袢利尿剂对骨质疏松症中地诺单抗诱导的低钙血症的影响：一项回顾性观察分析。
Influence of loop diuretics on denosumab-induced hypocalcaemia in osteoporosis: a retrospective observational analysis.
作者信息
Hirai Toshinori, Mori Yukari, Ogura Toru, Kondo Yuki, Sakazaki Yuka, Ishitsuka Yoichi, Sudo Akihiro, Iwamoto Takuya
机构信息
Department of Pharmacy, Faculty of Medicine, Mie University Hospital, Mie University, 2-174 Edobashi, Tsu, Mie, 514-8507, Japan.
Department of Pharmacy, Tokyo Medical and Dental University Hospital, Tokyo Medical and Dental University (TMDU), 1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan.
出版信息
J Pharm Health Care Sci. 2024 Sep 27;10(1):60. doi: 10.1186/s40780-024-00380-8.
BACKGROUND
We examined whether denosumab-induced hypocalcaemia is evident in osteoporosis when given loop diuretics that promote urinary calcium excretion.
METHODS
Japanese Spontaneous Adverse Drug Event Reports was analyzed to examine signals for denosumab-induced hypocalcaemia co-administered loop diuretics. We retrospectively included osteoporotic patients to detect predictors for denosumab-induced hypocalcaemia (corrected calcium level < 8.5 mg/dL) using multivariate logistic regression analysis. We compared differences in corrected calcium levels (ΔCa = nadir-baseline).
RESULTS
A significant signal for hypocalcaemia was detected (Reporting odds ratio = 865.8, 95% confidence interval [95% CI]: 596.8 to 1255.9, p < 0.0001). Among 164 patients (hypocalcaemia, 12%), loop diuretics have a significant association with hypocalcaemia (odds ratio [OR] = 6.410, 95% CI: 1.005 to 40.90, p = 0.0494). However, hypocalcaemia was found to be lower in high corrected calcium levels at baseline (OR = 0.032, 95% CI: 0.005 to 0.209, p < 0.0001) and calcium and vitamin D supplementation (OR = 0.285, 95% CI: 0.094 to 0.868, p = 0.0270). In the non-hypocalcaemia, ΔCa decreased significantly in the denosumab plus loop diuretics than in the denosumab alone (-0.9 [-1.3 to -0.7] mg/dL vs. -0.5 [-0.8 to -0.3] mg/dL, p = 0.0156). However, ΔCa remained comparable in the hypocalcaemia despite loop diuretics co-administration (-1.0 [-1.2 to -0.8] mg/dL vs. -0.8 [-1.5 to -0.7] mg/dL, p = 0.7904).
CONCLUSIONS
Loop diuretics may predispose to developing denosumab-induced hypocalcaemia.
背景
我们研究了在使用促进尿钙排泄的袢利尿剂时，地诺单抗诱导的低钙血症在骨质疏松症患者中是否明显。
方法
分析日本自发药品不良事件报告，以研究地诺单抗与袢利尿剂联合使用时诱导低钙血症的信号。我们回顾性纳入骨质疏松症患者，使用多因素逻辑回归分析检测地诺单抗诱导低钙血症（校正钙水平<8.5mg/dL）的预测因素。我们比较了校正钙水平的差异（ΔCa=最低点-基线）。
结果
检测到低钙血症的显著信号（报告比值比=865.8，95%置信区间[95%CI]：596.8至1255.9，p<0.0001）。在164例患者中（低钙血症患者占12%），袢利尿剂与低钙血症有显著关联（比值比[OR]=6.410，95%CI：1.005至40.90，p=0.0494）。然而，发现基线校正钙水平高时低钙血症发生率较低（OR=0.032，95%CI：0.005至0.209，p<0.0001），以及补充钙和维生素D时低钙血症发生率也较低（OR=0.285，95%CI：0.094至0.868，p=0.0270）。在非低钙血症患者中，地诺单抗加袢利尿剂组的ΔCa较地诺单抗单药组显著降低（-0.9[-1.3至-0.7]mg/dL对-0.5[-0.8至-0.3]mg/dL，p=0.0156）。然而，尽管联合使用袢利尿剂，低钙血症患者的ΔCa仍相当（-1.0[-1.2至-0.8]mg/dL对-0.8[-1.5至-0.7]mg/dL，p=0.7904）。
结论
袢利尿剂可能易导致地诺单抗诱导的低钙血症发生。
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