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Large Clinical Trial Finds Statins Safe and Likely Effective for Preventing Cardiovascular Events in Patients with Rheumatoid Arthritis

Embargo/Online Publication Date: 00:01 Hours ET, April 15, 2019

[05.01 Hours UK Time (BST)/14:01 Hours Australian Eastern Standard Time (AEST), April 15]

Monday, April 15, 2019 12:01 am EDT
"Lipids and Cardiovascular Risk Through the Lens of Rheumatoid Arthritis."

Results from a large clinical trial indicate that patients with rheumatoid arthritis are likely to experience the same level of cardiovascular benefits from statins as other individuals, without additional risks. The findings appear in Arthritis & Rheumatology, an official journal of the American College of Rheumatology.

Patients with rheumatoid arthritis have an approximately 50 percent higher risk of experiencing cardiovascular events such as heart attack and stroke compared with the general population. By lowering LDL cholesterol, statins are known to help prevent cardiovascular events in certain high-risk individuals, but it’s unclear whether they are safe and effective for patients with inflammatory conditions such as rheumatoid arthritis. 

 To investigate the potential risks and benefits of statins in moderate risk patients with rheumatoid arthritis, researchers designed the Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients with Rheumatoid Arthritis (TRACE RA), a multi-center, randomized, double-blind trial comparing the statin atorvastatin with placebo.

 The trial included 3,002 patients with rheumatoid arthritis who were over aged 50 years or had rheumatoid arthritis for more than 10 years, without clinical atherosclerosis, diabetes, or myopathy. Patients were randomized to receive atorvastatin 40mg daily or placebo.

 During a median follow-up of 2.5 years, 1.6 percent of patients who received atorvastatin and 2.4 percent of patients receiving placebo experienced cardiovascular death, heart attack, stroke, transient ischemic attack, or any arterial revascularization. After adjustments, there was a 40 percent lower risk of cardiovascular events for patients taking atorvastatin, although the difference was not statistically significant. This was because the overall rate of events was low.

 At the end of the trial, patients taking atorvastatin had significantly lower LDL cholesterol as well as significantly lower levels of C-reactive protein, a marker of inflammation, compared with patients taking placebo. Adverse events in the atorvastatin and placebo groups were similar.

 The paper’s lead author is Professor George Kitas of Dudley Group NHS Foundation Trust, while co-senior authors are Professor Jill Belch of the University of Dundee and Professor Deborah Symmons of the University of Manchester.

 “The trial found that the statin reduced levels of cholesterol by similar amounts as has been seen in other populations studied. The results also show that it is as safe for patients with rheumatoid arthritis to take statins as for the general population,” said Prof. Symmons. “In addition, because of the low overall rate of cardiovascular events in the trial population, there is no indication for all patients with rheumatoid arthritis to be prescribed a statin. This is unlike diabetes where the great majority of patients are recommended to take a statin.”

 The study authors recommend that patients with rheumatoid arthritis be prescribed statins according to national or local guidelines for managing cardiovascular risk in the general population.

 An accompanying editorial notes that the study provides information that will be useful for researchers and clinicians who focus on rheumatoid arthritis, and the results may be helpful when considering cardiovascular risk across other rheumatic diseases.

Additional Information

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Full Citation: “Trial of Atorvastatin for the Primary Prevention of Cardiovascular Events in Patients with Rheumatoid Arthritis (Trace Ra): A Multicenter, Randomized, Placebo Controlled Trial.” George D. Kitas, Peter Nightingale, Jane Armitage, Naveed Sattar, Jill J.F. Belch, and Deborah P.M. Symmons, on behalf of the TRACE RA consortium. Arthritis & Rheumatology; Published Online: April 15, 2019 (DOI: 10.1002/art.40892).

URL Upon Publicationhttp://doi.wiley.com/10.1002/art.40892 

Editorial: “Lipids and Cardiovascular Risk Through the Lens of Rheumatoid Arthritis.” Katherine P. Liao and Daniel H. Solomon. 

Disclosures: GDK has received honoraria for lectures, participation in advisory boards and/or hospitality by Roche, Abbvie, Pfizer, Novartis, UCB, BMS, GSK and received grant support from Lilly. PN has no conflicts of interest to declare. JA does not accept honoraria from the pharmaceutical industry, in line with CTSU departmental policy. NS has consulted for Amgen, Sanofi, Boehringer Ingelheim, Janssen, NovoNordik and Eli Lilly and received grant support from AstraZeneca and Boehringer Ingelheim. JJFB has consulted for Amgen, Sanofi, Bayer, Rexgenero, and Astra Zeneca.  DPMS has received honoraria for lectures from Roche. 

Author Contact:

University of Manchester, Lynn.Prime3@mft.nhs.uk and Michael.addelman@manchester.ac.uk.  

Twitter handles: @UoMMskResearch and @FBMH_UoM. Press Office, University of Dundee, Grant Hill, g.hill@dundee.ac.uk

Press Office, Dudley Group NHS Foundation Trust, Jackie Dietrich, dgft.communications@nhs.net

Twitter handle: @DudleyGroupNHS  Facebook: DudleyGroupNHS

About the Journal

Arthritis & Rheumatology is an official journal of the American College of Rheumatology (ACR) and covers all aspects of inflammatory disease. The American College of Rheumatology (www.rheumatology.org) is the professional organization whose members share a dedication to healing, preventing disability, and curing the more than 100 types of arthritis and related disabling and sometimes fatal disorders of the joints, muscles, and bones. Members include practicing physicians, research scientists, nurses, physical and occupational therapists, psychologists, and social workers. The journal is published by Wiley on behalf of the ACR. For more information, please visit http://wileyonlinelibrary.com/journal/art.

About Wiley

Wiley is a global leader in research and education. Our online scientific, technical, medical, and scholarly journals, and our digital learning, assessment, certification and student-lifecycle services and solutions help universities, academic societies, businesses, governments and individuals to achieve their academic and professional goals. For more than 200 years, we have delivered consistent performance to our stakeholders. The Company's website can be accessed at www.wiley.com.

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Contact:

Penny Smith +44 (0) 1243 770448 (UK)
newsroom@wiley.com
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