| Comparison 7. Itraconazole versus placebo | ||||||
|---|---|---|---|---|---|---|
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Placebo | Itraconazole | |||||
| Lung function: percentage change in FEV1 predicted from baseline Scale from: 0 to 100 Follow-up: mean 24 weeks | The mean lung function in the placebo group was: 0.32 | The mean lung function change in the itraconazole group was 4.94 lower (15.33 lower to 5.45 higher) | - | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,3 | |
| Lung function: percentage change in FEV1 predicted from baseline Scale from: 0 to 100 Follow-up: mean 48 weeks | Not reported | The mean lung function change in the itraconazole group was 3.71 lower (−13.26 lower to 20.68 higher) | Not estimable | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,3 | |
| Time to next pulmonary exacerbation Follow-up: mean 24 weeks | The median time to next exacerbation in the placebo group was: 134 days | The median time to next exacerbation in the itraconazole group was: 77 days | adjHR 1.34 (0.57 to 3.14) | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,4 | |
| proxy: number of patients with an exacerbation requiring AB Follow-up: mean 24 weeks | 389 per 1000 | 665 per 1000 (342 to 1000) | RR 1.71 (0.88 to 3.33) | 36 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,5 | |
| proxy: number of patients with an exacerbation requiring AB Follow-up: mean 48 weeks | 611 per 1000 | 831 per 1000 (544 to 1000) | RR 1.36 (0.89 to 2.08) | 36 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| proxy: number of patients with an exacerbation admitted to hospital Follow-up: mean 24 weeks | 176 per 1000 | 166 per 1000 (39 to 715) | RR 0.94 (0.22 to 4.05) | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| proxy: number of patients with an exacerbation admitted to hospital Follow-up: mean 48 weeks | 176 per 1000 | 222 per 1000 (58 to 851) | RR 1.26 (0.33 to 4.82) | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,4 | |
| Quality of life - all domains CFQ-R Scale from: 0 to 100 Follow-up: mean 24 weeks | Not reported | Not reported | Not estimable, but no significant differences found | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,7 | |
| Quality of life – change in respiratory domain CFQ-R Scale from: 0 to 100 Follow-up: mean 24 weeks | The mean change in CFQ-R score for the respiratory domain in the placebo group was: 4.77 | The mean change in CFQR score for the respiratory domain in the itraconazole group was: 3.76 | Not estimable, but no significant differences (p=0.87) | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,7 | |
| Minor adverse events - increased dyspnoea Follow-up: mean 24 weeks | 125 per 1000 | 111 per 1000 (18 to 700) | RR 0.89 (0.14 to 5.6) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Minor adverse events - rash Follow-up: mean 24 weeks | 62 per 1000 | 111 per 1000 (11 to 1000) | RR 1.78 (0.18 to 17.8) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Minor adverse events - hyperglycaemia Follow-up: mean 24 weeks | 0 per 1000 | 0 per 1000 (0 to 0) | RR 2.68 (0.12 to 61.58) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Minor adverse events - flu-like illness Follow-up: mean 24 weeks | 0 per 1000 | 0 per 1000 (0 to 0) | RR 6.26 (0.35 to 112.7) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Minor adverse events - diarrhoea Follow-up: mean 24 weeks | 62 per 1000 | 19 per 1000 (1 to 428) | RR 0.3 (0.01 to 6.84) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Minor adverse events (lower scores are better) - conjunctivitis Follow-up: mean 24 weeks | 62 per 1000 | 19 per 1000 (1 to 428) | RR 0.3 (0.01 to 6.84) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Major adverse events - haemoptysis Follow-up: mean 24 weeks | 62 per 1000 | 111 per 1000 (11 to 1000) | RR 1.78 (0.18 to 17.8) | 34 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
| Major adverse events - spontaneous pneumothorax Follow-up: mean 24 weeks | 0 per 1000 | 0 per 1000 (0 to 0) | RR 2.84 (0.12 to 65.34) | 35 (Aaron 2012) | ⊕⊝⊝⊝ very low1,2,6 | |
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).
Abbreviations: CFQ-R: cystic fibrosis questionnaire reviewed; CI: confidence interval; FEV1: forced expiratory volume in 1 second; MD: mean difference; RR: risk ratio
The quality of the evidence was downgraded by 1 due to unclear allocation, data reporting and sample size
The quality of the evidence was downgraded by 1 due to indirectness, as the therapeutic dosages were not achieved in 2/3 of the participants
The quality of the evidence was downgraded by 2 as the 95% CI crossed 2 clinical MIDs.
The quality of the evidence was downgraded by 2 as the 95% CI crossed the null effect and it is very wide. The study in underpowered to detect differences between groups.
The quality of the evidence was downgraded by 1 as the 95% CI crossed 1 default MID.
The quality of the evidence was downgraded by 2 as the 95% CI crossed 2 default MIDs
Not calculable, as no data was provided in the study.
From: 9, Pulmonary monitoring, assessment and management
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