Regular treatment with formoterol versus regular treatment with salmeterol for chronic asthma: serious adverse events

Christopher J Cates; Toby J Lasserson

doi:10.1002/14651858.CD007695.pub2

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Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 2

Forest plot of comparison: 1 Regular formoterol versus regular salmeterol, outcome: 1.1 All cause Mortality.

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Figure 3

Forest plot of comparison: 1 Regular formoterol versus regular salmeterol, outcome: 1.2 All cause Serious Adverse Events.

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Figure 4

Forest plot of comparison: 1 Regular formoterol versus regular salmeterol, outcome: 1.3 Asthma‐related Serious Adverse Events.

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Figure 5

Changes in asthma mortality (5‐34 age group) in three countries in relation to the introduction of isoprenaline forte in the UK and New Zealand and of fenoterol in New Zealand. (From Blauw 1995. With permission from the Lancet).

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Analysis 1.1

Comparison 1 Regular formoterol versus regular salmeterol, Outcome 1 All cause Mortality.

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Analysis 1.2

Comparison 1 Regular formoterol versus regular salmeterol, Outcome 2 All cause Serious Adverse Events.

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Analysis 1.3

Comparison 1 Regular formoterol versus regular salmeterol, Outcome 3 Asthma‐related Serious Adverse Events.

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Analysis 1.4

Comparison 1 Regular formoterol versus regular salmeterol, Outcome 4 All cause Serious Adverse Events (Sensitivity analysis).

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Analysis 1.5

Comparison 1 Regular formoterol versus regular salmeterol, Outcome 5 Asthma‐related Serious Adverse Events (Sensitivity analysis).

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Summary of findings for the main comparison. Regular formoterol compared to regular salmeterol for chronic asthma: serious adverse events

Regular formoterol compared to regular salmeterol for chronic asthma: serious adverse events
Patient or population: patients with asthma Settings: community Intervention: Regular formoterol Comparison: Regular salmeterol
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Regular salmeterol	Regular formoterol
All cause Mortality ‐ Adults Follow‐up: mean 6 months	2 per 1000¹	0 per 1000 (‐9 to 13)	See comment	1116 (3 studies)	⊕⊕⊝⊝ low^2,3	No deaths were related to asthma. Risks were calculated from pooled risk differences
All cause Mortality ‐ Children Follow‐up: 3 months	See comment	See comment	See comment	156 (1 study)	⊕⊝⊝⊝ very low^2,3,4	No deaths occurred in the single small study on children
All cause Serious Adverse Events ‐ Adults Follow‐up: mean 6 months	64 per 1000¹	50 per 1000 (30 to 80)	OR 0.77 (0.46 to 1.28)	1116 (3 studies)	⊕⊕⊝⊝ low^2,3
All cause Serious Adverse Events ‐ Children Follow‐up: 3 months	13 per 1000¹	12 per 1000 (1 to 168)	OR 0.95 (0.06 to 15.33)	156 (1 study)	⊕⊝⊝⊝ very low^2,3,4	There was only one child in each group with a serious adverse event
Asthma‐related Serious Adverse Events ‐ Adults Follow‐up: mean 6 months	12 per 1000¹	10 per 1000 (4 to 30)	OR 0.86 (0.29 to 2.57)	1116 (3 studies)	⊕⊕⊝⊝ low^2,3
Asthma‐related Serious Adverse Events ‐ Children Follow‐up: 3 months	See comment	See comment	Not estimable	156 (1 study)	⊕⊝⊝⊝ very low^2,3,4	No asthma‐related serious adverse events in the single small study on children
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; RR: Risk ratio; 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 Mean event rate in salmeterol arm of the included studies ² Unblinded studies ³ Confidence intervals too wide to reach firm conclusions ⁴ Only one small study found in children

Summary of findings for the main comparison. Regular formoterol compared to regular salmeterol for chronic asthma: serious adverse events

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Table 1. Intrinsic Efficacy of Beta‐agonists

Drug	Intrinsic Efficacy (%)
Isoprenaline, adrenaline	100
Fenoterol	42
Formoterol	20
Salbutamol	4.9
Salmeterol	< 2
Adapted from Hanania 2002. The authors acknowledge that it is difficult to determine the intrinsic efficacy of salmeterol given its high lipophilicity.

Table 1. Intrinsic Efficacy of Beta‐agonists

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Comparison 1. Regular formoterol versus regular salmeterol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 All cause Mortality Show forest plot	4	1272	Risk Difference (M‐H, Fixed, 95% CI)	‐0.00 [‐0.01, 0.01]

1.1 Adults	3	1116	Risk Difference (M‐H, Fixed, 95% CI)	‐0.00 [‐0.01, 0.01]
1.2 Children	1	156	Risk Difference (M‐H, Fixed, 95% CI)	0.0 [‐0.02, 0.02]
2 All cause Serious Adverse Events Show forest plot	4	1272	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.77 [0.47, 1.28]

2.1 Adults	3	1116	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.77 [0.46, 1.28]
2.2 Children	1	156	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.95 [0.06, 15.33]
3 Asthma‐related Serious Adverse Events Show forest plot	4	1272	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.86 [0.29, 2.57]

3.1 Adults	3	1116	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.86 [0.29, 2.57]
3.2 Children	1	156	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]
4 All cause Serious Adverse Events (Sensitivity analysis) Show forest plot	4	1272	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.75 [0.46, 1.24]

4.1 Adults	3	1116	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.75 [0.45, 1.24]
4.2 Children	1	156	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.95 [0.06, 15.33]
5 Asthma‐related Serious Adverse Events (Sensitivity analysis) Show forest plot	4	1272	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.76 [0.26, 2.17]

5.1 Adults	3	1116	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.76 [0.26, 2.17]
5.2 Children	1	156	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 1. Regular formoterol versus regular salmeterol

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