Rossini Maurizio, Adami Giovanni, Adami Silvano, Viapiana Ombretta, Gatti Davide
a Rheumatology Unit, Department of Medicine , University of Verona , Verona , Italy.
Expert Opin Drug Saf. 2016;15(3):321-32. doi: 10.1517/14740338.2016.1136287. Epub 2016 Jan 14.
Osteoporosis is a disease that has spread worldwide and has become a relevant public health problem. Over the last 2 decades, a number of drugs have been licensed for its treatment owing to their efficacy in preventing fragility fractures. The safety profiles of these drugs are well defined with data from extensive programs of pharmacovigilance to support it.
In this article we reviewed the long-term safety of Bisphosphonates, Calcium, Vitamin D, Selective Estrogen Receptor Modulators, Teriparatide and Denosumab. We excluded hormone replacement therapy that lost its indication for the treatment of osteoporosis. The license for the treatment of osteoporosis of Calcitonin was recently withdrawn and that of Strontium ranelate was severely limited. For both drugs, we report EMA statements about their safety profile.
The safety profile of most available drugs for the treatment of osteoporosis is well defined and the most serious adverse events are either rare or predictable. Osteoporosis treatment is a favorable choice in patients at moderate-high risk of fracture, while in patients at low risk pharmacological prevention should involve consideration of the balance between the beneficial effects of treatment, the probability of adverse effects and costs.
骨质疏松症是一种已在全球范围内蔓延并成为一个重要公共卫生问题的疾病。在过去20年里，一些药物因其在预防脆性骨折方面的疗效而被批准用于治疗。这些药物的安全性概况通过广泛的药物警戒计划所获得的数据得到了很好的界定。
在本文中，我们回顾了双膦酸盐类、钙、维生素D、选择性雌激素受体调节剂、特立帕肽和地诺单抗的长期安全性。我们排除了已失去骨质疏松症治疗适应证的激素替代疗法。降钙素治疗骨质疏松症的许可最近已被撤回，而雷奈酸锶的许可受到严格限制。对于这两种药物，我们报告了欧洲药品管理局（EMA）关于其安全性概况的声明。
大多数现有骨质疏松症治疗药物的安全性概况已得到很好的界定，最严重的不良事件要么罕见，要么可预测。骨质疏松症治疗对于中高骨折风险患者是一个有利选择，而对于低风险患者，药物预防应考虑治疗的有益效果、不良反应发生概率和成本之间的平衡。
