Rosano Giuseppe, Schiefke Ingolf, Göhring Udo-Michael, Fabien Vincent, Bonassi Stefano, Stein Jürgen
Department of Medical Sciences, IRCCS San Raffaele Pisana, 00166 Rome, Italy.
Department of Gastroenterology, Hepatology, Diabetology and Endocrinology, Klinikum St. Georg, 04129 Leipzig, Germany.
J Clin Med. 2020 Nov 6;9(11):3587. doi: 10.3390/jcm9113587.
Ferric carboxymaltose (FCM) has been shown to achieve rapid replenishment of iron stores and correction of anaemia in various populations with iron deficiency. A decrease in serum phosphate (PO) levels, which in most cases is asymptomatic, has been reported with IV iron preparations. Hypophosphataemia (HP) is a known adverse drug reaction with FCM. This post hoc pooled analysis investigates the frequency, duration, risk factors, and clinical signs of HP as reported in interventional clinical trials with FCM. Pooled data from subjects enrolled across 45 clinical trials in different therapy areas were included. A three-step adjudication process was utilised to identify adverse events of HP. Stratified analyses by therapy group and stepwise logistic regression analysis were used to identify predictors of HP. This pooled analysis confirms that FCM is associated with increased rates of serum PO lowering, but mean serum PO values were seen to recover at Week 4 and further recover at Week 8. Among all subjects receiving FCM therapy ( = 6879), 41.4% ( = 2847) reached a PO nadir value <2.5 mg/dL at any point on study and 0.7% ( = 49) reached a nadir <1 mg/dL. Although gastroenterology and women's health subjects were identified to be at higher risk, occurrence of severe HP (<1 mg/dL [0.3 mmol/L]) following FCM administration was not observed to be common among subjects in these studies. Furthermore, there was no correlation between laboratory serum PO values and the occurrence of reported adverse events related to low PO levels.
羧基麦芽糖铁（FCM）已被证明能在各类缺铁人群中快速补充铁储备并纠正贫血。静脉用铁制剂会导致血清磷酸盐（PO）水平下降，多数情况下并无症状。低磷血症（HP）是FCM已知的药物不良反应。这项事后汇总分析调查了在FCM干预性临床试验中报告的HP的发生频率、持续时间、风险因素及临床体征。纳入了来自不同治疗领域45项临床试验中受试者的汇总数据。采用三步判定流程来识别HP不良事件。通过治疗组进行分层分析以及逐步逻辑回归分析来识别HP的预测因素。这项汇总分析证实，FCM与血清PO降低率增加相关，但血清PO均值在第4周时有所恢复，并在第8周时进一步恢复。在所有接受FCM治疗的受试者（n = 6879）中，41.4%（n = 2847）在研究期间的任何时间点达到PO最低点值<2.5mg/dL，0.7%（n = 49）达到最低点<1mg/dL。尽管胃肠病学和女性健康领域的受试者被确定为风险较高，但在这些研究中，未观察到FCM给药后出现严重HP（<1mg/dL [0.3mmol/L]）在受试者中很常见。此外，实验室血清PO值与报告的与低PO水平相关的不良事件发生之间没有相关性。
