PMID- 24786143 OWN - NLM STAT- MEDLINE DCOM- 20150224 LR - 20211021 IS - 2047-9980 (Electronic) IS - 2047-9980 (Linking) VI - 3 IP - 3 DP - 2014 May 1 TI - The incidence of kidney injury for patients treated with a high-potency versus moderate-potency statin regimen after an acute coronary syndrome. PG - e000784 LID - 10.1161/JAHA.114.000784 [doi] LID - e000784 AB - BACKGROUND: Observational studies have raised concerns that high-potency statins increase the risk of acute kidney injury. We therefore examined the incidence of kidney injury across 2 randomized trials of statin therapy. METHODS AND RESULTS: PROVE IT-TIMI 22 enrolled 4162 subjects after an acute coronary syndrome (ACS) and randomized them to atorvastatin 80 mg/day versus pravastatin 40 mg/day. A-to-Z enrolled 4497 subjects after ACS and randomized them to a high-potency (simvastatin 40 mg/day x 1 months, then simvastatin 80 mg/day) versus a delayed moderate-potency statin strategy (placebo x 4 months, then simvastatin 20 mg/day). Serum creatinine was assessed centrally at serial time points. Adverse events (AEs) relating to kidney injury were identified through database review. Across both trials, mean serum creatinine was similar between treatment arms at baseline and throughout follow-up. In A-to-Z, the incidence of a 1.5-fold or >/= 0.3 mg/dL rise in serum creatinine was 11.4% for subjects randomized to a high-potency statin regimen versus 12.4% for those on a delayed moderate-potency regimen (odds ratio [OR], 0.91; 95% confidence interval [CI], 0.76 to 1.10; P=0.33). In PROVE IT-TIMI 22, the incidence was 9.4% for subjects randomized to atorvastatin 80 mg/day and 10.6% for subjects randomized to pravastatin 40 mg/day (OR, 0.88; 95% CI, 0.71 to 1.09; P=0.25). Consistent results were observed for different kidney injury thresholds and in individuals with diabetes mellitus or with moderate renal dysfunction. The incidence of kidney injury-related adverse events (AEs) was not statistically different for patients on a high-potency versus moderate-potency statin regimen (OR, 1.06; 95% CI, 0.68 to 1.67; P=0.78). CONCLUSIONS: For patients enrolled in 2 large randomized trials of statin therapy after ACS, the use of a high-potency statin regimen did not increase the risk of kidney injury. FAU - Sarma, Amy AU - Sarma A AD - Cardiovascular Division, Brigham and Women's Hospital, Boston, MA. FAU - Cannon, Christopher P AU - Cannon CP FAU - de Lemos, James AU - de Lemos J FAU - Rouleau, Jean L AU - Rouleau JL FAU - Lewis, Eldrin F AU - Lewis EF FAU - Guo, Jianping AU - Guo J FAU - Mega, Jessica L AU - Mega JL FAU - Sabatine, Marc S AU - Sabatine MS FAU - O'Donoghue, Michelle L AU - O'Donoghue ML LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20140501 PL - England TA - J Am Heart Assoc JT - Journal of the American Heart Association JID - 101580524 RN - 0 (Heptanoic Acids) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Pyrroles) RN - A0JWA85V8F (Atorvastatin) RN - AYI8EX34EU (Creatinine) RN - KXO2KT9N0G (Pravastatin) SB - IM MH - Acute Coronary Syndrome/*drug therapy MH - Acute Kidney Injury/*chemically induced/epidemiology MH - Atorvastatin MH - Creatinine/blood MH - Double-Blind Method MH - Drug Administration Schedule MH - Female MH - Heptanoic Acids/administration & dosage/*adverse effects/therapeutic use MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage/*adverse effects/therapeutic use MH - Incidence MH - Male MH - Middle Aged MH - Pravastatin/administration & dosage/*adverse effects/therapeutic use MH - Pyrroles/administration & dosage/*adverse effects/therapeutic use PMC - PMC4309063 OTO - NOTNLM OT - acute coronary syndrome OT - acute kidney injury OT - kidney OT - statins EDAT- 2014/05/03 06:00 MHDA- 2015/02/25 06:00 PMCR- 2014/06/01 CRDT- 2014/05/03 06:00 PHST- 2014/05/03 06:00 [entrez] PHST- 2014/05/03 06:00 [pubmed] PHST- 2015/02/25 06:00 [medline] PHST- 2014/06/01 00:00 [pmc-release] AID - jah3524 [pii] AID - 10.1161/JAHA.114.000784 [doi] PST - epublish SO - J Am Heart Assoc. 2014 May 1;3(3):e000784. doi: 10.1161/JAHA.114.000784.