Risk Factors Associated with a First Exacerbation Among Patients with COPD Classified as GOLD A and B in Routine Clinical Practice in the UK.

Purpose: Risk factors for exacerbations of chronic obstructive pulmonary disease (COPD) have been previously characterized for patients with more severe cases of COPD. It is unclear how the risk of first exacerbation may best be identified in patients with less severe disease. This study investigated risk factors for first exacerbation among English patients with COPD classified as Global Initiative for Chronic Obstructive Lung Disease (GOLD) group A or B. Patients and Methods: A retrospective cohort study using data from the UK Clinical Practice Research Datalink (CPRD) AURUM linked to Hospital Episode Statistics. Patients with COPD aged ≥35 years and classified as GOLD group A or B (2020 criteria) from January 2013-December 2019 were eligible. Patients were required to have 24 months history in CPRD (baseline). Two cohorts were defined: cohort 1 included patients with no severe exacerbations during baseline; cohort 2 included patients with no moderate or severe exacerbations during baseline. Risk factors associated with severe, or combined moderate and severe exacerbation were examined for up to 5 years of follow-up. Results: Overall, 194,948 patients were included in cohort 1 (mean age 66.2 years; 55.2% male), and 148,396 patients in cohort 2 (mean age 66.1 years; 56.6% male). Identified risk factors for exacerbation (and associated 1-year absolute risk of severe, or combined moderate and severe exacerbation, respectively) included: Medical Research Council dyspnea scale score (15.9%/28.4%); COPD Assessment Test score (9.6%/25.3%); GOLD grade of airflow limitation (forced expiratory volume in 1 second % predicted; 13.6%/27.5%); and lung cancer (8.1%/23.6%). After adjustment for risk factors, these factors remained independently associated with severe exacerbation at 1, 3, and 5 years of follow-up. Conclusion: The identified risk factors may aid physicians in the early recognition of patients with COPD classified as GOLD group A or B at risk of first exacerbation.

Predicting initiation of preventive migraine medications: exploratory study in a large U.S. medical claims database.

Objective: Despite guidelines that identify potential patients eligible for preventive migraine medications, their underutilization leaves patients at risk of acute medication overuse, disease progression, and higher healthcare resource utilization and disability. This exploratory, retrospective, observational study aimed to identify which factors predict preventive migraine medication initiation. Demographics and initiation of acute medication use were hypothesized to be predictive of initiation of preventive migraine medication.Methods: The Truven Health Analytics MarketScan1 U.S. Commercial and Medicare Supplemental claims database (2011-2013) was used to identify adults newly diagnosed with migraine. Patients were divided into 2 subgroups: initiated a preventive migraine medication (antidepressants, anti-epileptics, beta-blockers, or neurotoxins) within 1 year of migraine diagnosis and did not initiate a preventive migraine medication. Logistic regression models were constructed to identify factors associated with preventive migraine medication initiation.Results: Study population included 147,923 patients: 43,660 preventive migraine medication initiators and 104,263 non-preventive migraine medication patients. Best-fit model for predicting preventive migraine medication initiation included: female gender (odds ratio = 1.181 [95% CI = 1.144,1.218]; measured at date of first migraine diagnosis); headache diagnosis prior to migraine diagnosis (odds ratio = 1.538 [95% CI = 1.498,1.579]; measured 1-year before first migraine diagnosis); and sleep disorder (odds ratio = 1.206 [95% CI = 1.161,1.252]), headache/migraine-specific Emergency Department (ED) visit (odds ratio = 1.224 [95% CI = 1.168,1.283]), neurologist visit (odds ratio = 1.502 [95% CI = 1.459,1.547]), and acute medication refills with <90-day gap (odds ratio = 1.509 [95% CI = 1.470,1.549]) each measured at 1-year before first preventive migraine medication.Conclusions: In addition to consistent acute medication refills, specific comorbidity diagnoses, headache/migraine-specific ED utilization, and neurologist care are predictive of preventive migraine medication initiation in the 1-year post-incident migraine diagnosis.

Enhancing the Budget Impact Model for Institutional Use: A Tool with Practical Applications for the Hospital Oncology Pharmacy.

BACKGROUND: The cost of cancer care is increasing, and tools are needed to understand the economic impact of new drugs on the hospital pharmacy budget. OBJECTIVE: To develop an interactive budget impact model (BIM) through a collaborative effort of industry, academia, and modeling experts to evaluate the use of a new agent in non-small cell lung cancer (NSCLC); this BIM included an institutional module specific to the needs of practices that purchase medications for use in institutional settings. METHODS: Treatment regimens, doses, duration of therapy, toxicity, and cost data are from published sources. All input data may be modified to match the local population. Outputs include cost of care, reimbursement, and margin overall and by treatment regimen. RESULTS: The base case assumes 20 NSCLC patients progressing after initial therapy (3 receiving ramucirumab+docetaxel, 2 bevacizumab+erlotinib, 3 docetaxel, 6 erlotinib, and 6 pemetrexed), wholesale acquisition cost (WAC) purchase price, and reimbursement at WAC+4.3%. The model estimated the total cost and reimbursement for the institutional oncology pharmacy to be $699,413 and $729,487, respectively, resulting in a margin of $30,075 (difference due to rounding) for the year for regimens utilized in the treatment of NSCLC in the post-progression setting. Results will vary depending on the input data. CONCLUSIONS: There is an increasing need for institutional pharmacies to plan ahead and anticipate the impact of new drugs on their oncology budgets. This interactive Excel-based institutional BIM may provide evidence-based support for pharmacy decision making.

Measurement of testosterone: how important is a morning blood draw?

OBJECTIVE: Since testosterone levels exhibit a circadian variation with peak levels in the morning, evidence-based guidelines recommend measuring morning total testosterone (TT) levels as the initial diagnostic test for androgen deficiency. However, it has been suggested that morning blood draw may not be necessary in older men due to a blunted circadian rhythm. We sought to determine whether it is possible to expand the morning sampling window for measurement of TT. RESEARCH DESIGN AND METHODS: TT levels were measured in a subset of men (mean age of 61 years) participating in the 2013 Prostate Cancer Awareness Week. RESULTS: TT levels measured in blood drawn from 8 to 11 AM (n = 229) differed significantly from those drawn outside this window (n = 442) (411.7 vs 368.3 ng/dl; p = 0.0003). Differences in TT levels were evident across five blood draw time windows (p = < 0.0001) and persisted after adjustment for age and BMI. TT levels in blood drawn from 2 to 5 PM (344.3 ng/dl) and 5 to 8 PM (334.4 ng/dl) differed significantly from that drawn from 8 to 11 AM (p < 0.05), while TT levels from 11 AM to 2 PM (396.5 ng/dl) and 8 PM to 8 AM (373.4 ng/dl) did not (p = 0.90 and 0.73, respectively). CONCLUSION: Based on these findings, it may be possible to expand the blood draw time window for measurement of serum TT. This community-based study was not prospectively design to determine the most appropriate blood draw window for TT measurement. Only a single TT measurement was made without consideration for day-to-day variability, and TT levels were not measured in the same men at different blood draw times.

Initiation of human regular U-500 insulin use is associated with improved glycemic control: a real-world US cohort study.

AIM: Describe the characteristics of patients initiating human regular U-500 insulin (U-500R) and their subsequent glycemic control in a real-world setting. METHODS: US Humedica electronic health record system data (July 2007-September 2011) were used to identify patients with diabetes aged ≥18 years with ≥1 records for U-500R prescriptions, 6 months of preindex data, 12 months following first use of U-500R, and at least one glycated hemoglobin (HbA1c) value in both preindex and postindex periods. Paired t tests were used to measure the change in HbA1c from preindex to postindex periods (last or most recent values) and hypoglycemia. RESULTS: Among patients initiating U-500R (N=445), 96.9% had type 2 diabetes with mean age 57 years and mean body mass index 40.4 kg/m(2). Postindex prescriptions were written for U-500R alone (47.0%, group A) and concomitant U-500R/U-100 insulins (53.0%, group B). Concomitant oral antihyperglycemic agents (AHAs) and non-insulin injectable AHAs were used by 43.4% and 14.6% of patients, respectively. Following initiation of U-500R, mean HbA1c improved 0.68% in all patients (p<0.0001 compared with baseline), but the decrease in HbA1c did not differ significantly between groups (A: 0.78%; B: 0.60%). Overall, hypoglycemic events, largely captured in the outpatient setting, increased in incidence from 6.7% to 11.9% (p≤0.0001) and from 0.23 to 0.39 events/patient/year, an increase of 0.16 (p=0.003), from preindex to postindex. CONCLUSIONS: This real-world outcomes analysis demonstrates that U-500R initiation is associated with a clinically meaningful improvement in glycemic control over the subsequent 12-month period with modest increase in incidence and rate of hypoglycemia.

Treatment patterns in alpha-blocker therapy for benign prostatic hyperplasia.

This study examined treatment patterns and patient characteristics of men initiating alpha adrenergic blocker therapy (alpha-blocker) for benign prostatic hyperplasia (BPH). The 2009 Thomson Reuters MarketScan® Database was used to identify the newly initiated alpha-blocker: men ≥40 years old with continuous medical and pharmacy coverage for 12 months before and after alpha-blocker initiation, with no alpha-blocker or 5-alpha-reductase inhibitors in the previous year, and with ≥1 BPH diagnosis within 1 month before and 6 months after alpha-blocker initiation. This study analyzed patient demographics, clinical characteristics, adherence (percentage of men achieving medication possession ratio [MPR] ≥ 0.8), restarting the same alpha-blocker after discontinuation, switching to another BPH medication, and type of alpha-blocker (alpha 1 type selective or alpha 1 subtype selective agents). T tests and chi-square tests compared differences at the .05 significance level. A total of 13,474 men met the study criteria (mean age of 63.1 years). Two thirds of the men discontinued alpha-blocker in the 12-month period, among which restarts or switches were statistically different (p = .036) but numerically similar across cohorts. Adherence for alpha 1 type selective agents versus alpha 1 subtype selective agents at 6 months was 43.3% versus 38.1% (p < .01); at 12 months, 34.4% versus 30.5% (p < .01). Alpha-blocker discontinuation rates were high, which confirms low medication adherence reported among medications for several other chronic conditions; therefore, it is necessary to understand the reasons for alpha-blocker discontinuation.

Early discontinuation and suboptimal dosing of duloxetine treatment in patients with major depressive disorder: analysis from a US third-party payer perspective.

OBJECTIVE: Little is known about early discontinuation of duloxetine therapy or the effect that initial dose has on discontinuation in patients with major depressive disorder (MDD). METHODS: Data from a private payer insurance claim database included 6132 patients with MDD who started duloxetine between 7/1/2005 and 6/30/2006, had no prescription for duloxetine in the previous 3 months, and were enrolled for 12 months before and after initiation. Chi-square tests, t-tests, and logistic regression were used to compare demographic, clinical, and healthcare cost data stratified by length of continuation. Early discontinuation was defined as continuation ≤30 days. Healthcare costs, persistence, and adherence were compared between patients with suboptimal initial dose (<40 mg/day) and those with recommended initial dose (40-60 mg/day). RESULTS: Discontinuation rates were 16.8% at ≤30 days, 16.7% at 31-90 days, 14.9% at 91-180 days, and 51.6% at >180 days. Suboptimal initial dose, younger age, male gender, prior benzodiazepine use, insomnia, psychiatric disorders, infectious diseases, digestive disorders, genitourinary disorders, and injury/poisoning increased the likelihood of early discontinuation (Odds ratios [ORs]: 1.18-2.16), while recent use of SSRIs or venlafaxine XR decreased the likelihood (ORs: 0.67-0.68). Compared with patients who persisted with therapy for >180 days, patients who discontinued early had more hospital admissions, longer hospital stays, and more ER visits during the 1-year follow-up (all p-values <0.01). Patients with an initial dose <40 mg/day had shorter persistence (p < 0.001) and lower rates of adherence (p < 0.001) compared with patients with an initial dose of 40-60 mg/day. LIMITATIONS: Limitations of this study were those of all analyses based on data from insurance claim databases. CONCLUSIONS: Early discontinuation was associated with increased healthcare utilization. Demographic and clinical predictors of early discontinuation were identified that may help target care for at-risk patients. Beginning therapy within the recommended dose range may improve persistence.