A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose,International Journal of Clinical Pharmacy

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A systematic literature review and meta-analysis of the incidence of serious or severe hypersensitivity reactions after administration of ferric derisomaltose or ferric carboxymaltose
International Journal of Clinical Pharmacy ( IF 2.6 ) Pub Date : 2023-04-03 , DOI: 10.1007/s11096-023-01548-2
Nicholas A Kennedy ₁ , Maureen M Achebe ₂ , Patrick Biggar ₃ , Johannes Pöhlmann ₄ , Richard F Pollock ₄

Affiliation

Background

Intravenous iron is the preferred treatment for patients with iron deficiency anemia in a variety of clinical situations. Although uncommon, administration of modern IV iron formulations can result in hypersensitivity reactions (HSRs) and, rarely, anaphylactic or anaphylactoid reactions.

Aim

The objective of the present study was to systematically review the literature to identify and analyze data on the incidence of HSRs after administration of ferric derisomaltose (FDI) or ferric carboxymaltose (FCM).

Method

A prospectively-registered systematic literature review was conducted to identify prospective randomized controlled trials comparing FDI and FCM with other intravenous iron formulations or oral iron. Searches were conducted in PubMed (including MEDLINE), EMBASE, and the Cochrane Library in November 2020. The relative incidence of serious or severe HSRs occurring on the day or day after dosing of intravenous iron, recorded under the standardized Medical Dictionary for Regulatory Activities query for anaphylactic reaction.

Results

Data were obtained from seven randomized controlled trials of FCM (N = 2683) and ten of FDI (N = 3474) enrolling 10,467 patients in total. The number of patients experiencing any serious or severe HSR event was 29/2683 (1.08%) with FCM versus 5/3474 with FDI (0.14%). Bayesian inference of proportions showed the event rates to be significantly lower with FDI relative to FCM.

Conclusion

HSR events were uncommon with both intravenous iron formulations; however, the present study showed a significantly lower incidence of HSRs with FDI relative to FCM. Further large-scale, head-to-head trials of the iron formulations would be required to confirm this finding.

中文翻译：

一项系统的文献综述和荟萃分析，说明服用脱异麦芽糖铁或羧基麦芽糖铁后严重或重度超敏反应的发生率

背景

在各种临床情况下，静脉补铁是缺铁性贫血患者的首选治疗方法。尽管不常见，但现代静脉注射铁制剂的给药可导致超敏反应 (HSR)，并且在极少数情况下会导致过敏反应或类过敏反应。

目的

本研究的目的是系统地回顾文献，以确定和分析给予脱异麦芽糖铁 (FDI) 或羧基麦芽糖铁 (FCM) 后 HSR 发生率的数据。

方法

进行了一项前瞻性注册的系统文献综述，以确定将 FDI 和 FCM 与其他静脉铁剂或口服铁剂进行比较的前瞻性随机对照试验。于 2020 年 11 月在 PubMed（包括 MEDLINE）、EMBASE 和 Cochrane 图书馆中进行了搜索。在标准化医学词典中记录了在静脉注射铁剂给药后当天或第二天发生的严重或严重 HSR 的相对发生率，用于监管活动查询用于过敏反应。

结果

数据来自 7 项 FCM 随机对照试验 (N = 2683) 和 10 项 FDI (N = 3474)，共纳入 10,467 名患者。经历任何严重或严重 HSR 事件的患者人数在 FCM 中为 29/2683 (1.08%)，在 FDI 中为 5/3474 (0.14%)。比例的贝叶斯推断表明，与 FCM 相比，FDI 的事件发生率要低得多。