Archive for January, 2010

Inhaled steroids: more harm than good in COPD?

Friday, January 29th, 2010

In people who suffer from COPD, a progressive lung disease that makes it hard to breathe, adding an inhaled steroid to a so-called “long-acting beta-2 agonist” may do more harm than good, new research hints.

The benefit of the two-drug approach in COPD is limited, and furthermore, it’s accompanied by substantial risks of pneumonia and other infections, the research team reports.

Still, current guidelines recommend this combination for reducing exacerbations in patients with severe and very severe COPD, Dr. Gustavo J. Rodrigo, from Hospital Central de las Fuerzas Armadas in Montevideo, Uruguay, and his associates point out in the October issue of the journal Chest.

Two examples of drugs that contain only a long-acting beta-2 agonist, or LABA, are Serevent and Foradil. Two examples of drugs that contain both a LABA and an inhaled steroid are Advair and Symbicort.

In a large systematic review, Rodrigo and his colleagues compared the safety and efficacy of regular use of the two agents with that of regular use of a LABA alone.

Their literature search turned up 18 randomized controlled trials involving 12,446 stable patients with moderate-to-very severe COPD.

In the pooled analysis, combination therapy was associated with a significantly reduced risk of moderate COPD flare ups compared with LABA-only therapy (17.5 percent vs 20.1 percent).

Combined treatment had no effect on the incidence of severe COPD exacerbations, however.

Moreover, compared with the single-drug approach, the two-drug approach produced significantly greater improvements in lung function and health-related quality-of-life.

The authors emphasize, though, that “the size of these benefits did not reach the suggested clinically important minimal differences.”

The investigators also found that adding inhaled steroids to the treatment regimen significantly increased patients’ risk of developing pneumonia (by 63 percent), viral respiratory infections (by 22 percent), and fungal infections in the mouth (by 59 percent).

And the two-drug approach did not reduce overall death rates compared with single-drug therapy.

For now, Rodrigo and associates conclude, “it’s likely” that most patients with COPD with these levels of severity should be treated only with a LABA — at least until future research identifies which COPD patients are likely to benefit from inhaled steroids.

Mastectomy Not First Choice for Most Breast Cancer Patients

Thursday, January 21st, 2010

Contrary to common belief, most women diagnosed with breast cancer are not turning to mastectomy as their first choice for treatment but are first trying more conservative approaches, such as lumpectomy, a new survey has found.

The survey, reported in the Oct. 14 issue of the Journal of the American Medical Association, also found that U.S. doctors are doing a good job of presenting newly diagnosed breast cancer patients with a range of treatment options.

The researchers found that those women who did opt for mastectomy instead of breast-conserving surgery often did so because of their own preference and probably because of the perception that mastectomy offered better odds against the cancer coming back.

However, “the chances of surviving breast cancer are the same whether you have a lumpectomy or a mastectomy,” noted the study’s lead author, Dr. Monica Morrow, chief of the breast service and chairwoman of clinical oncology at Memorial Sloan-Kettering Cancer Center in New York City.

“There’s an overwhelming feeling that somehow ‘bigger’ surgery is better surgery,” Morrow said. “It’s something I hear over and over again: ‘I want to be safe so I will have the mastectomy.’ ”

The researchers wrote in their report that they undertook the study because there’s been a perception that women have been given mastectomies unnecessarily, when breast-conserving surgery might have been an option.

The team reviewed data from the U.S. National Cancer Institute’s Surveillance, Epidemiology and End Results registries in Los Angeles and Detroit. They included data on 1,984 women with intraductal, stage 1 or stage 2 breast cancer who completed a telephone survey about their experience with cancer surgery.

The women, 20 to 79 years old, included 953 women who listed their race as white or other, 502 Hispanic women and 529 black women.

Most of the women — 75 percent — chose breast-conserving surgery initially. According to Morrow, some women who chose breast-conserving surgery eventually had a mastectomy, and these were typically women with larger, stage 2 tumors. The choice did not appear to be affected by race, education or where a woman was treated, Morrow noted.

Of those who initially underwent mastectomy, many could identify the reason that mastectomy was the best option for them, suggesting that it was something discussed in detail with their doctor.

Almost 9 percent of the women chose to have a mastectomy because of personal preference.

Nearly one in five women sought a second opinion, and women with higher education levels were more likely to do so. But, regardless of education level, the researchers found that getting a second opinion was rarely a deciding factor in choosing the type of treatment.

“Most of the time, a second opinion didn’t make a difference in the recommendations that a woman is offered,” she said. “So if you feel comfortable with your surgeon, don’t feel obligated to seek a second opinion.”

Additional surgery was required in about 38 percent of women who first underwent a lumpectomy, according to the survey.

“This study addresses the concern that mastectomy is overused, and I really don’t think it’s being overused,” said Dr. Nora Jaskowiak, an associate professor of surgery and the surgical head of the University of Chicago Breast Center. “Surgeons definitely try to save as many breasts as is reasonable to do.”

“Patients and surgeons can discuss the options, and together they will make the best decision for that woman,” she said.

Outbreak Investigation Highlights Drug Safety Issues

Thursday, January 14th, 2010

An outbreak of bloodstream infections in the United States a few years ago was caused by contamination of pre-filled heparin and saline syringes made by a company that wasn’t following safety regulations, according to a new report that identified areas in medical monitoring systems that need to be improved.

Between October 2007 and February 2008, 162 bloodstream infections caused by the bacteria Serratia marcescens were reported at health-care facilities in nine states. An investigation traced the problem to pre-filled syringes from a single manufacturer.

“Close collaboration among federal agencies, public health authorities and clinicians was critical to the identification of the cause of this outbreak,” wrote Dr. David Blossom, of the U.S. Centers for Disease Control and Prevention, and colleagues.

An inspection of the company’s manufacturing facility revealed poor compliance with the U.S. Food and Drug Administration’s Good Manufacturing Practices and quality system regulations. A few days after the inspection, the company stopped making medical products, the authors of the report noted.

“In the course of the investigation, we also identified several challenges to medical product tracking that should be addressed promptly so that disease outbreaks caused by exposure to contaminated medications can be dealt with more efficiently in the future,” Blossom and colleagues wrote.

For example, none of the syringes had the manufacturer’s name on the label, which instead had the names of subsidiaries or different companies. A large number of distributors acted as middlemen between the maker and the health-care facilities that used the contaminated syringes.

The report appears in the Oct. 12 issue of the Archives of Internal Medicine.

In an accompanying editorial, one expert called for improvements in the FDA’s ability to monitor drug safety in the United States.

“We simply must, as a nation, recognize that we cannot reverse this trend toward globalization, that the solution to a safe drug supply is a strong FDA, not reliance on foreign governments,” wrote former FDA associate commissioner William K. Hubbard. He called for increased funding and staffing for the FDA.

Phone Counseling Helps Teens Quit Smoking

Wednesday, January 6th, 2010

New research suggests that teens are more likely to quit smoking if they receive telephone counseling to build their motivation and cognitive behavior skills.

Researchers developed a telephone-counseling program and evaluated it by recruiting 2,000 smokers who were juniors at 50 Washington state high schools.

After getting parent permission, the researchers tested the program on students at 25 of the high schools.

A year later, almost 90 percent of the students took part in a follow-up survey. Twenty-two percent of students said they’d stopped smoking for six months, compared to 18 percent of the other smokers who didn’t take part in the program. The counseling program also appeared to help smokers quit for three months, one month, seven days and to extend the period of time since the student last smoked a cigarette.

The teen study is the first of its kind to report a statistically significant difference in quit rates over a one-year period, the authors say.

“The results of the trial show that proactive identification and recruitment of adolescents via public high schools can produce a high level of intervention reach,” the authors wrote, “and that delivery of a proactive, personalized counseling intervention via the telephone by well-trained counselors can be effective in increasing teen smoking cessation.”

“[W]hen a game-changing study provides new hope for how tobacco-using youth can be treated, the collective ears of the public health community should perk to attention,” wrote Scott J. Leischow of the University of Arizona’s Arizona Cancer Center and Eva Matthews of the university’s department of family and community medicine in an accompanying commentary.