Although it did not accomplish exactly what it set out to do, the TRACE RA study is a firm step in the right direction, according toand of Brigham and Women’s Hospital in Boston.
To illustrate their point, Dr. Liao and Dr. Solomon presented a hypothetical RA patient called TR. She is firmly “average,” especially among the population represented in this study. Though she doesn’t seem like a glaring candidate for a statin, we can rightfully assume that – because of RA and a C-reactive protein above 2 mg/dL – her cardiovascular risk is higher than a member of the general population. The next step is determining if a statin will benefit such a patient, something relatively unexplored thus far.
Despite its abrupt termination, the coauthors “laud the investigators of TRACE RA, as this is the first trial among RA patients that was designed to study hard CVD endpoints.” At the very least, the study reinforced that statins are not associated with side effects when paired with typical RA treatments. In the future, Dr. Liao and Dr. Solomon suggested a focus on “better methods for identifying the appropriate patient population in RA to target for CV risk reduction strategies.”
These comments are adapted from an accompanying editorial (Arthritis Rheumatol. 2019 Apr 15. doi: 10.1002/art.40891). Dr. Solomon reported receiving salary support through research contracts from AbbVie, Amgen, Corrona, Genentech, Janssen, and Pfizer.
Atorvastatin proved safe and potentially effective in preventing cardiovascular events in RA patients, according to the prematurely terminated.
“TRACE RA suggests that atorvastatin 40 mg daily is safe for the primary prevention of [CV events] in patients with RA and appears to confer a similar degree of risk reduction in these patients as in other populations,” wroteof the Dudley (England) Group NHS Foundation Trust. The study was published in Arthritis & Rheumatology.
TRACE RA was a multicenter, double-blind, randomized trial that compared atorvastatin with placebo in preventing CV events by reducing LDL cholesterol. Its 3,002 patients with RA were randomized to receive either atorvastatin (1,504) or placebo (1,498). The goal was to follow the participants for 5 years. However, because of an unexpectedly low event rate, the trial was terminated early, resulting in a mean follow-up of 2.5 years.
At the end of the trial, those in the atorvastatin group had 0.77 mmol/L lower LDL cholesterol levels, compared with the placebo group (P less than .0001). Of the patients who received atorvastatin, 24 (1.6%) had a cardiac event versus 36 (2.4%) for placebo (hazard ratio, 0.66; 95% confidence interval, 0.39-1.11; P = .115). The estimated CV event risk reduction per 1 mmol/L reduction in LDL cholesterol was 42% (95% CI, –14% to 70%).
The coauthors acknowledged the study’s limitations, including the fact that it was terminated early because of a lower-than-expected CV event rate. This led to their results not being deemed statistically significant. They noted several reasons why this might have occurred – among them TRACE RA purposely excluding patients with the highest CV event risk – but also recognized that “the low event rate shows that there is a sizeable population of RA patients who have a relatively low CVD risk.”
“This does not support prescribing statins to all RA patients,” they added. “Instead, the decision to prescribe should be based on assessment of the individual RA patient’s risk using, at present, the relevant national or international recommendations and risk assessment tools.”
The study was funded by Arthritis Research UK and the British Heart Foundation. The coauthors report numerous potential conflicts of interest, including receiving honoraria for lectures and advisory boards participation, grant support, and consulting fees from various pharmaceutical companies.
SOURCE: Kitas GD et al. Arthritis Rheumatol. 2019 Apr 15. .
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