Jones Stephen G, Momin Soyal R, Good Matthew W, Shea Terence K, Patric Kenneth
BlueCross and BlueShield of Tennessee, Chattanooga, TN 37402, USA.
Am J Manag Care. 2009 Aug;15(8):491-6.
To determine if patients with diabetes mellitus taking a thiazolidinedione experienced higher proportions of distal upper and lower limb fractures compared with those not taking a thiazolidinedione, as recent US Food and Drug Administration safety alerts suggested.
This 3-year cross-sectional study used medical and pharmacy claims from a large southeastern managed care organization for continuously enrolled members from January 1, 2004, through December 31, 2006.
A total of 29,284 patients with type 2 diabetes mellitus aged 18 to 64 years were allocated to mutually exclusive study groups of thiazolidinedione users versus thiazolidinedione nonusers and thiazolidinedione type (pioglitazone hydrochloride, rosiglitazone maleate, or a combination). chi(2) Tests were used to determine if fracture proportions for thiazolidinedione users differed from those of thiazolidinedione nonusers and if thiazolidinedione type was significant. Multivariate logistic regression models and backward stepwise elimination algorithms were constructed to evaluate associations of fracture proportions with age, sex, and chronicity of drug use for 7462 members using a thiazolidinedione.
The mean (SE) fracture proportions were significantly higher for thiazolidinedione users (5.1% [0.5%]) versus nonusers (4.5% [0.3%]) (P = .03). Fracture proportions did not differ by thiazolidinedione type (P = .86). Overall, women experienced a higher mean (SE) proportion of fractures compared with men (6.0% [0.4%] vs 3.5% [0.3%]) (P <.001), regardless of thiazolidinedione use. On average, the odds of experiencing a fracture for women using a thiazolidinedione increased 2% for every year increase in age.
Patients with diabetes using thiazolidinediones, regardless of type, had higher proportions of distal upper and lower limb fractures compared with those not using thiazolidinediones. Fracture proportions were higher among women and increased with age.
如美国食品药品监督管理局近期发布的安全警报所示，确定服用噻唑烷二酮类药物的糖尿病患者与未服用该类药物的患者相比，上肢和下肢远端骨折的比例是否更高。
这项为期3年的横断面研究使用了美国东南部一家大型管理式医疗组织从2004年1月1日至2006年12月31日期间持续参保成员的医疗和药房理赔数据。
总共29284例年龄在18至64岁之间的2型糖尿病患者被分为相互排斥的研究组，即噻唑烷二酮类药物使用者组与非使用者组，以及噻唑烷二酮类药物类型组（盐酸吡格列酮、马来酸罗格列酮或联合用药）。使用卡方检验来确定噻唑烷二酮类药物使用者的骨折比例与非使用者是否不同，以及噻唑烷二酮类药物类型是否具有显著性。构建多因素逻辑回归模型和向后逐步排除算法，以评估7462名使用噻唑烷二酮类药物的成员的骨折比例与年龄、性别和用药时长之间的关联。
噻唑烷二酮类药物使用者的平均（标准误）骨折比例（5.1% [0.5%]）显著高于非使用者（4.5% [0.3%]）（P = 0.03）。骨折比例在不同噻唑烷二酮类药物类型之间无差异（P = 0.86）。总体而言，无论是否使用噻唑烷二酮类药物，女性的平均（标准误）骨折比例均高于男性（6.0% [0.4%] 对3.5% [0.3%]）（P < 0.001）。平均而言，使用噻唑烷二酮类药物的女性每增加一岁，发生骨折的几率增加2%。
与未使用噻唑烷二酮类药物的糖尿病患者相比，使用该类药物的患者上肢和下肢远端骨折的比例更高。女性的骨折比例更高，且随年龄增长而增加。
