Assessment of the safety and efficacy of micronized encapsulated ferric pyrophosphate in patients with iron deficiency anaemia: a phase-IV open-label clinical study.

An open-level, single-arm, phase-4 clinical trial was carried out to assess the safety and potential benefits of micronized coated ferric pyrophosphate (MEFP) in patients with iron deficiency anaemia (IDA). For 12 weeks, 60 patients between the ages of 18 and 60 with moderate IDA were randomly received MEFP by PO daily. The efficacy endpoints as haemoglobin levels, mean corpuscular haemoglobin (MCH), mean cell haemoglobin concentration (MCHC), packed cell volume (PCV), red blood cell count (RBC), serum ferritin and transferrin saturation (%) were measured. Adverse event reports and physical examinations were performed as a measure of safety assessment. The results revealed that haemoglobin, MCV, MCHC, serum ferritin, transferrin saturation (%), PCV and RBC increased significantly from baseline. Fewer occurrences were observed in a few patients, and their adverse events were minimal. There was no adverse effect on liver or renal functions. Few minor improvements were noticed at the completion of the study. In conclusion, MEFP appears to be effective in IDA and well tolerated, with a favourable safety profile. MEFP is an effective, safe therapeutic alternative in IDA subjects for increasing haemoglobin concentration and iron stores along with improvement of symptoms related to anaemia.