Canagliflozin treatment of Hispanic and non-Hispanic patients with type 2 diabetes in a US managed care setting.

BACKGROUND: Hispanic/Latino (H/L) ethnicity is associated with higher prevalence of type 2 diabetes mellitus (T2DM) and more complications and comorbidities. Few studies of antihyperglycemic agents (AHAs) have compared H/L with non-H/L patients. Randomized controlled trials and observational studies have shown canagliflozin (CANA) is effective at lowering hemoglobin A1C (A1C). OBJECTIVE: To describe characteristics and compare glycemic control between H/L and non-H/L patients with T2DM filling their first prescription for CANA. METHODS: This retrospective cohort study examined healthcare claims for diabetic patients who filled ≥1 prescription for CANA between 1 April 2013 and 31 October 2013. We captured available demographic data; ethnicity was imputed as previously published. Clinical data included the Diabetes Complications Severity Index (DCSI), A1C values, and claims for any AHA, with 6 months of follow-up. RESULTS: Our sample included 438 (11.4%) H/L individuals and 3408 (88.6%) non-H/L individuals; each cohort had 43% females. The H/L patients were younger (53 vs. 56 years, p < 0.001) with higher mean baseline A1C (8.9% vs. 8.5%, respectively; p = 0.028) compared to non-H/L patients. Mean DCSI was similar (H/L 0.92 vs. non-H/L 0.84, p = 0.289) between cohorts. More H/L patients (25%) were taking ≥3 AHAs at the first CANA prescription fill (vs. 21% for non-H/L; p = 0.044), most commonly metformin, followed by sulfonylureas, dipeptidyl peptidase-4 inhibitors, and basal insulin. Among patients with ≥2 fills for CANA, mean adherence (proportion of days covered) was slightly lower for H/L than non-H/L patients (0.77 vs. 0.80, p = 0.003). From their respective baseline A1C values, reduction in A1C was significantly greater for H/L than non-H/L patients (1.1% vs. 0.8%; p = 0.043). CONCLUSION: Compared with non-H/L patients, our H/L patients were younger and had higher mean baseline A1C. Significant improvement in glycemic control was observed for both cohorts, with greater improvement for H/L patients. Additional research is warranted, including longer follow-up and adjusting for possible confounding factors.

Characteristics and outcomes of patients with type 2 diabetes mellitus treated with canagliflozin: a real-world analysis.

BACKGROUND: Canagliflozin, an oral agent that inhibits sodium glucose co-transporter 2, improves glycemic control, body weight, and blood pressure and is generally well tolerated in patients with type 2 diabetes mellitus (T2DM). This study extends the scope of previous analyses by evaluating outcomes associated with the use of canagliflozin over a 6-month period in a real-world setting. METHODS: This retrospective cohort study used data obtained from a large health plan database for patients (≥18 years) with a diagnosis of T2DM who filled at least one canagliflozin prescription between April 1, 2013 and October 30, 2013 (first 7 months canagliflozin was commercially available in the USA) and were continuously enrolled in the health plan for 6 months prior to (baseline) and 6 months following the first canagliflozin prescription claim (follow-up). Changes in glycemic control were evaluated, along with characteristics of enrolled patients and changes in treatment patterns. RESULTS: 4017 patients (mean age 56 years, 43 % female) met the study inclusion criteria. Of these, at the time of first canagliflozin claim, 21 % used canagliflozin concomitantly with three or more other antihyperglycemic agents (AHAs), 29 % with two other AHAs, 30 % with one other AHA, and 20 % without other AHAs. During follow-up, patients received 3.4 (average) canagliflozin prescription fills and a mean of 148 total days of supply; median adherence (interquartile range [IQR]) was 86 % (66-98 %) for patients with ≥2 fills. Among patients with available glycated hemoglobin (A1C) measurements at baseline and follow-up (n = 826, baseline A1C 8.59 %), mean A1C reduction was 0.81 % (P < 0.001). Mean A1C reduction during the follow-up period was greatest in patients with the highest baseline A1C levels. Of the patients who used canagliflozin concomitantly with other AHAs, 20 % were observed to discontinue one or more other AHAs during follow-up. The most commonly discontinued baseline AHAs were: glucagon-like peptide-1 receptor agonists (16 %), dipeptidyl peptidase-4 inhibitors (15 %), insulin (13 %), sulfonylureas (13 %), and metformin (11 %). CONCLUSIONS: This real-world study on canagliflozin use in a range of patients with T2DM demonstrated significant improvements in mean A1C from baseline following the first canagliflozin prescription. In patients concomitantly using one or more additional AHAs at baseline, there appears to be a trend toward lower other AHA use after canagliflozin initiation.

Diabetes-Related Composite Quality End Point Attainment: Canagliflozin Versus Sitagliptin Based on a Pooled Analysis of 2 Clinical Trials.

PURPOSE: This post hoc analysis evaluated attainment of diabetes-related composite quality measures (CQMs) with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus (T2DM). We used pooled data from two 52-week Phase III clinical trials evaluating the efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg. METHODS: CQMs assessed included the combined attainment of glycosylated hemoglobin (HbA1c), blood pressure (BP), and LDL-C. To assess on-treatment differences at 52 weeks, odds ratios (ORs) and associated 95% CIs were calculated based on a logistic regression model. CQM attainment was assessed in the overall population and for patients with a body mass index ≥25 kg/m(2) at baseline. FINDINGS: Overall, baseline demographic and disease characteristics were comparable across treatment groups. Proportions of patients with T2DM meeting the CQMs HbA1c <7.0%, BP <130/80 mm Hg, and LDL-C <100 mg/dL and HbA1c <8.0%, BP <140/90 mm Hg, and LDL-C <100 mg/dL were similar at baseline. After 52 weeks of treatment, the proportion of patients meeting both CQMs was similar for canagliflozin 100 mg and sitagliptin 100 mg, and favored canagliflozin 300 mg versus sitagliptin 100 mg. For canagliflozin 300 mg, the OR was 1.79 (95% CI, 1.25-2.58) for the CQM HbA1c <7.0%, BP <130/80 mm Hg, and LDL-C <100 mg/dL; the OR was 1.49 (95% CI, 1.15-1.92) for the CQM HbA1c <8.0%, BP <140/90 mm Hg, and LDL-C <100 mg/dL. CQM attainments for patients with a body mass index ≥25 kg/m(2) were similar to those for the overall population. IMPLICATIONS: At 52 weeks of treatment, this analysis observed comparable CQM attainment for canagliflozin 100 mg, and superior CQM attainment for canagliflozin 300 mg, compared with sitagliptin 100 mg. ClinicalTrials.gov identifiers are NCT01106677 and NCT01137812.

Demographic Disparities Among Medicare Beneficiaries with Type 2 Diabetes Mellitus in 2011: Diabetes Prevalence, Comorbidities, and Hypoglycemia Events.

This study describes demographic characteristics, comorbidities, and hypoglycemia events in patients with type 2 diabetes mellitus (T2DM) identified using 2011 Medicare 5% Standard Analytical Files. Among 1,913,477 Medicare beneficiaries, 367,602 (19.2%) had T2DM. T2DM prevalence increased with age and was higher in blacks (26.4%) and Hispanics (25.5%) than in whites (18.0%); and in Medicare/Medicaid dual-eligible versus non-dual-eligible patients (28.0% vs 17.2%, respectively). Compared with whites, diagnosed hypertension and diabetic retinopathy were more common in blacks and Hispanics, and lipid metabolism disorders and atrial fibrillation were less common. Hypoglycemia requiring health care services was more common in blacks (4.7%) and Hispanics (3.6%) compared with whites (2.9%). T2DM, related comorbidities, and hypoglycemia are burdensome to the Medicare population. Differences in these endpoints were observed based on race/ethnicity, age, and dual-eligible status, highlighting the importance of demographic factors when determining T2DM management strategies.

Characteristics and short-term outcomes of patients with type 2 diabetes mellitus treated with canagliflozin in a real-world setting.

OBJECTIVE: Canagliflozin is a sodium glucose co-transporter 2 inhibitor that has been shown to improve glycemic control in type 2 diabetes mellitus (T2DM). This study aimed to describe the characteristics, treatment utilization, and outcomes of patients treated with canagliflozin in the real world within the first 6 months of it being commercially available. METHODS: This retrospective cohort study used a large US health plan database for commercial and Medicare Advantage enrollees. Patients aged 18 and over with T2DM who filled a canagliflozin prescription during 1 April 2013 to 30 September 2013 were eligible for inclusion. Patients were required to be enrolled for 6 months before (baseline period) and 3 months after (follow-up period) the first canagliflozin claim. RESULTS: Overall, 3234 patients met study criteria (mean age was 55.7 years; 43.4% were female). Among patients with available lab data at baseline and follow-up, mean HbA1c decreased from 8.54% at baseline to 7.76% at follow-up (p < 0.001); the proportion of patients with HbA1c ≥9.0% decreased by more than half (from 32.0% at baseline to 15.5% at follow-up, p < 0.001). Almost all (94.8%) patients received at least one baseline antihyperglycemic agent; among them, 33.6% received two and 41.5% received three or more agents. Compared to baseline, usage of antihyperglycemic agents during follow-up was lower for metformin, sulfonylureas, insulin, DPP-4 inhibitors, GLP-1 receptor agonists and thiazolidinediones. CONCLUSIONS: Patients treated with canagliflozin when first available in the US typically had poorly controlled HbA1c levels at baseline and had received multiple prior antihyperglycemic agents. Following the first canagliflozin claim, they had an improvement in HbA1c levels and used fewer antihyperglycemic agents. These study results should help clinicians and payers better understand the initial profile of patients receiving canagliflozin and short-term outcomes in the real world. Given the short follow-up time frame and the fact that HbA1c data was not available in all patients, future research on longer term outcomes is warranted.

Cost efficiency of canagliflozin versus sitagliptin for type 2 diabetes mellitus.

OBJECTIVES: To compare 1-year clinical outcomes and cost efficiency of treating adults with type 2 diabetes mellitus (T2DM) with canagliflozin (300 mg/day) or sitagliptin (100 mg/day), both added on a background of metformin and sulfonylurea. STUDY DESIGN: An economic model integrated data from an active-controlled, randomized trial, claims database analyses, and published literature. METHODS: The model adopted a US managed care payer perspective and included the clinical and economic impact of achieving specific clinical quality goals. The model was run separately for 2 single clinical quality metrics, glycated hemoglobin (A1C) < 7% (used as base case) or < 8%, and 4 composite metrics (A1C < 7% or < 8% combined with body mass index < 30 kg/m2 and blood pressure < 140/90 mm Hg or low-density lipoprotein cholesterol < 100 mg/dL). Cost savings of achieving versus not achieving metrics were derived from a claims database analysis. Drug and adverse event costs were included. RESULTS: In the base case, compared with sitagliptin 100 mg, treatment with canagliflozin 300 mg resulted in $215 in annual cost savings and 12.3 absolute percentage points more patients achieving goal. Similar findings were found across all other quality metrics (difference in proportion achieving goal ranging from 6.7% to 19.0% and annual savings ranging from $1 to $669). Canagliflozin remained cost saving versus sitagliptin in sensitivity analyses. CONCLUSIONS: Canagliflozin 300 mg may represent a cost-efficient T2DM treatment option versus sitagliptin 100 mg for patients on metformin plus sulfonylurea due to lower overall costs and better achievement of A1C and quality composite goals.

Chronic kidney disease in US adults with type 2 diabetes: an updated national estimate of prevalence based on Kidney Disease: Improving Global Outcomes (KDIGO) staging.

BACKGROUND: Kidney Disease Improving Global Outcomes (KDIGO) 2013 updated the classification and risk stratification of chronic kidney disease (CKD) to include both the level of renal function and urinary albumin excretion (UAE). The update subclassifies the previous category of moderate renal impairment. There is currently limited information on the prevalence of CKD based on this new classification in United States (US) adults with type 2 diabetes mellitus (T2DM). The objective of this study was to provide such estimates, for T2DM both overall and in those ≥ 65 years of age. We used the continuous National Health and Nutrition Examination Survey (NHANES) 1999-2012 to identify participants with T2DM. Estimated glomerular filtration rate (eGFR) and UAE were calculated using laboratory results and data collected from the surveys, and categorized based on the KDIGO classification. Projections for the US T2DM population were based on NHANES sampling weights. RESULTS: A total of 2915 adults diagnosed with T2DM were identified from NHANES, with 1466 being age ≥ 65 years. Prevalence of CKD based on either eGFR or UAE was 43.5% in the T2DM population overall, and 61.0% in those age ≥ 65 years. The prevalence of mildly decreased renal function or worse (eGFR < 60/ml/min/1.73 m2) was 22.0% overall and 43.1% in those age ≥ 65 years. Prevalence of more severe renal impairment (eGFR < 45 ml/min/1.73 m2) was 9.0% overall and 18.6% in those age ≥ 65 years. The prevalence of elevated UAE (> 30 mg/g) was 32.2% overall and 39.1% in those age ≥ 65 years. The most common comorbidities were hypertension, retinopathy, coronary heart disease, myocardial infarction, and congestive heart failure. CONCLUSIONS: This study confirms the high prevalence of CKD in T2DM, impacting 43.5% of this population. Additionally, this study is among the first to report US prevalence estimates of CKD based on the new KDIGO CKD staging system.

Attainment of diabetes-related quality measures with canagliflozin versus sitagliptin.

OBJECTIVE: To evaluate attainment of diabetes-related quality measures with canagliflozin, a sodium glucose cotransporter 2 inhibitor, versus sitagliptin in patients with type 2 diabetes mellitus (T2DM). STUDY DESIGN: This post hoc analysis included data from a 52-week, randomized, double-blind, phase 3 study comparing canagliflozin 300 mg and sitagliptin 100 mg in patients with T2DM on metformin plus sulfonylurea. METHODS: Individual and composite diabetes-related quality measures based on glycated hemoglobin (A1C), blood pressure (BP), low-density lipoprotein cholesterol (LDL-C) level, body mass index (BMI), and body weight were assessed in the overall population and a subgroup with a baseline BMI of at least 25 kg/m². RESULTS: At baseline, the proportion of patients meeting criteria for quality measures was similar between groups. At week 52, more canagliflozin-treated patients achieved quality measures of an A1C less than 8% or less than 7%, and fewer canagliflozintreated patients had an A1C greater than 9%, compared with sitagliptin. More patients achieved BP measurement less than 140/90 mm Hg, less than 140/80 mm Hg, or less than 130/80 mm Hg with canagliflozin versus sitagliptin. The proportion of patients with an LDL-C level less than 100 mg/dL was similar between groups. More patients had a BMI of at least 25 kg/m² and a greater than 10 lb (4.5 kg) weight loss from baseline, and a BMI less than 30 kg/m² at week 52, with canagliflozin versus sitagliptin. A greater proportion of patients achieved composite end points based on A1C, BP, and LDL-C level with canagliflozin versus sitagliptin. Similar results were observed in the subgroup of patients with a baseline BMI of at least 25 kg/m². CONCLUSION: In this study involving patients with T2DM on metformin plus sulfonylurea, after 52 weeks, patients treated with canagliflozin 300 mg demonstrated better attainment of individual and composite diabetes-related quality measures compared with patients treated with sitagliptin 100 mg.

Characterization of type 2 diabetes mellitus burden by age and ethnic groups based on a nationwide survey.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is the most common form of diabetes. Risk factors for its development include older age, obesity, family history of diabetes, history of gestational diabetes, impaired glucose metabolism, physical inactivity, and race/ethnicity. OBJECTIVE: The purpose of this study was to characterize T2DM burden, from a patient perspective, with respect to age and race/ethnicity. METHODS: Adults aged ≥18 years with T2DM from a large, Internet-based, nationwide survey were retrospectively analyzed. Demographic and clinical characteristics (glycemic control, body mass index [BMI], comorbidities, and diabetes-related complications), hypoglycemic episodes, and medication adherence were used to assess diabetes burden. Degree of burden was compared across age (18-64, 65-74, and ≥75 years) and racial/ethnic (white, African American, Hispanic, Asian, and American Indian) groups. RESULTS: An apparent association was found between glycemic control and medication adherence. Hispanics had the lowest percentage of participants with a hemoglobin A1c (HbA1c) level <7.0% (24.4%) and the highest percentage of those not knowing their HbA1c levels (55.4%) but also had the poorest medication adherence among racial/ethnic groups. Conversely, American Indians and whites had the best glycemic control, HbA1c knowledge, and medication adherence. The 18- to 64-year age group had the poorest glycemic control (28.8%), the most with unknown HbA1c levels (46.3%), and the poorest medication adherence of the age groups. Mean BMIs were high (>30 mg/kg(2)) for all racial/ethnic groups other than the Asian group (28.9 mg/kg(2)). Approximately 71% of Asians were obese or overweight compared with ≥90% in the other racial/ethnic groups. Mean BMIs decreased with increasing age group (34.5, 32.6, and 29.8 kg/m(2) for the age groups of 18-64, 65-74, and ≥75 years, respectively). Regarding diabetes-related comorbidities, the Asian group had the lowest percentages of those with hypertension (39.1%) and hypercholesterolemia (46.6%). The Asian group had the lowest mean Charlson Comorbidity Index (CCI) score (score of 1.4); the American Indian group had the highest CCI score (score of 1.8). Of the age groups, the 65- to 74-year group had the highest percentages of those with hypertension (69.0%) and hypercholesterolemia (67.4%). The mean CCI scores in the 65- to 74-year and ≥75-year age groups (scores of 1.8 for both) were significantly higher than in the 18- to 64-year age group. The Asian group had the lowest percentage of participants reporting hypoglycemia (37.3%). The 18- to 64-year age group had the highest percentage of participants reporting hypoglycemia (52.7%). Limitations of this study include selection bias (Internet-based survey), recall bias, missing values, and descriptive analyses without adjustment for multiplicity. CONCLUSION: There are many factors that contribute to diabetes burden and the complexity of diabetes management. The results of this study provide insight from a patient perspective regarding how these factors vary across age and race/ethnicity to aid in the individualization of diabetes treatment.

Diabetes-related quality measure attainment: canagliflozin versus sitagliptin based on a pooled analysis of 2 clinical trials.

OBJECTIVE: To evaluate attainment of diabetes-related quality measures with canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg in patients with type 2 diabetes mellitus. STUDY DESIGN: This post hoc analysis used pooled data from two 52-week, randomized, double-blind, phase 3 clinical trials that evaluated the comparative efficacy of canagliflozin and sitagliptin. One trial evaluated patients on metformin at baseline with add-on canagliflozin 100 mg, canagliflozin 300 mg, or sitagliptin 100 mg; the other trial evaluated patients on metformin and a sulfonylurea at baseline with add-on canagliflozin 300 mg or sitagliptin 100 mg. METHODS: Individual diabetes-related quality measures, including glycated hemoglobin (A1C), blood pressure (BP), low-density lipoprotein cholesterol (LDL-C), body mass index (BMI), and change in body weight, were assessed. RESULTS: At baseline, the proportions of patients meeting criteria for all quality measures were similar between groups. At 52 weeks, compared with sitagliptin 100-mg treatment, canagliflozin 100 mg demonstrated either comparable or superior glycemic control. Additionally, canagliflozin 100 mg versus sitagliptin 100 mg demonstrated superior attainment of BP, BMI, and weight-related quality measures; no difference was seen with respect to LDL-C. At 52 weeks, compared with sitagliptin 100-mg treatment, canagliflozin 300 mg demonstrated superior glycemic control at all thresholds of A1C, and superior BP, BMI, and weight-related quality measures; there was no difference in LDL-C quality measure attainment. CONCLUSION: We evaluated the comparative efficacy of canagliflozin 100 mg, canagliflozin 300 mg, and sitagliptin 100 mg on quality measure attainment after 52 weeks of treatment. Compared with sitagliptin 100 mg, canagliflozin 100 mg demonstrated comparable or superior attainment of diabetes-related quality measures. Compared with sitagliptin 100 mg, canagliflozin 300 mg demonstrated superior diabetes-related quality measure attainment, including glycemic, BP, and weight-related quality measures; there was no difference in LDL-C quality measure attainment between either dosage of canagliflozin and the 100-mg dosage of sitagliptin.

Real-world treatment pattern and outcomes among patients who took tapentadol IR or oxycodone IR.

OBJECTIVE: To evaluate differences in patient characteristics, healthcare resource utilization, and healthcare costs among patients receiving immediate release (IR) formulations of tapentadol (TAP IR) or oxycodone (OXY IR). METHODS: Patients (≥18 years) who took TAP IR or OXY IR (6/1/2009-7/31/2011) were selected from the OptumInsight Clinformatics Data Mart claims database. Patients were assigned to the TAP IR or OXY IR cohort based on initial drug usage (index event). Continuous health plan coverage 60 days before (baseline period) and after (follow-up period) the index event was required. TAP IR patients were matched to OXY IR patients (1:1) using exact match of key patient characteristics and propensity score matching with patient demographics and clinical characteristics as covariates. T-test and chi-squared test were utilized to evaluate differences in patient characteristics, healthcare utilization and charges among cohorts. RESULTS: Patient profiles during the baseline period significantly differed among TAP IR users (n = 17,539) and OXY IR users (n = 85,821) in the overall study population. The matched sample of TAP IR and OXY IR patients (n = 10,185 in both cohorts) had similar patient characteristics. During the 60-day follow-up period, patients who took TAP IR had a shorter mean hospital LOS (0.21 vs 0.35 days, p < 0.0001), a lower mean number of hospitalizations (0.07 vs 0.10, p < 0.0001), and lower mean inpatient ($2900 vs $4382, p < 0.001) and outpatient healthcare charges ($10,550 vs $11,084, p = 0.047). The higher index opioid prescription charge of TAP IR ($190 vs $150, p < 0.0001) was offset by other lower healthcare charges. CONCLUSIONS: The characteristics of patients who took TAP IR were different from patients who took OXY IR in many respects. In the sub-set of patients matched on demographic and clinical characteristics, those who took TAP IR used healthcare resources to a lesser extent, which was reflected in their lower healthcare charges, relative to OXY IR users.

Impact of bleeding-related complications and/or blood product transfusions on hospital costs in inpatient surgical patients.

BACKGROUND: Inadequate surgical hemostasis may lead to transfusion and/or other bleeding-related complications. This study examines the incidence and costs of bleeding-related complications and/or blood product transfusions occurring as a consequence of surgery in various inpatient surgical cohorts. METHODS: A retrospective analysis was conducted using Premier's Perspective™ hospital database. Patients who had an inpatient procedure within a specialty of interest (cardiac, vascular, non-cardiac thoracic, solid organ, general, reproductive organ, knee/hip replacement, or spinal surgery) during 2006-2007 were identified. For each specialty, the rate of bleeding-related complications (including bleeding event, intervention to control for bleeding, and blood product transfusions) was examined, and hospital costs and length of stay (LOS) were compared between surgeries with and without bleeding-related complications. Incremental costs and ratios of average total hospital costs for patients with bleeding-related complications vs. those without complications were estimated using ordinary least squares (OLS) regression, adjusting for demographics, hospital characteristics, and other baseline characteristics. Models using generalized estimating equations (GEE) were also used to measure the impact of bleeding-related complications on costs while accounting for the effects related to the clustering of patients receiving care from the same hospitals. RESULTS: A total of 103,829 cardiac, 216,199 vascular, 142,562 non-cardiac thoracic, 45,687 solid organ, 362,512 general, 384,132 reproductive organ, 246,815 knee/hip replacement, and 107,187 spinal surgeries were identified. Overall, the rate of bleeding-related complications was 29.9% and ranged from 7.5% to 47.4% for reproductive organ and cardiac, respectively. Overall, incremental LOS associated with bleeding-related complications or transfusions (unadjusted for covariates) was 6.0 days and ranged from 1.3 to 9.6 days for knee/hip replacement and non-cardiac thoracic, respectively. The incremental cost per hospitalization associated with bleeding-related complications and adjusted for covariates was highest for spinal surgery ($17,279) followed by vascular ($15,123), solid organ ($13,210), non-cardiac thoracic ($13,473), cardiac ($10,279), general ($4,354), knee/hip replacement ($3,005), and reproductive organ ($2,805). CONCLUSIONS: This study characterizes the increased hospital LOS and cost associated with bleeding-related complications and/or transfusions occurring as a consequence of surgery, and supports implementation of blood-conservation strategies.

Electronic medical records as a research tool: evaluating topiramate use at a headache center.

BACKGROUND: Electronic medical records (EMRs) are used in large healthcare centers to increase efficiency and accuracy of documentation. These databases may be utilized for clinical research or to describe clinical practices such as medication usage. METHODS: We conducted a retrospective analysis of EMR data from a headache clinic to evaluate clinician prescription use and dosing patterns of topiramate. The study cohort comprised 4833 unique de-identified records, which were used to determine topiramate dose and persistence of treatment. RESULTS: Within the cohort, migraine was the most common headache diagnosis (n = 3753, 77.7%), followed by tension-type headache (n = 338, 7.0%) and cluster or trigeminal autonomic cephalalgias (n = 287, 5.9%). Physicians prescribed topiramate more often for subjects with migraine and idiopathic intracranial hypertension (P < .0001) than for those with other conditions, and more often for subjects with coexisting conditions including obesity, bipolar disorder, and depression. The most common maintenance dose of topiramate was 100 mg/day; however, approximately 15% of subjects received either less than 100 mg/day or more than 200 mg/day. More than a third of subjects were prescribed topiramate for more than 1 year, and subjects with a diagnosis of migraine were prescribed topiramate for a longer period of time than those without migraine. CONCLUSIONS: Findings from our study using EMR demonstrate that physicians use topiramate at many different doses and for many off-label indications. This analysis provided important insight into our patient populations and treatment patterns.

Cost-effectiveness of a potential prophylactic Helicobacter pylori vaccine in the United States.

BACKGROUND: Helicobacter pylori vaccines are under development to prevent infection. We quantified the cost-effectiveness of such a vaccine in the United States, using a dynamic transmission model. METHODS: We compartmentalized the population by age, infection status, and clinical disease state and measured effectiveness in quality-adjusted life years (QALYs). We simulated no intervention, vaccination of infants, and vaccination of school-age children. Variables included costs of vaccine, vaccine administration, and gastric cancer treatment (in 2007 US dollars), vaccine efficacy, quality adjustment due to gastric cancer, and discount rate. We evaluated possible outcomes for periods of 10-75 years. RESULTS: H. pylori vaccination of infants would cost $2.9 billion over 10 years; savings from cancer prevention would be realized decades later. Over a long time horizon (75 years), incremental costs of H. pylori vaccination would be $1.8 billion, and incremental QALYs would be 0.5 million, yielding a cost-effectiveness ratio of $3871/QALY. With school-age vaccination, the cost-effectiveness ratio would be $22,137/QALY. With time limited to <40 years, the cost-effectiveness ratio exceeded $50,000/QALY. CONCLUSION: When evaluated with a time horizon beyond 40 years, the use of a prophylactic H. pylori vaccine was cost-effective in the United States, especially with infant vaccination.

Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life.

Migraine can be characterized as a chronic disorder with episodic attacks and the potential for progression to chronic migraine. We conducted a PubMed literature search (January 1, 1970 through May 31, 2008) for studies on the impact of migraine, including disability, health-related quality of life (HRQoL), comorbidities, and instruments used by health care professionals to treat patients with migraine. Numerous studies have shown that migraine substantially impairs a person's functions during attacks and diminishes HRQoL during and between attacks. Despite its impact, migraine remains underestimated, underdiagnosed, and undertreated. Several tools are available to help physicians assess the impact of migraine on the daily activities and HRQoL of their patients, such as the 36-Item Short-Form Health Survey and the Headache Impact Test. Improving communication during the office visit through active listening, use of open-ended questions, and use of the "ask-tell-ask" strategy can also help in assessing migraine-related impairment. Together, these tools and communication techniques can lead to a more complete assessment of how migraine affects patients' lives and can aid in the development of the optimal treatment plan for each patient. Both pharmacotherapy (acute and preventive treatment strategies) and nonpharmacological therapies play important roles in the management of migraine.

Evaluation of resource utilization and cost burden before and after an employer-based migraine education program.

OBJECTIVES: Study objectives were to determine the impact of migraine and severe headache on employer burden, resource utilization, and workplace productivity before and after a migraine education program; estimate the associated costs in an employed sample; and evaluate whether a migraine management program can help manage costs. METHODS: Employees of three US companies were informed of a company-specific web site with information regarding the study as well as a validated migraine screening questionnaire. Employees who screened positive for migraine completed a baseline survey examining migraine frequency and severity, Migraine Disability Assessment (MIDAS) grade, medical resource utilization, and impact on workplace productivity. After the baseline survey, employees received three print packets and six e-mailed newsletters of migraine management educational materials. Six months after the last mailing, participants completed a follow-up survey. Participants were stratified by MIDAS grade and prevention needs status. Direct and indirect migraine-related costs were estimated and differences between baseline and follow-up survey results were analyzed. RESULTS: Indirect costs and measures of migraine impact improved after the educational program. Three-month indirect costs of migraine decreased 34.5% and total costs decreased 14.7% after the educational program. CONCLUSION: Migraine management programs, including screening questionnaires and educational initiatives, may potentially help reduce the employer cost burden due to improvements in their employees' disability associated with migraine headache.

Resource utilization impact of topiramate for migraine prevention in the managed-care setting.

OBJECTIVE: To determine the pattern of headache-related resource utilization and costs before and after initiation of preventive migraine treatment with topiramate in a sample of a large managed-care population. METHODS: This study was a retrospective, longitudinal, cohort study analysis of medical and pharmacy claims using The HealthCore Integrated Research Network Database. Patients were required to have had at least one pharmacy claim for topiramate between 7/1/00 and 11/30/04, and at least 12 dosage units dispensed of any combination of acute migraine treatments (triptan, ergotamine, or ergotamine combination) during the 6-month period preceding the first pharmacy claim for topiramate (the index date). Headache-related inpatient and outpatient resource utilizations were compared pre-index vs. post-index period 1 (months 1-6) and pre-index vs. post-index period 2 (months 7-12). Statistical analyses included McNemar tests for categorical variables and paired t-tests for continuous variables. RESULTS: A total of 3246 patients met the inclusion criteria. The mean (+/- SD) age was 44 +/- 10 years and 88% were female. From pre- to post-index period 2, outpatient visits significantly decreased by 30% (p < 0.0001), diagnostic procedures decreased by 74% (p = 0.0013), emergency room (ER) visits decreased by 27% (p < 0.0001), and abortive prescriptions decreased by 25% (p < 0.0001). No significant differences were found in mean number of hospitalization days. Total headache-related inpatient costs and outpatient costs decreased (p < 0.01) during post-index period 2 (43 and 46%, respectively). Headache-related pharmacy costs increased from pre- to post-index period 2. CONCLUSION: Topiramate treatment for migraine prevention was associated with significantly lower healthcare resource use (ER visits, diagnostics, acute treatment) in the first 6 months of treatment, with continuing decreases, including physician office visits, during the second 6 months of treatment. LIMITATIONS: Since this study is a claims-based analysis there is the potential introduction of non-claims identifiable factors that might influence resource use such as lifestyle modifications and over-the-counter medications. In addition, adherence to topiramate treatment was not accounted for in this study. Nonetheless, this study provides important insights into the benefit of preventive migraine treatment in actual clinical practice.

Economic burden of transformed migraine: results from the American Migraine Prevalence and Prevention (AMPP) Study.

OBJECTIVE: To evaluate the impact of incident transformed migraine on health care resource utilization, medication use, and productivity loss. In addition, the study estimates the total direct and indirect costs associated with transformed migraine. BACKGROUND: Emerging evidence indicates that migraine may be a chronic progressive disorder characterized by escalating frequency of headache attacks, often termed transformed migraine. Little is known about the economic impact of transformed migraine. METHODS: AMPP is a 5-year, national, longitudinal survey study of headache in the US. The study utilized data from the 2006 follow-up survey based on an initial sample of 14,544 adults identified as having migraine in either the 2004 screening or 2005 baseline survey. A diagnosis of migraine was assigned based on criteria proposed by the International Classification of Headache Disorders, 2nd Edition. Participants completed self-administered, validated questionnaires on headache features, frequency, impairment, resource use, medication use, and productivity loss. Direct and indirect headache-related costs were estimated using unit cost assumptions from the PharMetrics Patient-Centric database, wholesale acquisition costs (Red Book), and wage data from the US Bureau of Labor Statistics. Those who developed transformed migraine were compared with those who did not develop transformed migraine in the 1-2 year interval between screening/baseline and follow-up. RESULTS: A total of 7796 (54%) identified migraine cases completed the 2006 follow-up survey. Of those cases, 359 (4.6%) developed transformed migraine. Participants who developed transformed migraine reported significantly more primary care visits, neurologist or headache specialist visits, pain clinic visits, and emergency room visits compared with participants whose migraine remained episodic. Hospital nights and urgent care visits did not reach statistical significance. Transformed migraine participants reported significantly more time missed at work or school because of headaches and more time where work or school productivity was reduced by >50% in the previous 3 months because of headaches. Average per-person annual total costs, including direct and indirect costs, were 4.4-fold greater for those who developed transformed migraine ($7750) compared with those who remained episodic ($1757). CONCLUSION: Transformed migraine exacts a significantly higher economic toll on patients and health care systems compared with other forms of migraine. Our findings support the need to prevent migraine progression and to provide appropriate management and treatment of transformed migraine.

The burden of migraine in the United States: current and emerging perspectives on disease management and economic analysis.

OBJECTIVES: Migraine is often perceived as a low-impact condition that imposes a limited burden to society and the health-care system. This study reviews the current understanding of the burden of migraine in the U.S., the history of economic understanding of migraine treatment and identifies emergent trends for future studies evaluating clinical and economic outcomes of migraine treatment. METHODS: This study traced the history of economic articles published on migraine by performing a literature search using PubMed MEDLINE database and ancestral searches of relevant articles. The intention was not to provide an exhaustive review of every article or adjudicate between studies with different findings. RESULTS: Migraine affects millions of individuals worldwide, generally during the most productive years of a person's life. Studies show that migraineurs are underdiagnosed, undertreated, and experience substantial decreases in functioning and productivity, which in turn translates into diminished quality of life for individuals, and financial burdens to both health-care systems and employers. Economic evaluations of migraine therapies have evolved with new clinical developments beginning with cognitive-behavioral therapy, introduction of triptans, concern over medication overuse, and emergence of migraine prophylaxis. Now recent clinical studies suggest that migraine may be a progressive disease with cardiovascular, cerebrovascular, and long-term neurologic effects. CONCLUSIONS: Migraine imposes a substantial burden on patients, families, employers and societies. The economic standards by which migraine and treatment are evaluated have evolved in response to clinical developments. Emerging evidence suggests that migraine is a chronic and progressive disease. If confirmed, approaches to acute and prophylactic treatments and economic evaluations of migraine treatment may require major reconsideration.

Assessing quality of care for migraineurs: a model health plan measurement set.

Quality of care measures are increasingly important to health plans, purchasers, physicians, and patients. Appropriate measures can be used to assess quality and evaluate improvement and are necessary components of pay-for-performance programs. Despite the broad scope of activity in the development of quality measures, migraine headache has received little attention. Given the enormous costs associated with migraine, especially in terms of lost productivity and preventable health care utilization, health plans could gain from a structured approach to measuring the quality of migraine care their beneficiaries receive. A potential migraine quality measurement set was developed through a review of migraine care literature and guidelines, interviews with leaders in migraine care, health care purchasing, and managed care, and the assembly of an advisory board. The board discussed candidate measures and established consensus on a testable measurement set. Twenty measures were developed, focused primarily on diagnosis and utilization. Areas of utilization include physician visits, emergency department visits, hospitalizations, and imaging. Use of both acute and preventive medications is included. More complex aspects of migraine care are also addressed, including triptan overuse, the relationship between acute and preventive medications, and follow-up after emergency department visits. The measures are currently being tested in health plans to assess their feasibility and value. A compelling case can be made for the development of migraine-specific quality measures for health plans. This effort to develop and test a starter set of measures should lead to new and innovative efforts to assess and improve quality of care for migraineurs.