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Inhaled salmeterol/fluticasone propionate: a review of its use in chronic obstructive pulmonary disease
Fenton C, Keating GM
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Adis International Limited, Auckland, New Zealand. demail@adis.co.nz
The salmeterol/fluticasone propionate dry powder inhaler (DPI) [Advair Diskus, Seretide Accuhaler] contains the long-acting beta2-adrenoceptor agonist salmeterol and the inhaled corticosteroid fluticasone propionate. In the US, twice-daily salmeterol/fluticasone propionate 50/250 microg is approved for use in adults with chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis, and in the EU, the twice-daily 50/500 microg dosage is approved for use in patients with severe COPD, repeat exacerbations and significant symptoms despite bronchodilator therapy. In patients with moderate-to-severe COPD, twice-daily inhaled salmeterol/fluticasone propionate 50/250 or 50/500 microg for 24-52 weeks improves predose forced expiratory volume in 1 second (FEV1) significantly more than salmeterol monotherapy, improves postdose or postbronchodilator FEV1 significantly more than fluticasone propionate monotherapy and results in clinically significant improvements in health-related quality of life. Salmeterol/fluticasone propionate 50/500 microg significantly reduced annual COPD exacerbations, especially in severe COPD. Some corticosteroid-related adverse events were increased in recipients of fluticasone propionate with or without salmeterol versus salmeterol monotherapy or placebo; withdrawal from fluticasone propionate, including combination therapy, needs careful management to minimise COPD exacerbations. The DPI combining a corticosteroid and long-acting beta2-agonist provides benefits over monotherapy and may encourage patient compliance in COPD.
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PMID: 15329047 [PubMed - in process]
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Combined corticosteroid and longacting beta-agonist in one inhaler for chronic obstructive pulmonary disease
Nannini L, Cates C, Lasserson T, Poole P
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Pulmonary Section, Hospital G. Baigorria, Ruta 11 Y Jm Estrada, G. Baigorria, Santa Fe - Rosario, ARGENTINA, 2152
BACKGROUND: Long-acting beta-agonists and inhaled corticosteroids have both been recommended in guidelines for the treatment of chronic obstructive pulmonary disease. Their co-administration in a combined inhaler is intended to facilitate adherence to medication regimens, and to improve efficacy. OBJECTIVES: To assess the efficacy of combined inhaled corticosteroid and long-acting beta-agonist preparations, compared to placebo or the individual components, in the treatment of adults with chronic obstructive pulmonary disease. SEARCH STRATEGY: We searched the Cochrane Airways Group chronic obstructive pulmonary disease (COPD) trials register. Date of last search April 2004. SELECTION CRITERIA: Studies were included if they were randomised and double-blind. Studies could compare a combined inhaled corticosteroids and long-acting beta-agonist preparation with either component preparation or placebo. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality and extracted data. The primary outcome was exacerbations. MAIN RESULTS: Six randomised trials with 4118 participants were included. Two different combination preparations (fluticasone/salmeterol and budesonide/formoterol) were used. Combination treatment was more effective than placebo for mean exacerbation rates, quality of life and lung function. No trials were found comparing the combination of drugs in a single inhaler with the same drugs both given in separate inhalers. Exacerbations: Fluticasone/salmeterol did not significantly reduce exacerbations compared with either of its component treatments in one large study. There was no significant difference when budesonide/formoterol was compared with budesonide. Budesonide/formoterol was more effective than formoterol in reducing exacerbations (Rate ratio: 0.78 [0.68 to 0.90], two studies). A pooled analysis of both combination therapies indicated that exacerbations were less frequent when compared with either placebo or long-acting beta-agonist (versus placebo Rate ratio: 0.76 [0.68, 0.84], three studies, versus beta-agonist, Rate ratio: 0.85 [0.77, 0.95], three studies), but not when compared with steroid. The clinical impact of this effect depends on the frequency of exacerbations experienced by patients. One full exacerbation was prevented for every two to four years of treatment in the type of patients included in the trials. Quality of Life: There were conflicting findings in quality of life and symptoms when fluticasone/salmeterol was compared with inhaled steroids alone (three studies). There was no significant difference between fluticasone/salmeterol and long-acting beta-agonist in quality of life scores (three studies). Budesonide/formoterol improved symptoms when compared with budesonide but not with formoterol. There were conflicting findings in quality of life scores when budesonide/formoterol was compared with component inhaled corticosteroid or beta-agonist. These may be accounted for by different study design. Lung Function: Treatment with either combination led to small, significant differences in lung function compared with component steroid medication. Fluticasone/salmeterol led to small improvements in FEV(1) compared with salmeterol, but budesonide/formoterol treatment did not increase FEV(1 )significantly when compared with formoterol. REVIEWERS' CONCLUSIONS: Compared with placebo, combination therapy led to clinically meaningful differences in quality of life, symptoms and exacerbations. However, there were conflicting results when the different combination therapies were compared with the mono-components alone. In order to draw firmer conclusions about the effects of combination therapy in a single inhaler more data are necessary, including the assessment of the comparative effects with separate administration of the two drugs in double-dummy trials.
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PMID: 15266502 [PubMed - as supplied by publisher]
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Salmeterol/fluticasone propionate in a Single Inhaler Device versus theophylline+fluticasone propionate in patients with COPD
Cazzola M, Noschese P, Centanni S, Santus P, Di Marco F, Spicuzza L, Di Maria GU
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Respiratory Medicine and Allergology Unit, A. Cardarelli Hospital, Via del Parco Margherita 24, 80121 Naples, Italy. mcazzola@qubisoft.it
STUDY OBJECTIVES: The aim of this study was to compare the relative efficacy in terms of improvement in symptoms and lung function of salmeterol/fluticasone propionate (SLM/FP) combination administered through the Diskus inhaler versus theophylline (THEO) added to FP Diskus in patients with stable chronic obstructive pulmonary disease (COPD). METHODS AND MEASUREMENTS: Eighty patients were randomized to receive 4 months of treatment in one of two treatment groups: (1) fixed combination of SLM 50 microg and FP 500 microg Diskus, 1 inhalation twice daily; or (2) FP Diskus 500 microg, 1 inhalation twice daily, plus oral titrated THEO twice daily. Patients attended the clinic before and after 4, 8, 12 and 16 weeks of treatment for evaluations of pulmonary function, and dyspnea, which was assessed using an analogic visual scale. Also the supplemental salbutamol use was measured. RESULTS:. Sixty-six patients completed the 4-month treatment period: 37 patients receiving SLM/FP and 29 patients receiving THEO+FP. Patients were withdrawn for various reasons, the most common of which were poor compliance with the protocol, exacerbation and GI events. A gradual increase in FEV(1) was observed with each treatment. Maximum significant increases in FEV(1) over baseline values that were observed after 4 months of treatment were as follows: SLM/FP 0.172 l (95% CI: 0.084-0.260) and THEO+FP 0.155 l (95% CI: 0.054-0.256). SLM/FP experienced significantly (p minor 0.05) greater improvements in dyspnea, and required significantly fewer supplemental salbutamol treatments than the THEO+FP group. CONCLUSIONS: Our results suggest that SLM/FP combination may provide substantial benefits in both physiologic and clinical outcomes in symptomatic patients with COPD. It also causes a more effective control than THEO+FP.
Publication Types:
• Clinical Trial
• Randomized Controlled Trial
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PMID: 15123223 [PubMed - indexed for MEDLINE]
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Inhaled combination therapy with long-acting beta 2-agonists and corticosteroids in stable COPD
Cazzola M, Dahl R
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Department of Respiratory Medicine, Unit of Pneumology and Allergology, Antonio Cardarelli Hospital, Naples, Italy. mcazzola@qubisoft.it
Long-acting beta(2)-agonists (LABAs) have been shown to be effective first-line bronchodilators in the treatment of COPD patients, and inhaled corticosteroids (ICSs) have been shown to reduce the frequency and/or severity of exacerbations in COPD patients. The concomitant use of a LABA and an ICS can influence both airway obstruction (ie, smooth muscle contraction, increased cholinergic tone, and loss of elastic recoil), and airway inflammation (ie, increased numbers of neutrophils, macrophages, and CD8+ lymphocytes, elevated interleukin-8 and tumor necrosis factor-alpha levels, and protease/antiprotease imbalance). They are also able to reduce the total number of bacteria adhering to the respiratory mucosa in a concentration-dependent manner without altering the bacterial tropism for mucosa, and to preserve ciliated cells. Several clinical trials support the concept of inhaled combination therapy with LABAs and corticosteroids in stable COPD patients. This type of therapy not only improves airflow obstruction but also provides clinical benefits, as manifested by sustained reduction in overall symptoms, improvements in health-related quality of life, and reductions in exacerbations. All of these effects are very important because, despite recent advances in our understanding of COPD and its treatment, therapy remains suboptimal for a considerable number of patients.
Publication Types:
• Review
• Review, Academic
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PMID: 15249466 [PubMed - indexed for MEDLINE]
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Budesonide/formoterol: in chronic obstructive pulmonary disease
Reynolds NA, Perry CM, Keating GM
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Adis International Limited, Auckland, New Zealand. demail@adis.co.nz
Budesonide/formoterol is a fixed-dose combination of the corticosteroid budesonide and the long-acting beta2-agonist formoterol, and is inhaled via the Turbuhaler device. In two large, randomised, double-blind, 12-month studies, patients with severe chronic obstructive pulmonary disease (COPD) receiving budesonide/formoterol 320/9 microg twice daily had a significantly higher forced expiratory volume in 1 second (FEV1) and significantly higher morning and evening peak expiratory flow at trial endpoint than recipients of budesonide or placebo; FEV1 was significantly higher than with formoterol in the larger study. In both studies, the rate of COPD exacerbations and exacerbations requiring oral corticosteroids was significantly reduced with budesonide/formoterol versus formoterol and placebo. Moreover, the time to first exacerbation was significantly prolonged with budesonide/formoterol versus all other treatment arms in the larger study. At 12 months, significant improvements in health-related quality-of-life scores were seen with budesonide/formoterol versus placebo in both studies. The reduction in total and individual symptom scores was significantly greater with budesonide/formoterol than with budesonide or placebo in the smaller study. Budesonide/formoterol was generally well tolerated by patients with severe COPD. The tolerability profile of the combination was similar to that of the individual components with no increase in the incidence of adverse events.
Publication Types:
• Review
• Review, Tutorial
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PMID: 14969576 [PubMed - indexed for MEDLINE]
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The efficacy and safety of fluticasone propionate (250 microg)/salmeterol (50 microg) combined in the Diskus inhaler for the treatment of COPD
Hanania NA, Darken P, Horstman D, Reisner C, Lee B, Davis S, Shah T
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Baylor College of Medicine, Pulmonary/Critical Care, Ben Taub General Hospital, 1504 Taub Loop, Houston, TX 77030, USA. hanania@bcm.tmc.edu
STUDY OBJECTIVES: To compare the efficacy and safety of the inhaled corticosteroid fluticasone propionate (FP) and the inhaled long-acting beta(2)-agonist salmeterol (SM), when administered together in a single device (Diskus; GlaxoSmithKline, Inc; Research Triangle Park, NC), with that of placebo and the individual agents alone in patients with COPD. DESIGN: Randomized, double-blind, multicenter, placebo-controlled study. SETTING: Seventy-six investigative sites in the United States. PATIENTS: Seven hundred twenty-three patients > or =40 years of age with COPD and a mean baseline FEV(1) of 42% predicted. INTERVENTIONS: FP (250 microg), SM (50 microg), FP plus SM combined in a single inhaler (FSC), or placebo administered twice daily through the Diskus device for 24 weeks. MEASUREMENTS: Primary efficacy measures were morning predose (ie, trough FEV(1)) for FSC compared with SM and 2-h postdose FEV(1) for FSC compared with FP. Other efficacy measures were as follows: morning peak expiratory flow rate (PEF); transition dyspnea index; chronic respiratory disease questionnaire; chronic bronchitis symptom questionnaire; exacerbations; and other symptomatic measures. RESULTS: At Endpoint (ie, the last on-treatment, post-baseline assessment), treatment with FSC significantly (p < or = 0.012) increased the morning predose FEV(1) (165 mL) compared with SM (91 mL) and placebo (1 mL), and significantly (p < or = 0.001) increased the 2-h postdose FEV(1) (281 mL) compared with FP (147 mL) and placebo (58 mL). Improvements in lung function with FSC compared with FP and SM, and with FP and SM compared with placebo, as measured by the average daily morning PEF, was observed within approximately 24 h after the initiation of treatment, indicating an early onset of effect (p < or = 0.034). Compared with placebo, FSC significantly improved dyspnea, quality of life, and symptoms of chronic bronchitis. The incidence of adverse effects (except for an increase in oral candidiasis with FSC and FP) were similar among the treatment groups. CONCLUSIONS: Treatment with FSC (FP, 250 microg, and SM, 50 microg) twice daily substantially improved morning lung function and sustained these improvements for over a period of 24 weeks compared with FP or SM treatment alone in patients with COPD, with no additional safety concerns for the combination treatment vs that with the individual components.
Publication Types:
• Clinical Trial
• Multicenter Study
• Randomized Controlled Trial
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PMID: 12970006 [PubMed - indexed for MEDLINE]
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Long-acting beta 2-adrenoceptor agonists or tiotropium bromide for patients with COPD: is combination therapy justified?
Tennant RC, Erin EM, Barnes PJ, Hansel TT
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Clinical Studies Unit, National Heart and Lung Institute, ImperialCollege, London, UK
Bronchodilators are the mainstay of therapy for patients with established chronic obstructive pulmonary disease (COPD) but, at present, the majority of patients use short-acting agents. There is increasing evidence that long-acting agents, such as the beta(2)-adrenoceptor agonists salmeterol and formeterol, and the new anticholinergic tiotropium bromide provide a better therapeutic option. In the treatment of COPD, long-acting beta(2)-adrenoceptor agonists (LABAs) given twice daily cause the same degree of bronchodilation as tiotropium bromide given once daily. Combined use of an inhaled LABA with tiotropium bromide should provide important therapeutic benefits, as these drugs have distinct and complementary pharmacological actions in the airways. Although clinical trials of this combination have not been performed, clinical experience with Combivent, a combination of a short-acting beta(2)-adrenoceptor agonist (salbutamol) and a short-acting anticholinergic (ipratropium bromide), in COPD is encouraging because the bronchodilation produced is of a magnitude greater than that of either component alone. However, because LABAs are given twice daily but tiotropium bromide is required only once daily, the challenge is to develop a combined inhaler that can be employed on a daily basis.
Publication Types:
• Review
• Review, Tutorial
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PMID: 12810191 [PubMed - indexed for MEDLINE]
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Combined corticosteroid and longacting beta-agonist in one inhaler for
chronic obstructive pulmonary disease.
Nannini L, Lasserson T, Poole P.
- Pulmonary Section, Hospital G. Baigorria, Ruta 11 Y Jm Estrada, G.
Baigorria, Santa Fe - Rosario, ARGENTINA, 2152
BACKGROUND: Long-acting beta-agonists and inhaled corticosteroids have
been recommended in guidelines for the treatment of chronic obstructive
pulmonary disease. However, they have only been available until recently
via separate administration. They have been developed in order to
facilitate adherence to medication regimens, and to improve efficacy.
OBJECTIVES: To assess the efficacy of combined inhaled corticosteroid and
long-acting beta-agonist preparations in the treatment of adults with
chronic obstructive pulmonary disease. SEARCH STRATEGY: We searched the
Cochrane Airways Group chronic obstructive pulmonary disease (COPD) trials
register (March 2003), the Cochrane Central Register of Controlled Trials
(The Cochrane Library Issue 1, 2003), LILACS (all years to March 2003) and
reference lists of articles. We also contacted manufacturers and
researchers in the field. SELECTION CRITERIA: Studies were included if they
were randomised, with adequate blinding procedures in place. Studies could
compare a combined inhaled corticosteroids and long-acting beta-agonist
preparation with either component preparation or placebo. Studies comparing
different members of each class of combined therapies were included DATA
COLLECTION AND ANALYSIS: Two reviewers independently assessed trial quality
and extracted data. MAIN RESULTS: Four randomised trials with 2986
participants were included. Two different combination preparations
(fluticasone/salmeterol and budesonide/formoterol) were studied in the
trials. No meta-analysis on clinical outcomes was possible due to different
outcome assessment across studies. All studies demonstrated a reduction in
exacerbation rates versus placebo. Budesonide/formoterol was more effective
than formoterol in reducing exacerbations in one study from 1.84 to 1.42
exacerbations per year. Fluticasone/salmeterol did not significantly reduce
exacerbations compared with either of its component treatments.
Fluticasone/salmeterol led to better quality of life compared with placebo
(two studies), although there were conflicting results when compared with
inhaled corticosteroid alone (two studies). There was no significant
difference between fluticasone/salmeterol and long-acting beta-agonist (two
studies). Budesonide/formoterol led to statistically significant
differences in quality of life compared with placebo, but not when compared
with component inhaled corticosteroid or beta-agonist (one study).
REVIEWER'S CONCLUSIONS: For the primary outcome of exacerbations,
budesonide/formoterol had a modest advantage over a component medication,
formoterol, in a single trial, but fluticasone/salmeterol did not result in
a significant reduction in exacerbations compared to either of its
components. The combination of steroids and long-acting beta-agonist in one
inhaler was effective in improving symptoms compared with placebo and on
certain clinical outcomes compared with one of the individual components
alone. In order to draw firmer conclusions about the effects of combination
therapy in a single inhaler more data are necessary, including the
assessment of the comparative effects with separate administration of the
two drugs in double-dummy trials.
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PMID: 14583994 [PubMed - as supplied by publisher]
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Maintenance therapy with budesonide and formoterol in chronic obstructive
pulmonary disease
Calverley PM, Boonsawat W, Cseke Z, Zhong N, Peterson S, Olsson H
- Dept of Medicine, Clinical Sciences, University Hospital Aintree,
Liverpool, UK
Background Inhaled longacting beta(2) agonists improve lung function and health status in symptomatic chronic obstructive pulmonary disease (COPD), whereas inhaled corticosteroids reduce the frequency of acute episodes of symptom exacerbation and delay deterioration in health status. We postulated that a combination of these treatments would be better than each component used alone.Methods 1465 patients with COPD were recruited from outpatient departments in 25 countries. They were treated in a randomised, double-blind, parallel-group, placebo-controlled study with either 50 &mgr;g salmeterol twice daily (n=372), 500 &mgr;g fluticasone twice daily (n=374), 50 &mgr;g salmeterol and 500 &mgr;g fluticasone twice daily (n=358), or placebo (n=361) for 12 months. The primary outcome was the pretreatment forced expiratory volume in 1s (FEV1) after 12 months treatment' and after patients had abstained from all bronchodilators for at least 6h and from study medication for at least 12h. Secondary outcomes were other lung function measurements, symptoms and rescue treatment use, the number of exacerbations, patient withdrawals, and disease-specific health status. We assessed adverse events, serum cortisol concentrations, skin bruising, and electrocardiograms. Analysis was as predefined in the study protocol.Findings All active treatments improved lung function, symptoms, and health status and reduced use of rescue medication and frequency of exacerbations. Combination therapy improved pretreatment FEV1 significantly more than did placebo (treatment difference 133 mL, 95% CI 105-161, p<0.0001), salmeterol (73 mL, 46-101, p<0.0001), or fluticasone alone (95 mL, 67-122, p<0.0001). Combination treatment produced a clinically significant improvement in health status and the greatest reduction in daily symptoms. All treatments were well tolerated with no difference in the frequency of adverse events, bruising, or clinically significant falls in serum cortisol concentration.Interpretation Because inhaled long-acting beta(2) agonists and corticosteroid combination treatment produces better control of symptoms and lung function, with no greater risk of side-effects than that with use of either component alone, this combination treatment should be considered for patients with COPD.
PMID: 12583942 [PubMed - as supplied by publisher]
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Combined salmeterol and fluticasone
in the treatment of chronic obstructive pulmonary
disease: a randomised controlled trial.
Calverley P, Pauwels R, Vestbo
J, Jones P, Pride N, Gulsvik A, Anderson J, Maden
C.
- Liverpool, UK
Background Inhaled longacting beta(2) agonists
improve lung function and health status in symptomatic
chronic obstructive pulmonary disease (COPD), whereas
inhaled corticosteroids reduce the frequency of
acute episodes of symptom exacerbation and delay
deterioration in health status. We postulated that
a combination of these treatments would be better
than each component used alone.Methods 1465 patients
with COPD were recruited from outpatient departments
in 25 countries. They were treated in a randomised,
double-blind, parallel-group, placebo-controlled
study with either 50 &mgr;g salmeterol twice
daily (n=372), 500 &mgr;g fluticasone twice
daily (n=374), 50 &mgr;g salmeterol and 500
&mgr;g fluticasone twice daily (n=358), or placebo
(n=361) for 12 months. The primary outcome was the
pretreatment forced expiratory volume in 1s (FEV1)
after 12 months treatment' and after patients had
abstained from all bronchodilators for at least
6h and from study medication for at least 12h. Secondary
outcomes were other lung function measurements,
symptoms and rescue treatment use, the number of
exacerbations, patient withdrawals, and disease-specific
health status. We assessed adverse events, serum
cortisol concentrations, skin bruising, and electrocardiograms.
Analysis was as predefined in the study protocol.Findings
All active treatments improved lung function, symptoms,
and health status and reduced use of rescue medication
and frequency of exacerbations. Combination therapy
improved pretreatment FEV1 significantly more than
did placebo (treatment difference 133 mL, 95% CI
105-161, p<0.0001), salmeterol (73 mL, 46-101,
p<0.0001), or fluticasone alone (95 mL, 67-122,
p<0.0001). Combination treatment produced a clinically
significant improvement in health status and the
greatest reduction in daily symptoms. All treatments
were well tolerated with no difference in the frequency
of adverse events, bruising, or clinically significant
falls in serum cortisol concentration.Interpretation
Because inhaled long-acting beta(2) agonists and
corticosteroid combination treatment produces better
control of symptoms and lung function, with no greater
risk of side-effects than that with use of either
component alone, this combination treatment should
be considered for patients with COPD.
PMID: 12583942 [PubMed - as supplied by publisher]
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Efficacy and safety of budesonide/formoterol
in the management of chronic obstructive pulmonary
disease.
Szafranski W, Cukier A, Ramirez
A, Menga G, Sansores R, Nahabedian S, Peterson S,
Olsson H.
- Dept Lung Diseases, Voivodeship Specialist Hospital,
Radom, Poland.
The efficacy and safety of budesonide/formoterol
in a single inhaler compared with placebo, budesonide
and formoterol were evaluated in patients with moderate-to-severe
chronic obstructive pulmonary disease (COPD). In
a 12-month, randomised, double-blind, placebo-controlled,
parallel-group study in 812 adults (mean age 64
yrs, mean forced expiratory volume in one second
(FEV1) 36% predicted normal), patients received
two inhalations twice daily of either budesonide/formoterol
(Symbicort) 160/4.5 microg (delivered dose), budesonide
200 microg (metered dose), formoterol 4.5 microg
or placebo. Severe exacerbations and FEV1 (primary
variables), peak expiratory flow (PEF), COPD symptoms,
health-related quality of life (HRQL), mild exacerbations,
use of reliever beta2-agonist and safety variables
were recorded. Budesonide/formoterol reduced the
mean number of severe exacerbations per patient
per year by 24% versus placebo and 23% versus formoterol.
FEV1 increased by 15% versus placebo and 9% versus
budesonide. Morning PEF improved significantly on
day 1 versus placebo and budesonide; after 1 week,
morning PEF was improved versus placebo, budesonide
and formoterol. Improvements in morning and evening
PEF versus comparators were maintained over 12 months.
Budesonide/formoterol decreased all symptom scores
and use of reliever beta2-agonists significantly
versus placebo and budesonide, and improved HRQL
versus placebo. All treatments were well tolerated.
These results suggest a role for budesonide/formoterol
in the long-term management of moderate-to-severe
chronic obstructive pulmonary disease.
PMID: 12570112 [PubMed - in process]
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Survival in COPD patients after
regular use of fluticasone propionate and salmeterol
in general practice
Soriano JB, Vestbo J, Pride NB, Kiri V, Maden
C, Maier WC.
- Worldwide Epidemiology Dept, GlaxoSmithKline Research
and Development, Greenford, Middlesex, UK. joan.b.soriano@gsk.com
Despite substantial evidence regarding the benefits
of combined use of inhaled corticosteroids and long-acting
beta2-agonists in asthma, such evidence remains
limited for chronic obstructive pulmonary disease
(COPD). Observational data may provide an insight
into the expected survival in clinical trials of
fluticasone propionate (FP) and salmeterol in COPD.
Newly physician-diagnosed COPD patients identified
in primary care during 1990-1999 aged > or =
50 yrs, of both sexes and with regular prescriptions
of respiratory drugs were identified in the UK General
Practice Research Database. Three-year survival
in 1,045 COPD patients treated with FP and salmeterol
was compared with that in 3,620 COPD patients who
regularly used other bronchodilators but not inhaled
corticosteroids or long-acting beta2-agonists. Standard
methods of survival analysis were used, including
adjustment for possible confounders. Survival at
year 3 was significantly greater in FP and/or salmeterol
users (78.6%) than in the reference group (63.6%).
After adjusting for confounders, the survival advantage
observed was highest in combined users of FP and
salmeterol (hazard ratio (HR) 0.48 (95% confidence
interval 0.31-0.73)), followed by users of FP alone
(HR 0.62 (0.45-0.85)) and regular users of salmeterol
alone (HR 0.79 (0.58-1.07)) versus the reference
group. Mortality decreased with increasing number
of prescriptions of FP and/or salmeterol. In conclusion,
regular use of fluticasone propionate alone or in
combination with salmeterol is associated with increased
survival of chronic obstructive pulmonary disease
patients managed in primary care.
PMID: 12412670 [PubMed - in process]
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Effectiveness of Fluticasone
Propionate and Salmeterol Combination Delivered via
the Diskus Device in the Treatment of Chronic Obstructive
Pulmonary Disease
Mahler DA, Wire P, Horstman D, Chang CN, Yates
J, Fischer T, Shah T.
- Dartmouth Hitchcock Medical Center, Lebanon, New
Hampshire.
This randomized controlled trial examined the benefits
of combining an inhaled corticosteroid, fluticasone
propionate (F), with an inhaled long-acting beta(2)-agonist,
salmeterol (S), to treat the inflammatory and bronchoconstrictive
components of chronic obstructive pulmonary disease
(COPD). A total of 691 patients with COPD received
the combination of F and S (FSC), S (50 mcg), F
(500 mcg), or placebo twice daily via the Diskus
device for 24 weeks. A significantly greater increase
in predose FEV(1) at the endpoint was observed after
FSC (156 ml) compared with S (107 ml, p = 0.012)
and placebo (-4 ml, p < 0.0001). A significantly
greater increase in 2-hour postdose FEV(1) at the
endpoint was observed after treatment with FSC (261
ml) compared with F (138 ml, p < 0.001) and placebo
(28 ml, p < 0.001). There were greater improvements
in the Transition Dyspnea Index with FSC (2.1) compared
with F (1.3, p = 0.033), S (0.9, p < 0.001),
and placebo (0.4, p < 0.0001). The incidence
of adverse effects (except for an increase in oral
candidiasis with FSC and F) was similar among the
treatment groups. We conclude that FSC improved
lung function and reduced the severity of dyspnea
compared with individual components and placebo.
PMID: 12379552 [PubMed - in process]
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