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首页> 外文期刊>Journal of Clinical Medicine >A Pooled Analysis of Serum Phosphate Measurements and Potential Hypophosphataemia Events in 45 Interventional Trials with Ferric Carboxymaltose
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A Pooled Analysis of Serum Phosphate Measurements and Potential Hypophosphataemia Events in 45 Interventional Trials with Ferric Carboxymaltose

机译：用铁羧乙型糖尿病患者血清磷酸盐测量和潜在的脾磷血症事件的汇总分析

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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 4 3? ) 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 4 3? lowering, but mean serum PO 4 3? values were seen to recover at Week 4 and further recover at Week 8. Among all subjects receiving FCM therapy ( n = 6879), 41.4% ( n = 2847) reached a PO 4 3? nadir value 2.5 mg/dL at any point on study and 0.7% ( n = 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 4 3? values and the occurrence of reported adverse events related to low PO 4 3? levels.
机译：已经证明了铁碳织物（FCM）实现了在缺乏缺铁的各种群体中的铁储存和贫血矫正的快速补充。在大多数情况下，血清磷酸盐（PO 4 3 3→）水平降低，静脉制剂是无症状的。次磷酸血症（HP）是与FCM的已知不利药物反应。该后HOC汇总分析研究了HP的频率，持续时间，危险因素和临床症状，如介入临床试验中的FCM。包括来自不同治疗区域的45项临床试验的受试者的汇集数据。利用三步判决过程来识别HP的不良事件。通过治疗组分层分析和逐步逻辑回归分析用于识别HP的预测因子。这种汇总的分析证实，FCM与血清PO 4 3的速率增加有关？降低，但意味着血清PO 4 3？观察到第4周恢复的值，并在第8周进一步恢复。在接受FCM治疗的所有受试者中，41.4％（n = 2847）达到PO 4 3？ Nadir值<2.5mg / dl在研究的任何点和0.7％（n = 49）达到Nadir <1 mg / d1。虽然胃肠学和女性的健康受试者被鉴定为较高的风险，但在这些研究中的受试者中未观察到FCM给药后的严重HP（<1mg / dl [0.3mmol / L]）的发生。此外，实验室血清PO 4 3之间没有相关性？价值观和报告与低PO 4 3相关的不良事件的发生？水平。

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