Treatment patterns and outcomes associated with sequential and non-sequential use of CDK4 & 6 inhibitors in patients with HR+, HER2- MBC in the real world.

PURPOSE: Cyclin Dependent Kinase 4 & 6 inhibitors (CDK4 & 6i) have transformed the management of HR+, HER2- metastatic breast cancer (MBC); however, the optimal sequence of these treatments and other systemic therapies for MBC remains unclear. METHODS: This study analyzed electronic medical records from the ConcertAI Oncology Dataset. US patients who received abemaciclib and at least one other systemic line of therapy (LOT) for HR+, HER2- MBC were eligible. Treatment sequences were grouped, and data for two pairs of groups are presented herein (N = 397): Group 1 (1L CDK4 & 6i to 2L CDK4 & 6i) vs. Group 2 (1L CDK4 & 6i to 2L non-CDK4 & 6i), and Group 3 (2L CDK4 & 6i to 3L CDK4 & 6i) vs. Group 4 (2L CDK4 & 6i to 3L non-CDK4 & 6i). Time-to-event outcomes (PFS and PFS-2) were analyzed using Kaplan-Meier method and Cox proportional hazard regression. RESULTS: In the total cohort of 690 patients, the most prevalent sequence was 1L CDK4 & 6i to 2L CDK4 & 6i (n = 165). For the 397 patients across Groups 1-4, sequential CDK4 & 6i demonstrated numerically longer PFS and PFS-2 versus non-sequential CDK4 & 6i. Adjusted results demonstrate that patients in Group 1 demonstrated significantly longer PFS (p = 0.05) versus Group 2. CONCLUSIONS: Although retrospective and hypothesis-generating, these data demonstrate numerically longer outcomes in the subsequent LOT associated with sequential CDK4 & 6i treatment.

Real-world outcomes in metastatic HR+/HER2-, HER2+ and triple negative breast cancer after start of first-line therapy.

Aim: We evaluated outcomes of first-line (1L) treatment of metastatic breast cancer by biomarker subtype in the community setting over the last decade. Methods: Eligible patients (n = 1518) were female, ≥18 years, diagnosed with metastatic breast cancer 2010 or later, had documented HR+/HER2-, HER2+, or triple negative breast cancer (TNBC); and initiated 1L therapy. Kaplan-Meier and Cox methods were used to evaluate 1L real-world progression-free survival and overall survival from start of 1L. Results: TNBC was diagnosed at an earlier stage and had higher tumor grade at initial diagnosis. 1L real-world progression-free survival and overall survival from start of 1L were shorter for TNBC than HR+/HER2- or HER2+. Conclusion: Overall prognosis for patients with metastatic TNBC remains poor, and new therapies are needed to improve clinical outcomes.

What is this article about? This study looked at how well women with metastatic breast cancer did after starting treatment. It compared three groups. The first group had tumors that respond to hormone therapy. The second group had tumors that respond to treatment that works on a specific protein. A third group had tumors that don't respond to either of those ­ called triple negative. The study looked at women 18 and older who had metastatic breast cancer in 2010 or later. They had all been treated at a community oncology practice. We looked at how long it took for the cancer to get worse, and how long until patients died, for each of the three groups. What were the results? There were 1518 patients in the study. Most (62.5%) were in the group that responds to hormone therapy. The rest had tumors that respond to treatment that works on the specific protein (23.4%), or had triple negative tumors (14.1%). Patients with triple negative tumors were diagnosed earlier, but they had worse tumor characteristics. They also had shorter time until their cancer got worse, and they did not live as long, compared with the other groups. What do the results of the study mean? This builds on other studies by showing that, even in a modern era, outcomes are poor for patients with triple negative breast cancer. It shows that new treatments are needed for patients with triple negative breast cancer.

Comparison of advanced ovarian cancer patients treated with or without bevacizumab in the US Community Oncology Clinics.

Aim: Real-world data on treatment patterns and outcomes of advanced ovarian cancer (OC) patients since bevacizumab approval in first-line (1L) OC treatment were assessed. Materials & methods: In this descriptive retrospective study using the ConcertAI Oncology Dataset, patient characteristics, treatment patterns and real-world progression-free survival (rwPFS) from start of 1L were evaluated among patients diagnosed with advanced OC between 2011-2020. Treatment data from structured sources were confirmed and/or supplemented by human review of unstructured data. Results: Median rwPFS for bevacizumab and non bevacizumab cohorts was 17.3 months (95% CI: 14.9, 20.4) and 15.7 months (95% CI: 12.3, 29.1), respectively. Patients with ≥10 doses during 1L had higher median rwPFS compared with patients receiving 3-9 doses. Conclusion: This real-world study suggests benefits of bevacizumab treatment in advanced OC were primarily experienced by patients who received ≥10 doses in 1L.

What is this article about? Bevacizumab (Avastin) is a medicine that treats cancer. It makes it harder for the cancer to get nutrients from blood. At first, you could only use it after other cancer medicine did not work. From 2018, bevacizumab could be used with cancer medicine as the first treatment. Experts said it should continue for a year after cancer medicine stopped. This would make it harder for the cancer to come back. What did we do? We checked if more patients got bevacizumab as their first medicine after 2018 approval. We also saw how long it took for the cancer to come back. We did this by looking at electronic medical records between January 2011 and August 2020. We looked for women who had cancer that was staring to spread or had spread. We compared women who got bevacizumab to women who only got other cancer medicines. What were the results? After 2018, more women got bevacizumab early. We saw that the cancer did not take longer to come back. We noticed that half the women took bevacizumab less than ten-times out of up to 22-times. The cancer took longer to come back for women who took bevacizumab ten or more times. What do the result mean? We do not know why so many women stopped treatment early. Other studies in different countries also showed better results for women who got more bevacizumab. This study can help doctors and patients decide how much bevacizumab to give when they might be thinking of stopping treatment.

Treatment patterns and overall survival in HER2+ metastatic breast cancer at US community oncology practices.

Aim: To describe real-world treatment patterns/outcomes among patients with HER2+ metastatic breast cancer (MBC). Materials & methods: Real-world treatments and overall survival (OS) were evaluated among adult women diagnosed with HER2+ MBC, with and without brain metastases (BMs), between 1 June 2012 and  31 May 2018 using electronic medical records from the Definitive Oncology Dataset. Results: Among 372 patients, 69% initiated first-line trastuzumab plus pertuzumab-based therapy; many therapy combinations were utilized in the second- to fourth-line. During follow-up (median 24.8 months), 18% of patients died (22% with and 16% without BMs). Mean OS was shortest among patients with BMs at MBC diagnosis in the third- and fourth-line. Conclusion: OS was poor, and no clear standard of care was observed among patients with HER2+ MBC progressing on trastuzumab-based therapies.

Real-world patterns on tumor mutation burden testing in a pan-tumor population.

Background: There is limited real-world information on use of tumor mutational burden (TMB) testing and characteristics of patients receiving it. Materials & methods: Patients ≥18 years old and diagnosed with advanced solid tumors between 1 January 2015 and 31 January 2019 with TMB testing (TMB cohort) and without it (non-TMB) were included in this retrospective, observational study. Results: The TMB cohort (n = 202) was younger than non-TMB (n = 212) (mean age: 62.1 vs 65.6 at diagnosis; p = 0.005). There were more Black patients in the TMB cohort (21.3 vs 11.8% in non-TMB; p = 0.004). Clinical characteristics were comparable between the two cohorts; however, systemic anticancer treatment was higher among TMB cohort (91.6 vs 77.8% in non-TMB). Conclusion: Notable differences were observed between patients receiving TMB test and those not receiving it.

Treatment patterns and clinical outcomes of palbociclib-based therapy received in US community oncology practices.

Background: Limited studies have evaluated palbociclib-based therapy use in patients with advanced/metastatic breast cancer in the real world. This retrospective study used medical records from US community oncology practices to address the gap. Materials & methods: Eligible patients receiving palbociclib-based therapy per label indication from 3 February 2015 to 31 December 2017 were included. Descriptive analyses were conducted for patient characteristics, treatment patterns and clinical outcomes. Results: The study included 233 patients who received palbociclib + aromatase inhibitor (P+AI) and 48 who received palbociclib + fulvestrant (P+F). Real-world progression-free rate for P+AI was 69.8% (46.8%) at 12 (24) months (P+F: 43.5% [39.9%]) months. Real-world survival rate was 89.8% (71.4%) at 12 (24) months (P+F: 76.3% [65.0%]). Conclusion: The study findings are consistent with previous studies of palbociclib-based therapy.

Comorbidities among patients with cancer who do and do not develop febrile neutropenia during the first chemotherapy cycle.

Patients receiving myelosuppressive chemotherapy with certain comorbidities are at increased risk of febrile neutropenia. A comprehensive evaluation of febrile neutropenia-related comorbidities across cancers is needed. This study compared comorbidity prevalence among patients with cancer who did and did not develop febrile neutropenia during the first chemotherapy cycle. This case-control study used administrative claims from adult patients with non-Hodgkin lymphoma or breast, lung, colorectal, ovarian, or gastric cancer who received chemotherapy between 2007 and 2012. Each patient who developed febrile neutropenia (case) was matched with up to four patients without febrile neutropenia (controls) by cancer type, metastasis, chemotherapy regimen, age group, and sex. For each comorbidity (identified in the year before chemotherapy began), the adjusted odds ratio (aOR) for febrile neutropenia by cancer type was evaluated using conditional logistic regression models adjusted for potential confounding factors. Of 31,331 eligible patients, 672 developed febrile neutropenia in the first chemotherapy cycle. A total of 3312 febrile neutropenia cases and matched controls were analyzed. Across tumor types, comorbidity prevalence was higher in patients who developed febrile neutropenia than in those without febrile neutropenia. Among patients with breast cancer, osteoarthritis was more prevalent in patients with febrile neutropenia (aOR, 1.85; 95% CI, 1.07 to 3.18). Among patients with non-Hodgkin lymphoma, renal disease was more prevalent in patients with febrile neutropenia (aOR, 2.25; 95% CI, 1.23 to 4.11). Patients who developed febrile neutropenia in the first chemotherapy cycle presented with comorbidities more often than otherwise similar patients who did not develop febrile neutropenia. These findings warrant further investigation and support the inclusion of comorbidities into febrile neutropenia risk models.

Antipsychotic patterns of use in patients with schizophrenia: polypharmacy versus monotherapy.

BACKGROUND: The objective of this study was to characterize real-world treatment patterns in the prescription of antipsychotic polypharmacy (≥ 2 concurrent antipsychotics) compared with antipsychotic monotherapy for patients with schizophrenia. METHODS: This study was a retrospective claims-based analysis of patients (aged 13-64 years) with schizophrenia belonging to an employer-based health plan. Duration of therapy was measured as the number of treatment days over one year following the initial date of antipsychotic therapy. Discontinuation was defined as a 90-day gap in antipsychotic treatment (or in at least one antipsychotic for the polypharmacy group). Logistic regression analyses were used to predict discontinuation within one year. Ordinary Least Squares (OLS) regressions were used to predict duration of therapy (by type of therapy) when controlling for gender, region, number of somatic and psychiatric comorbidities, Deyo-Charlson comorbidity score, and number of psychiatric and somatic medications. RESULTS: Of the 4,156 patients, 3,188 received monotherapy and 968 received polypharmacy. Mean age was 40 years (37.8 years for polypharmacy vs 40.3 years for monotherapy, p < 0.001). Within one year, 77% of the polypharmacy group and 54% of the monotherapy group discontinued treatment. The average duration of therapy was 163 [SD = 143] days in the polypharmacy group vs 253 [SD = 147] days in the monotherapy group. In both cohorts, patients <25 years had a higher frequency of discontinuations than those ≥ 26 years. Age and polypharmacy were independent predictors of treatment duration and discontinuation prior to one year. CONCLUSIONS: One quarter of patients with schizophrenia received antipsychotic polypharmacy. Discontinuation was higher in the polypharmacy group. Age and polypharmacy were significant predictors of treatment discontinuation.

Clinical and utilization outcomes associated with tumor mutational burden in a real-world pan-tumor population.

Aim & methods: This real-world study examined the association of tumor mutational burden (TMB) with clinical and healthcare utilization in adults diagnosed with advanced solid tumor 1 January 2015- 31 January 2019. Results: There were 170 patients in low-TMB group (TMB<10 mut/Mb) and 32 in high-TMB group (TMB ≥10 mut/Mb). Median overall survival was 18.8 (95% CI: 17.3-28.8) and 15.9 months (95% CI: 11.3-18.0) whereas median progression-free survival was 9.9 (95% CI: 8.6-11.4) and 7.8 months (95% CI: 3.8-12.5) for the low- and high-TMB groups, respectively. Hospitalization (49.4 vs 37.5%), emergency visit (25.3 vs 21.9%), and median overall cost of care (US$135,403 vs 87,570) were all lower in low-TMB group. Conclusion: Despite the limited sample, these data provide a historical perspective for examining real-world outcomes associated with TMB.

Lay abstract Tumor mutational burden (TMB) is the total number of mutations found in the DNA of cancer cells. Knowing the TMB may help plan the best treatment. The goal of this study was to examine whether higher TMB is directly associated with clinical outcomes or healthcare use and costs in patients who have not received immuno-oncology treatment. This study included 202 adult patients who were diagnosed with advanced solid tumors between January 2015 and January 2019. Patients were divided into two groups based on their TMB level. The study results indicate some relationship between TMB level and real-world outcomes. Future studies with a larger sample size are needed to confirm these results.

Treatment Outcomes in Patients with Metastatic Neuroendocrine Tumors: a Retrospective Analysis of a Community Oncology Database.

PURPOSE: Metastatic neuroendocrine tumors (mNETs) are rare, heterogeneous tumors that present diagnostic and treatment challenges, with limited data on the management of mNETs in clinical practice. The present study was designed to identify current diagnostic and treatment patterns in mNET patients treated in the US community oncology setting. METHODS: Patient-level data was collected from medical records of adults with mNETs from the Vector Oncology Data Warehouse, a comprehensive US community oncology network database. RESULTS: Of the 263 patients included (median follow-up, 22 months; range, 0.1-193.9), 30.4% (80/263) had intestinal tumors, 11.0% (29/263) had pancreatic, and 58.6% (154/263) had tumors of other or unknown location. Progression-free survival (PFS) from the start of first-line therapy differed significantly by tumor grade (log rank P = 0.0016) and location (P = 0.0044), as did overall survival (OS) (grade, P < 0.0001; location, P = 0.0068). Median PFS and OS for patients with undocumented tumor grade were shorter than for patients with G1/G2 tumors and longer than patients with G3 tumors. Median PFS and OS for patients with other or unknown tumors were shorter than for patients with intestinal tumors. CONCLUSIONS: While potentially confounded by the high number of patients with other or unknown tumor locations, this retrospective study of patients in a US community oncology setting identified the importance of awareness of tumor grade and tumor location at diagnosis, as these were direct correlates of PFS and OS.

Treatment Patterns and Outcomes in Stage IV Bladder Cancer in a Community Oncology Setting: 2008-2015.

INTRODUCTION: Current real-world data regarding treatment patterns in advanced bladder cancer in the community setting are limited. This study describes patient characteristics, treatment patterns, and effectiveness outcomes for stage IV bladder cancer in the community setting. METHODS: Medical records data of adults diagnosed with stage IV bladder cancer between January 1, 2008 and June 1, 2015 were retrospectively collected from a network of United States community oncology practices. Patient characteristics, treatment patterns, and efficacy outcomes were assessed. Across-group comparisons were conducted using bivariate analyses. Kaplan-Meier and Cox regression analyses of progression-free survival and overall survival (OS) were conducted. RESULTS: Of 508 patients (mean age, 70 ± 11 years), 75.2% were male, 79.1% white, 15.4% black, and 71.5% were ≥ 65 years. The most prevalent comorbidities were diabetes (23.4%) and renal disease (16.5%). Overall, 56% of patients received first-line platinum-based chemotherapy; the most common regimen was gemcitabine/carboplatin (23.6%), followed by gemcitabine/cisplatin (17%). The median OS was 9.4 months from stage IV bladder cancer diagnosis and 8.4 months from start of first-line therapy. Cox regression analysis of OS from diagnosis showed a higher risk of death for patients with no treatment (hazard ratio [HR], 2.06; P < .0001) or other treatment (HR, 1.83; P = .002) versus cisplatin and for patients with impaired performance (HR, 2.05; P < .0001). CONCLUSION: Platinum-based chemotherapy was the most prescribed treatment for stage IV bladder cancer in the community setting. Several patients were not treated with any chemotherapy, although we did not observe the reason for no treatment. This study highlights an unmet need in this population, particularly in a relapsed/refractory setting, and the need for improvement in outcomes.

Effectiveness Outcomes in Patients With Recurrent or Refractory Head and Neck Cancers: Retrospective Analysis of Data From a Community Oncology Database.

PURPOSE: The purpose of this study was to provide an understanding of the effectiveness of existing therapies in patients with advanced head and neck cancer (HNC), particularly in clinical practice. METHODS: Data from the electronic medical records of adult patients diagnosed with locally advanced or metastatic (Stage III-IVc) HNC between January 1, 2007, and October 1, 2015, were retrospectively collected from a network of community oncology practices in the United States. Eligible patients experienced disease progression despite having received prior systemic therapy. Kaplan-Meier and Cox regression analyses of progression-free survival (PFS) and overall survival (OS) were conducted. Patient-reported outcomes were also collected. FINDINGS: The study included 462 patients (median age 61.0 years; 80.7% male; 77.1% white). Most patients had a history of tobacco use (41.8% current, 41.8% past), and human papillomavirus testing was infrequent overall (11.0%). The median overall duration of follow-up was 16.4 months (range, 2.3-85.2 months). Median PFS values were 8.45 months with first-line treatment and 5.33 months with second-line treatment. PFS with first-line treatment was significantly associated with primary tumor location, performance status, and tobacco use. Performance status was a predictor of PFS in second-line treatment. Median OS values were 21.04 and 9.53 months from the start of the first and second lines of therapy, respectively. Abuse/excessive use of alcohol, older age, and impaired performance status were associated with a significantly increased risk for death in outcomes analyses. Outcomes were worse among patients initially diagnosed with Stage IVc disease versus those who progressed to Stage IVc. Past tobacco use and alcohol abuse were associated with worse patient-reported symptoms such as dry mouth and sore throat (smoking) and trouble swallowing (alcohol). IMPLICATIONS: This study of data from clinical practice shows that there remains a large unmet need for effective therapeutic options in advanced HNC. Patients' characteristics such as alcohol use and performance status were statistically significant predictors of PFS and OS in Stage III-IVc HNC.

Patient Characteristics and Costs in Recurrent or Refractory Head and Neck Cancer: Retrospective Analysis of a Community Oncology Database.

PURPOSE: The goal of this study was to describe patient characteristics, health resource utilization (HRU), and costs associated with treating recurrent or refractory head and neck cancer (HNC) among patients with disease progression in the community oncology setting. METHODS: This retrospective observational study was conducted by using data from the Vector Oncology Data Warehouse. Patients had been diagnosed with locally advanced or metastatic (stage III-IVc) HNC between January 1, 2007, and October 1, 2015. Patients also had evidence of at least 1 systemic anticancer therapy regimen following the diagnosis of advanced HNC, with at least 1 disease progression. Costs, treatment patterns, and HRU were evaluated beginning with diagnosis of advanced HNC through 3 lines of therapy. Costs of surgery or radiation were not available for inclusion in the analysis. Total cost for the study period and cost per month were analyzed by using a generalized linear regression model. FINDINGS: The study included 462 patients (median age, 61 years; range, 26-99 years); of these, 81% were male, 77% were white, and 21% were black. At initial diagnosis, the most frequent tumor locations were the hypopharynx/larynx (31%) and the oropharynx (31%). Human papilloma virus testing was most frequent among the oropharynx group (22% tested, 52% positive). Overall, 42% were current tobacco users and 22% were current or past alcohol abusers/excessive users. Platinum-based combination therapies were the most frequently administered chemotherapy in both first (42%) and second (40%) lines of treatment. Through the overall study period (mean, 20.5 months), 74% of patients were hospitalized, 19% had an emergency department visit, and 100% had an office visit. The overall mean (SD) duration of hospital stay was 12.6 days, and the median number of office visits per patient was 35. The mean monthly health care cost for the overall study period was $14,391 (95% CI, 12,739-16,044). Hospitalization costs represented ~57% of the total expenditures. Statistically significant predictors of higher overall cost included primary tumor location in the oral cavity, history of alcohol abuse/excess use, use of cetuximab, and higher comorbidity index. Older age and being stage IV versus other stages of disease at diagnosis were associated with lower overall cost. IMPLICATIONS: These data suggest that costs of care in patients with recurrent or refractory HNC are related to patient characteristics and treatment patterns. Identification of factors contributing to the costs of care in HNC may provide a useful foundation for developing strategies to control rising costs.

Differences in Health Care Use and Costs Among Patients With Cancer Receiving Intravenous Chemotherapy in Physician Offices Versus in Hospital Outpatient Settings.

PURPOSE: The current shift in site of care from community oncology practices to the hospital outpatient department to deliver oncology services may have significant implications for the economic and clinical outcomes of cancer care. Therefore, this study compares health care use and costs among patients with cancer receiving intravenous (IV) chemotherapy in physician offices (PO) versus in hospital outpatient settings (HOP). METHODS: This retrospective study, which was based on medical and pharmacy claims data, included patients (age, 18 to 64 years) initiating IV chemotherapy/biologic treatment between January 1, 2006, and August 31, 2012, who were diagnosed with early or metastatic breast cancer, metastatic lung cancer, metastatic colorectal cancer, or non-Hodgkin lymphoma or chronic lymphocytic leukemia. Patients were assigned to PO or HOP groups on the basis of where they received > 95% of their IV cancer therapy. RESULTS: The study sample included 18,740 patients (12,899 PO; 5,841 HOP) who had a mean age of 51.6 years and a Deyo-Charlson Comorbidity Index score of 5.37. Overall office visits (21.8 ± 13.8 PO v 21.2 ± 12.9, P < .005) and outpatient services (50.8 ± 35.5 PO v 48.5 ± 33.6, P < .001) were higher in the PO group than in the HOP group. Cancer-related inpatient hospitalizations (0.6 ± 1.2 PO v 0.7 ± 1.4 HOP, P = .002) were lower in the PO group than in the HOP group. Although quality-of-care metrics were similar between the HOP and PO groups, follow-up all-cause costs ($82,773 PO v $122,473 HOP) and cancer-related health care costs ($69,037 PO v $108,177 HOP) were higher in the HOP group than in the PO group. CONCLUSION: Despite similar resource use, all-cause and cancer-related health care costs in HOP were significantly higher compared with those in PO settings.

Statin safety: an assessment using an administrative claims database.

The large administrative databases of health plans contain information on drug-related medical adverse events (AE) and constitute an increasingly powerful tool for the assessment of drug safety. We conducted a retrospective observational study using an administrative managed care claims database covering 9 million members from diverse regions of the United States. Patients aged >or=18 years who received >or=2 prescriptions for lipid-lowering drugs between July 1, 2000 and December 1, 2004 were included in the study. Hospitalizations with diagnosis codes (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9]) related to muscle, kidney, and liver were determined for patients exposed to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), fibrates, extended-release niacin, cholesterol absorption inhibitors, or statin combination therapy. A total of 473,343 patients contributed 490,988 person-years of monotherapy and 11,624 person-years of combination dyslipidemia therapy. Rates of hospitalization due to AEs in patients on monotherapy with currently available statins were similar, whereas the incidence of hospitalization for muscle disorders increased 6.7-fold with cerivastatin therapy. Patients who received a lipid-lowering medication with a concomitant cytochrome P450 3A4 (CYP3A4) inhibitor had a 6-fold increased rate of muscle disorders, including rhabdomyolysis. Hypertension was associated with a 5-fold increase in both muscle and renal events, whereas patients with diabetes mellitus had a 2.5-fold increased risk of renal events. No hospitalized cases of the index AEs were observed in study subjects during the 6-month period before initiation of the lipid-lowering drug. Statin monotherapy as currently prescribed is generally well tolerated and safe.

Hypoglycemic events and glycosylated hemoglobin values in patients with type 2 diabetes mellitus newly initiated on insulin glargine or premixed insulin combination products.

PURPOSE: Rates of hypoglycemic events and their associated costs were compared among patients with type 2 diabetes mellitus newly initiated on insulin glargine or a premixed insulin fixed-combination product. METHODS: Patients newly initiated on insulin glargine or premixed insulin fixed-combination products (including pen delivery systems) between June 1, 2001, and February 29, 2004, were identified using an administrative claims database. Hypoglycemic events were identified from International Classification of Diseases, 9th Revision, Clinical Modification codes. Multivariate analyses were performed. RESULTS: A total of 2315 patients met the inclusion criteria. Of those, 1212 received insulin glargine and 1103 received a premixed fixed-combination insulin product. The mean +/- S.D. treatment duration was 13.7 +/- 8.1 months. Patients treated with premixed insulin had a higher hypoglycemic event rate than glargine patients (13.8 versus 7.0/100 patients/year; p = 0.027), which yielded a number needed to treat of 15 patients. The mean cost per hypoglycemic event was $1049 (95% confidence interval, $426-1672). The mean annual cost of all insulin use was $46 more for the insulin glargine cohort than for those who received premixed insulin ($534 versus $488, respectively) (p < 0.05). Mean postindex insulin use was higher in patients receiving premixed insulin than in those treated with insulin glargine (48.1 versus 43.8 units per day) (p < 0.05). CONCLUSION: Patients with type 2 diabetes mellitus who were newly initiated on insulin glargine had a lower rate of hypoglycemic events compared with patients newly initiated on a premixed fixed-combination insulin product. Treatment of 15 patients with insulin glargine instead of premixed insulin for one year would avoid one hypoglycemic event per year.

Evaluating Adherence to Dilated Eye Examination Recommendations Among Patients with Diabetes, Combined with Patient and Provider Perspectives.

BACKGROUND: Diabetes mellitus remains the leading cause of new cases of blindness among US adults. Routine dilated eye examinations can facilitate early detection and intervention for diabetes-related eye disease, providing an opportunity to reduce the risk for diabetes-related blindness in working-aged Americans. The Healthcare Effectiveness Data and Information Set (HEDIS) established criteria for performing dilated eye examination in patients with diabetes. OBJECTIVES: To obtain information about adherence and nonadherence to diabetic eye examinations among insured patients to understand the barriers to routine dilated eye examinations, and to identify ways to improve the quality of care for these patients. METHODS: This retrospective claims analysis is based on administrative claims from the HealthCore Integrated Research Database, a broad database representing claims from a large commercially insured population. Patients with diabetes and who had ≥1 dilated eye examinations between August 1, 2011, and July 31, 2013, were defined as adherent to the HEDIS recommendations. The analysis was augmented with findings from focus groups. The patient focus groups included adherent and nonadherent patients. The provider focus group participants were general practice or internal medicine physicians and ophthalmologists who provided medical care for the study population. For the administrative claims analysis, comparisons between the adherent and nonadherent patients were performed using t-tests for continuous data and chi-square tests for categorical data. RESULTS: Of 339,646 patients with diabetes identified in a claims data set, 43% were adherent and 57% were nonadherent to the HEDIS eye examination performance measure. The common barriers to routine eye examination cited by 29 patients across 4 focus groups included a lack of understanding of insurance benefits (N = 15), a lack of awareness of the importance of dilated eye examinations (N = 12), and time constraints (N = 12). The common barriers cited by 18 providers included the patient's level of education (N = 13), eye examinations as a lower priority than the management of other diabetes-related health issues (N = 12), and a lack of symptoms (N = 11). CONCLUSION: Several reasons for patient nonadherence to routine eye examination were identified, including a lack of understanding of insurance benefits, a lack of awareness or low prioritization of having an examination, patient education level, time constraints, and a lack of symptoms. These may be considered by providers and payers when developing programs to increase the rates of eye examinations and improve outcomes among patients with diabetes.

Differences in hypoglycemia event rates and associated cost-consequence in patients initiated on long-acting and intermediate-acting insulin products.

OBJECTIVE: To compare hypoglycemia event rates in patients initiated on long-acting insulin analog (glargine) or intermediate-acting insulin (NPH) and to analyze the associated cost-consequence from a managed care perspective. STUDY DESIGN: A retrospective analysis of pharmacy and medical claims and electronic laboratory result data using a southeastern United States managed care health plan. METHODS: Patients newly initiated on glargine or NPH between July 1, 2000 and August 31, 2002 were included. Hypoglycemia events were identified from medical claims by their ICD-9CM codes. Multivariable techniques were used to compare hypoglycemia event rates between cohorts. RESULTS: A total of 1434 patients were eligible (glargine = 310, NPH = 1124). The mean age was 53 years +/- 17 years and 51% of patients were male. The mean treatment duration was 8.6 months +/- 4.5 months. Multivariate analyses showed that patients in the NPH group had a higher hypoglycemia event rate than the glargine group (18.3 versus 7.3 per 100 patients per year; p = 0.009). The number needed to treat (glargine versus NPH) to avoid one hypoglycemia event per patient per year was nine patients at an A1C of 7%. The mean annual index medication cost was $47 more for glargine ($390) than for NPH ($343) per patient per year (p = 0.042). The mean cost per hypoglycemia event was $1087 (95% CI: $764-$1409). CONCLUSIONS: Patients treated with glargine had significantly lower hypoglycemia event rates compared to the NPH group. The risk difference indicated that one hypoglycemia event would be avoided for every nine patients treated with glargine instead of NPH. The cost increase associated with treating nine patients with glargine rather than NPH is less than the cost of treating one hypoglycemia event. In this population, the savings associated with reduced hypoglycemic events more than offset the increased acquisition cost associated with glargine.

Clinical outcomes and medication adherence in acute coronary syndrome patients with and without type 2 diabetes mellitus: a longitudinal analysis 2006-2011.

BACKGROUND: The presence of type 2 diabetes mellitus magnifies the risks associated with acute coronary syndrome (ACS), increasing the risk of recurrent cardiovascular events (CVEs) and doubling the risk of death. Managing cardiovascular risk factors has little effect on lowering the mortality risk in patients with type 2 diabetes. OBJECTIVE: To evaluate the relationship between type 2 diabetes mellitus and subsequent CVEs and medication adherence following ACS hospitalization. METHODS: Patients with ACS were identified using ICD-9-CM codes for acute myocardial infarction or unstable angina. The risk of subsequent CVEs was assessed at 1 and 3 years after the index ACS event based on type 2 diabetes status, adjusting for baseline demographic characteristics, comorbidities, medication use, and index ACS characteristics. RESULTS: Of 140,903 patients with ACS (mean age 66.8 years, 58.6% male), 27.4% had type 2 diabetes. During follow-up, 22.0% had subsequent CVEs (26.2% type 2 diabetes, 19.0% nondiabetes). After adjusting for other covariates, type 2 diabetes was associated with increased risk of subsequent CVEs by 9.7% at 1 year and 10.2% at 3 years (both P < 0.001). Most patients were not revascularized at first recurrence after index ACS discharge (79.2% type 2 diabetes, 77.5% nondiabetes). Patients with type 2 diabetes had statistically significant higher adherence rates for antiplatelet agents at 1 year and antihypertensives at 1 and 3 years versus nondiabetes patients. Persistence was higher in the type 2 diabetes group for antihypertensives and in the nondiabetes group for antiplatelet agents and statins. CONCLUSIONS: This analysis demonstrates that patients with type 2 diabetes have a higher risk of subsequent CVEs following an initial event versus those without diabetes, despite evidence of higher treatment persistence for certain medications. Adherence rates remained suboptimal, suggesting a continuing need for patient education.

Burden of First and Recurrent Cardiovascular Events Among Patients With Hyperlipidemia.

BACKGROUND: Acute cardiovascular (CV) events have been evaluated in patients with specific comorbidities but have not focused on patients with hyperlipidemia or on the their long-term costs. OBJECTIVES: To evaluate incidence of CV events, costs, and resource utilization among patients with hyperlipidemia and baseline risk of CV disease (CVD). METHODS: Patients (age 18 to 64 years) diagnosed with hyperlipidemia or using lipid-modifying medications were identified from administrative claims. Patients were categorized into 3 cohorts based on pre-index clinical characteristics-secondary prevention (SP; history of CV event, n = 15 613); high risk (HR; CVD, n = 47 600); and primary prevention (PP; no CV event history or CVD, n = 60 637)-and followed up to 2 years after the CV event. RESULTS: During follow-up, ≥1 new CV event occurred in 43.0% of the SP cohort, 33.9% of HR, and 20.9% of PP; and ≥3 new events occurred in 19.8% of the SP cohort, 12.9% of HR, and 5.5% of PP. Incremental total costs were $19 320 for SP, $20 003 for HR, and $17 650 for PP. Compared with patients with only 1 CV event, the mean 2-year cost was 30% higher in patients with 2 CV events and 48% higher in patients with 3 CV events. Only 50% of HR patients (with or without CV events) received statins. CONCLUSIONS: Patients with recurrent CV events had higher total health care costs during 24-month follow-up for each type of CV event. Total health care costs among patients with a CV event were higher for the initial as well as subsequent events. Statins and lipid-modifying medications were significantly underutilized in all cohorts, despite the presence of CVD.