By Beth Gilbert HealthDay Reporter
The annual meeting of the American College of Chest Physicians was held this year from Oct. 6 to 9 in Boston, hosting participants from around the world, including specialists and heath care professionals focused on pulmonary medicine, critical care, and sleep medicine. The conference featured presentations focusing on clinical updates in thoracic medicine.
In one study, Chitra Lal, M.D., of the Medical University of South Carolina in Charleston, and colleagues found that the efficacy and safety of low sodium oxybate (LXB) in participants with idiopathic hypersomnia are similar in the presence or absence of asthma and mild and controlled sleep apnea.
The authors titrated and optimized the dose of LXB (10 to 14 weeks) among participants with idiopathic hypersomnia and an apnea-hypopnea index ≤10 before a two-week stable-dose period. During a two-week double-blind randomized withdrawal period (DBRWP), participants were switched to placebo or continued with LXB.
Across subgroups with and without asthma or sleep apnea, the researchers found that participants who were randomly assigned to placebo showed worsening in their Idiopathic Hypersomnia Severity Scale, Epworth Sleepiness Scale, and Sleep Inertia Visual Analog Scale scores at the end of the DBRWP, while participants randomly assigned to continue LXB showed stable scores. In addition, significantly higher proportions of participants who were assigned to placebo reported worsening Patient Global Impression of Change score status (minimally, much, or very much worse) at the end of the DBRWP compared with participants receiving LXB, regardless of the presence or absence of asthma or sleep apnea. Incidences of treatment-emergent adverse events, including those that were serious, those related to the study drug, and those leading to withdrawal, were similar among participants with asthma or sleep apnea and among participants without these comorbidities.
“Overall, these findings inform clinicians about the efficacy and safety of LXB in this patient population with asthma and mild and controlled sleep apnea. This would increase the comfort level of clinicians in prescribing LXB for idiopathic hypersomnia in this specific patient population,” Lal said. “However, the small sample size and the inclusion of patients with mild and controlled sleep apnea only (exclusion of individuals with an apnea-hypopnea index >10 in the main study) would restrict extrapolation of these findings to the wider idiopathic hypersomnia population.”
Several authors disclosed ties to pharmaceutical companies, including Jazz Pharmaceuticals, which manufactures LXB (Xywav) and funded the study.
In a pooled post-hoc analysis of the ENHANCE phase 3 trials, Amy Dixon, Pharm.D., of Verona Pharma in Raleigh, North Carolina, and colleagues found that ensifentrine, a dual phosphodiesterase (PDE)3 and PDE4 inhibitor, is associated with improvements in symptoms and quality of life among patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).
The authors analyzed the effect of ensifentrine versus placebo in patients with symptomatic, moderate-to-severe COPD, paying particular attention to patient-reported outcomes according to smoking status (current versus former). The researchers found that ensifentrine treatment resulted in early and sustained improvements in symptoms and quality of life compared with placebo in patients with moderate-to-severe COPD, regardless of smoking status.
“Smoking status is known to play a role in the effectiveness of some COPD treatments,” Dixon said. “Ensifentrine offers nonsteroidal anti-inflammatory and bronchodilatory effects via a novel mechanism that provides meaningful improvements in symptoms and quality of life in a broad population of patients with COPD, regardless of smoking status.”
Several authors disclosed ties to pharmaceutical companies, including Verona Pharma, which manufactures ensifentrine and funded the ENHANCE studies.
In another pooled post-hoc analysis of the ENHANCE phase 3 trials, Jill Ohar, M.D., of the Wake Forest University School of Medicine in Winston-Salem, North Carolina, and colleagues found that ensifentrine is equally efficacious in COPD patients with and without chronic bronchitis.
For the study, 975 patients with moderate-to-severe COPD received ensifentrine or placebo in addition to their baseline therapy. Sixty-two percent of participating patients were also receiving long-acting bronchodilators, and 18 percent were receiving concomitant inhaled corticosteroids; the remaining patients received no additional therapy at baseline. The primary end point of the study was exacerbation rate and time to next exacerbation. Secondary end points included quality of life as measured by the St. George’s Respiratory Questionnaire, COPD symptoms as measured by the COPD Assessment Test, and dyspnea. The researchers found that ensifentrine was equally efficacious in patients both with and without chronic bronchitis.
“For a long time, we have only had bronchodilators and inhaled steroids for the treatment of COPD. Recently, two new classes of drugs have been approved for the treatment of COPD. These are the biologics as well as PDE3 and PDE4 inhibitors,” Ohar said. “The clinical implication of my poster and other data presented at CHEST 2024 and in print is that this compound is efficacious in many different phenotypes of COPD, whereby use of the biologics is limited to patients with a specific inflammatory profile, such as elevated eosinophil count.”
Several authors disclosed ties to pharmaceutical companies, including Verona Pharma, which manufactures ensifentrine and funded the ENHANCE studies.
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