Lilly USA, LLC, Indianapolis, IN 46285, USA.
Curr Med Res Opin. 2010 Jan;26(1):71-6. doi: 10.1185/03007990903427082.
Women without versus those with vertebral fracture may have different benefits and risks during raloxifene treatment. Our objective was to compare the effects of raloxifene to decrease risk for vertebral fracture and invasive breast cancer with its effect to increase risk for venous thromboembolism in postmenopausal women without or with baseline vertebral fracture.
The Multiple Outcomes of Raloxifene Evaluation trial included postmenopausal women with osteoporosis randomized to placebo, raloxifene 60 mg/day, or raloxifene 120 mg/day for 4 years. The protocol specified subgroups based on whether or not patients had a vertebral fracture at baseline. Absolute differences between placebo and raloxifene 60 mg/day (the approved dose) for endpoints in these groups were defined as the incidence in the raloxifene group minus the incidence in the placebo group.
Raloxifene decreased the incidence of vertebral fracture and invasive breast cancer while increasing the incidence of venous thromboembolism. All treatment by vertebral fracture status interaction p-values were greater than 0.13, indicating that the effect of raloxifene on these outcomes was not significantly different between patients without versus those with vertebral fractures. In women without baseline vertebral fracture, absolute risk differences between the raloxifene and placebo group included vertebral fracture -2.83%, invasive breast cancer -1.21%, and venous thromboembolism +0.28%. In women with baseline vertebral fracture, absolute risk differences between raloxifene and placebo group included vertebral fracture -8.21%, invasive breast cancer -0.75% and venous thromboembolism +0.91%. The analysis had limited power to test whether raloxifene had a significantly different effect on venous thromboembolism in women without versus those with a vertebral fracture.
In women without and in those with vertebral fractures at baseline, the effects of raloxifene to decrease vertebral fracture and invasive breast cancer were greater than its effects to increase venous thromboembolism.
与无椎体骨折的女性相比，椎体骨折女性在接受雷洛昔芬治疗时可能具有不同的获益和风险。我们的目的是比较雷洛昔芬降低绝经后无基线椎体骨折和有基线椎体骨折女性椎体骨折及浸润性乳腺癌风险的效果，以及增加静脉血栓栓塞风险的效果。
雷洛昔芬多种结局评估试验纳入了骨质疏松症绝经后女性，将其随机分配至安慰剂组、雷洛昔芬 60mg/天组或雷洛昔芬 120mg/天组，治疗 4 年。该方案根据患者基线时是否存在椎体骨折指定了亚组。这些组中安慰剂和雷洛昔芬 60mg/天（批准剂量）之间终点的绝对差异定义为雷洛昔芬组的发生率减去安慰剂组的发生率。
雷洛昔芬降低了椎体骨折和浸润性乳腺癌的发生率，同时增加了静脉血栓栓塞的发生率。所有按椎体骨折状态分层的治疗相互作用 p 值均大于 0.13，表明雷洛昔芬对这些结局的影响在无椎体骨折和有椎体骨折的患者之间没有显著差异。在无基线椎体骨折的女性中，雷洛昔芬组与安慰剂组之间的绝对风险差异包括椎体骨折-2.83%、浸润性乳腺癌-1.21%和静脉血栓栓塞+0.28%。在基线时有椎体骨折的女性中，雷洛昔芬组与安慰剂组之间的绝对风险差异包括椎体骨折-8.21%、浸润性乳腺癌-0.75%和静脉血栓栓塞+0.91%。该分析检测雷洛昔芬对无椎体骨折和有椎体骨折女性静脉血栓栓塞的影响是否存在显著差异的效能有限。
在基线时无椎体骨折和有椎体骨折的女性中，雷洛昔芬降低椎体骨折和浸润性乳腺癌的效果大于增加静脉血栓栓塞的效果。
