Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Statins for Primary Prevention of CV in RA Patients

In a randomized, placebo-controlled trial, atorvastatin (40 mg daily) was safe and resulted in significantly greater reduction of low-density lipoprotein cholesterol (LDL-C) in patients with rheumatoid arthritis (RA) than placebo, while reducing cardiovascular event (CVE) risk. Patients aged >50 years or with RA duration >10 years, without clinical atherosclerosis, diabetes, or myopathy, received atorvastatin 40 mg daily or matching placebo. Primary endpoint was a composite of CV death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization. Researchers found:

  • 3,002 patients (mean age 61 years, 74% female) were followed for a median of 2.51 years.
  • 1.6% of patients allocated atorvastatin had a primary endpoint compared with 2.4% on placebo.
  • At trial end, patients on atorvastatin had 0.77±0.04 mmol/L lower LDL-C vs placebo.
  • CVE risk reduction per mmol/L LDL-C reduction was 42%.
  • Adverse events were similar between groups.

Citation:

Kitas GD, Nightingale P, Armitage J, et al. Trial of atorvastatin for the primary prevention of cardiovascular events in patients with rheumatoid arthritis (TRACE RA): A multicenter, randomized, placebo controlled trial. Arthritis Rheum. doi:10/1002/art.40892.

Commentary:

We have known for a long time that RA patients have an increased risk of cardiovascular disease but have not had much guidance in its treatment. This study looks at patients who have had RA for more than 10 years and have no history of atherosclerosis or diabetes and compares atorvastatin vs placebo in preventing cardiovascular events. Participants receiving atorvastatin did have a reduction in their LDL-C, but unfortunately the trial was terminated early due to a low cardiovascular event rate; this unexpectedly low rate limits the statistical power of the study to compare events in the atorvastatin and placebo groups. Because of this, we cannot conclude from this study that statins should be used for primary prevention of cardiovascular disease. However, their use appears to be safe without increased risk of myopathy. — Arundathi Jayatilleke, MD