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The impact of statins in <jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content> is not established. We assessed whether atorvastatin is superior to placebo for the primary prevention of <jats:styled-content style=\"fixed-case\">CVE<\/jats:styled-content>s in <jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content> patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A randomized, double\u2010blind, placebo\u2010controlled trial was designed to detect a 32% <jats:styled-content style=\"fixed-case\">CVE<\/jats:styled-content> risk reduction based on an estimated 1.6% per annum event rate with 80% power at <jats:italic>P<\/jats:italic> &lt; 0.05. <jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content> patients age &gt;50 years or with a disease duration of &gt;10 years who did not have clinical atherosclerosis, diabetes, or myopathy received atorvastatin 40 mg daily or matching placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, stroke, transient ischemic attack, or any arterial revascularization. Secondary and tertiary end points included plasma lipids and safety.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 3,002 patients (mean age 61 years; 74% female) were followed up for a median of 2.51 years (interquartile range [<jats:styled-content style=\"fixed-case\">IQR<\/jats:styled-content>] 1.90, 3.49 years) (7,827 patient\u2010years). The study was terminated early due to a lower than expected event rate (0.70% per annum). Of the 1,504 patients receiving atorvastatin, 24 (1.6%) experienced a primary end point, compared with 36 (2.4%) of the 1,498 receiving placebo (hazard ratio [<jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content>] 0.66 [95% confidence interval (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>) 0.39, 1.11]; <jats:italic>P<\/jats:italic> = 0.115 and adjusted <jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content> 0.60 [95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> 0.32, 1.15]; <jats:italic>P<\/jats:italic> = 0.127). At trial end, patients receiving atorvastatin had a mean \u00b1 <jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content> low\u2010density lipoprotein (<jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content>) cholesterol level 0.77 \u00b1 0.04 mmoles\/liter lower than those receiving placebo (<jats:italic>P<\/jats:italic> &lt; 0.0001). C\u2010reactive protein level was also significantly lower in the atorvastatin group than the placebo group (median 2.59 mg\/liter [<jats:styled-content style=\"fixed-case\">IQR<\/jats:styled-content> 0.94, 6.08] versus 3.60 mg\/liter [<jats:styled-content style=\"fixed-case\">IQR<\/jats:styled-content> 1.47, 7.49]; <jats:italic>P<\/jats:italic> &lt; 0.0001). <jats:styled-content style=\"fixed-case\">CVE<\/jats:styled-content> risk reduction per mmole\/liter reduction in <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol was 42% (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content> \u221214%, 70%). The rates of adverse events in the atorvastatin group (n = 298 [19.8%]) and placebo group (n = 292 [19.5%]) were similar.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Atorvastatin 40 mg daily is safe and results in a significantly greater reduction of <jats:styled-content style=\"fixed-case\">LDL<\/jats:styled-content> cholesterol level than placebo in patients with <jats:styled-content style=\"fixed-case\">RA<\/jats:styled-content>. The 34% <jats:styled-content style=\"fixed-case\">CVE<\/jats:styled-content> risk reduction is consistent with the Cholesterol Treatment Trialists\u2019 Collaboration meta\u2010analysis of statin effects in other populations.<\/jats:p><\/jats:sec>","DOI":"10.1002\/art.40892","type":"journal-article","created":{"date-parts":[[2019,4,15]],"date-time":"2019-04-15T05:06:10Z","timestamp":1555304770000},"page":"1437-1449","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":117,"title":["A Multicenter, Randomized, Placebo\u2010Controlled Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients With Rheumatoid Arthritis"],"prefix":"10.1002","volume":"71","author":[{"given":"George D.","family":"Kitas","sequence":"first","affiliation":[{"name":"Dudley Group NHS Foundation Trust, Russells Hall Hospital, Stourbridge, UK and Research UK Centre for Epidemiology  Manchester UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Nightingale","sequence":"additional","affiliation":[{"name":"University of Birmingham  Birmingham UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane","family":"Armitage","sequence":"additional","affiliation":[{"name":"University of Oxford  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naveed","family":"Sattar","sequence":"additional","affiliation":[{"name":"University of Glasgow, Glasgow, UK and Oxford Centre for Diabetes, Endocrinology and Metabolism  Oxford UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill J. 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