Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials to the overall type 2 diabetes population in the United States.

AIM: To examine the generalizability of results from glucagon-like peptide-1 receptor agonist (GLP-1 RA) cardiovascular outcome trials (CVOTs) in the US type 2 diabetes (T2D) population. MATERIALS AND METHODS: Patients enrolled or eligible for inclusion in four CVOTs (EXSCEL, LEADER, REWIND, and SUSTAIN-6) were examined in reference to a retrospective clinical database weighted to match the age and sex distribution of the US adult T2D population. We descriptively compared key baseline characteristics of the populations enrolled in each trial to those of the reference population and estimated the proportions of individuals in the reference population represented by those in the trials for each characteristic. We also estimated the proportions of individuals in the reference population that might have been enrolled in each trial based upon meeting the trial inclusion and exclusion (I/E) criteria. RESULTS: No trial's enrolled population perfectly matched the reference population in key characteristics. The EXSCEL population most closely matched in mean age (62.7 vs. 60.5 years) and percentage with estimated glomerular filtration rate <60 (18.6 vs. 17.3%), while REWIND most closely matched in HbA1c, sex distribution, and proportion with a prior myocardial infarction. Based on I/E criteria, 42.6% of the reference population were eligible for enrolment in REWIND, versus 15.9% in EXSCEL, 13.0% in SUSTAIN-6, and 12.9% in LEADER. CONCLUSIONS: Although none of the trials are fully representative of the general population, among the four trials examined, results from baseline REWIND were found to be more generalizable to the US adult T2D population than those of other GLP-1 RA CVOTs.

Trends in use of and complications from intrauterine contraceptive devices and tubal ligation or occlusion.

BACKGROUND: Long-acting reversible contraceptives such as intrauterine devices (IUDs) are highly effective in preventing pregnancy, cost effective, and increasing in popularity. It is unclear whether changes in IUD use are associated with changes in rates of irreversible tubal sterilization. In this analysis, we evaluate changes in rates of tubal sterilization, insertion of copper or levonorgestrel (LNG) IUDs, and related complications over time. METHODS: Data were obtained from a retrospective claims database (OptumTM ClinformaticsTM Data Mart) of women aged 15 to 45 years who underwent insertion of copper or LNG IUD or tubal sterilization between 1/1/2006 and 12/31/2011. Outcomes of interest included annual rates of insertion or sterilization and annual rates of potential complications and side effects. RESULTS: The number of women included in the analysis each year ranged from 1,870,675 to 2,016,916. Between 2006 and 2011, copper IUD insertion claim rates increased from 0.18 to 0.25% and LNG IUD insertion claim rates increased from 0.63 to 1.15%, while sterilization claims decreased from 0.78 to 0.66% (P < 0.0001 for all comparisons). Increases in IUD insertion were apparent in all age groups; decreases in tubal sterilization occurred in women aged 20 to 34 years. The most common side effects and complications were amenorrhea (7.36-11.59%), heavy menstrual bleeding (4.85-15.69%), and pelvic pain (11.12-14.27%). Significant increases in claims of certain complications associated with IUD insertion or sterilization were also observed. CONCLUSION: Between 2006 and 2011, a decrease in sterilization rates accompanied an increase in IUD insertion rates, suggesting that increasing numbers of women opted for reversible methods of long-term contraception over permanent sterilization.

Updated cost-of-care estimates for commercially insured patients with multiple sclerosis: retrospective observational analysis of medical and pharmacy claims data.

BACKGROUND: For patients with multiple sclerosis (MS), previous research identified key disease sequelae as important cost drivers and suggested that among users of disease-modifying drugs (DMDs) in 2004, DMDs represented 73% of the total cost of care. More recent studies were limited to incident disease/treatment and/or excluded DMDs from cost estimates. To support contemporary pharmacoeconomic analyses, the present study was conducted to provide updated information about MS-related costs and cost drivers including DMDs. METHODS: For each of 2 years, 2006 and 2011, commercially insured, continuously eligible patients with ≥ 1 medical claim diagnosis of MS were sampled. MS-related charges were based on medical claims with MS diagnosis plus medical/pharmacy claims for DMDs. 2006 charges were adjusted to 2011 $ using the medical care component of the consumer price index (CPI). Subgroups of patients using DMDs (interferon [IFN] beta-1a intramuscular or subcutaneous, IFN beta-1b, glatiramer, natalizumab) in 2011 were identified. By-group differences were tested with bivariate statistics. RESULTS: Mean (standard deviation [SD]) age of 15,902 sample patients in 2011 was 47.6 (11.8) years, 76% female. Mean [SD] MS charges ($26,520 [$38,478] overall) were significantly (P < 0.001) higher for patients with common disease sequelae: malaise/fatigue (n = 2,235; $39,948 [$48,435]), paresthesia (n = 1,566; $33,648 [$45,273]), depression (n = 1,255; $42,831 [$51,693]), and abnormality of gait (n = 1,196; $48,361 [$55,472]). From 2006 to 2011, CPI-adjusted MS charges increased by 60%. Among patients treated with a single DMD in 2011, inpatient care was 6% of charges (range = 4%-8%; P = 0.155); outpatient care was 19% (range = 14%-20% except for natalizumab [29%]; P < 0.001); and DMDs were 75% (range = 67%-81%; P < 0.001). CONCLUSIONS: Common MS sequelae remain important cost drivers. Although MS treatment costs are increasing, the proportion of MS charges due to DMDs in 2011 is similar to that reported in 2004.

An Economic Evaluation of the Relationship Between Glycemic Control and Total Healthcare Costs for Adults with Type 2 Diabetes: Retrospective Cohort Study.

INTRODUCTION: Glycemic control is associated with better outcomes among individuals with type 2 diabetes (T2D). This research examines total US all-cause medical costs for adults with T2D with recommended glycemic control (HbA1c < 7%) compared to poor glycemic control (HbA1c ≥ 7%). METHODS: The study used administrative claims data linked to HbA1c laboratory test results from January 1, 2015 through June 30, 2021 to identify adults with T2D with a recorded HbA1c test. Patients with recommended glycemic control at index date were propensity score matched to patients with poor glycemic control. General linear models and two-part models were used to compare all-cause outpatient, drug, acute care and total costs for 1 year post index date. RESULTS: The study included 59,830 propensity-matched individuals. Results indicate that recommended glycemic control, compared to poor glycemic control, was associated with statistically significantly lower all-cause acute care ($23,868 ± $21,776 vs. $24,352 ± $22,223), drug ($10,277 ± $14,671 vs. $10,540 ± $14,928), and total medical costs ($41,381 ± $42,757 vs. $42,054 ± $43,422) but significantly higher outpatient costs ($7290 ± $12,028 vs. $7026 ± $11,587) (all p < 0.0001). Sensitivity analyses examined results based upon alternative HbA1c thresholds of ≤ 6.5% and < 8%. Results were generally robust to alternative HbA1c thresholds, with higher HbA1c thresholds associated with higher all-cause total costs as well as increased savings for having HbA1c below threshold. CONCLUSIONS: Glycemic control was associated with significantly lower all-cause total, drug, and acute care medical costs. Given the high prevalence of T2D in the USA, our results suggest potential economic benefits associated with glycemic control for healthcare providers.

The Association Between Obesity and the 5-Year Prevalence of Morbidity and Mortality Among Adults with Type 2 Diabetes.

INTRODUCTION: This retrospective claims database study examined the prevalence of mortality and morbidity among adults with type 2 diabetes (T2D) and obesity. METHODS: The study used deidentified data from 2007 to 2021 from the Optum® Market Clarity Dataset. A cohort of adults with T2D and obesity were identified, and age- and sex-adjusted prevalence rates were calculated for mortality, a composite cardiovascular outcome (CCO), a composite microvascular outcome (CMO), and other complications. Results were examined overall and by obesity class (class 1, class 2, and class 3). RESULTS: For the 15,970 adults included in the study, the prevalence of CCO and CMO after 5 years was 15.3% and 60.7%, respectively. The 5-year prevalence of mortality was 10.9%. There were statistically significant differences in prevalence rates by obesity class, with obesity class 3 associated with higher rates of morbidity and mortality compared to obesity classes 1 or 2. Specifically, after 5 years, the prevalence of mortality was 9.4%, 10.3% and 13.6% for obese classes 1, 2 and 3, respectively (P < 0.05 between class 3 and class 2 or 1). Similarly, For obesity classes 1, 2 and 3, the 5-year prevalence of CCO was 13.0%, 14.5% and 18.4% and the rates for CMO were 58.0%, 57.9% and 64.8%, respectively (both P < 0.05 between class 3 and class 2 or 1). Regarding other complications, differences in the prevalence of atherosclerotic cardiovascular disease (ASCVD) and obstructive sleep apnea (OSA) were statistically significantly higher with increasing obesity class. CONCLUSIONS: The results indicate that for a cohort of adults with T2D and obesity, obesity class 3 is associated with significantly higher mortality and morbidity, including CCO, CMO, ASCVD and OSA. These findings suggest that treatment which reduces obesity among individuals with T2D may have significant health benefits, although additional studies are needed to confirm the results.

Five-year morbidity and mortality rates in a U.S. population with obesity with and without prediabetes.

AIMS: This research examines the prevalence of morbidity and mortality among people with obesity with or without prediabetes. METHODS: This observational study uses Optum® Market Clarity deidentified data from 2007 to 2020. Individuals with obesity without prediabetes (obesity only) were matched 1:1 to adults with prediabetes plus obesity based upon age, sex, race, ethnicity, and region. Age and sex adjusted prevalence rates and 95 % CIs were calculated for morbidity and mortality for each 365-day period post index date and over the entire 5-year post-period. RESULTS: After 5-years, the adjusted mortality rate was 10.1 % for adults with obesity plus prediabetes and 6.9 % for adults with obesity only (p < 0.05). Five years post index date, the prevalence of type 2 diabetes was 25.3 % for people with obesity plus prediabetes and 9.2 % for people with obesity only (p < 0.05). Prevalence rates after 5 years for atherosclerotic cardiovascular disease (13.1 % v 8.1 %), composite cardiovascular outcome (7.0 % v 4.4 %) and composite cardio-renal outcome (8.9 % v 5.0 %) were significantly higher for adults with obesity plus prediabetes compared to adults with obesity only (all p < 0.05). CONCLUSIONS: Results of this study indicate that the presence of prediabetes contributes to the development of additional morbidity and mortality in adults with obesity.

The Association Between HbA1c and 1-Year Diabetes-Related Medical Costs: A Retrospective Claims Database Analysis.

INTRODUCTION: The American Diabetes Association (ADA) has identified a target hemoglobin A1c (HbA1c) < 7% as appropriate for most adults with type 2 diabetes (T2D). This research examines US diabetes-related healthcare costs for adults with T2D for individuals with glycemic control (HbA1c < 7%) compared to poor glycemic control (HbA1c ≥ 7%). METHODS: The Optum Clinformatics® Data Mart database from 2016 to 2020 was used to identify a cohort of adults with T2D who had a recorded HbA1c test (with first such date identified as the index date) and continuous insurance from 1 year prior through 1 year post index date. Patients with glycemic control were propensity matched to patients with poor glycemic control. Generalized linear models and two-part models examined diabetes-related outpatient, drug, acute care, and total costs over the 1-year post-period. RESULTS: There were 34,538 propensity matched individuals included in the study. Results indicate that glycemic control (HbA1c < 7%), compared to poor glycemic control (HbA1c ≥ 7%) ,was associated with statistically significantly lower annual diabetes-related acute ($5671 ± $4216 vs $6138 ± $4211), outpatient ($6051 ± $4216 vs $7259 ± $7771), drug ($3739 ± $4581 vs $4288 ± $4788), and total costs care ($13,704 ± $10,635 vs $16,460 ± $10,885) (all P < 0.0001). Sensitivity analyses also examined results based upon alternative HbA1c thresholds which were chosen on the basis of expert guidelines and prior clinical trial thresholds (< 6%, ≤ 6.5%, < 8%, and ≤ 9%). In all cases, being below threshold was associated with statistically significantly lower diabetes-related total costs and component costs. Results also illustrate that, in general, higher HbA1c thresholds are associated with higher diabetes-related costs. CONCLUSION: Glycemic control was found to be associated with significantly lower annual diabetes-related component and total costs. Results suggest economic benefits associated with having HbA1c at or below target.

The Association Between Sustained HbA1c Control and Long-Term Complications Among Individuals with Type 2 Diabetes: A Retrospective Study.

INTRODUCTION: The prevalence of type 2 diabetes (T2D) represents a rising burden in the US and worldwide, with the condition shown to be associated with relatively large human and economic costs. Part of the reason for such high costs associated with T2D is that the condition is often accompanied by additional health-related complications. The goal of this research is to examine the association between glycemic control and diabetes-related complications for individuals with T2D. METHODS: The Optum Clinformatics® Data Mart (CDM) database from 2007 to 2020 was used to identify adults with T2D. Individuals were classified as having sustained glycemic control (all hemoglobin A1c [HbA1c] < 7%) or poor glycemic control (all HbA1c ≥ 7%) over the 5-year post-period, and diabetes-related complications were identified based upon the Diabetes Complications Severity Index. Multivariable analyses examined the association between sustained glycemic control and diagnosis of a diabetes-related complication in the post-period. RESULTS: Maintaining HbA1c < 7% over the 5-year post-period, compared to maintaining HbA1c ≥ 7%, was associated with reduced odds of the diabetes-related complications of cardiovascular disease (odds ratio [OR] = 0.76, 95% confidence interval [CI] 0.61-0.94), metabolic disease (OR = 0.37, 95% CI 0.22-0.600), neuropathy (OR = 0.62, 95% CI 0.45-0.84), nephropathy (OR = 0.81, 95% CI 0.69-0.94), and peripheral vascular disease (OR = 0.52, 95% CI 0.33-0.83). There was no statistically significant association between sustained glycemic control and cerebrovascular disease. CONCLUSIONS: Sustained glycemic control was found to be associated with significant reductions in the odds of being diagnosed with diabetes-related complications over a 5-year post-period.

Trends in U.S. Insulin Use and Glucose Monitoring for People with Diabetes: 2009-2018.

BACKGROUND: The delivery and administration of insulin has undergone many changes over the years. This research examines U.S. trends in insulin use among people with type 1 diabetes (T1D) or type 2 diabetes (T2D) in the U.S. from 2009 to 2018. METHODS: The IBM® MarketScan® Commercial and Medicare databases were used to identify trends in insulin use over 10 years. The study included people with T1D or T2D who filled a prescription for insulin in any calendar year from 2009 to 2018. The analyses examined insulin regimen and delivery and the use of glucose monitoring systems. Generalized estimating equations were used to test whether trends were statistically significant. RESULTS: Individuals with T1D were most commonly prescribed a basal and bolus insulin regimen or short/rapid insulin only, while for people with T2D the use of basal-only insulin increased significantly over the study period. In both groups there was a significant decline in the use of premix insulin from 2009 to 2018. Insulin pump use increased for individuals with T1D, while disposable pen use increased for people in both cohorts. In both cohorts, there was a statistically significant increase in the use of continuous glucose monitoring, although this increase was more pronounced and occurred earlier among individuals with T1D. CONCLUSIONS: Results indicate significant changes in insulin regimens and delivery and glucose monitoring from 2009 to 2018. These findings suggest that insulin prescribing continues to change in response to the development of new therapeutics, advances in insulin delivery technology, and glucose monitoring systems.

Time to Failure on Oral Glucose-Lowering Agents for Patients with Type 2 Diabetes: A Retrospective Cohort Study.

INTRODUCTION: Research has shown that glycemic control is associated with lower rates of microvascular and long-term cardiovascular complications. In the analyses reported here, we examined treatment failure on oral glucose-lowering agents (GLAs), defined as having sustained hemoglobin A1c (HbA1c) ≥ 7%. METHODS: This study utilized the IBM® MarketScan® Claims and Laboratory Data from 1 January 2012 through 30 June 2018. Adults with type 2 diabetes (T2D) were classified based upon the maximum number of classes of GLAs prescribed per day during the time period from 1 July 2012 through 31 December 2012. Patients were followed for 5.5 years in order to examine time to failure on oral GLAs, defined based upon receipt of ≥ 2 consecutive HbA1c results ≥ 7%. Multivariable analyses employing a Cox proportional hazards model were used to examine time to failure overall and based upon the number of index classes of oral GLAs prescribed. For patients who had sustained HbA1c above the threshold, multivariable analyses examined the duration of time that HbA1c remained above the threshold (i.e, glycemic burden) and whether or not an additional oral or injectable class of GLA was added to the patient treatment regimen (i.e., clinical inertia). RESULTS: A total of 4156 patients were included in the study, of whom 16% were identified with sustained HbA1c ≥ 7% after 365 days (1 year) and 36% after 730 days (2 years), with half of all patients having sustained HbA1c above target after 1102 days (3 years). There was a statistically significant difference in time to having sustained HbA1c above target based upon index classes of therapy, with patients treated with more GLAs being quicker to have HbA1c above target (P < 0.0001). Among those patients who were found to have sustained HbA1c ≥ 7%, the average number of days in the post-period that HbA1c remained above target was 1026 (2.8 years). Only 36% of patients with sustained HbA1c above target added a GLA to their treatment regimen and, for patients who did add such a therapy, the average duration from identification of HbA1c above target until treatment intensification was 401 days (1.1 years). Multivariable analyses revealed that, among those with sustained HbA1c ≥ 7%, treatment with more classes of oral GLAs was associated with a significantly higher glycemic burden and significantly lower odds of clinical inertia. CONCLUSION: These results indicate that for many patients treated with oral GLAs, glycemic control is not consistently achieved. For patients with above-target HbA1c , the results indicate a relatively large glycemic burden and clinical inertia towards treatment intensification. The findings illustrate some limitations associated with treatment of T2D with oral GLAs.

The direct and indirect economic burden of hypothyroidism in the United States: a retrospective claims database study.

OBJECTIVE: To examine direct and indirect economic burden associated with hypothyroidism in the United States. METHODS: Medical costs attributable to hypothyroidism were estimated for patients with hypothyroidism. Non-hypothyroid (euthyroid) controls were matched to patients with hypothyroidism based upon patient characteristics and availability of productivity data. Multivariable analyses examined resource utilization, annual medical costs, comorbidities, and productivity costs. RESULTS: Estimates of hypothyroidism-related total medical costs ranged from $460 to $2,555 per patient per year. Compared to euthyroid controls, patients with hypothyroidism had significantly higher all-cause medical costs and medical resource utilization. For the subset of patients with available productivity data, hypothyroidism was associated with significantly higher absenteeism and long- and short-term disability costs but significantly lower worker's compensation costs. CONCLUSIONS: Hypothyroidism is associated with significant direct and indirect economic burden among employed, commercially insured patients in the US. Clinical Significance: Despite the availability of relatively inexpensive generic therapies for hypothyroidism, this study found significant direct and indirect costs associated with the condition. The large number of patients diagnosed with hypothyroidism combined with increased costs associated with hypothyroidism result in a significant burden for patients, payers, and employers.

Obesity and glycemic control among people with type 2 diabetes in the United States: A retrospective cohort study using insurance claims data.

AIMS: To examine body mass index (BMI) and HbA1c for individuals with type 2 diabetes (T2D) in the United States. METHODS: The retrospective study utilized data from IBM® MarketScan® Explorys® Claims-EMR Data for the years 2012-2019. Individuals with T2D and a recorded HbA1c laboratory result and BMI were included. The relationship between BMI and HbA1c was assessed descriptively and logistic regressions examined the relationship between benchmark BMI and the probability of having HbA1c above targets of 7% or 8% in the 1year post-period. RESULTS: In our sample of 44,723 patients, results indicated that compared to individuals of normal weight, those classified as obese class I or obese class II were 24% more likely to have a last HbA1c≥7% (Odds Ratio [OR]=1.24; 95% Confidence Interval [CI] 1.14-1.35 for both obese class I and obese class II), while those classified as obese class III were 16% more likely (OR=1.16; 95% CI 1.06-1.27). Results were similar when using a HbA1c threshold of 8%. CONCLUSIONS: Given the importance of glycemic control for people with T2D, these results suggest that treatments which reduce rates of obesity may help to improve health outcomes.

Trends in HbA1c and Body Mass Index Among Individuals with Type 2 Diabetes: Evidence from a US Database 2012-2019.

INTRODUCTION: Given the high rates of obesity and poor glycemic control among individuals with type 2 diabetes (T2D), this study examines current trends in HbA1c and body mass index (BMI) as well as the association between HbA1c and BMI among adults with T2D. METHODS: Data from the IBM® MarketScan® Explorys® Claims-EMR Data were used to construct eight annual cohorts for the years 2012-2019. Each annual cohort included adults identified with T2D who had at least one recorded HbA1c laboratory result and BMI value in the year of interest. Given these cohorts, trends in HbA1c and BMI were described over time using generalized estimating equation (GEE) tests. RESULTS: Results indicate that, over the study period from 2012-2019, average BMI increased significantly and there was a decrease in the percentage of adults with T2D who achieved glycemic control. In addition, for all years, higher BMI classification was associated with higher HbA1c values. When examining results for patients in different age groups, the findings were generally consistent with the overall population. In each age group, but most notably the age 18-44 group, the mean BMI increased over time and higher BMI was associated with higher HbA1c. CONCLUSION: Given the increase in BMI and decreasing percentage of individuals achieving glycemic control among adults with T2D found over the study period, therapies which decrease BMI as well as HbA1c can potentially have a significant impact on the management of T2D. The growing proportion of the younger age group with higher mean BMI may remain a key subgroup of interest.

The Association Between Switching from Synthroid® and Clinical Outcomes: US Evidence from a Retrospective Database Analysis.

INTRODUCTION: Clinical guidelines recommend levothyroxine as the standard of care for hypothyroidism and that patients should be treated with a consistent preparation of synthetic levothyroxine without switching among formulations. This study examines the likelihoods of negative clinical outcomes between continuous users of Synthroid® (AbbVie, Inc.) and patients who switch from Synthroid® to an alternative formulation of levothyroxine. METHODS: This retrospective cohort analysis utilized data from Optum Clinformatics™ DataMart covering May 1, 2000 to March 30, 2016. After 6 months of consistent use of Synthroid®, patients were categorized as continuous users or as switchers (by filling a prescription for an alternative formulation). Key outcomes included the likelihood of a thyroid-stimulating hormone (TSH) laboratory value out of a guideline recommended range and/or an adverse clinical composite endpoint identified by ICD codes in the patient's claims data over the following 2 years for any of the following: chronic kidney disease, depression, fatigue, heart failure, hyperlipidemia, hypertension, or obesity. Individual components of the composite endpoint were also examined. Outcomes were analyzed using multivariable logistic models on propensity score matched cohorts. Analyses controlled for patient characteristics using SAS 9.4 software. Chi-square and t tests were employed and P < 0.05 was pre-specified as statistically significant. RESULTS: Propensity score matching resulted in a sample of 9925 continuous users and 9925 switchers. Switchers were significantly more likely than continuers to have a TSH laboratory value out-of-range in the post-period [odds ratio (OR) 1.15; 95% confidence interval (CI) (1.08-1.23)]. Switchers were also more likely to have the composite clinical endpoint [OR 1.23; CI (1.12-1.37)] and to have individual diagnoses of chronic kidney disease, depression, fatigue, hypertension, or obesity in the post-period. CONCLUSIONS: Results of this large retrospective study over an extended time horizon support clinical guideline recommendations that switching among alternative formulations of synthetic levothyroxine should generally be avoided. Continuous use of Synthroid® was associated with a significantly higher likelihood of maintaining the TSH laboratory value within a guideline recommended range and a significantly lower likelihood of being diagnosed with adverse clinical outcomes.

Healthcare outcomes for patients with type 2 diabetes with and without comorbid obesity.

AIMS: Examine the burden of comorbid obesity associated with type 2 diabetes (T2D). METHODS: The IBM® MarketScan® Explorys Claims Electronic Medical Records Data were used to identify adults with T2D, two recorded body mass index (BMI) values, and continuous insurance coverage from 1 year prior through 1 year post index date. Patients with index BMI ≥18 kg/m2 and <30 kg/m2 (normal/overweight) were matched to patients with index BMI ≥ 30 kg/m2 (obese) using propensity score matching (PSM). Using the PSM cohort, multivariable analyses examined the association between obesity and patient comorbidities, healthcare costs, and resource utilization. RESULTS: In the matched cohort (16,006 normal/overweight; 16,006 obese), multivariable analyses showed that obesity, compared to normal/overweight, was associated with increased odds of a diabetes-related comorbidity (Odds Ratio [OR] = 1.29; 95% Confidence Interval [CI] 1.21-1.38) and an obesity-related comorbidity (OR = 1.42; 95% CI 1.29-1.56). Obesity was also associated with significantly higher annual diabetes-related and all-cause total costs and resource utilization. CONCLUSIONS: This research increases the knowledge of how patients with T2D and obesity should be of greater concern for healthcare providers compared to T2D patients without comorbid obesity, given their worse comorbidity profile, increased resource utilization, and higher healthcare costs.

The relationship between HbA1c reduction and healthcare costs among patients with type 2 diabetes: evidence from a U.S. claims database.

OBJECTIVE: To examine the relationship between hemoglobin A1c (HbA1c) reduction and healthcare costs among patients with type 2 diabetes (T2D). MATERIALS AND METHODS: Truven MarketScan databases over the time-period from 2013 through 2017 were utilized. Patients with T2D who had an HbA1c laboratory result from 1 January 2014 through 1 January 2017 were included, first such date identified as the index date. Generalized linear models examined the relationship between HbA1c and one-year post-period all-cause and diabetes-related costs. RESULTS: For patients with T2D (N = 77,622), multivariable analyses revealed that a 1% reduction in HbA1c was associated with a 2% reduction in all-cause total health care costs and a 13% reduction in diabetes-related total healthcare costs (both p < .0001), and that these reductions resulted in annual cost savings of $429 and $736, respectively. For patients with an index HbA1c ≥7% (N = 33,648), a 1% reduction in HbA1c was associated with a 1.7% reduction in all-cause total healthcare costs and a 6.9% reduction in diabetes-related healthcare costs (both p ≤ .0001), with associated annual cost savings of $545 and $555, respectively. The analyses also found that having an index HbA1c <7% compared to HbA1c ≥7% or having an index HbA1c ≥7% and subsequently reducing HbA1c to below 7%, was associated with significant cost reductions. CONCLUSION: Results suggest that there are economic benefits associated with HbA1c reduction and that these benefits are seen for all patients with T2D and for patients whose index HbA1c is above the American Diabetes Association recommended target.

Hypothyroidism Treatment Among Older Adults: Evidence from a Claims Database.

INTRODUCTION: Hypothyroidism is a common but often unrecognized condition associated with significant morbidity in the older adult population. This study characterizes a large population of older adults diagnosed with hypothyroidism and examines concordance of their treatment with recommendations from expert bodies, e.g., the American Thyroid Association and American Association of Clinical Endocrinologists. METHODS: Individuals seen in general and/or specialty practices who were age ≥ 65 years and diagnosed with hypothyroidism were included in this observational, retrospective cohort study using a large US claims database. Analyses describe the population and examine the prevalence of hypothyroidism, treatment with levothyroxine and, among those treated, whether TSH laboratory values are within a guideline-recommended target range. RESULTS: Prevalence of hypothyroidism in this older adult population increased from 5.62% to 8.24% over the 2007-2015 period. Among older adults diagnosed with hypothyroidism (N = 4025), a substantial proportion (28.0%) did not receive levothyroxine therapy, and, of those who were receiving such therapy (N = 2899), 32.9% did not have evidence of being monitored to determine whether the dosage was appropriate. Moreover, the laboratory results of those who were treated suggest that a significant proportion (17.4%) had a TSH level above the recommended target range, while TSH levels for a smaller proportion (3.7%) were below target. CONCLUSIONS: Many older adults diagnosed with hypothyroidism may not have received medical care complying with clinical practice guidelines. Results of this study reveal a number of areas to target to potentially improve the treatment of older adults with hypothyroidism.

Levothyroxine Treatment of Pregnant Women with Hypothyroidism: Retrospective Analysis of a US Claims Database.

BACKGROUND: Approximately 2-4% of women of reproductive age have hypothyroidism. This study characterizes pregnant women with hypothyroidism and examines adherence to guidelines during pregnancy. METHODS: Women age 18 to 49 who were pregnant in 2014 and identified with hypothyroidism (N = 3448) were included in the retrospective study. The analyses examined differences in characteristics and comorbidities between pregnant women treated with levothyroxine and untreated women and adherence to guidelines by measuring thyroid-stimulating hormone (TSH) target achievement for women treated with levothyroxine. RESULTS: The average age was 32.76 years, and the median TSH value was 1.97 mIU/l. Compared with untreated pregnant women, pregnant women treated with levothyroxine were significantly younger, had a lower Charlson Comorbidity Index score and had lower rates of comorbid type 2 diabetes and migraines. Among women treated with levothyroxine, 52.61% had a last recorded TSH value consistent with American Thyroid Association (ATA) guidelines, 23.85% were undertreated, 1.03% were overtreated, and 22.52% did not have TSH monitored during their pregnancy. CONCLUSIONS: A large percentage of pregnant women, including many treated with levothyroxine, was not treated in a manner consistent with clinical guidelines. Additionally, there were significant differences in general health and comorbidities between pregnant women treated with levothyroxine and those untreated.

The Association Between Adherence to Insulin Therapy and Health Care Costs for Adults with Type 2 Diabetes: Evidence from a U.S. Retrospective Claims Database.

BACKGROUND: Research has shown that many patients with type 2 diabetes (T2D) are not adherent to their medication regimen. OBJECTIVE: To examine the association between adherence to insulin therapy and all-cause health care costs for patients with T2D. METHODS: This study used the IQVIA PharMetrics Plus Linkable to Ambulatory Electronic Medical Record data from January 1, 2012, through September 30, 2017. Patients were included if they were identified with T2D and initiated therapy on basal insulin (BAS) or basal-bolus (BAS-BOL) combination at any time from January 1, 2013, through October 1, 2016. Patients aged < 18 years, who used an insulin pump, identified as pregnant, or did not have continuous insurance coverage from 1 year before initiation on insulin therapy through 1 year after initiation were excluded. Descriptive statistics compared patient characteristics and costs (in U.S. 2017 dollars) between patients who were adherent or nonadherent to their insulin therapy in the 1-year postperiod, where adherence was defined as having proportion of days covered (PDC) of at least 80%. In addition, generalized linear models were used to compare costs between adherent and nonadherent patients, while controlling for patient characteristics, previous general health and comorbidities, resource utilization, medication use and type of insulin. RESULTS: 13,296 patients were included in the BAS cohort (5,502 adherent; 7,794 nonadherent) and 10,069 in the BAS-BOL cohort (2,006 adherent; 8,063 nonadherent). Adherent patients had significantly lower all-cause total unadjusted costs following initiation on BAS ($29,322 vs. $31,888, P = 0.0134) and BAS-BOL combination ($36,229 vs. $40,147, P = 0.0078). Drug costs comprised 39.5%-45.4% of costs among adherent patients and 23.0%-25.9% of costs among nonadherent patients. Multivariable analyses revealed that adherent patients had significantly lower adjusted all-cause total costs than nonadherent patients in the BAS cohort ($30,127 vs. $37,049, 95% CI for difference -$8,460 to -$5,384) and the BAS-BOL cohort ($36,603 vs. $44,702, 95% CI for difference -$9,129 to -$6,980). CONCLUSIONS: In patients with T2D who initiated BAS or BAS-BOL combination therapy, adherence was associated with significantly lower all-cause total health care costs, despite significantly higher drug costs. These results illustrate the potential economic benefits associated with adherence to insulin therapy. DISCLOSURES": Eli Lilly and Company funded this study and was responsible for study design and execution. Bajpai, Eby, Faries, and Haynes are employees and own stock in Eli Lilly and Company. Lage received compensation from Eli Lilly and Company for her work on this research project.