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Meta-Analysis
. 2022 Oct;39(10):4678-4691.
doi: 10.1007/s12325-022-02242-x. Epub 2022 Aug 10.

A Systematic Review, Meta-Analysis, and Indirect Comparison of Blindly Adjudicated Cardiovascular Event Incidence with Ferric Derisomaltose, Ferric Carboxymaltose, and Iron Sucrose

Richard F Pollock  1 , Philip A Kalra  2 , Paul R Kalra  3   4 , Fozia Z Ahmed  5   6
Affiliations
Meta-Analysis

A Systematic Review, Meta-Analysis, and Indirect Comparison of Blindly Adjudicated Cardiovascular Event Incidence with Ferric Derisomaltose, Ferric Carboxymaltose, and Iron Sucrose

Richard F Pollock et al. Adv Ther. 2022 Oct.

Abstract

Introduction: Intravenous (IV) iron is the preferred treatment for patients with iron deficiency anemia (IDA) who require rapid replenishment of iron stores or in whom oral iron is not tolerated or effective. Data from two large-scale randomized controlled trials (RCTs) have recently been published reporting the incidence of adjudicated cardiovascular events after ferric derisomaltose (FDI) and iron sucrose (IS). The objective was to calculate the relative incidence of cardiovascular events with FDI and IS, and to conduct an indirect comparison with ferric carboxymaltose (FCM) based on previously published studies of cardiovascular risk.

Methods: RCTs reporting the incidence of blindly adjudicated cardiovascular events in IDA patients treated with IV iron were identified by systematic literature review (SLR). Pairwise random effects meta-analyses of FDI versus IS, and FCM versus IS were conducted for the pre-specified adjudicated composite cardiovascular endpoint of: death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, congestive heart failure, arrhythmia, and protocol-defined hypertensive and hypotensive events. Analyses were also conducted for the composite endpoint excluding blood pressure events. Meta-analysis results were combined in an adjusted indirect comparison to provide an indirect estimate of cardiovascular risk with FDI versus FCM.

Results: The SLR retrieved 694 unique articles, of which four were RCTs reporting the incidence of the composite cardiovascular endpoint; two studies comparing FCM (N = 1529) with IS (N = 1505), and two studies comparing FDI (N = 2008) with IS (N = 1000). The odds ratios of the composite CV endpoint were 0.59 (95% confidence interval: 0.39-0.90) for FDI versus IS, 1.12 (95% CI 0.90-1.40) for FCM versus IS, and the indirect OR for FDI versus FCM was 0.53 (95% CI 0.33-0.85).

Conclusions: Pooling data from four large-scale RCTs suggested that FDI was associated with significantly lower incidence of cardiovascular adverse events compared to both FCM and IS.

Keywords: Administration; Cardiovascular diseases; Intravenous; Iron; Iron deficiency anemia.

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Figures

Fig. 1
Fig. 1
Fixed and random effects meta-analyses of data from randomized controlled trials comparing the incidence of the composite adjudicated cardiovascular endpoint with A ferric derisomaltose versus iron sucrose, and B ferric carboxymaltose versus iron sucrose
Fig. 2
Fig. 2
Forest plot of results from sensitivity analyses around the indirect comparison. CI confidence interval, CKD chronic kidney disease, FCM ferric carboxymaltose, FDI ferric derisomaltose, IS iron sucrose, OR odds ratio
Fig. 3
Fig. 3
Summary of odds ratios from the random effects meta-analyses of ferric derisomaltose and ferric carboxymaltose versus iron sucrose, and the indirect treatment comparison of ferric derisomaltose and ferric carboxymaltose for A the composite cardiovascular endpoint and B the composite cardiovascular endpoint excluding hypotension and hypertension. CI confidence interval, FCM ferric carboxymaltose, FDI ferric derisomaltose, IS iron sucrose, OR odds ratio
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