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Ibandronate provides efficacy and safety in the treatment of metastatic bone disease

机译:伊班膦酸在转移性骨疾病的治疗中提供功效和安全性

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For patients with metastatic bone disease, preventing disease complications and palliating symptoms are the primary treatment goals. It is therefore essential that a bisphosphonate treatment has proven efficacy in preventing skeletal-related events (SREs). In addition, because patients with advanced cancer have a considerable disease burden and may be experiencing serious treatment-related adverse events (AEs), safety and tolerability should be considered when selecting a bisphosphonate. Ibandronate is a single-nitrogen, noncyclic bisphosphonate available in intravenous and oral formulations. In phase III placebo-controlled trials, both formulations provided similar risk reductions for SREs. In a recent study, ibandronate was at least as effective as zoledronic acid in decreasing serum and urine levels of bone markers (prognostic indicators of SREs). There are important differences in safety and tolerability between ibandronate and zoledronic acid. In comparative studies, ibandronate was associated with a markedly lower incidence of acute-phase reaction AEs than zoledronic acid. Intravenous ibandronate demonstrated a renal safety profile comparable to that of placebo in phase III, whereas there have been numerous reports of renal toxicity or renal failure with zoledronic acid use in clinical practice. The superior renal safety of ibandronate allows high-dose administration over consecutive days (loading dose) for rapid relief of metastatic bone pain. A registration study is currently under way to demonstrate the safety of 15-min ibandronate infusions. Overall, ibandronate has excellent efficacy and safety profiles. Ibandronate use could potentially reduce the incidence of some bisphosphonate-associated AEs among patients with metastatic bone disease.
机译:对于患有转移性骨病的患者,预防疾病并发症和姑息症状是主要的治疗目标。因此,至关重要的是,已证明双膦酸盐治疗具有预防骨骼相关事件(SRE)的功效。此外,由于晚期癌症患者的疾病负担很大,并且可能正在经历与治疗相关的严重不良事件(AE),因此在选择双膦酸盐时应考虑安全性和耐受性。伊班膦酸盐是单氮,非环状双膦酸盐,可静脉内和口服使用。在III期安慰剂对照试验中,两种制剂均可降低SRE的风险。在最近的一项研究中,伊班膦酸在降低血清和尿液中骨标志物(SRE的预后指标)方面至少与唑来膦酸一样有效。伊班膦酸和唑来膦酸在安全性和耐受性方面存在重要差异。在比较研究中,伊班膦酸与急性阶段反应不良事件的发生率显着低于唑来膦酸。静脉注射伊班膦酸在第三阶段中显示出与安慰剂相当的肾脏安全性,而在临床实践中有许多关于使用唑来膦酸的肾脏毒性或肾功能衰竭的报道。伊班膦酸的优越肾脏安全性允许连续几天大剂量给药(负荷剂量),以快速缓解转移性骨痛。目前正在进行一项注册研究,以证明15分钟伊班膦酸盐输注的安全性。总体而言,伊班膦酸盐具有出色的疗效和安全性。在患有转移性骨病的患者中,伊班膦酸的使用可能会降低某些与双膦酸盐有关的AE的发生率。

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