Edward Tuttle

Economic burden and co‐morbidities of atrial fibrillation in a privately insured population

ABSTRACT Objective: This study assesses the direct (medical and drugs) and indirect (work loss) annual costs associated with Atrial Fibrillation (AFIB) in a privately insured population. Background: AFIB is the most common sustained rhythm disturbance, affecting 2.3 million people in the United States. Methods: Cost and co-morbidity measures for AFIB patients were compared to matched controls using a privately insured administrative database (including medical, drug, and disability claims) for 2 million enrollees, 1999–2002 from 16 employers across the United States. Patients with an AFIB diagnosis on at least two occasions were included in the co-morbidity analysis (n = 3944). A non-AFIB control sample was randomly selected with a 1:1 ratio, with characteristics (i.e., age, gender, health plan) matched to AFIB patients. Excess medical costs (i.e., employer payments) were estimated for AFIB patients, defined as the difference in average annual costs between AFIB and control patients (n = 3944); excess work-loss costs were defined similarly for employees with available work-loss data (n = 603). Statistical significance in the descriptive analysis was measured by paired t-tests for cost, or Chi-square tests for co-morbidity comparisons. A two-part multivariate model of excess cost was further estimated to control for co-existing conditions and other patient characteristics. The excess costs of AFIB patients were estimated as the difference between the observed costs of AFIB patients and their estimated costs, assuming they did not have AFIB. Results: The multivariate analysis found that the excess annual direct cost of AFIB was

Understanding the Gap Between Efficacy in Randomized Controlled Trials and Effectiveness in Real-World Use of GLP-1 RA and DPP-4 Therapies in Patients With Type 2 Diabetes

12 349 ( p < 0.01), with AFIB patients approximately 5 times as costly as non-AFIB individuals (

Achievement of Glycated Hemoglobin Goals in the US Remains Unchanged Through 2014

15 553 versus

Assessment of treatment patterns and healthcare costs associated with probable Lennox–Gastaut syndrome

3204, respectively). The excess annual total cost was

Antibiotic treatment patterns, costs, and resource utilization among patients with community acquired pneumonia: a US cohort study

14 875 ( p < 0.01), with AFIB patients again approximately 5 times as costly as non-AFIB individuals (

Real‐world weight change among patients treated with glucagon‐like peptide‐1 receptor agonist, dipeptidyl peptidase‐4 inhibitor and sulfonylureas for type 2 diabetes and the influence of medication adherence

18 454 versus

Prevalence, referral patterns, testing, and surgery in aortic valve disease: leaving women and elderly patients behind?

3579, respectively). AFIB was associated with increased incidence of atrial flutter ( p < 0.01), heart failure (Relative Risk (RR) = 29, p < 0.01), other arrhythmias/conduction disorders (RR = 16, p < 0.01), heart attack (RR = 8, p < 0.01), and stroke (RR = 6, p < 0.01). Conclusions: AFIB is a costly disease and one for which more definitive therapies might offer some potential for reducing, not only the clinical impact, but also the economic burden of the disease.

The Expected Net Present Value of Developing Weight Management Drugs in the Context of Drug Safety Litigation

OBJECTIVE The objective of this study was to estimate and explain the gap between clinical efficacy and real-world (RW) effectiveness of type 2 diabetes medications. RESEARCH DESIGN AND METHODS This mixed-methods quasi-experimental study used retrospective claims (Optum/Humedica) to compare the change in HbA1c of RW patients with type 2 diabetes 12 months after starting a glucagon-like peptide 1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase 4 (DPP-4) inhibitor with published findings from randomized controlled trials (RCTs) evaluating these drugs. Selected RW patients were similar to RCT patients, and regression analysis was used in the RW data to adjust for differences between poorly adherent and adherent patients to explain why RCT and RW findings may differ. RESULTS RW patients initiating a GLP-1 RA (n = 221) or a DPP-4 (n = 652) experienced smaller reductions in HbA1c (GLP-1 RA: −0.52% [−6 mmol/mol], DPP-4: −0.51% [−6 mmol/mol])than reported in RCTs (−1.30% [−14 mmol/mol] from seven GLP-1 RA RCTs, n = 2,600; −0.68% [−8 mmol/mol] from four DPP-4 RCTs, n = 1,889). Baseline HbA1c, additional medications, and adherence were significant explanatory factors in the RW HbA1c change. Modeled estimates of RCT efficacy (−1.04% GLP-1 RA [−12 mmol/mol], −0.69% DPP-4 [−8 mmol/mol]) were within the RCTs’ reported range (GLP-1 RA: −0.84% to −1.60% [−9 to −18 mmol/mol], DPP-4: −0.47% to −0.90% [−5 to −10 mmol/mol]). Poor medication adherence accounted for approximately three-fourths of the gap between RW and expected RCT results (gap = 0.51% [6 mmol/mol] GLP-1 RA; 0.18% [3 mmol/mol] DPP-4). CONCLUSIONS Poor medication adherence is primarily why RW effectiveness is significantly less than RCT efficacy, suggesting an urgent need to effectively address adherence among patients with type 2 diabetes.

Reduced Healthcare Costs Among Clobazam-Treated Patients With Lennox–Gastaut Syndrome (P6.287)

IntroductionPrevious research has found that the percentage of US adults with diabetes achieving a glycated hemoglobin (HbA1c) target of <7.0% with currently available treatments has been fairly constant from 2003 to 2010, remaining at just over 50% [1]. The objective of this study was to compare the most recent data (2011–2014) with earlier data to track progress on HbA1c target achievement, for both the general target of <7.0% and inferred individualized targets based on age and the presence of complications.MethodsData from 2677 adults with self-reported diabetes from the National Health and Nutrition Examination Survey (NHANES) from 2007 to 2014 were examined to determine the percentage of adults who achieved HbA1c targets of <7% and an individualized target based on age and comorbidities. National estimates are reported by using weights that account for the complex sampling design of the NHANES.ResultsThe percentage of people with diabetes and HbA1c <7.0% slightly declined from 52.2% (95% CI 48.7–55.7%) to 50.9% (95% CI 47.2–54.7%) between the two most recent waves of data. Achievement of individualized targets declined from 69.8% (95% CI 66.5–73.0%) to 63.8% (95% CI 60.1–67.5%). The percentage with HbA1c >9.0% increased from 12.6% (95% CI 10.5–14.8%) to 15.5% (95% CI 12.9–18.2%). Achievement of individualized targets varied by age group and presence of comorbidities, but exhibited similar trends as general target achievement.ConclusionsDespite the development of many new medications to treat diabetes during the past decade, the proportion of patients achieving glycemic control targets has not improved.FundingIntarcia Therapeutics.

Real-World Evidence of Disease Burden in Obese Patients Hospitalized With Acute Bacterial Skin and Skin-Structure Infections

Lennox-Gastaut syndrome (LGS) is a chronic and severe form of epilepsy characterized by intractable seizures, cognitive impairment, and abnormal electroencephalogram findings with slow spike-wave complexes. It typically presents before age 8, but symptoms continue into adulthood and require lifelong treatment associated with significant clinical burden. Data on LGS-associated healthcare utilization and costs are limited. In this study we use a claims-based LGS classifier based on random forest methodology to identify patients with probable LGS from the a Medicaid multi-state database and assess its prevalence across the age spectrum, healthcare utilization, treatment patterns, costs, and comorbid conditions. The classifier identified patients with probable LGS across all ages, with up to 8% of 10-year-old patients with epilepsy identified as having probable LGS. The prevalence of probable LGS was lower in older age cohorts, indicating that it may be under-recognized in older patients. Our analysis showed that probable LGS is associated with considerably higher total healthcare and medical costs than non-LGS patients. The costs were generally consistent between age cohorts, suggesting that the cost burden extends beyond childhood and has a lifelong impact. Analysis of treatment patterns suggest that while the majority of probable LGS patients in this study received widest-spectrum AEDs, a considerable proportion did not and therefore may have been inadequately treated. Further, usage of clobazam and rufinamide was decreased in older compared to younger patient cohorts, indicating that older patient cohorts are less likely to be receiving optimum treatment for LGS. These findings indicate the need for increased clinical attention to LGS beyond pediatric years, with a focus on optimization of treatment for LGS patients of all ages with widest-spectrum AEDs. Timely recognition and adequate treatment of LGS are likely to result in improved outcomes and less costly management of this condition.