Publications by authors named "Dennis Niewoehner"
Background: Adjudicated cause-specific mortality has been used in major trials of chronic obstructive pulmonary disease. However, there is less experience with adjudicated major adverse cardiovascular events as a key efficacy outcome in chronic obstructive pulmonary disease trials. The Study to Understand Mortality and Morbidity in chronic obstructive pulmonary disease trial required a Clinical Endpoint Committee to adjudicate the outcomes of modified major adverse cardiovascular events and cause-specific mortality.
View Article and Find Full Text PDFRationale: Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are common, associated with acute inflammation, and may increase subsequent cardiovascular disease (CVD) risk.
Objectives: Determine whether AECOPD events are associated with increased risk of subsequent CVD.
Methods: We performed a secondary cohort analysis of the SUMMIT (Study to Understand Mortality and Morbidity) trial, a convenience sample of current/former smokers with moderate COPD from 1,368 centers in 43 countries.
Background: Bilirubin is a potent anti-oxidant and higher serum concentrations of bilirubin have been associated with better lung function, slower lung function decline, and lower incidence of chronic obstructive pulmonary disease (COPD). We sought to determine whether elevated bilirubin blood concentrations are associated with lower risk for acute exacerbations of COPD (AECOPD).
Methods: We performed a secondary analyses of data in the Simvastatin for Prevention of Exacerbations in Moderate-to-Severe COPD (STATCOPE) and the Azithromycin for Prevention of Exacerbations of COPD (MACRO) studies.
Background: Beta-blockers are commonly prescribed for patients with cardiovascular disease. Providers have been wary of treating chronic obstructive pulmonary disease (COPD) patients with beta-blockers due to concern for bronchospasm, but retrospective studies have shown that cardio-selective beta-blockers are safe in COPD and possibly beneficial. However, these benefits may reflect symptom improvements due to the cardiac effects of the medication.
View Article and Find Full Text PDFBackground: Observational data have been conflicted regarding the potential role of HIV antiretroviral therapy (ART) as a causative factor for, or protective factor against, COPD. We therefore aimed to investigate the effect of immediate versus deferred ART on decline in lung function in HIV-positive individuals.
Methods: We did a nested substudy within the randomised, controlled Strategic Timing of Antiretroviral Treatment (START) trial at 80 sites in multiple settings in 20 high-income and low-to-middle-income countries.
Rationale: Inhaled corticosteroids have been shown to decrease exacerbations in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Their effects in patients with milder airflow obstruction remain unclear.
Objectives: This was an analysis of exacerbations in the SUMMIT (Study to Understand Mortality and Morbidity) study.
Article Synopsis
- A study was conducted to evaluate the effects of very high doses of N-acetylcysteine (NAC) on patients with COPD and chronic bronchitis, with the hope of improving their respiratory health.
- Researchers included 51 patients in a double-blind trial, comparing the effects of NAC to a placebo over 8 weeks, assessing health status through the St George's Respiratory Questionnaire.
- The study was halted early due to safety concerns, and results showed no significant improvement in respiratory health or lung function between the NAC and placebo groups.
Objective: To evaluate the relationship between alcohol consumption and the risk of acute exacerbation of COPD (AECOPD).
Methods And Measurements: We conducted a secondary analysis of data previously collected in a large, multicenter trial of daily azithromycin in COPD. To analyze the relationship between amount of baseline self-reported alcohol consumption in the past 12 months and subsequent AECOPD, we categorized the subjects as minimal (<1 drink/month), light-to-moderate (1-60 drinks/month), or heavy alcohol users (>60 drinks/month).
The novel long-acting β2-agonist olodaterol demonstrated an acceptable safety profile in short-term phase II clinical studies. This analysis of four randomized, double-blind, placebo-controlled, parallel-group, phase III studies (1222.11, NCT00782210; 1222.
View Article and Find Full Text PDFBackground: The long-acting muscarinic antagonist (LAMA) umeclidinium (UMEC) and the combination of UMEC with the long-acting β2-agonist (LABA) vilanterol (UMEC/VI) are approved maintenance treatments for chronic obstructive pulmonary disease (COPD) in the US and EU. They are not indicated for the treatment of asthma.
Methods: In this 52-week, double-blind, placebo-controlled, parallel-group safety study (GSK study DB2113359; NCT01316887), patients were randomized 2:2:1 to UMEC/VI 125/25 mcg, UMEC 125 mcg, or placebo.
Background: The risk factors for acute episodes of respiratory disease in current and former smokers who do not have COPD are unknown.
Methods: Eight thousand two hundred forty-six non-Hispanic white and black current and former smokers in the Genetic Epidemiology of COPD (COPDGene) cohort had longitudinal follow-up (LFU) every 6 months to determine acute respiratory episodes requiring antibiotics or systemic corticosteroids, an ED visit, or hospitalization. Negative binomial regression was used to determine the factors associated with acute respiratory episodes.
Background: Retrospective studies have shown that statins decrease the rate and severity of exacerbations, the rate of hospitalization, and mortality in chronic obstructive pulmonary disease (COPD). We prospectively studied the efficacy of simvastatin in preventing exacerbations in a large, multicenter, randomized trial.
Methods: We designed the Prospective Randomized Placebo-Controlled Trial of Simvastatin in the Prevention of COPD Exacerbations (STATCOPE) as a randomized, controlled trial of simvastatin (at a daily dose of 40 mg) versus placebo, with annual exacerbation rates as the primary outcome.
Article Synopsis
- A study investigated how a dual long-acting inhaled bronchodilator, QVA149, affects exacerbations in severe COPD patients compared to other treatments.
- Researchers assigned 2224 patients into three groups receiving QVA149, glycopyrronium, or tiotropium over 64 weeks, with a focus on comparing rates of moderate to severe exacerbations.
- Results showed that QVA149 reduced exacerbation rates by 12% compared to glycopyrronium, while the safety profile was similar across all treatments, with most patients experiencing adverse events.
Article Synopsis
- The study examined how tiotropium, a medication for chronic obstructive pulmonary disease (COPD), affects exacerbations and hospitalizations in patients across the USA enrolled in clinical trials.
- Data from six trials showed that tiotropium significantly delayed the time to the first exacerbation and the first hospitalization over both 6 months and 1 year, with consistent reductions in overall exacerbation and hospitalization rates compared to a placebo.
- The results indicated that tiotropium effectively lowers the risk of exacerbations regardless of prior inhaled corticosteroid use, and it did not lead to an increased risk of heart-related issues.
Severe vitamin D deficiency: a biomarker of exacerbation risk? : a reply to Heulens.
Am J Respir Crit Care Med
January 2013
Article Synopsis
- PCV7 vaccine shows a stronger and longer-lasting antibody response compared to PPSV23 in COPD patients over 2 years, particularly for most serotypes tested.
- Despite the CDC's recommendations for pneumococcal vaccination, nearly 50% of COPD patients in the study had never received any vaccine.
- No significant differences were found in health outcomes like exacerbations or hospitalizations between those receiving either vaccine.
Background: Improving a patient's ability to self-monitor and manage changes in chronic obstructive pulmonary disease (COPD) symptoms may improve outcomes.
Objective: To determine the efficacy of a comprehensive care management program (CCMP) in reducing the risk for COPD hospitalization.
Design: A randomized, controlled trial comparing CCMP with guideline-based usual care.
Lightweight ambulatory oxygen devices are provided on the assumptions that they enhance compliance and increase activity, but data to support these assumptions are lacking. We studied 22 patients with severe chronic obstructive pulmonary disease receiving long-term oxygen therapy (14 men, average age = 66.9 y, FEV(1) = 33.
View Article and Find Full Text PDFVitamin D levels and risk of acute exacerbations of chronic obstructive pulmonary disease: a prospective cohort study.
Am J Respir Crit Care Med
February 2012
Rationale: Low blood levels of 25-hydroxyvitamin D (25[OH]D) have been associated with a higher risk of respiratory infections in general populations and higher risk of exacerbations of lung disease in people with asthma. We hypothesized that low blood levels of 25(OH)D in patients with chronic obstructive pulmonary disease (COPD) would be associated with an increased risk of acute exacerbations of COPD (AECOPD).
Objectives: To determine if baseline 25(OH)D levels relate to subsequent AECOPD in a cohort of patients at high risk for AECOPD.
Article Synopsis
- This study examined the effects of adding fluticasone/salmeterol (FSC) to tiotropium (TIO) in patients with moderate to severe COPD over 24 weeks.
- The results showed that combining FSC with TIO significantly improved lung function metrics and reduced the need for rescue albuterol.
- However, there were no notable differences in health status or COPD exacerbations between the two treatment groups, and the incidence of adverse events was similar.
Background: Acute exacerbations adversely affect patients with chronic obstructive pulmonary disease (COPD). Macrolide antibiotics benefit patients with a variety of inflammatory airway diseases.
Methods: We performed a randomized trial to determine whether azithromycin decreased the frequency of exacerbations in participants with COPD who had an increased risk of exacerbations but no hearing impairment, resting tachycardia, or apparent risk of prolongation of the corrected QT interval.
Article Synopsis
- Leukotrienes may play a role in acute COPD exacerbations, but their modifiers like zileuton haven't been thoroughly tested for this purpose.
- A study was conducted to assess the safety and effectiveness of zileuton versus a placebo for hospitalized COPD patients, focusing on hospital stay duration and treatment failure rates.
- The results showed no significant difference in hospital stay or treatment failures between the two groups, though zileuton did reduce certain leukotriene levels, indicating it might be safe but not necessarily effective in improving patient outcomes in this context.