PMID- 32744704
OWN - NLM
STAT- MEDLINE
DCOM- 20210429
LR  - 20210429
IS  - 2284-0729 (Electronic)
IS  - 1128-3602 (Linking)
VI  - 24
IP  - 14
DP  - 2020 Jul
TI  - A pilot study on secondary anemia in "frailty" patients treated with Ferric 
      Sodium EDTA in combination with vitamin C, folic acid, copper gluconate, zinc 
      gluconate and selenomethionine: safety of treatment explored by HRV non-linear 
      analysis as predictive factor of cardiovascular tolerability.
PG  - 7776-7783
LID - 22280 [pii]
LID - 10.26355/eurrev_202007_22280 [doi]
AB  - OBJECTIVE: Iron deficiency anemia (IDA) in patients with heart disease is 
      correlated with decreased exercise capacity and poor health-related quality of 
      life, and predicts worse cardiovascular outcomes, especially for elderly 
      patients. IDA can worsen cardiac function that can be monitored with Heart Rate 
      Variability (HRV) analysis, providing important information about cardiac health. 
      In a recent study we explored the effect and the tolerability of the 
      administration of Ferric Sodium EDTA in combination with vitamin C, folic acid, 
      copper gluconate, zinc gluconate and selenomethionine (Ferachel Forte(R)) in 
      "frailty" patients with secondary anemia and low kidney failure, by analysing the 
      HRV frequency domain. The aim of the present study is the further confirmation of 
      the safety of the already evaluated intervention, by analysing non-linear domain 
      of HRV. PATIENTS AND METHODS: In this pilot study we enrolled 52 "frailty" 
      elderly patients, with a recent diagnosis of secondary anemia due to iron 
      deficiency, with Class II New York Heart Association (NYHA) hypertensive heart 
      disease, low kidney failure, and atherosclerosis. The patients were divided in 2 
      groups: Group A (N=23 patients) received oral administration of Ferric Sodium 
      EDTA in combination with vitamin C, folic acid, copper gluconate, zinc gluconate 
      and selenomethionine (Ferachel Forte(R)) 2 tabs/day, containing 60 mg of Fe3+, for 
      24 days; Group B (N=29 patients) received intravenous administration of ferrous 
      gluconate 63 mg/day added to saline solution, while they were hospitalized (15+/-5 
      days). We evaluated laboratory values of hemoglobin (Hb) and sideremia levels. 
      Furthermore, we measured ECG signals before and after treatment, using non-linear 
      analysis techniques. RESULTS: Both intravenous and oral treatments evaluated in 
      this study, were effective and safe about the cardiovascular risk in "frailty" 
      elderly patients, as resulted from non-linear HRV analysis. Efficacy results 
      showed that hemoglobin and sideremia levels after treatments are significantly 
      increased. The HRV non-linear analysis showed that all parameters evaluated, 
      except for the SD1 values in the Group A, were not affected by treatments, 
      confirming the absence of cardiovascular risk of the therapy. CONCLUSIONS: 
      Non-linear HRV evaluation confirmed that oral administration of Ferric Sodium 
      EDTA, in combination with vitamin C, folic acid, copper gluconate, zinc gluconate 
      and selenomethionine (Ferachel forte(R)) did not impact the cardiovascular risk, 
      without causing adverse events typically reported with other iron supplementation 
      therapies, both oral and intravenous.
FAU - Marchitto, N
AU  - Marchitto N
AD  - Alfredo Fiorini Hospital, Terracina, (Latina), Italy. 
      annalisa.curcio@merqurio.it.
FAU - Curcio, A
AU  - Curcio A
FAU - Iannarelli, N
AU  - Iannarelli N
FAU - Petrucci, A
AU  - Petrucci A
FAU - Romano, A
AU  - Romano A
FAU - Pironti, M
AU  - Pironti M
FAU - Paparello, P T
AU  - Paparello PT
FAU - Raimondi, G
AU  - Raimondi G
LA  - eng
PT  - Journal Article
PL  - Italy
TA  - Eur Rev Med Pharmacol Sci
JT  - European review for medical and pharmacological sciences
JID - 9717360
RN  - 0 (Drug Combinations)
RN  - 0 (Ferric Compounds)
RN  - 0 (Gluconates)
RN  - 0 (Iron Chelating Agents)
RN  - 935E97BOY8 (Folic Acid)
RN  - 964MRK2PEL (Selenomethionine)
RN  - 9G34HU7RV0 (Edetic Acid)
RN  - KJ3C78Y22Z (Fe(III)-EDTA)
RN  - PQ6CK8PD0R (Ascorbic Acid)
RN  - R4R8J0Q44B (gluconic acid)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Anemia, Iron-Deficiency/blood/complications/diagnosis/*drug therapy
MH  - Ascorbic Acid/adverse effects/*therapeutic use
MH  - Drug Combinations
MH  - Edetic Acid/adverse effects/therapeutic use
MH  - Female
MH  - Ferric Compounds/adverse effects/*therapeutic use
MH  - Folic Acid/adverse effects/*therapeutic use
MH  - Frail Elderly
MH  - Frailty/*complications/diagnosis/physiopathology
MH  - Gluconates/adverse effects/*therapeutic use
MH  - Heart Disease Risk Factors
MH  - Heart Diseases/*complications/diagnosis/physiopathology
MH  - Heart Rate/*drug effects
MH  - Humans
MH  - Iron Chelating Agents/adverse effects/*therapeutic use
MH  - Male
MH  - Pilot Projects
MH  - Renal Insufficiency/complications/diagnosis/physiopathology
MH  - Risk Assessment
MH  - Selenomethionine/adverse effects/*therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
EDAT- 2020/08/04 06:00
MHDA- 2021/04/30 06:00
CRDT- 2020/08/04 06:00
PHST- 2020/08/04 06:00 [entrez]
PHST- 2020/08/04 06:00 [pubmed]
PHST- 2021/04/30 06:00 [medline]
AID - 22280 [pii]
AID - 10.26355/eurrev_202007_22280 [doi]
PST - ppublish
SO  - Eur Rev Med Pharmacol Sci. 2020 Jul;24(14):7776-7783. doi: 
      10.26355/eurrev_202007_22280.