Atorvastatin=placebo for primary prevention in pts with rheumatoid arthritis

Reference

Kitas GD, Nightingale P, Armitage J, et al. A Multicenter, Randomized, Placebo-Controlled Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2019;71(9):1437-1449.

Synopsis

Patients with rheumatoid arthritis are at higher risk of cardiovascular disease than the general population. These study investigators, funded by government, a foundation, and industry, randomized patients with at least 10 years of rheumatoid arthritis who had not had a previous cardiovascular event to receive atorvastatin (a relatively high dose of 40 mg daily; n=1504) or placebo (n=1498). The patients also had to be at least 50 years of age and free from diabetes or myopathies. There was no run-in period. The study did not require measurement of baseline lipids as a condition of enrollment and the researchers used any prior lipid assessments for comparison, if available. The researchers assessed liver function three months after enrollment and evaluated outcomes every six months after enrollment. After a median of 2.5 years, the study was stopped at which time the main outcome, major vascular event (nonfatal myocardial infarction, nonfatal ischemic stroke, transient ischemic attack, any revascularization procedure, or cardiovascular death), occurred in similar rates between the atorvastatin-treated patients (1.6%) and placebo-treated patients (2.4%, p=0.12). The study was stopped early because the rate of events was much lower than they had expected. The authors report changes in various biomarkers that represent an improved cardiovascular risk profile, but biomarkers are only a probabilistic tool whereas the measurement of the real outcomes is what needs emphasis.