屈螺酮与高钾血症之间的关联：一项比较安全性研究。
The association between drospirenone and hyperkalemia: a comparative-safety study.
作者信息
Bird Steven T, Pepe Salvatore R, Etminan Mahyar, Liu Xinyue, Brophy James M, Delaney Joseph Ac
机构信息
Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research (CDER)/Office of Management/CDER Academic Collaboration Program, Bldg 22, 10903 New Hampshire Avenue, Silver Spring, MD USA 20993.
University of Florida, College of Pharmacy, Pharmaceutical Outcomes & Policy, 101 S. Newell Drive (HPNP), PO Box 100496, Gainesville FL, USA 32611.
出版信息
BMC Clin Pharmacol. 2011 Dec 30;11:23. doi: 10.1186/1472-6904-11-23.
BACKGROUND
Drospirenone/ethinyl-estradiol is an oral contraceptive (OC) that possesses unique antimineralocorticoid activity. It is conjectured that drospirenone, taken alone or concomitantly with spironolactone, may be associated with an increased risk of hyperkalemia.
METHODS
A retrospective cohort study was conducted evaluating women between 18-46 years of age in the Lifelink™ Health Plan Claims Database. The study was restricted to new users of OCs between 1997-2009. Cox proportional hazards models were used to estimate the time to first occurrence of hyperkalemia diagnosis. The main analysis compared OCs containing drospirenone with OCs containing levonorgestrel, a second generation OC not known to impact potassium homeostasis. Logistic regression evaluated concomitant prescribing of drospirenone and spironolactone
RESULTS
The cohort included 1,148,183 women, averaging 28.8 years of age and 280 days of OC therapy. 2325 cases of hyperkalemia were identified. The adjusted hazard ratio (HR) for hyperkalemia with drospirenone compared to levonorgestrel was 1.10 (95%CI 0.95-1.26). There was an increased risk of hyperkalemia with norethindrone HR 1.15 (95%CI: 1.00-1.33) and norgestimate HR 1.27 (95%CI: 1.11-1.46). Other OCs were unassociated with hyperkalemia. The odds of receiving spironolactone while taking drospirenone were 2.66 (95%CI 2.53-2.80) times higher than the odds of receiving spironolactone and levonorgestrel. Only 6.5% of patients taking drospirenone and spironolactone had a serum potassium assay within 180 days of starting concomitant therapy.
CONCLUSIONS
A clinically significant signal for hyperkalemia with drospirenone was not demonstrated in the current study. Despite the bolded warning for hyperkalemia with joint drospirenone and spironolactone administration, physicians are actually using them together preferentially, and are not following the recommended potassium monitoring requirements in the package insert.
背景
屈螺酮/炔雌醇是一种具有独特抗盐皮质激素活性的口服避孕药（OC）。据推测，单独服用屈螺酮或与螺内酯同时服用，可能会增加高钾血症的风险。
方法
在Lifelink™健康计划索赔数据库中对18至46岁的女性进行了一项回顾性队列研究。该研究仅限于1997年至2009年间口服避孕药的新用户。使用Cox比例风险模型来估计首次诊断高钾血症的时间。主要分析将含屈螺酮的口服避孕药与含左炔诺孕酮的口服避孕药进行比较，左炔诺孕酮是一种已知不会影响钾稳态的第二代口服避孕药。逻辑回归评估了屈螺酮和螺内酯的联合处方情况。
结果
该队列包括1148183名女性，平均年龄28.8岁，口服避孕药治疗时间平均为280天。共识别出2325例高钾血症病例。与左炔诺孕酮相比，屈螺酮导致高钾血症的调整后风险比（HR）为1.10（95%CI 0.95 - 1.26）。炔诺酮导致高钾血症的风险增加，HR为1.15（95%CI：1.00 - 1.33），去氧孕烯炔雌醇导致高钾血症的风险增加，HR为1.27（95%CI：1.11 - 1.46）。其他口服避孕药与高钾血症无关。服用屈螺酮时接受螺内酯的几率比服用左炔诺孕酮时接受螺内酯的几率高2.66倍（95%CI 2.53 - 2.80）。在开始联合治疗的180天内，只有6.5%服用屈螺酮和螺内酯的患者进行了血钾检测。
结论
在本研究中未发现屈螺酮导致高钾血症的临床显著信号。尽管对于屈螺酮与螺内酯联合使用导致高钾血症有显著警告，但医生实际上更倾向于同时使用它们，并且未遵循药品说明书中推荐的血钾监测要求。
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