RATIONALE: Iron deficiency, in the absence of anaemia, is common in patients with idiopathic and heritable pulmonary arterial hypertension (PAH) and is associated with a worse clinical outcome. Oral iron absorption may be impeded by elevated circulating hepcidin levels. The safety and benefit of parenteral iron replacement in this patient population is unclear. OBJECTIVES: To evaluate the safety and efficacy of parenteral iron replacement in pulmonary arterial hypertension. METHODS: In two randomised, double blind, placebo-controlled 12 week crossover studies, 39 patients in Europe received a single infusion of ferric carboxymaltose (Ferinject®) 1000 mg (or 15 mg/kg if weight < 66.7Kg) or saline as placebo and 17 patients in China received iron dextran (Cosmofer®) 20 mg iron/kg body weight or saline placebo. All patients had idiopathic or heritable PAH and iron deficiency at entry as defined by: a serum ferritin < 37 µg/l or iron < 10.3 µmol/l or transferrin saturations < 16.4%. RESULTS: Both iron treatments were well tolerated and improved iron status. Analysed separately and combined, there was no effect on any measure of exercise capacity (using cardiopulmonary exercise testing or 6 minute walk test) or cardio-pulmonary haemodynamics, as assessed by right heart catheterisation, cardiac magnetic resonance or plasma NT-proBNP, at 12 weeks. CONCLUSION: Iron repletion by administration of a slow release iron preparation as a single infusion to PAH patients with iron deficiency without overt anaemia was well tolerated but provided no significant clinical benefit at 12 weeks. Clinical trial registered with ClinicalTrials.gov (NCT01447628).
- Howard, Lsge
- He, J.
- Watson, G. M. J.
- Huang, L.
- Wharton, J.
- Luo, Q.
- Kiely, D. G.
- Condliffe, R.
- Pepke-Zaba, J.
- Morrell, N. W.
- Sheares, K. K.
- Ulrich, A.
- Quan, R.
- Zhao, Z.
- Jing, X.
- An, C.
- Liu, Z.
- Xiong, C.
- Robbins, P. A.
- Dawes, T.
- de Marvao, A.
- Rhodes, C. J.
- Richter, M. J.
- Gall, H.
- Ghofrani, H. A.
- Zhao, L.
- Huson, L.
- Wilkins, M. R.
