Real-world hospitalization risk in patients with epilepsy treated with perampanel.

AIM: The aim of this study was to evaluate the risk of hospitalization and emergency department admission following initiation of perampanel treatment in patients with epilepsy. METHODS: This study is a retrospective longitudinal cohort study (Optum® Clinformatics® Datamart). Patients 4 to 11 years of age with a diagnosis of partial onset seizures or ≥12 years of age with primary generalized tonic-clonic seizures who had ≥1 perampanel prescription between 1/1/2014 and 3/31/2018 were eligible for the study. Additionally, patients were required to have 12-months of continuous enrollment before (pre-) and after (post-) the date of the first perampanel prescription (index-date). One-year relative-risks of all-cause and epilepsy-related hospitalizations and emergency department (ED) visits were estimated following initiation of perampanel treatment. Outcomes were also evaluated among a subsets of patients who were adherent to perampanel treatment, defined as a Medication Possession Ratio (MPR) ≥80%. RESULTS: A total of 320 patients were included in the study, mean age 38.2 ±â€¯19 years, 56.6% female. In the overall population, the relative risks of hospitalizations or ED visits after perampanel initiation were not significantly different. Among the 145 patients who had an MPR ≥80%, initiation of perampanel treatment resulted in a significantly lower risk of epilepsy-related hospitalization (relative risk [RR] = 0.68, confidence interval [CI] [0.47, 0.98]), all-cause ED visits (RR = 0.80, CI [0.66, 0.98]), and epilepsy-related ED visits (RR = 0.74, CI [0.57, 0.95]) in the follow-up period. CONCLUSIONS: Adherence to perampanel treatment was associated with significant reductions in one-year hospitalizations and ED visit risk in real world settings.

Influence of titration of antiseizure medications on treatment selection: Results of an online survey with clinicians in the United States.

INTRODUCTION: Most antiseizure medications (ASM) need to be titrated before the optimal dose is achieved. Titration can last several weeks to months. We assessed the impact titration schedules have on ASM treatment-related decisions in the United States (US). METHODS: An online survey was conducted with different healthcare providers (HCPs) in the US involved in the treatment and management of patients with epilepsy. The survey contained three sections: the first section with screening questions; the second on key factors that influence a HCP's decision-making when selecting treatments for different types of seizures and different treatment lines; and the third on the HCP's knowledge and perceptions regarding ASM titration for the treatment of patients with epilepsy. RESULTS: One-hundred and fifty HCPs (63% neurologists) completed the survey. Most HCPs considered titration schedule to be important, with only 1-3% of HCPs, depending on type of seizure, considering the titration schedule to be "not important at all" when prescribing therapy. Healthcare providers' acceptance of titration increased with shorter durations (≥50% accepted titration periods of ≤2 weeks), and lower number of tablets/capsules per dose (≥50% accepted ≤3 tablets/capsules per dose), doses (≥50% accepted ≤2 doses/day), and steps (≥50% accepted ≤3 steps/dose change). Most HCPs (68-91% depending on type of seizure) considered a titration duration of 6 or more weeks only somewhat acceptable or somewhat or highly unacceptable. Almost all HCPs selected "somewhat familiar", "familiar", or "very familiar" as the attribute that best defines their knowledge level of titration, with only 4% selecting "a little familiar". While 87% of HCPs agreed or strongly agreed that they could easily understand titration schedules, only 27% of them agreed or strongly agreed that patients could easily understand titration schedules and 58% of HCPs considered that adhering to the titration schedule was difficult for patients. Most HCPs agreed or strongly agreed that a complex or long titration schedule renders it difficult to achieve their treatment objectives. CONCLUSIONS: Healthcare providers take into account the duration and complexity of the titration period in their ASM prescribing decision-making and prefer shorter and simpler titration schedules, particularly for patients who are experiencing convulsive seizures and starting monotherapy. There was a clear difference between the HCP's belief in their own ability to understand a titration schedule, and their belief that the patient would be able to follow the titration schedule appropriately.

Real-world impact of antiepileptic drug combinations with versus without perampanel on healthcare resource utilization in patients with epilepsy in the United States.

OBJECTIVES: Combination regimens of antiepileptic drugs (AEDs) with various mechanisms of action (MOA) are commonly used in patients with refractory epilepsy. However, outcomes related to combination AEDs with novel MOA, such as perampanel (PER), are not well described. This study compared healthcare resource utilization (HRU) among recipients of PER-based combinations versus recipients of other non-PER-based combinations. METHODS: This retrospective study used claims data from the Symphony Health's IDV® (Integrated Dataverse) database (August 2012 to July 2018). Patients were aged ≥12 years with epilepsy or non-febrile convulsions, were treated with AED combinations, and had ≥12 and ≥6 months pre- and post-index date, respectively (date of initiation of the second AED in the combination). AEDs were categorized based on MOA: selective non-competitive antagonist of AMPA receptors (i.e., PER), sodium channel blocker (SC), synaptic vesicle protein 2A binding (SV2), and gamma-aminobutyric acid analog (G). Patients were then classified into MOA-based cohorts: PER + SC, PER + SV2, PER + G, SC + SC, SC + SV2, SC + G, SV2 + G, and G + G. HRU outcomes were evaluated during follow-up and compared between PER-based cohorts and non-PER-based cohorts. RESULTS: On average, patients in the PER + SC (N = 3,592), PER + SV2 (N = 2,200), and PER + G (N = 1,313) cohorts were younger and had a lower Quan-Charlson comorbidity index than those in non-PER-based cohorts. PER + SC and PER + SV2 users had significantly fewer all-cause hospitalizations than non-PER-based users (adjusted RR range: 0.66-0.89, all P < 0.05), while PER + G recipients had fewer all-cause hospitalizations than recipients of SV2 + G and G + G (adjusted RR range: 0.92-0.94). Similar trends were observed for epilepsy-related hospitalizations. Across all comparisons, PER-based combinations were associated with significantly lower rates of all-cause clinic/office/outpatient visits relative to non-PER-based combinations (adjusted RR range: 0.69-0.86, all P < 0.05). SIGNIFICANCE: Results showed that patients treated with PER-based combinations had fewer all-cause and epilepsy-related hospitalizations, and fewer all-cause clinic/office/outpatient visits compared with patients treated with most other non-PER-based combinations.

Internet access and use by COPD patients in the National Emphysema/COPD Association Survey.

BACKGROUND: Technology offers opportunities to improve healthcare, but little is known about Internet use by COPD patients. We tested two hypotheses: Internet access is associated with socio-demographic disparities and frequency of use is related to perceived needs. METHODS: We analyzed data from a 2007-2008 national convenience sample survey of COPD patients to determine the relationship between Internet access and frequency of use with demographics, socio-economic status, COPD severity, and satisfaction with healthcare. RESULTS: Among survey respondents (response rate 7.2%; n = 914, 59.1% women, mean age 71.2 years), 34.2% reported lack of Internet access, and an additional 49% had access but used the Internet less than weekly. Multivariate models showed association between lack of access and older age (OR 1.10, 95% CI 1.07, 1.13), lower income (income below $30,000 OR 2.47, 95% CI 1.63, 3.73), less education (high school highest attainment OR 2.30, 95% CI 1.54, 3.45), comorbid arthritis or mobility-related disease (OR 1.56, 95% CI 1.05, 2.34). More frequent use (at least weekly) was associated with younger age (OR 0.95, 95% CI 0.93, 0.98), absence of cardiovascular disease (OR 0.48, 95% CI 0.29, 0.78), but with perception of needs insufficiently met by the healthcare system, including diagnostic delay (OR 1.72, 95% CI 1.06, 2.78), feeling treated poorly (OR 2.46, 95% CI 1.15, 5.24), insufficient physician time (OR 2.29, 95% CI 1.02, 5.13), and feeling their physician did not listen (OR 3.14, 95% CI 1.42, 6.95). CONCLUSIONS: An analysis of the characteristics associated with Internet access and use among COPD patients identified two different patient populations. Lack of Internet access was a marker of socioeconomic disparity and mobility-associated diseases, while frequent Internet use was associated with less somatic disease but dissatisfaction with care.

Patient-Reported Outcome Measures in Adult Patients Diagnosed with Epilepsy Being Treated with Perampanel.

BACKGROUND: Epilepsy is a complex disorder that can affect patients' medical, psychological, and social well-being. The purpose of this study was to evaluate the patient-reported outcome (PRO) measures of health-related quality of life (HRQoL), satisfaction, and adherence in adult patients diagnosed with epilepsy treated with perampanel in the United States (US). METHODS: A US-based, multicenter, observational cross-sectional survey was completed by 61 patients taking perampanel with or without other antiseizure medications (ASMs). Respondents were ≥18 years old, had a physician-confirmed diagnosis of epilepsy, used perampanel for ≥4 months, and provided informed consent. Patients responded to questions concerning their demographic characteristics, treatment history, experiences before perampanel, experiences while taking perampanel, HRQoL, treatment satisfaction, and medication adherence. RESULTS: Patients (N=61) were 42.8 years old on average; majority were female (63.9%) and white (75.4%). Mean time on perampanel was 2.5 years, with sodium channel blockers often (55.7%) used concomitantly with perampanel. Patients reported, on average, 5.5 (standard deviation [SD]=13.2) seizures/month after initiating perampanel, whereas these same patients reported experiencing 20.4 (SD=60.0) seizures/month prior to perampanel. When comparing their experience on perampanel with their experience with previous ASMs, more patients "strongly agreed" that perampanel allowed them to live a more normal life (36.1% vs 27.5%) and worked as intended if they missed taking a dose (16.4% vs 7.8%). Average satisfaction scores were high, with ratings of 71.8 for effectiveness, 84.0 for convenience, and 71.9 for global satisfaction (0-100 scores). Perampanel use was associated with improvements in HRQoL and fewer symptoms of depression and anxiety. The majority of patients were adherent (62.3%) to perampanel. DISCUSSION: Perampanel use was associated with reductions in number of seizures, better HRQoL, and high adherence rates. These results provide initial evidence that perampanel can be an effective, tolerable, and valid option for patients with epilepsy in the real world.

Comparison of resource use by COPD patients on inhaled therapies with long-acting bronchodilators: a database study.

BACKGROUND: The purpose of this analysis was to compare health care costs and utilization among COPD patients who had long-acting beta-2 agonist (LABA) OR long-acting muscarinic antagonist (LAMA); LABA AND LAMA; or LABA, LAMA, AND inhaled corticosteroid (ICS) prescription claims. METHODS: This was a 12 month pre-post, retrospective analysis using COPD patients in a national administrative insurance database. Propensity score and exact matching were used to match patients 1:1:1 between the LABA or LAMA (formoterol, salmeterol, or tiotropium), LABA and LAMA (tiotropium/formoterol or tiotropium/salmeterol), and LABA, LAMA and ICS (bronchodilators plus steroid) groups. Post-period comparisons were evaluated with analysis of covariance. Costs were evaluated from a commercial payer perspective. RESULTS: A total of 523 patients were matched using 29 pre-period variables (e.g., demographics, medication exposure). Post-match assessments indicated balance among the cohorts. COPD-related costs differed among groups (LABA or LAMA $2,051 SE = 91; LABA and LAMA $2,823 SE = 62; LABA, LAMA and ICS $3,546 SE = 89; all p < .0001) with the differences driven by study medication costs. However, non-study COPD medication costs were higher for the LABA or LAMA therapy group ($911 SE = 91) compared to the LABA and LAMA therapy group ($668 SE = 58; p = 0.0238) and non-study respiratory medications were approximately $100 greater for the LABA or LAMA therapy group relative to both LABA and LAMA (p = .0018) and LABA, LAMA, and ICS (p = .0071) therapy groups. While there was no observed difference in outpatient costs, there was a slightly higher number of outpatient visits per patient in the LABA and LAMA (25.5 SE = 0.9, p = 0.0070) relative to the LABA or LAMA therapy group (22.3 SE = 0.8) and higher utilization (89.7% of patients) with COPD visits in the LABA and LAMA therapy group relative to both the LABA or LAMA (73.8%; p < .0001) and LABA, LAMA and ICS therapy groups (85.3; p = 0.0305). CONCLUSIONS: Significant cost differences driven mainly by pharmaceuticals were observed among LABA or LAMA, LABA and LAMA and LABA, LAMA and ICS therapies. A COPD-related cost offset was observed from single bronchodilator to two bronchodilators. Addition of an ICS with two bronchodilators resulted in higher treatment costs without reduction in other COPD-related costs compared with two bronchodilators.

Compliance with antihypertensive therapy in the elderly: a comparison of fixed-dose combination amlodipine/benazepril versus component-based free-combination therapy.

BACKGROUND: Treatment regimens that require fewer dosage units and less frequent dosing to decrease the complexity and cost of care are among the strategies recommended to improve compliance with antihypertensive therapy. Simplifying therapy may be particularly important for elderly patients, who are more likely to have co-morbid conditions and to be taking multiple medications. OBJECTIVE: To determine rates of compliance with antihypertensive therapy and total costs of care among elderly Medicaid recipients treated with fixed-dose combination amlodipine besylate/benazepril versus a dihydropyridine calcium channel antagonist and ACE inhibitor prescribed as separate agents (free combination). STUDY DESIGN: A longitudinal, retrospective, cohort analysis of South Carolina Medicaid claims for ambulatory services, hospital services, Medicare crossover, and prescription drug for the years 1997-2002. Follow-up was 12 months from the index date, defined as the first prescription dispensing date for a study drug. PATIENTS: South Carolina Medicaid beneficiaries aged >or=65 years. MAIN OUTCOME MEASURE: Outcomes variables included compliance defined as the medication possession ratio (MPR), which was the total days' supply of drug (excluding last prescription fill) divided by the length of follow-up (with number of hospital days subtracted from the numerator and denominator). We hypothesized that elderly individuals receiving fixed-dose combination amlodipine besylate/benazepril HCl would be more compliant with therapy than those receiving a dihydropyridine calcium channel antagonist and ACE inhibitor as free combination. RESULTS: There were 2336 individuals in the fixed-combination group and 3368 in the free-combination group. The mean age was 76.0 +/- 7.2 years, and 82.6% were female. Compliance rates were significantly higher with fixed-dose versus free-combination therapy (63.4% vs 49.0%; p < 0.0001). The average total cost of care for patients receiving the fixed-dose combination was $US3179 compared with $US5236 (2002 values) for the free-combination regimen. In multivariate regression analyses on the log of total cost of care, average total costs increased by 0.5% for each 1-unit increase in MPR, and for each additional co-morbidity (measured by the chronic disease score) there was an increase of 10.4%. However, average total costs were reduced by 12.5% for patients using fixed-dose versus free-combination therapy (p < 0.003). CONCLUSION: Use of fixed-dose amlodipine besylate/benazepril HCl by elderly Medicaid recipients was associated with improved compliance and lower healthcare costs compared with a dihydropyridine calcium channel antagonist and ACE inhibitor prescribed as separate agents.

Evaluation of adverse events of oral antihyperglycemic monotherapy experienced by a geriatric population in a real-world setting: a retrospective cohort analysis.

BACKGROUND AND OBJECTIVE: To evaluate and compare the risk of adverse events (AEs) associated with the use of metformin, sulfonylureas and thiazolidinediones among geriatric patients in a usual care setting. METHODS: An electronic medical record database was utilized to identify geriatric patients with type 2 diabetes mellitus aged > or =65 years from 1996 to 2005. Patients naive to oral antihyperglycemic drug (OAD) therapy were followed for 395 days post initiation of metformin, sulfonylurea or thiazolidinedione treatment. AEs related to study drugs were evaluated during the follow-up period, and the risks of developing an AE were evaluated and adjusted for differences in baseline characteristics by OAD treatment. RESULTS: A total of 5438 patients (mean age 73.2 [SD 5.08] years, 56.1% female) were identified. During the follow-up period, 12.5% of patients experienced an AE (8.3% of metformin, 13.9% of sulfonylurea and 19.8% of thiazolidinedione recipients). Sulfonylurea (odds ratio [OR] 1.74; 95% CI 1.41, 2.13) and thiazolidinedione (OR 2.86; 95% CI 2.23, 3.65) recipients were more likely to experience an AE than metformin recipients, after adjustment for baseline demographic and co-morbidity differences. The average time to onset of a metformin AE (175 days) was less than that for sulfonylurea or thiazolidinedione treatment (192 and 201 days, respectively). The most common AEs were abdominal pain with metformin (42.3%) and weight gain >4.5 kg for sulfonylureas (63.2%) and thiazolidinediones (68.2%). Hypoglycaemia occurred in 2.6% and 2.2% of sulfonylurea and thiazolidinedione recipients, respectively. DISCUSSION AND CONCLUSIONS: Geriatric patients in a real-world setting experienced AEs with metformin, sulfonylurea and thiazolidinedione therapy, although rates differed from those seen in clinical trials, particularly for weight gain and hypoglycaemia. Lactic acidosis occurred at a higher rate with metformin therapy than has been reported in clinical trials, but our results were in the same range for abdominal pain and lower for diarrhoea, nausea/vomiting and dyspepsia. AEs related to sulfonylurea therapy were in the same range as in clinical trials for weight gain but lower for hypoglycaemia, dizziness and headaches. AEs related to thiazolidinedione therapy were more common in our study than in clinical trials, and within the same range for weight gain and elevated liver enzymes but lower for hypoglycaemia and oedema. While AE reporting is likely to be different in a real-world setting than in clinical trials, the observed variances may also be due to the aetiology of diabetes and the physiological response to hypoglycaemia in an older population.

Improved persistence and adherence to diuretic fixed-dose combination therapy compared to diuretic monotherapy.

BACKGROUND: Diuretics are recommended as initial treatment for hypertension. Several studies have suggested suboptimal persistence and adherence to thiazide diuretic monotherapy; this study compared patient persistence and adherence with hydrochlorothiazide (HCTZ) monotherapy to fixed-dose combinations containing HCTZ. METHODS: Patients with at least one prescription claim during 2001 to 2003 for either HCTZ or one of the following fixed-dose combinations: angiotensin-receptor blockers/HCTZ (ARB/HCTZ), angiotensin-converting enzyme inhibitor/HCTZ (ACEI/HCTZ), or beta blockers/HCTZ (BB/HCTZ) were identified. Patients were required to be continuously benefit-eligible six months pre- and one year post-index date, and to have no prescription claims for any antihypertensive therapy six months prior to the index date. Patients were followed for one year to assess persistence, medication possession ratio (MPR), adherence (MPR >80%), and proportion of days covered (PDC) with initial antihypertensive therapy. Logistic regression was used to calculate adjusted odds ratios for persistence, adherence and PDC, adjusted for age, gender, business segment, RxRisk disease categories, average co-pay and concurrent cardiovascular-related medication utilization. RESULTS: The study cohort consisted of 48,212 patients; 72.5% used HCTZ, 13.2% ACEI/HCTZ, 9.3% ARB/HCTZ, and 5.0% BB/HCTZ. Mean age was 53.7 years and 66.5% were female. A significantly lower proportion of patients using HCTZ (29.9%) remained persistent with therapy at 12 months compared with ARB/HCTZ (52.6%; OR = 0.37, CI = 0.36, 0.38), ACEI/HCTZ (51.4%; OR = 0.38, CI = 0.37, 0.39), and BB/HCTZ (51.9%; OR = 0.38, 0.37, 0.40). Similarly, PDC was lower for HCTZ patients (32.5%) as compared to ARB/HCTZ (53.7%; OR = 0.39, CI = 0.37, 0.40), ACEI/HCTZ (50.9%; OR = 0.42, CI = 0.40, 0.43), and BB/HCTZ (51.3%; OR = 0.44, CI 0.42, 0.45). MPR was also significantly lower for HCTZ patients as compared to those using fixed-dose combination therapies. CONCLUSION: Initiating HCTZ fixed-dose combination therapy with an ACEI, ARB, or BB was associated with greater persistence and adherence as compared to HCTZ monotherapy. Further research is needed to determine the relationship between improved persistence and adherence with blood pressure control.

Racial differences in medication compliance and healthcare utilization among hypertensive Medicaid recipients: fixed-dose vs free-combination treatment.

OBJECTIVE: To assess compliance with antihypertensive therapy and healthcare utilization among African American and White Medicaid recipients who are receiving fixed-dose combination amlodipine besylate/benazepril HCl or a dihydropyridine calcium channel blocker plus an angiotensin-converting enzyme inhibitor prescribed as separate agents (free-combination). DESIGN: Longitudinal, retrospective, cohort analysis of South Carolina Medicaid claims for the years 1997 through 2002. Followup was 12 months from the index date, defined as the first prescription dispensing date for a study drug. SETTING AND PARTICIPANTS: South Carolina Medicaid beneficiaries receiving fixed-dose (n=3363) and free-combination (n=713) therapy, including 3016 African Americans and 1060 White patients. MAIN OUTCOME MEASURES: Compliance was defined as the total days' supply of drug (excluding last prescription fill) divided by the length of followup; healthcare utilization included cost and number of claims associated with ambulatory services, hospital care, and prescription drugs. RESULTS: The cohort (N=4076) was 74.0% African American; mean age was 62.2 years. Compliance was significantly greater in patients who received fixed-dose therapy than in those who received free-combination therapy (58.6% vs 48.1%; P<.05). The average total cost of care was lower for the fixed-dose group ($4605) than for the free-combination group ($8531). African Americans and Whites were equally likely to receive the fixed-dose combination. However, compliance was lower among African American patients than among White patients (55% vs 61% respectively; P<.05). Costs and claims for ambulatory and hospital services were higher for African American patients, whereas drug costs and claims were higher for White patients. CONCLUSION: Fixed-dose amlodipine besylate/benazepril HCl was associated with higher compliance rates than was free-combination therapy, independent of race. Lower compliance rates among African American patients may have contributed to the higher healthcare resource use and costs observed. Efforts to enhance medication compliance tailored to African Americans may improve outcomes and reduce costs in this high-risk population.

Effect of prescription copayments on adherence and treatment failure with oral antidiabetic medications.

BACKGROUND: Previous studies have shown that an increase in cost sharing by patients for medications results in reduced medication use. The purpose of our study was to determine whether the amount of members' copayments predicted oral antidiabetic treatment failure in a managed care population and to analyze the relationship between copayments, adherence to therapy, and hemoglobin A(1c) levels in patients with type-2 diabetes. METHODS: Health plan members 18 years of age or older with type-2 diabetes and who were newly initiated on an oral antidiabetic drug (OAD) between January 1, 2002, and January 31, 2006, were identified from a managed care population in the U.S. Members were required to have continuous eligibility for six or more months before and 12 months after the index prescription and were placed into four treatment groups. These patients were followed for one year. The time during which they took the index OAD was measured until treatment failure (discontinuation of therapy or a switch of the index OAD) or censoring of patient data. The medication possession ratio (MPR), which was used to calculate adherence, was defined as the number of days that a patient had a supply of the index OAD during the year after the index fill, divided by 365 days. Copays were identified for every prescription, and the amount for each 30 days of treatment was calculated. We used multivariate analyses to assess the impact of copays on treatment failure, adjusting for differences in member characteristics. RESULTS: Adherence was poor, with an overall mean MPR of 0.57, decreasing from 0.58 for the group with a copay of less than $10 to 0.52 for patients with a copay of $20 or more. Initial treatment failed for 13,091 patients (70%), with approximately 60% of all members discontinuing treatment. This discontinuation rate ranged from 55% in the lowest copayment group (below $10) to 67% in those with a copay of $30 or more. For every $10 increase in copay, OAD treatment was 26% more likely to fail (95% confidence interval, 22.3-29.8%; P < 0.0001). CONCLUSION: Higher copays for health plan members were a significant predictor of treatment failure. With the increased trend toward more cost sharing by members of health plans, ongoing evaluation will be necessary to determine the impact on treatment persistence in patients with chronic conditions.

Loss of glycemic control in patients with type 2 diabetes mellitus who were receiving initial metformin, sulfonylurea, or thiazolidinedione monotherapy.

STUDY OBJECTIVES: To examine glycosylated hemoglobin (A1C) values longitudinally in patients who newly started metformin, sulfonylurea, or thiazolidinedione monotherapy; in a subset of patients whose A1C values were 7% or greater before starting therapy (baseline) and who achieved A1C goal (A1C < 7%) during therapy, rates of secondary failure (i.e., A1C value returned to > or = 7% during therapy) were compared for each drug. DESIGN: Four-year retrospective analysis. DATA SOURCE: Administrative database from a large health care plan. PATIENTS: Patients who filled at least one prescription for metformin (5453 patients), sulfonylurea (2373), and thiazolidinedione (1590) therapy, respectively, between January 1, 2001, and March 31, 2004, were enrolled. MEASUREMENTS AND MAIN RESULTS: Patients' demographic and clinical characteristics, baseline A1C values, changes in A1C values (last available result during follow-up minus baseline value), and A1C values before and after the addition of an antidiabetic drug other than the index drug (therapy intensification) were documented. Mean age was 50.7 years; 5027 (53.4%) were men. Mean baseline A1C value was 8.4%, and about 70% of patients had an AIC value of 7% or greater before starting therapy. Mean follow-up was 1.9 years, and mean decrease in A1C values was 1.47% (to 6.91%). The probabilities of attaining A1C goals were similar for patients receiving metformin, sulfonylurea, or thiazolidinedione therapy. The rate of therapy intensification among patients taking metformin (24.7%) was lower than that of patients taking a sulfonylurea (30.1%, p<0.001) but similar to that of those taking a thiazolidinedione (24.6%). Secondary failure occurred in 36.3% of patients; mean time from the start of therapy to its failure was about 1.51 years. Patients receiving a sulfonylurea were 1.25 (95% confidence interval [CI] 1.05-1.50) times more likely than patients receiving metformin to experience secondary failure, whereas failure rates were similar for thiazolidinediones and metformin (odds ratio 0.78, 95% CI 0.62-0.99). CONCLUSION: In the subset of patients assessed for secondary failure, although treatment initially reduced A1C values, more than one third experienced failure. Real-world studies of A1C goal attainment must follow patients on a long-term basis to assess the maintenance of glycemic control over time.

Failure to intensify hypertension therapy after rejected aliskiren claims.

BACKGROUND: Failure to intensify therapy when indicated is a serious problem in the management of hypertension. Patients having an antihypertensive prescription rejected because of utilization management tools may be at a high risk of failing to intensify their therapy when it is warranted. OBJECTIVE: The goal of this study was to investigate the patterns of therapy change after rejected aliskiren claims because of utilization management tools such as prior authorization, step therapy, and restrictive formulary. METHODS: A retrospective study was conducted using data from a large national pharmacy benefits manager. Patients with a rejected aliskiren claim because of utilization management and who were naive to aliskiren treatment before having a rejected aliskiren claim were included. Patients were followed up for 6 months after the initial rejected aliskiren claim to see whether there was a therapy change. Therapy change was defined as titration of old regimens, fulfillment of aliskiren, or fulfillment of a new antihypertensive medication not used previously. RESULTS: A total of 1955 patients were identified (mean age, 64.5 years; 54.4% female). Six months after having rejected aliskiren claims, 36.8% overcame the utilization management and filled aliskiren; 45.1% filled a new antihypertensive medication not used previously; and 10.8% patients titrated old antihypertensive medications. More than one quarter of patients (28.4%) had no change in their antihypertensive treatment. Logistic regression analysis revealed that patients rejected because of prior authorization (odds ratio = 4.00 [95% CI, 1.89-8.44]) or step therapy (odds ratio = 2.59 [95% CI, 1.26-5.32]) were more likely to have a therapy change compared with patients rejected because of a restrictive formulary. CONCLUSIONS: A significant number of patients had no therapy change 6 months after having rejected aliskiren claims because of utilization management tools, indicating potential clinical inertia or lack of therapy intensification in hypertension management. Patients with restrictive formularies were least likely to have a therapy change. More aggressive follow-up with patients with a rejected claim may be warranted to reduce treatment gaps.

Adherence to current guidelines for chronic obstructive pulmonary disease (COPD) among patients treated with combination of long-acting bronchodilators or inhaled corticosteroids.

BACKGROUND: To estimate the potential cost savings by following the current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guideline recommendations in patients being treated for chronic obstructive pulmonary disease (COPD) with the combination of long-acting ß(2)-agonist (LABA), long-acting muscarinic antagonist (LAMA) or inhaled corticosteroids (ICS). METHODS: The Geisinger Health System (GHS) database was utilized to identify subjects between January 1, 2004 to March 12, 2007. The index date was based on the first prescription of a LAMA plus LABA, LAMA plus LABA/ICS, or LABA plus ICS. Patients were included in the study if they: had a COPD diagnosis; had data representative of treatment 12 months prior to and 12 months post index date; were 40 years of age or over; had no prior diagnosis for asthma; and had pulmonary function test (PFT) data. We examined the baseline characteristics of these patients along with their healthcare resource utilization. Based on PFT data within 30 days of the index date, a subgroup was classified as adhering or non-adhering to GOLD guidelines. RESULTS: A total of 364 subjects could be classified as adhering or non-adherent to current GOLD guidelines based on their PFT results. The adherent subgroup received COPD medications consistent with current GOLD guidelines. Of the LAMA plus LABA cohort, 25 patients adhered and 39 patients were non-adherent to current GOLD guidelines. In the cohort of LABA plus ICS, 74 patients were adherent and 180 patients non-adherent to current GOLD guidelines. In the cohort of LAMA plus LABA/ICS, 21 patients were adherent and 25 patients non-adherent to current GOLD guidelines. GOLD adherence was associated with mean total cost of all services savings of $5,889 for LAMA plus LABA, $3,330 for LABA + ICS, and $10,217 for LAMA plus LABA/ICS cohorts. CONCLUSION: Staging of COPD with a PFT and adherence to current GOLD guidelines was associated with lower costs in subjects with moderate to severe COPD. Appropriate use of LAMA plus LABA, LABA plus ICS, and LAMA plus LABA/ICS has economic as well as clinical benefits for patients and payers.

Gender differences in symptoms and care delivery for chronic obstructive pulmonary disease.

BACKGROUND: Morbidity and mortality for women with chronic obstructive pulmonary disease (COPD) are increasing, and little is known about gender differences in perception of COPD care. METHODS: Surveys were administered to a convenience sample of COPD patients to evaluate perceptions about symptoms, barriers to care, and sources of information about COPD. RESULTS: Data on 295 female and 273 male participants were analyzed. With similar frequencies, women and men reported dyspnea and rated their health as poor/very poor. Although more women than men reported annual household income <$30,000, no significant gender differences in frequency of health insurance, physician visits, or ever having had spirometry were detected. In adjusted models (1) women were more likely to report COPD diagnostic delay (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.13-2.45, p=0.01), although anxiety (OR 1.83, 95% CI 1.10-3.06, p=0.02) and history of exacerbations (OR 1.60, 95% CI 1.08-2.37, p=0.01) were also significant predictors, (2) female gender was associated with difficulty reaching one's physician (OR 2.54, 95% CI 1.33-4.86, p=0.004), as was prior history of exacerbations (OR 2.25, 95% CI 1.21-4.20, p=0.01), and (3) female gender (OR 2.15, 95% CI 1.10-4.21, p=0.02) was the only significant predictor for finding time spent with their physician as insufficient. CONCLUSIONS: Significant gender-related differences in the perception of COPD healthcare delivery exist, revealing an opportunity to better understand what influences these attitudes and to improve care for both men and women.

Variation in adherence with Global Initiative for Chronic Obstructive Lung Disease (GOLD) drug therapy guidelines: a retrospective actuarial claims data analysis.

OBJECTIVES: Chronic obstructive pulmonary disease (COPD) is an irreversible and often progressive disease that requires lifelong adherence to complicated drug therapy regimens. The well established Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines recommend specific drug therapy protocols, yet patient adherence to drug therapy and physician adherence to prescribing guidelines is reported to be suboptimal. In this claims based analysis of COPD patients, drug therapy treatment patterns including inhaled corticosteroids and long acting bronchodilator use were evaluated by COPD severity level. METHODS: A cohort of patients with COPD (without co-existing asthma) was identified in Thomas Reuters MarketScan Commercial Database 2007 (diagnosis codes 491.xx, 492.xx, 496.xx). Using one year (2007) of claims data, a COPD severity risk score was calculated for each patient using established claim logic. Severity levels of mild, moderate, severe, and very severe were established to mimic the GOLD severity levels. Each patient's claim experience was examined for inhaled corticosteroid and long acting bronchodilator use for compliance with GOLD guidelines. RESULTS: Prevalence of COPD (without co-existing asthma) was 0.7% (44,366 cases). The distribution of COPD subjects into claim based severity levels was 30% mild, 53% moderate, 14% severe and 3% very severe. Claims for inhaled corticosteroid therapy were identified for 8% of mild and 19% of moderate COPD patients; claims for short acting bronchodilator therapy without concomitant use of long acting bronchodilators were identified for 20% of moderate, 14% of severe and 8% of very severe COPD patients; and claims for single long acting bronchodilator therapy in combination with inhaled corticosteroid therapy were identified for 12% of moderate, 19% of severe and 2% of very severe COPD patients. CONCLUSIONS: This analysis suggests less than optimal compliance with recommended drug therapy treatment for COPD patients based on GOLD guidelines. This study further suggests the utility of claims data analyses for providing reasonable aggregate distributions of COPD severity which allows for health plans and disease management programs to stratify COPD patients by severity level and examine opportunities for improved drug therapy management. Study findings should be considered in the context of the study limitations.

Treatment of COPD: relationships between daily dosing frequency, adherence, resource use, and costs.

BACKGROUND: Medication adherence is important in managing COPD. This study analyzed real-world use of inhaled medications for COPD to characterize relationships between daily dosing frequency, adherence, healthcare resource utilization, and cost. METHODS: This retrospective study used a large administrative claims database covering 8 million insured lives in the US from 1999 to 2006. Patients were stratified based on the recommended daily dosing frequency of their first COPD drug claim following COPD diagnosis. Adherence was measured using proportion of days covered (PDC) over 12 months following treatment initiation. Healthcare resource use included inpatient, outpatient, and emergency room visits. A multivariate regression model assessed the relationship between adherence and one-year healthcare resource use, controlling for demographics, comorbidities, and baseline resource use. Unit healthcare costs were obtained from the 2005 Medical Expenditure Panel Survey, adjusted to 2008 dollars. RESULTS: Based on a sample of 55,076 COPD patients, adherence was strongly correlated with dosing frequency. PDC was 43.3%, 37.0%, 30.2% and 23.0% for QD, BID, TID, and QID patient cohorts, respectively. Regression analysis showed that one-year adherence was correlated with healthcare resource utilization. For 1000 COPD patients, a 5% point increase in PDC reduced the annual number of inpatient visits (-2.5%) and emergency room visits (-1.8%) and slightly increased outpatient visits (+.2%); the net reduction in annual cost was approximately $300,000. CONCLUSION: COPD patients who initiated treatment with once-daily dosing had significantly higher adherence than other daily dosing frequencies. Better treatment adherence was found to yield reductions in healthcare resource utilization and cost.

Impact of comorbid conditions and race/ethnicity on glycemic control among the US population with type 2 diabetes, 1988-1994 to 1999-2004.

OBJECTIVE: To measure trends in glycemic control in type 2 diabetes in the United States from 1988-1994 to 1999-2004 and to identify factors influencing glycemic control, including the presence of comorbid conditions and race/ethnicity. METHODS: Participants in the National Health and Nutrition Examination Surveys (1988-1994 and 1999-2004) aged ≥30 years with diagnosed type 2 diabetes were identified. Outcome measures included glycemic control [glycosylated hemoglobin (A1C) <7%] and pharmacologic treatment rate. Comorbid conditions assessed included obesity, hyperlipidemia, and hypertension. RESULTS: Prevalence of type 2 diabetes increased from 5.8% in 1988-1994 to 7.1% in 1999-2004. Rates of treatment for type 2 diabetes improved, from 72.3% to 82.2%. The proportion of patients who achieved A1C <7% did not change significantly (44.4% to 50.1%, P=.06); however, blood pressure and cholesterol level both improved. During 1999-2004, only 14% of persons treated for type 2 diabetes did not have an additional comorbid condition; 21% had all three comorbid conditions. During 1999-2004, among treated patients, non-Hispanic blacks were 0.43 times as likely (95% CI 0.29-0.63), and Mexican Americans were 0.47 times as likely (95% CI 0.32-0.68), to have A1C <7% compared to non-Hispanic whites. CONCLUSIONS: Despite improved treatment rates, one in two individuals with type 2 diabetes has A1C of ≥7%. Most type 2 diabetic subjects also suffer from hypertension, hyperlipidemia, and/or obesity, and glycemic control rates were lowest for those with all three conditions. Non-Hispanic blacks and Mexican Americans are less likely to achieve glycemic control as compared to non-Hispanic whites.

Effects of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker therapy after hospital discharge on subsequent rehospitalization for acute myocardial infarction and heart failure.

American College of Cardiology/American Heart Association guidelines recommend angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) therapy following acute myocardial infarction (MI) or development of heart failure (HF). This study estimated the effects of initiating these therapies after hospitalization for MI or HF on subsequent 1-year rehospitalization rates for MI or HF. A retrospective multivariate analysis of medical claims for 14,327 patients receiving and 7905 not receiving an ACEI or ARB after discharge for MI or HF was conducted. Rehospitalization for MI or HF was lower for treated vs untreated patients (MI: odds ratio [OR]=0.53, P<.001; HF: OR=0.52, P<.001). Rehospitalization was lower in treated patients with high medication compliance (medication possession ratio [MPR]>80%) and medium compliance (MPR 40%-79%) vs patients with low compliance (ORs for MI: high=0.54, medium=0.69; P<.001); ORs for HF: high=0.38, medium=0.62; P<.001). In conclusion, ACEI or ARB therapy initiated after hospitalization for MI or HF reduced risk of rehospitalization, and greater risk reduction was achieved with higher medication compliance.

Trends in blood pressure control and treatment among type 2 diabetes with comorbid hypertension in the United States: 1988-2004.

OBJECTIVES: The objectives of this study were to examine the trends in the prevalence of type 2 diabetic patients with comorbid hypertension and blood pressure (BP) control rates in the United States and determine factors associated with these outcomes. METHODS: We used data from National Health and Nutrition Examination Surveys (NHANES) III (1988-1994) and NHANES 1999-2004, a cross-sectional sample of the noninstitutionalized US populations. Type 2 diabetic patients were identified as patients at least 30 years of age with physician-diagnosed diabetes who were taking insulin or oral antidiabetic drugs to manage the condition. A diagnosis of hypertension was based on physician diagnosis, treatment with antihypertensive medications, or BP at least 140/90 mmHg. BP control was defined as diabetic patients who maintained BP <130/80 mmHg. Logistic regression was used to estimate risks of high BP, and odds of high BP treatment and control rates, after adjusting for demographic and clinical risk factors. RESULTS: The age-adjusted prevalence of diabetic patients and those with hypertension increased significantly from 5.8 to 7.1% and 3.9 to 4.7%, respectively, from NHANES III to NHANES 1999-2004. Among diabetic patients with hypertension, patients who were treated with medication or lifestyle or behavioral modification therapy have increased significantly from 76.5 to 87.8% during the observation period. The proportion of patients who controlled BP increased from 15.9 to 29.6%, but 70% of patients still did not meet the target BP goal. CONCLUSION: Aggressive public health efforts are needed to improve BP control in type 2 diabetic patients with hypertension.