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Войти в исследования Clinical nutrition ESPEN · 2026
Characterizing clinical patterns and associated factors of zinc-induced copper deficiency: Insights from large-scale pharmacovigilance databases.
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Hiyama Yoko, Yamada Tomoyuki, Tomota Emi, Tomita Takashi, Furukawa Chisa, Nakamura Touko, Imai Hanano, Nagao Akiko, Sato Maki, Asada Mizuho, Goda Mitsuhiro, Ishizawa Keisuke, Matsuo Hiroaki
Аннотация
BACKGROUND & AIMS: Zinc-induced copper deficiency (ZICD) is a severe complication of zinc therapy; however, its reporting trends and associated patient characteristics remain unclear. This study aimed to identify clinical patterns and factors potentially associated with ZICD using large-scale pharmacovigilance databases.
METHODS: We retrospectively analyzed the Japanese Adverse Drug Event Report database (JADER) and performed a supplementary exploratory analysis using VigiBase. Adult patients receiving oral zinc were included. Multivariable logistic regression explored factors potentially associated with copper deficiency.
RESULTS: Among 2646 JADER patients, copper deficiency was reported in 100 (3.8%). Multivariable analysis indicated zinc dosage (per 1-mg/kg/day increase; adjusted reporting odds ratio [aROR], 3.51; 95% confidence interval (CI), 2.51-4.90), chronic kidney disease (CKD; aROR, 9.29; 95% CI, 5.88-14.67), advanced age (≥70 years; aROR, 1.93; 95% CI, 1.21-3.08), and female (aROR, 1.64; 95% CI, 1.06-2.52) as potential copper deficiency-associated factors, whereas acid suppressants were inversely associated. The median onset was 137 days, occurring earlier in patients with CKD than in those without (119.5 vs. 260 days). Among co-reports with copper deficiency, cytopenia was the predominant adverse event (JADER, 93%; VigiBase, 85%). In VigiBase, these reports were concentrated in the Western Pacific Region (93.5%), where a similar trend was observed for advanced age, but not for female.
CONCLUSIONS: Advanced age, CKD, and higher zinc dosages are potentially associated with ZICD. The geographical concentration of reports suggests reporting disparities contributing to a global under-recognition of this complication, necessitating continued international vigilance and rigorous copper and hematological monitoring during zinc therapy.
METHODS: We retrospectively analyzed the Japanese Adverse Drug Event Report database (JADER) and performed a supplementary exploratory analysis using VigiBase. Adult patients receiving oral zinc were included. Multivariable logistic regression explored factors potentially associated with copper deficiency.
RESULTS: Among 2646 JADER patients, copper deficiency was reported in 100 (3.8%). Multivariable analysis indicated zinc dosage (per 1-mg/kg/day increase; adjusted reporting odds ratio [aROR], 3.51; 95% confidence interval (CI), 2.51-4.90), chronic kidney disease (CKD; aROR, 9.29; 95% CI, 5.88-14.67), advanced age (≥70 years; aROR, 1.93; 95% CI, 1.21-3.08), and female (aROR, 1.64; 95% CI, 1.06-2.52) as potential copper deficiency-associated factors, whereas acid suppressants were inversely associated. The median onset was 137 days, occurring earlier in patients with CKD than in those without (119.5 vs. 260 days). Among co-reports with copper deficiency, cytopenia was the predominant adverse event (JADER, 93%; VigiBase, 85%). In VigiBase, these reports were concentrated in the Western Pacific Region (93.5%), where a similar trend was observed for advanced age, but not for female.
CONCLUSIONS: Advanced age, CKD, and higher zinc dosages are potentially associated with ZICD. The geographical concentration of reports suggests reporting disparities contributing to a global under-recognition of this complication, necessitating continued international vigilance and rigorous copper and hematological monitoring during zinc therapy.