Pavlova Velichka, Filipova Elena, Uzunova Katya, Kalinov Krassimir, Vekov Toni
Science Department, Tchaikapharma High-Quality Medicines, Inc., 1 G.M. Dimitrov Blvd, 1172 Sofia, Bulgaria.
Department of Informatics, New Bulgarian University, 21 Montevideo Street, 1618 Sofia, Bulgaria.
Endocr Metab Immune Disord Drug Targets. 2018;18(5):502-507. doi: 10.2174/1871530318666180423121833.
Thiazolidinediones are a group of synthetic medications used in type 2 diabetes treatment. Among available thiazolidinediones, pioglitazone is gaining increased attention due to its lower cardiovascular risk in type 2 diabetes mellitus sufferers and seems a promising future therapy. Accumulating evidence suggests that diabetic patients may exert bone fractures due to such treatments. Simultaneously, the female population is thought to be at greater risk. Still, the safety outcomes of pioglitazone treatment especially in terms of fractures are questionable and need to be clarified.
We searched MEDLINE, Scopus, PsyInfo, eLIBRARY.ru electronic databases and clinical trial registries for studies reporting an association between pioglitazone and bone fractures in type 2 diabetes mellitus patients published before Feb 15, 2016. Among 1536 sources that were initially identified, six studies including 3172 patients proved relevant for further analysis.
Pooled analysis of the included studies demonstrated that after treatment with pioglitazone patients with type 2 diabetes mellitus had no significant increase in fracture risk [odds ratio (OR): 1.18, 95% confidence interval (CI): 0.82 to 1.71, p=0.38] compared to other antidiabetic drugs or placebo. Additionally, no association was found between the risk of fractures and pioglitazone therapy duration. The gender of the patients involved was not relevant to the risk of fractures, too.
Pioglitazone treatment in diabetic patients does not increase the incidence of bone fractures. Moreover, there is no significant association between patients' fractures, their gender and the period of exposure to pioglitazone. Additional longitudinal studies need to be undertaken to obtain more detailed information on bone fragility and pioglitazone therapy.
噻唑烷二酮类是用于治疗2型糖尿病的一组合成药物。在现有的噻唑烷二酮类药物中，吡格列酮因其在2型糖尿病患者中较低的心血管风险而受到越来越多的关注，似乎是一种有前途的未来治疗方法。越来越多的证据表明，糖尿病患者可能因这类治疗而发生骨折。同时，女性人群被认为风险更大。然而，吡格列酮治疗的安全性结果，尤其是在骨折方面，仍存在疑问，需要加以澄清。
我们检索了MEDLINE、Scopus、PsyInfo、eLIBRARY.ru电子数据库和临床试验注册库，以查找2016年2月15日前发表的关于吡格列酮与2型糖尿病患者骨折之间关联的研究。在最初识别的1536篇文献中，6项研究（包括3172名患者）被证明与进一步分析相关。
纳入研究的汇总分析表明，与其他抗糖尿病药物或安慰剂相比，2型糖尿病患者接受吡格列酮治疗后骨折风险没有显著增加[比值比（OR）：1.18，95%置信区间（CI）：0.82至1.71，p = 0.38]。此外，未发现骨折风险与吡格列酮治疗持续时间之间存在关联。所涉及患者的性别与骨折风险也无关。
糖尿病患者接受吡格列酮治疗不会增加骨折发生率。此外，患者的骨折情况、性别与吡格列酮暴露时间之间没有显著关联。需要进行更多的纵向研究，以获取关于骨脆性和吡格列酮治疗的更详细信息。
