Rescue Medication Use as an Indicator of Symptom Burden in Patients with COPD: A Post Hoc Analysis of the EMAX Trial

Background: In chronic obstructive pulmonary disease (COPD), both the time needed for patients to gain symptom improvement with long-acting bronchodilator therapy and whether an early response is predictive of a sustained response is unknown. This study aimed to investigate how quickly meaningful symptom responses are seen in patients with COPD with bronchodilator therapy and whether these responses are sustained. Methods: Early MAXimisation of bronchodilation for improving COPD stability (EMAX) was a 24-week, double-blind, double-dummy, parallel-group trial that randomised patients to umeclidinium/vilanterol (UMEC/VI), umeclidinium or salmeterol. Daily Evaluating Respiratory Symptoms in COPD (E-RS:COPD) score and rescue salbutamol use were captured via an electronic diary and analysed initially in 4-weekly periods. Post hoc analyses assessed change from baseline in daily E-RS:COPD score and rescue medication use weekly (Weeks 1–8), and association between E-RS:COPD responder status at Weeks 1–4 and later time points. Results: In the intent-to-treat population ( n = 2425), reductions from baseline in E-RS:COPD scores and rescue medication use were apparent from Day 2 with all treatments. Treatment differences for UMEC/VI versus either monotherapy plateaued by Week 4–8 and were sustained at Weeks 21–24; improvements were consistently greater with UMEC/VI. For all treatments, most patients (60–85%) retained their Weeks 1–4 E-RS:COPD responder/non-responder status at Weeks 21−24. Among patients receiving UMEC/VI who were E-RS:COPD responders at Weeks 1–4, 70% were responders at Weeks 21–24. Conclusion: Patients with symptomatic COPD had greater potential for early symptom improvements with UMEC/VI versus either monotherapy. This benefit was generally maintained for 24 weeks. Early monitoring of treatment response can provide clinicians with an early indication of a patient’s likely longer-term response to prescribed bronchodilator treatment and will facilitate appropriate early adjustments in care. Clinical Trial Registration: NCT03034915, 2016-002513-22 (EudraCT Number). The reviews of this paper are available via the supplemental material section.

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Efficacy of umeclidinium/vilanterol according to the degree of reversibility of airflow limitation at screening: a post hoc analysis of the EMAX trial

Respiratory Research ◽

10.1186/s12931-021-01859-w ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Claus F. Vogelmeier ◽

Paul W. Jones ◽

Edward M. Kerwin ◽

Isabelle H. Boucot ◽

François Maltais ◽

...

Keyword(s):

Lung Function ◽

Rescue Medication ◽

Inhaled Corticosteroids ◽

Full Range ◽

Medication Use ◽

Airflow Limitation ◽

Chronic Obstructive ◽

Double Blind ◽

Once Daily ◽

Post Hoc

Abstract Background In patients with chronic obstructive pulmonary disease (COPD), the relationship between short-term bronchodilator reversibility and longer-term response to bronchodilators is unclear. Here, we investigated whether the efficacy of long-acting bronchodilators is associated with reversibility of airflow limitation in patients with COPD with a low exacerbation risk not receiving inhaled corticosteroids. Methods The double-blind, double-dummy EMAX trial randomised patients to umeclidinium/vilanterol 62.5/25 µg once daily, umeclidinium 62.5 µg once daily, or salmeterol 50 µg twice daily. Bronchodilator reversibility to salbutamol was measured once at screening and defined as an increase in forced expiratory volume in 1 s (FEV1) of ≥ 12% and ≥ 200 mL 10−30 min post salbutamol. Post hoc, fractional polynomial (FP) modelling was conducted using the degree of reversibility (mL) at screening as a continuous variable to investigate its relationship to mean change from baseline in trough FEV1 and self-administered computerised-Transition Dyspnoea Index (SAC-TDI) at Week 24, Evaluating Respiratory Symptoms-COPD (E-RS) at Weeks 21–24, and rescue medication use (puffs/day) over Weeks 1–24. Analyses were conducted across the full range of reversibility (−850–896 mL); however, results are presented for the range −100–400 mL because there were few participants with values outside this range. Results The mean (standard deviation) reversibility was 130 mL (156) and the median was 113 mL; 625/2425 (26%) patients were reversible. There was a trend towards greater improvements in trough FEV1, SAC-TDI, E-RS and rescue medication use with umeclidinium/vilanterol with higher reversibility. Improvements in trough FEV1 and reductions in rescue medication use were greater with umeclidinium/vilanterol compared with either monotherapy across the range of reversibility. Greater improvements in SAC-TDI and E-RS total scores were observed with umeclidinium/vilanterol versus monotherapy in the middle of the reversibility range. Conclusions FP analyses suggest that patients with higher levels of reversibility have greater improvements in lung function and symptoms in response to bronchodilators. Improvements in lung function and rescue medication use were greater with umeclidinium/vilanterol versus monotherapy across the full range of reversibility, suggesting that the dual bronchodilator umeclidinium/vilanterol may be an appropriate treatment for patients with symptomatic COPD, regardless of their level of reversibility.

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The relevance of baseline symptom burden in advanced gastroesophageal cancer to treatment toxicity assessment

10.21203/rs.3.rs-629797/v1 ◽

2021 ◽

Author(s):

Mark A Baxter ◽

Russell D Petty

Keyword(s):

Symptom Burden ◽

Toxicity Assessment ◽

Gastroesophageal Cancer ◽

Treatment Toxicity ◽

Post Hoc Analysis ◽

Perceived Impact ◽

Pre Treatment ◽

Gastroesophageal Adenocarcinoma ◽

Post Hoc ◽

Significant Symptom

Abstract Advanced gastroesophageal adenocarcinoma (GOA) is a poor prognosis disease associated with significant symptom burden at diagnosis. In this post-hoc analysis of the GO2 trial, we report the baseline symptom burden in the GOA patient cohort. We also demonstrate that by taking pre-treatment symptom burden into consideration, observed treatment related toxicity is significantly lower. We conclude that the reported perceived impact of treatment on toxicity in the GO2 trial was largely driven by baseline disease symptom burden. We propose a need for better methods of reported treatment toxicity in high symptom disease.

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Abstract 12948: Low Use of Statins in People With Type 2 Diabetes With or Without Cardiovascular Disease: A Capture Post Hoc Analysis

Circulation ◽

10.1161/circ.142.suppl_3.12948 ◽

2020 ◽

Vol 142 (Suppl_3) ◽

Author(s):

Jose Luis Arenas ◽

Fahri Byram ◽

Patrice Darmon ◽

Timothy Davis ◽

Guillermo Dieuzeide ◽

...

Keyword(s):

Type 2 Diabetes ◽

Serum Lipid ◽

Medication Use ◽

Study Participant ◽

Lipid Lowering ◽

Pcsk9 Inhibitors ◽

Post Hoc Analysis ◽

Post Hoc ◽

Statin Use

Background and aim: The association between LDL levels, CVD and the benefits of statin use are well established. The CAPTURE study estimated the contemporary (2019) global prevalence of CVD and medication use in adults with type 2 diabetes across 13 countries. This post hoc analysis assessed serum lipid status and statin use in people with type 2 diabetes without CVD (NoCVD), with established CVD, and atherosclerotic CVD (AsCVD, a subgroup of CVD). Methods: CAPTURE was a multinational, cross-sectional and non-interventional study. Participant information on CVD status, serum lipid profiles, and medication use were ascertained during single routine clinical visit in primary or specialist setting. This analysis included people who had data on serum LDL-C and lipid-lowering therapies. LDL-C targets were set at <100 mg/dL (<2.6 mmol/L) and <70 mg/dL (<1.8 mmol/L) for people without and with CVD/AsCVD, respectively according to the ADA 2019 guidelines. Data were analyzed descriptively. Results: The CAPTURE study enrolled 9823 people aimed to be representative of the general type 2 diabetes population. Most (>80%) had blood LDL-C information. Mean serum levels of lipids varied across 3 groups. (Table) The overall use of any statin was 38% in the NoCVD, 53% in CVD, and 55% in AsCVD groups. In those with documented serum LDL-C levels, 48% in the NoCVD, 67% in CVD, and 66% in AsCVD groups were above LDL-C targets with statin use of 34%, 57%, and 60%, respectively in these participants. Overall, the use of ezetimibe was 3-8% in all the groups and usually in combination with a statin. PCSK9 inhibitors use was <0.1% and used only in participants with CVD. (Table) Conclusion: In conclusion, this CAPTURE post hoc analysis found that two-thirds of people with CVD and AsCVD had LDL-C levels above recommendations and only around 60% of them were on statins. Intolerability of statins might partly explain this lower than expected statin use.

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Symptom burden and quality of life in patients with high-risk essential thrombocythaemia and polycythaemia vera receiving hydroxyurea or pegylated interferon alfa-2a: a post-hoc analysis of the MPN-RC 111 and 112 trials

The Lancet Haematology ◽

10.1016/s2352-3026(21)00343-4 ◽

2022 ◽

Vol 9 (1) ◽

pp. e38-e48 ◽

Cited By ~ 1

Author(s):

Gina L Mazza ◽

Carolyn Mead-Harvey ◽

John Mascarenhas ◽

Abdulraheem Yacoub ◽

Heidi E Kosiorek ◽

...

Keyword(s):

Quality Of Life ◽

Symptom Burden ◽

Pegylated Interferon ◽

Interferon Alfa ◽

Polycythaemia Vera ◽

Essential Thrombocythaemia ◽

Post Hoc Analysis ◽

Pegylated Interferon Alfa ◽

Post Hoc

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Abstract #295 GLP-1 Receptor Agonists and Death From Any Cause in Elderly Patients with Type 2 Diabetes Mellitus: A Post-Hoc Analysis

Endocrine Practice ◽

10.1016/s1530-891x(20)47140-x ◽

2018 ◽

Vol 24 ◽

pp. 80-81

Author(s):

Konstantinos Toulis ◽

Krishna Gokhale ◽

G. Neil Thomas ◽

Wasim Hanif ◽

Krishnarajah Nirantharakumar ◽

...

Keyword(s):

Diabetes Mellitus ◽

Type 2 Diabetes ◽

Type 2 Diabetes Mellitus ◽

Elderly Patients ◽

Post Hoc Analysis ◽

Receptor Agonists ◽

Post Hoc

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Abstract #245 Efficacy and Safety of Semaglutide in Elderly Subjects with Type 2 Diabetes: A Post Hoc Analysis of the Sustain 7 Trial

Endocrine Practice ◽

10.1016/s1530-891x(20)47090-9 ◽

2018 ◽

Vol 24 ◽

pp. 51-52

Author(s):

Vanita Aroda ◽

Danny Sugimoto ◽

David Trachtenbarg ◽

Mark Warren ◽

Gurudutt Nayak ◽

...

Keyword(s):

Type 2 Diabetes ◽

Elderly Subjects ◽

Efficacy And Safety ◽

Post Hoc Analysis ◽

Post Hoc

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Response-Specific Scalp Distributions in Deception Detection and ERP Correlates of Psychopathic Personality Traits

Journal of Psychophysiology ◽

10.1027/0269-8803.18.1.13 ◽

2004 ◽

Vol 18 (1) ◽

pp. 13-26 ◽

Cited By ~ 13

Author(s):

Antoinette R. Miller ◽

J. Peter Rosenfeld

Keyword(s):

Deception Detection ◽

Event Related Potential ◽

Psychopathic Personality ◽

P300 Amplitude ◽

Group Differences ◽

Post Hoc Analysis ◽

P300 Component ◽

Psychopathic Personality Inventory ◽

Post Hoc ◽

First Time

Abstract University students were screened using items from the Psychopathic Personality Inventory and divided into high (n = 13) and low (n = 11) Psychopathic Personality Trait (PPT) groups. The P300 component of the event-related potential (ERP) was recorded as each group completed a two-block autobiographical oddball task, responding honestly during the first (Phone) block, in which oddball items were participants' home phone numbers, and then feigning amnesia in response to approximately 50% of items in the second (Birthday) block in which oddball items were participants' birthdates. Bootstrapping of peak-to-peak amplitudes correctly identified 100% of low PPT and 92% of high PPT participants as having intact recognition. Both groups demonstrated malingering-related P300 amplitude reduction. For the first time, P300 amplitude and topography differences were observed between honest and deceptive responses to Birthday items. No main between-group P300 effects resulted. Post-hoc analysis revealed between-group differences in a frontally located post-P300 component. Honest responses were associated with late frontal amplitudes larger than deceptive responses at frontal sites in the low PPT group only.

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