Real-world efficacy: intravenous palonosetron three-drug regimen for chemotherapy-induced nausea and vomiting with highly emetogenic chemotherapy.

AIM: Real-world palonosetron effectiveness was evaluated in an antiemetic regimen with highly emetogenic chemotherapy (HEC). PATIENTS & METHODS: In this Phase IV, prospective, multicenter observational study, HEC-treated cancer patients received palonosetron, a neurokinin 1 receptor antagonist, and dexamethasone. Primary objective was to assess complete response (CR) for acute (≤24 h), delayed and overall (≤120 h) chemotherapy-induced nausea and vomiting. RESULTS: Of 159 patients, 65.4% had breast cancer, 64.8% received anthracycline (doxorubicin)-plus-cyclophosphamide-containing chemotherapy; 155 completed one HEC cycle. CR was 60.0% acute, 39.4% delayed and 34.8% overall, and then increased (all phases) in 69 patients completing four HEC cycles. Anthracycline (doxorubicin) plus cyclophosphamide-receiving patients had especially low CR. CONCLUSION: Even within a recommended three-drug antiemetic regimen, palonosetron may provide suboptimal chemotherapy-induced nausea and vomiting control with HEC in real-world settings.

Assessment of pharmacists' views on biosimilar naming conventions.

BACKGROUND: As the date for the introduction of biosimilars in the United States approaches, questions remain regarding the naming, coding, and approval process for these agents that will need to be carefully considered. OBJECTIVES: To (a) ascertain pharmacists' awareness of and comfort level with biosimilars and (b) determine the impact of identical or different nonproprietary names on pharmacists' confidence in substituting interchangeable biologics. METHODS: The Academy of Managed Care Pharmacy, the American Pharmacists Association, and the American Society of Health-System Pharmacists fielded a survey to their membership or a partial segment of their membership. The survey consisted of 2 sections: (1) current processes for reporting biologics being dispensed and (2) familiarity and preferences regarding biosimilars. RESULTS: A substantial majority (70.1%) of respondents reported regularly using National Drug Code numbers as the identifier for biological products dispensed to patients; however, 10.4% of respondents reported using either the nonproprietary name or the Healthcare Common Procedure Coding System code as the identifier. When presented with 3 scenarios for naming conventions of interchangeable biosimilars and asked to rate their level of confidence (1 = not confident, 5 = very confident) to substitute, 74.6% of pharmacists indicated that they would be confident or very confident in substituting an interchangeable biosimilar with the reference product if both shared the same active ingredient or nonproprietary name of the reference biologic; 25.3% of pharmacists were confident in substituting when the nonproprietary name is not shared with the biologic; and 37.3% of pharmacists expressed confidence in substituting when the biologic and biosimilar product did not share the same nonproprietary name because of a prefix or suffix. CONCLUSIONS: The imminent entry of biosimilars into the U.S. market highlights the need to carefully evaluate current processes of identification, reporting, and recording of the biological products dispensed. The results of this survey indicate that the ultimate decision on the naming convention for biosimilars may influence dispensing pharmacists, with the majority of respondents being most comfortable with biosimilars having the same nonproprietary name as the reference biologic.

Cognition in MCI and Alzheimer's disease: baseline data from a longitudinal study of the NTB.

Baseline data are summarized from a study examining the psychometric properties of the Neuropsychological Test Battery (NTB) and its subtests, and correlating the NTB with other cognitive and functional assessments. A multicenter, longitudinal, non-interventional study included mild to moderate Alzheimer's disease (AD, n = 196), mild cognitive impairment (MCI, n = 70), or normal cognition participants (NC, n = 75). The NTB, other cognitive assessment tools, functional/behavioral questionnaires, and health outcome assessments were administered. At baseline composite NTB, NTB memory, and NTB executive function z-scores were significantly lower for participants with AD compared with MCI, and for participants with MCI compared with NC. The composite NTB z-score had high test-retest reliability between screening and baseline. The results of this study suggest that NTB exhibits good reliability in patients with mild to moderate AD and MCI.

Cost of care for malignant and benign renal masses.

BACKGROUND: Limitations of current diagnotic techniques may allow some patients with presumed renal cell carcinoma (RCC) to undergo nephrectomy without definitive confirmation of malignancy. OBJECTIVES: To confirm previous estimates of postnephrectomy renal mass diagnosis and to assess the economic impact of nephrectomy. METHODS: This retrospective cohort analysis identified commercial enrollees who underwent nephrectomy with a diagnosis of RCC between July 1, 2000, and March 30, 2008. Study subjects were stratified based on medical claims for benign or malignant disease after the nephrectomy date. Cohorts were compared on resource utilization before and after nephrectomy, occurrence of postsurgical complications, and associated 1-year costs of care. RESULTS: Of 10,404 patients undergoing nephrectomy for presumed RCC, 1613 (15.5%) were subsequently identified as having benign disease, despite median presurgical diagnostic expenditures of $1311 per patient (interquartile range [IQR], $467-$2606). Median expenditures for the 12 months postnephrectomy were $26,920 per patient (IQR, $16,851-$46,982) for those with malignant disease and $23,951 per patient (IQR, $14,873-$38,190) for those with benign disease (P<.0001). For patients with benign disease, 17.5% experienced a postsurgical adverse event, resulting in a 1.5-fold increase in expenditures (median $31,838 per patient for those with event vs $22,770 per patient for those without event; P<.0001). CONCLUSIONS: In this study, approximately 1 in 6 patients were found to have a benign renal mass postnephrectomy. Given the risk of surgical complications and related economic consequences, methods for better identifying malignant versus benign disease prior to surgery could provide significant benefits to patients and payers.

Cumulative burden of oral corticosteroid adverse effects and the economic implications of corticosteroid use in patients with systemic lupus erythematosus.

BACKGROUND: Corticosteroids (CSs) are used to treat patients with systemic lupus erythematosus (SLE) and are associated with potential adverse events (AEs). However, few data are currently available on the risk of AEs in CS users in an SLE population. OBJECTIVE: To examine AEs related to CS use and costs of treating CS-related AEs in patients with SLE. METHODS: In a retrospective cohort study using claims data (study period: January 1, 2000-June 30, 2010), patients aged ≥18 years having ≥2 SLE-related (International Classification of Diseases, Ninth Revision, Clinical Modification code 710.0x) outpatient or ≥1 inpatient/emergency department claim were identified with an index diagnosis date deemed as the date of first SLE diagnosis. Receipt of CS therapy was assessed within 6 months of the index diagnosis date. Cox models were used to evaluate risk of AEs in CS users and nonusers. Associated costs were computed for AEs where risk was significantly different among the cohorts. RESULTS: Of 2717 patients with SLE, 989 received CSs and 1728 did not. Users of CSs were ~1.5 times more likely to develop chronic AEs (sleep disturbances, migraines, cataracts, hypertension, and type 2 diabetes mellitus) and ~2 times more likely to develop acute AEs (pneumonia, herpes zoster, fungal infections, and nausea/vomiting) compared with CS nonusers. The mean annual cost for managing AEs was $4607 and was highest for diabetes mellitus ($9764), hypertension ($8773), and sleep disturbances ($5599). Applying differences in 1-year event rates (CS user: 58.1%; CS nonuser: 75.1%) to cost estimates yielded an additional $784 per year per CS user to manage known CS-related AEs compared with CS nonusers. CONCLUSIONS: Although CSs are prescribed to control SLE symptoms, these results highlight potential risks and costs associated with their use, which providers/payers should consider when making treatment decisions.

Longitudinal changes in functional disability in Alzheimer's disease patients.

BACKGROUND: Functional impairment is a core symptom of Alzheimer's disease (AD) often measured by loss of ability to perform activities of daily living (ADL). The objective is to describe the progressive loss of specific ADL functional capabilities expressed by AD patients' cognitive ability. METHODS: Data are from ELN-AIP-901, an observational study of cognitive progression in participants aged 50-85 with AD (n = 196), mild cognitive impairment (n = 70), or cognitively normal (n = 75). Participants were evaluated using the Mini-Mental Status Exam (MMSE) and the Disability Assessment for Dementia (DAD) every six months for ≤2 years. Hierarchical regression was used to estimate annual change in DAD and MMSE; first, by individuals' rate of change using linear regression, then controlling for baseline diagnosis. RESULTS: Over a two-year period, in AD participants, a 1-point change in MMSE was associated with a 3-point change in DAD (2.79, 95% CI: 1.97-3.63); DAD items within the finance, medication, and outings subdomains were impacted earlier than other subdomains; a hierarchy of functional impairment was observed, with instrumental ADL generally impaired prior to basic ADL. CONCLUSIONS: ADL are impacted in a progressive and hierarchical manner associated with cognitive decline, but substantial variability remains among individuals, as well as in the relative order of items affected.

Dependence as a unifying construct in defining Alzheimer's disease severity.

This article reviews measures of Alzheimer's disease (AD) progression in relation to patient dependence and offers a unifying conceptual framework for dependence in AD. Clinicians typically characterize AD by symptomatic impairments in three domains: cognition, function, and behavior. From a patient's perspective, changes in these domains, individually and in concert, ultimately lead to increased dependence and loss of autonomy. Examples of dependence in AD range from a need for reminders (early AD) to requiring safety supervision and assistance with basic functions (late AD). Published literature has focused on the clinical domains as somewhat separate constructs and has given limited attention to the concept of patient dependence as a descriptor of AD progression. This article presents the concept of dependence on others for care needs as a potential method for translating the effect of changes in cognition, function, and behavior into a more holistic, transparent description of AD progression.

A qualitative assessment of the concept of dependence in Alzheimer's disease.

BACKGROUND: The Dependence Scale (DS) was designed to assess levels of patient need for care due to deficits typical of Alzheimer's disease (AD). This study examined content validity of the DS based on input from patients, caregivers, and clinicians. METHODS: Qualitative interviews with experts, patients, and caregivers were used to collect information on the concept of dependence and to assess content validity. RESULTS: Nine clinicians rated item relevance ''high'' with consensus on the primacy of functional abilities and dependence in the measurement of AD progression. Twenty-two US, 11 UK, and 14 informal caregivers from Spain participated in focus groups; 18 patients participated in 3 separate focus groups. Discussion supported DS hierarchy of dependence, capture of mild-to-severe dependence, suitability of response options, and short recall time frame. CONCLUSIONS: Clinicians, caregivers, and patients support content validity of the DS in mild-to-moderate AD. The DS may be valuable to capture dependence within future clinical dementia trials.

Prevalence and impact of dementia-related functional limitations in the United States, 2001 to 2005.

These analyses examined the relationship between dementia and comorbid conditions with respect to degree of functional impairment and emotional impact. Analyses were conducted using National Health Interview Survey (2001 through 2005) data from a subset of individuals aged > or =60 years with activity limitations attributed to dementia, senility, or Alzheimer disease compared with those whose limitations were attributed to other conditions. The mean number of limited activities was 6.84 (95% confidence interval: 6.48-7.20) for persons with dementia-related limitations and 4.87 (95% confidence interval: 4.81-4.93) for those with limitations not dementia related. Both groups reported similar prevalence of diabetes, acute myocardial infarction, heart disease, prostate cancer, breast cancer, angina, and emphysema; respondents with dementia-related functional limitations were more likely to report diabetes, depression or anxiety, and vision problems as being related to functional limitations. Persons with dementia-related functional limitations were also more likely than persons with non-dementia-related functional limitations to report feeling sad, hopeless, worthless, nervous, and that "everything is an effort." Improving or maintaining functional independence in patients with dementia will likely require a multifaceted approach across disease states. Additional research will help define the impact of dementia on the development and progression of functional limitations related to comorbidities.

Burden of Alzheimer's disease and association with negative health outcomes.

OBJECTIVE: To examine the association of Alzheimer's disease (AD) with common chronic conditions, acute care events, and risk of hospitalization. STUDY DESIGN: Retrospective matched cohort analysis. METHODS: Community-dwelling subjects with a diagnosis of and/or medication for AD were matched to subjects without AD based on age, sex, and geographic region. Administrative claims from commercially insured health plans for medical and pharmacy services provided from January 1, 2000, to March 31, 2006 (inclusive) were analyzed. The Deyo Charlson Index (DCI) was used to assess the number of chronic conditions. The outcomes of interest were risk of fractures and hospitalization. RESULTS: Among 5396 persons with AD and a matched cohort of 5396 persons without the condition, subjects with AD were more likely to have a diagnosis for any of the DCI components, had a higher rate of fractures (17.7% vs 7.9%, P <.00) and other urgent medical events (eg, pneumonia 14.0% vs 6.3%, P <.00), and were more likely to be hospitalized (odds ratio = 1.7; 95% confidence interval = 1.5, 1.9). There were significant differences in the medication use between the 2 groups, with the use of psychotics/tranquilizers 9-fold higher among persons with AD. CONCLUSION: Persons with AD have higher odds of experiencing a fracture, being hospitalized, and requiring other acute care medical services than those without AD. The disease also is associated with a higher prevalence of common chronic conditions.

Does synchronizing initiation of therapy affect adherence to concomitant use of antihypertensive and lipid-lowering therapy?

Although efficacious medications are available to treat hypertension and dyslipidemia, treatment adherence is often poor. This retrospective study evaluated adherence in patients newly initiating antihypertensive (AH) and lipid-lowering (LL) therapies simultaneously versus within 180 days of one another. Data were analyzed for US managed care plan enrollees initiating AH before LL (cohort 1;n = 7099), LL before AH (cohort 2; n = 3229), or AH/LL simultaneously (cohort 3; n = 5072). A multivariate model evaluated potential predictors of adherence (medication possession ratio >or= 0.80 over a bimonthly period). Percentages of patients adherent to AH/LL at 2, 6, and 12 months were as follows: 59.4%, 32.7%, and 31.3% in cohort 1; 45.0%, 30.8%, and 31.0% in cohort 2; and 75.2%, 34.4%, and 34.0% in cohort 3, respectively. After adjustment for potential confounders, patients initiating AH before LL therapy, or LL before AH therapy, were less likely to be adherent than patients prescribed both agents simultaneously (odds ratios = 0.838 and 0.691, respectively; P , 0.0001). Synchronous initiation of AH and LL therapies is an important predictor of adherence.

Patient dependence and longitudinal changes in costs of care in Alzheimer's disease.

BACKGROUND/AIMS: To examine the incremental effect of patients' dependence on others, on cost of medical and nonmedical care, and on informal caregiving hours over time. METHODS: Data are obtained from 172 patients from the Predictors Study, a large, multicenter cohort of patients with probable Alzheimer disease (AD) followed annually for 4 years in 3 University-based AD centers in the USA. Enrollment required a modified Mini-Mental State Examination score >or=30. We examined the effects of patient dependence (measured by the Dependence Scale, DS) and function (measured by the Blessed Dementia Rating Scale, BDRS) on medical care cost, nonmedical care cost, and informal caregiving time using random effects regression models. RESULTS: A one-point increase in DS score was associated with a 5.7% increase in medical cost, a 10.5% increase in nonmedical cost, and a 4.1% increase in caregiving time. A one-point increase in BDRS score was associated with a 7.6% increase in medical cost, a 3.9% increase in nonmedical cost and an 8.7% increase in caregiving time. CONCLUSIONS: Both functional impairment and patient dependence were associated with higher costs of care and caregiving time. Measures of functional impairment and patient dependence provide unique and incremental information on the overall impact of AD on patients and their caregivers.

Characteristics, drug therapy, and outcomes from a database of 500,000 hospitalized patients with a discharge diagnosis of heart failure.

Knowledge related to acute heart failure (HF) and its management in "real-world" clinical practice is limited. The authors delineated characteristics and drug therapy for hospitalized HF patients and their association with clinical and economic outcomes. The NDCHealth (National Data Corporation, Atlanta, GA) database, containing billing data from a geographically diverse sample of approximately 300 hospitals, was screened for admissions in 2003 of either a primary or secondary discharge diagnosis of HF. Of 2.5 million admissions screened, 496,534 patients (19.7%) had a primary (131,057) or secondary (365,477) discharge diagnosis of HF. Mean age was 73.1+/-13.9 years, and 55.4% were women. Mean length of hospital stay was 8.7+/-28.6 days, and in-hospital mortality was 7.1%. Mean hospital cost per admission was dollars 18,667. Admissions with HF as a secondary diagnosis were associated with a worse prognosis. HF commonly exists in hospitalized patients and is associated with significant morbidity, mortality, and economic burden, irrespective of whether it is the primary diagnosis or a secondary comorbidity.

Current management of anemia in critically ill patients: analysis of a database of 139 hospitals.

PURPOSE: This analysis focused on three objectives: 1) to measure packed red blood cell (pRBC) use across different critical care settings; 2) to characterize transfused and nontransfused critically ill patients; and (3) to identify potential predictors of transfusion use. METHODS: A retrospective analysis of critically ill patients from 139 hospitals across the United States was conducted. Hospital administrative and laboratory data were collected for patients 18 years of age and older admitted to the intensive care unit (ICU) (including coronary care unit and intermediate care units) from January 1, 2004, to May 31, 2005. Multivariate analyses controlling for patient and hospital heterogeneity evaluated the association between pRBC transfusions and patients' ICU or hospital length of stay. RESULTS: A total of 180,221 patients met all inclusion criteria, with 29,331 (16.3%) receiving pRBCs during their ICU stay. There was differential use of pRBCs by ICU/coronary care unit setting (ie, 23% of general ICU patients versus 7% of intermediate coronary care unit patients). Increasing age [odds ratio (OR), 1.007; 95% confidence interval (CI), 1.006-1.008], declining hemoglobin concentrations (OR, 2.315; 95% CI, 2.288-2.342), mechanical ventilation (OR, 1.338; 95% CI, 1.287-1.392), dialysis (OR, 2.071; 95% CI, 1.913-2.242), and presence of acute renal failure (OR, 1.259; 95% CI, 1.193-1.329), congestive heart failure (OR, 1.156; 95% CI, 1.106-1.208), or septicemia (OR, 1.143; 95% CI, 1.071-1.221) were associated with a higher likelihood of pRBC use. Each pRBC transfusion significantly increased hospital length of stay (1.6, 0.5, and 2.7 additional days for patients with 1, 2, and 3 or more transfusions, respectively, P < 0.0001) as compared with nontransfused patients. CONCLUSIONS: Multiple factors increased the likelihood of pRBC use in ICU patients. In addition, pRBC transfusion was associated with increased length of stay. Clinicians should evaluate the risk-benefit ratio and consider interventions to limit any unnecessary pRBC use in the critically ill.

The effects of patient function and dependence on costs of care in Alzheimer's disease.

OBJECTIVES: To estimate incremental effects of patients' dependence and function on costs of care during the early stages of Alzheimer's disease (AD) and to compare strengths of their relationships with different cost components. DESIGN: Multicenter, cross-sectional, observational study. SETTING: Three university hospitals in the United States. PARTICIPANTS: One hundred seventy-nine community-living patients with probable AD, with modified Mini-Mental State Examination scores of 30 or higher. MEASUREMENTS: Patients' dependence was measured using the Dependence Scale (DS). Functional capacity was measured using the Blessed Dementia Rating Scale (BDRS). Total cost was measured by summing direct medical costs and informal costs. Direct medical costs included costs of hospitalization, outpatient treatment and procedures, assistive devices, and medications. Informal costs were estimated from time spent helping with basic and instrumental activities of daily living for up to three caregivers per patient using national average hourly earnings as wage rate. RESULTS: DS and BDRS were associated with higher total cost; a 1-point increase in DS was associated with a $1,832 increase in total cost, and a 1-point increase in BDRS was associated with a $3,333 increase. Examining component costs separately identified potential differences between DS and BDRS. A 1-point increase in BDRS was associated with a $1,406 increase in direct medical cost. A 1-point increase in DS was associated with a $1,690 increase in informal cost. CONCLUSION: Patients' dependence and function related differently to direct medical and informal cost, suggesting that measures of function and dependence provided unique information for explaining variations in cost of care for patients with AD, highlighting the value in measuring both constructs.

Pharmacy and medical costs associated with switching between venlafaxine and SSRI antidepressant therapy for the treatment of major depressive disorder.

BACKGROUND: While much has been published on utilization of antidepressants and associated resource use, surprisingly little information is available on the relationship between a change in antidepressant agent and health care utilization. Given that many patients will not respond to initial therapy (and therefore would be candidates for switching treatment) and the array of antidepressant medications on the market, information on the impact of switching would be beneficial to both providers and policymakers. OBJECTIVE: To explore patterns of antidepressant drug use and depression-related and all-cause medical costs for patients who switched therapy between 2 drug classes, selective serotonin reuptake inhibitors (SSRIs) and the selective norepinephrine reuptake inhibitor (SNRI) venlafaxine. METHODS: Using an administrative claims database of 36 million members from 61 health plans, this retrospective cohort analysis examined patients who had (1) a diagnosis of major depressive disorder (MDD, International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] code 296.2x for MDD single episode, 296.3x for MDD recurrent episode, 300.4 for dysthymic disorder, and 311 for depressive disorder not elsewhere classified) and (2) a newly prescribed antidepressant during the year 2002. Costs were defined as amounts paid by health plans for all inpatient, outpatient, physician and pharmacy services (i.e., allowed charges after subtraction of member cost-share). Depression-related costs were defined using (1) medical claims with primary diagnosis of depression and (2) pharmacy claims for antidepressants. Using an index date of the first antidepressant claim, 12 months of pre-index and postindex data were available for all eligible patients. Switching was defined as occurring between the SSRIs and venlafaxine (i.e., patients who switched within the SSRI drug class across different SSRIs were treated as non-switchers until they switched to venlafaxine), and there was no minimum or maximum gap in therapy. The SSRIs included fluoxetine, citalopram, sertraline, and paroxetine; the only SNRI on the market at the time was venlafaxine. Multivariate regression analyses determined predictors of switching and factors influencing overall and depression-related costs, while controlling for confounding factors. For the 12-month period following the index date (fixed length of follow-up), the study compared per-patient per-year (PPPY) costs for (1) patients who switched versus those who did not switch and (2) patients with single versus multiple trials of SSRI for the subgroup of patients who switched from an SSRI to venlafaxine. For the time periods before versus after the switch (variable lengths of follow-up), per-patient means and medians of monthly cost averages (with follow-up periods <1 month set to 1 month for 16.5% [n=272] of SSRI-to-venlafaxine switchers and 14.1% [n=103] of venlafaxine-to-SSRI switchers) were calculated for the subgroup of patients who made a switch. RESULTS: A total of 48,950 patients were included in the study, with 43,653 (89.2%) treated first with SSRIs and 5,297 (10.8%) treated first with venlafaxine. Of the initial SSRI users, 1,645 (3.8%) switched to venlafaxine, and of the initial venlafaxine users, 733 (13.8%) switched to an SSRI. Mean (standard deviation [SD]) 12-month total (medical plus pharmacy) depression-related costs in 2002-2003 dollars were 118.0% higher for SSRI switchers ($1,225 [$3,438] vs. $562 [$2,153], P<0.001) and 18.4% higher for venlafaxine switchers ($863 [$1,503] vs. $729 [$1,185], P=0.021) as compared with non-switchers. From the pre-switch to post-switch periods, depression-related mean monthly medical costs declined by 66.4% among switchers from SSRIs ($113 [$912] vs. $38 [$347], P=0.001) and by 61.1% among switchers from venlafaxine ($54 [$299] vs. $21 [$138], P=0.005). Monthly mean depression-related pharmacy costs increased by 62.2% following a switch from an SSRI to venlafaxine (from $45 [$38] to $73 [$62], P<0.001) and declined by 17.3% following a switch from venlafaxine to an SSRI (from $52 [$45] to $43 [$38], P<0.001). After adjustment for multiple covariates including demographic characteristics, 10 selected comorbidities, and physician specialty, general linear models with log-transformed costs as the dependent variables demonstrated significant associations between switching and total costs (both all-cause and depression-related) in both the SSRI and the venlafaxine cohorts. CONCLUSIONS: Although relatively few patients switched antidepressant drug classes, patients who made a switch had higher all-cause health care costs and higher depression-related costs than patients who did not switch. Switching drug classes was associated with lower mean monthly depression-related health care costs following the switch. For those patients switching from an SSRI to venlafaxine, mean medical cost reductions offset higher pharmacy costs; for patients switching from venlafaxine to an SSRI, mean medical and pharmacy costs declined.

Calcium channel blockers, angiotensin receptor blockers, and angiotensin-converting enzyme inhibitors: effectiveness in combination with diuretics or beta-blockers for treating hypertension.

This retrospective database analysis compared the effectiveness of dihydropyridine calcium channel blockers (DHPs), angiotensin-converting enzyme (ACE) inhibitors, and angiotensin receptor blockers (ARBs) added to diuretics or beta-blockers. Adults with hypertension treated with diuretic or beta-blocker monotherapy between 1998 and 2001 were identified from a large US electronic medical records database of primary care practices. Patients were required to have a baseline blood pressure (BP) > or =140/90 mmHg (> or =130/80 mmHg for diabetes mellitus) and recorded BP measurements within 6 months before and 1-12 months following index date. Patients were matched 1:1:1 by propensity score to correct for differences in baseline characteristics. 1875 patients met study criteria and 660 (220 in each cohort) were matched based on propensity scores. Matched cohorts had no significant differences in baseline characteristics. Mean changes in systolic/diastolic BP were -17.5/-8.8, -15.7/-6.3, and -13.0/-8.0 mmHg with DHPs, ACE inhibitors, and ARBs, respectively. Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High BP 6/7 goal attainment for each regimen was 47.3%, 40.0%, and 32.2%, respectively. DHPs, ACE inhibitors, and ARBs improved BP when added to patients' beta-blocker or diuretic therapy. The greatest benefits were observed with DHPs, followed by ACE inhibitors, then ARBs.

Risk of recurrent emergency department visits or hospitalizations in children with asthma receiving nebulized budesonide inhalation suspension compared with other asthma medications.

OBJECTIVE: To examine whether nebulized budesonide inhalation suspension treatment reduces asthma-related emergency department visit/hospitalization recurrence risk in children compared with other asthma medications, particularly non-nebulized inhaled corticosteroids. RESEARCH DESIGN AND METHODS: Longitudinal, retrospective claims analysis of data from a managed care organization database in the United States (July 1, 2000-June 30, 2002). Participants were children aged < or = 8 years with an asthma diagnosis and asthma-related emergency department visit or hospitalization (index event). Asthma medication use, evaluated by asthma-related prescriptions < or = 30 days after the index event, determined treatment groups. MAIN OUTCOME MEASURE: Emergency department visit/hospitalization recurrence risk from post-index day 31-180 across treatment groups. RESULTS: Of 10,176 patients with an index event, 13% experienced a post-index recurrence. For patients receiving asthma prescriptions < or = 30 days after the index event, those receiving budesonide inhalation suspension showed a significant reduction in emergency department visit/hospitalization recurrence risk compared with those not prescribed this treatment (adjusted hazard ratio, 0.71; 95% confidence interval, 0.57-0.89). For patients receiving asthma controller medication in the post-index period, those receiving budesonide inhalation suspension had a significantly lower recurrence risk than patients receiving prescriptions for other controller medications (hazard ratio, 0.71; 95% confidence interval, 0.52-0.97). Recurrence risk was significantly reduced (53%) in patients receiving budesonide inhalation suspension prescriptions compared with non-nebulized inhaled corticosteroid prescriptions (hazard ratio, 0.47; 95% confidence interval, 0.28-0.78). CONCLUSION: For children aged < or = 8 years, budesonide inhalation suspension treatment after an asthma-related emergency department visit/hospitalization was associated with a significantly reduced risk of recurrence compared with other asthma medications and with non-nebulized inhaled corticosteroids. Because this was an observational study, results should be interpreted cautiously. However, this study allowed evaluation of treatment in real-world practice settings not often included in clinical trials.

Once-daily bupropion associated with improved patient adherence compared with twice-daily bupropion in treatment of depression.

The main aim of this study was to examine the impact of dosing regimens on patients' persistence to bupropion. A nationally representative patient-level database comprising of pharmacy and medical claims was used to identify patients with depression (ICD-9-CM: 296.2, 296.3, 300.4, 311), who had initiated therapy with bupropion sustained release (b.i.d.; 2 doses/d) or extended release (q.d.; 1 dose/d) tablets from September 2003 to February 2004; had no previous antidepressant or benzodiazepine use; and had 9 months of follow-up. Persistence was measured using prescription claims, and calculated using the medication possession ratio [MPR; (total days supply; all filled prescriptions)/270 d]. Multivariate logistic regression compared the likelihood of achieving MPR > or = 0.70 controlling for age, sex, and index date. A total of 3132 patients were included (b.i.d.: n = 2382; q.d.: n = 756). q.d. patients on average had a significantly higher MPR than b.i.d. patients [q.d. 0.52 (+/-0.35), b.i.d. 0.35 (+/-0.26)]; P < 0.001) and had a higher likelihood of achieving an MPR > or = 0.70 (q.d. 35%, b.i.d. 12%, P < 0.0001). After controlling for differences in baseline characteristics, b.i.d. patients were only one-fourth as likely (odds ratio = 0.260, 95% confidence interval: 0.214-0.316) to achieve MPR >0.7. The use of the once-daily, extended release formulation of bupropion appeared to significantly improve patients' persistence to therapy for the treatment of depression.

The economic effect of switching from sildenafil to another phosphodiesterase type 5 inhibitor.

Patients who could benefit from additional education about treatments for erectile dysfunction (ED) may prematurely discontinue or switch ED medications, resulting in unnecessary resource utilization. In a retrospective cohort study using a large, aggregated health claims database, the costs associated with switching from sildenafil to another phosphodiesterase type 5 (PDE-5) inhibitor were compared with those for patients refilling sildenafil. Of the 15,584 patients with an index sildenafil claim, 10,863 had a second PDE-5 inhibitor prescription (10,137 for sildenafil, 726 for vardenafil or tadalafil). Erectile dysfunction-attributable costs in the six-month preindex period were similar (P = .72), but postindex six-month ED costs were higher in patients who initially switched from sildenafil (dollar 173.38) versus patients who refilled sildenafil (dollar 131.51; P < .001). Regression analysis estimated that corrected ED-attributable and overall costs were 41% (P < .001) and 43% (P < .001) higher for patients who switched versus those who refilled sildenafil, respectively.