Scolaris Content Display Scolaris Content Display

Contenido relacionado

Ir a:

Revisiones y protocolos relacionados

Respuestas clínicas Cochrane

Topics

Temas

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

Ir a la figura de la revisiónAbrir en una pestaña nueva

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.1 Number of participants with exacerbations requiring steroids, antibiotics, or both.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.1 Number of participants with exacerbations requiring steroids, antibiotics, or both.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.2 Quality of life: change from baseline in SGRQ total score.
Figuras y tablas -
Figure 4

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.2 Quality of life: change from baseline in SGRQ total score.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.8 Number of participants with ≥ 1 unit improvement in TDI focal score.
Figuras y tablas -
Figure 5

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.8 Number of participants with ≥ 1 unit improvement in TDI focal score.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.13 Use of rescue medications (change from baseline in number of puffs per day).
Figuras y tablas -
Figure 6

Forest plot of comparison: 1 Umeclidinium bromide versus placebo, outcome: 1.13 Use of rescue medications (change from baseline in number of puffs per day).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 1 Number of participants with exacerbations requiring steroids, antibiotics, or both.
Figuras y tablas -
Analysis 1.1

Comparison 1 Umeclidinium bromide versus placebo, Outcome 1 Number of participants with exacerbations requiring steroids, antibiotics, or both.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 2 Quality of life: change from baseline in SGRQ total score.
Figuras y tablas -
Analysis 1.2

Comparison 1 Umeclidinium bromide versus placebo, Outcome 2 Quality of life: change from baseline in SGRQ total score.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 3 Quality of life: number of participants with ≥ 4 units improvement in SGRQ total score.
Figuras y tablas -
Analysis 1.3

Comparison 1 Umeclidinium bromide versus placebo, Outcome 3 Quality of life: number of participants with ≥ 4 units improvement in SGRQ total score.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 4 Non‐fatal serious adverse events.
Figuras y tablas -
Analysis 1.4

Comparison 1 Umeclidinium bromide versus placebo, Outcome 4 Non‐fatal serious adverse events.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 5 Total number of deaths.
Figuras y tablas -
Analysis 1.5

Comparison 1 Umeclidinium bromide versus placebo, Outcome 5 Total number of deaths.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 6 Number of participants with hospital admissions due to COPD exacerbation.
Figuras y tablas -
Analysis 1.6

Comparison 1 Umeclidinium bromide versus placebo, Outcome 6 Number of participants with hospital admissions due to COPD exacerbation.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 7 Improvement in symptoms: TDI focal score.
Figuras y tablas -
Analysis 1.7

Comparison 1 Umeclidinium bromide versus placebo, Outcome 7 Improvement in symptoms: TDI focal score.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 8 Number of participants with ≥ 1 unit improvement in TDI focal score.
Figuras y tablas -
Analysis 1.8

Comparison 1 Umeclidinium bromide versus placebo, Outcome 8 Number of participants with ≥ 1 unit improvement in TDI focal score.

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 9 Lung function: change from baseline in trough FEV1 (L).
Figuras y tablas -
Analysis 1.9

Comparison 1 Umeclidinium bromide versus placebo, Outcome 9 Lung function: change from baseline in trough FEV1 (L).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 10 Lung function: change from baseline in trough FVC (L).
Figuras y tablas -
Analysis 1.10

Comparison 1 Umeclidinium bromide versus placebo, Outcome 10 Lung function: change from baseline in trough FVC (L).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 11 Lung function: change from baseline in peak FEV1 (L).
Figuras y tablas -
Analysis 1.11

Comparison 1 Umeclidinium bromide versus placebo, Outcome 11 Lung function: change from baseline in peak FEV1 (L).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 12 Adverse events (not including serious adverse events).
Figuras y tablas -
Analysis 1.12

Comparison 1 Umeclidinium bromide versus placebo, Outcome 12 Adverse events (not including serious adverse events).

Ir a la figura de la revisiónAbrir en una pestaña nueva

Comparison 1 Umeclidinium bromide versus placebo, Outcome 13 Use of rescue medications (change from baseline in number of puffs per day).
Figuras y tablas -
Analysis 1.13

Comparison 1 Umeclidinium bromide versus placebo, Outcome 13 Use of rescue medications (change from baseline in number of puffs per day).

Ir a la figura de la revisiónAbrir en una pestaña nueva
Summary of findings for the main comparison. Umeclidinium bromide compared with placebo for stable chronic obstructive pulmonary disease

Umeclidinium bromide vs placebo for stable chronic obstructive pulmonary disease

Patient or population: people with chronic obstructive pulmonary disease (COPD)
Setting: community
Intervention: umeclidinium bromide
Comparison: placebo

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with placebo

Risk with umeclidinium bromide

Number of participants with exacerbations requiring steroids, antibiotics, or both

157 per 1000

102 per 1000
(79 to 130)

OR 0.61
(0.46 to 0.80)

1922
(4 RCTs)

⊕⊕⊕⊕
HIGH

Quality of life: number of participants with ≥ 4 units improvement in SGRQ total score

342 per 1000

429 per 1000
(376 to 486)

OR 1.45
(1.16 to 1.82)

1397
(3 RCTs)

⊕⊕⊕⊝
MODERATEa

Mean quality of life: change from baseline in SGRQ total score was 4.79 lower (8.84 lower to 0.75 lower) in umeclidinium group (1119 participants, 3 RCTs)

Non‐fatal serious adverse events

51 per 1000

66 per 1000
(45 to 96)

OR 1.33
(0.89 to 2.00)

1922
(4 RCTs)

⊕⊕⊕⊝
MODERATEb

Larger studies may help refine this estimate

Number of participants with hospital admissions due to COPD exacerbation

20 per 1000

18 per 1000
(5 to 58)

OR 0.86
(0.25 to 2.92)

1922
(4 RCTs)

⊕⊕⊝⊝
LOWc

Few events, so larger studies may help refine this estimate

Number of participants with ≥ 1 unit improvement in TDI focal score

336 per 1000

464 per 1000
(410 to 521)

OR 1.71
(1.37 to 2.15)

1441
(3 RCTs)

⊕⊕⊕⊕
HIGH

Mean improvement in TDI focal score change from baseline was 0.76 higher (0.43 higher to 1.09 higher) in umeclidinium group (1193 participants, 3 RCTs)

Change from baseline in trough FEV1 (L)

Mean change from baseline in trough FEV1 (L) across control groups ranged from 0.123 to 0.139

Mean change from baseline in trough FEV1 (L) in the intervention group was 0.14 higher (0.12 higher to 0.17 higher)

‐

1381
(4 RCTs)

⊕⊕⊕⊕
HIGH

Adverse events (not including serious adverse events)

239 per 1000

250 per 1000
(211 to 292)

OR 1.06
(0.85 to 1.31)

1922
(4 RCTs)

⊕⊕⊕⊝
MODERATEb

*The risk in the intervention group (and its 95% confidence interval) is based on assumed risk in the comparison group and relative effect of the intervention (and its 95% CI).

CI: confidence interval; OR: odds ratio; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to the estimate of effect
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of effect but may be substantially different
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of effect
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

a‐1 for inconsistency: unexplained significant heterogeneity

b‐1 for imprecision: the CI includes non‐appreciable benefit and potential harm

c‐2 for imprecision: the CI includes both appreciable benefit and harm

Figuras y tablas -
Summary of findings for the main comparison. Umeclidinium bromide compared with placebo for stable chronic obstructive pulmonary disease
Ir a la tabla de la revisión
Comparison 1. Umeclidinium bromide versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Number of participants with exacerbations requiring steroids, antibiotics, or both Show forest plot

4

1922

Odds Ratio (M‐H, Fixed, 95% CI)

0.61 [0.46, 0.80]

2 Quality of life: change from baseline in SGRQ total score Show forest plot

3

1119

Mean Difference (IV, Random, 95% CI)

‐4.79 [‐8.84, ‐0.75]

2.1 Umeclidinium 62.5 μg

2

584

Mean Difference (IV, Random, 95% CI)

‐4.53 [‐6.97, ‐2.10]

2.2 Umeclidinium 125 μg

2

535

Mean Difference (IV, Random, 95% CI)

‐5.04 [‐15.05, 4.97]

3 Quality of life: number of participants with ≥ 4 units improvement in SGRQ total score Show forest plot

3

1397

Odds Ratio (M‐H, Fixed, 95% CI)

1.45 [1.16, 1.82]

3.1 Umeclidinium 62.5 μg

2

732

Odds Ratio (M‐H, Fixed, 95% CI)

1.62 [1.19, 2.21]

3.2 Umeclidinium 125 μg

2

665

Odds Ratio (M‐H, Fixed, 95% CI)

1.29 [0.93, 1.79]

4 Non‐fatal serious adverse events Show forest plot

4

1922

Odds Ratio (M‐H, Fixed, 95% CI)

1.33 [0.89, 2.00]

5 Total number of deaths Show forest plot

4

1922

Peto Odds Ratio (Peto, Fixed, 95% CI)

1.68 [0.52, 5.48]

6 Number of participants with hospital admissions due to COPD exacerbation Show forest plot

4

1922

Odds Ratio (M‐H, Random, 95% CI)

0.86 [0.25, 2.92]

6.1 Umeclidinium 62.5 μg

2

801

Odds Ratio (M‐H, Random, 95% CI)

3.20 [0.91, 11.24]

6.2 Umeclidinium 125 μg

3

1121

Odds Ratio (M‐H, Random, 95% CI)

0.43 [0.18, 1.03]

7 Improvement in symptoms: TDI focal score Show forest plot

3

1193

Mean Difference (IV, Fixed, 95% CI)

0.76 [0.43, 1.09]

8 Number of participants with ≥ 1 unit improvement in TDI focal score Show forest plot

3

1441

Odds Ratio (M‐H, Fixed, 95% CI)

1.71 [1.37, 2.15]

9 Lung function: change from baseline in trough FEV1 (L) Show forest plot

4

1381

Mean Difference (IV, Fixed, 95% CI)

0.14 [0.12, 0.17]

10 Lung function: change from baseline in trough FVC (L) Show forest plot

4

1381

Mean Difference (IV, Fixed, 95% CI)

0.22 [0.17, 0.26]

11 Lung function: change from baseline in peak FEV1 (L) Show forest plot

2

1035

Mean Difference (IV, Fixed, 95% CI)

0.17 [0.14, 0.19]

12 Adverse events (not including serious adverse events) Show forest plot

4

1922

Odds Ratio (M‐H, Fixed, 95% CI)

1.06 [0.85, 1.31]

13 Use of rescue medications (change from baseline in number of puffs per day) Show forest plot

4

1531

Mean Difference (IV, Fixed, 95% CI)

‐0.45 [‐0.76, ‐0.14]
Figuras y tablas -
Comparison 1. Umeclidinium bromide versus placebo
Ir a la tabla de la revisión