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Study finds no increased kidney risk with high dose statins
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Across two large randomized trials of patients after an ACS, use of high-dose statins did not increase the risk for kidney injury as compared with a lower-dose regimen, according to preliminary research presented at an American Heart Association Emerging Science Series webinar.
Researchers analyzed data from two trials in which survivors of ACS were randomly assigned to high- or low-dose statins: PROVE IT-TIMI 22 (n=4,162) and A-to-Z (n=4,497). The former trial evaluated patients assigned atorvastatin (Lipitor, Pfizer) 80 mg daily vs. pravastatin (Pravachol, Bristol-Myers Squibb) 40 mg daily for the prevention of major adverse cardiac events following ACS. The latter compared patients assigned simvastatin (Zocor, Merck) 40 mg daily for 1 month followed by simvastatin 80 mg daily vs. placebo for 4 months followed by simvastatin 20 mg daily. In both trials, serum creatinine was assessed at baseline and serial time points during follow-up.
Baseline mean serum creatinine was 1.03 mg/dL in PROVE IT-TIMI 22 and 1.14 mg/dL in A-to-Z. Relative change in serum creatinine over time was the same between treatment groups across the two trials, according to data presented.
In both cases, the researchers found that the group assigned higher-dose statins did not have increased risk for adverse events compared with the group assigned lower-dose statins (0.92% vs. 0.91%, P=0.97).
“Across two large randomized trials of patients after an ACS, the use of intensive statin therapy did not increase serum creatinine or the risk of kidney injury,” Amy Sarma, MD, MHS, resident physician at Brigham and Women’s Hospital, said at the webinar. “These findings provide important reassurance to clinicians that the use of high-potency statins is safe for patients after ACS.”
“We feel reassured that when we looked at the subsets of patients potentially vulnerable to kidney injury [such as those with diabetes and those who were older], we again saw no signals of adverse effects,” she said.
For this study, the incidence of kidney injury was adapted according to the Kidney Disease: Improving Global Outcomes classification with baseline creatinine as the referent. The incidence of adverse events related to kidney injury was determined through review of the adverse events database.
For more information:
Sarma A. AHA Emerging Science Series. Cardiovascular Risk: From Epigenetics to Pharmacotherapy. June 19, 2013.
Sarma S. Circulation. 2013;doi:10.1161/CIR.0b013e31829ecc16.
Disclosure: Sarma reports no relevant financial disclosures. PROVE IT-TIMI 22 was funded by Bristol-Myers Squibb and Daiichi Sankyo. A-to-Z was funded by Merck.