission were identified in an administrative claims database. Treatment regimens were assessed before and after hospitalization. The proportion of patients who had progression, reduction, or no change in therapy was compared across hemoglobin A1c subgroups: hemoglobin A1c <7.0%, hemoglobin A1c 7.0%-7.9%, and hemoglobin A1c ≥8.0%. RESULTS: Four hundred patients were included (192 in hemoglobin A1c <7.0% group, 94 in hemoglobin A1c 7.0%-7.9% group, and 114 in hemoglobin A1c ≥8.0% group). Demographically, hemoglobin A1c subgroups did not differ significantly (mean age, 57 years; 47.5% male). With respect to therapeutic regimen overall, 28%, 24%, and 48% of patients experienced progression, reduction, and no change, respectively. Across hemoglobin A1c subgroups, 37.7% of patients in the hemoglobin A1c ≥8.0% subgroup had therapy progression compared with 26% and 20.2% in the hemoglobin A1c <7.0% and hemoglobin A1c 7.0%-7.9% subgroups, respectively (P = .032 and P = .006, respectively). Within the progression category, progression via insulin initiation was significantly higher in the hemoglobin A1c ≥8.0% subgroup (55.8%) than in the hemoglobin A1c <7.0% subgroup (16%, P<.001), but not significantly higher than in the hemoglobin A1c 7.0%-7.9% subgroup (36.8%, P = .084). In the hemoglobin A1c ≥8.0% subgroup, a lower percentage of patients, 35.1%, experienced no therapy change than in both the hemoglobin A1c <7.0% subgroup (52.6%) and the hemoglobin A1c 7.0%-7.9% subgroup (54.3%) (P = .003 and P = .006, respectively). There was no difference between subgroups in reduction of therapy. CONCLUSIONS: A higher proportion of patients with a hemoglobin A1c level ≥8.0% had progression of their antidiabetes therapy after hospitalization and fewer patients had no change in therapy than those in lower hemoglobin A1c subgroups. These data suggest that clinicians may be using hemoglobin A1c measurements to guide discharge planning treatment decisions.

Epidemiology of adult idiopathic inflammatory myopathies in a U.S. managed care plan.

INTRODUCTION: Idiopathic inflammatory myopathies have a reported incidence of 0.1 to 1 per 100,000 person-years and prevalence of 0.55 to 6 per 100,000 in the United States. METHODS: We retrospectively examined medical claims for adults aged ≥18 years with myositis (International Classification of Diseases, Ninth Revision, Clinical Modification codes 710.3 [dermatomyositis], 710.4 [polymyositis], and 728.81 [interstitial myositis]) from 2003 to 2008 in a large US managed care database. RESULTS: The incidence and prevalence cohorts comprised 1,941 and 3,112 subjects, respectively. From 2003 to 2008, the adjusted annual incidence of myositis ranged from 5.8 to 7.9 per 100,000 person-years, and the annual prevalence of myositis ranged from 14.0 to 17.4 per 100,000. CONCLUSIONS: The incidence and prevalence of idiopathic inflammatory myopathies in the managed care plan studied was higher than previously reported in the United States. Because of the limitations inherent in claims analysis, additional research is needed to substantiate these results.

Epidemiology of systemic sclerosis in a large US managed care population.

OBJECTIVE: To estimate the incidence and prevalence of systemic sclerosis (SSc) in a large US managed care organization (MCO) database. METHODS: Subjects with claims-based evidence of SSc (ICD-9-CM code 710.1x) were identified from a health plan database. Incidence and prevalence for the period 2003-2008 were calculated. RESULTS: The overall age- and sex-adjusted incidence rate (2003-2008) for SSc was 5.6 cases per 100,000 person-years. The annual prevalence of SSc ranged from 13.5 in 2003 to 18.4 (per 100,000) in 2008. CONCLUSION: This analysis suggests a higher incidence and lower prevalence of SSc in this MCO than those previously reported for the United States.

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.