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. 2004 Jan 26;2004(1):CD003133. doi: 10.1002/14651858.CD003133.pub2

Comparison 1. Leukotriene Receptor Antagonists (LTRA) + ICS vs. same dose of ICS in SYMPTOMATIC patients.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 Patients with exacerbations requiring systemic steroids with higher than licensed AL doses at 4 to 16 weeks 2 451 Risk Ratio (M‐H, Fixed, 95% CI) 0.34 [0.13, 0.88]
1.1 Pranlukast 450 mg bid 1 83 Risk Ratio (M‐H, Fixed, 95% CI) 0.19 [0.01, 3.77]
1.2 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 0.37 [0.14, 1.01]
2 Patients with exacerbations requiring systemic steroids with licensed AL doses at 4 to 16 weeks 4 988 Risk Ratio (M‐H, Fixed, 95% CI) 0.64 [0.38, 1.07]
2.1 Montelukast 5 mg die 1 541 Risk Ratio (M‐H, Fixed, 95% CI) 0.80 [0.34, 1.91]
2.2 Montelukast 10 mg die 2 423 Risk Ratio (M‐H, Fixed, 95% CI) 0.54 [0.28, 1.06]
2.3 Zafirlukast 20 mg bid 1 24 Risk Ratio (M‐H, Fixed, 95% CI) 1.0 [0.07, 14.21]
3 Patients with exacerbations requiring hospital admission using licensed AL doses 2 934 Risk Ratio (M‐H, Fixed, 95% CI) 0.35 [0.01, 8.43]
3.1 Montelukast 5 mg die 1 541 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.2 Montelukast 10 mg die 1 393 Risk Ratio (M‐H, Fixed, 95% CI) 0.35 [0.01, 8.43]
4 Change from baseline FEV1 (L) using higher than licensed LTRA doses at 6 weeks 2 343 Mean Difference (IV, Fixed, 95% CI) 0.10 [0.01, 0.20]
4.1 Pranlukast 450 mg bid 1 79 Mean Difference (IV, Fixed, 95% CI) 0.41 [‐0.65, 1.47]
4.2 Zafirlukast 80 mg bid 1 264 Mean Difference (IV, Fixed, 95% CI) 0.1 [0.01, 0.19]
5 Change from baseline FEV1 using licensed doses of LTRA (at 4 to 16 weeks) 3 1123 Mean Difference (IV, Random, 95% CI) 0.06 [‐0.01, 0.14]
5.1 Montelukast 5 mg die 1 502 Mean Difference (IV, Random, 95% CI) 0.03 [‐0.01, 0.07]
5.2 Montelukast 10 mg die 1 389 Mean Difference (IV, Random, 95% CI) 0.12 [0.07, 0.17]
5.3 Zafirlukast 20 mg bid 1 232 Mean Difference (IV, Random, 95% CI) 0.01 [‐0.13, 0.15]
6 Change from baseline Am PEFR (L/min) using higher than licensed AL doses at 6 weeks 2 382 Mean Difference (IV, Fixed, 95% CI) 27.19 [18.60, 35.78]
6.1 Pranlukast 450 mg bid 1 79 Mean Difference (IV, Fixed, 95% CI) 51.0 [35.20, 66.80]
6.2 Zafirlukast 80 mg bid 1 303 Mean Difference (IV, Fixed, 95% CI) 17.2 [6.96, 27.44]
7 Change from baseline AM PEFR using licensed doses of LTRA at 4‐16 weeks 4 1681 Mean Difference (IV, Fixed, 95% CI) 7.65 [3.55, 11.75]
7.1 Montelukast 5 mg die 1 436 Mean Difference (IV, Fixed, 95% CI) 9.40 [‐4.61, 23.41]
7.2 Montelukast 10 mg die 2 1013 Mean Difference (IV, Fixed, 95% CI) 7.07 [2.63, 11.51]
7.3 Zafirlukast 20 mg bid 1 232 Mean Difference (IV, Fixed, 95% CI) 13.14 [‐3.22, 29.50]
8 Change from baseline in mean asthma symptom using higher than licensed AL doses at 6 weeks 2 381 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.46 [‐0.66, ‐0.25]
8.1 Pranlukast 450 mg bid 1 79 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.48 [‐0.93, ‐0.03]
8.2 Zafirlukast 80 mg bid 1 302 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.45 [‐0.68, ‐0.22]
9 Change from baseline mean asthma symptom score using licensed doses using licensed doses of AL at 4 ‐ 16 wks 2 1018 Mean Difference (IV, Fixed, 95% CI) ‐0.10 [‐0.24, 0.03]
9.1 Montelukast 5 mg die 0 0 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
9.2 Montelukast 10 mg die 2 1018 Mean Difference (IV, Fixed, 95% CI) ‐0.10 [‐0.24, 0.03]
10 Change from baseline mean daily use of B2‐agonists (puffs) using higher than licensed AL doses at 6 weeks 2 382 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.43 [‐0.63, ‐0.22]
10.1 Pranlukast 450 mg bid 1 79 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.73 [‐1.19, ‐0.27]
10.2 Zafirlukast 80 mg bid 1 303 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.35 [‐0.58, ‐0.12]
11 Change from baseline mean daily use of B2‐agonists (puffs/day or %) using licensed doses of AL at 4 to 16 wee 4 1699 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.15 [‐0.24, ‐0.05]
11.1 Montelukast 5 mg die 1 450 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.15 [‐0.33, 0.04]
11.2 Montelukast 10 mg die 2 1018 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.14 [‐0.26, ‐0.01]
11.3 Zafirlukast 20 mg bid 1 231 Std. Mean Difference (IV, Fixed, 95% CI) ‐0.21 [‐0.47, 0.05]
12 Change in night‐time awakenings(episodes/week) using higher than licensed AL doses at 6 weeks 2 382 Mean Difference (IV, Fixed, 95% CI) ‐0.52 [‐1.35, 0.32]
12.1 Pranlukast 450 mg bid 1 79 Mean Difference (IV, Fixed, 95% CI) ‐0.90 [‐4.94, 3.14]
12.2 Zafirlukast 80 mg bid 1 303 Mean Difference (IV, Fixed, 95% CI) ‐0.5 [‐1.35, 0.35]
13 Change from baseline in night‐time awakenings(episodes/week) using licensed doses of LTRA 1 393 Mean Difference (IV, Fixed, 95% CI) ‐0.59 [‐1.68, 0.50]
13.1 Montelukast 5 mg die 0 0 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
13.2 Montelukast 10 mg die 1 393 Mean Difference (IV, Fixed, 95% CI) ‐0.59 [‐1.68, 0.50]
14 Change in quality of life using licensed doses of AL 2 921 Mean Difference (IV, Fixed, 95% CI) 0.08 [‐0.03, 0.20]
14.1 Montelukast 5 mg die 1 296 Mean Difference (IV, Fixed, 95% CI) 0.09 [‐0.13, 0.31]
14.2 Montelukast 10 mg die 1 625 Mean Difference (IV, Fixed, 95% CI) 0.08 [‐0.06, 0.22]
15 Change in mean serum ECP concentration (ug/L) using higher than licensed AL doses at 6 +/‐ 4 weeks 1 79 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
15.1 Pranlukast 450 mg bid 1 79 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
16 Change from baseline NO concentration (ppb) using higher than licensed AL doses at 6 +/‐ 4 weeks 1 79 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
16.1 Pranlukast 450 mg bid 1 79 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
17 Change from baseline eosinophil counts using licensed AL doses at 4 to 16 weeks 2 849 Mean Difference (IV, Random, 95% CI) ‐0.07 [‐0.14, ‐0.00]
17.1 Montelukast 5 mg die 1 464 Mean Difference (IV, Random, 95% CI) ‐0.11 [‐0.17, ‐0.05]
17.2 Montelukast 10 mg die 1 385 Mean Difference (IV, Random, 95% CI) ‐0.04 [‐0.06, ‐0.02]
18 Withdrawals due to poor asthma control/exacerbations 5 1975 Risk Ratio (M‐H, Fixed, 95% CI) 0.64 [0.29, 1.39]
18.1 Montelukast 5 mg die 1 545 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
18.2 Montelukast 10 mg die 2 1032 Risk Ratio (M‐H, Fixed, 95% CI) 0.46 [0.16, 1.31]
18.3 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 1.04 [0.27, 4.11]
18.4 Zafirlukast 20 mg bid 1 30 Risk Ratio (M‐H, Fixed, 95% CI) 1.0 [0.07, 14.55]
19 Overall withdrawals 7 2082 Risk Ratio (M‐H, Fixed, 95% CI) 0.92 [0.69, 1.24]
19.1 Montelukast 5 mg die 1 545 Risk Ratio (M‐H, Fixed, 95% CI) 1.47 [0.53, 4.08]
19.2 Montelukast 10 mg die 2 1032 Risk Ratio (M‐H, Fixed, 95% CI) 0.91 [0.63, 1.32]
19.3 Pranlukast 450 mg bid 1 83 Risk Ratio (M‐H, Fixed, 95% CI) 0.31 [0.03, 2.86]
19.4 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 0.81 [0.42, 1.58]
19.5 Zafirlukast 20 mg bid 2 54 Risk Ratio (M‐H, Fixed, 95% CI) 1.5 [0.27, 8.24]
20 Withdrawals due to adverse effects 6 2030 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.37, 1.22]
20.1 Montelukast 5 mg die 1 545 Risk Ratio (M‐H, Fixed, 95% CI) 0.49 [0.04, 5.38]
20.2 Montelukast 10 mg die 3 1034 Risk Ratio (M‐H, Fixed, 95% CI) 0.65 [0.28, 1.48]
20.3 Pranlukast 450 mg bid 1 83 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
20.4 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 0.73 [0.28, 1.88]
21 Headache 4 1933 Risk Ratio (M‐H, Fixed, 95% CI) 1.17 [0.92, 1.50]
21.1 Montelukast 5 mg die 1 547 Risk Ratio (M‐H, Fixed, 95% CI) 1.02 [0.58, 1.78]
21.2 Montelukast 10 mg die 2 1018 Risk Ratio (M‐H, Fixed, 95% CI) 1.19 [0.90, 1.59]
21.3 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 1.44 [0.59, 3.49]
22 Overall adverse effects 4 1623 Risk Ratio (M‐H, Fixed, 95% CI) 1.01 [0.90, 1.13]
22.1 Montelukast 5 mg die 1 547 Risk Ratio (M‐H, Fixed, 95% CI) 0.93 [0.76, 1.12]
22.2 Montelukast 10 mg die 1 625 Risk Ratio (M‐H, Fixed, 95% CI) 1.09 [0.91, 1.31]
22.3 Pranlukast 450 mg bid 1 83 Risk Ratio (M‐H, Fixed, 95% CI) 2.80 [0.12, 66.70]
22.4 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 1.01 [0.81, 1.26]
23 Elevated liver enzymes 3 1301 Risk Ratio (M‐H, Fixed, 95% CI) 1.30 [0.50, 3.35]
23.1 Montelukast 5 mg die 1 547 Risk Ratio (M‐H, Fixed, 95% CI) 1.95 [0.18, 21.37]
23.2 Montelukast 10 mg die 1 386 Risk Ratio (M‐H, Fixed, 95% CI) 0.86 [0.27, 2.77]
23.3 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 5.22 [0.25, 108.01]
24 Nausea 4 1391 Risk Ratio (M‐H, Fixed, 95% CI) 0.67 [0.34, 1.32]
24.1 Montelukast 5 mg die 1 547 Risk Ratio (M‐H, Fixed, 95% CI) 0.39 [0.08, 1.99]
24.2 Montelukast 10 mg die 1 393 Risk Ratio (M‐H, Fixed, 95% CI) 0.47 [0.17, 1.33]
24.3 Pranlukast 450 bid 1 83 Risk Ratio (M‐H, Fixed, 95% CI) 2.80 [0.12, 66.70]
24.4 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 1.31 [0.36, 4.78]
25 Death 3 1308 Risk Ratio (M‐H, Fixed, 95% CI) 0.35 [0.01, 8.49]
25.1 Montelukast 5 mg die 1 547 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
25.2 Montelukast 10 mg die 1 393 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
25.3 Zafirlukast 80 mg bid 1 368 Risk Ratio (M‐H, Fixed, 95% CI) 0.35 [0.01, 8.49]
26 % nocturnal awakenings 2 856 Mean Difference (IV, Fixed, 95% CI) ‐6.25 [‐12.72, 0.23]
26.1 Montelukast 10 mg die 1 625 Mean Difference (IV, Fixed, 95% CI) ‐6.60 [‐15.51, 2.31]
26.2 Zafirlukast 20 mg bid 1 231 Mean Difference (IV, Fixed, 95% CI) ‐5.85 [‐15.26, 3.56]