Jing 2011.
Methods | Randomised, double‐blind, placebo‐controlled trial, 12 weeks duration, followed by an open‐label trial, of another 12 weeks duration | |
Participants | Inclusion criteria:
Exclusion criteria:
WHO FC II/III n = 66 |
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Interventions | Vardenafil (5 mg once daily for 4 weeks then 5 mg twice daily; n = 44) or placebo (n = 22) | |
Outcomes | The primary efficacy endpoint was the 6MWD, assessed at the end of the 12‐week randomised treatment period. Secondary measures of efficacy included cardiopulmonary haemodynamics (mean RAP, cardiac index, mean PAP, and PVR) measured by right‐heart catheterisation; the Borg dyspnoea index; WHO functional class (at baseline and Week 12); and occurrence of clinical worsening events defined as death (all causes) or hospitalisation for PAH progression | |
Notes | Publicly funded Trial was conducted at nine centers in China and were enrolled in the trial between September 2008 and May 2009 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was computer‐generated using the DMS System, with a block size of 6. The 2:1 randomisation ratio (vardenafil: placebo) was the same for each centre |
Allocation concealment (selection bias) | Low risk | Placebo‐controlled |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Placebo‐controlled |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not explicitly stated but assumed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Withdrawals were accounted for: 2 participants randomised to placebo were lost to follow‐up without any follow‐up data being recorded. 4 participants in the placebo group and 1 participant in the vardenafil group withdrew because of clinical worsening. Thus, 59 participants completed the randomised phase |
Selective reporting (reporting bias) | Low risk | Prespecified outcomes were reported |
Other bias | Low risk | Other risk of bias is unlikely |