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

Salem 2013.

Methods Randomised, placebo‐controlled trial
6 weeks duration
Participants Inclusion criteria:
  • Adults with symptomatic secondary PH with NYHA functional class

  • The underlying aetiologies of PH were: dilated cardiomyopathy, COPD, chronic thromboembolic disease, ILD, and valvular heart disease (mitral and aortic regurgitation)


Exclusion criteria:
  • Primary pulmonary hypertension

  • Hypotension

  • Allergy to sildenafil

  • IHD (WHO Group 2 ‐ 5)


n = 40
Interventions Oral sildenafil (N=20) or matched placebo (N=20) was given in a titrated dose, starting with 25 mg 3 times daily for 1 week, then the dose was doubled to 50 mg 3 times daily according to side effects and tolerability until 6‐week period
Outcomes Improvement in NYHA functional class
PASP
LVEF
Notes Funding source not stated
Location of trial and dates of recruitment not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using simple randomisation (1:1) to either sildenafil therapy in a titrating dose or placebo
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 Unclear risk It was unclear if the outcome assessors were blinded to the intervention
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk It was not explicitly stated if all randomised participants completed the trial; no withdrawals were reported
Selective reporting (reporting bias) Low risk Prespecified outcomes were reported
Other bias Low risk Other risk of bias is unlikely