Association Between Gastrointestinal Events and Health Care Resource Utilization Among Patients with Osteoporosis: Analysis of a U.S. Managed Care Population.

BACKGROUND: Among patients on osteoporosis therapy, including oral bisphosphonates (BIS), upper gastrointestinal (GI) conditions have been linked with lower adherence to treatment and increased treatment discontinuation in clinical practice. Patients who are nonadherent to treatment have a higher risk of osteoporotic fractures and, consequently, have greater use of health care services. The burden of upper gastrointestinal events on health care resource utilization (HCRU) among women initiating oral BIS has not been well investigated. OBJECTIVE: To examine the association of upper GI events and HCRU in women initiating oral BIS.  METHODS: Using a U.S. national claims database, this retrospective study identified women aged ≥ 55 years who were prescribed oral BIS during 2001-2011 and had no history of GI events 12 months prior to treatment initiation. Patients with medical claims for an upper GI event ≤ 4 months posttreatment initiation were cases; all others were controls. The date of the first upper GI event among cases and a randomly assigned date ≤ 4 months posttreatment initiation among controls was the index date. Cases were matched 1:1 to controls by propensity scores derived from logistic regression of pre-index patient characteristics. Outcomes were all-cause and osteoporosis (OP)-related HCRU in the 6-month post-index period. Differences were assessed using McNemar's test. RESULTS: Of the 62,863 eligible patients, 4,751 (7.6%) experienced an upper GI event ≤ 4 months posttreatment initiation (cases); 4,739 cases were matched with 4,739 controls. Compared with controls, cases had higher rates of all-cause HCRU (outpatient: 99.3% vs. 87.8%; inpatient: 20.2% vs. 6.4%; emergency room [ER]: 12.5% vs. 7.4%; all P less than 0.0001) and OP-related HCRU (outpatient: 24.6% vs. 18.2%; inpatient: 3.4% vs. 1.0%; ER: 0.7% vs. 0.4%; all P less than 0.05). CONCLUSIONS: Patients with upper GI events had higher rates of all-cause and OP-related health care utilization. Upper GI events may pose an incremental HCRU burden among patients initiating BIS.

Therapeutic practice patterns related to statin potency and ezetimibe/simvastatin combination therapies in lowering LDL-C in patients with high-risk cardiovascular disease.

BACKGROUND: Statin combination therapy and statin uptitration have been shown to be efficacious in low-density lipoprotein cholesterol (LDL-C) lowering and are recommended for patients with high-risk coronary heart disease (CHD) who do not reach guideline-endorsed LDL-C goals on statin monotherapy. OBJECTIVE: This analysis evaluated treatment practice patterns and LDL-C lowering for patients with CHD/CHD risk equivalent on statin monotherapy in a real-world practice setting in the United States. METHODS: In this retrospective, observational study, patients with CHD/CHD risk equivalent on statin therapy were identified during 2004 to 2008 in a US managed care database. Prescribing patterns and effect of switching from statin monotherapy to combination ezetimibe/simvastatin therapy vs uptitration to higher statin dose/potency level and no change from initial statin potency on LDL-C lowering were assessed. Percentage of change from baseline in LDL-C levels and odds ratios for LDL-C goal attainment were estimated with analyses of covariance and logistic regression. RESULTS: Of 27,919 eligible patients on statin therapy, 2671 (9.6%) switched to ezetimibe/simvastatin therapy, 11,035 (39.5%) uptitrated statins, and 14,213 (50.9%) remained on the same statin monotherapy. LDL-C reduction from baseline and attainment of LDL-C <100 and <70 mg/dL were substantially greater for patients who switched to ezetimibe/simvastatin therapy (-24.0%, 81.2%, and 35.2%, respectively) than for patients who titrated (-9.6%, 68.0%, and 18.4%, respectively) or remained on initial statin therapy (4.9%, 72.2%, and 23.7%, respectively). The odds ratios for attainment of LDL-C <100 and <70 mg/dL were also higher for patients who switched than for patients who uptitrated and had no therapy change than for patients who titrated vs no therapy change. Similarly, among a subgroup of patients not at LDL-C <100 mg/dL on baseline therapy, attainment of LDL-C <100 and <70 mg/dL was greater for patients who switched than for statin uptitration vs no change, as well as for patients who uptritrated statins vs no therapy change. CONCLUSION: In this study, LDL-C lowering and goal attainment rates improved substantially for patients with high-risk CHD on statin monotherapy who switched to combination ezetimibe/statin or uptitrated their statin therapies; however, approximately one-third of these patients still did not attain the optional recommended LDL-C goal of <70 mg/dL. Moreover, these higher efficacy lipid-lowering therapies were infrequently prescribed, indicating the need for further assessment of barriers to LDL-C goal attainment in actual practice settings.

Increasing pharmaceutical copayments: impact on asthma medication utilization and outcomes.

OBJECTIVES: Unintended consequences may result from changes in pharmacy benefit design. The objective was to determine the impact of increasing patient prescription copayments for guideline recommended, long-term asthma controller (LTC) medications on asthma-related medication use and healthcare services. STUDY DESIGN: We used 2005 MarketScan healthcare and pharmacy claims data to identify asthma (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] diagnosis code 493.xx) patients aged 12 to 64 years who were continuously enrolled through 2006 with ≥ 1 claim for an asthma medication in 2005. LTCs included: inhaled corticosteroid (ICS) (n = 10,251), ICS plus long-acting beta agonist (COMBO) (n =27,407), and leukotriene receptor antagonist (LTRA) (n = 20,664). METHODS: Using multivariable models, we estimated the associations between changes in LTC copayments and LTC consumption and asthma-related outpatient and emergency department (ED) visits. RESULTS: Patients were dichotomized into ≥ $5 average increase in patient copayments per month of medication supplied (yes/no). The mean annual change (2005-2006) in copayments per month was $13.23 versus -$3.88 (ICS), $11.76 versus -$3.06 (COMBO), and $9.78 versus -$2.06 (LTRA). The ≥ $5 group experienced a significant decline in average annual days of medication supplied of -47.1 days of ICS (95% CI -43.5 to -50.8), -35.3 days of COMBO (-32.4 to -38.2), and -47.5 days of LTRA (-43.2 to -51.7). Among COMBO and LTRA medication users, the ≥ $5 copayment increase was associated with more asthma-related outpatient visits and ED visits compared with the < $5 group. CONCLUSIONS: The findings suggest that even small changes in average copayment for asthma medications can result in significant reductions in medication use and unintended increases in healthcare services.

Asthma Severity in patients initiating controller monotherapy versus combination therapy.

BACKGROUND: Asthma treatment guidelines recommend medications based on the level of asthma control. OBJECTIVE: To evaluate differences in asthma control between patients who initiated asthma controller monotherapy versus combination therapy. PATIENTS AND METHODS: Children (5-16 years; n = 488) and adults (17-80 years; n = 530) with asthma and no controller therapy in the prior 6 months were included. Telephone surveys were conducted within 5 days of filling a new asthma controller prescription with either the caregiver of children or the adult patient. Demographics, asthma control before therapy, and asthma-related resource use were assessed for patients initiating monotherapy (filling one asthma controller prescription) and combination therapy (filling more than one controller medication or a fixed-dose combination). RESULTS: Mean pediatric age was 10 years; 53% were male. Mean adult age was 47 years; 25% were male. There were no significant differences in asthma control score between patients receiving monotherapy and combination therapy. Children on combination therapy did not have more nighttime awakening or short-acting ß-agonist use but were more likely to have been hospitalized due to asthma attack (p = .05) and have more unscheduled (p = .0374) and scheduled (p = .009) physician visits. Adults on combination therapy were more likely to have been hospitalized due to asthma attack (p < .05) and have regular doctor visits for asthma (p < .01). CONCLUSIONS: Assessment of asthma control scores in the 4 weeks before index medication suggests that asthma severity during a treatment-free period did not differ significantly for patients initiating controller monotherapy versus combination therapy. From these findings, it appears that although physicians may not focus on asthma control when choosing the intensity of initial controller therapy, the intensity of health-care encounters may be an influence.

Loss of early gains in low-density lipoprotein cholesterol goal attainment among high-risk patients.

BACKGROUND: Guidelines recommend a low-density lipoprotein cholesterol (LDL-C) measurement of <70 mg/dL as a reasonable goal in high-risk patients with coronary heart disease (CHD) or atherosclerotic vascular disease (AVD). METHODS: This retrospective, cross-sectional study examined LDL-C goal attainment monthly trends from January 1, 2004, to August 31, 2008, in a large, managed-care claims database in the United States. High-risk CHD or AVD patients who had at least one LDL-C test during that time period were included (N = 284,915). Average LDL-C values and percent of patients not achieving LDL-C goal (LDL-C ≥70 mg/dL) were obtained by averaging patient level LDL-C values for each month. A linear trend analysis with first-order autocorrelated errors was conducted. RESULTS: The proportion of patients treated with lipid-lowering therapy gradually increased from 58.5% in 2004 to 70.5% in 2008. Mean LDL-C values in patients treated with lipid-lowering therapy decreased from 100.4 to 96.4 mg/dL, whereas LDL-C remained relatively constant in untreated patients (114.3 mg/dL). In treated patients, the percentage with LDL-C ≥70 mg/dL decreased from 87.5% in January 2004 to 73.8% in December 2006 (P < .0001), then gradually declined between January 2007 (79.6%) and August 2008 (76.2%; P < .0001). Among untreated patients, 92.9% had LDL-C levels ≥70 mg/dL in January 2004 and 93.0% in August 2008. CONCLUSION: In conclusion, the percentage of high-risk patients with CHD or AVD treated with lipid-lowering therapy who achieve LDL-C <70 mg/dL levels has increased since 2004, although a large proportion of these patients still do not meet this goal. Additionally, 1 of 4 high-risk patients otherwise eligible for lipid-lowering therapy remains untreated. These data suggest the need for renewed efforts to support guideline-based LDL-C lowering in high-risk patients.

Switching from high-efficacy lipid-lowering therapies to simvastatin and low-density lipoprotein cholesterol goal attainment in coronary heart disease/coronary heart disease-equivalent patients.

BACKGROUND: The availability of generic simvastatin in 2006 has prompted substantial changes in formulary recommendations for lipid-management agents. OBJECTIVE: To assess the impact of switches from high-efficacy lipid-lowering therapy to simvastatin on low-density lipoprotein cholesterol (LDL-C) and goal attainment in coronary heart disease (CHD) or CHD risk-equivalent patients in a managed care setting. METHODS: In this retrospective observational study, we estimated the least squares mean difference in the percent change from baseline LDL-C and the odds ratios for LDL-C goal attainment rates (<100 mg/dL and <70 mg/dL) at follow-up for each baseline high-efficacy lipid-lowering therapy with the analysis of covariance and logistic regressions, respectively. RESULTS: We identified 18,061 patients who, between September 1, 2004 and October 31, 2008, were either switched from or remained on their initial high-efficacy LDL-C lowering therapy: ezetimibe/simvastatin fixed-dose combination (E/S), rosuvastatin, or atorvastatin. The difference in percent change in LDL-C levels from baseline were 25.2 (95% confidence interval 21.2-29.2), 13.0 (6.0-20.0), and 3.1 (0.3-5.9) greater in switchers to simvastatin in the E/S, rosuvastatin, and atorvastatin comparisons, respectively, after adjusting for age, sex, and starting dose of the initial therapy. For switchers, the percent of patients at LDL-C <100 mg/dL at follow-up decreased from 83.5% to 63.8% in the E/S, 67.7% to 52.7% in the rosuvastatin, and 65.1% to 60.2% in the atorvastatin cohorts. The percent of patients at LDL-C <70 mg/dL at follow-up was lower for all switcher groups compared with nonswitchers. CONCLUSIONS: Among CHD/CHD risk-equivalent patients, switching to simvastatin was associated with increases in LDL-C levels and lower LDL-C goal attainment rates. The public health impact of this phenomenon on population risk and CHD events remains to be determined.

Persistent asthma defined using HEDIS versus survey criteria.

OBJECTIVES: To describe the relationships between persistent asthma defined by administrative versus survey data and their stability over time. STUDY DESIGN: Longitudinal survey and retrospective administrative database. METHODS: Administrative data were used to identify patients meeting the Healthcare Effectiveness Data and Information Set (HEDIS) criteria for persistent asthma in year 1 (2006). At the end of year 2 and on 3 occasions during year 3, patients were mailed a survey to define persistent asthma based on symptoms and medication use in the prior month and exacerbations in the prior 12 months. Administrative data were also used to define medical utilization for asthma in year 3. RESULTS: Of 13,833 eligible patients, 2895 (20.9%) returned the survey; 2751 of these respondents reported physician-diagnosed asthma, of whom 2517 (91.5%) had survey-defined persistent asthma. Patients having survey-defined persistent asthma (68.0%) were more likely to requalify as having HEDIS-defined persistent asthma in year 2 than patients not having survey-defined persistent asthma (22.2%). However, 81.6% of survey respondents who did not requalify as having HEDIS-defined persistent asthma in year 2 had survey-defined persistent asthma. Patients with survey-defined persistent asthma in year 2 had significantly more medical utilization for asthma in year 3 than patients without survey-defined persistent asthma. Approximately 82% of the 799 patients completing all 4 surveys had persistent asthma on all surveys. CONCLUSIONS: HEDIS-defined persistent asthma is generally consistent with survey-defined persistent asthma. Persistent asthma usually remains persistent over a 3-year period, indicating that it is a stable characteristic of asthma for most patients. The low survey response rate suggests that further population-based studies will be necessary to confirm the validity and generalizability of our study findings regarding persistent asthma.

Impact of asthma controller medications on medical and economic resource utilization in adult asthma patients.

OBJECTIVE: To compare asthma-related resource utilization, adherence and costs among adults prescribed asthma controller regimens. RESEARCH DESIGN AND METHODS: Medical and pharmacy claims from a US managed-care claims database were used to identify adults (18-56 years) initiating asthma controller therapy. Patients had 2 years continuous enrollment and ≥ 1 medical claims for asthma (ICD9: 493.xx) (January 2004 - March 2009). Asthma exacerbations, short-acting ß-agonist (SABA) fills, adherence (MPR ≥ 0.80) and asthma-related costs were assessed for 1 year after the initial asthma controller medication claim. Separate logistic and negative binomial regression models for monotherapy and combination therapy were developed to examine the impact of controller therapy on outcomes. RESULTS: A total of 28 074 patients [inhaled corticosteroids (ICS) (26.3%), leukotriene modifiers (LM) (23.2%), ICS + long acting ß-agonist (LABA) (48.5%), ICS + LM (2%)] were included. LM patients had lower odds of ≥ 6 SABA fills (OR(adj) = 0.83, 95% CI: 0.73-0.96) and lower rates of asthma exacerbations (RR(adj) = 0.82, 0.75-0.89) vs. ICS patients. Odds of ≥ 6 SABA fills were similar for ICS + LM vs. ICS + LABA (OR(adj) = 1.3, 0.96-1.76); the rate of asthma exacerbations was greater for ICS + LM compared with ICS + LABA (OR(adj) = 1.4, 1.2-1.6). The proportion adherent was greatest for LM (14.9%) and ICS + LABA (4.1%). LM patients had higher unadjusted pharmacy costs, but lower medical costs compared to ICS patients. For combination therapy, ICS + LM had higher unadjusted mean medical and pharmacy costs vs. ICS + LABA. Higher adjusted mean total costs in the post-index period were observed for LM vs. ICS patients ($837 vs. 684) and for ICS + LM vs. ICS + LABA patients ($1223 vs. 873). CONCLUSIONS: LM monotherapy was associated with lower medical costs but higher total costs resulting from greater treatment adherence. Conversely, higher costs for ICS + LM resulted from greater exacerbations compared to ICS + LABA despite similar adherence. Higher total costs with LM were due to drug costs. Precise utilization of the medications filled by patients could not be determined.

Patient characteristics and prescription fill patterns for allergic rhinitis medications, with a focus on montelukast, in a commercially insured population.

BACKGROUND: Allergic rhinitis (AR), also known as hay fever, is caused by an overreaction of the immune system to airborne allergens. AR is a substantial cause of widespread morbidity, medical treatment costs, and reduced productivity at work and school. OBJECTIVE: The goal of this research was to describe patient characteristics and prescription fill patterns for patients with AR and to determine those factors associated with the use of montelukast in a large population of commercially insured patients who sought medical treatment for AR. METHODS: This was a retrospective cohort study using administrative claims data from a commercially available database. Patients, aged 4 to 64 years, with >or=3 years' continuous enrollment and >or=1 medical claim for AR between January 1, 2004, and December 31, 2006, were included. Patients with a concomitant asthma diagnosis were excluded. Patients' demographic and clinical characteristics, comorbidities, health care resource utilization, AR-related medication use, and AR-related physician office visits were assessed for 12 months before the first AR medication fill (index) in 2006. Stepwise logistic regression was used to identify factors predicting the initiation of montelukast therapy for the treatment of AR in 2006. RESULTS: The study population consisted of 75,140 children (mean [SD] age, 10.6 [4.0] years) and 226,236 adults (mean age, 43.8 [11.8] years). Slightly more than half (52.4%) of the pediatric population was male compared with 44.7% of the adult population. Fifty percent of patients had no pharmacy fills for an AR medication in 2006. Among patients with AR pharmacy fills (n = 150,751), 78.1% had a single index medication fill (montelukast represented 4.5%) and 21.9% were prescribed multiple index medications. Children with AR were more likely to fill a prescription for montelukast (n = 7513) if they were 4 to 11 years of age; male; diagnosed with cough/wheeze; and had 1 or 2 oral corticosteroid fills, >or=3 antibiotic fills, and AR-related physician office visits in the prior 12 months (all, P < 0.001). Prescription fills for montelukast among adult patients with AR were significantly (P < 0.001) associated with other respiratory/atopic conditions; prior fills for antihistamines, oral corticosteroids, or intranasal corticosteroids; and AR-related physician office visits in the prior 12 months. Children and adults with health plans based in the midwestern or southern region of the United States had greater odds of initiating montelukast than those with plans based in the western region (P < 0.001). CONCLUSIONS: Half of the patients identified with AR did not fill a prescription for an AR medication. Among those patients with AR-related prescription drug fills, most were prescribed a single index pharmacotherapy and did not receive additional AR medications within 30 days of the index date. The use of montelukast was limited and was more commonly prescribed to children and adults with AR whose condition was not controlled with other AR medications.

Relationship of asthma control to asthma exacerbations using surrogate markers within a managed care database.

OBJECTIVE: To compare the relationship of surrogate markers of asthma control to subsequent asthma exacerbations. STUDY DESIGN: Retrospective cohort. METHODS: Administrative data were used to identify patients who met the Healthcare Effectiveness Data and Information Set (HEDIS) criteria for persistent asthma in 2006 and 2007. The following potential surrogate markers of asthma control assessed in 2007 were compared for their ability to predict asthma exacerbations in 2008 (defined as oral corticosteroid dispensing or an asthma hospitalization or emergency department visit): dispensing of any controller, unweighted medication ratio (the ratio of controller to total medication), weighted medication ratio, and the number of short-acting beta-agonist (SABA) canisters dispensed. Weighted medication ratios were weighted for controller potency and for doses per container. RESULTS: Meeting the HEDIS criteria for persistent asthma were 8634 patients (60.5% female) aged 18 to 56 years (mean age, 42.7 years), of whom 6.5% experienced emergency hospital care and 27.3% received oral corticosteroids in 2008. The largest effect size for predicting reduced emergency hospital care was for the number of SABA canisters dispensed (odds ratio [OR], 0.49; 95% confidence interval [CI], 0.40-0.60), followed by the unweighted medication ratio (OR, 0.54; 95% CI, 0.40-0.72), and then the weighted medication ratio (OR, 0.57; 95% CI, 0.45-0.73). Dispensing of any controller was associated with a nonsignificant increased risk of emergency hospital care (OR, 1.41; 95% CI, 0.95-2.09). CONCLUSIONS: The number of SABA canisters dispensed is most strongly related to improved asthma outcomes, followed by the unweighted medication ratio; dispensing of any controller is least related. Health plans can use the number of SABA canisters dispensed and the unweighted medication ratio for asthma population management or for provider quality-of-care assessment to reduce asthma exacerbations, which exact a high economic and humanistic cost.

Using the pediatric asthma therapy assessment questionnaire to measure asthma control and healthcare utilization in children.

BACKGROUND: : The usefulness of questionnaires to assess asthma control in clinical practice is recognized in recent international guidelines. While several questionnaires have been developed to measure asthma control in adults, there has been little study of the performance of such instruments in children. OBJECTIVE: : To determine whether there is an association between asthma-related healthcare use and poor asthma control, as determined by categorical score on the control domain of the Asthma Therapy Assessment Questionnaire for children and adolescents (the pediatric ATAQ). METHODS: : An analysis of a 1998 mailed survey of parents or caregivers of children aged 5-17 years with asthma enrolled in three large managed-care organizations in the Northeast and Midwest US was conducted. Pediatric ATAQ control domain score (reported for the past 4 weeks) was the main outcome measure. The pediatric ATAQ control domain was scored from 0 to 7, with 0 indicating no asthma control problems as measured by the questionnaire, and higher scores indicating increasing asthma problems. The hypothesis of an association between pediatric ATAQ control domain score and asthma-related healthcare use (hospitalizations, ER or urgent care facility visits, and doctor visits for worsening asthma in the past 12 months) was examined. RESULTS: : 406 completed surveys were received. Asthma-related hospitalizations, ER/urgent care visits, and doctor visits were reported for 38, 173, and 319 children, respectively. Of the three control score categories (0, 1-3, and 4-7), children with a control score of 4-7 were more likely to have been hospitalized (p = 0.01), to have visited the ER or urgent care facility (p < 0.0001), or to have visited a doctor (p = 0.0001) because of asthma managed care.In multivariate models including demographic variables and a measure of general health status, higher odds of ER/urgent care visits (odds ratio [OR] 3.47, 95% CI 1.92, 6.26) and doctor visits (OR 7.14; 95% CI 2.40, 21.2) was observed for children with an asthma control score of 4-7 than for children with no identified asthma control problems (score of 0). An asthma control score of 4-7 was significantly associated with hospitalization in a multivariate model including only demographic variables (OR 3.06; 95% CI 1.28, 7.33) but not in a model that included general health status (OR 2.44; 95% CI 0.96, 6.16). Relative to an excellent health status, a fair or poor health status was significantly associated with asthma-related hospitalization (OR 7.03; 95% CI 1.71, 28.87). Compared with White race, Black race was significantly associated with hospitalization (OR 2.30; 95% CI 1.05, 5.04) and ER/urgent care visits (OR 2.89; 95% CI 1.67, 5.01). CONCLUSIONS: : Children identified as having poor asthma control using the pediatric ATAQ instrument had significantly higher rates of asthma-related hospitalizations, ER or urgent care visits, and doctor visits than those with good control. This asthma control measure may be useful in identifying children in need of more intensive asthma management.

LDL-C goal attainment among patients newly diagnosed with coronary heart disease or diabetes in a commercial HMO.

BACKGROUND: Patients beginning treatment with lipid-modifying drugs should have their serum lipid levels monitored and, if necessary, their drug therapy adjusted to reach and maintain their treatment goals. Patients with coronary heart disease or diabetes are at high risk of coronary events and are particularly important target groups for monitoring and dose adjustment of lipid-modifying drug therapy. OBJECTIVE: to determine from administrative claims the rates of lipid testing, treatment with low-density lipoprotein cholesterol (LDL-C)-lowering drug therapy, and LDL-C goal attainment defined as LDL-C < 100 mg per DL in the time period after a new diagnosis of coronary heart disease or diabetes among patients who had not previously received lipid-modifying drug therapy. METHODS: an index date was defined by a new diagnosis of coronary heart disease or diabetes between January 1, 1999 and December 31, 2000, preceded by a 12-month pre-index period without lipid-modifying drug treatment in a commercial health maintenance organization (HMO) database for the southeastern united states. coronary heart disease (CHD) was defined by a diagnosis code for myocardial infarction (International Classification of Diseases, Ninth Edition, Clinical Modification [ICD-9-CM] code 410.xx) or angina/ischemic heart disease (411.xx), or a procedural code for angioplasty (icd-9-cM 36.1x-36.3x; Current Procedural Terminology [CPT] 92980-92984, 92995-92996) or coronary artery bypass graft (icd-9-cM 36.01, 36.02, 36.05, 36.09; CPT 33510-33545). diabetes was identified either by an icd-9-cM diagnosis code 250.xx or a pharmacy claim for an antihyperglycemic medication. Patients were followed in the post-index period until loss of eligibility or a maximum of 42 months (mean = 26 months, range=12-42 months). We calculated the proportion of patients with lipids treated and at LDL-C goal (defined as V < 100 mg per DL) in months 1-6 after the index date. among those not at goal in months 1-6, we estimated the proportion treated to goal in months 7-12 and in month 7 to the end of the post-index period. Logistic regression was used to estimate the odds of goal attainment in months 7-12 and in month 7 to the end of the post-index period among patients who were not at goal in months 1-6. RESULTS: Laboratory lipid values were available for 4,676 (40.4%) of 11,552 patients who had not previously received lipid-modifying drug therapy in months 1-6 after the index date, of whom 72.7% (n = 3,400) had an LDL-C > or =100 mg per DL (63.5% for CHD and 76.7% for diabetes). Of 1,245 patients tested and treated with lipid-modifying therapy in months 1-6, 485 (39.0%) were at LDL-C goal in months 1-6 (48.2% of CHD and 28.8% of diabetes patients), and 760 (61.0%) were not at LDL-C goal (51.8% of those with CHD and 71.2% of those with diabetes). Goal attainment (cumulative) among those treated improved to 50.1% in months 7-12 and 58.4% in month 7 to the end of the post-index period. Patients not attaining goal in months 1-6, and who continued treatment in months 7-12 and month 13 to the end of the post-index period, had a 48.8% (95% confidence interval [CI], 44.0%-53.6%) predicted probability of attaining their goals. The odds of goal attainment in month 7 to the end of post-index period (among those not at goal in months 1-6) were greater for (a) age e 65 years (odds ratio [or] = 2.45, 95% CI, 1.62-3.72), (b) history of hypertension (or = 1.91, 95% CI, 1.20-3.03), (c) greater number of distinct medications (or = 1.07, 95% CI, 1.01-1.14 per additional medication), (d) months of observation post-index (or = 1.04, 95% CI = 1.01-1.08 per additional month), and (e) months supply of lipid-modifying medication (or = 1.04, 95% CI, 1.01-1.07 per additional month), and were lower for LDL-C > or = 130 mg per DL in months 1-6 (or = 0.53, 95% CI, 0.35-0.82) and a history of dyslipidemia (or = 0.54, 95% CI, 0.35-0.83). The odds of LDL-C goal attainment were not affected by diagnosis (CHD vs. diabetes), gender, statin titration (34% of patients), lipid-modifying drug switching (39% of patients), or treatment with a high-potency LDL-C-lowering drug dosage (one of sufficient strength to reduce LDL-C by > 40%). CONCLUSION: of patients receiving lipid testing and lipid drug treatment in the 6 months after an initial diagnosis of CHD or diabetes, 61% were not at the LDL-C goal of < 100 mg per DL. Among those not at LDL-C goal in the first 6 months of treatment, only about half who continued treatment subsequently attained their LDL-C goal, despite statin titration or switching of their lipid-modifying drug therapy.

Factors influencing the acceptance of changes in antiretroviral therapy among HIV-1-infected patients.

Physicians routinely consider modifying antiretroviral therapy (ART) regimen for their patients with HIV. Little is known about the factors associated with patients' willingness to accept providers' recommended ART changes. This multicenter prospective observational study examined factors associated with willingness to accept ART changes recommended by their providers among HIV-infected adults from six urban outpatient HIV clinics. Patients were surveyed using the Patient Attitudes about Altering Antiretroviral Therapy Survey questionnaire (PAAARTS). Factors associated with willingness to accept ART changes were assessed using a multivariate generalized estimating equation (GEE) model to account for correlated responses. The Classification and Regression Trees (CART) analysis was also performed to determine subgroups of patients with higher acceptance of change. 216 of 289 patients (75%) definitely accepted recommended changes. Odds for acceptance were 3.2, 2.3, and 2.8 times higher for patients with higher attitudes and beliefs about ART (p < 0.01; 95% confidence interval [CI] = 1.59, 6.52), patients who rated their provider's care as excellent (p < 0.05; 95% CI = 1.07, 4.78), and non-Hispanic patients (p < 0.05; 95% CI 1.03, 7.57), respectively. CART analysis showed similar results and identified that when patients had less positive attitude about ART, acceptance rates were higher for non-Hispanic patients with higher assessments of their patient-provider communication. While most patients accepted providers' recommendation for ART changes, this willingness was influenced by both patients' attitudes and beliefs about ART and their assessment of either the effectiveness of patient-provider communication or their rating of providers' care. ART acceptance rates among Hispanic patients were lower.

Trends in lipid management among patients with diabetes.

OBJECTIVE: To examine trends in lipid management (cholesterol testing, treatment, and goal attainment) among patients with diabetes and to analyze the factors associated with initiation of lipid-lowering therapy. METHODS: We conducted a longitudinal, retrospective study of patients with diabetes identified during a 24-month baseline period (January 1, 1995, to December 31, 1996) and for whom follow-up was continued for 5 years (1997 to 2001). Generalized estimating equations were used to test for time trend effects in lipid management. We modeled the days from baseline to the first lipid-lowering prescription fill date with a multivariate Cox proportional hazards regression model. RESULTS: Rates of lipid testing, treatment, and goal attainment significantly improved (P<0.001) during the 5-year study period: from 37% to 67% for lipid testing; from 19% to 41% for treatment with a lipid-lowering agent; from 22% to 37% for achievement of low-density lipoprotein cholesterol (LDL-C) levels < 100 mg/dL; and from 54% to 75% for achievement of LDL-C levels < 130 mg/dL. The relative likelihood (hazard rate) of treatment with lipid-lowering agents was greater for patients with LDL-C levels > or = 100 mg/dL relative to patients with LDL-C concentrations < 100 mg/dL. Treatment with lipid-lowering agents of patients with a cardiovascular event during follow-up was approximately 3 times more likely relative to those without such an event. CONCLUSION: We found that rates of lipid testing, treatment, and goal attainment improved significantly between 1997 and 2001. Nevertheless, ample room for improvement of these rates continues to exist. Particular attention may be warranted to ensure that patients with diabetes receive lipid-lowering agents not only after a cardiovascular event but also before such an event occurs.

Administrative claims analysis of asthma-related health care utilization for patients who received inhaled corticosteroids with either montelukast or salmeterol as combination therapy.

OBJECTIVE: To compare asthma-related health care resource utilization among a matched cohort of asthma patients using inhaled corticosteroids (ICSs) plus either montelukast (MON) or salmeterol (SAL) as combination therapy for asthma, during a time prior to the availability of fixed-dose combinations of ICS/SAL. METHODS: A retrospective analysis using the PHARMetrics patient-centric claims database was conducted for the period preceding the market introduction of combination fluticasone-SAL in September 2000. Patients had to meet the following criteria for inclusion in the study: they had to be between the ages of 4 and 55 years; they had to have been continuously enrolled for 2 years; they had to have initiated ICS/MON or ICS/SAL therapy between July 1, 1998, and June 30, 1999; and they had to have had either (a) a diagnosis of asthma (based on International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) codes of 493.xx) for 2 outpatient visits, 1 or more emergency department (ED) visits, or 1 or more hospitalizations within 1 year or (b) pharmacy claim records that contained a National Drug Code for an antiasthma medication (betaagonist, theophylline, ICS, cromolyn, or leukotriene) 2 or more times within 1 year. ICS/MON and ICS/SAL patients were matched 1 to 1 on age and propensity score. Outcomes included asthma-related hopitalizations and ED visits with ICD-9-CM codes of 493.xx, and oral corticosteroid (OCS) fills and short-acting beta-agonist (SABA) fills. Multivariate regression analyses were performed. Subgroup analyses based on sequential or concurrent initiation of combination therapy were also conducted. RESULTS: A total of 1,216 patients were matched (ICS/MON = 608; ICS/SAL= 608). Decreased odds of ED visits and/or hospitalizations were observed with ICS/MON (adjusted odds ratio [OR] = 0.58; 95% confidence interval [CI], 0.35- 0.98) versus ICS/SAL. The odds of postindex OCS fills were not different for ICS/MON and ICS/SAL patients (adjusted OR = 1.04; 95% CI, 0.79-1.38). Postindex pharmacy claims for SABAs were significantly higher among ICS/MON patients versus ICS/SAL patients (adjusted relative risk [RR] = 1.33; 95% CI, 1.17-1.52), and this difference remained regardless of prior use or no prior use of ICSs. In subgroup analyses, mean change in SABA fills varied by how combination therapy was initiated, with sequential addition of asthma controllers leading to a reduction in SABA fills in both groups. For patients with concurrent initiation of combination therapy, the odds of ED visits/hospitalizations were significantly lower in patients initiating ICS/MON (adjusted OR = 0.25; 95% CI, 0.08-0.79). CONCLUSION: In this matched cohort, use of ICS/MON compared with ICS/SAL resulted in similar odds of OCS fills, decreased odds of ED visits and asthmarelated hospitalizations, but higher utilization of SABA.

Asthma-related health care resource use among patients starting fluticasone or montelukast therapy.

STUDY OBJECTIVES: To compare patterns of asthma-related health care resource use among patients prescribed fluticasone or montelukast as singlecontroller therapy for asthma, and to confirm patterns previously observed in retrospective analyses examining outcomes among patients receiving fluticasone or montelukast for asthma. DESIGN: Retrospective cohort study. DATA SOURCE: Administrative claims data drawn from United States health insurers in 35 states, covering 17 million privately insured patients. PATIENTS; A total of 4758 patients aged 2-55 years with asthma who were prescribed either fluticasone or montelukast from July 1, 1998-June 30, 1999, were continuously enrolled for at least 24 months, had no evidence of controller therapy for 6 months before the start of drug therapy, and had no evidence of chronic obstructive pulmonary disease or other respiratory illness. MEASUREMENTS AND MAIN RESULTS: Patients were identified using an algorithm based on medical and pharmacy insurance claims. Patients were matched between groups based on a propensity score of clinical characteristics and age; this resulted in 1512 patients/treatment group. Asthma-related health care claims incurred for 12 months before and after the start of controller therapy were analyzed. After adjustment, the fluticasone-treated group had greater risk than the montelukast-treated group of requiring therapy with a short-acting beta-agonist in the follow-up period (relative risk 1.12, 95% confidence interval [CI] 1.03-1.20). Odds were similar across treatment groups for needing an emergency department visit and/or hospitalization (odds ratio 1.08, 95% CI 0.74-1.58) and for needing therapy with an oral corticosteroid (odds ratio 1.02, 95% CI 0.84-1.26). CONCLUSION: The start of therapy with either fluticasone or montelukast as a single-controller for asthma was associated with similar asthma-related health care resource use in this matched population.

Macrovascular risk factors in patients with diabetes: physician treatment strategies and extent of control.

OBJECTIVE: To describe current approaches used by physicians to address macrovascular risk factors among patients with diabetes and their effect on glycosylated hemoglobin (HbA1c), blood pressure, and cholesterol (low-density lipoprotein cholesterol [LDL-C]) goal attainment. METHODS: Newly referred or diagnosed patients with diabetes (N = 1,808) under the care of 133 community physicians were enrolled in a 12-month prospective multi-center observational study. The invited physicians treat a large number of patients with diabetes and included endocrinologists, internists, and primary care physicians. Patient and physician characteristics, physician ranking of treatment strategy priority, and patient ranking of diabetes-related complications of greatest concern were recorded at enrollment. Follow-up treatment rates and goal attainment rates for glucose (HbA1c <7%), cholesterol (LDL-C <100 mg/dL), and blood pressure (less than 130/80 mm Hg) were examined, both overall and for the most frequently occurring treatment strategies. RESULTS: After evaluating the metabolic profiles of patients enrolled in the study, physicians assigned the highest treatment priority to glucose control for 67.6% of patients. Treatment rates during the 12-month follow-up were highest for glycemic control (87.2%), followed by blood pressure management (77.9%), and lipid control (63.9%). Among treated patients, goal attainment for HbA1c, LDL-C, and blood pressure was 57.6%, 47.7%, and 22.8%, respectively. Regardless of treatment strategy, follow-up goal attainment was the highest for HbA1c (54.8% to 72.3%), followed by LDL-C (41.7% to 48.4%), and lowest for blood pressure (12.0% to 37.1%). CONCLUSION: These findings suggest the need for strategies that emphasize combined glucose, blood pressure, and cholesterol treatment in order to achieve more effective control of microvascular and macrovascular risk factors among patients with diabetes.

Outcomes of patients treated with fluticasone propionate or montelukast sodium.

The authors conducted a retrospective database study of patients with asthma (age range, 6-55 yr) who initiated fluticasone propionate or montelukast sodium treatment between an index period of July 1998 and June 1999. All patients were observed for 12 months before and after the index period. Changes in asthma-related hospitalizations, emergency department visits, oral corticosteroid use, and short-acting beta-agonist use were analyzed. The odds of postindex asthma-related events were estimated. In multivariate analysis, use of a short-acting beta agonist (SABA) was significantly associated with fluticasone treatment (odds ratio [OR], 1.65; 95% confidence interval [CI], 1.21-2.26) and preindex use of SABAs (OR, 1.84; 95% CI, 1.34-2.53). In this managed care population, fluticasone and montelukast provided similar effectiveness.

Treatment effectiveness of inhaled corticosteroids and leukotriene modifiers for patients with asthma: an analysis from managed care data.

We compared measures of treatment effectiveness when inhaled corticosteroids (ICSs) or leukotriene modifiers (LMs) were used as controller monotherapy for asthma. Asthma patients aged 6-55 years initiating ICS or LM monotherapy between July 1998 and June 1999 (index prescription) were identified using a managed care claims database. Asthma-related hospitalizations, emergency department (ED) visits, and use of short-acting beta-agonists and oral corticosteroids (OCSs) were assessed as proxies for treatment effectiveness. Propensity score was used to adjust for baseline differences between treatment cohorts. The change in the annual rate of claims from the preindex to postindex period for each measure was compared across treatment groups. Logistic regression models of the postindex composite events (hospitalization and/or ED) and OCS use were estimated. Nine hundred sixty patients were initiated on LMs (n = 153) and ICSs (n = 807). The mean annual rate of claims for OCSs increased in the ICS group (0.2) but was unchanged in the LM group (adjusted mean difference in change, 0.2; 95% CI, 0.05-0.4; p = 0.01). The mean annual rate of claims for short-acting beta-agonists increased in both the ICS and LM groups by 1.1 and 0.5, respectively (adjusted mean difference in change, 0.6; 95% CI, -0.06. 1.1; p = 0.08). Similar changes in annualized rates of claims for hospitalizations and ED visits were observed between treatment groups. In logistic regression models, greater odds of postindex OCS use was observed among the ICS group (odds ratio for ICS versus LM = 1.7; 95% CI, 1.04-2.8; p = 0.04). No association between treatment groups and postindex hospitalization and/or ED events was observed. In this managed care population, patients treated with ICSs or LMs had similar measures of treatment effectiveness, as measured by asthma-related health care resource use.