Academic Unit of Bone Metabolism, The University of Sheffield, Sheffield, UK.
Metabolic Bone Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Osteoporos Int. 2022 Mar;33(3):737-744. doi: 10.1007/s00198-021-06160-6. Epub 2021 Oct 15.
Zoledronate could be contributing to the development of acute kidney injury in a small number of patients. Since estimated glomerular function (eGFR) is simpler to obtain and at least as good a predictor as creatinine clearance (CrCl), it should be used in everyday practice.
Zoledronate is widely used for the treatment of osteoporosis. A potential side effect is acute kidney injury (AKI). Advice from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in 2019 stated that CrCl and not estimated glomerular filtration rate (eGFR) should be used and that treatment should not be given if CrCl < 35 ml/min. The objective of this study was to compare our current method of assessing renal function (eGFR) with the method proposed by the MHRA (CrCl) for predicting AKI after zoledronate infusions.
The evaluation was performed at the Metabolic Bone Centre in Sheffield Teaching Hospitals, UK. Data on all the patients who had zoledronate from 1/09/2015 to 1/10/2020 were included.
Data on 4405 patients were retrieved (total number of infusions 7660). Creatinine in the 14 days post-infusion was available for a total of 969 infusions and AKI was observed within 14 days following 45 infusions (4.6%). One patient died due to pneumonia. One patient needed continued haemodialysis. Severe AKI (threefold in creatinine and/or eGFR < 15 ml/min/173 m) was observed within 1 year following 24 infusions. If the MHRA recommendations had been followed, 996 infusions with baseline CrCl < 35 ml/min would not have been given. Of these, follow-up data on serum creatinine within 14 days were available for 142 infusions, showing AKI in only four (2.8%). Logistic regression showed that both CrCl and eGFR were significant factors in predicting AKI within 14 days, but that the current recommended cut-off of CrCl 35 ml/min had poor sensitivity.
Since eGFR is at least as good a predictor of AKI as CrCl, and permits the treatment of more patients at high fracture risk, we recommend that eGFR is used to determine renal function for zoledronate treatment. We suggest that the infusion is given over 30 min in patients with eGFR < 50 ml/min/1.73 m.
唑来膦酸可导致少数患者发生急性肾损伤。由于估计肾小球滤过率(eGFR)更容易获得,并且至少与肌酐清除率(CrCl)一样是预测急性肾损伤(AKI)的良好指标,因此应在日常实践中使用。
唑来膦酸广泛用于骨质疏松症的治疗。其潜在的副作用是急性肾损伤(AKI)。2019 年,英国药品和保健产品监管局(MHRA)的建议指出,应使用 CrCl 而不是估计肾小球滤过率(eGFR),并且如果 CrCl < 35 ml/min,则不应给予治疗。本研究的目的是比较我们目前评估肾功能(eGFR)的方法与 MHRA 提出的方法(CrCl),以预测唑来膦酸输注后 AKI 的发生。
评估在英国谢菲尔德教学医院的代谢性骨病中心进行。纳入了 2015 年 9 月 1 日至 2020 年 10 月 1 日期间所有接受唑来膦酸治疗的患者的数据。
共检索到 4405 例患者的数据(输注总数为 7660 例)。输注后 14 天内可获得总共 969 次的肌酐数据,45 次输注后 14 天内观察到 AKI(4.6%)。1 例患者因肺炎死亡。1 例患者需要持续血液透析。24 次输注后 1 年内观察到严重 AKI(肌酐升高 3 倍和/或 eGFR < 15 ml/min/173 m)。如果遵循 MHRA 的建议,996 次基线 CrCl < 35 ml/min 的输注将不会进行。其中,142 次输注可获得输注后 14 天内的血清肌酐随访数据,仅发现 4 例(2.8%)出现 AKI。逻辑回归显示,CrCl 和 eGFR 均为预测 14 天内 AKI 的重要因素,但目前推荐的 CrCl 35 ml/min 的截断值敏感性较差。
由于 eGFR 至少与 CrCl 一样能很好地预测 AKI,并且可以治疗更多高骨折风险的患者,因此我们建议使用 eGFR 来确定唑来膦酸治疗的肾功能。我们建议在 eGFR < 50 ml/min/1.73 m 的患者中,将输注时间延长至 30 分钟以上。