Table H-13Strength of evidence for the comparative efficacy of ICS + LTRA and ICS

Number of studies (Number of subjects)DesignQualityConsistencyDirectnessResult, magnitude of effectOther modifying factors*Overall strength of evidence
LTRA + ICS compared with ICS same dose
1 (5,871)1 SR w/MAGoodSome inconsistencyDirectExacerbations: non- statistically significant reduction in the risk of exacerbations requiring systemic steroids: RR 0.64, 95% CI: 0.38, 1.07

Symptoms: No difference

Rescue medicine use: LTRA+ICS > ICS [SMD −0.15, 95% CI: −0.24, − 0.05]

Quality of Life: No difference [WMD 0.08, 95% CI: −0.03, 0.20]
Few trials tested licensed doses of LTRAs: just 4 trials did so for the primary outcome: exacerbations requiring systemic steroidsLow
BUD + ML compared with BUD same dose
1 (639)RCT (16 weeks)FairSome inconsistencyDirectMixed results: BUD+ML > BUD for most outcome measures; no difference for someNoneLow
BDP + ML compared to BDP same dose
1 (642)RCT (16 weeks)FairSome inconsistencyDirectMixed results: BDP+ML > BDP for most outcome measures; no difference for someNoneLow
LTRA + ICS compared with ICS increased dose
1 (5,871)1 SR w/MAGoodSome inconsistencyDirectSymptoms: No difference [change from baseline in symptoms score (WMD 0.01, 95% CI: − 0.09, 0.10)]

Exacerbations: No difference [risk of exacerbation requiring systemic steroids: RR 0.92, 95% CI: 0.56, 1.51]

Rescue medicine use: No difference
Only 3 trials in the MA compared licensed doses of LTRAs with increasing the dose of ICSs

Power of the MA is insufficient to confirm the equivalence
Moderate
BUD + ML compared with BUD increased dose
2 (960)RCTs (12–16 weeks)FairSome inconsistencyDirectNo difference for most outcomes (one trial); One trial reported fewer exacerbations with increased dose BUDNoneLow
Fluticasone (FP)+Montelukast (ML) compared with Fluticasone (FP) increased dose
1 (182)RCT (48 weeks, triple cross- over)FairNot applicableDirectNo difference in hospitalizations due to asthma symptoms; 43 (FP+ML) vs. 47 (FP) oral steroid coursesPrimary outcome was a composite outcome including FEV1Low

Abbreviations: BUD = Budesonide; CI = confidence interval; ICS = Inhaled Corticosteroids; LTRAs = Leukotriene receptor antagonists; MA=meta-analysis; ML = Montelukast; QOL = quality of life; RCT= randomized controlled trial; RR= Risk Ratio; SMD = standard mean difference; SM = Salmeterol;; SR=systematic review; WMD = weighted mean difference.

From: Appendix H, Strength of evidence

Cover of Drug Class Review: Controller Medications for Asthma
Drug Class Review: Controller Medications for Asthma: Final Update 1 Report [Internet].
Jonas DE, Wines RCM, DelMonte M, et al.
Portland (OR): Oregon Health & Science University; 2011 Apr.
Copyright © 2011 by Oregon Health & Science University.

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