Primary Care COPD Patients Compared with Large Pharmaceutically-Sponsored COPD Studies : An UNLOCK Validation Study
TL;DR: Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations, as hitherto unknown GOLD I exacerbation characteristics are revealed.
Abstract: Background: Guideline recommendations for chronic obstructive pulmonary disease (COPD) are based on the results of large pharmaceutically-sponsored COPD studies (LPCS). There is a paucity of data on disease characteristics at the primary care level, while the majority of COPD patients are treated in primary care. Objective: We aimed to evaluate the external validity of six LPCS (ISOLDE, TRISTAN, TORCH, UPLIFT, ECLIPSE, POET-COPD) on which current guidelines are based, in relation to primary care COPD patients, in order to inform future clinical practice guidelines and trials. Methods: Baseline data of seven primary care databases (n = 3508) from Europe were compared to baseline data of the LPCS. In addition, we examined the proportion of primary care patients eligible to participate in the LPCS, based on inclusion criteria. Results: Overall, patients included in the LPCS were younger (mean difference (MD)-2.4; p = 0.03), predominantly male (MD 12.4; p = 0.1) with worse lung function (FEV1% MD -16.4; p = 1 and >= 2 exacerbations, although results were not statistically significant. Our findings add to the literature, as we revealed hitherto unknown GOLD I exacerbation characteristics, showing 34% of mild patients had >= 1 exacerbations per year and 12% had >= 2 exacerbations per year. The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT). Conclusion: Primary care COPD patients stand out from patients enrolled in LPCS in terms of gender, lung function, quality of life and exacerbations. More research is needed to determine the effect of pharmacological treatment in mild to moderate patients. We encourage future guideline makers to involve primary care populations in their recommendations.
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TL;DR: De NHG-Standaard COPD adviseert terughoudendheid, want het is nog steeds de vraag of deze middelen wel effectief zijn bij patiënten met stadium GOLD I and II, die het leeuwendeel vormen in de eerste lijn.
Abstract: Te veel COPD-patienten krijgen nog langdurig langwerkende betamimetica (LWBM) of inhalatiecorticosteroiden (ICS). De NHG-Standaard COPD adviseert terughoudendheid, want het is nog steeds de vraag of deze middelen wel effectief zijn bij patienten met stadium GOLD I en II, die het leeuwendeel vormen in de eerste lijn. Kruis et al. laten zien dat de patienten die wij in de huisartsenpraktijk zien minder ernstige klachten hebben dan de patientenpopulatie in de grote trials, waarop de richtlijnen zijn gebaseerd.
TL;DR: Omdat zowel diabetes, COPD als corticosteroïden geassocieerd zijn met osteopenie, is het nuttig in voorkomende gevallen mogelijke oste Openie uit te sluiten.
Abstract: COPD (chronic obstructive pulmonary disease) en diabetes zijn veelvoorkomende ziekten en komen ook samen veel voor. Daarnaast hebben deze ziekten gezamenlijke risicofactoren, zoals roken en een algemeen ongezonde leefstijl, en zijn in die zin comorbiditeiten van elkaar. Wanneer naast diabetes COPD voorkomt, verdient het aanbeveling zowel de diabetes zo nauwkeurig mogelijk te volgen als de COPD zo goed mogelijk te behandelen. Het is daarbij vooral belangrijk om te zorgen dat het aantal exacerbaties zo laag mogelijk blijft. Goede luchtwegverwijding is essentieel en hoewel enigszins tegen het gevoel in, zijn inhalatiecorticosteroiden daarbij niet gecontra-indiceerd, zolang ze worden toegepast om exacerbaties te voorkomen en daarmee de noodzaak van prednisolonkuren. Omdat zowel diabetes, COPD als corticosteroiden geassocieerd zijn met osteopenie, is het nuttig in voorkomende gevallen mogelijke osteopenie uit te sluiten.
TL;DR: No gender differences in the rate of exacerbations of COPD in a prospective longitudinal study is observed, and rates of decline in post-bronchodilator forced expiratory volume and forced vital capacity did not differ between women and men during 48 months of follow-up.
Abstract: Background/Aims: Despite increasing awareness of the burden of chronic ob structive pulmonary disease (COPD) in women, knowledge regarding gender dif ferences in COPD outcomes is limited. Therefore, we aimed to evaluate whether COPD outcomes, including exacerbations, lung function, and symptoms differ by gender.
Methods: We recruited patients with COPD from two Korean multicenter pro spective cohorts. After propensity score matching, the main outcome, the inci dence of moderate or severe exacerbations was analyzed using a negative binomial regression model. We also assessed changes in lung function and symptom scores including the St. George’s respiratory questionnaire for COPD (SGRQ-C), COPD assessment test (CAT), and the modified Medical Research Council (mMRC) dys pnea score.
Results: After propensity score matching, 74 women and 74 men with COPD were included. The incidence rates of exacerbations in women and men were not sig nificantly different (incidence rate ratio, 1.49; 95% confidence interval [CI], 0.88 to 2.54). There was no significant difference in the incidence rates adjusted for medication possession ratios of long-acting muscarinic antagonists, long-acting β-agonists, and inhaled corticosteroids during the follow-up period (incidence rate ratio, 1.47; 95% CI, 0.86 to 2.52). Rates of decline in post-bronchodilator forced expiratory volume in 1 second and forced vital capacity did not differ between women and men during 48 months of follow-up. The changes in scores on the SGRQ-C, CAT, and mMRC Questionnaire in women were also similar to those in men.
Conclusions: We observed no gender differences in the rate of exacerbations of COPD in a prospective longitudinal study. Further studies are needed to confirm these findings in the general COPD population.
01 Jan 2017
TL;DR: This is an expert interview piece and as such has not undergone the journal’s standard peer review process.
Abstract: Disclosure: Mario Cazzola has participated as a speaker, and advisor in scientific meetings and courses under the sponsorship of Almirall, AstraZeneca, Biofutura, Boehringer Ingelheim, Chiesi Farmaceutici, GlaxoSmithKline, Menarini Group, Lallemand, Mundipharma, Novartis, Pfizer, Verona Pharma, and Zambon, and is or has been a consultant to Chiesi Farmaceutici, Lallemand, Novartis, Verona Pharma, and Zambon. This is an expert interview piece and as such has not undergone the journal’s standard peer review process. No funding was received for the publication of this article.
TL;DR: This research presents a novel and scalable approach called “SmartCardiovascular Intervention for Respiratory Disease,” which aims to provide real-time information about the progression of disease and its Kessler’s disease progression.
Abstract: 1Respiratory Group, The George Institute for Global Health, Sydney, NSW 2042, Australia; 2West China Hospital, Sichuan University, Chengdu, People’s Republic of China; 3State Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People’s Republic of China; 4National Heart & Lung Institute, Imperial College, London, UK; 5Pulmonary and Critical Care Division, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA, USA
References
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University of Manchester1, University of Barcelona2, St George's Hospital3, University of Marburg4, University of Texas Health Science Center at San Antonio5, Imperial College London6, University of Modena and Reggio Emilia7, University of Michigan8, Hokkaido University9, University of British Columbia10
TL;DR: It is recommended that spirometry is required for the clinical diagnosis of COPD to avoid misdiagnosis and to ensure proper evaluation of severity of airflow limitation.
Abstract: Chronic obstructive pulmonary disease (COPD) remains a major public health problem. It is the fourth leading cause of chronic morbidity and mortality in the United States, and is projected to rank fifth in 2020 in burden of disease worldwide, according to a study published by the World Bank/World Health Organization. Yet, COPD remains relatively unknown or ignored by the public as well as public health and government officials. In 1998, in an effort to bring more attention to COPD, its management, and its prevention, a committed group of scientists encouraged the U.S. National Heart, Lung, and Blood Institute and the World Health Organization to form the Global Initiative for Chronic Obstructive Lung Disease (GOLD). Among the important objectives of GOLD are to increase awareness of COPD and to help the millions of people who suffer from this disease and die prematurely of it or its complications. The first step in the GOLD program was to prepare a consensus report, Global Strategy for the Diagnosis, Management, and Prevention of COPD, published in 2001. The present, newly revised document follows the same format as the original consensus report, but has been updated to reflect the many publications on COPD that have appeared. GOLD national leaders, a network of international experts, have initiated investigations of the causes and prevalence of COPD in their countries, and developed innovative approaches for the dissemination and implementation of COPD management guidelines. We appreciate the enormous amount of work the GOLD national leaders have done on behalf of their patients with COPD. Despite the achievements in the 5 years since the GOLD report was originally published, considerable additional work is ahead of us if we are to control this major public health problem. The GOLD initiative will continue to bring COPD to the attention of governments, public health officials, health care workers, and the general public, but a concerted effort by all involved in health care will be necessary.
17,023 citations
TL;DR: Representatives from many countries serve as a network for the dissemination and implementation of programs for diagnosis, management, and prevention of COPD.
Abstract: Representatives from many countries serve as a network for the dissemination and implementation of programs for diagnosis, management, and prevention of COPD. The GOLD Board of Directors is grateful to the many GOLD National Leaders who participated in discussions of concepts that appear in GOLD reports.
3,165 citations
TL;DR: The reduction in death from all causes among patients with COPD in the combination-therapy group did not reach the predetermined level of statistical significance, and there were significant benefits in all other outcomes among these patients.
Abstract: We conducted a randomized, double-blind trial comparing salmeterol at a dose of 50 μg plus fluticasone propionate at a dose of 500 μg twice daily (combination regimen), administered with a single inhaler, with placebo, salmeterol alone, or fluticasone propionate alone for a period of 3 years. The primary outcome was death from any cause for the comparison between the combination regimen and placebo; the frequency of exacerbations, health status, and spirometric values were also assessed. Results Of 6112 patients in the efficacy population, 875 died within 3 years after the start of the study treatment. All-cause mortality rates were 12.6% in the combinationtherapy group, 15.2% in the placebo group, 13.5% in the salmeterol group, and 16.0% in the fluticasone group. The hazard ratio for death in the combination-therapy group, as compared with the placebo group, was 0.825 (95% confidence interval [CI], 0.681 to 1.002; P = 0.052, adjusted for the interim analyses), corresponding to a difference of 2.6 percentage points or a reduction in the risk of death of 17.5%. The mortality rate for salmeterol alone or fluticasone propionate alone did not differ significantly from that for placebo. As compared with placebo, the combination regimen reduced the annual rate of exacerbations from 1.13 to 0.85 and improved health status and spirometric values (P<0.001 for all comparisons with placebo). There was no difference in the incidence of ocular or bone side effects. The probability of having pneumonia reported as an adverse event was higher among patients receiving medications containing fluticasone propionate (19.6% in the combination-therapy group and 18.3% in the fluticasone group) than in the placebo group (12.3%, P<0.001 for comparisons between these treatments and placebo). Conclusions The reduction in death from all causes among patients with COPD in the combinationtherapy group did not reach the predetermined level of statistical significance. There were significant benefits in all other outcomes among these patients. (ClinicalTrials.gov number, NCT00268216.)
3,037 citations
TL;DR: The St George's Respiratory Questionnaire is a standardized self-completed questionnaire for measuring impaired health and perceived well-being in airways disease and the background and rationale for its development are discussed together with an analysis of its performance.
2,621 citations
"Primary Care COPD Patients Compared..." refers methods in this paper
...We used the St Georges Respiratory Questionnaire (SGRQ) which is designed to measure health- related quality of life in patients with asthma and COPD [34]....
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TL;DR: Although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype, which has implications for the targeting of exacerbation-prevention strategies across the spectrum of disease severity.
Abstract: BACKGROUND: Although we know that exacerbations are key events in chronic obstructive pulmonary disease (COPD), our understanding of their frequency, determinants, and effects is incomplete. In a large observational cohort, we tested the hypothesis that there is a frequent-exacerbation phenotype of COPD that is independent of disease severity. METHODS: We analyzed the frequency and associations of exacerbation in 2138 patients enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study. Exacerbations were defined as events that led a care provider to prescribe antibiotics or corticosteroids (or both) or that led to hospitalization (severe exacerbations). Exacerbation frequency was observed over a period of 3 years. RESULTS: Exacerbations became more frequent (and more severe) as the severity of COPD increased; exacerbation rates in the first year of follow-up were 0.85 per person for patients with stage 2 COPD (with stage defined in accordance with Global Initiative for Chronic Obstructive Lung Disease [GOLD] stages), 1.34 for patients with stage 3, and 2.00 for patients with stage 4. Overall, 22% of patients with stage 2 disease, 33% with stage 3, and 47% with stage 4 had frequent exacerbations (two or more in the first year of follow-up). The single best predictor of exacerbations, across all GOLD stages, was a history of exacerbations. The frequent-exacerbation phenotype appeared to be relatively stable over a period of 3 years and could be predicted on the basis of the patient's recall of previous treated events. In addition to its association with more severe disease and prior exacerbations, the phenotype was independently associated with a history of gastroesophageal reflux or heartburn, poorer quality of life, and elevated white-cell count. CONCLUSIONS: Although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype. This has implications for the targeting of exacerbation-prevention strategies across the spectrum of disease severity. (Funded by GlaxoSmithKline; ClinicalTrials.gov number, NCT00292552.)
2,459 citations
"Primary Care COPD Patients Compared..." refers background in this paper
...Selection for large COPD studies The proportion of patients from primary care that would be eligible to be included in the LPCS ranged from 17% (TRISTAN trial) to 42% (ECLIPSE and UPLIFT study) (Table 7)....
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...In addition to five large trials, we decided to include the ECLIPSE cohort study as well, because this is an important observational study often cited in guidelines, especially with regard to exacerbation frequency patterns....
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...Exacerbation data Individual datasets: UNLOCK studies reporting exacerbation data were compared with baseline data of the ISOLDE, TRISTAN, TORCH, UPLIFT and ECLIPSE studies (Table 3)....
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...The proportion of primary care patients eligible for inclusion in LPCS ranged from 17% (TRISTAN) to 42% (ECLIPSE, UPLIFT)....
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...Overall mean MRC scores were similar in the UNLOCK studies compared to ECLIPSE: 2.1 (0.8) and 2.7 (1.1), respectively....
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