Quality -of-life scores ( Piper Fatigue Scale MD 0.73 , 95 % CI 0.29 to 1.18 ; I2 = 0 % ; studies = 3 ) and peak oxygen consumption ( MD 2.77 mL/kg/min , 95 % CI -0.89 to 6.43 ; I2 = 36 % ; 2 studies , 32 participants ) were associated with very low- quality evidence , and we remain uncertain about the role of intravenous iron for these metrics .
Current evidence is insufficient to show benefit of intravenous iron preparations for the treatment of non-anaemic iron deficiency across a variety of patient population s , beyond stating that it may result in a small , clinical ly insignificant increase in haemoglobin concentration .
BACKGROUND Iron deficiency is one of the most common nutritional deficiencies , and has a number of physiological manifestations .
Early , or non-anaemic iron deficiency can result in fatigue and diminished exercise capacity .
Oral iron preparations have a high incidence of intolerable side effects , and are ineffective in certain forms of iron deficiency .
Consequently , intravenous iron preparations are increasingly used in the treatment of non-anaemic iron deficiency .
The newer , more stable iron preparations in particular purport to have a lower incidence of side effects , and are now used across a range of different patient population s. OBJECTIVES To assess the effects of intravenous iron therapy in the treatment of adults with non-anaemic iron deficiency .
Sodium ferric gluconate (SFG) in complex with sucrose for IV infusion: bioequivalence of a new generic product with the branded product in healthy volunteers
Abstract Objective : Parenteral sodium ferric gluconate in complex ( Ferrlecit [ br and ed SFG ] ) is used to treat patients with iron deficiency anemia undergoing chronic hemodialysis and receiving supplemental epoetin . This comparative pharmacokinetic study ( GeneraMedix , Inc. , Study 17909 ) evaluates whether the recently approved generic product Nulecit ( generic SFG ) and the br and ed product Ferrlecit ( br and ed SFG ) are bioequivalent . Methods : In this open-label study , 240 healthy volunteers in a fasting state were assigned r and omly to a single 10-min intravenous ( IV ) infusion of 125 mg of generic or br and ed SFG .  Total and transferrin-bound iron concentrations were determined for the 36-h period after infusion and corrected for pretreatment levels . Maximum concentration ( Cmax ) and area under the concentration – time curve of 0 to 36 h ( AUC[0–36 ] ) were compared between the two products . Demonstration of bioequivalence required that the 90 % confidence intervals of each parameter evaluated for generic SFG were within 80 % to 125 % of the corresponding values for br and ed SFG . Results : Uncorrected and baseline-corrected mean serum concentrations of total serum iron during the 36-h assessment period were similar for generic and br and ed SFG . For total serum iron , the geometric mean ratios of corrected Cmax and AUC[0–36 ] were 100 % . For transferrin-bound iron , the geometric mean ratios were 87 % for corrected Cmax and 92 % for corrected AUC[0–36 ] . All associated 90 % confidence intervals were within the range of 80 % to 125 % . Conclusions : A new generic SFG in complex for IV infusion is bioequivalent to the br and ed SFG in complex for IV infusion . The generic SFG is AB rated by the FDA and considered therapeutically equivalent to the br and ed product
Quality -of-life scores ( Piper Fatigue Scale MD 0.73 , 95 % CI 0.29 to 1.18 ; I2 = 0 % ; studies = 3 ) and peak oxygen consumption ( MD 2.77 mL/kg/min , 95 % CI -0.89 to 6.43 ; I2 = 36 % ; 2 studies , 32 participants ) were associated with very low- quality evidence , and we remain uncertain about the role of intravenous iron for these metrics .
Current evidence is insufficient to show benefit of intravenous iron preparations for the treatment of non-anaemic iron deficiency across a variety of patient population s , beyond stating that it may result in a small , clinical ly insignificant increase in haemoglobin concentration .
BACKGROUND Iron deficiency is one of the most common nutritional deficiencies , and has a number of physiological manifestations .
Early , or non-anaemic iron deficiency can result in fatigue and diminished exercise capacity .
Oral iron preparations have a high incidence of intolerable side effects , and are ineffective in certain forms of iron deficiency .
Consequently , intravenous iron preparations are increasingly used in the treatment of non-anaemic iron deficiency .
The newer , more stable iron preparations in particular purport to have a lower incidence of side effects , and are now used across a range of different patient population s. OBJECTIVES To assess the effects of intravenous iron therapy in the treatment of adults with non-anaemic iron deficiency .