Efficacy and safety of fluticasone propionate/salmeterol 250/50mcg Diskus administered once daily

Kerwin, Edward; Nathan, Robert A.; Meltzer, Eli O.; Ortega, Héctor; Yancey, Steven W.; Schoaf, Lynne; Dorinsky, Paul

doi:10.1016/j.rmed.2007.12.002

Cited by 15 publications

(15 citation statements)

References 26 publications

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“…Treatment differences between the twice-daily (320/18 g daily) and once-daily (320/9 or 160/9 g daily) BUD/FM groups were more often significant in the evening at the end of the oncedaily dosing interval. These results are consistent with those reported by Kerwin et al,11 in which significantly better results were observed with twice-daily (200/100 g daily) versus once-daily (250/50 g daily) dosing of fluticasone/salmeterol DPI for evening pulmonary function variables measured at the end of the oncedaily dosing interval. Although measurable reductions in pulmonary function were observed for the BUD/FM 320/9 g once-daily group, down-titrating the dose of FM resulted in a minimal loss of asthma control over 12 weeks.…”

Section: Discussionsupporting

confidence: 92%

8574

Berger¹

2010

allergy asthma proc

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Asthma guidelines recommend titrating maintenance medications to the lowest effective dose. This study assessed the efficacy and tolerability of reducing the frequency of dosing in patients previously controlled with twice-daily budesonide/formoterol (BUD/FM) pressurized metered-dose inhaler (pMDI) to once-daily regimens of BUD/FM pMDI or BUD pMDI. This was a 12-week, randomized, double-blind, double-dummy, placebo (PBO)/active-controlled, multicenter study (N = 752) of patients aged > or =16 years with mild to moderate asthma. After 4-5 weeks on single-blind BUD/FM pMDI 160/9 micrograms twice daily (320/18 micrograms daily), patients with stable asthma received BUD/FM pMDI 160/9 micrograms twice daily (320/18 micrograms daily; morning and evening), BUD/FM pMDI 320/9 micrograms once daily (evening), BUD/FM pMDI 160/9 micrograms once daily (evening), BUD pMDI 320 micrograms once daily (evening), or PBO. BUD/FM (once or twice daily) was more effective (p < or = 0.003) than BUD and PBO on evening peak expiratory flow (primary variable), morning pulmonary function assessments, daily symptoms, and nighttime rescue medication use. Twice-daily BUD/FM was more effective (p < or = 0.05) than both once-daily doses for evening pulmonary function assessments and daytime rescue medication use. All treatments were well tolerated. Once- or twice-daily BUD/FM showed better efficacy than BUD once daily or PBO; results generally were more favorable with twice-daily dosing compared with both once-daily dosing regimens, which had one-half the daily FM dose.

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Section: Discussionsupporting

confidence: 92%

8574

Berger¹

2010

allergy asthma proc

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“…There were two main comparisons: (1) the combination of LABA and ICS compared to a similar dose of ICS (N = 24 studies): Boonsawat 2008; Chuchalin 2002; Creticos 1999; Di Franco 1999; GOAL; Grutters 1999; Karaman 2007; Kerwin 2008; Miraglia del Giudice 2007; Murray 2004; Nelson 2003; O’Byrne 2001; Overbeek 2005; Pearlman 1999a; Pearlman 1999b; Prieto 2005; Rojas 2007; SAS30015; SAS30021; SAS40068; SLGF75; Stelmach 2008; Strand 2004; Weersink 1997) and (2) LABA + ICS versus higher dose ICS (N = four studies: Chuchalin 2008; SAM40034; SAM40036; Sorkness 2007). Assessment of the risk of bias and meta-analysis results are provided for each comparison.…”

Section: Resultsmentioning

confidence: 99%

Addition of long-acting beta2-agonists to inhaled steroids as first line therapy for persistent asthma in steroid-naive adults and children

Chróinín

Greenstone

Lasserson

et al. 2009

Cochrane Database of Systematic Reviews

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Background Consensus statements recommend the addition of long-acting inhaled ß2-agonists (LABA) only in asthmatic patients who are inadequately controlled on inhaled corticosteroids (ICS). It is not uncommon for some patients to be commenced on ICS and LABA together as initial therapy. Objectives To compare the efficacy of combining inhaled corticosteroids with long-acting ß2-agonists (ICS+LABA) with inhaled corticosteroids alone (ICS alone) in steroid-naive children and adults with persistent asthma. We assessed two protocols: (1) LABA + ICS versus a similar dose of ICS (comparison 1) and (2) LABA + ICS versus a higher dose of ICS (comparison 2). Search methods We identified randomised controlled trials through electronic database searches (May 2008). Selection criteria Randomised trials comparing ICS + LABA with ICS alone in children and adults with asthma who had no inhaled corticosteroids in the preceding 28 days prior to enrolment. Data collection and analysis Each author assessed studies independently for risk of bias and extracted data. We obtained confirmation from the trialists when possible. The primary endpoint was rate of patients with one or more asthma exacerbations requiring rescue systemic corticosteroids. Results are expressed as relative risks (RR) for dichotomous data and as mean differences (MD) or standardised mean differences (SMD) for continuous data. Main results Twenty-eight study comparisons drawn from 27 trials (22 adult; five paediatric) met the review entry criteria (8050 participants). Baseline data from the studies indicated that trial populations had moderate or mild airway obstruction (FEV1 65% predicted), and that they were symptomatic prior to randomisation. In comparison 1, the combination of ICS and LABA was not associated with a significantly lower risk of patients with exacerbations requiring oral corticosteroids (RR 1.04; 95% confidence interval (CI) 0.73 to 1.47) or requiring hospital admissions (RR 0.38; 95% CI 0.09 to 1.65) compared to a similar dose of ICS alone. The combination of LABA and ICS led to a significantly greater improvement from baseline in FEV1 (0.12 L/sec; 95% CI 0.07 to 0.17), in symptoms (SMD −0.26; 95% CI −0.37 to −0.14) and in rescue ß2-agonist use (−0.41 puffs/day; 95% CI −0.73 to −0.09) compared with a similar dose of ICS alone. There was no significant group difference in the risk of serious adverse events (RR 1.15; 95% CI 0.64 to 2.09), any adverse events (RR 1.02; 95% CI 0.96 to 1.09), study withdrawals (RR 0.95; 95% CI 0.82 to 1.11), or withdrawals due to poor asthma control (RR 0.94; 95% CI 0.63 to 1.41). In comparison 2, the combination of LABA and ICS was associated with a higher risk of patients requiring oral corticosteroids (RR 1.24; 95% CI 1 to 1.53) and study withdrawal (RR 1.31; 95% CI 1.07 to 1.59) than a higher dose of ICS alone. For every 100 patients treated over 43 weeks, nine patients using a higher dose ICS compared to 11 (95% CI 9 to 14) on LABA and ICS suffered one or more exacerbations requiring rescue oral cortico...

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“…Responsiveness was also evaluated by applying a distribution-based approach to ASRMU diary data from a placebocontrolled study conducted to compare once-daily dosing with twice-daily dosing with FP/SAL and also included an FP 250 mcg once-daily arm (Trial 9) [43]. Effect sizes were calculated for each treatment arm using the following formula: the absolute value of the difference from baseline to weeks 1 through 12 scores, divided by the standard deviation at baseline.…”

Section: Responsivenessmentioning

confidence: 99%