使用质子泵抑制剂的患者中利塞膦酸钠治疗的椎体骨折疗效。
Vertebral fracture efficacy during risedronate therapy in patients using proton pump inhibitors.
机构信息
Department of Rheumatology, AP-HP Cochin Hospital, Paris Descartes University, 27 rue Faubourg Saint Jacques, Paris 75014, France.
出版信息
Osteoporos Int. 2012 Jan;23(1):277-84. doi: 10.1007/s00198-011-1574-5. Epub 2011 Mar 2.
UNLABELLED
Recent evidence suggests that proton pump inhibitor (PPI) use may affect fracture risk, an important issue for patients being concurrently treated for osteoporosis. The results of our post hoc analysis showed that, regardless of PPI concomitant use, risedronate significantly reduced the risk of new vertebral fractures compared with placebo.
INTRODUCTION
Recent evidence suggests that PPI use may affect fracture risk, an important issue for patients being concurrently treated for osteoporosis. Moreover, data suggest that concomitant use of PPIs may wane the anti-fracture effect of bisphosphonates. We explored the relationship between concomitant use of PPIs and incident vertebral fractures among patients treated with risedronate or placebo. Bone mineral density (BMD) and upper gastrointestinal (UGI) adverse events (AEs) were also assessed.
METHODS
This study is a post hoc analysis of a subset of patients participating in three prospective, randomized, placebo-controlled clinical trials, with durations of up to 3 years, which evaluated the efficacy of risedronate in reducing fracture risk: Vertebral Efficacy with Risedronate Trial-MultiNational (VERT-MN); Vertebral Efficacy with Risedronate Trial-North America (VERT-NA); and the risedronate Hip Intervention Program (HIP).
RESULTS
Total enrollment included 2,729 risedronate and 2,725 placebo patients. Concomitant acid-suppressing drugs were used by 8.8% of the total population (n = 482). Regardless of PPI concomitant use, risedronate significantly reduced the risk of new vertebral fractures compared with placebo (risk reduction: PPI users 57%, p = 0.009; PPI non-users 38%, p < 0.001). BMD increased with risedronate, independent of PPI use. PPI users were at a 2.5-fold greater risk of experiencing at least one UGI AE compared with non-users.
CONCLUSIONS
Risedronate significantly reduced the risk of new vertebral fractures compared with placebo, regardless of PPI concomitant use.
目的
最近的证据表明，质子泵抑制剂（PPI）的使用可能会影响骨折风险，这是同时接受骨质疏松症治疗的患者的一个重要问题。我们的事后分析结果表明，无论是否同时使用 PPI，利塞膦酸钠与安慰剂相比，显著降低了新发椎体骨折的风险。
方法
这是对参与三项前瞻性、随机、安慰剂对照临床试验的患者子集进行的事后分析，这些试验的持续时间长达 3 年，评估了利塞膦酸钠降低骨折风险的疗效：多国（VERT-MN）和北美（VERT-NA）的椎体功效利塞膦酸钠试验；以及利塞膦酸钠髋部干预计划（HIP）。
结果
总入组人数包括 2729 名利塞膦酸钠和 2725 名利塞膦酸钠安慰剂患者。总人群中（n=482）有 8.8%同时使用抑酸药物。无论是否同时使用 PPI，利塞膦酸钠与安慰剂相比，显著降低了新发椎体骨折的风险（风险降低：PPI 使用者 57%，p=0.009；PPI 非使用者 38%，p<0.001）。无论是否使用 PPI，利塞膦酸钠均可增加骨密度。与非使用者相比，PPI 使用者发生至少一次上消化道不良事件的风险增加 2.5 倍。
结论
无论是否同时使用 PPI，利塞膦酸钠与安慰剂相比，显著降低了新发椎体骨折的风险。
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