Metastatic non-small-cell lung cancer without driver mutations: projections by therapy line in Western Europe, 2021-2026.

Aim: To estimate the incidence, prevalence and treated prevalence by line of therapy (LOT) for non-small-cell lung cancer (NSCLC) patients without driver mutations from 2021 to 2026. Materials & methods: Country-specific registry data for Western Europe were used to project incidence and prevalence of NSCLC; LOT information was obtained from CancerMPact® Treatment Architecture physician surveys. Results: Incidence, prevalence and treated prevalence across LOTs for NSCLC are projected to increase across five WE countries, including for stage IV patients without driver mutations (184,966 cases [2021] to 197,925 [2026]). Pembrolizumab monotherapy is utilized by ∼50% of NSCLC patients with programmed death-ligand 1 expression ≥50%. Conclusion: Improved treatment options for NSCLC patients without known driver mutations are important for combating the projected increase in prevalence.

Lung cancer is the leading cause of cancer-related death in Europe. This study estimated how the number of patients living with, and being treated for, lung cancer is projected to change between 2021 and 2026 in Western Europe by collecting past data on lung cancer in France, Germany, Italy, Spain and the UK, and analyzing the trends to create estimates for the future. The number of new cases of lung cancer is projected to increase each year from 2021 to 2026, and in line with this, the number of patients receiving treatment for their disease will increase. Improving treatment options for lung cancer will be an important step to combat the expected increase in cancer cases.

Real-world treatment patterns and clinical outcomes after introduction of immune checkpoint inhibitors: Results from a retrospective chart review of patients with advanced/metastatic non-small cell lung cancer in the EU5.

BACKGROUND: Real-world evidence is increasingly used to guide treatment and regulatory decisions for non-small cell lung cancer (NSCLC). Real-world treatment patterns and clinical outcomes among patients with advanced/metastatic NSCLC in France, Germany, Italy, Spain, and the UK (EU5) were assessed. METHODS: This retrospective physician-completed patient chart review assessed treatment patterns (regimen, duration of treatment [DOT], time to discontinuation), and clinical outcomes (duration of response [DOR], progression-free survival [PFS], and overall survival [OS]) of patients with stage IIIB/C or IV NSCLC who received pembrolizumab-based first-line induction chemotherapy. RESULTS: Overall, 322 patients were included; at first-line maintenance (1LM), 92% had stage IV NSCLC, 68% had nonsquamous histology, and 89% had no central nervous system (CNS)/brain metastasis. The two most common 1LM regimens were pembrolizumab monotherapy (76% overall) and pembrolizumab + pemetrexed (21% overall). Docetaxel monotherapy was the most common second-line regimen in all countries except Germany (54% overall). For 1LM therapy, the overall median DOT and DOR were 5 and 10 months, respectively; PFS was 7 months and OS was 8 months. Germany had a longer duration of each outcome except for DOR which was longer in Spain. Clinical outcomes were generally poorer for patients with squamous histology and CNS/brain metastases. CONCLUSIONS: This study demonstrated differences in treatment patterns and clinical outcomes in NSCLC across the EU5 and patient subgroups. Improved survival was generally associated with response to first-line therapy, nonsquamous histology, and CNS/brain metastases absence. These real-world data provide valuable insights which may aid treatment decision-making and clinical trial design.

The Utility of ctDNA in Lung Cancer Clinical Research and Practice: A Systematic Review and Meta-Analysis of Clinical Studies.

This systematic review with embedded meta-analysis aimed to evaluate the clinical utility of circulating tumor DNA (ctDNA) in lung cancer. After screening and review of the Embase database search, 111 studies from 2015 to 2020 demonstrated ctDNA's value in prognostication/monitoring disease progression, mainly in patients with advanced/metastatic disease and non-small cell lung cancer. ctDNA positivity/detection at any time point was associated with shorter progression-free survival and overall survival, whereas ctDNA clearance/decrease during treatment was associated with a lower risk of progression and death. Validating these findings and addressing challenges regarding ctDNA testing integration into clinical practice will require further research.

Authors' reply to "Comment on generalizability of GLP-1 RA CVOTs in US T2D population".

The authors of the manuscript "Generalizability of Glucagon-Like Peptide-1 Receptor Agonist Cardiovascular Outcome Trials Enrollment Criteria to the US Type 2 Diabetes Population" respond to a letter to the editor.

A retrospective real-world study of dapagliflozin versus other oral antidiabetic drugs added to metformin in patients with type 2 diabetes.

OBJECTIVES: The efficacy of dapagliflozin as add-on therapy to metformin has been assessed in randomized trials. However, its effectiveness has not been assessed in a US real-world setting. METHODS: Electronic medical record (EMR) data were used to compare clinical outcomes among patients with type 2 diabetes (T2D) treated with dapagliflozin and metformin with or without other oral antidiabetic drugs (D + M ± OAD), versus metformin with at least 1 other OAD (M + OAD). Adult patients with T2D on these regimens from January 01, 2014, to February 28, 2015, were identified in a US EMR database, with the date of first prescription for dapagliflozin (D + M ± OAD) or other OAD (M + OAD) as the index date. Patients were observed for 12 months before the index date (baseline) and 12 months afterward (ie, follow-up). Patients in the M + OAD group were propensity score matched 1:1 to those in the D + M ± OAD group. Outcomes included change in glycated hemoglobin (A1C) level, weight, and systolic and diastolic blood pressures (SBP/DBP) from baseline to follow-up. RESULTS: A total of 1093 patients receiving M + OAD were matched to 1093 patients receiving D + M ± OAD. Compared with those given M + OAD, patients given D + M ± OAD had a greater reduction in A1C level (mean, -1.0% vs -0.7%; P <.01), greater weight loss (-1.8 kg vs -0.7 kg, P <.01), and greater change in SBP (-3.6 mm Hg vs -0.1 mm Hg, P <.01) and DBP (-2.0 mm Hg vs -0.6 mm Hg, P <.01) from baseline to follow-up. CONCLUSIONS: In current US clinical practice, patients receiving D + M ± OAD had greater reductions in important clinical outcomes of T2D-A1C level, weight loss, and blood pressure-versus patients receiving M + OAD. This study supports the use of dapagliflozin as add-on therapy to metformin with or without other OADs for patients with T2D.

Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population.

OBJECTIVES: Guidance to industry from the FDA requires studies to evaluate the cardiovascular safety of novel type 2 diabetes (T2D) medications. Although the objectives of such cardiovascular outcomes trials (CVOTs) are similar, differences in features such as enrollment criteria present a challenge when trying to assess the applicability of these studies to real-world T2D populations. This study evaluated the proportions of US adults with T2D who met the eligibility criteria for each of the 4 sodium-glucose cotransporter-2 (SGLT2) inhibitor CVOTs. STUDY DESIGN: A cross-sectional retrospective study was conducted using data from the National Health and Nutrition Examination Survey (NHANES) and published patient eligibility criteria for completed or ongoing SGLT2 inhibitor CVOTs. METHODS: Data on T2D diagnosis and other relevant clinical and demographic characteristics were extracted from the NHANES (2009-2010 and 2011-2012). Weighted analysis of these data was used to estimate the percentage of US adults with T2D who met the eligibility criteria for the CANVAS program (CANagliflozin cardioVascular Assessment Study) (canagliflozin; NCT01032629, NCT01989754), and the DECLARE-TIMI 58 (dapagliflozin; NCT01730534), EMPA-REG OUTCOME (empagliflozin; NCT01131676), and VERTIS-CV (ertugliflozin; NCT01986881) trials. RESULTS: The weighted analysis identified a population of 23,941,512 US adults from data on key inclusion criteria and information indicating a diagnosis of T2D. Of these, 4.1% met the criteria for EMPA-REG OUTCOME, 4.8% for VERTIS-CV, 8.8% for the CANVAS program, and 39.8% for the DECLARE-TIMI 58 trial. CONCLUSIONS: There were considerable differences in the proportions of US adults with T2D who met the eligibility criteria for these studies.The DECLARE-TIMI 58 trial criteria were the most generalizable to the US T2D population.

Generalizability of glucagon-like peptide-1 receptor agonist cardiovascular outcome trials enrollment criteria to the US type 2 diabetes population.

OBJECTIVES: Cardiovascular outcomes trials (CVOTs) for evaluating the safety of novel antidiabetic agents are required by the FDA. CVOTs vary in their design and inclusion criteria, making it difficult to evaluate their applicability to the general population. This study examined the proportion of adults eligible for 7 ongoing or completed glucagon-like peptide-1 receptor agonist (GLP-1 RA) CVOTs. STUDY DESIGN: This cross-sectional, retrospective, cohort study compared data from the National Health and Nutrition Examination Survey (NHANES) with published eligibility criteria from GLP-1 RA CVOTs. METHODS: Patient information on T2D status and other relevant characteristics were extracted from the 2009 to 2010 and the 2011 to 2012 NHANES. Weighted analyses of these data were used to calculate the numbers of adults with T2D in the US population who would have met eligibility criteria for enrollment in the following published or ongoing CVOTs: ELIXA (lixisenatide; NCT01147250), EXSCEL (Exenatide Study of Cardiovascular Event Lowering) (exenatide once weekly; NCT01144338), FREEDOM-CVO (exenatide via ITCA 650 miniature osmotic pump; NCT01455896), HARMONY Outcomes (albiglutide; NCT02465515), LEADER (Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results) (liraglutide; NCT01179048), REWIND (Researching Cardiovascular Events With a Weekly INcretin in Diabetes) (dulaglutide; NCT01394952), and SUSTAIN-6 (semaglutide; NCT01720446). RESULTS: The proportion of adults with T2D eligible for enrollment varied substantially among CVOTs (6.4%-47.2%); EXSCEL, which had a pragmatic study design, had the most generalizable inclusion criteria. More than 60% of patients with T2D would have qualified for enrollment into at least 1 GLP-1 RA CVOT. CONCLUSIONS: Most adults with T2D in the United States would have qualified for enrollment into at least 1 of the GLP-1 RA CVOTs evaluated. EXSCEL had the most generalizable eligibility criteria of these trials and ELIXA the least.

Comparison of costs and outcomes of dapagliflozin with other glucose-lowering therapy classes added to metformin using a short-term cost-effectiveness model in the US setting.

OBJECTIVE: To compare 1-year costs and benefits of dapagliflozin (DAPA), a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, with those of other treatments for type 2 diabetes (T2D), such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), sulfonylureas (SUs), thiazolidinediones (TZDs), and dipeptidyl peptidase-4 inhibitors (DPP-4i), all combined with metformin. METHODS: A short-term decision-analytic model with a 1-year time horizon was developed from a payer's perspective in the United States setting. Costs and benefits associated with four clinical end-points (glycated hemoglobin [A1C], body weight, systolic blood pressure [SBP], and risk of hypoglycemia) were evaluated in the analysis. The impact of DAPA and other glucose-lowering therapy classes on these clinical end-points was estimated from a network meta-analysis (NMA). Data for costs and quality-adjusted life-years (QALYs) associated with a per-unit change in these clinical end-points were taken from published literature. Drug prices were taken from an annual wholesale price list. All costs were inflation-adjusted to December 2016 costs using the medical care component of the consumer price index. Total costs (both medical and drug costs), total QALYs, and incremental cost-effectiveness ratios (ICERs) were estimated. Sensitivity analyses (SA) were performed to explore uncertainty in the inputs. To assess face validity, results from the short-term model were compared with long-term models published for these drugs. RESULTS: The total annual medical cost for DAPA was less than that for GLP-1RA ($186 less), DPP-4i ($1,142 less), SU ($2,474 less), and TZD ($1,640 less). Treatment with DAPA resulted in an average QALY gain of 0.0107, 0.0587, 0.1137, and 0.0715 per treated patient when compared with GLP-1RA, DPP-4i, SU, and TZD, respectively. ICERs for DAPA vs SU and TZD were $19,005 and $25,835, respectively. DAPA was a cost-saving option when compared with GLP-1RAs and DPP-4is. Among all four clinical end-points, change in weight had the greatest impact on total annual costs and ICERS. Sensitivity analysis showed that results were robust, and results from the short-term model were found to be similar to those of published long-term models. CONCLUSION: This analysis showed that DAPA was cost-saving compared with GLP-1RA and DPP-4i, and cost-effective compared with SU and TZD in the US setting over 1 year. Furthermore, the results suggest that, among the four composite clinical end-points, change in weight and SBP had an impact on cost-effectiveness results.

Comparing Medication Adherence and Persistence Among Patients with Type 2 Diabetes Using Sodium-Glucose Cotransporter 2 Inhibitors or Sulfonylureas.

BACKGROUND: Patients with type 2 diabetes treated with pharmacotherapy should be adherent to and persistent with their medications to experience glycemic control and prevent associated complications. OBJECTIVE: To compare medication adherence and persistence among patients with type 2 diabetes who are newly initiating a sodium-glucose cotransporter 2 (SGLT-2) inhibitor or a sulfonylurea. METHODS: This was a retrospective, observational cohort study using the MarketScan claims databases. The patients who were selected for the study had newly initiated treatment with an SGLT-2 inhibitor or a sulfonylurea between January 1, 2015, and December 31, 2015 (index date; class of earliest medication is defined as the index class); were aged ≥18 years on the index date; were continuously enrolled with health insurance for 12 months before and 6 months after (ie, follow-up) the index date; and had ≥1 baseline diagnoses of type 2 diabetes. Study exclusions were type 1 diabetes, pregnancy, and gestational diabetes. Medication adherence was measured by the proportion of days covered (PDC) with the index class during the follow-up period and dichotomized as adherent (PDC ≥80%) or nonadherent. Persistence was defined as the number of days from the index date until a >60-day continuous gap in days without the index drug class (ie, discontinuation) or the end of follow-up. A propensity score model was used to match patients receiving an SGLT-2 inhibitor to patients receiving a sulfonylurea in a 1:1 ratio based on patient characteristics. Logistic (ie, adherence) and Cox (ie, persistence) regression models were fit to the matched samples. RESULTS: Initially, the study included 17,724 patients who received an SGLT-2 inhibitor and 25,490 patients who received a sulfonylurea. After propensity score matching, 13,657 patients remained in each cohort. Compared with patients receiving a sulfonylurea, a statistically significantly greater percentage of patients receiving an SGLT-2 inhibitor were adherent to therapy (61.4% vs 53.9%, respectively; odds ratio of adherence, 1.364; 95% confidence interval [CI], 1.30-1.43; P <.001) and persistent (76.1% vs 68.9%, respectively; hazard ratio of discontinuation, 0.746; 95% CI, 0.71-0.78; P <.001). CONCLUSION: Maintaining adherence to and persistence with antidiabetes medication is vital to glycemic control among patients with type 2 diabetes. In this real-world study, patients who newly initiated treatment with SGLT-2 inhibitors were more likely to adhere to treatment and persist with the initiated therapy than similar patients who newly initiated treatment with sulfonylureas.

Economic burden of comorbid chronic kidney disease and diabetes.

OBJECTIVE: To estimate real-world healthcare utilization and expenditures across the spectrum of chronic kidney disease (CKD), as determined by estimated glomerular filtration rate (eGFR) categories in patients with diabetes. METHODS: This study employed a retrospective cohort study design using the Truven Healthcare and Claims Dataset from 2009-2012. Index date was defined as the first eGFR value during a continuous enrollment period of 24 months. Cohorts of patients were stratified by Kidney Disease: Improving Global Outcomes CKD stage based on eGFR (stages 1: ≥90 mL/min/1.73 m2; 2: 60-89; 3A: 45-59; 3B: 30-44; 4: 15-29; 5: <15). Healthcare expenditures (total patient and payer paid claims) and utilization (number of claims or visits) were estimated 12-months post-index date using generalized linear modeling and negative binomial modeling, respectively, after adjusting for baseline characteristics. RESULTS: Of 130,098 patients with an index eGFR value and 24-months continuous enrolment, 64,521 (49.59%) were in stage 1 CKD, 47,816 (36.75%) were in stage 2, 13,377 (10.28%) were in stage 3A, 3,217 (2.47%) were in stage 3B, 898 (0.69%) were in stage 4, and 269 (0.21%) were in stage 5. Patients in stages 3A, 3B, and 4 CKD had 1.32 (95% CI = 1.22-1.43), 1.59 (95% CI = 1.41-1.80), and 2.65 (95% CI = 2.23-3.14) times higher rates of diabetes-associated inpatient visits, respectively, compared with stage 1 CKD patients. Patients in stages 3A, 3B, and 4 CKD had increased incremental total annual healthcare expenditures of $1,732 (95% CI = $1,109-$2,356), $2,632 (95% CI = $1,647-$3,619), and $6,949 (95% CI = $5,466-$8,432), respectively, compared with stage 1 CKD patients. LIMITATIONS: The claims data were generated for billing and reimbursement, not for research purposes. CONCLUSIONS: These real-world data suggest an incremental and significant increase in economic burden in diabetes as kidney function declines, starting with moderate (stage 3A) CKD.

Patient preferences for diabetes treatment attributes and drug classes.

OBJECTIVE: To identify which treatment attributes are most influential in determining patient preferences for diabetes treatments and explore patient preferences for diabetes drug classes. RESEARCH DESIGN AND METHODS: US adults with type 1 or type 2 diabetes completed an online adaptive conjoint analysis survey. The survey examined 14 attributes, including efficacy, regimen, and risk of common side effects and rare but serious adverse events. Respondents selected between hypothetical treatments with different attributes. Sawtooth Software, ordinary least-squares regression, and hierarchical Bayes regression were used to calculate utilities (i.e. preference weights), importance ratings, and shares of preference across 13 diabetes drug classes or combination products. RESULTS: A total of 167 adults (mean age 58 years; 55% female) with type 1 or type 2 diabetes completed the survey. Based on importance ratings, the most influential attributes driving preferences were regimen, risk of diarrhea, weight change, risk of hypoglycemia, and efficacy. Sodium-glucose co-transporter-2 inhibitors (SGLT-2is) were highly preferred in direct comparison to each of the other classes (range: 84.2-99.9%), with the exception of dipeptidyl peptidase-4 inhibitors (DPP-4is); DPP-4is (52.9%) were preferred over SGLT-2is (47.1%). CONCLUSIONS: Although preferences varied across participants, attributes with the greatest likelihood of affecting daily life and routine were generally more influential in determining patient preferences. DPP-4is and SGLT-2is were overwhelmingly preferred over other drug classes, primarily due to favorable regimen and side effect profiles. Understanding patient preferences can help optimize patient-centered treatment and may lead to improved patient satisfaction, adherence, and outcomes. LIMITATIONS: The primary limitations of this study are that a small sample size of type 1 diabetes patients were included, which may reduce the reliability of the preference estimates, and patients were recruited from a patient panel and may not be representative of patients with diabetes in the US.

Quality measure attainment with dapagliflozin plus metformin extended-release as initial combination therapy in patients with type 2 diabetes: a post hoc pooled analysis of two clinical studies.

BACKGROUND: The use of quality measures attempts to improve safety and health outcomes and to reduce costs. In two Phase III trials in treatment-naive patients with type 2 diabetes, dapagliflozin 5 or 10 mg/d as initial combination therapy with metformin extended-release (XR) significantly reduced glycated hemoglobin (A1C) from baseline to 24 weeks and allowed higher proportions of patients to achieve A1C <7% vs dapagliflozin or metformin monotherapy. OBJECTIVE: A pooled analysis of data from these two studies assessed the effect of dapagliflozin 5 or 10 mg/d plus metformin XR (combination therapy) compared with placebo plus metformin XR (metformin monotherapy) on diabetes quality measures. Quality measures include laboratory measures of A1C and low-density lipoprotein cholesterol (LDL-C) as well as vital status measures of blood pressure (BP) and body mass index (BMI). The proportion of patients achieving A1C, BP, and LDL-C individual and composite measures was assessed, as was the proportion with baseline BMI ≥25 kg/m2 who lost ≥4.5 kg. Subgroup analyses by baseline BMI were also performed. RESULTS: A total of 194 and 211 patients were treated with dapagliflozin 5- or 10-mg/d combination therapy, respectively, and 409 with metformin monotherapy. Significantly higher proportions of patients achieved A1C ≤6.5%, <7%, or <8% with combination therapy vs metformin monotherapy (P<0.02). Significantly higher proportions of patients achieved BP <140/90 mmHg (P<0.02 for each dapagliflozin dose) and BP <130/80 mmHg (P<0.02 with dapagliflozin 5 mg/d only) with combination therapy vs metformin monotherapy. Similar proportions (29%-33%) of patients had LDL-C <100 mg/dL across treatment groups. A higher proportion of patients with baseline BMI ≥25 kg/m2 lost ≥4.5 kg with combination therapy. Combination therapy had a more robust effect on patients with higher baseline BMI. CONCLUSION: Initial combination therapy with dapagliflozin 5 or 10 mg/d and metformin improved quality measures relevant to clinical outcomes and diabetes care.

Health care burden of dyspepsia among nonvalvular atrial fibrillation patients.

BACKGROUND: Although dyspepsia is common among nonvalvular atrial fibrillation (NVAF) patients, its impact on patient health and cost has not been adequately studied. OBJECTIVE: To evaluate the incremental health care burden associated with dyspepsia among NVAF patients and its impact on warfarin treatment. METHODS: NVAF patients ≥ 18 years of age with continuous insurance coverage were identified (January 1, 2007, to December 31, 2009) from the MarketScan Commercial and Medicare Research databases. Patients with 1 inpatient or 2 outpatient dyspepsia diagnoses within 12 months following any NVAF diagnosis were grouped into the dyspeptic cohort, and patients without any dyspepsia diagnosis were grouped into the nondyspeptic cohort. Of the overall cohorts, patients were matched by key patient characteristics. Dyspepsia was further categorized as having a prior history of dyspepsia (chronic) or no dyspepsia (nonchronic) during the baseline period. Health care resource utilization, associated costs, and warfarin use were evaluated during a 12-month follow-up period. RESULTS: Of NVAF patients included in the study (N = 142,322), 10.4% were diagnosed with dyspepsia. After matching for key characteristics, NVAF patients with dyspepsia had significantly greater inpatient, outpatient, and prescription claims per patient year than those without dyspepsia (1.24 ± 1.21 vs. 0.36 ± 0.68, P < 0.0001; 110.18 ± 101.03 vs. 66.98 ± 72.43, P < 0.0001; and 52.13 ± 35.30 vs. 44.29 ± 32.41, P < 0.0001, respectively). This greater number of claims was reflected in higher annual inpatient, outpatient, and prescription payments ($23,610 ± $54,748 vs. $5,509 ± $19,142, P < 0.0001; $18,182 ± $28,790 vs. $9,765 ± $22,009, P < 0.0001; and $4,661 ± $5,628 vs. $3,897 ± $4,586, P < 0.0001, respectively). NVAF patients with chronic dyspepsia were the least likely to take warfarin for stroke prevention. CONCLUSIONS: NVAF patients with dyspepsia experienced more all-cause hospitalizations and required more outpatient medical services, all associated with greater expenditures than NVAF patients without dyspepsia. Additionally, dyspepsia may be a barrier to warfarin use among NVAF patients.

The high-cost, type 2 diabetes mellitus patient: an analysis of managed care administrative data.

BACKGROUND: Type 2 diabetes mellitus (T2DM) affects 25.8 million individuals in the United States and exerts a substantial economic burden on patients, health care systems, and society. Few studies have categorized costs and resource use at the patient level. The goals of this study were to assess predictors of being a high-cost (HC) patient and compare HC T2DM patients with not high-cost (NHC) T2DM patients. METHODS: Using managed care administrative claims data, patients with two or more T2DM diagnoses between 2005 and 2010 were selected. Patients were followed for 1 year after their first observed T2DM diagnosis; patients not continuously enrolled during this period were excluded from the study. Study measures included annual health care expenditures by component (i.e., inpatient, outpatient, pharmacy, total). Patients accruing total costs in the top 10% of the overall cost distribution (i.e., patients with costs > $20,528) were classified as HC a priori; all other patients were considered NHC. To assess predictors of being HC, a logistic regression model was estimated, accounting for demographics; underlying comorbidity burden (using the Charlson Comorbidity Index [CCI] score); diagnoses of renal impairment, obesity, or hypertension; and receipt of insulin, oral antidiabetics only, or no antidiabetics. RESULTS: A total of 1,720,041 patients met the inclusion criteria; 172,004 were HC. The mean (SD) CCI score for HC patients was 4.3 (3.0) versus 2.1 (1.7) for NHC patients. Mean (SD; upper 95% confidence interval-lower 95% confidence interval) annual per-patient costs were $56,468 ($65,604; $56,778-$56,157) among HC patients and $4,674 ($4,504; $4,695-$4,652) among NHC patients. Inpatient care and pharmacy costs were higher for HC patients than for NHC patients. The strongest predictor of being an HC patient was having a CCI score of 2 or greater (odds ratio [OR] = 4.896), followed by a diagnosis of obesity (OR = 2.106), renal impairment (OR = 2.368), and insulin use (OR = 2.098). CONCLUSIONS: High-cost T2DM patients accrue approximately $52,000 more in total annual health care costs than not high-cost T2DM patients. Patients were significantly more likely to be high-cost if they had comorbid conditions, a diagnosis of obesity, or used insulin.

Rate of hypoglycemia in patients with type 2 diabetes receiving metformin plus saxagliptin versus metformin plus sulfonylurea: a retrospective observational cohort study using administrative claims data.

OBJECTIVES: Hypoglycemia is a limiting factor in the management of diabetes. Studies comparing oral antidiabetic medications are needed to identify treatment options that can help clinicians and patients minimize their associated hypoglycemia risk. The purpose of this study was to compare hypoglycemia rates in patients with type 2 diabetes on metformin who initiated treatment with saxagliptin versus sulfonylurea (SU). METHODS: This retrospective analysis utilized US healthcare claims data from the Truven Health MarketScan Research Databases. Data were from adults on metformin monotherapy who added saxagliptin or SU between 1 August 2009 and 31 December 2010. Hypoglycemia event rates were compared during the 4 months after initiation of saxagliptin or SU. A hypoglycemia event was defined as a diagnosis of hypoglycemia on an outpatient or emergency room claim, a principal diagnosis on a hospital claim, or a glucagon injection in an outpatient setting. Patients taking SU were matched to patients taking saxagliptin (5 to 1) using propensity scores, and the rate ratio was further adjusted using multivariate regression. A total of 22,592 patients (1567 taking saxagliptin; 21,025 taking SU) qualified. RESULTS: During 120 days of follow-up, there were 396 hypoglycemia events. Most of the hypoglycemia events (91.9%) occurred in the outpatient setting. There were no inpatient or emergency room hypoglycemia events in the saxagliptin cohort. The overall unadjusted rate of hypoglycemia was significantly lower in the saxagliptin cohort than in the SU cohort (1.74 vs 5.58 per 100 person-years; p < 0.001). The rate of hypoglycemia also was significantly lower in the saxagliptin cohort versus the propensity-matched SU cohort (1.74 vs 4.45 per 100 person-years; p = 0.005). Matching reduced the treatment effect by approximately 20%. The rate ratio comparing saxagliptin with the unmatched and propensity-matched SU cohorts was 0.31 (95% CI: 0.14-0.6) and 0.39 (95% CI: 0.17-0.77), respectively. The multivariate adjustment decreased the hypoglycemia rate ratio 0.37 (95% CI: 0.19-0.74). CONCLUSION: In a database reflective of real-world clinical practice, saxagliptin had a lower risk of hypoglycemia than SU in patients with type 2 diabetes receiving metformin. These results add confidence to similar findings from clinical trials.

Predictors of medication adherence in patients with type 2 diabetes mellitus.

OBJECTIVE: Medical professionals are often challenged by lack of patient compliance with pharmaceutical treatments. Research has shown that patients with diabetes have one of the lowest medication adherence rates at 65% to 85%. Some causes have been identified in the literature, but the influence of type of medication is unknown. This study assessed the impact of a broad range of factors on medication adherence and persistence among adult patients with type 2 diabetes mellitus. METHODS: Patients were selected from the Truven Health MarketScan Research Databases of healthcare administrative claims (2009 through 2012), assigned to mutually exclusive cohorts based on initiation of saxagliptin (a dipeptidyl peptidase-4 [DPP-4] inhibitor), or a glucagon-like peptide 1 (GLP-1) receptor agonist (daily or twice daily formulation), sulfonylurea (SU), or thiazolidinedione (TZD), and screened for continuous enrollment 1 year before and after drug initiation. Adherence and persistence were measured using proportion of days covered and time to discontinuation, respectively. Multivariate models were used to examine the impact of study drug and demographic and clinical factors. RESULTS: Overall, 45.1% of patients were adherent with their study drug over the 1 year follow-up period. Adherence was higher among patients who were male, older, or residing in non-Southern states. Adherence was better with mail-order use and lower levels of cost sharing. Patients taking a GLP-1 (OR = 0.40, 95% CI = 0.37, 0.42), SU (OR = 0.49, 95% CI = 0.46, 0.52), or TZD (OR = 0.54, 95% CI = 0.51, 0.57) were less likely to be adherent compared with those taking saxagliptin. Results were mixed regarding the impact of comorbidities and polypharmacy on medication adherence. Influencing factors may be the type of comorbidity, overall health level, number of drugs, and complexity of the drug regimen. KEY LIMITATIONS: Adherence was measured using data for prescriptions dispensed and it is not known whether patients actually took the medications, hence adherence may be overestimated. Whether patients who discontinued the study drugs switched to other diabetes medications or discontinued treatment completely was not measured. CONCLUSION: Identified risk factors can guide medical professionals in their attempts to increase the likelihood of patient adherence to drug treatment regimens.