Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

International Journal of Chronic Obstructive Pulmonary Disease
Anthony D'UrzoPablo Altman

Abstract

Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 μg, placebo (both delivered via the Breezhaler device), or tiotropium 18 μg (delivered via the HandiHaler device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality...Continue Reading

Citations

Aug 19, 2016·Frontiers in Physiology·Isabela HenriquesPatricia R M Rocco
Jan 23, 2016·The Lancet. Respiratory Medicine·Lies LahousseGuy G Brusselle
Apr 12, 2017·Postgraduate Medicine·Nicola A HananiaBarbara P Yawn
Dec 16, 2017·Expert Review of Respiratory Medicine·Paola RoglianiGiuseppe De Angelis
Dec 19, 2019·Pharmacological Reviews·M G MateraM Cazzola
Sep 3, 2016·American Journal of Respiratory and Critical Care Medicine·Sara RoversiAlvar Agustí
Sep 19, 2019·Kardiologiia·Z R AisanovE N Kalmanova

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