The Attitude Doc

Oct. 21, 2009 (Philadelphia) -- For many people with rheumatoid arthritis, the traditional, and much cheaper, disease-modifying antirheumatic drugs (DMARDs) appear to work just as well as newer TNF blockers that target the underlying disease process, a large study shows.

The findings also suggest that a step-up approach in which patients are started on methotrexate alone, with additional drugs added only if needed, may be preferable to immediate combination treatment, says Larry W. Moreland, MD, chief of rheumatology at University of Pittsburgh.

Moreland and colleagues studied 755 patients, mostly white women. All had early rheumatoid arthritis, with an average of less than four months since diagnosis, and had not yet received disease-modifying antirheumatic drugs (DMARDs).

The study was designed to compare the older and the newer drugs and to look at the benefit of starting with combination therapy compared to step-up therapy.

The patients were divided into four groups. Two groups began with immediate combination therapy: either methotrexate combined with sulfasalazine and hydroxychloroquine (the traditional DMARDs) or methotrexate and the TNF blocker Enbrel.

The other two groups began with methotrexate alone, with step-up treatment adding either sulfasalazine/hydroxychloroquine or Enbrel only if they had persistent disease activity at six months.

Arthritis Drugs: No Difference between DMARDs, TNF Blockers

Two years later, there was no significant difference in disease activity between patients taking triple DMARD therapy or methotrexate + Enbrel. This held true whether they received immediate combination treatment or step-up therapy.

“What this means in real clinical practice is that patients should be started on methotrexate alone, with other drugs added only if they don’t respond,” Moreland says.

“You always want to try to expose the patient to as few drugs as possible,” he says.

Although the traditional DMARDs worked just as well in the study as the TNF blocker, Moreland isn’t ready to conclude that holds true for all patients.

"While the results may show that, overall, both treatments have similar outcomes, we still are not certain how to best treat individual patients," he says.

Moreland tells WebMD that X-ray images, taken during the study, may show whether one strategy is better at halting disease progression. But those images aren't available yet.

“We clearly need better predictors of who will benefit from which treatment,” says Mayo Clinic rheumatologist John Davis, MD. He moderated a news conference to discuss the new studies at the annual meeting of the American College of Rheumatology.

In the meantime, Davis tells WebMD he tries to prescribe the least aggressive treatment that works. “I have patients that do very well on methotrexate alone,” he says.

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SOURCES:

American College of Rheumatology Annual Meeting, Philadelphia, Oct. 17-21, 2009.

Larry W. Moreland, MD, chief of rheumatology, University of Pittsburgh.

John Davis, MD, assistant professor of medicine, division of rheumatology, Mayo Clinic, Rochester, Minn.

Oct. 21, 2009 -- Parents of boys may get federal funds to pay for the GardasilHPV vaccine to prevent sexually transmitted genital warts, a CDC advisory panel today ruled.

But the Advisory Committee on Immunization Practices (ACIP) did not fully recommend the vaccine to boys, as it does for girls. Full recommendation would make the vaccine routine and mandate energetic efforts by doctors and vaccination programs to encourage boys to get the vaccine. It would also require doctors to give the vaccine to patients who request it for themselves or for their children.

The "permissive recommendation" today extended by the ACIP means that doctors may or may not offer the vaccine. If they choose not to give it, they need only refer patients to a doctor or program that does.

The ACIP also recommended that parents or women may choose either Gardasil or the newly approved Cervarix for prevention of cervical cancer. Both vaccines protect against the two human papilloma virus (HPV) strains most likely to cause cancer.

Parents or young women may choose Gardasil if they also want protection against the two genital wart HPV viruses included in Gardasil but not in Cervarix. But the ACIP declined to recommend one vaccine over the other.

Both vaccines are most effective if given to children before they become sexually active. The ACIP recommends them for girls at age 11 or 12. But they can be given as early as age 9 and as late as age 26.

The ruling by the ACIP now includes Gardasil for boys in the federal Vaccines for Children program. The FDA recently approved Gardasil for use in boys and men ages 9 to 26.

There's no argument that Gardasil can't prevent genital warts in boys -- it does. But the vaccine is expensive, and cost-benefit analyses suggest that making the vaccine routine for boys would add to soaring U.S. health care costs.

Moreover, the ACIP has not yet seen definitive studies showing that the vaccine will prevent penile, anal, and oral cancers in men, although experts tell WebMD that HPV is a major cause of these cancers. Pending such evidence -- scheduled for presentation to the ACIP next February -- the panel was skittish about full approval of the costly vaccine for boys.

SOURCES:

Meeting of the Advisory Committee on Immunization Practices, Atlanta, Oct. 21-22, 2009.

WebMD Health News: "FDA OKs New HPV Vaccine Cervarix."

WebMD Health News: " HPV Vaccine Gardasil OK'd for Boys."

Oct. 21, 2009 -- Gaining no weight during pregnancy or even losing a little weight may be healthier for obese women and their babies than gaining too much weight.

In research made public today, the investigators from Kaiser Permanente confirmed that obese women who gain more weight than they should during pregnancy are more likely to keep the weight on.

Nearly three out of four women in the study gained more than 15 pounds during pregnancy, and, on average, these women retained 40% of the extra weight a full year after giving birth.

"Younger women and first-time mothers were the most likely to gain too much weight," obstetrician/gynecologist and study lead author Kimberly K. Vesco, MD, tells WebMD. "The extra weight increased the risk for complications like hypertension, diabetes, preeclampsia, C-sections, and birth injuries."

Half of Pregnant Women Overweight

Nearly half of pregnant women in the United States today are either overweight or obese -- up from about 25% four decades ago.

Obesity is defined as having a body mass index (BMI) of 30 or more, and for most women that means carrying at least 30 extra pounds. A BMI of 18.5-24.9 is considered normal weight, and 25-29.9 is considered overweight.

For example, a 5-foot, 2-inch-tall woman who weighs 135 pounds would be considered at the upper limit of the normal range (BMI = 25), and she would be considered obese at 165 pounds (BMI = 30).

A 5-foot, 7-inch woman would be considered normal weight up to 160 pounds (BMI = 25) and obese at 195 (BMI = 30).

The independent health policy group Institute of Medicine now recommends that normal-weight women gain between 25 and 35 pounds during pregnancy, overweight women gain 15 to 25 pounds, and that obese women gain between 11 and 20 pounds.

A total of 1,656 women with BMIs of 30 or more at the start of their pregnancies were enrolled in the newly published study. The women were followed for up to 18 months after delivery.

Putting Pregnant Women on a Diet

Some studies suggest that babies born to obese women who don't gain much weight during pregnancy have fewer delivery complications and better outcomes than babies born to women who gain more weight than is recommended.

The Kaiser researchers recently began recruitment for a study examining whether very obese women and their babies fare even better when they gain no weight at all.

The "Healthy Moms" study, funded by a $2.2 million grant from the federal government, will include women who are 50 to 100 pounds above their normal weight at the start of pregnancy, Kaiser Permanente Center for Health Research senior investigator Victor Stevens, PhD, tells WebMD.

"These are not women with just a few pounds to lose," he says. "These are women who are carrying so much extra weight that it is a risk to themselves and their baby."

Putting Pregnant Women on a Diet continued...

Half of the women recruited for the study will receive standard care, including a single counseling session to discuss diet and nutrition.

The other half will receive more intensive counseling to teach them strategies for healthy eating and they will attend weekly support sessions designed to reinforce positive behaviors. They will also be given personalized eating plans that will restrict their calories to about 2,000 a day, Stevens says.

The goal is for these women to be within 3% of their pre- pregnancy weight after delivery.

"The new IOM guidelines call for gaining no more than 20 pounds, but for women who are very obese this may not be the best advice," Stevens says. "We want to see if outcomes are better if these women gain no weight or even lose some weight."

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SOURCES:

Vesco, K.K., Obstetrics and Gynecology, November 2009; vol 114: pp 1069-1075.

Kimberly K. Vesco, MD, MPH, investigator, Kaiser Permanente Center for Health Research, Portland.

Victor Stevens, PhD, senior investigator, Kaiser Permanente Center for Health Research, Portland.

News release, Kaiser Permanente Center for Health Research.

News release,: Institute of Medicine.

WebMD Health News: "Pregnancy Weight Gain: New Guidelines."

WebMD Health News: " Pregnancy: No Weight Gain for Obese Women?"

Oct. 21, 2009 (Philadelphia) -- Using a more sensitive measure of joint damage than in the past, researchers have found that the popular supplement glucosamine does not appear to slow the progression of knee osteoarthritis.

Previous studies that used X-rays to determine whether glucosamine can prevent joint damage in knee osteoarthritis have produced conflicting results. But it was widely acknowledged that X-rays were less than optimal at spotting bone and cartilage damage.

For the new study, researchers turned to souped-up MRI scanners. MRI itself is far more sensitive than traditional X-rays, and the scanners used in the study are twice as powerful as conventional MRI machines, says C. Kent Kwoh, MD, of the University of Pittsburgh School of Medicine.

"Unfortunately, we did not find any evidence that glucosamine can prevent or slow joint damage in individuals with mild to moderate knee pain," he tells WebMD.

The study involved 201 men and women, average age 52, with mild to moderate knee pain due to osteoarthritis. Participants were randomly assigned to take either 1,500 milligrams of glucosamine hydrochloride or a placebo, once daily.

MRI scans and X-rays were taken of both knees, both at the beginning of the study and six months later.

At the end of the six months, the odds of having worsening cartilage damage were the same in both groups. There was also no significant difference in the chance of having worsening bone damage.

Importantly, the analysis took into account risk factors such as age, sex, body mass index, and pain that could affect the results.

Additionally, when a urine biomarker was used as a basis for comparison, there was no difference in the formation of new cartilage between the two groups.

Kwoh reported the findings at the 73rd Annual Scientific Meeting of the American College of Rheumatology.

Kwoh says this isn't the last word on the effectiveness of glucosamine. While six months is long enough to demonstrate a benefit in terms of pain, "we may have to follow people for longer to see a structural benefit [in the cartilage and bone]," Kwoh says.

Also, interpretation of the results was complicated by the fact that the placebo group had less arthritis progression during the study than the researchers had predicted. "We thought they would do worse," he says.

Additionally, there are two forms of glucosamine supplements: the glucosamine hydrochloride used in the study and glucosamine sulfate. "For now, we are cautioning our patients that if they want to take glucosamine, they might want to consider the sulfate formulation," Kwoh says.

Cleveland Clinic rheumatologist Elaine Husni, MD, who moderated a press conference to discuss the findings, says that not a week goes by in which she is not asked about glucosamine.

"To those who really want to take it, I tell them to try it for three to six months. If it's not working after that, I tell them not to waste their money," she tells WebMD.

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SOURCES:

American College of Rheumatology Annual Meeting, Philadelphia, Oct. 17-21, 2009.

C. Kent Kwoh, MD, professor of medicine and epidemiology, division of rheumatology and clinical immunology, University of Pittsburgh School of Medicine.

Elaine Husni, MD, Cleveland Clinic.

Oct. 21, 2009 -- Memory fuzzy after missing out on sleep? Researchers may be one step closer to figuring out what to do about it.

Sleep deprivation makes it harder for the brain to memorize newly learned information, and scientists may have found a way around that problem.

Writing in Nature, University of Pennsylvania graduate student Christopher G. Vecsey, professor Ted Abel, PhD, and colleagues identify a chemical chain reaction linked to sleep deprivation -- and a possible solution.

The researchers used electrical shocks to train lab mice not to move in certain cages, and then deprived some of the mice of sleep for five hours. Those sleep-deprived mice were worse at remembering not to move around in those cages than mice that had been allowed to sleep.

When deprived of sleep, the mice made more of an enzyme called phosphodiesterase 4 (PDE4). In turn, the surplus of PDE4 caused a shortfall of a compound called cAMP, which is involved in forming new memories in a brain area called the hippocampus.

The researchers ran the tests on more mice. And this time, they injected some of the mice with rolipram, an experimental drug that blocks PDE4. For comparison, other mice got placebo shots.

The mice got those shots right after being trained not to move in certain cages, but before sleep deprivation. Sleep-deprived mice that had gotten the rolipram shot aced the memory test; they remembered not to scurry around the cages where they were likely to get shocked.

The researchers aren't recommending rolipram for sleep-deprived people.

But they say their study shows that "it may be possible" to make drugs that target PDE4, and that such drugs "may prove useful in the treatment of the cognitive effects of sleep deprivation."

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SOURCES:

Vecsey, C. Nature, Oct. 22, 2009; vol 46: pp 1122-1125.

News release, Nature.