Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study
Hiroshi Kawabata, Takeshi Tamura, Soichiro Tamai, Akiko Fujibayashi, Motoi Sugimura, Study Group, Jun Hayakawa, Hisato Oku, Yoshiaki Ota, Sonoe Nishiguchi, Kiyohiko Yamada, Michio Nomura, Toshiro Mizutani, Yoshihiro Tamura, Kyoka Amemiya, Mamoru Urabe, Hirofumi Henmi, Kozo Aisaka, Atsuya Fujito, Masataka Oku, Chisei Tei, Akinori Kawata, Masaya Hirose, Masuo Yoshioka, Chizue Nishizawa, Ikuyo Horiguchi, K Hirai, Akiko Tanabe, Shohei Yoshida, Yoshihiro Umezawa, Yuji Kashiwazaki, Hideki Kamegai, Toshio Saito, Kazutoshi Naritaka, Shigehito Yamauchi, Kenji Akazawa, Koji Kobiki, Hiroshi Tsujioka, Yukari Sumi, Reiko Matsumoto, Mari Kiuchi, Yukari Utsugisawa, Masanori Maruyama, Hiroyuki Furumoto, Kazuhiro Minegishi, Masao Takane, Asuka Yoshii, T Yokokura, Hideki Hanashi, Sumie Yukawa
Abstract
A multicenter, randomized, open-label, phase III study was conducted to compare the efficacy and safety of intravenous ferric derisomaltose (FDI) versus saccharated ferric oxide (SFO) in Japanese patients with iron deficiency anemia associated with menorrhagia. FDI can be administered as a single dose up to 1000 mg, whereas SFO has a maximum single dose of 120 mg. The primary endpoint, which was the maximum change in hemoglobin concentration from baseline, was noninferior for the FDI group compared with the SFO group. The incidence of treatment-emergent adverse events was lower in the FDI group (66.2%) than in the SFO group (90.8%). Notably, the incidence of serum phosphorus level < 2.0 mg/dL was significantly lower in the FDI group (8.4%) than in the SFO group (83.2%), and severe hypophosphatemia (≤ 1.0 mg/dL) occurred in 6.7% of SFO‑treated patients compared with none in the FDI group. The percentage of patients who achieved the cumulative total iron dose during the 8-week treatment period was higher in the FDI group (92.8%) than in the SFO group (43.2%). The study met its primary endpoint, and also demonstrated the tolerability of a high dose of FDI per infusion, with a lower incidence of hypophosphatemia.