CKD Patients Commonly Suffer Adverse Safety Events

Frequent events included high venous hemoglobin and hyperkalemia.
Frequent events included high venous hemoglobin and hyperkalemia.

Adverse safety events in chronic kidney disease (CKD) are common and varied, with frequent association between disparate events, researchers found.

Jeffrey C. Fink, MD, of the University of Maryland Medical System in Baltimore, and colleagues noted in a paper published online ahead of print in Journal of the American Society of Nephrology that CKD patients are at high risk for adverse safety events because of their impaired renal function, altered drug clearance, comorbid conditions, and frequent hospitalizations. Dr. Fink's team looked at the frequency of adverse safety events among non-dialysis CKD patients by examining participants in the Safe Kidney Care cohort study.

The analysis revealed that 185 of 267 participants (69.3%) experienced at least one adverse safety event in the class I category (patient-reported adverse safety incidents) or the class II category (hazardous clinical disturbances detected at study evaluations that have the potential for correction with treatment or with medical modification). More than one third (102 participants, or 38.2%) had more than one event, and 48 (18%) suffered at least one event from each class.

Self-reported hypoglycemia was the most common class I event recorded, with a higher adjusted rate conditional on use of diabetes medication within the last 30 days. The second most common class I event was falling or severe dizziness. Only patients with diabetes reported hypoglycemia. The 42 patients with diabetes who reported falling or severe dizziness were also likely to experience hypoglycemia. Among the 87 persons with diabetes who reported at least one episode of hypoglycemia, 33% also reported falling or severe dizziness.

The most common class II event was high venous hemoglobin, with a value of 13.5 g/dL serving as a safety threshold. However, no participant had this event when conditional on use of an erythropoiesis-stimulating agent. The next most common class II event was hyperkalemia (serum potassium greater than 5.5 mEq/L), which became the most common class II event when conditional on the use of a renin-angiotensin-aldosterone system blocker, a potassium-sparing diuretic, a nonsteroidal anti-inflammatory drug, or any other agent that could lead to hyperkalemia.

“The occurrence of these events ranged from sporadic to common but was frequent when considered in aggregate; this demonstrates the susceptibility of the CKD population to complications of medical care,” Dr. Fink and his colleagues wrote. “The causal relationship between treatment, or medications, and the class I and II events as we define them is difficult to confirm, but by focusing our analysis on events that occur conditional on medications that could account for such events, we offer a potential causal link between treatment and adverse safety event with the risk for harmful consequences.”

Participants suffering no adverse safety event were more likely to be older, male, African American, and free of diabetes, with a higher glomerular filtration rate, and were less likely to have had cancer or cardiovascular disease. Those with no events also took fewer medications than those with events.

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