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In line with an anti-inflammatory role for IL-10 in experimental arthritis, AIA in IL-10KO mice caused increased joint swelling and an overall exacerbation of joint pathology as compared to wild-type (WT) controls.
However, in the INSPIRE (Investigating New Standards for Prophylaxis in Reduction of Exacerbations) study (table 1) that compared LABA plus ICS (salmeterol/fluticasone propionate) with tiotropium, overall exacerbation rates were similar [ 14].
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Other common AEs (≥2% of patients overall) were COPD exacerbation (2.4%) and cough (2.2%).
CASIS scores significantly differed between levels of self-reported severity, self-reported overall health, and exacerbation status for COPD patients.
In the asthma group, the CASIS was able to significantly distinguish between clinician-rated and patient-rated severity, overall health, and exacerbation status for patients with asthma.
Annual rates in the placebo arm were similar across the trials ranging from 0.60 to 0.74 exacerbations per patient per year and these rates set the overall number of exacerbations that occurred in the model.
These studies also had a very low overall rate of exacerbations observed and are not the ideal data source for exacerbations, but are the best data to describe the exacerbation benefits of indacaterol currently available.
Overall, 340 pulmonary exacerbations were identified from a cohort of 424 patients.
The purpose of the UPLIFT trial was to assess the effect of the interventions on overall lung function; exacerbations were only a secondary objective.
Fourth, given the inconsistency across the data, we could not complete a network meta-analysis for risk of moderate-to-severe exacerbations overall.
Finally, in a randomized controlled trial, although no overall reduction in exacerbations could be found after a one-year treatment with a high dose vitamin D, it was clear that, in a subgroup of patients with COPD very deficient for vitamin D at baseline, supplementation resulted in 43% reduction of exacerbations [ 197].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com