Study stopped early because statins increased the risk of acute kidney injury in patients with kidney disease

This study was published in the Journal of the American Medical Association 2016 Mar 1;315(9):877-88

 

Study title and authors:

High-Dose Perioperative Atorvastatin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial.

Billings FT 4th, Hendricks PA, Schildcrout JS, Shi Y, Petracek MR, Byrne JG, Brown NJ.

Department of Anesthesiology, Vanderbilt University School of Medicine, Nashville, Tennessee

 

This study can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/26906014

This study investigated the relationship between short-term high-dose perioperative atorvastatin and acute kidney injury following cardiac surgery. The study included 615 patients (199 statin-naïve and 416 statin-using) and 308 of these were randomized to atorvastatin and 307 to placebo. The average patient age was 67 years.
(i) Patients naive to statin treatment were randomly assigned 80 mg of atorvastatin the day before surgery, 40 mg of atorvastatin the morning of surgery, and 40 mg of atorvastatin daily following surgery or matching placebo.
(ii) Patients already taking a statin prior to study enrolment continued taking the preenrollment statin until the day of surgery, were randomly assigned 80 mg of atorvastatin the morning of surgery and 40 mg of atorvastatin the morning after or matching placebo, and resumed taking the previously prescribed statin on postoperative day 2.

The study found:
(a) After an interim review, the data and safety monitoring board recommended stopping the group naive to statin treatment due to a 235% increased risk of acute kidney injury among these participants with chronic kidney disease receiving atorvastatin.
(b) After a further review, the data and safety monitoring board later recommended stopping for futility, as the data revealed statins were increasing the risk of acute kidney injury by 6% overall and by 61% in statin naïve patients.
(c) Those who took statins had a 25% increased risk of the more serious stage 2 or stage 3 acute kidney injury compared to those who did not take statins.

The study also revealed:
(d) Those given the statins had a 20% increased risk of muscle pain compared to those taking placebo.
(e) Those given the statins had a 44% increased risk of stroke compared to those taking placebo.
(f) Those given the statins had a 11% increased risk of atrial fibrillation compared to those taking placebo.
(g) Those given the statins had a 202% increased risk of in hospital death compared to those taking placebo.

Links to other studies:
Statins increase the risk of diabetes in kidney transplant patients
Statin use is associated with a 30-36% increased incidence of acute and chronic kidney disease
Statin use associated with a 59% increased risk of kidney failure

Atrial fibrillation induced by simvastatin

This paper was published in Heart and Vessels 2003 Jul;18(3):157-9

Study title and authors:
Atrial fibrillation induced by simvastatin treatment in a 61-year-old man.

Akahane T, Mizushige K, Nishio H, Fukui H, Kuriyama S.
Third Department of Internal Medicine, Nara Medical University, Nara, Japan.

This paper can be accessed at: http://www.ncbi.nlm.nih.gov/pubmed/12955433

This paper describes the case of a man  who developed atrial fibrillation after starting statin therapy. Atrial fibrillation is a heart condition that causes an irregular and often abnormally fast heart rate. Symptoms of atrial fibrillation include heart palpitations, fainting, shortness of breath, or chest pain. The disease increases the risk of heart failure, dementia, and stroke

(i) A 61 year old man started simvastatin treatment (5 mg once daily).
(ii) Two weeks later he developed palpitation.
(iii) He visited hospital because the palpitation was persistant for two days.
(iv) An electrocardiogram revealed atrial fibrillation.
(v) Simvastatin was withdrawn and his heart rate returned to normal after three days.
(vi) The patient was followed for 19 months after the withdrawl of simvastatin and has not complained of palpitation while also maintaining a normal heart rhythm.