The Center for Health Research, Kaiser Permanente Northwest, Portland, OR 97227, USA.
Pharmacoepidemiol Drug Saf. 2010 Mar;19(3):266-72. doi: 10.1002/pds.1923.
Angiotensin-converting enzyme (ACE) inhibitors are recommended for patients with chronic kidney disease (CKD) because they slow disease progression. But physicians' concerns about the risk of hyperkalemia (elevated serum potassium level), a potentially fatal adverse effect, may limit optimal management with ACE-inhibitors. We synthesized known predictors of hyperkalemia into a prognostic risk score to predict the risk of hyperkalemia.
We assembled a retrospective cohort of adult patients with possible CKD (at least one estimated glomerular filtration rate (eGFR) value less than 60 ml/min/1.73 m(2)) who started an ACE-inhibitor (i.e., incident users) between 1998 and 2006 at a health maintenance organization. We followed patients for hyperkalemia: (1) potassium value >5.5 mmol/L; or (2) diagnosis code for hyperkalemia. Cox regression synthesized a priori predictors recorded in the electronic medical record into a risk score.
We followed 5171 patients and 145 experienced hyperkalemia, a 90-day risk of 2.8%. Predictors included: age, eGFR, diabetes, heart failure, potassium supplements, potassium-sparing diuretics, and a high dose for the ACE-inhibitor (lisinopril). The risk score separated high-risk patients (top quintile, observed risk of 6.9%) from low-risk patients (bottom quintile, observed risk of 0.7%). Predicted and observed risks agreed within 1% for each quintile. The risk increased gradually in relation to declining eGFR with no apparent threshold for contraindicating ACE-inhibitors.
The risk score separated high-risk patients (who may need more intensive laboratory monitoring) from low-risk patients. The risk score should be validated in other populations before it is ready for use in clinical practice.
血管紧张素转换酶(ACE)抑制剂被推荐用于慢性肾脏病(CKD)患者,因为它们可以减缓疾病进展。但是,医生对高钾血症(血清钾水平升高)的风险(一种潜在的致命不良反应)的担忧可能会限制 ACE 抑制剂的最佳管理。我们将已知的高钾血症预测因素综合到一个预后风险评分中,以预测高钾血症的风险。
我们组建了一个回顾性队列,包括 1998 年至 2006 年期间在健康维护组织开始使用 ACE 抑制剂(即新使用者)的可能患有 CKD(至少有一个估计肾小球滤过率(eGFR)值小于 60ml/min/1.73m(2))的成年患者。我们随访患者高钾血症:(1)血钾值>5.5mmol/L;或(2)高钾血症的诊断代码。Cox 回归将电子病历中记录的预先确定的预测因素综合到风险评分中。
我们随访了 5171 名患者,其中 145 名发生了高钾血症,90 天的风险为 2.8%。预测因素包括:年龄、eGFR、糖尿病、心力衰竭、钾补充剂、保钾利尿剂和 ACE 抑制剂的高剂量(赖诺普利)。风险评分将高危患者(最高五分位数,观察到的风险为 6.9%)与低危患者(最低五分位数,观察到的风险为 0.7%)分开。对于每个五分位数,预测风险和观察风险相差不到 1%。随着 eGFR 的下降,风险逐渐增加,而 ACE 抑制剂的禁忌症没有明显的阈值。
风险评分将高危患者(可能需要更密集的实验室监测)与低危患者分开。在将风险评分应用于临床实践之前,应在其他人群中进行验证。