Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the <scp>PATHOS</scp> study

Larsson, Kjell; Janson, Christer; Lisspers, Karin; Jorgensen, L.; Stratelis, Georgios; Telg, Gunilla; Ställberg, Björn; Johansson, Gunnar

doi:10.1111/joim.12067

Cited by 73 publications

(64 citation statements)

References 35 publications

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“…The exacerbation rates in the budesonide/formoterol and fluticasone/salmeterol groups were 0.80 and 1.09 per patient-years, respectively (p < 0.0001), and yearly rates for COPD-related hospitalizations were 0.1 and 0.21, respectively (p < 0.0001). All other healthcare outcome were also significantly reduced with budesonide/formoterol vs fluticasone/salmeterol combination [22,23]. Therefore, also this study suggests that long-term with budesonide/ formoterol combination was associated with fewer healthcare utilization-defined exacerbations than fluticasone/salmeterol combination in patients with moderate and severe COPD.…”

Section: Comparative Clinical Efficacy Of Fluticasone/salmeterol and mentioning

confidence: 56%

Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS

Latorre

Novelli

Vagaggini

et al. 2015

Pulmonary Pharmacology & Therapeutics

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a b s t r a c tInhaled corticosteroids (ICS) are frequently recommended for the treatment of asthma and COPD, often in combination with long-acting beta2-agonists (LABA), depending on the severity of the disease and/or on the specific phenotype. Several ICS/LABA combinations are currently available that differ in their pharmacokinetic characteristics and dose of both components. Thus, this review assesses differences in the efficacy and the safety profiles of the ICS components in the two more frequently used ICS/LABA combinations (budesonide/formoterol and fluticasone/salmeterol) for the management of COPD.Whereas the basic mechanism of action is similar for all ICS (binding with the intracellular glucocorticoid receptor, which mediates both genomic and non genomic effects), the pharmacokinetic and characteristics of ICS are quite different in terms of receptor affinity, bioavailability, lipophilicity and drug persistence in the airways. Fluticasone persists longer in airway mucus and requires more time to dissolve in the lining fluid and then enter the airway wall, whereas budesonide is cleared more quickly from the airways.Comparative efficacy of the two major ICS/LABA combinations recommended for the treatment of COPD show similar efficacy in terms of reduction of exacerbations, improvement in forced expiratory volume in the first second (FEV1) and quality of life. One retrospective cohort study suggested a greater efficacy for the budesonide/formoterol combination on hospital or emergency department admissions, oral corticosteroid courses, and addition of tiotropium, and an observational real-life study reported a greater reduction of COPD exacerbations with budesonide/formoterol than with fluticasom/salmeterol combination.Among the potential side effects of chronic ICS treatment in patients with COPD, recently the use of fluticasone or fluticasone/salmeterol combination has been associated with a higher prevalence of pneumonia in the major long-term studies. On the other hand, no similar increased risk of pneumonia has been reported in patients with COPD treated with the budesonide/formoterol combination. A recent population-based cohort study from the Quebec database showed that the adjusted odds ratio for having severe pneumonia was higher for fluticasone (2.1) than for budesonide (1.17) or other ICS (1.41). Of the ICS studied, only fluticasone demonstrated a dose-related increase in risk of pneumonia in patients with COPD. This difference between fluticasone and budesonide may be explained by the longer retention of fluticasone in the airways, with potentially greater inhibition of type-1 innate immunity.Therefore, the risk:benefit ratio should be evaluated thoroughly when choosing an ICS/LABA combination for patients with COPD.

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Section: Comparative Clinical Efficacy Of Fluticasone/salmeterol and mentioning

confidence: 56%

Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS

Latorre

Novelli

Vagaggini

et al. 2015

Pulmonary Pharmacology & Therapeutics

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“…Two matched cohorts of 2734 patients each were identified, with a follow-up comprising more than 19,000 patient-years. The study reports that treatment with budesonide/formoterol significantly reduces the number of exacerbations and hospitalizations compared to fluticasone/salmeterol [132].…”

Section: Real Life Studies: Overcoming Some Of the Limitationsmentioning

confidence: 99%

“…This Swedish retrospective, observational study compared exacerbation rates (defined as hospitalizations, emergency visits and administration of oral steroids or antibiotics for COPD) in patients with moderate to severe COPD who had been treated with either budesonide/formoterol or fluticasone/salmeterol [132]. Information was collected for more than 21,000 patients followed for up to 11 years from primary care medical records and data from national hospital, pharmacy and cause of death registries [132].…”

Section: Real Life Studies: Overcoming Some Of the Limitationsmentioning

confidence: 99%

“…Information was collected for more than 21,000 patients followed for up to 11 years from primary care medical records and data from national hospital, pharmacy and cause of death registries [132]. A propensity score was calculated based on age, gender, lung function, number of outpatient visits for acute exacerbations, number of prescriptions for other medications, significant comorbidities, and number of previous hospitalizations [132]. A score between 0 and 1 was given to each patient and a very tight matching was performed.…”

Section: Real Life Studies: Overcoming Some Of the Limitationsmentioning

confidence: 99%

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Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

Saturni¹,

Bellini²,

Braido³

et al. 2014

Pulmonary Pharmacology & Therapeutics

187

144

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a b s t r a c tRandomized Controlled Trials (RCTs) are the "gold standard" for evaluating treatment outcomes providing information on treatments "efficacy". They are designed to test a therapeutic hypothesis under optimal setting in the absence of confounding factors. For this reason they have high internal validity. The strict and controlled conditions in which they are conducted, leads to low generalizability because they are performed in conditions very different from real life usual care. Conversely, real life studies inform on the "effectiveness" of a treatment, that is, the measure of the extent to which an intervention does what is intended to do in routine circumstances. At variance to RCTs, real life trials have high generalizability, but low internal validity. Recently the number of real life studies has been rapidly growing in different areas of respiratory medicine, particularly in asthma and COPD. The role of such studies is becoming a hot topic in respiratory medicine, attracting research interest and debate.In the first part of this review we discuss some of the advantages and disadvantages of different types of RCTs and analyze the strengths and weaknesses of real life trials, considering the recent examples of some studies conducted in COPD. We then discuss methodological approaches and options to overcome some of the limitations of real life studies.Comparing the conclusions of effectiveness and efficacy trials can provide important pieces of information. Indeed, these approaches can result complementary, and they can guide the interpretation of each other results.

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“…Salmeterol and formoterol were identified as β2-receptor agonists that inhibit early and late phase antigen-induced airway hyper-responsiveness (9,10). Previous reports indicate that the combination of inhaled salmeterol and formoterol is a commonly used treatment protocol for patients with COPD (11,12).…”

Section: Introductionmentioning

confidence: 99%

Efficacy of salmeterol and formoterol combination treatment in mice with chronic obstructive pulmonary disease

Wang

Yang

2017

Exp Ther Med

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Abstract. Chronic obstructive pulmonary disease (COPD) is a severe lung disease characterized by progressive airflow limitation. Salmeterol and formoterol are two commonly used drugs in COPD therapy, which act as β2-receptor agonists. In the current study, a mouse model of COPD induced by airway lipopolysaccharide inhalation was established. The therapeutic efficacy of salmeterol and formoterol co-treatment was investigated in this model over a 56-day-long observation period. It was also identified that functional residual capacity and inspiratory resistance were significantly improved after salmeterol and/or formoterol treatment compared with the control group (all P<0.01). Furthermore, histological staining of lung tissue samples indicated that inflammation, thickening of the smooth muscle, goblet cell hyperplasia and pulmonary small vessel obstruction were reduced in the mice treated with salmeterol and/or formoterol, suggesting that salmeterol and formoterol were beneficial for ongoing airway and blood vessel remodeling in mice with COPD. The most common treatment-associated adverse events were hypertension and proteinuria. In conclusion, combined salmeterol and formoterol treatment was more effective compared with either single agent, suggesting that salmeterol and formoterol combined treatment has therapeutic value for the clinical treatment of patients with COPD.

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Combination of budesonide/formoterol more effective than fluticasone/salmeterol in preventing exacerbations in chronic obstructive pulmonary disease: the PATHOS study

Cited by 73 publications

References 35 publications

Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS

Differences in the efficacy and safety among inhaled corticosteroids (ICS)/long-acting beta2-agonists (LABA) combinations in the treatment of chronic obstructive pulmonary disease (COPD): Role of ICS

Randomized controlled trials and real life studies. Approaches and methodologies: a clinical point of view.

Efficacy of salmeterol and formoterol combination treatment in mice with chronic obstructive pulmonary disease

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