Effectiveness trials: critical data to help understand how respiratory medicines really work?

Heddini, Andreas; Sundh, Josefin; Ekström, Magnus; Janson, Christer

doi:10.1080/20018525.2019.1565804

Cited by 8 publications

(6 citation statements)

References 29 publications

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“…36 Other RCTs examining the effect of betablockers in COPD are ongoing and positive result from these trials would have the potential to bring a valuable yet inexpensive tool to the COPD treatment arsenal. 37 The need for such RCTs is highlighted by the fact that fears of prescribing beta-blockers to COPD patients still exist. 35 Studies indicate that ASA might play a protective role in COPD, regardless of CVD, 14,38 though no RCTs assessing the issue are currently available.…”

Section: Discussionmentioning

confidence: 99%

<p>Impact of Comorbidities and Commonly Used Drugs on Mortality in COPD – Real-World Data from a Primary Care Setting</p>

Ellingsen¹,

Johansson²,

Larsson³

et al. 2020

COPD

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Background: Life expectancy is significantly shorter for patients with chronic obstructive pulmonary disease (COPD) than the general population. Concurrent diseases are known to infer an increased mortality risk in those with COPD, but the effects of pharmacological treatments on survival are less established. This study aimed to examine any associations between commonly used drugs, comorbidities and mortality in Swedish real-world primary care COPD patients. Methods: Patients with physician-diagnosed COPD from a large primary care population were observed retrospectively, utilizing primary care records and mandatory Swedish national registers. The time to all-cause death was assessed in a stepwise multiple Cox proportional hazards regression model including demography, socioeconomic factors, exacerbations, comorbidities and medication. Results: During the observation period (1999)(2000)(2001)(2002)(2003)(2004)(2005)(2006)(2007)(2008)(2009)) 5776 (32.5%) of 17,745 included COPD patients died. Heart failure (hazard ratio [HR]: 1.88, 95% confidence interval [CI]: 1.74-2.04), stroke (HR: 1.52, 95% CI: 1.40-1.64) and myocardial infarction (HR: 1.40, 95% CI: 1.24-1.58) were associated with an increased risk of death. Use of inhaled corticosteroids (ICS; HR: 0.79, 95% CI: 0.66-0.94), beta-blockers (HR: 0.86, 95% CI: 0.76-0.97) and acetylsalicylic acid (ASA; HR: 0.87, 95% CI: 0.77-0.98) was dose-dependently associated with a decreased risk of death, whereas use of long-acting muscarinic antagonists (LAMA; HR: 1.33, 95% CI: 1.14-1.55) and N-acetylcysteine (NAC; HR: 1.26, 95% CI: 1.08-1.48) were dose-dependently associated with an increased risk of death in COPD patients. Conclusion: This large, retrospective, observational study of Swedish real-world primary care COPD patients indicates that coexisting heart failure, stroke and myocardial infarction were the strongest predictors of death, underscoring the importance of timely recognition and treatment of comorbidities. A decreased risk of death associated with the use of ICS, betablockers and ASA, and an increased risk associated with the use of LAMA and NAC, was also found. Plain Language SummaryPatients with chronic obstructive lung disease (COPD) die earlier than healthy people. Having certain other diseases (for instance heart disorders) at the same time as COPD is common and known to increase the risk of death. It is not certain whether medication can improve survival or not. There is a need for deeper knowledge of the connection between other diseases, drugs and COPD deaths.

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Section: Discussionmentioning

confidence: 99%

<p>Impact of Comorbidities and Commonly Used Drugs on Mortality in COPD – Real-World Data from a Primary Care Setting</p>

Ellingsen¹,

Johansson²,

Larsson³

et al. 2020

COPD

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“…Effectiveness studies provide real-world context to complement conventional RCTs, as they enrol patients more representative of those prescribed treatment in routine care, do not involve dummy inhalers [ 20 ] and allow physicians and patients to prescribe and take their medication as they would in usual care settings. The Salford Lung Study demonstrated the effectiveness of once-daily FF/VI single-inhaler therapy over usual care in a COPD population [ 21 ].…”

Section: Introductionmentioning

confidence: 99%

INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice

et al. 2021

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IntroductionReal-world trial data comparing single- with multiple-inhaler triple therapy (MITT) in COPD patients are currently lacking. The effectiveness of once-daily single-inhaler fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) and MITT were compared in usual clinical care.MethodsINTREPID was a multicentre, randomised, open-label, phase IV effectiveness study comparing FF/UMEC/VI 100/62.5/25 µg via the ELLIPTA inhaler with a clinician's choice of any approved non-ELLIPTA MITT in usual COPD clinical practice in five European countries. Primary end-point was proportion of COPD Assessment Test (CAT) responders (≥2-unit decrease in CAT score from baseline) at week 24. Secondary end-points in a subpopulation included change from baseline in forced expiratory volume in 1 s (FEV1) and percentage of patients making at least one critical error in inhalation technique at week 24. Safety was also assessed.Results3092 patients were included (FF/UMEC/VI n=1545; MITT n=1547). The proportion of CAT responders at week 24 was significantly greater with FF/UMEC/VI versus non-ELLIPTA MITT (OR 1.31, 95% CI 1.13–1.51; p<0.001) and mean change from baseline in FEV1 was significantly greater with FF/UMEC/VI (77 mL versus 28 mL; treatment difference 50 mL, 95% CI 26–73 mL; p<0.001). The percentage of patients with at least one critical error in inhalation technique was low in both groups (FF/UMEC/VI 6%; non-ELLIPTA MITT 3%). Safety profiles, including incidence of pneumonia serious adverse events, were similar between treatments.ConclusionsIn a usual clinical care setting, treatment with once-daily single-inhaler FF/UMEC/VI resulted in significantly more patients gaining health status improvement and greater lung function improvement versus non-ELLIPTA MITT.

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“…Всем участникам лечебного процесса: регулирующим организациям, страховым компаниям, пациентам, врачам необходима надежная и достоверная информация о преимуществах, аспектах безопасности и экономической эффективности лекарственных средств, предполагающая поиск доказательств и их использование для принятия оптимального клинического решения [7]. Ядром доказательной медицины является иерархическая классификация, где систематические обзоры, метаанализы и рандомизированные клинические исследования (РКИ) обычно рассматриваются как самый высокий уровень клинических доказательств [8].…”

Section: рандомизированные клинические исследованияunclassified

Combined therapy with inhaled glucocorticosteroids and long-acting β2-agonists in patients with bronchial asthma: the problem of choice

Синопальников

2021

Medicinskij sovet

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Bronchial asthma remains one of the most common chronic respiratory diseases. The apparent heterogeneity of BA underlies the concept of phenotype-specific or patient-centered therapy. However, in real clinical practice, BA continues to be regarded as a rather homogeneous pathological condition and its treatment in the vast majority of cases retains an empirical approach, the basis of which are inhaled glucocorticosteroids, usually in combination with long-acting beta2-agonists. Since this group of drugs is very representative, the physician is faced with the question of choosing the optimal drug. The basis of evidence-based medicine is a hierarchical classification, where systematic reviews, meta-analyses, and randomized clinical trials are considered the highest level of evidence. Because randomized clinical trials are conducted in carefully selected highly selected patient populations, they have little relevance to patients encountered in everyday clinical practice. In contrast, pragmatic randomized clinical trials assess the clinical efficacy of the investigational agent in a large, unselected population in which patients with comorbidities are included. In this context, the Salford Lung Study (SLS) is of particular interest. It was conducted before the registration of a new combination drug containing the modern ICS fluticasone furoate and the long-acting beta2-agonist vilanterol. The SLS results indicated not only that the use of fluticasone furoate with vilanterol provides better control of BA compared to continued "conventional therapy" (ICS ± LABAs) in symptomatic patients, but also leads to a consistent improvement in the surrogate parameters of quality of life.

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Effectiveness trials: critical data to help understand how respiratory medicines really work?

Cited by 8 publications

References 29 publications

<p>Impact of Comorbidities and Commonly Used Drugs on Mortality in COPD – Real-World Data from a Primary Care Setting</p>

<p>Impact of Comorbidities and Commonly Used Drugs on Mortality in COPD – Real-World Data from a Primary Care Setting</p>

INTREPID: single- versus multiple-inhaler triple therapy for COPD in usual clinical practice

Combined therapy with inhaled glucocorticosteroids and long-acting β2-agonists in patients with bronchial asthma: the problem of choice

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