Statins may have some benefits in patients with RA
medwireNews: Findings from the TRACE RA trial suggest that atorvastatin has a favorable safety profile and may reduce low-density lipoprotein (LDL) cholesterol levels in patients with rheumatoid arthritis (RA).
However, rates of the composite primary endpoint of cardiovascular death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization were not significantly different among patients treated with atorvastatin versus placebo, say George Kitas (Dudley Group NHS Foundation Trust, UK) and study co-authors.
As reported in Arthritis & Rheumatology, 1.6% of 1504 participants who were randomly assigned to receive atorvastatin 40 mg/day experienced the primary endpoint over a median 2.51 years of follow-up. This was numerically lower than the 2.4% event rate for the 1498 patients allocated to receive placebo, with a nonsignificant hazard ratio of 0.66 favoring atorvastatin.
The TRACE RA (Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients with Rheumatoid Arthritis) investigators note that the event rate for the primary outcome in this trial was “unexpectedly low,” which resulted in “limited statistical power to detect an effect during the planned five years of follow-up, [and] premature termination of the trial.”
Therefore, “it is not surprising that the hazard ratio for the primary endpoint was not significant,” they add.
Nonetheless, the researchers found that atorvastatin-treated patients had significantly lower average levels of LDL cholesterol compared with those given placebo at the end of the study, at 2.21 versus 2.98 mmol/L.
Moreover, a comparable proportion of patients in the atorvastatin and placebo arms experienced adverse events, at 19.8% and 19.5%, respectively. Rates of hospitalizations, elevations of liver or muscle enzymes, worsening of RA, and myalgia were also similar in both arms.
Noting that 86% of study participants were receiving conventional DMARDs, 16% biologic DMARDs, and 17% corticosteroids, Kitas and colleagues say: “These results suggest that atorvastatin 40mg (and lower doses) is safe to use in patients with RA already receiving DMARD therapy.”
The authors of an accompanying editorial, Katherine Liao and Daniel Solomon (both from Brigham and Women’s Hospital, Boston, Massachusetts, USA) say that TRACE RA was “the first trial among RA patients that was designed to study hard CVD [cardiovascular disease] endpoints.”
They believe that the broad inclusion criteria – age of more than 50 years, RA disease duration of more than 10 years, and no statin therapy at baseline – “were appropriate,” but that “better methods for identifying the appropriate patient population in RA to target for CV risk reduction strategies” are needed.
The study authors say that their trial “does not support prescribing statins to all RA patients.”
Rather, “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 – while disease specific algorithms are developed and validated,” they conclude.
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