Neoadjuvant chemotherapy use trends among older women with breast cancer: 2010-2017.

PURPOSE: This study assessed chemotherapy use trends before (neoadjuvant chemotherapy [NAC]) or after surgery (adjuvant chemotherapy [AdC]) among older women with breast cancer and examined factors related to NAC receipt. METHODS: Women (> 65 years) diagnosed with stage I-III breast cancer during 2010-2017 who received NAC or AdC were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. All patients were stratified into six strata based on subtype (hormone receptor-positive/human epidermal growth factor receptor 2-negative [HR + /HER2-], HER2 + , and triple-negative breast cancer [TNBC]) and stage (I-II and III). Cochran-Armitage tests were performed to test temporal trends of NAC use in each stratum. Multivariable logistic regression analyses were performed to identify factors (sociodemographic and clinical) related to NAC use. RESULTS: Among included older (mean ± standard deviation: 72.3 ± 5.2 years) women (N = 8,495) with stage I-III breast cancer, NAC use increased from 11.7% (2010) to 32.6% (2017). Significant increases in NAC were found in all strata (p < .0001) with more substantial increases in HER2 + disease and TNBC compared to HR + /HER2- disease. Multivariable logistic regressions identified the youngest age category (66-69 years) and later stage as significant (p < 0.05) predictors of NAC receipt in most strata, in addition to diagnosis year. CONCLUSION: Similar to the overall breast cancer population, NAC use increased among a population of older women. NAC was received by most patients with stage III HER2 + disease or TNBC in more recent years and was more common among younger elderly women and those in stage III.

Economic Burden of Chronic Comorbidities Among Community-Dwelling Older Adults With Dementia: A Propensity Score Matched National-Level Study.

OBJECTIVE: This study examined the extent to which chronic comorbidities contribute to excess health care expenditures between older adults with dementia and propensity score (PS)-matched nondementia controls. METHODS: This was a retrospective, cross-sectional, PS-matched case (dementia): control (nondementia) study of older adults (65 y or above) using alternative years data from pooled 2005 to 2015 Medical Expenditure Panel Surveys (MEPS). Chronic comorbidities were identified based on Clinical Classifications System or ICD-9-CM codes. Ordinary least squares regression was utilized to quantify the impact of chronic comorbidities on the excess expenditures with logarithmic transformation. Expenditures were expressed as 2019 US dollars. All analyses accounted for the complex survey design of MEPS. RESULTS: The mean yearly home health care expenditures were particularly higher among older adults with dementia and co-occurring anemia, eye disorders, hyperlipidemia, and hypertension compared with PS-matched controls. Ordinary least squares regression models revealed that home health care expenditures were 131% higher (ß=0.837, P <0.001) among older adults with dementia compared with matched nondementia controls before adjusting for chronic comorbidities. When additionally adjusting for chronic comorbidities, the percentage increase, while still significant ( P <0.001) decreased from 131% to 102%. CONCLUSIONS: The excess home health care expenditures were partially explained by chronic comorbidities among community-dwelling older adults with dementia.

Healthcare utilization and costs among patients with chronic migraine, episodic migraine, and tension-type headache enrolled in commercial insurance plans.

OBJECTIVE: To quantify and compare healthcare utilization and costs for patients with chronic migraine (CM), episodic migraine (EM), and tension-type headache (TTH) enrolled in US commercial health plans. METHODS: This retrospective cohort study used the Optum Clinformatics® Data Mart database from January 2015 to December 2018. Adult patients with a diagnosis of EM, CM or TTH and at least 12 months of continuous enrollment before and after diagnosis were included. Inverse probability of treatment weighting was used to adjust for baseline differences among the three groups. Patient demographic and clinical characteristics at baseline, and healthcare utilization and costs during follow-up, were described and compared between the three groups. RESULTS: A total of 45,849 patients were included: 8955 with CM, 31,961 with EM, and 4933 with TTH. The total all-cause annual direct medical costs of patients with CM ($17,878) were 1.38 times higher (95% CI: 1.31-1.44) than those with EM ($12,986), and 2.26 times higher (95% CI: 2.08-2.47) than those with TTH ($7902). The annual migraine/TTH-related costs of patients with CM ($1869) were 4.19 times higher (95% CI: 3.92-4.48) than those with EM ($446), and 11.90 times (95% CI: 10.59-13.52) higher than those with TTH ($157). In the adjusted analyses, for all service categories (emergency department, inpatient, outpatient, and prescriptions), the expected costs in the migraine groups were higher than in the TTH group (all p < 0.001), while controlling for covariates. Main findings were consistent in both weighted and unweighted samples, and with both unadjusted and adjusted analyses. CONCLUSION: This study provides an updated assessment of healthcare utilization and expenditures for adult patients with primary headache disorders. Compared to TTH, migraine is associated with higher resource use and direct medical costs, especially for those with a chronic condition. Future studies are needed to understand the indirect medical costs (productivity loss) and humanistic burden (quality of life) between migraine and TTH.

Impact of emergency department opioid use on future health resource utilization among patients with migraine.

OBJECTIVE: The purpose of this study was to evaluate the subsequent health resource utilization (HRU) between patients with migraine who received opioid medications at their emergency department (ED) visits ("opioid recipients") versus patients with migraine who did not receive opioid medications at their ED visits ("non-recipients"). BACKGROUND: Previous studies have found that opioid use is common among patients with migraine at emergency settings. Medication overuse, especially the use of opioids, is associated with migraine progression, which can ultimately lead to substantial health resource use and costs. There is limited evidence on opioid use specifically in emergency settings and its impact on future HRU among people with migraine. METHOD: This retrospective cohort study used electronic health record data from the Baylor Scott & White Health between December 2013 and April 2017. Adult patients who had at least 6 months of continuous enrollment before (baseline or pre-index) and after (follow-up) the first date they had an ED visit with a diagnosis of migraine (defined as index date) were enrolled in the study. Opioid use and HRU during follow-up period between opioid recipients and non-recipients were summarized and compared. RESULTS: A total of 788 patients met the eligibility criteria and were included in this study. During the 6-month follow-up period, compared to patients with migraine who were non-recipients at their index ED visits, opioid recipients had significantly more all-cause (3.6 [SD = 6.3] vs. 1.9 [SD = 4.8], p < 0.0001) and migraine-related (1.6 [SD = 4.2] vs. 0.6 [SD = 2.1], p < 0.0001) opioid prescriptions (RXs), and more all-cause (2.6 [SD = 4.3] vs. 1.6 [SD = 2.6], p = 0.002) and migraine-related (0.6 [SD = 1.4] vs. 0.3 [SD = 0.8], p = 0.001) ED visits. In addition, opioid recipients had higher risk of future migraine-related ED visits controlling for covariates (HR = 1.49, 95% CI = 1.09-2.03, p = 0.013). Factors that were significantly (p < 0.05) related to future migraine-related ED visits include previous opioid use (HR = 2.12, 95% CI = 1.24-3.65, p = 0.007), previous ED visits (HR = 2.38, 95% CI = 1.23-4.58, p = 0.010), hypertension (HR = 1.46, 95% CI = 1.07-2.00, p = 0.017), age between 45 and 64 years (HR = 0.68, 95% CI = 0.48-0.97, p = 0.033), female sex (HR = 1.82, 95% CI = 1.12-2.86, p = 0.015), and tobacco use disorder (HR = 1.45, 95% CI = 1.07-1.97, p = 0.017). Sub-analyses were restricted to the group of patients who were opioid naïve at baseline (n = 274, defined as having ≤1 opioid RXs during the 6-month pre-index period). Patients who were baseline opioid naïve but received opioids during their index ED visits were more likely to have future migraine-related ED visits compared to patients who were baseline opioid naïve and did not receive any opioids during their index ED visits, controlling for covariates (HR = 2.90, 95% CI = 1.54-5.46, p = 0.001). CONCLUSION: Opioid use among patients with migraine presenting to the ED is associated with increased future HRU, which highlights the need for optimizing migraine management in emergency settings.

A network meta-analysis of efficacy and safety of first-line and second-line therapies for the management of metastatic renal cell carcinoma.

WHAT IS KNOWN AND OBJECTIVE: Metastatic renal cell carcinoma (mRCC) is the most common type of kidney cancers. Disease-specific survival for mRCC has been significantly improved with the introduction of new targeted agents since 2005. However, there is a lack of head-to-head clinical trials comparing the efficacy between therapies. This study compared indirectly progression-free survival (PFS) and overall survival (OS) among first-line and second-line therapies in patients with mRCC using network meta-analysis (NMA). METHODS: The PubMed, MEDLINE, Cochrane Library and Web of Science were searched to identify phase II or phase III randomized controlled trials (RCTs) of targeted and biological therapies in patients with mRCC published between January 2000 and June 2020. The Bayesian fixed-effect NMA was performed to evaluate relative PFS and OS of first-line and second-line therapies of axitinib, bevacizumab, cabozantinib, everolimus, lenvatinib, nivolumab, ipilimumab, pazopanib, sorafenib, sunitinib, temsirolimus, tivozanib, avelumab and pembrolizumab, which were approved by the Food and Drug Administration or European Medicines Agency. End points were compared using hazard ratio (HR) and 95% credible interval (CrI). The surface under the cumulative ranking curve (SUCRA) was estimated to assess the probability of being the best treatment. RESULTS AND DISCUSSION: A total of 26 RCTs (first line: 19, second line: 9) with 13 893 patients were included in the NMA. For the first-line therapy, cabozantinib was associated with the highest improved PFS (HR = 0.26, 95% CrI = 0.14-0.44) followed by avelumab + axitinib and pembrolizumab + axitinib (HR = 0.27, SUCRA = 90%). Pembrolizumab + axitinib had a high likelihood of being the preferred treatment when using OS as the outcome measure (HR = 0.41, 95% CrI = 0.16-0.85). Avelumab + axitinib had the lowest HR compared with placebo + interferon on discontinuations due to AE (HR = 1.04, 95% CrI = 0.54-1.86). For second-line therapy, cabozantinib was identified as the most effective treatment option when assessing PFS (HR = 0.17, 95% CrI = 0.12-0.24). Axitinib had the lowest HR of OS and discontinuation due to AE (HR = 0.54, 95% CrI = 0.40-0.71; HR = 0.98, 95% CrI = 0.42-1.97, respectively). Pazopanib was the second choice in terms of OS (HR = 0.56, 95% CrI = 0.28-1.00; SUCRA = 76%) compared with placebo. WHAT IS NEW AND CONCLUSION: With respect to PFS and OS improvement, cabozantinib, avelumab + axitinib and pembrolizumab + axitinib are likely to be the preferred options for the first-line therapy and cabozantinib and axitinib for the second-line therapy in the management of mRCC. Regarding safety, avelumab + axitinib and temsirolimus were considered preferred treatment options in first-line and second-line therapies. More future research is needed to establish subgroup analyses, allowing evaluation of the impact of some of the differences in patient characteristics, including treatment effect modifiers.

Patterns and predictors of opioid use among migraine patients at emergency departments: A retrospective database analysis.

OBJECTIVES: To compare medication use and health resource utilization between migraineurs with evidence of opioid use at emergency department visit versus no opioid use at emergency department visit, and to examine predictors of opioid use among migraineurs at emergency department visits. METHODS: This was a retrospective study using REACHnet electronic health records (December 2013 to April 2017) from Baylor Scott & White Health Plan. The index date was defined as the first migraine-related emergency department visit after ≥6 months of enrollment. Adult patients with a migraine diagnosis and ≥6 months of continuous enrollment before and after their index dates were included. Descriptive statistics and bivariate analyses were used to compare medication use and health resource utilization between opioid users and non-opioid users. Multivariable logistic regression was used to examine predictors of opioid use at emergency department visits. RESULTS: A total of 788 migraineurs met eligibility criteria. Over one-third (n = 283, 35.9%) received ≥1 opioid medication during their index date emergency department visit. Morphine (n = 103, 13.1%) and hydromorphone (n = 85, 10.8%) were the most frequently used opioids. Opioid users had more hospitalizations and emergency department visits during their pre-index period (both p < 0.05). Significant (p < 0.05) predictors of opioid use at emergency department visits included past migraine-related opioid use (2-4 prescriptions, Odds Ratio = 1.66; 5-9 prescriptions, Odds Ratio = 2.12; ≥10 prescriptions, Odds Ratio = 4.43), past non-migraine-related opioid use (≥10 prescriptions, Odds Ratio = 1.93), past emergency department visits (1-3 visits, Odds Ratio = 1.84), age (45-64 years, Odds Ratio = 1.45), and sleep disorder (Odds Ratio = 1.43), controlling for covariates. CONCLUSION: Opioids were commonly given to migraineurs at emergency departments. Previous opioid use, health resource utilization, age, and specific comorbidities might be used to identify migraineurs with a high risk of opioid use.

Increased Fracture Risk with Furosemide Use in Children with Congenital Heart Disease.

OBJECTIVES: To determine the association of furosemide therapy with the incidence of bone fractures in children with congenital heart disease. STUDY DESIGN: We conducted a retrospective cohort study with data extracted from the 2008-2014 Texas Medicaid databases. Pediatric patients aged <12 years diagnosed with congenital heart disease, cardiomyopathy, or heart failure were included. Patients taking furosemide were categorized into a furosemide-adherent group (medication possession ratio of ≥70%), and a furosemide-nonadherent group (medication possession ratio of <70%). A third group of patients was matched to the furosemide user groups by using propensity score matching. A multivariate logistic regression and Cox proportional hazard model with a Kaplan-Meier plot (time-to-fracture) were used to compare the 3 groups, controlling for baseline demographics and clinical characteristics. RESULTS: After matching, 3912 patients (furosemide adherent, n = 254; furosemide nonadherent, n = 724; no furosemide, n = 2934) were identified. The incidence of fractures was highest for the furosemide-adherent group (9.1%; 23 of 254), followed by the furosemide-nonadherent group (7.2%; 52 of 724), which were both higher than for patients who did not receive furosemide (5.0%; 148 of 2934) (P < .001). Using logistic regression, both furosemide groups were more likely to have fractures than the no furosemide group: furosemide-adherent OR of 1.9 (95% CI, 1.17-2.98; P = .009); furosemide nonadherent OR of 1.5 (95% CI, 1.10-2.14; P = .01). In the Cox proportional hazard model, the risk of fractures for the furosemide-adherent group was significantly higher compared with the no furosemide group (HR, 1.6; 95% CI, 1.00-2.42; P = .04). CONCLUSIONS: Furosemide therapy, even with nonconsistent dosing, was associated with an increased risk of bone fractures in children with congenital heart disease.

Patterns of antiepileptic drug use in patients with potential refractory epilepsy in Texas Medicaid.

OBJECTIVES: Antiepileptic drug (AED) monotherapy is usually effective in 60% of the patients with epilepsy while the remaining patients have refractory epilepsy. This study compared treatment patterns (adherence, persistence, addition, and switching) associated with refractory and nonrefractory epilepsy. METHODS: Texas Medicaid claims from 09/01/07-12/31/13 were analyzed, and patients eligible for the study 1) were between 18 and 62 years of age, 2) had a prescription claim for an AED during the identification period (03/01/08-12/31/11) with no prior baseline AED use (6-month), and 3) had evidence of epilepsy diagnosis within 6 months of AED use. Based on AED use in the identification period, patients were categorized into "refractory" (≥3AEDs) and "nonrefractory" (<3AEDs) cohorts. The index date was the date of the first AED claim. Patients in both cohorts were matched 1:1 using propensity scoring and compared for adherence (proportion of days covered (PDC) ≥80% vs. <80%), persistence, addition (yes/no), and switching (yes/no) using multivariate conditional regression models. Conditional logistic regression and Cox proportional hazard models were used to address the study objectives. RESULTS: Of the 10,599 eligible patients, 2798 (26.5%) patients in the refractory cohort were matched to patients in the nonrefractory cohort. Patients in the refractory cohort had significantly higher (p < 0.005) mean (±Standard deviation (SD)) adherence (88.6% (±19.1%) vs. 77.0% ±â€¯(25.8%)) and persistence (328.0 (±87.3) days vs. 294.9 ±â€¯(113.4) days) as compared with patients in the nonrefractory cohort. Compared with patients with nonrefractory epilepsy, patients with refractory epilepsy were 3.6 times (odds ratio (OR) = 3.553; 95% confidence interval (CI) = 3.060-4.125; p < 0.0001) more likely to adhere to AEDs and had a 34.7% (hazard ratio (HR) = 0.653; 95% CI = 0.608-0.702; p < 0.0001) lower hazard rate of discontinuation of AEDs. Also, patients with refractory epilepsy were 3.7 times (OR = 3.723; 95% CI = 2.902-4.776; p < 0.0001) more likely to add an alternative AED and 3.6 times (OR = 3.591; 95% CI = 3.010-4.284; p < 0.0001) more likely to switch to an alternative AED. CONCLUSION: Patients with refractory epilepsy were significantly more likely to adhere and persist to AED regimen and were significantly more likely to add and switch to an alternative AED than patients with nonrefractory epilepsy.

Direct and indirect costs among patients with binge-eating disorder in the United States.

OBJECTIVE: To quantify the economic burden of binge-eating disorder (BED) in terms of work productivity loss, healthcare resource utilization, and healthcare costs. METHODS: Respondents of the US National Health and Wellness Survey 2013 were invited to participate in a follow-up internet survey to identify adults with BED using DSM-5 criteria. Work productivity loss, healthcare resource utilization, and direct and indirect costs were assessed for BED respondents and matched non-BED respondents using generalized linear models or two-part models as appropriate. RESULTS: A total of 1,720 people were included in our analysis (N = 344 with BED; N= 1,376 without BED). BED respondents had higher levels of activity impairment than non-BED respondents (41.29% vs. 23.18%, p < .001). Employed BED respondents (N = 178) had a greater level of work impairment than employed non-BED respondents (N = 686) (36.83% vs. 14.41%, p = .009). Higher healthcare resource utilization in the past 6 months among BED respondents was reported than matched non-BED respondents: numbers of surgeries (0.23 vs. 0.13, p = .021), ER visits (0.26 vs. 0.15, p = .016), and physician visits (6.09 vs. 4.56, p = .002). BED respondents reported higher total direct costs than matched non-BED respondents ($20,194 vs. $14,465, p = .005). The indirect costs among employed BED respondents were also higher than those without BED ($19,327 vs. $9,032, p < .001). DISCUSSION: Individuals with BED reported significantly greater economic burden with respect to work productivity loss, level of healthcare resource utilization, and costs compared to non-BED respondents. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2017; 50:523-532).

Integration of pharmacists into patient-centered medical homes in federally qualified health centers in Texas.

OBJECTIVES: To describe the integration and implementation of pharmacy services in patient-centered medical homes (PCMHs) as adopted by federally qualified health centers (FQHCs) and compare them with usual care (UC). SETTING: Four FQHCs (3 PCMHs, 1 UC) in Austin, TX, that provide care to the underserved populations. PRACTICE DESCRIPTION: Pharmacists have worked under a collaborative practice agreement with internal medicine physicians since 2005. All 4 FQHCs have pharmacists as an integral part of the health care team. Pharmacists have prescriptive authority to initiate and adjust diabetes medications. PRACTICE INNOVATION: The PCMH FQHCs instituted co-visits, where patients see both the physician and the pharmacist on the same day. PCMH pharmacists are routinely proactive in collaborating with physicians regarding medication management, compared with UC in which pharmacists see patients only when referred by a physician. EVALUATION: Four face-to-face, one-on-one semistructured interviews were conducted with pharmacists working in 3 PCMH FQHCs and 1 UC FQHC to compare the implementation of PCMH with emphasis on 1) structure and workflow, 2) pharmacists' roles, and 3) benefits and challenges. RESULTS: On co-visit days, the pharmacist may see the patient before or after physician consultation. Pharmacists in 2 of the PCMH facilities proactively screen to identify diabetes patients who may benefit from pharmacist services, although the UC clinic pharmacists see only referred patients. Strengths of the co-visit model include more collaboration with physicians and more patient convenience. Payment that recognizes the value of PCMH is one PCMH principle that is not fully implemented. CONCLUSION: PCMH pharmacists in FQHCs were integrated into the workflow to address specific patient needs. Specifically, full-time in-house pharmacists, flexible referral criteria, proactive screening, well defined collaborative practice agreement, and open scheduling were successful strategies for the underserved populations in this study. However, reimbursement plans and provider status for pharmacists should be established to sustain this model of care.

Comparing survival outcomes between neoadjuvant and adjuvant chemotherapy within breast cancer subtypes and stages among older women: a SEER-Medicare analysis.

BACKGROUND: This study aimed to compare survival outcomes of neoadjuvant (NAC) and adjuvant chemotherapy (AdC) within each breast cancer subtype and stage among older women. METHODS: Older (≥ 66 years) women newly diagnosed with stage I-III invasive ductal breast cancer during 2010-2017 and treated with both chemotherapy and surgery within one year were identified from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database. Analyses were performed within each of six groups, jointly defined based on subtype (hormone receptor [HR]-positive/human epidermal growth factor receptor 2 [HER2]-negative, HER2 + , and triple-negative) and stage (I-II and III). Kaplan-Meier curves and multivariable Cox models were used to compare overall and recurrence-free survival between NAC and AdC, with optimal full matching performed for confounding adjustment. RESULTS: Among 8,495 included patients, 8,329 (20.6% received NAC) remained after matching. Before multiple testing adjustment, Cox models showed that NAC was associated with a lower hazard for death among stage III HER2 + patients (hazard ratio = 0.347, 95% confidence interval CI 0.161-0.745) but a higher hazard for death among triple-negative patients (stage I-II: hazard ratio = 1.558, 95% CI 1.024-2.370; stage III: hazard ratio = 2.453; 95% CI 1.254-4.797). A higher hazard for death/recurrence was associated with NAC among stage I-II HR + /HER2- patients (hazard ratio = 1.305, 95% CI 1.007-1.693). No significant difference remained after multiple testing adjustment. CONCLUSIONS: The opposite trends (before multiple testing adjustment) of survival comparisons for advanced HER2 + and triple-negative disease warrant further research. Caution is needed due to study limitations such as cancer stage validity.

Cost-effectiveness of expanded newborn screening in Texas.

OBJECTIVE: Texas House Bill 790 resulted in the expansion of the newborn screening panel from 7 disorders to 27 disorders. Implementation of this change began in 2007. The objective of this study was to estimate the incremental cost-effectiveness of the expanded newborn screening program compared with the previous standard screening in Texas. METHODS: A Markov model (for a hypothetical cohort of Texas births in 2007) was constructed to compare lifetime costs and quality-adjusted life-years (QALYs) between the expanded newborn screening and preexpansion newborn screening. Estimates of costs, probabilities of sequelae, and utilities for disorder categories were obtained from a combination of Texas statistics, the literature, and expert opinion. A baseline discount rate of 3% was used for both costs and QALYs, with a range of 0% to 5%. Analyses were conducted from a payer's perspective, and so only direct medical cost estimates were included. RESULTS: The lifetime incremental cost-effectiveness ratio for expanded versus preexpansion screening was about $11,560 per QALY. The results remained robust to both deterministic and probabilistic sensitivity analyses. CONCLUSIONS: Expanded newborn screening does result in additional expenses to the payer, but it also improves patient outcomes by preventing avoidable morbidity and mortality. The screened population benefits from greater QALYs as compared with the unscreened population. Overall, expanded newborn screening in Texas was estimated to be a cost-effective option as compared with unexpanded newborn screening.

Efficacy and safety of dipeptidyl peptidase-4 inhibitors in type 2 diabetes: meta-analysis.

BACKGROUND: An up-to-date assessment of dipeptidyl peptidase-4 (DPP-4) inhibitors is needed to include newly available data. OBJECTIVE: To assess the efficacy and safety of DPP-4 inhibitors, including sitagliptin, saxagliptin, vildagliptin, and linagliptin, in type 2 diabetes. METHODS: We conducted a search of MEDLINE for randomized controlled trials (RCTs) of DPP-4 inhibitors in type 2 diabetes through November 2011, using the key terms sitagliptin, saxagliptin, vildagliptin, and linagliptin. We also searched for completed, but unpublished, trials at relevant web sites. RCTs were selected for meta-analysis if they (1) compared DPP-4 inhibitors with placebo or an antihyperglycemic agent; (2) had study duration of 12 or more weeks; (3) had 1 or more baseline and posttreatment efficacy and/or safety outcome; and (4) were published in English. RESULTS: In 62 evaluated articles, DPP-4 inhibitors lowered hemoglobin A(1c) (A1C) significantly more than placebo (weighted mean difference [WMD] -0.76%; 95% CI -0.83 to -0.68); however, heterogeneity was substantial (I(2) = 82%). Exclusion of Japanese trials (n = 7) resulted in a reduction of heterogeneity (I(2) = 59%). In the non-Japanese RCTs (n = 55), DPP-4 inhibitors were associated with a reduction in A1C (WMD -0.65%; 95% CI -0.71 to -0.60) but higher risk of hypoglycemia (odds ratio [OR] 1.30; 95% CI 1.00 to 1.68) compared to placebo. The 7 Japanese-specific RCTs showed a greater reduction in A1C (WMD -1.67%; 95% CI -1.89 to -1.44) and a nonsignificant increase in risk of hypoglycemia (OR 1.41; 95% CI 0.51 to 3.88) with DPP-4 inhibitors versus placebo. When comparing DPP-4 inhibitors to active comparators, the I(2) was still high after deleting Japanese studies. In these 17 active comparator trials, there was no significant difference in A1C reduction (WMD 0.04%; 95% CI -0.09 to 0.16) or risk of hypoglycemia (OR 0.60; 95% CI 0.22 to 1.61) for DPP-4 inhibitors compared to other antihyperglycemics. There were similar odds of any or serious adverse events with DPP-4 inhibitors compared to placebo, but a decreased risk compared to other antihyperglycemics. CONCLUSIONS: DPP-4 inhibitors were associated with a reduction in A1C with comparable safety profiles compared to placebo, but no significant difference in A1C compared to other hyperglycemics. Differences in efficacy and safety were observed between Japanese and non-Japanese patients.

Effect of social influences on pharmacists' intention to report adverse drug events.

OBJECTIVES: To identify the groups or individuals that influence pharmacists' decision making to report adverse drug events (ADEs), determine the differences in social influence or subjective norm between intenders and nonintenders, and determine the relationship between subjective norm toward reporting serious ADEs and practice and demographic characteristics. DESIGN: Nonexperimental cross-sectional study. SETTING: Texas during June and July 2009. PARTICIPANTS: 1,500 Texas pharmacists. INTERVENTION: As part of a larger survey, 3 and 18 items were used to assess pharmacists' intentions and subjective norm, respectively, to report serious ADEs to the Food and Drug Administration (FDA). MAIN OUTCOME MEASURE: Pharmacists' subjective norm toward reporting serious ADEs. RESULTS: The survey had a response rate of 26.4% (n = 377). Most pharmacists intended to report serious ADEs that they would encounter (15.87 ± 4.22 [mean ± SD], possible range 3-21, neutral = 12). The mean subjective norm scores were moderately high and positive (28.75 ± 9.38, 1-49, 16), indicating that the referents had a moderate influence on pharmacists regarding reporting serious ADEs to FDA. FDA had the greatest (34.82 ± 12.16) and drug manufacturers the lowest (21.55 ± 13.83) social influence. The most important salient referents (important others) in pharmacists' decisions to report serious ADEs were FDA, patients, pharmacy associations, pharmacy managers/bosses, and hospitals and hospital groups. Gender (female equals higher), pharmacists' years of experience (negative correlation), and knowledge of ADE reporting (positive correlation) were associated with subjective norm. CONCLUSION: Pharmacists had a moderately high subjective norm, suggesting that ADE reporting intentions is influenced by others and that the opinions of others are of great importance in pharmacists' intentions regarding ADE reporting. The main drivers of subjective norm were FDA, patients, pharmacy associations, and managers/bosses.

Pharmacist reporting of serious adverse drug events to the Food and Drug Administration.

OBJECTIVE: To identify barriers to and facilitators of pharmacist reporting of serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHOD: Two focus groups consisting of practicing pharmacists were held in Austin, TX, in 2009. The following open-ended questions were used in the focus groups: (1) What do you think would make it easier to report serious ADEs to the FDA? (2) What do you think would make it more difficult to report serious ADEs to the FDA? A content analysis was performed on the generated transcripts. RESULTS: 13 pharmacists practicing in hospital and community settings in Texas participated. Pharmacists identified 27 barriers to and facilitators of reporting serious ADEs to FDA. Lack of patients' complete medical histories and lack of time were the barriers most frequently cited. Knowledge and awareness of ADEs and ADE reporting emerged as important factors that would facilitate reporting serious ADEs to FDA. CONCLUSION: These findings highlight the factors that facilitate and/or inhibit pharmacist reporting of serious ADEs to FDA. Improved knowledge of ADEs and ADE reporting would facilitate reporting behaviors, while lack of time, lack of complete patient medical histories, and lack of compensation issues serve as important barriers to reporting. Interventions are needed to address these factors.

Healthcare Utilization, Costs, and Adverse Events of Real-Time Continuous Glucose Monitoring versus Traditional Blood Glucose Monitoring Among US Adults with Type 1 Diabetes.

OBJECTIVE: To compare healthcare utilization, costs, and incidence of diabetes-specific adverse events (ie, hyperglycemia, diabetic ketoacidosis, and hypoglycemia) in type 1 diabetes adult patients using real-time continuous glucose monitoring (rtCGM) versus traditional blood glucose monitoring (BG). METHODS: Adult patients (≥18 years old) with type 1 diabetes in a large national administrative claims database between 2013 and 2015 were identified. rtCGM patients with 6-month continuous health plan enrollment and ≥1 pharmacy claim for insulin during pre-index and post-index periods were propensity-score matched with BG patients. Healthcare utilization associated with diabetic adverse events were examined. A difference-in-difference (DID) method was used to compare the change in costs between rtCGM and BG cohorts. RESULTS: Six-month medical costs for rtCGM patients (N = 153) increased from pre- to post-index period, while they decreased for matched BG patients (N = 153). DID analysis indicated a $2,807 (P = .062) higher post-index difference in total medical costs for rtCGM patients. Pharmacy costs for both cohorts increased. DID analysis indicated a $1,775 (P < .001) higher post-index difference in pharmacy costs for rtCGM patients. The incidence of hyperglycemia for both cohorts increased minimally from pre- to post-index period. The incidence of hypoglycemia for rtCGM patients decreased, while it increased marginally for BG patients. Inpatient hospitalizations for rtCGM and BG patients increased and decreased marginally, respectively. CONCLUSIONS: rtCGM users had non-significantly higher pre-post differences in medical costs but significantly higher pre-post differences in pharmacy costs (mostly due to the rtCGM costs themselves) compared to BG users. Changes in adverse events were minimal.

Improving Asthma Management: Patient-Pharmacist Partnership Program in Enhancing Therapy Adherence.

Community pharmacist interventions can assist in improving adherence in patients with asthma. The objective of the study was to assess the feasibility of patient-centered counseling using the developed asthma-specific tools to identify barriers to adherence and identify their preliminary effect on adherence barrier score and asthma control. Adult patients with persistent asthma were invited to participate in a 3-month pre-post intervention study involving community pharmacist-provided patient-centered counseling. Bivariate analyses were conducted to determine whether there were changes in outcomes from the pre to post period. Of 36 recruited patients, 17 completed both pre and post surveys. At baseline, patients had a mean ACT score of 15.1 ± 3.5, with 94% having uncontrolled asthma, and an average of 4.2 ± 2.5 reported barriers. The following barriers were most common: not having an Asthma Action Plan (52.9%), use of inhaler more or less often than prescribed (47.1%) and forgetfulness (41.2%). The ACT score increased by 2.7 ± 5.4, which was not statistically significant; however, it might be clinically significant. Two barrier scores improved as a result of the intervention. Preliminary evidence on the feasibility of identifying and addressing patient-specific barriers to adherence delivered by pharmacists showed that it has the potential to resolve barriers and improve asthma outcomes.

Real-world opioid use among patients with migraine enrolled in US commercial insurance and risk factors associated with migraine progression.

BACKGROUND: Migraineurs may be categorized as having episodic migraine (EM: < 15 headache days/month) or chronic migraine (CM: ≥ 15 days/month for > 3 months with ≥ 8 days/month having features of migraine). Opioid use has been linked to progression from EM to CM. OBJECTIVE: To describe the utilization of opioid prescriptions among patients with migraine, to determine the association between opioid use and migraine progression, and to explore demographic and clinical risk factors for migraine progression. METHODS: This retrospective cohort study used Optum's deidentified Clinformatics Data Mart Database from January 2015 to December 2018. Adult patients with a migraine diagnosis and continuous health plan enrollment were included. Opioid use was measured by average daily morphine equivalent dose, also known as morphine milligram equivalent (MME). Descriptive statistics were used to summarize the opioid use by patient demographic and clinical characteristics. A Cox proportional hazards model with stepwise selection was used to determine the risk factors of new-onset CM. RESULTS: Overall, 35% of patients with migraine (27,331 of 78,134) received prescription opioids (> 0 MME/day) during the 12-month follow-up period. Higher opioid dosage was found in patients who had CM and comorbidities of interest. Compared with patients with EM, patients with CM were twice as likely to receive at least 20 MME/day (CM 3.8% vs EM 1.9%) and had a higher median opioid day supply (CM 20 vs EM 10) during follow-up. About 7% of patients with CM with at least 1 opioid prescription had at least 50 MME/day in any 90-day period during follow-up. A significant association was found between MME level and the likelihood of new-onset CM. Additional significant risk factors of migraine progression included younger age, female sex, South and West regions, and having a diagnosis of medication overuse headache, depression, back pain, or fibromyalgia (all P < 0.05). CONCLUSIONS: Despite guidelines and the availability of more migraine-specific treatments, opioids are still commonly prescribed to patients with migraines in real-world practice, especially for those with CM. In this study population, a higher risk of new-onset CM was associated with receiving higher opioid doses.

Influence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration.

AIM: To investigate the influence of pharmacists' attitudes on intention to report serious adverse drug events (ADEs) to the Food and Drug Administration (FDA). METHODS: This cross-sectional study used a mail survey to collect data from hospital and community pharmacists practicing in Texas, United States. Three and 16 items were used to measure intention and attitudes, respectively, using a seven-point bipolar scale. Pharmacists' demographic and practice characteristics, and past reporting were also measured. RESULTS: The response rate was 26.4% (n= 377/1500 pharmacists). Most pharmacists intended (n= 297, 78.8%) to report serious ADEs that they will encounter to the FDA through MedWatch. Overall, pharmacists held favourable attitudes towards reporting serious ADEs (mean = 24.5, SD = 6.7, possible range 1-49, neutral = 16). Pharmacists intending to report serious ADEs had more favourable attitudes than those who did not (P < 0.001). About 90% of the pharmacists believed that reporting serious ADEs would improve patient safety. However, 72.6% indicated that reporting serious ADEs was time consuming and over half (55.5%) of the respondents believed that reporting serious ADEs disrupted the normal workflow. Non-intenders held stronger beliefs that ADE reporting would disrupt the normal workflow and was time consuming compared with intenders. Years of experience, number of hours worked and practice setting were associated with pharmacists' attitudes towards reporting (P < 0.05). CONCLUSIONS: Most pharmacists held moderately favourable attitudes and high intentions toward reporting serious ADEs to the FDA. This study's findings contribute to an increased understanding of individual factors that influence pharmacists' attitude and intention towards reporting serious ADEs to the FDA.

Cost-effectiveness of lanthanum carbonate versus sevelamer hydrochloride for the treatment of hyperphosphatemia in patients with end-stage renal disease: a US payer perspective.

OBJECTIVE: To assess the cost-effectiveness of lanthanum carbonate (LC) versus sevelamer hydrochloride (SH) as a treatment for hyperphosphatemia in end-stage renal disease (ESRD) patients. METHODS: A Markov model was developed to estimate health outcomes; quality-adjusted life years (QALYs) and life-years saved (LYS), as well as associated costs. The model incorporated patient-level data from a randomized head-to-head crossover study that compared the reduction of serum phosphorus using LC and SH for 4 weeks each. The model included patients previously treated with calcium-based binders. Both the intent-to-treat (ITT) population and the cohort of patients who completed treatment in both periods of the study (i.e., completer population) were assessed. The baseline risks of cardiovascular disease (CVD), all-cause mortalities for CVD, and non-CVD patients were derived from a large US renal database. Patient outcomes were modeled for 10 years, and incremental cost-effectiveness ratios (ICERs) were calculated for LC relative to SH. Deterministic and probabilistic sensitivity analyses (PSA) were performed to test the robustness of the base-case model. RESULTS: For the ITT population, the ICERs of LC versus SH were $24,724/QALY and $15,053/LYS, respectively (in US dollars). When the completer population was considered, the ICERs of LC versus SH were $15,285/QALY and $9,337/LYS (Table 2), respectively. The PSA indicated 61.9% and 85.8% probabilities for ITT and completer populations of LC being cost-effective at the $50,000/QALY willingness-to-pay threshold, respectively. CONCLUSION: LC is a cost-effective strategy compared with SH in the treatment of ESRD patients with hyperphosphatemia who were previously treated with calcium-based binders. Sensitivity analyses demonstrated the robustness of the pharmacoeconomic model.