Long‐acting beta<sub>2</sub>‐agonist in addition to tiotropium versus either tiotropium or long‐acting beta<sub>2</sub>‐agonist alone for chronic obstructive pulmonary disease

Charlotta Karner; Christopher J Cates

doi:10.1002/14651858.CD008989.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Forest plot of comparison: 1 LABA plus tiotropium versus tiotropium, outcome: 1.1 Change in quality of life.

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Figure 4

Forest plot of comparison: 1 LABA plus tiotropium versus tiotropium, outcome: 1.2 Hospital admission (all cause).

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Figure 5

Forest plot of comparison: 1 LABA plus tiotropium versus tiotropium, outcome: 1.3 Hospital admission (exacerbation).

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Figure 6

Forest plot of comparison: 1 LABA plus tiotropium versus tiotropium, outcome: 1.4 Mortality (all cause).

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Analysis 1.1

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 1 Change in quality of life.

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Analysis 1.2

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 2 Hospital admission (all cause).

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Analysis 1.3

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 3 Hospital admission (exacerbation).

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Analysis 1.4

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 4 Mortality (all cause).

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Analysis 1.5

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 5 Exacerbation.

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Analysis 1.6

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 6 Trough FEV1.

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Analysis 1.7

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 7 Symptom score.

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Analysis 1.8

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 8 Serious adverse event (non‐fatal).

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Analysis 1.9

Comparison 1 LABA plus tiotropium versus tiotropium, Outcome 9 Withdrawal.

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Summary of findings for the main comparison. LABA plus tiotropium versus tiotropium for chronic obstructive pulmonary disease

LABA plus tiotropium versus tiotropium for chronic obstructive pulmonary disease
Patient or population: chronic obstructive pulmonary disease Settings: Intervention: LABA plus tiotropium versus tiotropium
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Tiotropium	LABA plus tiotropium
Change in quality of life St George's Respiratory Questionaire (SGRQ). Scale from: 0 to 100. Follow‐up: 6 to 12 months	The mean change in quality of life in the control group was ‐4.5 units¹	The mean change in quality of life in the intervention group was ‐6.3 units¹ (‐7.43 to ‐4.79)	MD ‐1.61 (‐2.93 to ‐0.29)	732 (2 studies)	⊕⊕⊕⊝ moderate²	The mean treatment effect was statistically significant but it was smaller than what is regarded as a clinically important difference.
Exacerbations leading to hospital admission Number of patients experiencing one or more events Follow‐up: 6 to 12 months	88 per 1000	93 per 1000 (57 to 148)	OR 1.07 (0.63 to 1.81)	732 (2 studies)	⊕⊕⊝⊝ low^2,3
Hospital admission (all cause) Number of patients experiencing one or more events Follow‐up: 6 to 12 months	119 per 1000	120 per 1000 (79 to 179)	OR 1.01 (0.63 to 1.61)	732 (2 studies)	⊕⊕⊝⊝ low^2,3
Mortality (all cause) Number of patients Follow‐up: 3 to 12 months	4 per 1000	6 per 1000 (2 to 16)	OR 1.56 (0.56 to 4.33)	3263 (5 studies)	⊕⊕⊝⊝ low⁴
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; OR: Odds ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ The control group risk is based on Aaron 2007. ² One study was a year long with high and unbalanced dropouts. ³ Wide confidence interval and few participants and events. ⁴ There were two trials with no deaths and few deaths in the remaining three trials, leading to a wide confidence interval. Mortality was largely unknown in those who discontinued treatment.

Summary of findings for the main comparison. LABA plus tiotropium versus tiotropium for chronic obstructive pulmonary disease

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Comparison 1. LABA plus tiotropium versus tiotropium

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in quality of life Show forest plot	2	732	Mean Difference (Fixed, 95% CI)	‐1.61 [‐2.93, ‐0.29]

1.1 Salmeterol	1	304	Mean Difference (Fixed, 95% CI)	‐1.8 [‐3.32, ‐0.28]
1.2 Formoterol	1	428	Mean Difference (Fixed, 95% CI)	‐1.0 [‐3.70, 1.70]
2 Hospital admission (all cause) Show forest plot	2	732	Odds Ratio (M‐H, Fixed, 95% CI)	1.01 [0.63, 1.61]

2.1 Salmeterol	1	304	Odds Ratio (M‐H, Fixed, 95% CI)	1.03 [0.61, 1.76]
2.2 Formoterol	1	428	Odds Ratio (M‐H, Fixed, 95% CI)	0.95 [0.36, 2.50]
3 Hospital admission (exacerbation) Show forest plot	2	732	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.63, 1.81]

3.1 Salmeterol	1	304	Odds Ratio (M‐H, Fixed, 95% CI)	1.16 [0.66, 2.06]
3.2 Formoterol	1	428	Odds Ratio (M‐H, Fixed, 95% CI)	0.64 [0.15, 2.69]
4 Mortality (all cause) Show forest plot	5	3263	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.56 [0.56, 4.33]

4.1 Salmeterol	1	304	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.59 [0.45, 5.62]
4.2 Formoterol	2	683	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
4.3 Indacaterol	2	2276	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.48 [0.26, 8.57]
5 Exacerbation Show forest plot	3		Odds Ratio (M‐H, Random, 95% CI)	Totals not selected

5.1 Salmeterol	1		Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.2 Formoterol	2		Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6 Trough FEV1 Show forest plot	5	3263	Mean Difference (Fixed, 95% CI)	0.07 [0.05, 0.09]

6.1 Salmeterol	1	304	Mean Difference (Fixed, 95% CI)	0.03 [‐0.07, 0.13]
6.2 Formoterol	2	683	Mean Difference (Fixed, 95% CI)	0.06 [0.02, 0.11]
6.3 Indacaterol	2	2276	Mean Difference (Fixed, 95% CI)	0.07 [0.05, 0.10]
7 Symptom score Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7.1 Formoterol	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
8 Serious adverse event (non‐fatal) Show forest plot	5	3263	Odds Ratio (M‐H, Fixed, 95% CI)	1.09 [0.76, 1.55]

8.1 Salmeterol	1	304	Odds Ratio (M‐H, Fixed, 95% CI)	0.95 [0.37, 2.40]
8.2 Formoterol	2	683	Odds Ratio (M‐H, Fixed, 95% CI)	1.07 [0.54, 2.13]
8.3 Indacaterol	2	2276	Odds Ratio (M‐H, Fixed, 95% CI)	1.14 [0.72, 1.81]
9 Withdrawal Show forest plot	5	3263	Odds Ratio (M‐H, Random, 95% CI)	1.00 [0.74, 1.37]

9.1 Salmeterol	1	304	Odds Ratio (M‐H, Random, 95% CI)	0.84 [0.54, 1.33]
9.2 Formoterol	2	683	Odds Ratio (M‐H, Random, 95% CI)	1.46 [0.52, 4.09]
9.3 Indacaterol	2	2276	Odds Ratio (M‐H, Random, 95% CI)	0.93 [0.65, 1.34]

Comparison 1. LABA plus tiotropium versus tiotropium

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