Study: Chantix May Be Linked to Heart Risk

Researchers Say Taking the Quit-Smoking Drug May Raise the Risk of Heart Attack

July 4, 2011 -- A new study shows an increase in the risk of heart attacks and other cardiovascular events among smokers who take the drug Chantix to help them quit.

The researchers, who reviewed 14 studies on Chantix, found a 72% increase in these events compared to smokers taking a placebo.

The study is published in the Canadian Medical Association Journal.

"Action needs to be taken by the company," says study researcher Sonal Singh, MD, MPH, referring to Pfizer, the maker of Chantix. "They need to put accurate safety information on the label."

In a statement, Pfizer points out that only 1.06% of the nearly 5,000 people in the analysis taking Chantix reported a problem compared to 0.82% of the people taking placebo.

"The actual difference in cardiovascular event rates seen in the Singh analysis was less than one quarter of one percent," the statement notes. "The analysis contains several limitations; most notably that it is based on a small number of events, which raises concerns about the reliability of the authors' conclusions."

Singh, an assistant professor of medicine at Johns Hopkins University, says safety concerns led him to stop prescribing Chantix a year ago.

This is not the first time that the safety profile of Chantix has been called into question. A black box warning, the FDA's most serious safety warning, was added to the Chantix label in 2009 due to concerns of a link with suicidal thoughts and behaviors, depression, hostility, and other behavioral changes.

Last month, the FDA issued a notice that Chantix may be associated with a small, increased risk of heart attacks and other cardiovascular problems among smokers with cardiovascular disease.

The new study finds that Chantix users with no previous history of cardiovascular disease are also at increased risk of serious problems.

In their analysis of data from 14 studies, the researchers found that 52 out of the 4,908 men and women taking Chantix experienced a serious cardiovascular event, such as heart attack, abnormal heart rhythm, stroke, heart failure, or related death, compared to 27 out of the 3,308 in the placebo group. That led the authors to conclude that Chantix raised the risk of serious cardiovascular problems by nearly 72% compared to placebo.

"Our findings have potential regulatory and clinical implications," the researchers conclude.

Tina Kaufman, PhD, an assistant professor of medicine and smoking cessation coordinator at Oregon Health and Science University, says that while the study does raise important safety concerns that doctors should discuss with their patients, the results are not likely to change prescribing practices among the cardiologists with whom she works.

"We're talking about a small risk compared to the huge benefits of quitting," says Kaufman, who was not involved in the study. "It's far more dangerous for them to continue smoking."

Study: Massage Helps Treat Low Back Pain

Researchers Say Massage Provides Pain Relief and Improves Daily FunctioningBy Brenda Goodman
WebMD Health News

July 5, 2011 -- Massage may be serious medicine, at least when it comes to treating persistent low back pain, a new study shows.

Low back pain is one of the top reasons people seek medical attention in the U.S., and it is notoriously tough to treat. Studies show very few medical therapies, from medications to injections to surgeries, reliably relieve it, and some can aggravate the problem.

The new study randomly assigned 400 adults with moderate-to-severe low back pain lasting for at least three months to either weekly whole-body massages for relaxation, weekly massages that focused on specific muscle problems around the lower back and hips, or usual care.

People assigned to the usual care group were tracked by researchers, but they dealt with their back problems on their own. The approach could include, for instance, taking pain medications or muscle relaxants, seeing doctors or chiropractors, physical therapy, or simply not doing anything.

After 10 weeks, participants in both massage groups reported greater average improvements in pain and functioning compared to those in the usual care group. And the type of massage they received didn't seem to matter.

That's good news, researchers say, because relaxation, or Swedish-style, massage is the kind most commonly taught in massage schools and is thus widely available.

For most, the improvements seen with massage were modest.

Daily functioning, for example, improved, on average, between 2 to 4 points on a 23-point scale. Average pain improved about 2 points on a 10-point scale.

Experts say that's a bit better than the degree of benefit that most people see from taking over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, for low back pain.

But for a substantial minority, however, the improvements were much greater.

At the end of the 10-week intervention, 36% and 39% of patients in the massage groups said their pain was nearly or completely gone, compared to 4% in the usual care group.

"It's not really harmful, and it does help a significant chunk of people who have not benefited from other treatments," says study researcher Daniel C. Cherkin, PhD, associate director and senior scientific investigator with the Center for Health Studies at Group Health Cooperative in Seattle.

The study was funded by the National Center for Complementary and Alternative Medicine. It's published in the Annals of Internal Medicine.

"I think this trial is good news in the sense that it suggests that massage is a useful option that helps some substantial fraction of these patients," says study researcher Richard A. Deyo, MD, a professor in the department of family medicine at Oregon Health and Science University in Portland.

"Like in most other treatments, this is not a slam dunk, and it's not like a cure," Deyo tells WebMD, "But it's something that seems to offer a significant benefit for a substantial number of patients."

Study: CT Screening Cuts Lung Cancer Deaths

CT Scans May Be Better Screening Method Than X-Rays for People at High Risk of Lung Cancer

June 29, 2011 -- Screening smokers and former smokers for lung cancer with low-dose CT imaging saves lives, a huge, decade-long study shows, but experts say it is too soon to recommend screening for everyone at risk.

Heavy smokers and former smokers who had the CT imaging were 20% less likely to die of lung cancer than smokers who got traditional chest X-rays.

Results from the National Lung Screening Trial, which included more than 53,000 people, were reported Wednesday in the New England Journal of Medicine.

The study is the first to show that screening can reduce lung cancer mortality by finding tumors early. But many questions remain, including who should have the test and at what cost to the health care system.

"We now know that it is possible to reduce deaths from lung cancer with low-dose CT, and now we need to figure out what to do with this knowledge," Dartmouth Medical School professor of medicine Harold C. Sox, MD, tells WebMD. "There are about 94 million smokers or former smokers in the United States, and screening even a portion of them would be very expensive."

Lung cancer claims about 157,000 lives a year in the U.S., according to the National Cancer Institute, which sponsored the study together with the American College of Radiology Imaging Network.

Beginning in the summer of 2002, more than 53,000 heavy smokers and former heavy smokers between the ages of 55 and 74 were enrolled in the study at 33 sites across the country.

The participants were randomly assigned to receive three annual screenings with either low-dose spiral CT or standard chest X-ray.

A traditional X-ray produces a single image of the chest, while spiral CT involves multiple, three-dimensional images of the chest cavity.

Studies show standard X-ray screening to be somewhat effective for identifying lung cancers, but it has never been shown to reduce deaths from the disease.

During the screening phase of the trial, 39% of the low-dose CT participants and 16% of the standard X-ray group had at least one positive screening result; more than nine out of 10 positive tests in the first round of screening led to further diagnostic testing.

Study: Chantix May Be Linked to Heart Risk

Researchers Say Taking the Quit-Smoking Drug May Raise the Risk of Heart Attack

July 4, 2011 -- A new study shows an increase in the risk of heart attacks and other cardiovascular events among smokers who take the drug Chantix to help them quit.

The researchers, who reviewed 14 studies on Chantix, found a 72% increase in these events compared to smokers taking a placebo.

The study is published in the Canadian Medical Association Journal.

"Action needs to be taken by the company," says study researcher Sonal Singh, MD, MPH, referring to Pfizer, the maker of Chantix. "They need to put accurate safety information on the label."

In a statement, Pfizer points out that only 1.06% of the nearly 5,000 people in the analysis taking Chantix reported a problem compared to 0.82% of the people taking placebo.

"The actual difference in cardiovascular event rates seen in the Singh analysis was less than one quarter of one percent," the statement notes. "The analysis contains several limitations; most notably that it is based on a small number of events, which raises concerns about the reliability of the authors' conclusions."

Singh, an assistant professor of medicine at Johns Hopkins University, says safety concerns led him to stop prescribing Chantix a year ago.

This is not the first time that the safety profile of Chantix has been called into question. A black box warning, the FDA's most serious safety warning, was added to the Chantix label in 2009 due to concerns of a link with suicidal thoughts and behaviors, depression, hostility, and other behavioral changes.

Last month, the FDA issued a notice that Chantix may be associated with a small, increased risk of heart attacks and other cardiovascular problems among smokers with cardiovascular disease.

The new study finds that Chantix users with no previous history of cardiovascular disease are also at increased risk of serious problems.

In their analysis of data from 14 studies, the researchers found that 52 out of the 4,908 men and women taking Chantix experienced a serious cardiovascular event, such as heart attack, abnormal heart rhythm, stroke, heart failure, or related death, compared to 27 out of the 3,308 in the placebo group. That led the authors to conclude that Chantix raised the risk of serious cardiovascular problems by nearly 72% compared to placebo.

"Our findings have potential regulatory and clinical implications," the researchers conclude.

Tina Kaufman, PhD, an assistant professor of medicine and smoking cessation coordinator at Oregon Health and Science University, says that while the study does raise important safety concerns that doctors should discuss with their patients, the results are not likely to change prescribing practices among the cardiologists with whom she works.

"We're talking about a small risk compared to the huge benefits of quitting," says Kaufman, who was not involved in the study. "It's far more dangerous for them to continue smoking."

Study: New Drug Bardoxolone Improves Kidney Function

In Phase II Trial, New Kidney Drug Improved Kidney Function About 30%

June 24, 2011 -- A new drug appears to improve kidney function in people with type 2 diabetes who have chronic kidney disease, new research suggests.

The drug, known as bardoxolone methyl, works in a new way, says researcher David Warnock, MD, the Hilda B. Anderson professor of medicine at the University of Alabama at Birmingham. He is slated to present the results of the phase II trial of the drug today at the European Renal Association-European Dialysis and Transplant Association Congress in Prague.

"This is a promising new treatment that may change the course, the whole way we approach severe kidney disease in diabetics," Warnock tells WebMD.

The results are also published in The New England Journal of Medicine.

Diabetes is a major cause of kidney disease, which boosts the risk of kidney failure and the need for dialysis.

"There are 26 million Americans who have chronic kidney disease," Warnock says. "There are 500,000 on dialysis."

The hope, Warnock says, is to improve kidney function with the drug enough to delay or prevent the need for dialysis, which costs about $75,000 a year per patient.

Lynda Szczech, MD, president of the National Kidney Foundation, who reviewed the findings for WebMD, said the results look impressive, but she awaits results from the final clinical trial (phase III), now under way.

In the study, Warnock and his colleagues looked at three doses of the drug -- 25, 75, and 150 milligrams daily. They compared the drug treatment to placebo. The patients remained on other medications, such as blood pressure-lowering drugs, with the bardoxolone added on.

The new drug is an antioxidant that reduces inflammation, working in a new way. The reduction in inflammation leads to improved kidney function, Warnock says.

In all, they evaluated 227 patients, average age 67. The patients were equally divided into the placebo group and the three drug groups.

The researchers followed them for 52 weeks, evaluating the effect at 24 weeks and at 52 weeks.

Compared to placebo, people on the drug had an increase in their average GFR, a measure of kidney function.

Normal GFR is about 90 to 120 milliliters per minute; below 15 is considered late-stage kidney disease.

At the start of the study, all four groups had similar average GFRs, ranging from about 31 to 33.

At 24 weeks, those on the drug had increases in their kidney function, but no substantial differences occurred in the placebo group. At the 52-week mark, those on the drug still had improvement, but there was no substantial improvement in those on placebo.

The 75 mg dose was deemed best, as it produced on average about a 30% increase in kidney function at 52 weeks, Warnock says. ''The maximal effect was apparent in the first 12 to 20 weeks," he says. After that, it reached a plateau and stabilized.