Discussion
ADVERSE EFFECT
The ACCESS trial showed that the new formulation of Fe-ASP was non-inferior to the traditional oral iron supplementation with FeSOIron supplementation is the mainstay of the management of IDA. Oral FeSOWith the studied formulation of conjugated iron Fe-ASP, it is anticipated that iron is converted to a smaller extent in the stomach into insoluble salts. In this way, more iron reaches the duodenum to become absorbed whereas GI side effects are less often. The current study did not show any major impact of the use of this formulation on the GI adverse effect. There are four clinical studies in a small patient population where Fe-ASP was prospectively administered for 15 to 60 days in patients with IDA. Efficacy was compared to patients treated with ferrous gluconate. In three of these studies, concentrations of hemoglobin (Hb) in blood were greater at the end of treatment with Fe-ASP than with ferrous gluconate. However, oral Fe-ASP supplementation had superior GI tolerability in 96.6% of treated patients compared to 89.2% of patients treated with comparator formulations [The current study has one main strength and three limitations. The main strength is the pragmatic nature of the trial. Study participants were relatively aged (mean age of both groups above 60 years) with substantial comorbidities. Enrolment was done using strict criteria of substantial decrease of Hb, RBC count, and ferritin. It may be conceived that a study investigating the effect of oral iron supplementation should enroll younger people without comorbidities and pregnant women all of which do not present with limitations of iron absorption. However, study participants have the characteristics of patients routinely managed in the clinical setting. The main study limitations are the single-center design and the limited number of participants. Although the study was powered for non-inferiority, the superior efficacy of Fe-ASP over FeSOACCESS is the most recent clinical trial which is evaluating the treatment efficacy of one Fe-ASP formulation in IDA. Fe-ASP was not inferior to FeSO