Open-label study of the efficacy and safety of intravenous ferric carboxymaltose in pregnant women with restless legs syndrome.
OBJECTIVE
The objective of this study was to test the efficacy and safety of intravenous ferric carboxymaltose (FCM) in pregnant women with restless legs syndrome (RLS) and iron deficiency or anemia. The open-label pilot study (exploratory) was performed at the University Hospital of Zürich and the Neurocenter of Southern Switzerland (Lugano).


METHODS
Nineteen women in the third trimester of pregnancy with moderate-to-severe RLS and serum ferritin levels <35 µg/l or hemoglobin (Hb) < 11.0 g/dl were included in the study. RLS was graded according to the International Restless Legs Syndrome (IRLS) Study Group rating scale. All participants had a score of ≥20 or had RLS ≥3 times/week. Based on the Hb levels, 500 or 700 mg of FCM was administered over 20 min. The primary end point was a ≥ 50% reduction in the mean IRLS score one week after FCM infusion. The secondary end points included periodic limb movements (PLMs; assessed using nocturnal foot actigraphy), sleep quality (assessed using the Pittsburgh Sleep Quality Index), and safety.


RESULTS
The IRLS score decreased from 23 ± 7 (baseline) to 13 ± 7 (P <0.01), whereas the PLM index decreased from 35 ± 26 (baseline) to 25 ± 20 (P <0.001). Significant improvement in sleep quality was also reported (P <0.029), and treatment was well tolerated. Three serious adverse events were reported, but they were considered unrelated to treatment.


CONCLUSIONS
These data provide promising evidence on the safety and efficacy of FCM for moderate-to-severe RLS in pregnant women with iron deficiency or anemia. Therefore, a future placebo-controlled study is warranted.
Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091 Zürich, Switzerland.
Juliane
J
Schneider
Department of Obstetrics and Gynecology, University Hospital Zurich, Frauenklinikstrasse 26, 8091 Zürich, Switzerland.
Alexander
A
Krafft
Department of Neurology, Neurocenter of Southern Switzerland, Ospedale Civico, Via Tesserete 46, 6900 Lugano, Switzerland.
Mauro
M
Manconi
Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091 Zürich, Switzerland.
Astrid
A
Hübner
Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091 Zürich, Switzerland.
Christian
C
Baumann
Department of Neurology, University Hospital Zurich, Frauenklinikstrasse 26, 8091 Zürich, Switzerland.
Esther
E
Werth
Department of Obstetrics and Gynecology, Ospedale Civico, Via Tesserete 46, 6900 Lugano, Switzerland.
Thomas
T
Gyr
Department of Neurology, Neurocenter of Southern Switzerland, Ospedale Civico, Via Tesserete 46, 6900 Lugano, Switzerland; Department of Neurology, University Hospital Bern, Freiburgstasse 4, 3010 Bern, Switzerland. Electronic address: claudio.bassetti@insel.ch.
Claudio
C
Bassetti
D061605:Administration, Intravenous; D000328:Adult; D018798:Anemia, Iron-Deficiency / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage*; D005293:Ferritins / Q000097:blood; D006801:Humans; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010865:Pilot Projects; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011446:Prospective Studies; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D013557:Switzerland; D013997:Time Factors; D016896:Treatment Outcome
D005290:Ferric Compounds; C522335:ferric carboxymaltose; D008320:Maltose; D005293:Ferritins
Actigraphy; Anemia; Ferric carboxymaltose; Pregnancy; Restless legs syndrome