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The Effect of Maintenance Treatment with Erdosteine on Exacerbation Treatment and Health Status in Patients with COPD: A Post-Hoc Analysis of the RESTORE Dataset.
Get PDFPurpose: To explore the effect of erdosteine on COPD exacerbations, health-related quality of life (HRQoL), and subjectively
assessed COPD severity.
Patients and methods: This post-hoc analysis of the RESTORE study included participants with COPD and spirometrically
moderate (GOLD 2; post-bronchodilator forced expiratory volume in 1 second [FEV1] 50‒79% predicted; n = 254), or severe airflow
limitation (GOLD 3; post-bronchodilator FEV1 30‒49% predicted; n = 191) who received erdosteine 300 mg twice daily or placebo
added to usual maintenance therapy for 12 months. Antibiotic and oral corticosteroid use was determined together with patientreported
HRQoL (St George’s Respiratory Questionnaire, SGRQ). Patient and physician subjective COPD severity scores (scale 0‒4)
were rated at baseline, 6 and 12 months. Data were analyzed using descriptive statistics for exacerbation severity, COPD severity, and
treatment group. Comparisons between treatment groups used Student’s t-tests or ANCOVA as appropriate.
Results: Among GOLD 2 patients, 43 of 126 erdosteine-treated patients exacerbated (7 moderate-to-severe exacerbations),
compared to 62 of 128 placebo-treated patients (14 moderate-to-severe exacerbations). Among those with moderate-to-severe
exacerbations, erdosteine-treated patients had a shorter mean duration of corticosteroid treatment (11.4 days vs 13.3 days for
placebo, P = 0.043), and fewer patients required antibiotic treatment with/without oral corticosteroids (71.4% vs 85.8% for placebo,
P < 0.001). Erdosteine-treated GOLD 2 patients who exacerbated showed significant improvements from baseline in SGRQ total
scores and subjective disease severity scores (patient- and physician-rated), compared with placebo-treated patients regardless of
exacerbation severity. Among GOLD 3 patients, there were no significant differences between treatment groups on any of these
measures.
Conclusion: Adding erdosteine to the usual maintenance therapy of COPD patients with moderate airflow limitation reduced the
number of exacerbations, the duration of treatment with corticosteroids and the episodes requiring treatment with antibiotics.
Additionally, treatment with erdosteine improved HRQoL and patient-reported disease severity
Withdrawal from treatment as an outcome in the Isolde study of COPD
No full textObjectives: To investigate the determinants of patient withdrawal from our study, and the effect
of these withdrawals on the outcome of treatment with inhaled corticosteroids in patients with
COPD.
Design: A double-blind, placebo-controlled, randomized trial.
Setting: Eighteen outpatient centers in the United Kingdom.
Participants: Seven hundred fifty-one patients with stable COPD defined clinically as baseline postbronchodilator FEV1 > 0.8 L and < 85% predicted, FEV1/FVC ratio < 70%, and FEV1 change after albuterol < 10% of predicted.
Intervention: Random assignment of either 500 micrograms bid of inhaled fluticasone propionate (FP)using a spacer device or an identical placebo inhaler. Treatment was continued for 3 years or
until patients withdrew from follow-up.
Measurements and results: Postbronchodilator FEV1 was measured on three occasions before
randomization and every 3 months thereafter. Health status was assessed by the disease-specific
St. George Respiratory Questionnaire (SGRQ) and the modified short-form 36 questionnaire
(SF-36) at baseline and every 6 months. Three hundred thirty-nine patients withdrew, of whom
156 patients received FP. Prescription of frequent courses of oral prednisolone was the most
common reason for withdrawing as specified in the protocol (69 patients in the FP group
withdrew due to respiratory symptoms, compared with 93 patients in the placebo group). This
explained the significantly greater dropout of placebo-treated patients that was most evident
when FEV1 was < 50% predicted. Patients withdrawing had a significantly more rapid decline in health status, measured by both the SGRQ and the SF-36 (p < 0.001). Those withdrawing from the placebo group had a more rapid decline in FEV1 and more exacerbations than the FP-treated
groups. Baseline FEV1 was lower in dropouts than in patients completing the study receiving
placebo, but there was no difference between the respective groups receiving FP.
Conclusions: Patients who withdrew from follow-up were those with the most rapidly deteriorating
health status and lung function. Losing these patients from the final analysis can reduce the
power of a study to achieve its primary end point
Randomised, double blind, placebo controlled study of fluticasone propionate in patients with moderate to severe chronic obstructive pulmonary disease: The ISOLDE trial
Get PDFObjectives
To determine the effect of long term inhaled corticosteroids on lung function, exacerbations, and health status in patients with moderate to severe chronic obstructive pulmonary disease.
Design
Double blind, placebo controlled study.
Setting
Eighteen UK hospitals.
Participants
751 men and women aged between 40 and 75 years with mean forced expiratory volume in one second (FEV1) 50% of predicted normal.
Interventions
Inhaled fluticasone propionate 500mg twice daily from a metered dose inhaler or identical placebo.
Main outcome measures
Efficacy measures: rate of decline in FEV1 after the bronchodilator and in health status, frequency of exacerbations, respiratory
withdrawals. Safety measures: morning serum cortisol concentration, incidence of adverse events.
Results
There was no significant difference in the annual rate of decline in FEV1 (P = 0.16). Mean FEV1
after bronchodilator remained significantly higher
throughout the study with fluticasone propionate
compared with placebo (P < 0.001). Median
exacerbation rate was reduced by 25% from 1.32 a
year on placebo to 0.99 a year on with fluticasone
propionate (P = 0.026). Health status deteriorated by 3.2 units a year on placebo and 2.0 units a year on fluticasone propionate (P = 0.0043). Withdrawals because of respiratory disease not related to malignancy were higher in the placebo group (25% v 19%, P = 0.034).
Conclusions
Fluticasone propionate 500 mg twice daily did not affect the rate of decline in FEV1 but did
produce a small increase in FEV1. Patients on
fluticasone propionate had fewer exacerbations and a slower decline in health status. These improvements in clinical outcomes support the use of this treatment in patients with moderate to severe chronic obstructive pulmonary disease
Current pharmacotherapy of COPD
No full textThis chapter focuses on the pharmacological treatment of stable COPD. The main treatments of stable COPD are initially short-acting or long-acting bronchodilators, comprising β-agonists (SABAs and LABAs) or antimuscarinics (SAMAs and LAMAs), preferably combined in a single-inhaler dual therapy (LABA/LAMA). A subset of patients may benefit from ICS added to LABA/LAMA treatment, preferably in a single-inhaler triple therapy (SITT; LABA/LAMA/ICS). These treatments improve symptoms and quality of life and reduce exacerbations. Since ICS have side-effects (e.g. pneumonia), they should be given only to patients with higher blood eosinophil counts (>100, preferably >300 cells·μL−1), and their benefits must be balanced with their risks. In patients not controlled by SITT, additional treatments are roflumilast, macrolide maintenance, and possibly dupilumab for eosinophilic COPD
Effect of erdosteine on the rate and duration of COPD exacerbations: the RESTORE study (Reducing Exacerbations and Symptoms by Treatment with ORal Erdosteine)
No full textInflammation and oxidative stress are involved in Chronic Obstructive Pulmonary Disease (COPD) exacerbations. Erdosteine is a muco-active agent with antioxidant, anti-inflammatory and bacterial anti-adhesive properties.
Aim: To assess the efficacy of erdosteine added to usual maintenance therapy in reducing the frequency and duration of exacerbations.
Methods: RESTORE is a randomized, double-blind, placebo-controlled, parallel group trial on 467 adult patients (40–80 years, 74% males; mean 64.8 years) with GOLD stage II-III COPD who were randomized to either erdosteine 300 mg bid or placebo for 12 months. The main outcome measures were the rate and duration of exacerbations; secondary outcomes included subject’s and physician’s severity scores (S1 and S2, respectively), the score of the Saint George’s Respiratory Questionnaire (SGRQ), and the use of reliever medications.
Results: Compared to placebo, erdosteine reduced overall mean exacerbation rate by 17.1% (p=0.01) and mild exacerbation rate by 57.1% (p=0.002), but it did not change the rate of moderate/severe exacerbations. Erdosteine lowered mean exacerbation duration (-24.6%, p=0.023), an effect seen in both mild (-22.1%, p=0.039) and moderate/severe exacerbations. Erdosteine improved S1 and S2 (p= 0.022 and p=0.048 respectively), reduced the use of reliever medication (p<0.001), but not the SGRQ score. The percentage of patients with adverse events were similar in both treatment groups.
Conclusions: Erdosteine reduces the rate and duration of COPD exacerbations with a placebo-like safety profile; it may represent a useful additional COPD treatment
Effect of erdosteine in moderately severe COPD patients
No full textBackground: In RESTORE study (528 pts, GOLD II-III) erdosteine 300 mg bid added to usual COPD therapy reduced exacerbation rate by 17.1% (p=0.01) and lowered duration by 24.6% (p=0.02).
Aim and Objective: To assess the effect of erdosteine on exacerbation rate and time to first exacerbation in moderately severe COPD spirometrically defined patients.
Methods: Exacerbations were defined as a symptomatic worsening requiring change in regular medication or health care resources utilization. In this post-hoc analysis we consider 254 GOLD II (2011 definition) patients. The frequency of exacerbations per patient/year (12 months treatment) were analyzed non-parametrically (Wilcoxon rank sum test), the time free from first exacerbation using the log-rank test (Kaplan–Meier).
Results: Compared to more severe patients, GOLD II patients had similar baseline characteristics but higher FEV1 and FVC values. After 1-year treatment in GOLD II subgroup, 74 exacerbations (57.8%) have been registered in the placebo vs. 53 (42.1%) in the erdosteine group. Erdosteine reduced the exacerbation rate by 47% (OR: 0.530, 95% CI 0.322-0.872, p= 0.017). This result was independent from individual variables or background treatment including ICS use. Additionally erdosteine increased the time to first exacerbation (Median time: 183 vs. 167 days Δ% +7.1 vs placebo P>0.001).
Conclusions: Erdosteine significantly reduced the exacerbation rate and increase the time to first exacerbation. Although the time to first event was a less sensitive marker in the total study population it improved significantly in this subgroup with a large benefit on exacerbation rate, suggesting a potential role of erdosteine in moderately severe COPD
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