A daily 40-mg regimen of atorvastatin is safe and produced a significantly greater reduction in LDL cholesterol than placebo among patients with rheumatoid arthritis, according to data published in Arthritis & Rheumatology.
“The extent to which statins affect lipid levels and reduce [cardiovascular events] in RA remains uncertain, due to the small number of RA patients included in general population trials,” George D. Kitas, MD, PhD, FRCP, directorate of research and development at the Dudley Group NHS Foundation Trust, and colleagues wrote.
The researchers noted that “the lack of robust primary prevention data, coupled with the multifaceted pharmacological potential of statins in RA suspected at that time, prompted the Trial of Atorvastatin for the primary prevention of Cardiovascular Events in patients with Rheumatoid Arthritis (TRACE RA), the only statin trial with hard [cardiovascular event] endpoints in this population.”
A daily 40-mg regimen of atorvastatin is safe and produced a significantly greater reduction in LDL cholesterol than placebo among patients with RA, according to data.
To determine whether atorvastatin is superior to placebo in the prevention of cardiovascular events among patients with RA, Kitas and colleagues conducted the TRACE RA study, a multicenter, double-blind, randomized trial comparing atorvastatin and placebo. The trial was conducted in 102 rheumatology facilities throughout the United Kingdom, and included 3,002 participants who met the 1987 American College of Rheumatology criteria for RA and were older than 50 years or had an RA disease duration for more than 10 years. Individuals with clinical atherosclerosis, diabetes or myopathy were excluded.
Between Aug. 7, 2007, and Nov. 21, 2011, a total of 1,504 participants were treated with daily 40-mg doses of atorvastatin, while 1,498 received placebo. The researchers followed the participants for a median of 2.51 years, representing 7,827 person-years of follow-up. Primary endpoints included cardiovascular death, myocardial infarction, stroke, transient ischemic attack or any arterial revascularization. Secondary and tertiary endpoints included plasma lipids and safety.
According to the researchers, 1.6% of participants in the atorvastatin group experienced a primary endpoint, compared with 2.4% among those treated with placebo (adjusted HR = 0.6; 95% CI, 0.321.15). In addition, by the end of the trial, participants in the atorvastatin group demonstrated 0.77 ± 0.04 mmol/L lower LDL cholesterol, compared with those in the placebo group (P < .0001). Levels of C-reactive protein were also significantly lower in the treatment: 2.59 mg/L vs. 3.6 mg/L for the placebo (P < .0001).
The risk reduction for cardiovascular events, per mmol/L LDL cholesterol reduction, was 42% (95% CI, –14 to 70), according to the researchers. Rates of adverse events were 19.8% in the atorvastatin group and 19.5% in the placebo group.
“TRACE RA suggests that atorvastatin 40mg daily is safe for the primary prevention of [cardiovascular events] in patients with RA and appears to confer a similar degree of risk reduction in these patients as in other populations,” Kitas and colleagues wrote. “[Cardiovascular event] rates are reducing in this population: this requires further investigation and does not support a primary prevention strategy involving statin use in all RA patients.” – by Jason Laday
Disclosure: Kitas reports honoraria for lectures, advisory board participation and/or hospitality from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Pfizer, Roche and UCB, as well as grant support from Eli Lilly. Please see the full study for additional author disclosures.