scholarly journals Inhaled Drug Therapy-Associated Adverse Reactions in Obstructive Respiratory Diseases: A Review of a Decade of Reporting to the Portuguese Pharmacovigilance System

Author(s):  
Willy Fonseca ◽  
Cristina Monteiro ◽  
Luís Taborda-Barata

Inhaled medication used for treatment of chronic obstructive lung diseases (asthma, chronic obstructive pulmonary disease-COPD, and Asthma-COPD overlap) may be associated with adverse drug reactions (ADRs). The aim of this study was to characterise spontaneous reports (SRs) of suspected ADRs received by the Portuguese Pharmacovigilance System (PPS), from 2007 to 2017. Methods: Retrospective observational study of SRs associated with single substance and combination inhalers, analysed in terms of pharmacological class of the involved drugs, sex and age range of the involved patients, and seriousness and type of ADRs. Results: 230 SRs were analysed, accounting for a total of 599 suspected ADRs. Inhaled corticosteroid/long-acting beta-2 agonist combination had the highest frequency in SRs (32.2%) and in ADRs (32.7%). There was a slight predominance in men (51.3%) and non-elderly adults were the most affected age group (39.1%). Most SRs were serious (70.4%). In total, “respiratory, thoracic and mediastinal diseases” ADRs were the most reported (19.5%), with “dyspnea” being the most frequent (4.8%). Conclusions: Most SRs were associated with controller medications and were expected. Most ADRs involved non-elderly adults, were serious and of respiratory nature and many were due to overuse of reliever medication.

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Yoko Azuma ◽  
Atsushi Sano ◽  
Takashi Sakai ◽  
Satoshi Koezuka ◽  
Hajime Otsuka ◽  
...  

Abstract Background Chronic obstructive pulmonary disease (COPD) is an important risk factor for postoperative complications and mortality. To determine the effects of perioperative combination therapy, using a long-acting muscarinic antagonist (LAMA) and a long-acting β2 agonist (LABA), on preoperative lung function, postoperative morbidity and mortality, and long-term outcome in COPD patients. Methods Between January 2005 and October 2019, 130 consecutive patients with newly diagnosed COPD underwent surgery for lung cancer. We conducted a retrospective review of their medical record to evaluate that LAMA/LABA might be an optimal regimen for patients with COPD undergoing surgery for lung cancer. All patients were received perioperative rehabilitation and divided into 3 groups according to the type of perioperative inhaled therapy and management: LAMA/LABA (n = 64), LAMA (n = 23) and rehabilitation only (no bronchodilator) (n = 43). We conducted a retrospective review of their medical records. Results Patients who received preoperative LAMA/LABA therapy showed significant improvement in lung function before surgery (p < 0.001 for both forced expiratory volume in 1 s (FEV1) and percentage of predicted forced expiratory volume in 1 s (FEV1%pred). Compared with patients who received preoperative LAMA therapy, patients with LAMA/LABA therapy had significantly improved lung function (ΔFEV1, LAMA/LABA 223.1 mL vs. LAMA 130.0 mL, ΔFEV1%pred, LAMA/LABA 10.8% vs. LAMA 6.8%; both p < 0.05). Postoperative complications were lower frequent in the LAMA/LABA group than in the LAMA group (p = 0.007). In patients with moderate to severe air flow limitation (n = 61), those who received LAMA/LABA therapy had significantly longer overall survival and disease-free survival compared with the LAMA (p = 0.049, p = 0.026) and rehabilitation-only groups (p = 0.001, p < 0.001). Perioperative LAMA/LABA therapy was also associated with lower recurrence rates (vs. LAMA p = 0.006, vs. rehabilitation-only p = 0.008). Conclusions We believe this treatment combination is optimal for patients with lung cancer and COPD.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
David Slade ◽  
Riju Ray ◽  
Chad Moretz ◽  
Guillaume Germain ◽  
François Laliberté ◽  
...  

Abstract Background Adherence to chronic obstructive pulmonary disease (COPD) maintenance medication is important for managing symptoms and exacerbation risk, and is associated with reduced mortality, hospitalizations, and costs. This study compared on-treatment exacerbations, medical costs, and medication adherence in patients with COPD initiating treatment with umeclidinium/vilanterol (UMEC/VI) or tiotropium (TIO). Methods This retrospective matched cohort study selected patients from Optum’s de-identified Clinformatics Data Mart database who initiated maintenance treatment with UMEC/VI or TIO between 01/01/2014 and 12/31/2017 (index date defined as the first dispensing). Eligible patients were ≥ 40 years of age and had ≥ 12 months continuous health plan coverage pre- and post-index; ≥ 1 medical claim for COPD pre-index or on the index date; no moderate/severe COPD-related exacerbations on the index date; no asthma diagnosis pre- or post-index; no maintenance medication fills containing inhaled corticosteroids, long-acting β2-agonists, or long-acting muscarinic antagonists pre-index or on the index date; and no fills for both UMEC/VI and TIO on the index date. Outcomes included time-to-first (Kaplan–Meier analysis) and rates of on-treatment COPD-related moderate/severe exacerbations, medication adherence (proportion of days covered [PDC] and proportion of adherent patients [PDC ≥ 0.8]), and COPD-related medical costs per patient per month (PPPM). Propensity score matching was used to adjust for potential confounders. Results Each cohort included 3929 matched patients. Kaplan–Meier rates of on-treatment COPD-related exacerbations were similar between cohorts (hazard ratio at 12 months; overall: 0.93, moderate: 0.92, severe: 1.07; all p > 0.05). UMEC/VI versus TIO initiators had significantly higher adherence (mean PDC: 0.44 vs 0.37; p < 0.001; proportion with PDC ≥ 0.8: 22.0% vs 16.4%; p< 0.001) and significantly lower mean on-treatment COPD-related total medical costs ($867 vs $1095 PPPM; p = 0.028), driven by lower outpatient visit costs. Conclusions These findings provide valuable information for physicians considering UMEC/VI or TIO as initial maintenance therapy options for patients with COPD.


2021 ◽  
Vol 31 (1) ◽  
pp. 75-87
Author(s):  
I. V. Leshchenko ◽  
A. S. Meshcheryakova

Chronic obstructive pulmonary disease (COPD) is the leading cause of death in the structure of respiratory diseases. The problem of rational pharmacotherapy of COPD have attracted attention of the medical scientific society for many years. The understanding of the pathogenesis of the disease has deepened and approaches to the therapy have changed. Some COPD patients need regular fixed-combination therapy: long-acting bronchodilators (LABD) and inhaled corticosteroids (ICS) in order to prevent exacerbations and reduce the severity of symptoms of the disease. Blood eosinophils count is one of criteria for choosing regular therapy. The appearance of fixed triple combinations of ICS/LABD increased the effectiveness of COPD therapy, and a new delivery device for fixed combination of budesonide/formoterol makes it possible to use ICS successfully in the most severe patients.


2021 ◽  
Author(s):  
Jorge Machado Alba

Introduction: Chronic obstructive pulmonary disease (COPD) affects approximately 174 million people worldwide.The objective was to determine the trends of the use of medications for COPD in a group of Colombian patients. Methods: This was a retrospective study on prescription patterns of bronchodilators and other medications used in COPD from a population database with follow-up at 12 and 24 months. Patients older than 18 years of age of any sex who had COPD between 2017 and 2019 were included. Sociodemographic variables, medications, treatment schedules for COPD, comorbidities, comedications, and the specialty of the prescriber were considered. Results: A total of 9,476 people with a diagnosis of COPD were evaluated. They had a mean age of 75.9 ± 10.7 years, 50.1% were men, and 86.8% were prescribed by a general practitioner. At the beginning of the follow-up, on average, they received 1.6 medications/patient, mainly short-acting antimuscarinics (3784; 39.9%), followed by short-acting β-agonists (2997, 31.6%) and inhaled corticosteroids (ICS) (2239, 23.6%), but 5083 (53.6%) patients received a long-acting bronchodilator. At the beginning of the follow-up, 645 (6.8%) patients were put on triple therapy with antimuscarinics, β-agonists, and ICS, and at 12 months, this rose to 1388 (20.6%). A total of 57.9% had comorbidities, most often hypertension (44.4%). Conclusions: This group of patients with COPD treated in Colombia frequently received short-acting bronchodilators and ICS, but a growing proportion are undergoing controlled therapy with long-acting bronchodilators, a situation that can improve the indicators of morbidity, exacerbations, and hospitalization.


MedAlliance ◽  
2020 ◽  
Vol 8 (2) ◽  
pp. 32-39

Chronic obstructive pulmonary disease (COPD) and pulmonary tuberculosis (TB) are a common pathology among respiratory diseases. Both conditions may have common risk factors, aggravating each other, accom-panied by the development of bronchial obstructive syndrome, requiring mandatory medical correction to increase the effectiveness of therapy for both the main and concomitant pathologies. The aim of the study was to study the effectiveness of treatment of TB in patients with COPD first diagnosed with tuberculosis, including those associated with HIV when prescribing long-acting β2-agonists. Materials and methods. A simple com-parative study included 60 patients of a TB dispensary aged 30–65 years. Patients were divided into 2 groups of 30 people (TB+COPD and TB+COPD+HIV), each of whom for 2 months received a long-acting β-agonist (indacaterol) as an accompanying therapy for the cor-rection of bronchial obstructive syndrome (BOS), with subsequent assessment of the effectiveness of therapy. Results. Subjectively, patients of both groups noted the rapid development of positive dynamics (short-ness of breath decreased from 1–3 days of taking the drug, coughing — within a week, tolerance to physical exertion improved), which was confirmed by indica-tors of the function of external respiration (FEV1). The state of the cardiovascular system was assessed by the results of daily monitoring of blood pressure (BPM). In the COPD+TB group, there is a certain average daily systolic blood pressure (SBP) with a tendency to nor-malize indicators, which is possibly associated with a decrease in the severity of hypoxia during bronchodi-lator therapy. In the COPD+TB+HIV group, the average daily level of SBP increased by 1 mm Hg, but given the very low starting rates, the increase in blood pressure had a positive effect on the patients' condition. The average heart rate (HR) during bronchodilator thera-py did not tend to increase. The best TB treatment re-sults were obtained in the TB+COPD group. In terms of the closure rate of TB+COPD decay cavities — 26.6%, TB+COPD+HIV — 20.0%), the TB+COPD+HIV group had longer periods of abacillation and closure of decay cav-ities, which is associa ted with the severity of the under-lying and associated diseases. The drug was well toler-ated in both groups. Conclusion. The use of 300 mcg long-acting β-adrenomimetics in the complex therapy of β2-adrenergic agonists for patients with TB+COPD and TB+ COPD+HIV can reduce the severity of bronchial obstruction syndrome, improve quality of life, increase adherence to TB treatment, thereby shortening hospi-talization and reduce the likelihood of disability of pa-tients, without the development of side effects from other organs and systems.


Sign in / Sign up

Export Citation Format

Share Document