1.
Pharmacokinetic, Pharmacodynamic, and Safety Profiles of Ferric Carboxymaltose in Chinese Patients with Iron-deficiency Anemia.
Ding, Y, Zhu, X, Li, X, Zhang, H, Wu, M, Liu, J, Palmen, M, Roubert, B, Li, C
Clinical therapeutics. 2020;(2):276-285
Abstract
PURPOSE Iron deficiency (ID) is one of the most commonly known nutritional deficiencies and is considered the primary cause of anemia (iron-deficiency anemia). Ferric carboxymaltose (FCM), an intravenous iron preparation, has been widely used for >10 years for iron-deficiency anemia treatment worldwide because of its many advantages. METHODS This single-center, open-label, single dose escalation study in Chinese subjects was designed to assess the pharmacokinetic/pharmacodynamic parameters and safety of FCM in this population. The first 12 subjects received a 500-mg dose; after assessing safety data from the first 6 subjects in this cohort, another 12 subjects were assigned to the 1000-mg dose cohort. FINDINGS After an infusion of FCM over 15 min, a rapid dose-dependent increase in total serum iron levels was observed with a median Tmax of 30 min following the start of the infusion for both cohorts. The Cmax and AUC for the 1000-mg dose were ~1.8-fold (p = 0.2929) and 2.3-fold (p = 0.0318) those associated with the 500-mg dose, respectively. Mean terminal t1/2 values were 12.3 and 10.5 h for the 2 cohorts. The renal elimination of FCM was negligible (<0.1%). Increase in mean serum iron levels and ferritin concentrations showed dose dependency. Iron-binding capacity was transiently well utilized after dosing, as indicated by transferrin saturation >88% with 500-mg FCM and >90% with 1000-mg FCM. Hemoglobin levels did not show significant changes during the 7-day observation period, whereas mean reticulocyte counts significantly increased in both cohorts, suggesting activation of the hematopoietic system. FCM was well tolerated in these Chinese subjects. No new or unexpected treatment-emergent adverse events were attributable to FCM. IMPLICATIONS The pharmacokinetic/pharmacodynamic and safety profiles in Chinese subjects seemed comparable to those in white and Japanese populations. ChinaDrugTrials.org.cn identifier: CTR20160863.
2.
Markers of Iron Status Are Associated with Risk of Hyperuricemia among Chinese Adults: Nationwide Population-Based Study.
Li, X, He, T, Yu, K, Lu, Q, Alkasir, R, Guo, G, Xue, Y
Nutrients. 2018;(2)
Abstract
BACKGROUND Elevated serum uric acid (SUA) involved in iron metabolism, has been increasingly recognized as a risk factor for gout and cardiovascular diseases. The objective of this study was to examine the associations between markers of iron status with risk of hyperuricemia (HU) in Chinese adult population. METHODS Data were extracted from the 2009 wave of the China Health and Nutrition Survey, consisting of 7946 apparently healthy adults. Serum ferritin (SF), transferrin, soluble transferrin receptors (sTfR), hemoglobin (Hb), high-sensitivity C-reactive protein (hs-CRP), and SUA were measured. Diet was assessed with three consecutive 24 h recalls. Demographic characteristics, smoking status, alcohol consumption, and physical activities were investigated using a structured questionnaire. Multilevel mixed-effects models were constructed to estimate the associations of SF, transferrin, sTfR, and Hb with SUA and the risk of HU. RESULTS The crude prevalence of HU was 16.1%. SF, transferrin, and Hb levels were positively associated with SUA and the risk of HU after adjustment for cluster effects and potential confounders (all p-trend < 0.05). Compared with participants in the lowest quartile of SF, those in the highest quartile had significantly higher SUA concentrations (β = 0.899 mg/dL, 95% confidence interval (CI): 0.788, 1.010; p < 0.001) and higher risk of HU (odds ratio (OR) = 3.086, 95% CI: 2.450, 3.888; p < 0.001). Participants with the highest quartile of transferrin had significantly higher SUA concentrations (β = 0.488 mg/dL, 95% CI: 0.389, 0.587; p < 0.001) and higher risk of HU (OR: 1.900; 95% CI: 1.579, 2.286; p < 0.001) when compared with those with the lowest quartile. In male participants, those in the highest quartile of Hb had significantly higher risk of HU when compared to the reference group (OR: 1.401, 95% CI: 1.104, 1.777; p < 0.01); however, this association was not found in female participants (OR: 1.093; 95% CI: 0.821, 1.455; p = 0.544). CONCLUSION SF, transferrin, and Hb levels were positively associated with the risk of HU, and additional studies are needed to confirm the findings, as well as to elucidate their underlying mechanisms.