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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Absence of Drug-Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial
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Absence of Drug-Drug Interaction of Anastrozole on Levonorgestrel Delivered Simultaneously by an Intravaginal Ring: Results of a Phase 2 Trial

机译：静脉内环同时左旋血管抑制左旋孔的药物 - 药物相互作用：2阶段试验的结果

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摘要

Intravaginal rings (IVRs) are an established option for continuous administration of drugs in women. The combination of anastrozole (ATZ) and levonorgestrel (LNG) in an IVR with an intended 4-week wearing period has been considered for long-term treatment of endometriosis-associated pelvic pain. A randomized, parallel-group, multicenter phase 2b study to assess the efficacy and safety of different dose combinations in women with symptomatic endometriosis has recently been performed. This paper will focus on the investigation of pharmacokinetic (PK) effects of ATZ on LNG using data collected from this study. Two hundred sixteen patients were randomized to the treatment group with IVRs releasing LNG 40 mu g/day alone or in combination with ATZ 300 mu g/day, 600 mu g/day, or 1050 mu g/day for 12 weeks. PK blood samples were taken before dosing and before IVR replacement or removal (days 28, 56, and 84). The primary PK parameter was the plasma concentration in apparent steady state of ATZ and LNG at the end of each IVR wearing period. Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 mu g/L at 300, 600, and 1050 mu g/day nominal release, respectively). All point estimates for LNG concentration in apparent steady state ratios between the mono and combination IVR groups were close to 1, and the 90% confidence interval limits were in the 0.80 to 1.25 range (1.01 [0.85-1.19], 1.03 [0.88-1.20], 0.94 [0.80-1.10]). In conclusion, our data indicate there is no evidence of drug-drug interaction of ATZ on LNG.
机译：阴道环（IVR）是连续施用妇女药物的建立选择。 Anstrozole（ATZ）和左旋醛植物（LNG）在IVR中的组合具有预期的4周佩戴时期，已经考虑了对子宫内膜异位症相关的骨盆疼痛的长期治疗。最近进行了随机，并行组的多中心2B研究，以评估具有对症状子宫内膜异位症的不同剂量组合的疗效和安全性。本文将专注于使用本研究中收集的数据的ATZ对液化杆菌的药代动力学（PK）效应的调查。将两百十六名患者随机分为治疗组，用IVRS释放LNG40μg/天，或与ATZ300μg/天组合，600μg/日，或1050μmg/天12周。在给药前和IVR替代或去除之前进行PK血液样品（第28,56和84天）。主PK参数是每个IVR佩戴时期结束时ATZ和LNG的明显稳定状态的等离子体浓度。 PK分析结果表明，ATZ浓度分别随着剂量的增加（7.85,15.48和32.61μmg/ L分别为300,600和1050μg/天称义释放）比例成比例地增加。单一和组合IVR基团之间表观稳态比的LNG浓度的所有点估计接近1，90％置信区间限制在0.80至1.25范围内（1.01 [0.85-1.9]，1.03 [0.88-1.20 ]，0.94 [0.80-1.10]）。总之，我们的数据表明，没有ATZ对LNG的药物药物相互作用的证据。

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