![]() ![]() 11, 12 Published clinical commentaries have declared that the potassium-lowering effect of SPS is indistinguishable from laxatives or extremely low-potassium diets. More current and better designed studies have been unable to demonstrate efficacy of SPS for treating hyperkalemia. 7, 8 One showed a greater decline in serum potassium when sorbitol only was administered than with sorbitol and SPS. Two of the other studies showed serum potassium decline coincidental to increased urine output. Further, they included “failed to show any increase” as an outcome indicating efficacy of treatment. A statement from the article reads,“As shown in Table 1, 30 patients either demonstrated a significant fall in plasma potassium or failed to show any increase in these values during the period observed.” 9(p118) Since no statistical analysis was done, the results are only significant because the authors declare them so. If Kayexalate was effective at reducing potassium, why did this treatment not result in dangerously low levels of potassium? For the other 30 cases, the duration of therapy was 1 to 6 days. In 2 of these cases, SPS was administered over a period of months. This was the largest of the aforementioned studies, including 32 cases. The study by Scherr et al, published in the New England Journal of Medicine (1961), used SPS. They concluded, “There is no randomised evidence that potassium-exchange resins are effective.” 6(p14)įour of the early studies that supported the use of ion exchange resins for treatment of hyperkalemia were published by Bernard et al, 7 Palmer et al, 8 Scherr et al, 9 and Flinn et al. “The FDA first approved Kayexalate for the treatment of hyperkalemia on June 5, 1958, 4 years before passage of the Kefauver-Harris Drug Amendments, which require drug manufacturers to prove the effectiveness of their products before marketing them.” 5(p733) In a review, Mahoney et al did a literature search back to 1966 that identified 1,974 potentially relevant articles. 4 The FDCA is the basis for modern pharmacy law. The Food, Drug, and Cosmetic Act (FDCA) was passed in 1938. In a 2009 clinical review, Nyirenda et al wrote, “Guidelines for treatment of hyperkalaemia are based on consensus or expert opinion because of a lack of controlled clinical trials.” 3 To further support my observation, I enlist a published author. It is my opinion that just such a downgrade is appropriate. Any further downgrade of this recommendation would put it into the risk is greater than benefit category. In Part 2 of the guideline, the AHA describes the evidence as “Class IIb, Level of Evidence C,” which it defines as, “Recommendation’s usefulness/efficacy less well established…Only diverging expert opinion, case studies, or standard of care.” 2(pS660) In the AHA guidelines, this is the weakest level of evidence that can be recommended. This course of treatment is based on weak evidence. 1 The treatment includes calcium, albuterol, sodium bicarbonate, insulin, dextrose, and Kayexalate. ![]() ![]() A suggested course of treatment for hyperkalemia is provided in Part 12: Cardiac Arrest in Special Situations: Part 12.6 Cardiac Arrest Associated With Life-Threatening Electrolyte Disturbances. The 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care include advanced adult cardiovascular life support (ACLS) in Part 8. ![]()
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