Medication Safety Research Chair, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Saudi Pharm J. 2012 Jan;20(1):69-73. doi: 10.1016/j.jsps.2011.08.002. Epub 2011 Aug 23.
Several nonsteroidal anti-inflammatory drugs (NSAIDs) have been linked to cardiac death. The mechanism that is responsible for this adverse effect appears to be ischemic insult; however, another possible mechanism involves hyperkalemia. The objective of the present study was to determine the feasibility of conducting pharmacoepidemiological studies in Saudi Arabia using refill prescription data to investigate the association between NSAIDs and increased serum potassium concentrations.
This retrospective cohort study included patients from an academic medical center in Riyadh, Saudi Arabia. The patients who were recently prescribed NSAIDs were compared to a control group of paracetamol users, with respect to the drugs' effects on serum potassium concentrations. The covariates that affected the potassium concentration or the use of NSAIDs were controlled for in the analysis. The studied outcome was the first serum potassium concentration of more than 5 mEq/L.
A total of 184 patients were prescribed NSAIDs (n = 101) or paracetamol (n = 83) and met the inclusion criteria. Compared to the control group, the patients who received NSAIDs were more likely to be women, were less likely to use angiotensin-converting enzyme inhibitors, and were more likely to have lower baseline serum creatinine concentrations. The other baseline characteristics were similar between the patients in the NSAID group and the patients who received paracetamol. Compared to the patients who were prescribed paracetamol, those who were prescribed NSAIDs did not have an increased risk of hyperkalemia (odds ratio, 1.1, 95% confidence interval, 0.17-6.7, P = 0.95).
In the present, small feasibility study, no increase in the risk of hyperkalemia was associated with NSAIDs compared to paracetamol. The present study was exploratory and included only a small number of patients; therefore, this study may not be sufficiently powered to detect small differences between the groups. Future studies with larger sample sizes are needed to investigate the association between NSAIDs and hyperkalemia.
几种非甾体抗炎药（NSAIDs）与心脏死亡有关。导致这种不良反应的机制似乎是缺血性损伤；然而，另一种可能的机制涉及高钾血症。本研究的目的是确定使用再配药数据在沙特阿拉伯进行药物流行病学研究的可行性，以调查 NSAIDs 与血清钾浓度升高之间的关联。
这项回顾性队列研究包括来自沙特阿拉伯利雅得一家学术医疗中心的患者。与对照组（对乙酰氨基酚使用者）相比，比较了最近开处方 NSAIDs 的患者，观察药物对血清钾浓度的影响。在分析中控制了影响钾浓度或 NSAIDs 使用的协变量。研究结果是首次血清钾浓度超过 5 mEq/L。
共有 184 名患者被开了 NSAIDs（n=101）或对乙酰氨基酚（n=83），并符合纳入标准。与对照组相比，接受 NSAIDs 的患者更可能是女性，不太可能使用血管紧张素转换酶抑制剂，且基线血清肌酐浓度较低。两组患者的其他基线特征相似。与服用对乙酰氨基酚的患者相比，服用 NSAIDs 的患者没有更高的高钾血症风险（比值比，1.1，95%置信区间，0.17-6.7，P=0.95）。
在目前这项小型可行性研究中，与对乙酰氨基酚相比，NSAIDs 并未增加高钾血症的风险。本研究是探索性的，只纳入了少数患者；因此，本研究可能没有足够的效力来检测两组之间的微小差异。需要更大样本量的未来研究来调查 NSAIDs 与高钾血症之间的关联。
