Beth Hahn

Impact of Irritable Bowel Syndrome on Quality of Life and Resource Use in the United States and United Kingdom

Background: Although irritable bowel syndrome (IBS) is not a life-threatening condition, it can have a serious impact on a patient’s daily activities and quality of life. This effect on quality of life has not been compared previously across different cultures. Methods: We compared measures of health-related quality of life and health care resource utilization using a cross-sectional point-in-time postal survey of a random sample of 500 members of the International Foundation for Functional Gastrointestinal Disorders in the US and 500 members of the IBS Network support group in the UK. The analysis was limited to persons who reported that a physician had told them they had IBS. A general health status questionnaire, the SF-36, and a disease-specific questionnaire, the Irritable Bowel Syndrome Quality of Life questionnaire (IBSQOL), were self-administered as part of the survey to measure health-related quality of life. Results on the SF-36 were compared with published normative data for adults in the US and UK with and without chronic diseases. Results: The UK group (n = 343) reported significantly poorer quality of life on the SF-36 and on four parameters of the IBSQOL than did the US group (n = 287). The general health status of persons with IBS in either country was much poorer compared with that of general populations in the respective countries. Health care resource utilization (i.e. emergency room, doctor and hospital outpatient visits) of persons with IBS was similar in the two countries, as was the direct effect of IBS on employment. Nearly one third of those surveyed missed at least 1 day of work due to IBS in the previous 4 weeks, and a greater percentage cut back in their work or activites due to IBS. Taken together, average time lost or cut back amounted to nearly 5 days or 1 work-week. Conclusion: IBS has a significant impact on quality of life and resource use in both the US and UK. The effect on quality of life, however, appears to be greater in the UK than in the US.

Clarithromycin-resistant helicobacter pylori in patients with duodenal ulcer in the united states

Background:Clarithromycin is a key component of several antimicrobial treatment regimens for Helicobacter pylori. Cure rates with clarithromycin-containing regimens are significantly decreased when resistance is present. Resistance develops by a point mutation in the ribosomal RNA of some organisms exposed to clarithromycin. We studied the prevalence of clarithromycin-resistant organisms in patients with duodenal ulcer in the United States from 1993–96.Methods:Patients with endoscopic evidence of a duodenal ulcer were studied. Gastric biopsies were cultured for H. pylori and antimicrobial sensitivity was determined by the E-test (epsilometer agar diffusion gradient).Results:In 1993–94, three of 78 patients (4%) had clarithromycin-resistant strains of H. pylori. In 1995–96, 44 of 348 patients (12.6%; p= 0.025) had resistant strains of H. pylori. Patients who had previously failed antimicrobial treatment for H. pylori accounted for much of the increase in resistant strains (25%).Conclusions:Failed therapy with clarithromycin-based regimens is a growing cause of antimicrobial resistance in H. pylori in the United States. Whereas the overall rates of primary resistance are low, the increase in secondary resistance over a short period of time is worrisome. New treatments that prevent the emergence of resistance may be important in the future.

Alosetron improves quality of life in women with diarrhea-predominant irritable bowel syndrome

OBJECTIVES:The aim of this study was to assess the impact of alosetron, a treatment recently approved in the United States for irritable bowel syndrome in diarrhea-predominant female patients, on health-related quality of life.METHODS:Quality of life was assessed as part of two 12-wk randomized, double-blind, placebo-controlled irritable bowel syndrome studies comparing alosetron 1 mg b.i.d. with placebo (S3BA3001 and S3BA3002). Patients completed a validated disease-specific quality of life questionnaire, the Irritable Bowel Syndrome Quality of Life Questionnaire (IBSQOL), at baseline and at the 12-wk or final visit. The clinical relevance of data were also evaluated by a minimal meaningful difference instrument.RESULTS:A total of 626 and 647 patients were enrolled in studies S3BA3001 and S3BA3002, respectively. Approximately 70% of patients in each study had diarrhea-predominant IBS. In diarrhea-predominant patients enrolled in S3BA3001, statistically significant (p < 0.05) improvements with alosetron versus placebo were observed on all nine IBSQOL scales (emotional health, mental health, sleep, energy, physical functioning, food/diet, social functioning, role–physical, and sexual relations) and for all but one scale (mental health) in S3BA3002. In both studies, a significantly greater percentage of patients treated with alosetron (p < 0.05) experienced clinically meaningful improvement on three of the nine IBSQOL scales (food/diet, social functioning, and role–physical) compared with patients treated with placebo. Patients treated with alosetron did not show worsening in any quality of life domain compared with patients treated with placebo.CONCLUSIONS:These results in women with diarrhea-predominant IBS demonstrate that alosetron significantly improves health-related quality of life.

Systematic literature review and meta-analysis of US-approved LAMA/LABA therapies versus tiotropium in moderate-to-severe COPD

Dual bronchodilator maintenance therapy may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) versus long-acting muscarinic antagonist (LAMA) monotherapy. The efficacy and safety of US-approved LAMA/long-acting beta-agonist (LABA) combinations versus tiotropium (TIO), a LAMA, were assessed. This systematic review and meta-analysis (GSK: 206938), conducted in MEDLINE, MEDLINE In-process, and EMBASE following Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines, identified randomized clinical trials (>8 weeks) in moderate-to-severe COPD (per Global Initiative for Chronic Obstructive Lung Disease guidelines), receiving LAMA/LABA or TIO. Endpoints: difference in change from baseline in lung function (forced expiratory volume in 1 s [FEV1]; trough, peak, area under the curve 0–3 h post-dose (AUC0–3), St George’s Respiratory Questionnaire (SGRQ) responder rate (≥4-unit improvement), SGRQ total score, and rescue medication use at 12 and 24 weeks. Safety was also assessed. From 5683 citations, the meta-analysis included eight clinical trials. LAMA/LABA significantly improved FEV1 trough (Week 12: 63.0 mL, 95% confidence intervals [CI]: 39.2, 86.8; Week 24: 66.1 mL, 95% CI: 40.0, 92.3), peak (Week 12: 91.5 mL, 95% CI: 70.5, 112.4; Week 24: 92.4 mL, 95% CI: 72.9, 111.9), AUC0–3 (Week 12: 126.8 mL, 95% CI: 108.1, 145.4), SGRQ responder rate at Week 12 (risk ratio: 1.19; 95% CI: 1.09, 1.28), mean SGRQ total score (Week 12: −1.87, 95% CI: −2.72, −1.02; Week 24: −1.05, 95% CI: −2.02, −0.09), and rescue medication use (Week 24: −0.47 puffs/day, 95% CI: −0.64, −0.30) versus TIO (all p ≤ 0.03). The SGRQ responder rate at 24 weeks and adverse events were not significantly different between treatments. US-approved LAMA/LABA therapies improved lung function, SGR,Q and rescue medication use versus TIO, without compromising safety.Chronic lung disease: Examining dual therapy efficacyDual maintenance therapies combining two types of long-acting bronchodilator appear to be effective and safe for treating moderate-to-severe chronic obstructive pulmonary disease (COPD). Given that patients with COPD often have poor quality of life and, in the US, incur substantial healthcare costs, it is vital to provide optimal symptom management to improve lung function and limit exacerbations over time. Beth Hahn at GSK, North Carolina, and co-workers carried out a literature review and meta-analysis of 8 clinical trials, which indicates that combined long-acting muscarinic antagonist (LAMA)/long-acting beta-agonist (LABA) treatments—currently prescribed in the US—are an effective and safe way of tackling COPD symptoms. The team compared patients using LAMA/LABA for 12 weeks with those on single LAMA (tiotropium) treatment and found LAMA/LABA significantly improved lung function and reduced exacerbation risk.

Rates of escalation to triple COPD therapy among incident users of LAMA and LAMA/LABA

BACKGROUND Improved outcomes have been reported for patients with chronic obstructive pulmonary disease (COPD) receiving combination long-acting muscarinic antagonist/long-acting β2-agonist (LAMA/LABA) therapy compared with LAMA monotherapy. However, little is known about the relative characteristics of these patients and their rates of escalation to triple therapy (TT, combining a LAMA, LABA, and inhaled corticosteroid). This study aimed to characterize patients initiating treatment with the LAMA tiotropium (TIO) and the fixed-dose LAMA/LABA combination therapy umeclidinium/vilanterol (UMEC/VI), and to compare rates of escalation to TT between patients receiving these therapies. METHODS Retrospective study of patients with COPD enrolled in a US health insurance plan during 2013-2015 and newly initiated on TIO or UMEC/VI. Patients were ≥40 years of age at index (date of therapy initiation) with continuous enrollment for 12 months pre-index and ≥30 days post-index. LAMA users were propensity score matched 1:1 to LAMA/LABA users, with TT initiation rates reported by cohort using pharmacy claims. RESULTS 35,357 patients initiating on TIO and 2407 patients initiating on UMEC/VI were identified. After propensity score matching, the rate of TT initiation was significantly higher in new TIO users (n = 1320) than in new UMEC/VI users (n = 1320) (0.92 vs 0.49 per 100 months of exposure, respectively; p < 0.001). Relative to the UMEC/VI cohort, the TIO cohort had an 87% higher risk of TT initiation (hazard ratio: 1.87; 95% confidence interval: 1.4-2.5; p = 0.001). CONCLUSIONS Patients receiving UMEC/VI progressed to TT more slowly, and were at lower risk of progressing to TT, than patients receiving TIO.

Effects of Systemic Corticosteroids on Blood Eosinophil Counts in Asthma: Real-World Data

Abstract Introduction: Systemic corticosteroids (SCS) are effective anti-inflammatory therapies for patients with severe or persistent asthma. Use of SCS reduces blood eosinophil counts; the magnitude and duration of reduction in real-world settings needs further investigation. Objective: To examine the SCS effect on blood eosinophil counts over time among patients with asthma in a real-world setting. Methods: This retrospective study used Reliant Medical Group (Worcester, MA) electronic medical records between January 2011 and December 2015. Patients aged ≥12 years with ≥1 SCS prescription (first: index date), ≥1 asthma diagnosis, and ≥1 eosinophil count in each 12-month pre- and post-index periods were included for the study. Endpoints included SCS treatment patterns, time to SCS discontinuation, and changes in index blood eosinophil counts (≥150, ≥300, and ≥400 cells/µL) with SCS initiation and discontinuation. Results: At index visit, 642 of 1198 included patients had a blood eosinophil count ≥150 cells/µL. After an average initial SCS prescription of 35 mg/day, mean (% change) eosinophil counts at month 1 in the ≥150, ≥300, and≥400 cells/µL subgroups decreased from index by 112 (−30%), 202 (−34%), and 290 (−36%) cells/µL, respectively. Of the patients with an eosinophil count ≥150 cells/µL at index, who discontinued SCS within 7, 14, or 21 days after the index date, 21%, 26%, and 25% had an eosinophil count <150 cells/µL 1-month post-index, respectively. Conclusion: Blood eosinophil counts decreased following initiation of SCS therapy and had not returned to index levels several weeks after SCS discontinuation. The time frame of SCS discontinuation is an important consideration when identifying patients with eosinophilic asthma.

Burden of disease associated with a COPD eosinophilic phenotype

Purpose Based on blood and sputum samples, up to 40% of patients with COPD have eosinophilic inflammation; however, there is little epidemiology data characterizing the health care burden within this sub-population. Given that COPD-attributable medical costs in the USA are predicted to approach

Health characteristics of patients with asthma, COPD and asthma–COPD overlap in the NHANES database

50 billion by 2020, we analyzed the effect of blood eosinophil counts and exacerbations on health care resource utilization and costs. Patients and methods This cross-sectional study used electronic medical records and insurance claims data from the Reliant Medical Group (January 2011–December 2015). Eligible patients were ≥40 years of age, continuously enrolled during the year of interest (2012, 2013, 2014, or 2015), had ≥1 COPD-related code in the preceding year, and documented maintenance therapy use. Patients with ≥1 blood eosinophil count recorded were stratified into 2 cohorts: <150 cells/µL and ≥150 cells/µL. Endpoints included demographics, clinical characteristics, health care resource utilization, and costs. The impact of blood eosinophil count and exacerbation patterns on health care resource utilization and costs was assessed with multivariate analyses. Results On average, 2,832 eligible patients were enrolled annually, of whom ~28% had ≥1 eosinophil count recorded during the year. The ≥150 cells/µL cohort had numerically higher all-cause and COPD-related health care resource utilization and cost each year compared with the <150 cells/µL cohort, but varied by service and year. Among patients with exacerbations, the ≥150 cells/µL cohort exhibited significantly higher COPD-related costs compared with the <150 cells/µL cohort. Conclusion Blood eosinophil counts may be a useful biomarker for burden of disease in a subgroup of patients with COPD.

MATERNAL PSYCHOLOGICAL DISTRESS : THE ROLE OF CHILDREN'S HEALTH

Introduction Asthma and COPD have overlapping characteristics. As there are limited data on whether asthma–COPD overlap (ACO) represents a distinct condition, this study aimed to determine the similarities and differences of ACO with asthma and COPD. Methods US population-based, cross-sectional study using National Health and Nutrition Examination Survey data (2009–2012) compared participants with ACO vs those with asthma or COPD, each as mutually exclusive disease states. Demographics, health status, disability/limitations, health care resource utilization, clinical characteristics, and peripheral blood eosinophil counts were analyzed. Results A total of 1,609, 479, and 299 participants with asthma, COPD, and ACO, respectively, were included. An age-matched asthma subgroup included 299 participants from the asthma group. Compared with asthma and COPD, participants with ACO had worse health status, increased disease burden, and more comorbid conditions. The ACO, vs age-matched asthma subgroup, had lower percent predicted prebronchodilator forced expiratory volume in 1 second (82.1% vs 88.0%; P=0.017). The ACO group had significantly more asthma attacks in the past year than the age-matched asthma subgroup (49.8% vs 38.4%; P<0.001). The ACO group had more participants with postbronchodilator forced expiratory volume in 1 second <80% predicted (52.1%) vs COPD (30.8%; P=0.003) and more participants with blood eosinophil counts ≥400 cells/µL (16.9%) vs COPD (9.5%; P=0.007) and the asthma subgroup (6.7%; P=0.014). Conclusion The ACO group represents an important subset of patients with chronic respiratory disease with an increased burden of disease over asthma and COPD individually. Early identification of this population will enable appropriate therapeutic interventions in a timely manner.