scholarly journals One‐year clinically important deterioration and long‐term clinical course in Japanese patients with COPD: a multicenter observational cohort study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yuki Abe ◽  
Masaru Suzuki ◽  
Hironi Makita ◽  
Hirokazu Kimura ◽  
Kaoruko Shimizu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Disease Progression ◽  
Clinical Outcomes ◽  
Japanese Patients ◽  
Drop Out ◽  
Chronic Obstructive ◽  
First Year ◽  
Severe Exacerbation ◽  
Clinically Important Deterioration

Abstract Background Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners. Methods Among Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥ 100 mL decrease in forced expiratory volume in 1 s (FEV1), ≥ 4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality. Results Patients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID. Conclusions Adoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.

scholarly journals One-year Clinically Important Deterioration and Long-Term Clinical Course in Japanese patients with COPD: A Multicenter Observational Cohort Study

2021 ◽  
Author(s):  
Yuki Abe ◽  
Masaru Suzuki ◽  
Hironi Makita ◽  
Hirokazu Kimura ◽  
Kaoruko Shimizu ◽  
...  
Keyword(s):  
Cohort Study ◽  
Disease Progression ◽  
Clinical Outcomes ◽  
Japanese Patients ◽  
Drop Out ◽  
Chronic Obstructive ◽  
First Year ◽  
Severe Exacerbation ◽  
Clinically Important Deterioration

Abstract Background: Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease with a complex progression of many clinical presentations, and clinically important deterioration (CID) has been proposed in the Western studies as a composite endpoint of disease progression. The aim of this study was to investigate the relationships between 1-year CID and the following long-term clinical outcomes in Japanese patients with COPD who have been reported to have different characteristics compared to the Westerners.Methods: Among Japanese patients with COPD enrolled in the Hokkaido COPD cohort study, 259 patients who did not drop out within the first year were analyzed in this study. Two definitions of CID were used. Definition 1 comprised ≥100 mL decrease in forced expiratory volume in 1 second (FEV1), ≥4-unit increase in St George’s Respiratory Questionnaire (SGRQ) score from baseline, or moderate or severe exacerbation. For Definition 2, the thresholds for the FEV1 and SGRQ score components were doubled. The presence of CID was evaluated within the first year from enrollment, and analyzed the association of the presence of CID with following 4-year risk of exacerbations and 9-year mortality.Results: Patients with CID using Definition 1, but not any single CID component, during the first year had a significantly worse mortality compared with those without CID. Patients with CID using Definition 2 showed a similar trend on mortality, and had a shorter exacerbation-free survival compared with those without CID.Conclusions: Adoption of CID is a beneficial and useful way for the assessment of long-term disease progression and clinical outcomes even in Japanese population with COPD. The definition of CID might be optimized according to the characteristics of COPD population and the observation period for CID.

scholarly journals Comparative Effectiveness of Pneumococcal Vaccination With PPV23 and PCV13 in COPD Patients Over a 5-Year Follow-Up Cohort Study

2021 ◽  
Author(s):  
Galina L. Ignatova ◽  
Sergey N. Avdeev ◽  
Vladimir Nikolayevich Antonov
Keyword(s):  
Cohort Study ◽  
Pneumococcal Vaccination ◽  
Clinical Effectiveness ◽  
Chronic Obstructive ◽  
First Year ◽  
Clinical Effects ◽  
Copd Exacerbations ◽  
Bode Index

Abstract BackgroundVaccination against Streptococcus pneumoniae is among the most effective measures for preventing pneumonia and reducing the rate of chronic obstructive pulmonary disease (COPD) exacerbations. The objective of this work was to evaluate the long-term effectiveness of PCV13 and PPV23 for preventing pneumonia and COPD exacerbations.MethodsThe open-label, prospective, observational cohort study involved 302 male patients aged ≥45 years: PCV13 group (n=123); PPV23 group (n=32); and vaccine-naïve group (n=147). The primary endpoint included the frequency of pneumonia episodes and COPD exacerbations per year over a 5-year follow-up period. The secondary endpoints included the dynamics of dyspnea severity (MMRC), the BODE index, FEV1, the CAT index, the SGRQ score, and the results of 6-min walk test.ResultsVaccination with PCV13 and PPV23 significantly reduces the total rate of pneumonia during the first year after vaccination. Starting with the second year, clinical effectiveness in PPV23 group decreases compared with both PCV13 group and vaccine-naïve patients. Pneumonia by year 5 after vaccination were registered in versus 47% of patients in the PPV23 group 3.3% of patients in the PCV13 group (p<0.001); COPD exacerbations – in 81.3% versus 23.6%, respectively (p<0.001). Vaccination with PCV13 significantly reduced and maintained the BODE index over the 5-year follow-up period.ConclusionAlthough both vaccines have comparable clinical effects during the first year after vaccination, only PCV13 is characterized by persistent clinical effectiveness during the 5-year follow-up period. Patients older than 55 years on PPV23 have significantly higher risks of having pneumonia episodes more frequently during the long-term follow-up.

scholarly journals Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis

2021 ◽  
pp. 00663-2020
Author(s):  
MeiLan K Han ◽  
Gerard J Criner ◽  
Mark T Dransfield ◽  
David MG Halpin ◽  
Christine E Jones ◽  
...  
Keyword(s):  
Health Status ◽  
Clinical Outcomes ◽  
Prognostic Value ◽  
Phase Iii ◽  
Severe Exacerbation ◽  
Increased Risk ◽  
Unit Increase ◽  
Clinically Important Deterioration ◽  
The Impact

IntroductionClinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes, and effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.MethodsIMPACT was a Phase III, double-blind, 52-week multicenter trial. Patients with symptomatic COPD and ≥1 moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg, FF/VI 100/25 µg, or UMEC/VI 62.5/25 µg. CID at the timepoint of interest was defined as: a moderate/severe exacerbation, or ≥100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (≥4.0 unit increase in St George's Respiratory Questionnaire total score or ≥2.0 unit increase in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to Week 52 in patients with/without a CID by Week 28. A prospective analysis evaluated time-to-first CID with each treatment.ResultsPatients with a CID by Week 28 had significantly increased exacerbation rates after Week 28, smaller improvements in lung function and health status at Week 52 (all p<0.001), and increased risk of all-cause mortality after Week 28 versus patients who were CID-free. FF/UMEC/VI significantly reduced CID risk versus dual therapies (all p<0.001).ConclusionsPrevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.FundingGSK (CTT116855/NCT02164513).

scholarly journals Diabetes as a risk factor for severe exacerbation and death in patients with COPD: a prospective cohort study

2020 ◽  
Vol 30 (4) ◽  
pp. 822-827
Author(s):  
Maria T Castañ-Abad ◽  
Josep Montserrat-Capdevila ◽  
Pere Godoy ◽  
Josep R Marsal ◽  
Marta Ortega ◽  
...  
Keyword(s):  
Cohort Study ◽  
Hospital Admission ◽  
Lung Disease ◽  
Prospective Cohort ◽  
Obstructive Lung Disease ◽  
Chronic Obstructive Lung Disease ◽  
Chronic Obstructive ◽  
Severe Exacerbation ◽  
Copd Patients ◽  
Global Initiative

Abstract Background Type 2 diabetes comorbidity is common in patients with COPD. One of the most frequent causes of hospital admission in patients with COPD are exacerbations. Methods Prospective cohort study, which included 512 patients with COPD recruited in a primary care centre in Mollerussa (Lleida, Spain). Inclusion criteria were: patients &gt;40 years of age with COPD according to the Global Initiative for Chronic Obstructive Lung Disease. Variables collected were as follows: age, gender, civil status, education level, smoking habit, severity (Global Initiative for Chronic Obstructive Lung Disease), comorbidities (Charlson), history of severe exacerbations, dyspnoea (mMRC), BODEx, EuroQol 5 D and depression (HAD). Logistic regression was used to determine the association of diabetes with risk of hospital admission and death. Results Prevalence of diabetes was 25.8%. During the second year of follow up, 18.2% of patients with COPD and diabetes were admitted for exacerbation, in comparison with 8.9% non-diabetic COPD patients. The variables associated with hospital admission were diabetes (ORa=1.54); gender (men, ORa=1.93); age (ORa=1.02); number of hospital admissions during the previous year: 1 (ORa=2.83) or more than one admission (ORa=4.08); EuroQol 5 D (ORa=0.76) and BODEx (ORa=1.24). With the exclusion of BODEx, all these variables were associated with a higher risk of death. Conclusion Prevalence of diabetes is high in patients suffering from COPD. COPD patients with diabetes are at higher risk of severe exacerbation and death. The suggested predictive model could identify patients at higher risk so that adequate preventive and therapeutic measures can be implemented.

scholarly journals Impact of chronic obstructive pulmonary disease and dyspnoea on clinical outcomes in ticagrelor treated patients undergoing percutaneous coronary intervention in the randomized GLOBAL LEADERS trial

2019 ◽  
Vol 6 (4) ◽  
pp. 222-230
Author(s):  
Mariusz Tomaniak ◽  
Ply Chichareon ◽  
Kuniaki Takahashi ◽  
Norihiro Kogame ◽  
Rodrigo Modolo ◽  
...  
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Clinical Outcomes ◽  
Primary Endpoint ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Copd Patients ◽  
Percutaneous Coronary ◽  
All Cause Mortality

Abstract Aims To evaluate long-term safety and efficacy of ticagrelor monotherapy in patients undergoing percutaneous coronary interventions (PCIs) in relation to chronic obstructive pulmonary disease (COPD) at baseline and the occurrence of dyspnoea reported as adverse event (AE) that may lead to treatment non-adherence. Methods and results This is a non-prespecified, post hoc analysis of the randomized GLOBAL LEADERS trial (n = 15 991), comparing the experimental strategy of 23-month ticagrelor monotherapy following 1-month dual antiplatelet therapy (DAPT) after PCI with the reference strategy of 12-month DAPT followed by 12-month aspirin monotherapy. Impact of COPD and dyspnoea AE (as a time-dependent covariate) on clinical outcomes was evaluated up to 2 years. The primary endpoint was a 2-year all-cause mortality or non-fatal, centrally adjudicated, new Q-wave myocardial infarction. The presence of COPD (n = 832) was the strongest clinical predictor of 2-year all-cause mortality after PCI [hazard ratio (HR) 2.84; 95% confidence interval (CI) 2.21–3.66; P adjusted = 0.001] in this cohort (n = 15 991). No differential treatment effects on 2-year clinical outcomes were found in patients with and without COPD (primary endpoint: HR 0.88; 95% CI 0.58–1.35; P = 0.562; P int = 0.952). Overall, at 2 years dyspnoea was reported as an AE in 2101 patients, more frequently among COPD patients, irrespective of treatment allocation (27.2% in experimental arm vs. 14.5% in reference arm, P = 0.001). Its occurrence was not associated with a higher rate of the primary endpoint (P adjusted = 0.640) in the experimental vs. the reference arm. Conclusion In this exploratory analysis, COPD negatively impacted long-term prognosis after PCI. Despite higher incidence of dyspnoea in the experimental arm, in particular among COPD patients, the safety of the experimental treatment strategy appeared not to be affected. Clinical trial registration unique identifier NCT01813435.

scholarly journals Sociodemographic, labour market marginalisation and medical characteristics as risk factors for reinfarction and mortality within 1 year after a first acute myocardial infarction: a register-based cohort study of a working age population in Sweden

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033616
Author(s):  
Mo Wang ◽  
Marjan Vaez ◽  
Thomas Ernst Dorner ◽  
Syed Ghulam Rahman ◽  
Magnus Helgesson ◽  
...  
Keyword(s):  
Risk Factors ◽  
Myocardial Infarction ◽  
Acute Myocardial Infarction ◽  
Cohort Study ◽  
Labour Market ◽  
Work Disability ◽  
First Year ◽  
Risk Of Mortality ◽  
All Cause Mortality

ObjectivesResearch covering a wide range of risk factors related to the prognosis during the first year after an acute myocardial infarction (AMI) is insufficient. This study aimed to investigate whether sociodemographic, labour market marginalisation and medical characteristics before/at AMI were associated with subsequent reinfarction and all-cause mortality.DesignPopulation-based cohort study.ParticipantsThe cohort included 15 069 individuals aged 25–64 years who had a first AMI during 2008–2010.Primary and secondary outcome measuresThe outcome measures consisted of reinfarction and all-cause mortality within 1 year following an AMI, which were estimated by univariate and multivariable HRs and 95% CIs by Cox regression.ResultsSociodemographic characteristics such as lower education showed a 1.1-fold and 1.3-fold higher risk for reinfarction and mortality, respectively. Older age was associated with a higher risk of mortality while being born in non-European countries showed a lower risk of mortality. Labour market marginalisation such as previous long-term work disability was associated with a twofold higher risk of mortality. Regarding medical characteristics, ST-elevation myocardial infarction was predictive for reinfarction (HR: 1.14, 95% CI: 1.07 to 1.21) and all-cause mortality (HR: 3.80, 95% CI: 3.08 to 4.68). Moreover, diabetes mellitus, renal insufficiency, stroke, cancer and mental disorders were associated with a higher risk of mortality (range of HRs: 1.24–2.59).ConclusionsSociodemographic and medical risk factors were identified as risk factors for mortality and reinfarction after AMI, including older age, immigration status, somatic and mental comorbidities. Previous long-term work disability and infarction type provide useful information for predicting adverse outcomes after AMI during the first year, particularly for mortality.

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