Ferrous citrate 62mg tablets

ObjectiveTo evaluate the efficacy and safety of 12 phosphorus-lowering drugs for hyperphosphatemia in chronic kidney disease 3-5 stages.Study design & methodsSystematic review and network meta-analysis of randomized controlled trials (RCTs). We searched 3 databases from inception through September 2023 for RCTs evaluating 12 phosphorus-lowering drugs. We performed frequentist random-effects network meta-analyses and present mean differences and 95% CIs. Subgroup analyses were performed between the dialysis and nondialysis patients to assess robustness, source of heterogeneity, and risk of bias using the Cochrane risk of bias assessment tool.ResultsWe included 121 trials (18,376 participants) and compared 13 drugs or placebo. In terms of efficacy, except for sodium ferrous citrate, all drugs lowered the level of serum phosphorus compared with placebo. Sucroferric oxyhydroxide (PA21), nicotinic acid, and tenapanor were most likely to be ranked the best, second best, or third best. Calcium/magnesium carbonate, nicotinic acid, and colestilan posed lower risks for hypercalcemia than calcium-based phosphorus binders. All phosphorus-lowering drugs significantly affect serum intact parathyroid hormone levels compared with placebo. Colestilan, tenapanor, and PA21 posed a higher risk for gastrointestinal discomfort. In addition, iron-containing drugs showed positive effects on iron parameters.LimitationsFew high-quality RCTs; unclear allocation concealment and blinding; low evidence quality reduced reliability.ConclusionsPA21 has the best phosphorus-lowering effect in hyperphosphatemic adults with chronic kidney disease; considering efficacy and safety, calcium carbonate shows evidence of being the most appropriate drug with or without dialysis.RegistrationRegistered at PROSPERO (CRD42024500243).

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Objective: To evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride/sodium ferrous citrate (5-ALA-HCl/SFC) in patients with adult-onset Still’s disease (AOSD) refractory to corticosteroids. Methods/design: This multicenter, investigator-initiated, randomized, double-blind, placebo-controlled, parallel-group phase II trial was designed to enroll 30 participants but was prematurely terminated after enrolling four participants because of slow recruitment. Participants were randomized to receive 5-ALA-HCl/SFC (100 or 300 mg/day) or placebo for 8 weeks. The primary endpoint was the achievement of adapted ACR 30 at week 4. Results: All four enrolled participants achieved adapted ACR 30 at week 4. Adapted ACR 50/ 70/ 90 responses and improvements in systemic feature score, serum ferritin, and quality of life varied among individuals. No serious adverse events were observed. Conclusion: Efficacy signals were observed, especially in the high-dose group; however, the small sample size precludes definitive conclusions. Further research is required to confirm this.

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ObjectiveA phase III, double-blind, placebo-controlled, randomized withdrawal trial of SPP‑004 (5‑aminolevulinic acid hydrochloride and sodium ferrous citrate) was conducted to confirm the efficacy and safety of SPP-004 for maintenance of clinical response in patients diagnosed with Leigh syndrome (LS) showing central nervous system disorders.MethodsFifty-four patients entered a 24-week open-label period of SPP-004 administration. Among them, 28 patients who showed improvement on the Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) for cranial nervous symptoms and myopathy symptoms proceeded to a 48-week double-blind (DB) period, where they were randomized (1:1) to receive SPP‑004 or placebo (n = 14 each). Efficacy was evaluated using NPMDS for the full analysis set (FAS) during the DB‑period (SPP-004 n = 13, Placebo n = 14) and the entire study period (n = 54). Safety evaluation focused on adverse events (AEs) in all 54 patients administered SPP-004.ResultsThe primary endpoint, the proportion of patients who discontinued due to inadequate efficacy at 48 weeks, was lower in the SPP-004 group (15.4% [95% CI: 1.9-45.4%]) compared to the placebo group (50.0% [23.0-77.0%]). Over 80% of the SPP-004 group showed maintained efficacy (p = 0.0486). All adverse drug reactions were mild, with no notable differences in AEs between groups.ConclusionThese findings suggest that SPP-004 is safe and may provide therapeutic effect for LS patients who achieved an initial clinical response.

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Objective A phase III, double-blind, placebo-controlled, randomized withdrawal trial of SPP-004 (5-aminolevulinic acid hydrochloride and sodium ferrous citrate) in patients diagnosed as Leigh syndrome (LS) was conducted to confirm the efficacy and safety of SPP-004 in patients with LS showing central nervous system disorders. Methods Fifty-four patients entered a 24-week open-label period of SPP-004 administration. Among them, 28 patients showing improved scores on the Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) for cranial nervous symptoms and myopathy symptoms proceeded to a 48-week double-blind (DB) period, where they were randomized (1:1) to receive SPP-004 or placebo ( n =14 each). Efficacy was evaluated using NPMDS for the full analysis set (FAS) during the DB-period (SPP-004 n =13, Placebo n =14) and the entire study period ( n =54). Safety evaluation focused on adverse events (AEs) in all 54 patients administered SPP-004. Results The primary endpoint, the proportion of patients who discontinued due to inadequate efficacy at 48 weeks, was lower in the SPP-004 group (15.4% [95% CI: 1.9-45.4%]) compared to the placebo group (50.0% [23.0-77.0%]). Over 80% of the SPP-004 group maintained efficacy (p=0.0486). All adverse drug reactions were mild, with no notable differences in AEs between groups. Conclusion These findings suggest that SPP-004 is safe and may provide therapeutic effect for LS symptoms.

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Background/Objectives: Iron deficiency (ID) is the most common nutritional disorder in childhood worldwide. It has profound consequences for growth, neurodevelopment, behaviour, and overall health. Despite the long-standing efficacy of oral ferrous salts, their poor gastrointestinal tolerability and adherence challenges have spurred the development of alternative formulations and innovative dosing strategies. Methods: We conducted a narrative review of national and international guidelines, pediatric randomized controlled trials, observational and cohort studies, cost-effectiveness analyses, diagnostic method papers, and reviews, with emphasis on diagnostic innovations, therapeutic outcomes, tolerability, and formulation-specific efficacy. Results: Ferrous salts remain the gold standard for efficacy, low cost, and guideline endorsement, but up to 40% of children experience GI intolerance. Therefore, a lower dosage of ferrous salts has been proposed for IDA as still being an efficacious and better-tolerated schedule. Also, alternate-day dosing improves absorption and tolerability and is supported by a recent pediatric RCT. Newer formulations-ferric polymaltose, ferrous bisglycinate, co-processed bisglycinate with alginate (Feralgine™), and vesicular encapsulated forms such as sucrosomial and liposomal ferric pyrophosphate-showed improved tolerability and palatability, supporting adherence with hematologic outcomes comparable to ferrous salts, particularly in children with intolerance, malabsorption, or inflammatory comorbidities. Intravenous iron is effective and safe with modern preparations and is reserved for severe anemia, malabsorption, or oral therapy failure. Conclusions: Oral ferrous salts should remain the first-line therapy in pediatric ID/IDA. Future pediatric trials should prioritize head-to-head comparisons of formulations, hepcidin-guided dosing, and patient-centred outcomes, including neurocognitive trajectories and quality of life.

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