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.

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.

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.

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.

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.

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.

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.

Provider organization performance assessment utilizing diabetes physician recognition program.

OBJECTIVE: To examine the level of care in a large provider organization with respect to the Diabetes Physician Recognition Program (DPRP) standards of care and describe treatment patterns, diabetes-related complications, and achievement of clinical goals among patients stratified by glycemic control levels. STUDY DESIGN: Observational, retrospective, chart review study assessing care among patients with diabetes. METHODS: Diabetic patients aged > or =5 years who were prescribed insulin or oral hypoglycemics/antihyperglycemics for at least 12 months by 1 of 14 DPRP-participating physicians from the provider organization were eligible. A sample of patient medical charts was collected. Descriptive statistics were generated to assess demographic and clinical variables, with subanalyses for patients in the 3 glycosylated hemoglobin (A1C) cohorts. Data were used to describe the demographics, disease prevalence, comorbidities, clinical outcomes, and treatment patterns of the study population. Results were assessed according to national treatment guidelines. RESULTS: Almost all DPRP recognition measures were met and/or exceeded. More than 90% of patients received appropriate assessments. The majority achieved the A1C, blood pressure, and low-density lipoprotein control levels recommended by national treatment guidelines. Patients with multiple comorbidities had worse levels of control, with only 14.3% of patients achieving all 3 treatment goals. Nearly 30% of patients had diabetes-related complications, most commonly kidney disease. CONCLUSIONS: Differences in control and treatment patterns exist in patients with varying levels of glycemic control. Opportunities exist to improve diabetes care through goal attainment. Further research is needed to determine whether specific measures of care correlate with levels of glycemic control.

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.

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.

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.

Comorbid conditions and glycemic control in elderly patients with type 2 diabetes mellitus, 1988 to 1994 to 1999 to 2004.

OBJECTIVES: To compare the prevalence of type 2 diabetes mellitus in the U.S. elderly population between 1988 to 1994 and 1999 to 2004 and to assess glycemic control and comorbid conditions in this population. DESIGN: Serial U.S. population-based cross-sectional surveys. SETTING: National Health and Nutrition Examination Surveys (1988-1994 and 1999-2004). PARTICIPANTS: Survey participants aged 65 and older with type 2 diabetes mellitus. MEASUREMENTS: Glycemic control, measured as hemoglobin A1C (hA1C) less than 7%, prevalence of comorbid conditions, pharmacologic treatment rate, blood pressure, and serum cholesterol. RESULTS: The prevalence of diagnosed type 2 diabetes mellitus in the U.S. elderly population increased from 12.0% to 14.1% (P=.004) between 1988 and 2004. Many patients had comorbid conditions; in 1999 to 2004, 36.7% had nephropathy, 31.5% renal insufficiency, 20.2% history of myocardial infarction, and 17.9% heart failure. The proportion of patients treated with antihyperglycemic medication increased from 75.1% in 1988 to 1994 to 85.6% in 1999 to 2004 (P<.001), and glycemic control rates also improved, from 44.7% to 54.8% (P<.001). Greater improvement in glycemic control rates was evident in patients without comorbidities (P<.001). Adjusted for patient characteristics, including duration of diabetes mellitus, patients with nephropathy or renal insufficiency were 40% less likely to achieve controlled hA1C as those without. CONCLUSION: Despite improvements in the rates of treatment and glycemic control, approximately half of elderly patients diagnosed with type 2 diabetes mellitus have hA1C levels of 7% or higher. Many patients suffer from comorbid conditions, which may present a challenge for successful diabetes mellitus management.

Secondary failure of glycemic control for patients adding thiazolidinedione or sulfonylurea therapy to a metformin regimen.

OBJECTIVE: To assess glycemic control and secondary failure in patients adding thiazolidinedione or sulfonylurea therapy to a metformin regimen in a managed care setting. STUDY DESIGN: Retrospective cohort study using administrative claims data. METHODS: Participants (mean age, 51.1 years; 55.4% female) were required to have at least 1 prescription claim for a sulfonylurea (n = 300) or a thiazolidinedione (n = 279) between January 1, 2001, and March 31, 2004, as well as metformin use during the prior 6 months and continued metformin use. Secondary failure was measured for patients who initially achieved a glycosylated hemoglobin (A1C) level of less than 7.0% and was defined as a subsequent A1C level of at least 7.0%. RESULTS: The mean baseline A1C level was 8.2% and was higher for the patients receiving a combination of metformin and sulfonylurea (A1C level, 8.4%) compared with patients receiving a combination of metformin and thiazolidinedione (A1C level, 8.0%) (P < .05). Overall, 77.7% of patients had a baseline A1C level of at least 7.0%. The mean A1C level decreased by 1.2 (to 7.0%), and 65.1% of patients with a baseline A1C level of at least 7.0% reached goal A1C level. Therapy intensification via addition of another antihyperglycemic agent occurred in 60.7% of study patients. Approximately 2 in 5 patients (41.5%) who initially achieved goal A1C level experienced secondary failure; the mean time to failure was 1.3 years. CONCLUSION: Although most patients failing metformin monotherapy reached goal A1C level after addition of a sulfonylurea or a thiazolidinedione, 41.5% of patients observed for up to 4 years who initially attained goal A1C level experienced secondary failure.

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.

Persistence, adherence, and risk of discontinuation associated with commonly prescribed antihypertensive drug monotherapies.

OBJECTIVE: To assess 1-year persistence and adherence with monotherapy using the most commonly dispensed individual agent in 4 antihypertensive drug classes: hydrochlorothiazide (HCTZ), amlodipine, lisinopril, or valsartan. DESIGN: Retrospective, longitudinal analysis of initial prescriptions during 2001 to 2002 from a nationwide administrative claims database representing 11 million covered lives in the United States. MEASUREMENTS: Drug utilization following initiation. Cox proportional hazards regression models controlled for demographics, case-mix, and concomitant treatments. RESULTS: Records for 60,685 subjects were included: HCTZ (n = 18,713), amlodipine (n = 11,520), lisinopril (n = 21,138), or valsartan (n = 9314). Over 1 year, 31% to 44% of subjects utilized no treatment for at least 60 days. Medication possession ratio (MPR) and adherence measures ranged from 73% to 90%. Valsartan was associated with significantly (P < .001) more favorable measures of persistence, length of therapy, time to discontinuation, MPR, and risk of discontinuation, compared with HCTZ, amlodipine, or lisinopril. The risk of discontinuation was 53%, 32%, and 14% greater for HCTZ, amlodipine, and lisinopril, respectively, versus valsartan (all comparisons P < .001). CONCLUSION: Among antihypertensive agents studied, valsartan was associated with the most favorable utilization patterns. Health care providers and systems should evaluate the use of antihypertensive drugs within their populations to identify and manage treatment discontinuation.