Vioxx Recall: An Opportunity to Review Your Treatment for Arthritis.
WHEN THE POPULAR ARTHRITIS DRUG VIOXX was pulled off the market this fall, many arthritis sufferers felt as if a door were being slammed on one of their treatment options. Even patients taking other medications worried: Are drugs similar to Vioxx-called COX-2 inhibitors--safe?
But Daniel Solomon, MD, a rheumatologist and epidemiologist at the Arthritis Center of Brigham and Women's Hospital in Boston and an associate professor at Harvard Medical School, says arthritis patients should view the news as an opportunity. "There's been tremendous overuse of the COX-2 medications. It's well-documented and I don't think anyone would dispute that," says Dr. Solomon. "The Vioxx recall is a good opportunity to re-evaluate the right treatment. Arthritis represents a very broad range of painful conditions. It's important for doctors and patients to re-evaluate the need for ongoing medication, as well as to consider other options such as physical therapy".
You may find you don't actually need a COX-2 drug such as Vioxx or Celebrex, the other most commonly prescribed medication of this type. "Patients need to realize that these are fancy, expensive Motrins," says Dr. Solomon. "They're not God's gift to arthritis sufferers. They're just a little easier on the belly."
Older, more proven nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (found in Motrin and Advil) or naproxen sodium (Aleve), may be adequate to relieve your arthritis pain. You can also combat arthritis with exercise and diet.
What about Celebrex?
Merck & Co. spent nearly $80 million last year advertising Vioxx, promising arthritis' patients "a beautiful morning," and the drug was used by 2 million people worldwide. But Merck had to yank Vioxx off the market after a study confirmed longstanding concerns that the medication increases the risk of heart attack and stroke. The three-year Merck study actually aimed to test whether the drug could prevent the return of precancerous colon growths; the US Food and Drug Administration (FDA) pressed the company to also look at cardiovascular safety. Patients in the study who took Vioxx for more than 18 months proved twice as likely to suffer a heart attack or stroke.
If you've been taking Vioxx, there's no test to determine if you've already suffered cardiovascular damage. Most experts, however, suggest the risk of clot formation likely drops once the drug is discontinued. Hayes Wilson, MD, chief of rheumatology at Piedmont Hospital in Atlanta and a medical adviser to the Arthritis Foundation, tells Vioxx users, "Don't panic." The risk of an individual Vioxx user suffering a heart attack or stroke related to the drug is "very small," according to the FDA.
So what about Celebrex, which manufacturer Pfizer Inc. has similarly promoted with millions of dollars in advertising? David Felson, MD, MPH, a researcher at the Boston University Medical School Arthritis Center, says, "I believe it's safe. The data do not suggest a similar problem." Dr. Solomon agrees that Celebrex has "a clean bill of health."
Pfizer, in fact, recently announced it would launch a study of whether Celebrex actually helps prevent heart attacks by reducing inflammation in the body. The two-year trial will also hope to dispel any shadow cast over the drug by the Vioxx recall.
The European Agency for the Evaluation of Medical Products, however, cites increased cardiac risk for all COX-2 drugs. In the wake of the Vioxx recall, the FDA has said it will take a second look at the data on the medications, including Celebrex, to see if there is a similar "class effect" on cardiovascular health. All COX-2 inhibitors work by blocking a protein by that name that's been linked to inflammation. They gained popularity in part because they cause fewer ulcers and gastrointestinal problems than traditional NSAIDs.
Pfizer also makes Bextra, another COX-2 inhibitor. The company recently warned that Bextra poses a risk to patients undergoing coronary artery bypass surgery, but said there were no known long-term risks to other users.
Other COX-2 alternatives to Vioxx are now in the pipeline pending FDA approval, including Arcoxia, which is already used in many countries, and Prexige, which is used in Britain although the American FDA rejected it, asking for more data.
Even if Celebrex and other drugs of its type besides Vioxx are perfectly safe, Dr. Solomon says, they may not be right for you unless you're at high risk for gastrointestinal bleeding. He believes the popularity of Celebrex and Vioxx shows how patients and physicians often mistakenly think new "wonder drugs" must be better than older, less-expensive options.
Changing your lifestyle
So before you let Madison Avenue convince you that you need a newfangled "wonder drug," consider the simple, proven benefits of lifestyle changes--diet and exercise. "Diet and exercise are great for osteoporosis," says Dr. Solomon. "That's always the first thing you should do."
Stretching exercises and physical therapy can help reduce arthritis symptoms, as can low-impact exercises such as swimming and biking, even tai chi. Exercise has the added benefit of promoting weight loss, which reduces the stress on your joints.
Tufts researcher Miriam Nelson, PhD, has explored the effectiveness of exercise and diet against arthritis and other aspects of aging in a series of bestselling books (see the Web site www.strongwomen.com for a complete list). In the book Strong Women and Men Beat Arthritis, Nelson collaborated with fellow Tufts researchers Kristin R. Baker, PhD, and Ronenn Roubenoff, MD, MHS, to arm arthritis sufferers with the tools to overcome the pain and limitations of oseteoarthritis and rheumatoid arthritis. The team of Tufts researchers designed a research-based nutrition and exercise program that empowers arthritis sufferers to take the small progressive steps that will enable them to live pain-free. (The $14.95 book may be ordered from Tufts at healthletter.tufts.edu/books/sw_arthritis.html or by calling 973-579-3760.)
"We randomized men and women who had osteoarthritis of the knees to either a home-based strength-training program or a control group for four months," Nelson explains. "The men and women in the strength-training program were given instruction periodically, but otherwise, they followed the exercise program on their own. After four months, those who strength trained had a 43 percent reduction in pain, a 44 percent improvement in physical function, and a 71 percent increase in muscle strength. Furthermore, the subjects also experienced a reduction in depression and a big boost in self-esteem and self-confidence."
The program, a 16-week at-home progressive strength-training plan, uses simple ankle weights and dumbbells. It also highlights the importance of eating a well-balanced diet, detailing the significance of particular vitamins and minerals for arthritis sufferers, such as the omega-3-fatty acids found in fish. (See box at right for more tips.)
Do you need a "wonder drug"?
What if you also need medication for your arthritis pain? "There are a range of options" that patients and their physicians should consider before opting for a medication such as Celebrex, says Dr. Solomon. He and other experts, including those at the Arthritis Foundation (which has a helpful Drug Guide on its Web site at www.arthritis.org/conditions/DrugGuide), recommend that arthritis sufferers explore various possibilities to find the treatment that's right for you. It's not unusual, says the Arthritis Foundation, for patients to try several options before finding one that works.
In terms of medications, here are some of the choices to consider:
• Salicylates --This oldest category of NSAIDs includes good old aspirin, which many doctors and patients still prefer. The frequent large doses necessary for controlling arthritis pain and inflammation may cause side effects, so consult your doctor, who may prescribe a nonacetylated salicylate, a chemical variation with fewer side effects. If you're already taking aspirin for prevention of heart disease or stroke, ask your doctor before taking any other NSAID for arthritis pain. And don't combine aspirin with a COX-2 inhibitor, as the aspirin reduces most of the COX-2 drug's stomach-protecting benefits.
• Ibuprofen, naproxen and diclofenac --If these traditional NSAIDs cause gastrointestinal problems, they may be combined with over-the-counter stomach-protecting drugs such as Prilosec or Pepcid (known as "proton-pump inhibitors"). "This combination can be equally as effective as COX-2 inhibitors," says Dr. Solomon, "and taking two different medications can be cheaper." This typically means taking more doses daily than the once-a-day COX-2 drugs, however.
• Nabumetone --Dr. Felson recommends this prescription NSAID as a "relatively benign" alternative if you experience stomach problems from other NSAIDs.
• Acetaminophen --Sold over the counter in such familiar brands as Tylenol, this may also be combined with codeine as an effective arthritis treatment, according to Dr. Solomon.
New treatments and therapies
If none of these options provide relief, COX-2 inhibitors aren't the only new weapons in the battle against arthritis pain. Other treatments being developed include:
• Injectable painkillers --These last six months to a year. The FDA has approved two brands for knee pain, Hyalgan and Synvisc, both of which use hyaluronic acid to lubricate joints. Patients get several shots over a period of weeks.
• Topical NSAIDs --A recent study tested diclofenac drops, rubbed into painful knee joints, to treat arthritis without gastrointestinal side effects.
• Glucosamine --The National Institutes of Health is conducting a large-scale study, to be published next year, on the effectiveness of glucosamine against osteoarthritis of the knee. Glucosamine is a compound that occurs naturally in the body. The glucosamine in dietary supplements, however, comes from shellfish, so if you have a shellfish allergy you should consult your doctor before taking these supplements. Diabetics should also be wary--glucosamine is an amino sugar.
Other treatments for arthritis abound, though the evidence that they can help may be sparse. Another dietary supplement found naturally in the body, chondroitin sulfate, has been promoted as an arthritis fighter. (The Arthritis Foundation offers a free 24-page guide to supplements, which you can order at www.arthritis.org/conditions/SupplementGuide.) Claims are made for acupuncture, for the antioxidants found in tart cherries, even for bee-venom injections.
So if you're concerned about the Vioxx recall, don't panic. Instead, take advantage of this opportunity for a fresh look at how you're managing your arthritis pain. You may find that you don't need the most expensive "wonder drugs." You may even be able to do as much to combat arthritis with diet and exercise as you've previously achieved with drugs.
Says Nelson, "We have seen firsthand what a difference changes in lifestyle can make for people with arthritis."
On Your Table: Diet vs. Arthritis
Tufts researchers recommend ways you can eat to beat arthritis. For detailed menus as well as step-by-step exercise plans, see the book Strong Women and Men Beat Arthritis.
• Omega-3 fatty acids from fish --The best sources of these inflammation--suppressors are coldwater fish such as salmon, halibut and sardines.
• Other Omega-3 sources --Though not as powerful as fish, other sources include flaxseed oil, pecans, walnuts, tofu and, to a lesser degree, green leafy vegetables.
• Fruits and vegetables --Eat a minimum of six servings of produce daily, at least three each of fruits and of vegetables.
• The right oils --Pick canola and soybean oils instead of corn, safflower and cottonseed oil, which contain more omega-6 fatty acids that may compete in the body with healthy omega-3s.
• vitamin D --Milk is the only food with appreciable amounts of this nutrient that staves off arthritis symptoms. You may need to supplement your Vitamin D intake to get at least 400 International Units daily (milk has only 300 units a cup).