Table 3

Validation of the discriminant capacity over treatment of the 6MWT

Author, year, referenceQuality (Jadad)SSc patientsInclusion criteria for PAHInterventionComparatorStudy durationEffect size (95% CI) for 6MWTEffect size (95% CI) for haemodynamic measures
Denton et al, 200675/5N=52 (79%)CTD-related PAHBosentanPlacebo12.16 weeks0.30 (−0.2 to 0.8)mPAP
WHO III/IV62.5 mg ×2/dayNo data
6MWT 150–500 mduring 4 weeks thenPVR
mPAP >25 mm Hg,125×2 mg/dayNo data
PVR >240250 mg/day
Girgis et al, 2007144/5N=38 (46%)CTD-related PAHSitaxsentanPlacebo12 weeks0.57 (−0.2 to 1.3)mPAP
WHO II, III and IV50 mg/day−0.9 (−1.67 to 0.1)
6MWT >450 m excluded100 mg/dayPVR
mPAP >25 mm Hg at rest PVR ≥240300 mg/day−1.1 (−1.9 to 0.3)
Badesch et al, 2007155/5N=38 (45%)CTD-related PAHSildenafilPlacebo12 weeks0.65 (0.0 to 1.3)mPAP
WHO II-IV20 mg × 3/day0.68 (0.0 to 1.3)−0.5 (−1.2 to 0.1)
6MWT 100–450 m40 mg × 3/day0.31 (−0.2 to 1.0)−0.4 (0.9 to 0.2)
mPAP ≥25 mm Hg80 mg × 3/day−0.4 (−1.0 to 0.2)
PVR
−0.5 (−1.1 to 0.1)
−0.3 (−0.9 to 0.3)
−0.3 (−0.9 to 0.3)
Badesch et al, 2000133/5N=110 (100%)SSc-related PAHEpoprostenolConventional12 weeks1.2 (0.8 to 1.6)mPAP
mPAP ≥35 mm Hgintravenouslytherapy−0.6 (−0.9 to −0.2)
PVR >240Starting fromPVR
2 ng/kg/min intravenously and increased based on symptoms and adverse events plus conventional therapy−0.9 (−1.3 to −0.5)
Oudiz et al, 2004103/5N=45 (50%)SSc-related PAHTreprostinil intravenouslyPlacebo12 weeks1.37 (0.9 to 1.9)mPAP −1.0 (−1.4 to −0.6)
mPAP ≥25 mm Hg
PVR ≥3 Wood unitsStarting from 1.25 to 2.5 ng/kg/min and increases of 1.25–2.5 ng/kg/min every 1–2 weeks.PVR −2.3 (−2.8 to −1.8)
6MWT 50.450 mTarget dose based on response to therapy and adverse effects and did not exceed 22.5 ng/kg/min
  • 6MWT, 6 min walk test; mPAP, mean pulmonary artery pressure; PAH, pulmonary arterial hypertension; PVR, pulmonary vascular resistance; SSc, systemic sclerosis.