Symptom Burden and GOLD Classification in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone Propionate/Salmeterol Therapy.

Background: Long-acting muscarinic antagonist/long-acting ß2-agonist (LAMA/LABA) provide greater improvements in lung function and symptoms than inhaled corticosteroid (ICS)/LABA in patients with chronic obstructive pulmonary disease (COPD). This study evaluated symptom burden and Global Initiative for Obstructive Lung Disease (GOLD) categorization among patients who recently initiated umeclidinium/vilanterol (UMEC/VI; LAMA/LABA) or fluticasone propionate/salmeterol (FP/SAL; ICS/LABA) single-inhaler dual therapy. Methods: COPD-diagnosed Medicare Advantage enrollees aged ≥65 years were identified from the Optum Research Database (ORD). Eligible patients had ≥1 pharmacy claim for UMEC/VI or FP/SAL in the 6-month period before sample identification, with no evidence of triple therapy (ICS/LAMA/LABA), asthma, or lung cancer. Symptom burden was assessed via cross-sectional surveys using the COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) dyspnea scale. Patients were classified into GOLD categories using patient-reported symptoms and claims-based exacerbation history. Treatment groups were balanced on potential confounders using inverse probability of treatment weighting (IPTW). CAT and mMRC scores were analyzed with generalized linear regression models using IPTW propensity scores. Results: The final analytic sample included 789 respondents (UMEC/VI: N=392; FP/SAL: N=397). Approximately 66% patients were classified as GOLD B when assessing symptoms with CAT and mMRC together, or CAT alone; more patients were classified as GOLD A (~40%) than GOLD B (~36%) using mMRC alone. Proportions of patients in each GOLD group were similar between treatment cohorts. Post-IPTW multivariable modeling showed similar symptom burden between treatment groups. Conclusion: After controlling for baseline characteristics, symptom burden was similar between patients receiving UMEC/VI or FP/SAL. GOLD classification using mMRC produced more conservative results compared with CAT, potentially underestimating patient symptoms. Many patients receiving FP/SAL were classified as GOLD A or B, despite GOLD recommending non-ICS-containing therapy in these patients. These findings support the need for routine assessment of symptoms in patients with COPD.

The Impact of Stool Consistency on Bowel Movement Satisfaction in Patients With IBS-C or CIC Treated With Linaclotide or Other Medications: Real-World Evidence From the CONTOR Study.

GOALS: This study aimed to characterize the impact of stool consistency on patient-reported bowel movement (BM) satisfaction in patients with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation, with a focus on linaclotide. BACKGROUND: As new medications for constipation become available, understanding patients' perceptions of treatment effects may help clinicians manage patient expectations and inform clinical decision-making. MATERIALS AND METHODS: Data were derived from the Chronic Constipation and IBS-C Treatment and Outcomes Real-world Research Platform (CONTOR) study from 2 patient-reported 7-day daily BM diaries to create a dataset of 2922 diaries representing 26,524 BMs for 1806 participants. Binary variables were created for: medication(s) used in the past 24 hours and categorization of BMs as loose or watery stools (LoWS), hard or lumpy stools (HoLS), or intermediate (neither LoWS nor HoLS). The relationship between stool consistency, medication use, and BM satisfaction was analyzed using logistic regression with SEs corrected for repeated observations. RESULTS: BMs characterized as intermediate stools and LoWS were satisfactory more often (61.2% and 51.2%, respectively) than HoLS (19.4%). Participants who reported taking linaclotide rated a similar proportion of BMs as satisfactory when described as LoWS (65.6%) or intermediate (64.1%). Linaclotide use was associated with higher odds of BMs being reported as satisfactory compared with nonlinaclotide use (odds ratio: 1.23, P<0.05). CONCLUSIONS: Overall, CONTOR participants were more likely to report BMs classified as LoWS or intermediate as satisfactory, versus HoLS. Participants taking linaclotide were more likely to be satisfied, particularly those reporting LoWS, versus those not taking linaclotide.

Patient-Reported Burden of Illness in a Prevalent COPD Population Treated with Long-Acting Muscarinic Antagonist Monotherapy: A Claims-Linked Patient Survey Study.

INTRODUCTION: Symptom burden in inadequately controlled chronic obstructive pulmonary disease (COPD) considerably impacts quality of life, healthcare resource utilization (HCRU) and associated costs. This claims-linked cross-sectional survey study assessed symptom burden and HCRU among a prevalent population of COPD patients prescribed long-acting muscarinic antagonist (LAMA) monotherapy. METHODS: Patients were identified using claims data from the Optum Research Database. Eligible patients were aged ≥ 40 years with 12 months' continuous enrollment in a US health plan, ≥ 2 medical claims containing COPD diagnosis codes ≥ 30 days apart, and ≥ 2 claims for LAMA monotherapy in the latter half of the 12-month sample identification period. Patients were mailed a cross-sectional survey assessing patient-reported outcomes (PROs) [COPD assessment test (CAT) and modified medical research council dyspnea scale (mMRC)], clinical characteristics, smoking history, and demographics. Patients also completed the Exacerbations of Chronic Pulmonary Disease Tool (EXACT-PRO) daily diary for 7 days. HCRU was assessed from claims data. RESULTS: The study included 433 patients with a self-reported healthcare provider COPD diagnosis, and both claims-based and self-reported LAMA monotherapy treatment (mean age 71.0 years; 59.8% female). Most patients (85.5%) reported a high symptom burden (CAT score ≥ 10), 45.5% had high levels of dyspnea (mMRC grade ≥ 2), and 64.4% reported more severe daily symptoms by the EXACT-PRO. Most patients (71.6%) reported high scores on ≥ 2 PROs. More patients with high symptom burden had COPD-related emergency department visits than those with lower disease burden (27.6% vs 12.7%, P = 0.012). CONCLUSIONS: In conclusion, a large proportion of patients with COPD receiving LAMA monotherapy experienced a high symptom burden and may benefit from therapy escalation. Healthcare professionals can use validated PROs to help them assess symptom burden. FUNDING: GlaxoSmithKline (GSK study number: 205862).

Health Care Resource Use and Costs Pre- and Post-Treatment Initiation With Linaclotide: Retrospective Analyses of a U.S. Insured Population.

As expected, pharmacy costs increased with the introduction of this new treatment in a market dominated by over-the-counter and generic treatments. On the other hand, outpatient GI-related and irritable bowel disease health care resource use and costs substantially decreased among commercial and Medicare patients following linaclotide treatment initiation.

Clinical characteristics, healthcare costs, and resource utilization in hepatitis C vary by genotype.

BACKGROUND: In the United States, approximately 3 million people are infected with hepatitis C virus (HCV). Genotypes of HCV variably affect disease progression and treatment response. However, the relationships between HCV genotypes and liver disease progression, healthcare resource utilization, and healthcare costs have not been fully explored. RESEARCH DESIGN AND METHODS: In this retrospective study of patients with chronic hepatitis C (CHC), healthcare claims from a large US health plan were used to collect data on patient demographic and clinical characteristics. MAIN OUTCOME MEASURES: Main outcome measures include healthcare resource utilization (HCRU) and healthcare costs. Linked laboratory data provided genotype and select measures to determine liver disease severity. RESULTS: The sample (mean age 50.6 years, 63.5% male) included 10,331 patients, of whom 79.1% had genotype (GT)1, 12.8% had GT2, and 8.1% had GT3. Descriptive analyses demonstrated variation by HCV genotype in liver and non-liver related comorbidities, liver disease severity, and healthcare costs. The highest percentage of patients with liver-related comorbidities and advanced liver disease was found among those with GT3. Meanwhile, patients with GT2 had lower HCRU and the lowest costs, and patients with GT1 had the highest total all-cause costs. These differences may reflect differing rates of non-liver-related comorbidities and all-cause care. Multivariable analyses showed that genotype was a significant predictor of costs and liver disease severity: compared with patients having GT1, those with GT3 were significantly more likely to have advanced liver disease. Patients with GT2 were significantly less likely to have advanced disease and more likely to have lower all-cause costs. LIMITATIONS: Results may not be generalizable to patients outside the represented commercial insurance plans, and analysis of a prevalent population may underestimate HCRU and costs relative to a sample of treated patients. CONCLUSIONS: These results suggest that liver disease progression varies by genotype and that CHC patients with GT3 appear to have more severe liver disease. These findings highlight the importance of effective HCV treatment for all patients and support guidelines for treatment of high-risk patients, including those with GT3.

Quality of life of HIV-infected patients who switch antiretroviral medication due to side effects or other reasons.

OBJECTIVE: The objective of this study was to investigate changes in health-related quality of life (HRQOL) among HIV patients following switch from a first- to second-line antiretroviral therapy (ART) regimen. RESEARCH DESIGN AND METHODS: This was an observational study of adult HIV patients in the US at 35 academic and community health centers. Patients were required to be switching an antiretroviral regimen for the first time at the enrollment visit. Patients were assigned to a study cohort based on whether the switch was due to treatment-related side effects or for any other reason as reported by their physician. Patients completed the Medical Outcomes Study-Human Immunodeficiency Virus (MOS-HIV) health survey, the Depression, Anxiety, and Stress Scale Short Form (DASS-21), and the Human Immunodeficiency Virus Treatment Satisfaction Questionnaire-status (HIVTSQs) at the enrollment visit (baseline) and a follow-up survey was completed approximately 4 weeks later. The within cohort change in survey measures from baseline to follow-up was assessed by two-sample paired t-test. RESULTS: Patients who switched their ART regimen due to treatment-related side effects (n = 50) had statistically significant improvements (p < .05, baseline to follow-up) in mean Physical and Mental Health Summary scores (MOS-HIV scale) and in all three HIVTSQ summary scores. Patients who switched for other reasons (n = 44) did not experience statistically significant improvements in these same measures. CONCLUSIONS: HIV patients whose regimen was switched due to treatment-related side effects experienced an improvement in QOL following the switch. Physicians should take the potential impact on QOL into consideration when deciding on a switch in ART regimen, particularly when patients are intolerant of their current treatment. The results are based on a patient survey and may have been influenced by recall and response bias.