Bisphosphonate use and the risk of adverse jaw outcomes

被引:135
作者
Cartsos, Vassiliki M. [2 ]
Zhu, Shao [3 ]
Zavras, Athanasios I. [1 ]
机构
[1] Harvard Univ, Sch Dent Med, Dept Oral Hlth Policy & Epidemiol, Boston, MA 02115 USA
[2] Tufts Univ, Sch Dent Med, Dept Orthodont, Boston, MA 02111 USA
[3] Ingenix i3 Drug Safety, Basking Ridge, NJ USA
关键词
adverse effect; alendronate; bisphosphonates; cancer; drug safety; medical claims; osteonecrosis of the jaw; osteoporosis; pamidronate; surveillance; zoledroific acid;
D O I
10.14219/jada.archive.2008.0016
中图分类号
R78 [口腔科学];
学科分类号
1003 [口腔医学];
摘要
Background. While,osteonecrosis of the jaw (ONJ) has been associated I with the prolonged use of bisphosphonates (BPs), there is limited information about the risk of ONJ among users of oral BPs or about the magnitude of the risk among users of intravenous (IV) BPs. Methods. The authors studied medical claims data from 714,217 people with osteoporosis or cancer to identify diagnostic codes or procedure codes for three outcomesi inflammatory conditions of the jaws, including osteo necrosis; major jaw surgery necessitated by necrotic or inflammatory indications; and jaw surgeries necessitated by a malignant process. The authors calculated stratified odds ratios and, 95 percent confidence intervals. Results. The results indicate that oral administration of BPs decreases the risk of adverse bone outcomes. In contrast, IV administration strongly and significantly increases the risk (P <.05) of adverse jaw outcomes or surgery. Across both osteoporosis and cancer, patients receiving IV BPs had a fourfold increased risk, of having inflammatory jaw conditions and a greater than sixfold increased risk of having undergone major surgical resection in the jaw. Conclusions. Mode of bisphosphonate use results in different risk profiles for adverse jaw outcomes. While the authors documented an increased risk of inflammatory condition and surgical procedures of the jaw for users of IV BPs, they did not find these observed increases for users of oral BPs. Clinical Implications. Physicians and dentists must be aware of the higher frequency of adverse jaw effects in patients receiving IV BPs, especially osteonecrosis of the jaw. While the authors' results have internal consistency, more clinical studies are needed to replicate and clarify the observed associations over long follow up periods.
引用
收藏
页码:23 / 30
页数:8
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