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意大利口服双膦酸盐治疗骨质疏松症的持久性回顾性评估:TOBI 研究。

Retrospective evaluation of persistence in osteoporosis therapy with oral bisphosphonates in Italy: the TOBI study.

机构信息

Department of Medicine, Surgery and Neuroscience, University of Siena, Policlinico Le Scotte, Viale Bracci 2, 53100, Siena, Italy.

Department of Surgical and Oncology Sciences, University of Palermo, Palermo, Italy.

出版信息

Aging Clin Exp Res. 2019 Nov;31(11):1541-1547. doi: 10.1007/s40520-019-01205-7. Epub 2019 Apr 27.

Abstract

UNLABELLED

The patients' persistence with osteoporosis treatments is low. This retrospective, multicenter survey showed that almost 30% of osteoporotic patients discontinued the treatment within the first 6 months and that those taking drinkable bisphosphonates were less likely to interrupt the therapy; instead, the use of generic bisphosphonates was associated to a more precocious interruption.

PURPOSE

Low persistence with osteoporosis medications is associated with higher fracture risk. This study aimed to assess the persistence to treatment with oral bisphosphonates among Italian osteoporotic patients under treatment for at least 6 months and to evaluate whether the different oral formulations of bisphosphonates may influence the interruption of the therapy.

METHODS

723 consecutive osteoporotic patients, aged 50 years or over, referred as outpatients for a follow-up visit after receiving a prescription of an oral bisphosphonate for the first time for at least 6 months were enrolled in this retrospective, multicenter survey carried out under conditions of usual clinical practice. All the patients enrolled were submitted to a standardized interview.

RESULTS

191 patients turned out to have discontinued treatment (28.7%), the more common causes for interruption being the adverse events (43.9%), fear of adverse events (23.3%) and perceived absence of efficacy of the treatment (15.8%). The osteoporotic patients taking drinkable bisphosphonate or on treatment with aromatase inhibitors or under the age of 70 years were less likely to interrupt the treatment. However, these associations were no longer significant when the pharmaceutical formulation (generic vs branded) was included into the multivariate logistic regression model.

CONCLUSION

This study suggests that the new drinkable formulations of bisphosphonates could be an interesting option able to reduce upper GI adverse events, thus increasing persistence; whereas the generic formulations of bisphosphonates were associated to a premature discontinuation.

摘要

目的

骨质疏松症药物的低依从性与更高的骨折风险相关。本研究旨在评估意大利骨质疏松症患者口服双膦酸盐治疗至少 6 个月的依从性,并评估不同的口服双膦酸盐制剂是否会影响治疗的中断。

方法

723 例连续的骨质疏松症患者,年龄≥50 岁,在首次接受至少 6 个月的口服双膦酸盐处方后,作为门诊患者进行随访,被纳入本回顾性多中心研究。所有纳入的患者均接受了标准化访谈。

结果

191 例患者停止治疗(28.7%),中断治疗的常见原因是不良事件(43.9%)、对不良事件的恐惧(23.3%)和认为治疗无效(15.8%)。使用可饮用双膦酸盐、接受芳香化酶抑制剂治疗或年龄<70 岁的骨质疏松症患者中断治疗的可能性较小。然而,当将药物制剂(仿制药与品牌药)纳入多变量逻辑回归模型时,这些关联不再显著。

结论

本研究表明,新型可饮用双膦酸盐制剂可能是一种有趣的选择,能够减少上消化道不良事件,从而提高依从性;而双膦酸盐的仿制药制剂与过早停药有关。

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