Improving the Management of COPD in Women Jenkins, Christine R., MD; Chapman, Kenneth R., MD; Donohue, James F., MD ...
Chest,
03/2017, Letnik:
151, Številka:
3
Journal Article
Recenzirano
Odprti dostop
COPD is a highly debilitating disease that represents a substantial and growing health burden in women. There is increasing evidence for sex-related differences in COPD risk, progression, and ...outcomes. However, the disease receives scant attention as a women’s health issue. Thus, a multifaceted approach is required to address COPD in women, including greater awareness, minimization of risk, and further elucidation of the sex-specific factors (biological and cultural) that affect risk, disease progression, and treatment success. This article reviews the current literature on the topic and provides suggestions for achieving better outcomes for the millions of women with COPD worldwide.
Purified α1 proteinase inhibitor (A1PI) slowed emphysema progression in patients with severe α1 antitrypsin deficiency in a randomised controlled trial (RAPID-RCT), which was followed by an ...open-label extension trial (RAPID-OLE). The aim was to investigate the prolonged treatment effect of A1PI on the progression of emphysema as assessed by the loss of lung density in relation to RAPID-RCT.
Patients who had received either A1PI treatment (Zemaira or Respreeza; early-start group) or placebo (delayed-start group) in the RAPID-RCT trial were included in this 2-year open-label extension trial (RAPID-OLE). Patients from 22 hospitals in 11 countries outside of the USA received 60 mg/kg per week A1PI. The primary endpoint was annual rate of adjusted 15th percentile lung density loss measured using CT in the intention-to-treat population with a mixed-effects regression model. This trial is registered with ClinicalTrials.gov, number NCT00670007.
Between March 1, 2006, and Oct 13, 2010, 140 patients from RAPID-RCT entered RAPID-OLE: 76 from the early-start group and 64 from the delayed-start group. Between day 1 and month 24 (RAPID-RCT), the rate of lung density loss in RAPID-OLE patients was lower in the early-start group (-1·51 g/L per year SE 0·25 at total lung capacity TLC; -1·55 g/L per year 0·24 at TLC plus functional residual capacity FRC; and -1·60 g/L per year 0·26 at FRC) than in the delayed-start group (-2·26 g/L per year 0·27 at TLC; -2·16 g/L per year 0·26 at TLC plus FRC, and -2·05 g/L per year 0·28 at FRC). Between months 24 and 48, the rate of lung density loss was reduced in delayed-start patients (from -2·26 g/L per year to -1·26 g/L per year), but no significant difference was seen in the rate in early-start patients during this time period (-1·51 g/L per year to -1·63 g/L per year), thus in early-start patients the efficacy was sustained to month 48.
RAPID-OLE supports the continued efficacy of A1PI in slowing disease progression during 4 years of treatment. Lost lung density was never recovered, highlighting the importance of early intervention with A1PI treatment.
CSL Behring.
Objectives Gastroesophageal reflux disease (GERD) is implicated as a risk factor for bronchiolitis obliterans syndrome after lung transplantation, but its effects on acute rejection, early allograft ...function, and survival are unclear. Therefore, we sought to systematically understand the time-related impact of pretransplant GERD on graft function (spirometry), mortality, and acute rejection early after lung transplantation. Methods From January 2005 to July 2008, 215 patients underwent lung transplantation; 114 had preoperative pH testing, and 32 (28%) had objective evidence of GERD. Lung function was assessed by forced 1-second expiratory volume (FEV1 ; percent of predicted) in 97 patients, mortality by follow-up (median, 2.2 years), and acute rejection by transbronchial biopsy. Results Pretransplant GERD was associated with decreased FEV1 early after lung transplantation ( P = .01) such that by 18 months, FEV1 was 70% of predicted in double lung transplant patients with GERD versus 83% among non-GERD patients ( P = .05). A similar decrease was observed in single lung transplantation (50% vs 60%, respectively; P = .09). GERD patients had lower survival early after transplant ( P = .02)—75% versus 90%. Presence of GERD did not affect acute rejection ( P = .6). Conclusions For lung transplant recipients, pretransplant GERD is associated with worse early allograft function and survival, but not increased acute rejection. The compromise in lung function is substantial, such that FEV1 after double lung transplant in GERD patients approaches that of single lung transplant in non-GERD patients. We advocate thorough testing for GERD before lung transplantation; if identified, aggressive therapy early after transplant, including fundoplication, may prove efficacious.
Objectives We hypothesized that inhaled nitric oxide (iNO) would not decrease death or neurodevelopmental impairment (NDI) in infants enrolled in the National Institute of Child Health and Human ...Development Preemie iNO Trial (PiNO) trial, nor improve neurodevelopmental outcomes in the follow-up group. Study design Infants <34 weeks of age, weighing <1500 g, with severe respiratory failure were enrolled in the multicenter, randomized, controlled trial. NDI at 18 to 22 months corrected age was defined as: moderate to severe cerebral palsy (CP; Mental Developmental Index or Psychomotor score Developmental Index <70), blindness, or deafness. Results Of 420 patients enrolled, 109 who received iNO (52%) and 98 who received placebo (47%) died. The follow-up rate in survivors was 90%. iNO did not reduce death or NDI (78% versus 73%; relative risk RR, 1.07; 95% CI, 0.95-1.19), or NDI or Mental Developmental Index <70 in the follow-up group. Moderate-severe CP was slightly higher with iNO (RR, 2.41; 95% CI, 1.01-5.75), as was death or CP in infants weighing <1000 g (RR, 1.22; 95% CI, 1.05-1.43). Conclusions In this extremely ill cohort, iNO did not reduce death or NDI or improve neurodevelopmental outcomes. Routine iNO use in premature infants should be limited to research settings until further data are available.
The COPD Assessment Test Gupta, Nisha, MSc; Pinto, Lancelot, MD; Benedetti, Andrea, PhD ...
Chest,
November 2016, Letnik:
150, Številka:
5
Journal Article
Recenzirano
Background The COPD Assessment Test (CAT) is a valid disease-specific questionnaire measuring health status. However, knowledge concerning its use regarding patient and disease characteristics ...remains limited. Our main objective was to assess the degree to which the CAT score varies and can discriminate between specific patient population groups. Methods The Canadian Cohort Obstructive Lung Disease (CanCOLD) is a random-sampled, population-based, multicenter, prospective cohort that includes subjects with COPD (Global Initiative for Chronic Obstructive Lung Disease GOLD classifications 1 to 3). The CAT questionnaire was administered at three visits (baseline, 1.5 years, and 3 years). The CAT total score was determined for sex, age groups, smoking status, GOLD classification, exacerbations, and comorbidities. Results A total of 716 subjects with COPD were included in the analysis. The majority of subjects (72.5%) were not previously diagnosed with COPD. The mean FEV1 /FVC ratio was 61.1 ± 8.1%, with a mean FEV1 % predicted of 82.3 ± 19.3%. The mean CAT scores were 5.8 ± 5.0, 9.6 ± 6.7, and 16.1 ± 10.0 for GOLD 1, 2, and 3+ classifications, respectively. Higher CAT scores were observed in women, current smokers, ever-smokers, and subjects with a previous diagnosis of COPD. The CAT was also able to distinguish between subjects who experience exacerbations vs those who had no exacerbation. Conclusions These results suggest that the CAT, originally designed for use in clinically symptomatic patients with COPD, can also be used in individuals with mild airflow obstruction and newly diagnosed COPD. In addition, the CAT was able to discriminate between sexes and subjects who experience frequent and infrequent exacerbations. Trial Registry ClinicalTrials.gov; No.: NCT00920348 ; Study ID No.: IRO-93326.
SMART isn't Chapman, Kenneth R., MD, MSc, FRCPC, FACP
Journal of allergy and clinical immunology,
03/2010, Letnik:
125, Številka:
3
Journal Article
Recenzirano
Overreliance on bronchodilator therapy had led to a crisis-oriented approach to care whereby symptoms were responded to rather than prevented.1 Guidelines subsequently emphasized the early use of ...inhaled corticosteroids to quench underlying airways inflammation, thereby preventing symptoms and clinical instability.2,3 This widely adopted approach has been successful in reducing asthma mortality, and more recent guidelines have taught physicians to titrate their maintenance therapy to suppress all or nearly all day-to-day symptoms of asthma not only because this is intrinsically worthwhile to patients seeking to improve their quality of life but also because targeting good control reduces the likelihood of exacerbations and lung function lost to remodeling.4 In this issue of the Journal, Bateman et al5 report their extensive examination of the relationship between day-to-day symptoms and the risk of future exacerbations. The investigators examined the relationship between control and exacerbation risk not only in patients assigned to a conventional regimen of maintenance anti-inflammatory therapy and separate quick relief bronchodilator but also in patients who were treated with the novel single maintenance and reliever therapy (SMART) whereby patients use a low dose of scheduled ICS/long-acting β-agonist (LABA) maintenance therapy and the same medication as a quick reliever to treat breakthrough symptoms. ...far, only the fixed dose combination of budesonide with formoterol has been used in this fashion.
Summary Background Patients who have asthma-related emergency department (ED) visits or hospitalizations are at risk for recurrent exacerbation events. Our objectives were to assess whether receiving ...a controller medication at discharge affects risk of recurrence and whether delaying controller initiation alters this risk. Methods Asthma patients with an ED visit or inpatient (IP) stay who received a controller dispensing within 6 months were identified from healthcare claims. Cox proportional hazards of the time to first recurrence of an asthma-related ED or IP visit in the 6-month period following the initial event were constructed, with time following discharge without controller medication as the primary predictor. Results A total of 6139 patients met inclusion criteria, 78% with an ED visit and 22% with an IP visit; 15% had a recurrence within 6 months. The adjusted hazard ratio (HR) associated with not having controller medication at discharge was 1.79 (95% confidence interval CI, 1.42–2.25). The controller-by-time interaction was significant ( P < 0.001), with hazard rising as time-to-controller initiation increased. Delaying initiation by 1 day approximately tripled the risk (HR 2.95; 95%CI 1.48–5.88). Sensitivity analyses, including accounting for controller fills prior to the index event, did not substantially alter these results. Conclusions This observational study shows that the risk of a recurrent asthma-related ED visit or IP stay increased as the time to initiate a controller increased. Our findings support the importance of early controller initiation following an asthma-related ED or IP visit in reducing risk of recurrence.
Background Indacaterol is an inhaled, long-acting β2 -agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD. Methods Subjects with moderate to severe COPD who completed ...a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV1 at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire SGRQ). Results Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV1 relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally > 4 units. Conclusions During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes. Trial registry ClinicalTrials.gov ; No.: NCT00677807 ; URL: www.clinicaltrials.gov
Abstract Purpose The purpose of the study was to prospectively establish the use of a novel multidetector computed tomography unit (MDCT) with 320 × 0.5 detector rows for the evaluation of ...tracheomalacia by using a dynamic expiratory low-dose technique. Methods Six adult patients (5 men, 1 woman; mean age, 53.7 years 37–70 years) referred for a clinical suspicion of tracheomalacia were studied on a 320-row MDCT unit by using the following parameters: 120 kVp, 40–50 mA, 0.5-second gantry rotation, and z-axis coverage of 160 mm sufficient to cover the thoracic trachea to the proximal bronchi. Image acquisition occurred during a forceful exhalation. The image data set was subject to the following analyses: cross-sectional area of airway lumen at 4 predefined locations (thoracic inlet, aortic arch, carina, and bronchus intermedius) and measurement of airway volume. Results All 6 patients had evidence of tracheomalacia, the proximal trachea collapsed at a later phase of expiration (3–4 seconds) than the distal trachea (2–3 seconds). The most common region of airway collapse occurred at the level of the aortic arch (5/6 83%), Three patients (50%) had diffuse segmental luminal narrowing that involved the tracheobronchial tree. The radiation dose (estimated dose length product, computed tomography console) measured 293.9 mGy in 1 subject and 483.5 mGy in 5 patients. Conclusions Four-dimensional true isophasic and isovolumetric imaging of the central airways by using 320-row MDCT is a viable technique for the diagnosis of tracheomalacia; it provides a comprehensive assessment of airways dynamic.