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Statins

Cholesterol Lowering in Intermediate-risk Persons without Cardiovascular Disease.

11 Jul, 16 | by flee

Implementation of statin therapy in practice for primary prevention of cardiovascular disease is controversial due to concerns over costs and side-effects with broader use and uncertainty regarding LDL goals in the primary prevention population. Previous primary prevention trials suggest a reduction in cardiovascular outcomes in largely white patients with significant risk factors for coronary disease. The HOPE-3 trial randomized a diverse population of 12,000 individuals over 55 years of age (women over 60) with 1-2 relatively modest risk factors for cardiovascular disease (annual risk ~1%) but otherwise no indication for statin therapy to 10 mg of rosuvastatin daily vs placebo. The composite primary outcome was death from cardiovascular causes, non- fatal MI or stroke. Nearly 13% of patients were excluded following roll-in based on side-effects or lab abnormalities. For remaining patients, over median follow of 5.6 years there was a significant reduction in the primary endpoint: 3.7% vs 4.8% favoring treatment (HR 0.76 [CI 0.64-0.91]) with a NNT of 91. An expanded ‘co-primary’ outcome which also included heart failure, revascularization and resuscitated cardiac arrest resulted in a NNT of 73. Of note, there was a significant increase in muscle aches and weakness in the rosuvastatin group (5.8% vs 4.7%) but this did not clearly impact drug discontinuation, which was common at 23.7%. In fact, therapy discontinuation was 2.5% higher in the placebo group. Myopathy or rhabdomyolysis events were very rare, but there was a significant increase in cataracts in the rosuvastin group.

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Statin does not protect against acute kidney injury following cardiac surgery

29 Mar, 16 | by flee

Although statins affect mechanisms that lead to postoperative acute kidney injury (AKI), observational studies have failed to demonstrate a consistent effect of statin therapy on the risk of AKI after cardiac surgery. The Statin AKI Cardiac Surgery randomized control trial sought to determine if high-dose, short-term atorvastatin reduced the risk of AKI following cardiac surgery.  This double-blind, placebo-controlled, single center trial, evaluated high-dose perioperative atorvastatin on AKI in 615 patients undergoing elective coronary artery bypass surgery, valvular heart surgery, or ascending aortic surgery.  The intervention arm received atorvastation 80mg the day prior to surgery, 40mg day of surgery, and 40mg daily for the duration of hospitalization. Patients were randomized with stratification for prior statin use, presence of chronic kidney disease (GFR < 60 ml/min/1.73m2), and history or diabetes. The primary outcome of AKI was defined as an increase of 0.3mg/dL in serum creatinine or initiation of renal replacement therapy within 48 hours of surgery.  The study was terminated after a second interim analysis for concern of increased risk of AKI among statin naïve patients and for futility among patients who were previously on a statin.

 

 

Conclusion: High-dose statin therapy does not reduce the risk of AKI following cardiac surgery.

 

Summarized by Lauren E. Thompson and Steven M. Bradley

 

Billings FT 4th, Hendricks PA, Schildcrout JS, Shi Y, Petracek MR, Byrne JG, Brown NJ. High-Dose Perioperative Atorvastatin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial.

JAMA. 2016;315(9):877-888.

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