The incidence of kidney injury for patients treated with a high-potency versus moderate-potency statin regimen after an acute coronary syndrome

Amy Sarma, Christopher P. Cannon, James A de Lemos, Jean L. Rouleau, Eldrin F. Lewis, Jianping Guo, Jessica L. Mega, Marc S. Sabatine, Michelle L. O'Donoghue

Research output: Contribution to journalArticle

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Abstract

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 highpotency (simvastatin 40 mg/day×1 months, then simvastatin 80 mg/day) versus a delayed moderate-potency statin strategy (placebo×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 moderatepotency 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.

Original languageEnglish (US)
Article number000784
JournalJournal of the American Heart Association
Volume3
Issue number3
DOIs
StatePublished - 2014

Fingerprint

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Acute Coronary Syndrome
Kidney
Incidence
Wounds and Injuries
Simvastatin
Pravastatin
Creatinine
Odds Ratio
Confidence Intervals
Serum
Acute Kidney Injury
Observational Studies
Diabetes Mellitus
Therapeutics
Databases

Keywords

  • Acute coronary syndrome
  • Acute kidney injury
  • Kidney
  • Statins

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

The incidence of kidney injury for patients treated with a high-potency versus moderate-potency statin regimen after an acute coronary syndrome. / Sarma, Amy; Cannon, Christopher P.; de Lemos, James A; Rouleau, Jean L.; Lewis, Eldrin F.; Guo, Jianping; Mega, Jessica L.; Sabatine, Marc S.; O'Donoghue, Michelle L.

In: Journal of the American Heart Association, Vol. 3, No. 3, 000784, 2014.

Research output: Contribution to journalArticle

Sarma, Amy ; Cannon, Christopher P. ; de Lemos, James A ; Rouleau, Jean L. ; Lewis, Eldrin F. ; Guo, Jianping ; Mega, Jessica L. ; Sabatine, Marc S. ; O'Donoghue, Michelle L. / The incidence of kidney injury for patients treated with a high-potency versus moderate-potency statin regimen after an acute coronary syndrome. In: Journal of the American Heart Association. 2014 ; Vol. 3, No. 3.
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AU - Lewis, Eldrin F.

AU - Guo, Jianping

AU - Mega, Jessica L.

AU - Sabatine, Marc S.

AU - O'Donoghue, Michelle L.

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N2 - 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 highpotency (simvastatin 40 mg/day×1 months, then simvastatin 80 mg/day) versus a delayed moderate-potency statin strategy (placebo×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 moderatepotency 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.

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 highpotency (simvastatin 40 mg/day×1 months, then simvastatin 80 mg/day) versus a delayed moderate-potency statin strategy (placebo×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 moderatepotency 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.

KW - Acute coronary syndrome

KW - Acute kidney injury

KW - Kidney

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