Decline of COPD exacerbations in clinical trials over two decades - a systematic review and meta-regression.
Respir Res
; 20(1): 186, 2019 Aug 16.
Article
em En
| MEDLINE
| ID: mdl-31420040
ABSTRACT
BACKGROUND:
An important goal of chronic obstructive pulmonary disease (COPD) treatment is to reduce the frequency of exacerbations. Some observations suggest a decline in exacerbation rates in clinical trials over time. A more systematic understanding would help to improve the design and interpretation of COPD trials.METHODS:
We performed a systematic review and meta-regression of the placebo groups in published randomized controlled trials reporting exacerbations as an outcome. A Bayesian negative binomial model was developed to accommodate results that are reported in different formats; results are reported with credible intervals (CI) and posterior tail probabilities (pB).RESULTS:
Of 1114 studies identified by our search, 55 were ultimately included. Exacerbation rates decreased by 6.7% (95% CI (4.4, 9.0); pB < 0.001) per year, or 50% (95% CI (36, 61)) per decade. Adjusting for available study and baseline characteristics such as forced expiratory volume in 1 s (FEV1) did not alter the observed trend considerably. Two subsets of studies, one using a true placebo group and the other allowing inhaled corticosteroids in the "placebo" group, also yielded consistent results.CONCLUSIONS:
In conclusion, this meta-regression indicates that the rate of COPD exacerbations decreased over the past two decades to a clinically relevant extent independent of important prognostic factors. This suggests that care is needed in the design of new trials or when comparing results from older trials with more recent ones. Also a considerable effect of adjunct therapy on COPD exacerbations can be assumed. REGISTRATION PROSPERO 2018 CRD4218118823.Palavras-chave
Texto completo:
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Bases de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos como Assunto
/
Progressão da Doença
/
Doença Pulmonar Obstrutiva Crônica
Tipo de estudo:
Clinical_trials
/
Prognostic_studies
/
Systematic_reviews
Limite:
Humans
Idioma:
En
Revista:
Respir Res
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Alemanha