Seguridad de los bifosfonatos en el tratamiento de la osteoporosis

M. Giner-Soriano , D. Gómez-Ulloa , A. Vila-Bundó , A. Álvarez-Carrera , F. Montañés-Muñoz
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Abstract

Apart from bisphosphonates adverse events described in premarketing phases; case reports, pharmacovigilance studies and alerts from regulatory agencies about other adverse events not previously described have been published in the last years. The objective of our study is the description of adverse events potentially attributable to bisphosphonates in the usual clinical practice.

We describe the adverse events of two bisphosphonates (risedronate and alendronate) in a historical cohort through a revision of medical hystory.

A total of 110 patients of 63.4 years were included, 103 (93.6%) of them were women. 33 (30%) were receiving bisphosphonate treatment at the data collection time. 68 (61.8%) received risedronic acid. In 88.2% (n = 97) of our patients the reason to start a bisphosphonate treatment was primary prevention of fractures, and in 6.4% (n = 7) of patients there was a previous diagnosis of fracture. The rest of treatments were off-label. 82 (74.5%) of our patients had any adverse event potentially attributable to bisphosphonates. The most frequent adverse events were musculoskeletal pain (58.2%) and gastrointestinal effects (24.5%).

Bisphosphonates are a well tolerated therapeutic group. The adverse events incidence in our population was similar to the incidence described in literature.

双膦酸盐治疗骨质疏松症的安全性
除了上市前阶段描述的双磷酸盐不良事件外;病例报告、药物警戒研究和监管机构关于其他不良事件的警报在过去几年中已经发表。我们研究的目的是描述在通常的临床实践中可能归因于双磷酸盐的不良事件。我们通过修订医学术语描述了一个历史队列中两种双膦酸盐(利塞膦酸盐和阿仑膦酸盐)的不良事件。共纳入110名63.4岁的患者,其中103名(93.6%)为女性。33人(30%)在数据收集时正在接受双磷酸盐治疗。利塞膦酸治疗68例(61.8%)。88.2%(n=97)的患者开始双磷酸盐治疗的原因是主要预防骨折,6.4%(n=7)的患者先前诊断为骨折。其余的治疗方法都是标示外的。82名(74.5%)患者有任何可能归因于双磷酸盐的不良事件。最常见的不良事件是肌肉骨骼疼痛(58.2%)和胃肠道影响(24.5%)。双膦酸盐是一种耐受性良好的治疗组。我们人群中的不良事件发生率与文献中描述的发生率相似。
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