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Should you take statins for rheumatoid arthritis?

Last updated: June 2010

Rheumatoid arthritis is a disease that causes the immune system, which normally fights infection, to attack healthy joints. This produces inflammation in the joints, resulting in pain, swelling, and ultimately the destruction of cartilage and bone. A recent study, published in the journal Arthritis & Rheumatism, found that the disease is on the rise among women; they make up about 75 percent of the more than 1.3 million people with rheumatoid arthritis in the U.S.

Treatments have improved significantly in recent years, but patients still face an increased risk of disability and premature death. Surprisingly, the No. 1 cause of their shortened life span is not rheumatoid arthritis but a heightened risk of cardiovascular disease associated with it. There appears to be a link between chronic inflammation that leads to joint damage in people with rheumatoid arthritis and damage to the heart and blood vessels, increasing the risk of heart attack and stroke.

The cholesterol-lowering drugs known as statins are FDA-approved to reduce elevated levels of LDL cholesterol in the blood, which can build up on artery walls and trigger a heart attack or stroke. These drugs also appear to reduce inflammation in the body for some people. In doing so, the drugs might offer dual benefits for people with rheumatoid arthritis, reducing both their disease and their increased cardiovascular risk.

Now a growing number of experts, as well as new European guidelines, recommend expanding treatment criteria to allow more people with rheumatoid arthritis to take statins. (Prescribing a statin to reduce the symptoms of rheumatoid arthritis is an off-label use in the U.S.)

But others say the studies don't endorse that broader use. "They show a measurable but very small statin effect on some inflammatory scores, like how much joint swelling a patient has," says Eric Matteson, M.D., a professor of medicine and chief of rheumatology at the Mayo Clinic, and chairman of the communications committee of the American College of Rheumatology. "What we're really interested in is: Will those patients live longer? Will they get less joint damage, less joint deformity, and less vascular disease related to the underlying inflammation? All those are unanswered questions."

What is the evidence for the use of statins for rheumatoid arthritis?

Only a few published clinical trials have investigated the effects of statins for rheumatoid arthritis, and most of them involved small numbers of patients.

In the Trial of Atorvastatin in Rheumatoid Arthritis (TARA), a large randomized controlled double-blind experiment, 116 people received either atorvastatin (Lipitor) or a placebo in addition to existing treatment with an antirheumatic drug. After six months, the statin group showed reductions in swollen joint counts, cholesterol levels, and markers of inflammation compared with the placebo group.

In addition, a large observational study from Japan found that people with rheumatoid arthritis who took statins had less pain and lower swollen joint counts than those who did not. And in a very small randomized placebo-controlled double-blind trial (involving just 20 patients), high-dose atorvastatin boosted the anti-inflammatory effects of HDL (good) cholesterol after 12 weeks but did not alter rheumatoid arthritis symptoms.

What are the statin risks

Although atorvastatin was well-tolerated in TARA, there are no data on the long-term safety of statins used by people with rheumatoid arthritis. The following risks associated with statin use for high cholesterol have been reported in the general population:

Liver damage might occur in 1 to 3 percent of adults, and might be more likely if they also take methotrexate (Rheumatrex and generic) or leflunomide (Arava and generic), drugs that are used to treat rheumatoid arthritis.

Muscle damage might range from mild pain to, in rare cases, rhabdomyolysis, in which muscle breakdown can lead to kidney failure and coma. In a 2010 safety announcement, the FDA warned of an increased risk of muscle injury with 80 mg of simvastatin (Zocor and generic) compared with lower doses and possibly other statins. Muscle risks might also increase in people who use a statin while taking cyclosporine drugs (Gengraf, Neoral), which are used to treat rheumatoid arthritis. In general, the lowest statin dose possible should be prescribed to avoid muscle pain, a side effect in up to 10 percent of the people who take these medications.

Type 2 diabetes risk was 9 percent higher in people who took a statin in a 2010 meta-analysis of 13 randomized controlled trials that was published in The Lancet medical journal. That increase was outweighed by the drug's benefits in people with moderate or high cardiovascular risk.

What precautions should you take?

In addition to the drug interactions described above, tell your doctor if you use or plan to use medications that might increase the side effects of statins, such as antifungals, certain antibiotics, calcium-channel blockers, nefazodone, and warfarin (Coumadin and generic).

Avoid consuming large amounts of grapefruit or grapefruit juice, which has been shown to increase the potential for side effects associated with atorvastatin (Lipitor); lovastatin (Mevacor and generic); and simvastatin (Zocor and generic).

Your doctor should test your liver enzyme levels and muscle enzymes before you start statin treatment and again after the first 12 weeks. Liver tests should be repeated annually.

Immediately report any potential sign of liver damage, including fatigue, nausea, vomiting, a markedly reduced appetite, jaundice, or pain in the upper-right portion of your abdomen.

Immediately report possible symptoms of rhabdomyolysis, such as muscle pain, tenderness, soreness, or weakness, or brown, red, or dark-colored urine.

Women of childbearing age should use effective contraception while taking statins, and avoid them altogether if they are pregnant, trying to become pregnant, or breast-feeding.

What other options can you try?

Starting drug treatment for RA soon after you're diagnosed might help. Taking a disease-modifying antirheumatic drug (DMARD) early on helps prevent irreparable joint damage that might occur if DMARD use is delayed. They include hydroxychloroquine (Plaquenil and generic); sulfasalazine (Azulfidine and generic); minocycline (Dynacin, Minocin, and generic); or methotrexate (Rheumatrex and generic). Prompt treatment is also associated with lower cardiovascular risk.

Use the lowest possible dose of corticosteroid medications like prednisone for the shortest time possible. Those drugs reduce inflammation in patients with rheumatoid arthritis but might enhance cardiovascular risk.

Ask your doctor to assess your cardiovascular risk each year.

If your risk score is sufficiently high to require statin treatment based on established guidelines, make sure you receive it. A recent study found that the drugs are underprescribed for high-risk RA patients.

Engage in low-impact aerobic exercises—such as walking—and muscle-strengthening exercises. They lower cardiovascular risk and reduce pressure on the joints. But if a joint is swollen and inflamed, do gentle range-of-motion exercises to keep it flexible, and rest.

Quit smoking. It's a major cause of heart disease and might increase the severity of RA.

If those treatments aren't effective, your doctor might recommend another type of drug, called biologic DMARDs, which are injected or given intravenously. They are quite expensive but might be helpful for people who do not do well on the conventional treatments. Read on for more detailed information about the use of biologic medications to treat rheumatoid arthritis in our most recent Best Buy Drugs report.

Bottom line. Statins should be considered in the management of high cholesterol in RA patients because of their cardiovascular risk status. And statins might provide some benefit in reducing the pain associated with the symptoms of rheumatoid arthritis. The evidence does not support statin use in RA patients who don't have traditional cardiovascular risk factors. Our advice: Talk with your doctor about all available treatments for RA and about monitoring and controlling your cardiovascular risk.

This off-label drug use report is made possible through a collaboration between Consumer Reports Best Buy Drugs and the American Society of Health-System Pharmacists. This is the 13th in a series based on professional reports prepared by ASHP.

These materials were made possible by a grant from the state Attorney General Consumer and Prescriber Education Grant Program, which is funded by a multistate settlement of consumer fraud claims regarding the marketing of the prescription drug Neurontin (gabapentin).

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