Summary of findings 6. Group 4 Pulmonary hypertension due to CTEPH ‐ PDE5i compared to placebo.
| Group 4 Pulmonary hypertension due to CTEPH ‐ PDE5i compared to placebo | ||||||
| Patient or population: people with pulmonary hypertension due to CTEPH Setting: outpatients Intervention: PDE5 inhibitors Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with comparison (placebo/sildenafil) | Risk with PDE5i | |||||
| Improvement in WHO functional class | 0 per 1000 | 444 per 1000 | OR 17.18 (0.78 to 380.84) | 19 (1 RCT) | ⊕⊕⊝⊝ LOWa | ‐ |
| Six‐minute walk distance ‐ sildenafil compared to placebo | Baseline 331 metres | MD 18 metres higher (24 lower to 59 higher) | ‐ | 19 (1 RCT) | ⊕⊕⊝⊝ LOWa | ‐ |
| Six‐minute walk distance ‐ sildenafil compared to bosentan | Ranges from 422 ‐ 455 metres | MD 20 metres higher (28 lower to 69 higher) | ‐ | 227 (2 RCTs) | ⊕⊕⊕⊝ MODERATEb | ‐ |
| Mortality ‐ sildenafil versus placebo | No deaths reported | not estimable | 20 (1 RCT) | ⊕⊕⊝⊝ LOWa | ‐ | |
| Mortality ‐ sildenafil versus bosentan | 40 per 1000 | 54 per 1000 (9 to 261) | OR 1.36 (0.22 to 8.48) | 106 (1 RCT) | ⊕⊕⊝⊝ LOWa | ‐ |
| Quality of life | ‐ | MD 0.26 lower (1.17 lower to 0.64 higher) | ‐ | 34 (1 RCT) | ⊕⊕⊝⊝ LOWa | CamPHOR scale; higher scores indicate worse quality of life |
| Mean PAP ‐ sildenafil versus placebo | ‐ | MD 6.2 mmHg lower (12.4 lower to 0 higher) | ‐ | 19 (1 RCT) | ⊕⊕⊝⊝ LOWa | The higher the PAP, the worse the pulmonary hypertension |
| Mean PAP ‐ sildenafil versus bosentan | ‐ | MD 0.76 mmHg higher (3.96 lower to 5.48 higher) | ‐ | 227 (2 RCTs) | ⊕⊕⊕⊝ MODERATEb | The higher the PAP, the worse the pulmonary hypertension |
| Cardiac index ‐ sildenafil versus placebo | ‐ | MD 0 L/min/m2 higher (0.4 lower to 0.4 higher) | ‐ | 19 (1 RCT) | ⊕⊕⊝⊝ LOWa | The lower the cardiac index, the worse the pulmonary hypertension |
| Cardiac index ‐ sildenafil versus bosentan | ‐ | MD 0.04 L/min/m2 higher (0.22 lower to 0.31 higher) | ‐ | 227 (2 RCTs) | ⊕⊕⊕⊝ MODERATEb | The lower the cardiac index, the worse the pulmonary hypertension |
| PVR ‐ sildenafil versus placebo | ‐ | MD 0.89 WU lower (1.85 lower to 0.06 higher) | ‐ | 19 (1 RCT) | ⊕⊕⊝⊝ LOWa | The higher the PVR, the worse the pulmonary hypertension |
| PVR ‐ sildenafil versus bosentan | ‐ | MD 0.01 WU lower (0.27 lower to 0.25 higher) | ‐ | 227 (2 RCTs) | ⊕⊕⊕⊝ MODERATEb | The higher the PVR, the worse the pulmonary hypertension |
| *The risk in the intervention group (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; CTEPH: chronic thromboembolic pulmonary hypertension; MD: mean difference; OR: odds ratio; PAP: pulmonary arterial pressure; PDE‐5i: phosphodiesterase‐5 inhibitor; PVR: pulmonary vascular resistance; RCT: randomised controlled trials; WHO: World Health Organization | ||||||
| GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
aDowngraded twice due to imprecision owing to small participant numbers in only one trial. bDowngraded once due to imprecision.