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

Comparison 3. Leukotriene Receptor Antagonists (LTRA) + ICS vs. ICS (TAPERING protocol) in WELL CONTROLLED patients.

Outcome or subgroup title No. of studies No. of participants Statistical method Effect size
1 % Change from baseline ICS dose at 12 ‐24 weeks 4 930 Mean Difference (IV, Fixed, 95% CI) ‐2.84 [‐7.40, 1.72]
1.1 Zafirlukast 20 mg die 2 571 Mean Difference (IV, Fixed, 95% CI) ‐0.23 [‐5.97, 5.50]
1.2 Montelukast 10 mg die 2 359 Mean Difference (IV, Fixed, 95% CI) ‐7.32 [‐14.84, 0.19]
2 Last ICS dose tolerated (mcg) at 12 ‐24 weeks 4 932 Mean Difference (IV, Random, 95% CI) ‐40.65 [‐111.22, 29.93]
2.1 Zafirlukast 20 mg die 2 573 Mean Difference (IV, Random, 95% CI) 5.60 [‐47.22, 58.43]
2.2 Montelukast 10 mg die 2 359 Mean Difference (IV, Random, 95% CI) ‐103.32 [‐235.02, 28.37]
3 Change from baseline in ICS dose (mcg) 1 134 Mean Difference (IV, Fixed, 95% CI) 66.95 [‐25.41, 159.31]
3.1 Montelukast 10 mg die 1 134 Mean Difference (IV, Fixed, 95% CI) 66.95 [‐25.41, 159.31]
4 Complete withdrawal from ICS 3 607 Risk Ratio (M‐H, Fixed, 95% CI) 1.18 [0.95, 1.47]
4.1 Zafirlukast 20 mg bid 1 359 Risk Ratio (M‐H, Fixed, 95% CI) 1.06 [0.81, 1.40]
4.2 Montelukast 10 mg 2 248 Risk Ratio (M‐H, Fixed, 95% CI) 1.38 [0.97, 1.96]
5 Final FEV1 (L) at lowest tolerated dose (at 12 ‐20 weeks) 2 621 Mean Difference (IV, Fixed, 95% CI) 0.13 [‐0.02, 0.27]
5.1 Zafirlukast 20 mg bid 2 621 Mean Difference (IV, Fixed, 95% CI) 0.13 [‐0.02, 0.27]
6 Change from baseline in FEV1 (L) at lowest tolerated dose (at 6‐24 weeks) 2 164 Mean Difference (IV, Fixed, 95% CI) ‐0.00 [‐0.10, 0.09]
6.1 Montelukast 10 mg die 2 164 Mean Difference (IV, Fixed, 95% CI) ‐0.00 [‐0.10, 0.09]
7 Final Am PEFR (L/min) at 12 ‐20 weeks 2 500 Mean Difference (IV, Fixed, 95% CI) 17.98 [‐1.68, 37.64]
7.1 Zafirlukast 20 mg bid 2 500 Mean Difference (IV, Fixed, 95% CI) 17.98 [‐1.68, 37.64]
8 Change from baseline in morning PEFR (L/min) at lowest tolerated dose 2 183 Mean Difference (IV, Fixed, 95% CI) 7.90 [‐1.61, 17.40]
8.1 Montelukast 10 mg die 2 183 Mean Difference (IV, Fixed, 95% CI) 7.90 [‐1.61, 17.40]
9 Final mean symptom scores (episodes/week) at 12 ‐20 weeks 2 487 Mean Difference (IV, Fixed, 95% CI) ‐0.06 [‐0.17, 0.05]
9.1 Zafirlukast 20 mg bid 2 487 Mean Difference (IV, Fixed, 95% CI) ‐0.06 [‐0.17, 0.05]
10 Change in symptom scores at 6‐24 weeks 1 50 Mean Difference (IV, Fixed, 95% CI) ‐0.5 [‐0.79, ‐0.21]
10.1 Montelukast 10 mg bid 1 50 Mean Difference (IV, Fixed, 95% CI) ‐0.5 [‐0.79, ‐0.21]
11 Final mean daily use of B2‐agonists (puffs/day) at lowest tolerated dose ( at 12‐20 weeks) 2 496 Mean Difference (IV, Fixed, 95% CI) ‐0.21 [‐0.73, 0.32]
11.1 Zafirlukast 20 mg bid 2 496 Mean Difference (IV, Fixed, 95% CI) ‐0.21 [‐0.73, 0.32]
12 Absolute change in mean daily use of B2‐agonists (puffs/week) at lowest tolerated dose (at 6‐24 weeks) 3 409 Mean Difference (IV, Fixed, 95% CI) ‐0.12 [‐0.76, 0.52]
12.1 Montelukast 10 mg die 3 409 Mean Difference (IV, Fixed, 95% CI) ‐0.12 [‐0.76, 0.52]
13 Change in serum eosinophils at lowest tolerated dose (at 6‐ 24 weeks) 2 167 Mean Difference (IV, Fixed, 95% CI) 0.18 [‐1.13, 1.50]
13.1 Montelukast 10 mg die 2 167 Mean Difference (IV, Fixed, 95% CI) 0.18 [‐1.13, 1.50]
14 Patients with 1 or more exacerbations requiring systemic steroids 4 502 Risk Ratio (M‐H, Fixed, 95% CI) 0.47 [0.20, 1.09]
14.1 Zafirlukast 20 mg bid 1 262 Risk Ratio (M‐H, Fixed, 95% CI) 0.50 [0.10, 2.41]
14.2 Montelukast 10 mg die 3 240 Risk Ratio (M‐H, Fixed, 95% CI) 0.45 [0.17, 1.25]
15 Patients with 1 or more exacerbations requiring hospital admission 2 231 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
15.1 Montelukast 10 mg die 2 231 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
16 Overall withdrawals 6 1110 Risk Ratio (M‐H, Fixed, 95% CI) 0.77 [0.60, 0.98]
16.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 0.94 [0.66, 1.34]
16.2 Montelukast 10 mg die 4 489 Risk Ratio (M‐H, Fixed, 95% CI) 0.63 [0.45, 0.89]
17 Withdrawals due to adverse effects 6 1110 Risk Ratio (M‐H, Fixed, 95% CI) 0.88 [0.52, 1.51]
17.1 Zafirlukast 20mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 1.68 [0.73, 3.82]
17.2 Montelukast 10 mg die 4 489 Risk Ratio (M‐H, Fixed, 95% CI) 0.49 [0.23, 1.05]
18 Withdrawals due to poor asthma control/exacerbations 6 1110 Risk Ratio (M‐H, Fixed, 95% CI) 0.63 [0.42, 0.95]
18.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 0.74 [0.21, 2.59]
18.2 Montelukast 10 mg die 4 489 Risk Ratio (M‐H, Fixed, 95% CI) 0.62 [0.40, 0.95]
19 Overall adverse effects 6 1100 Risk Ratio (M‐H, Random, 95% CI) 0.95 [0.83, 1.08]
19.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Random, 95% CI) 0.98 [0.89, 1.09]
19.2 Montelukast 10 mg die 4 479 Risk Ratio (M‐H, Random, 95% CI) 0.82 [0.54, 1.25]
20 Serious adverse events 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 2.47 [1.53, 3.97]
20.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 2.47 [1.53, 3.97]
21 Elevated liver enzymes 6 1099 Risk Ratio (M‐H, Fixed, 95% CI) 1.67 [0.86, 3.21]
21.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 2.83 [0.75, 10.68]
21.2 Montelukast 10 mg die 4 478 Risk Ratio (M‐H, Fixed, 95% CI) 1.31 [0.61, 2.79]
22 Headache 6 1100 Risk Ratio (M‐H, Fixed, 95% CI) 0.79 [0.58, 1.08]
22.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 0.85 [0.56, 1.28]
22.2 Montelukast 10 mg die 4 479 Risk Ratio (M‐H, Fixed, 95% CI) 0.73 [0.47, 1.16]
23 Nausea 6 1100 Risk Ratio (M‐H, Fixed, 95% CI) 1.49 [0.70, 3.19]
23.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 1.30 [0.52, 3.27]
23.2 Montelukast 10 mg die 4 479 Risk Ratio (M‐H, Fixed, 95% CI) 1.99 [0.50, 7.86]
24 Death 6 1100 Risk Ratio (M‐H, Fixed, 95% CI) 3.1 [0.13, 75.10]
24.1 Zafirlukast 20 mg bid 2 621 Risk Ratio (M‐H, Fixed, 95% CI) 0.0 [0.0, 0.0]
24.2 Montelukast 10 mg die 4 479 Risk Ratio (M‐H, Fixed, 95% CI) 3.1 [0.13, 75.10]
25 Patients unable to taper inhaled corticosteroids 1 226 Risk Ratio (M‐H, Fixed, 95% CI) 0.76 [0.51, 1.11]
25.1 Montelukast 10 mg 1 226 Risk Ratio (M‐H, Fixed, 95% CI) 0.76 [0.51, 1.11]
26 Change in expired NO concentration (ppb) at 6 weeks 1 50 Mean Difference (IV, Fixed, 95% CI) 0.03 [‐3.45, 3.51]
26.1 Montelukast 10 mg die 1 50 Mean Difference (IV, Fixed, 95% CI) 0.03 [‐3.45, 3.51]