The Interaction of Acute-Phase Reaction and Efficacy for Osteoporosis After Zoledronic Acid: HORIZON Pivotal Fracture Trial.
The Interaction of Acute-Phase Reaction and Efficacy for Osteoporosis After Zoledronic Acid: HORIZON Pivotal Fracture Trial.
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DOI：
10.1002/jbmr.4434
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发表时间：
2022-01
影响因子：
6.2
通讯作者：
Cauley, Jane A.
中科院分区：
文献类型：
--
作者：
Black, Dennis M.;Reid, Ian R.;Napoli, Nicola;Ewing, Susan K.;Shiraki, Masataka;Nakamura, Toshitaka;Takeuchi, Yasuhiro;Schafer, Anne L.;Kim, Tiffany Y.;Cauley, Jane A.
唑来膦酸(ZOL)作为每年一次的输液在降低骨折风险方面是有效的。急性时相反应(APR)是常见的，由输液后3天内出现流感样症状组成。这项分析的目的是调查APR的发生是否会影响药物疗效。这项分析使用了为期3年的随机临床试验、健康结果和使用唑来膦酸每年一次的枢轴骨折减少试验(Horizon-PFT)的数据。首次注射后3天内的不良反应被确认为不良反应，ZOL的发生率高于安慰剂。为了比较服用ZOL和服用安慰剂3年后的平均骨密度变化，对有无APR的妇女进行了t检验。采用Logistic回归分析APR的发生与椎体形态骨折发生率之间的关系。用COX回归分析有无APR的女性发生非椎体骨折和髋部骨折的风险。Logistic和COX模型被用来确定ZOL与安慰剂在有和没有APR的妇女中发生骨折的风险。这项分析包括3862名服用ZOL的女性和3852名服用安慰剂的女性，其中42.4%的服用ZOL的女性经历了APR，而服用安慰剂的女性有11.8%经历了APR。ZOL组和安慰剂组的平均骨密度变化在有APR和没有APR的女性中的差异是相似的(均P交互作用&>0.10)。在ZOL女性中，有APR的女性比没有APR的女性脊柱骨折风险低51%(优势比[OR]=0.49，p<；0.001)。非椎体骨折和髋部骨折也有相似但不显著的趋势(相对风险[RH]=0.82，p=0.10；RH=0.70，p=0.22)。在有APR的女性中，与治疗相关的脊椎骨折风险的降低(OR=0.19)比没有APR的女性(OR=0.38)更大(p交互作用=0.01)。我们的结果表明，经历过APR的开始使用ZOL的女性在使用ZOL时将有更大的脊柱骨折风险降低。
Zoledronic acid (ZOL) as a yearly infusion is effective in reducing fracture risk. An acute-phase reaction (APR), consisting of flu-like symptoms within 3 days after infusion, is commonly seen. The objective of this analysis was to investigate whether APR occurrence influences drug efficacy. This analysis uses data from the 3-year randomized clinical trial, Health Outcomes and Reduced Incidence with Zoledronic Acid Once Yearly-Pivotal Fracture Trial (HORIZON-PFT). APRs were identified as adverse events within 3 days of first infusion with higher frequency in ZOL than placebo. To compare mean 3-year change in bone mineral density (BMD) in ZOL versus placebo, among women with and without APR, t tests were used. Logistic regression was used to examine the relationship between APR occurrence and odds of incident morphometric vertebral fracture. Cox regression was used to determine the risk of nonvertebral and hip fractures for women with versus without APR. Logistic and Cox models were used to determine the risk of incident fracture in ZOL versus placebo for women with and without an APR. The analysis included 3862 women in the ZOL group and 3852 in placebo, with 42.4% in ZOL versus 11.8% in placebo experiencing an APR. The difference in BMD mean change for ZOL versus placebo was similar for women with and without an APR (all p interaction >0.10). Among ZOL women, those with APR had 51% lower vertebral fracture risk than those without (odds ratio [OR] = 0.49, p < 0.001). A similar but nonsignificant trend was observed for nonvertebral and hip fracture (relative hazard [RH] = 0.82, p = 0.10; RH = 0.70, p = 0.22, respectively). There was a greater treatment-related reduction in vertebral fracture risk among women with APR (OR = 0.19) than those without (OR = 0.38) (p interaction = 0.01). Our results suggest that women starting ZOL who experience an APR will have a larger reduction in vertebral fracture risk with ZOL.
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影响因子：
158.5
作者：
Lyles, Kenneth W.;Colon-Emeric, Cathleen S.;Boonen, Steven
通讯作者：
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影响因子：
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