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. 2019 Jan 31;2019(1):CD012621. doi: 10.1002/14651858.CD012621.pub2

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:
  • Between 12 and 65 years of age

  • WHO functional classes II and III PAH despite the use of conventional therapies, including oral anticoagulants, digoxin, diuretics, or supplemental oxygen. (WHO Group 1)

  • A baseline 6MWD between 150 metres and 550 metres

  • a resting mean PAP ≥ 25 mmHg and PAWP ≤15 mmHg, and PVR > 4 Wood Units measured by right‐heart catheterisation at enrolment


Exclusion criteria:
  • No PAH‐specific treatments (prostanoids, endothelin receptor antagonists, or phosphodiesterase type 5 inhibitors) were allowed for at least 3 months before enrolment

  • Acute responders to a vaso‐reactivity test were excluded.


WHO FC II/III
n = 66
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
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