Panel Urges Further Research to determine which DCIS Patients may be Candidates for Less-Invasive Therapy

December 20th, 2009

Ductal carcinoma in situ (DCIS), the most common non-invasive lesion of the breast, presents unique challenges for patients and providers largely because the natural course of the untreated disease is not well understood. Because most women diagnosed with DCIS are treated, it is difficult to determine the comparative benefits of different treatment strategies versus active surveillance, meaning systematic follow-up. An independent panel convened by the NIH urged the scientific community to identify appropriate biomarkers and other prognostic factors to better predict the risk of developing breast cancer.

“Instead of treating all women diagnosed with DCIS, we need to determine which individuals are likely to develop invasive breast cancer and which will not,” said Dr. Carmen Allegra, panel chair and Chief of Hematology and Oncology at the University of Florida. “If we could accurately predict this, we might save some women from undergoing unnecessary invasive treatments while achieving the same positive outcomes.”

DCIS is a condition in which a spectrum of abnormal cells are found in the breast duct and have not spread outside the duct to other tissues in the breast. Since the advent of widespread screening mammography in the early to mid 1980’s, rates of DCIS have increased sharply. It is estimated that more than one million U.S. women will be living with a prior diagnosis of DCIS by 2020.

Despite the connotations associated with the term carcinoma, DCIS is associated with ten-year survival rates close to 100% when treated with currently available therapies. These include breast-conserving surgery (local excision, with or without radiation), removal of the breast (mastectomy), and/or tamoxifen. It is important to stress that each of these treatment options has physical and emotional impacts to patients and should be weighed accordingly. The panel recognized that there are relatively few reliable data on the comparative effectiveness of both diagnostic and therapeutic options in DCIS.

To improve our understanding of this complex disease, the panel recommended efforts to ensure detailed collection of clinical, pathological, imaging, and molecular data about DCIS using standardized reporting measures, annotated specimen repositories, and multicenter databases.

The panel emphasized the importance of patient preferences and recommended improved communication between patients and providers, and serious consideration of new nomenclature that more closely reflects the excellent survival rates for this condition.

Efforts to improve communication would also include further development of formal decision aids. Such tools would reduce misinformation and improve understanding of a DCIS diagnosis and the risks and benefits of various treatment options. Individuals who have DCIS should have access to the best possible information and guidance to aid them in making care decisions that reflect their unique circumstances, perspectives, and preferences.

The panel’s updated draft state-of-the-science statement will be available later today at http://consensus.nih.gov. The conference was sponsored by the NIH Office of Medical Applications of Research and the National Cancer Institute along with other NIH and Department of Health and Human Services components. This conference was conducted under the NIH Consensus Development Program, which convenes conferences to assess the available scientific evidence and develop objective statements on controversial medical is sues.

The 14-member conference panel included experts in the fields of oncology, radiology, surgery (general and reconstructive), pathology, radiation oncology, internal medicine, epidemiology, biostatistics, nursing, obstetrics and gynecology, preventative medicine and population health, and social work. A complete listing of the panel members and their institutional affiliations is included in the draft conference statement. Additional materials, including panel bios, photos, and other related resources, are available at http://consensus.nih.gov/2009/dcismedia.htm.

In addition to the material presented at the conference by speakers and the comments of conference participants presented during discussion periods, the panel considered pertinent research from the published literature and the results of a systematic review of the literature. The systematic review was prepared through the Agency for Healthcare Research and Quality Evidence-based Practice Centers (EPC) program, by the Minnesota Evidence-based Practice Center. The EPCs develop evidence reports and technology assessments based on rigorous, comprehensive syntheses and analyses of the scientific literature, emphasizing explicit and detailed documentation of methods, rationale, and assumptions. The evidence report on diagnosis and management of DCIS is available at http://www.ahrq.gov/clinic/tp/dcistp.htm.

The panel’s statement is an independent report and is not a policy statement of the NIH or the federal government. The NIH Consensus Development Program was established in 1977 as a mechanism to judge controversial topics in medicine and public health in an unbiased, impartial manner. NIH has conducted 119 consensus development conferences, and 32 state-of-the-science (formerly “technology assessment”) conferences, addressing a wide range of issues. A backgrounder on the NIH Consensus Development Program process is available at http://consensus.nih.gov/backgrounder.htm.

Lack of sleep may play role in Alzheimer’s: study

December 13th, 2009

A study in mice suggests lack of sleep may play a role in the development of Alzheimer’s disease, U.S. researchers said on Thursday.

The findings, reported in the journal Science, are some of the first to link sleep with the development of Alzheimer’s, the most common form of dementia.

Researchers at Barnes-Jewish Hospital in St. Louis studied levels of amyloid beta — a protein that accumulates in the brain of people with Alzheimer’s — in mice genetically engineered to have a version of Alzheimer’s disease.

Amyloid levels rose in the brain when the mice were awake, and fell when they slept.

When the researchers prevented the mice from sleeping, it made matters worse, said Dr. David Holtzman of Barnes-Jewish Hospital, who worked on the study.

“Sleep deprivation markedly accelerated amyloid-beta plaque formation,” he said in an e-mail.

When the team injected orexin — a compound that regulates sleep — into the brains of the mice, the mice stayed awake longer, and amyloid beta levels rose. And when they blocked orexin, these levels decreased.

In people, orexin plays a role in the sleep disorder narcolepsy, which causes excessive sleepiness.

Holtzman said the findings suggest drugs that target orexin may be useful to try as Alzheimer’s treatments.

They also reinforce the need to treat sleep disorders, not only because they cause immediate problems, but because they may have a long-term impact on brain health, he said.

Despite decades of research, doctors still have few effective weapons against Alzheimer’s, a mind-robbing form of dementia for which there are few effective treatments and no cure. Many treatments that have shown promise in mice have had little effect on humans with Alzheimer’s disease.

More than 35 million people globally will suffer from Alzheimer’s disease or other forms of dementia in 2010, according to the Alzheimer’s Association.

Women With Atrial Fibrillation Face Rougher Road Than Men

December 6th, 2009

Women with atrial fibrillation are significantly more likely to have a stroke or die than are men with the heart condition, a new study has found.

Despite this, the study suggests, women with the condition receive less medical attention than men.

Atrial fibrillation occurs when the two small upper chambers of the heart, the atria, quiver rather than beat effectively. This can lead to pooling and clotting of blood. If a clot travels from the atria to an artery in the brain, it can cause a stroke.

Rush University Medical Center researchers reviewed past studies and medical literature and found that women with atrial fibrillation are more likely than men to experience symptomatic attacks and have recurrences, and that women have significantly higher heart rates during atrial fibrillation, which increases the risk for stroke.

“Stroke is one of the most devastating results of cardiovascular disease, and atrial fibrillation increases the risk of stroke,” the lead investigator, Dr. Annabelle Volgman, medical director of the Heart Center for Women at Rush University Medical Center, said in a news release from the hospital. “Women are at higher risk of atrial fibrillation-related stroke than men and are more likely to live with stroke-related disability, which can significantly lower quality of life.”

Volgman and her fellow researchers reviewed 20 years of studies that examined gender differences in atrial fibrillation and “were able to determine the most rational, safe and effective gender-specific approach to therapy for women.”

For starters, prevention therapies should be emphasized, the researchers said, as should treatments to ensure safe management once the condition is diagnosed.

Their findings and recommendations related to gender differences included:
Women are not prescribed blood thinners as often as men, resulting in a higher incidence of the formation of clots that break loose and block other vessels. The risk/benefit ratio should be assessed individually for each woman.
Women have a greater risk of bleeding from anticoagulation therapy, so this treatment must be monitored carefully.
Closely monitor women being treated with antiarrhythmic drugs because they have a higher risk for life-threatening arrhythmias and slow heart rates requiring permanent pacing.
Women’s hormonal fluctuations can cause more life-threatening arrhythmias.
Monitor women’s potassium levels in the blood because they have a higher risk of low levels, which boost the risk for drug-related arrhythmias.
Because women have a higher sensitivity to such therapies as statins and vasodilators, liver and kidney function should be closely watched.
Women are referred less often or later for non-drug treatments such as pacemaker implantation or ablation. Ablative therapy should remain an option for symptomatic women because they have success rates similar to those of men.

The study also found that, in general, women with atrial fibrillation have a lower quality of life than men with the disease. But the researchers said that careful assessment and relief of symptoms, and adequate control of heart rate or rhythm can make things better.

“For women with atrial fibrillation, these gender differences should always be kept in mind to help prevent strokes and heart failure and improve their quality of life,” Volgman said.

DOSAGE AND ADMINISTRATION LEVITRA

November 29th, 2009

For most patients, the recommended starting dose of LEVITRA is 10 mg, taken orally approximately 60 minutes before sexual activity. The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and side effects. The maximum recommended dosing frequency is once per day. LEVITRA can be taken with or without food. Sexual stimulation is required for a response to treatment.

Geriatrics: A starting dose of 5 mg LEVITRA should be considered in patients 65 years of age (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations and PRECAUTIONS).

Hepatic Impairment: For patients with mild hepatic impairment (Child-Pugh A), no dose adjustment of LEVITRA is required. Vardenafil clearance is reduced in patients with moderate hepatic impairment (Child-Pugh B), and a starting dose of 5 mg LEVITRA is recommended. The maximum dose in patients with moderate hepatic impairment should not exceed 10 mg. LEVITRA has not been evaluated in patients with severe hepatic impairment (Child-Pugh C)

Scans Shed New Light on Concussions

November 24th, 2009

Researchers say they’ve discovered a new way to detect evidence of brain damage after concussions, potentially paving the way toward more effective treatments for head injuries.

By detecting damage from concussions early with the help of the latest brain scanning technology, doctors could begin cognitive rehabilitation treatment and prevent complications, study author Dr. Michael Lipton, an associate director of the Gruss Magnetic Resonance Research Center at Albert Einstein College of Medicine of Yeshiva University, explained in a university news release.

An estimated 1 million Americans suffer from concussions each year, often as a result of accidents and mishaps at sporting events. It can be difficult for doctors to gauge the severity of concussions since symptoms can appear much later; an estimated 30 percent suffer permanent impairment.

In the new study, researchers used diffusion tensor imaging to scan the brains of 20 people who experienced concussions and 20 healthy people.

MRI and CT scans showed no signs of trouble in the brains of the concussion patients, but the diffusion tensor imaging scans did in 15 of them.

“For the first time, we appear to be able to identify the subtle pathology sometimes caused by concussion, providing researchers a ‘pathology target’ for the development of therapies to reduce or eliminate the damage,” study co-author Craig Branch, director of the Gruss Magnetic Resonance Research Center, said in the news release.

Soluble Fiber, But Not Bran, Soothes Irritable Bowel

November 19th, 2009

People with the chronic condition known as irritable bowel syndrome may find relief by consuming soluble fiber (psyllium).

But they’ll get no relief — and perhaps more bowel upset — from bran, a new Dutch study found.

IBS, which involves chronic abdominal discomfort and irregular bowel habits, affects about one in 10 Americans. Some experts have advised increased intake of dietary fiber, but data on the effectiveness of this approach has been limited.

In the study, published online Aug. 28 in BMJ, a team at the University Medical Center Utrecht had 275 adult patients with IBS consume either 10 grams of psyllium (soluble fiber), bran (insoluble fiber) or a placebo twice daily for three months. They then checked patient symptoms at one, two and three months, including abdominal pain and quality of life.

The researchers found psyllium to be most effective in treating IBS. After three months of follow-up, people taking psyllium had a 90-point drop in symptom severity, on average. This compared to a 58-point drop among those taking bran and 49-point drop for those taking the placebo. While symptom severity was eased, the researchers found no difference between the groups in terms of abdominal pain or quality of life.

Bran showed “no clinically relevant benefit,” the researchers said in a news release. In fact, many patients couldn’t tolerate the bran and this group experienced the highest dropout rate.

The findings suggest that psyllium, but not bran, may be a useful first treatment approach to help manage IBS, the researchers said, while bran may not help — or may even exacerbate — the condition.

Treating COPD Early Improves Outcomes

November 12th, 2009

Although there is no cure for chronic obstructive pulmonary disease (COPD), starting treatment early may slow progression of the illness and add years to the lives of sufferers, new research finds.

COPD is a progressive, destructive disease of the lungs that is usually brought on by years of smoking. Symptoms include restricted breathing, secretion of mucus, oxidative stress and airway inflammation. It is estimated that as many as 24 million Americans have COPD, and the number is rising.

Three reports published in the Aug. 29 issue of The Lancet, a special issue devoted to COPD, offer new insight into treatments, including a new anti-inflammatory drug that shows promise.

In the first report, patients who began treatment early with the inhaled drug tiotropium (Spiriva) had better outcomes compared with untreated patients.

“If you treat moderate disease with these anticholinergic drugs, you get clear improvements in lung function, health-related quality of life, exacerbations and even, maybe, in mortality, but that was not statistically significant, but there was a trend,” said lead researcher Dr. Marc Decramer, a professor in the department of pathophysiology at University Hospital of the University of Leuven in Belgium.

In addition, “you seem to reduce the rate at which the disease progresses,” he noted.

For the study, Decramer’s group followed 2,376 patients with early COPD who took part in a study for four years. These patients were randomly assigned to receive Spiriva or a placebo.

The researchers found that the rate of decline in lung function was 12 percent lower among patients receiving Spiriva than for patients receiving the placebo.

In addition, patients taking Spiriva were healthier. Flare-ups of the disease were cut 18 percent, and hospitalizations resulting from flare-ups were reduced 26 percent, compared with patients taking the placebo, the researchers found.

For the best outcomes, Decramer said, COPD needs to be diagnosed in its early stages, and aggressive therapy should begin as soon as possible.

“We need to treat these patients earlier than we presently do,” Decramer said.

Dr. Norman Edelman, chief medical officer of the American Lung Association, agreed that the findings highlight the need to start COPD treatment when the illness is still mild.

“The major new finding is the efficacy of an anticholinergic in patients with relatively mild COPD in improving lung function and quality of life,” Edelman said. “The effects were small but seem real. This is of significance because it points out the usefulness of case finding and treatment of relatively early COPD cases, a somewhat neglected area in clinical practice.”

Two other reports in the same edition of the journal show the benefit of the new drug roflumilast (Daxas) in treating COPD.

Daxas, an anti-inflammatory, is still going through the drug approval process in the United States and elsewhere.

In one study, Dr. Leonardo Fabbri from the University of Modena in Italy and colleagues randomly assigned 3,091 patients with severe COPD to Daxas or a placebo. Over a year, patients taking Daxas experienced improved lung function and had 17 percent fewer flare-ups than patients taking a placebo.

“These results suggest that different subsets of patients exist within the broad range of COPD, and that targeted specific therapies could improve disease management,” the researchers concluded.

In a second report, a research team led by Dr. Klaus F. Rabe, of Leiden University Medical Center in the Netherlands, tested the benefit of Daxas when added to standard COPD treatment with long-acting bronchodilators or anticholinergics.

In this trial, 1,677 patients with moderate-to-severe COPD were randomly assigned to Daxas or a placebo for 24 weeks. Patients were also receiving the bronchodilator salmeterol (Serevent) or the anticholinergic Spiriva.

The researchers found that adding Daxas to treatment with Serevent or Spiriva improved lung function over either drug alone. In addition, Daxas improved respiratory symptoms.

In both studies, Daxas was associated with more adverse side effects, including nausea, diarrhea and weight loss, researchers note.

“Roflumilast improves lung function in patients with moderate-to-severe COPD who are already being treated with long-acting bronchodilators [beta-2 agonists or anticholinergic drugs], although with expected class-specific adverse events. Roflumilast could become an important, concomitant treatment for these patients,” Rabe’s team wrote.

“These effects are clinically important, but not terribly striking,” said Dr. Paul O’Byrne, a professor of medicine at McMaster University Medical Center in Ontario, Canada, and author of an accompanying journal editorial.

For now, there is still no definitive treatment for COPD or treatment that stops the progression in the decrease in lung function.

One problem with these studies is that they don’t compare Daxas with inhaled corticosteroids, which are also anti-inflammatories, OByrne said. “We don’t know what advantage roflumilast has in patients already taking inhaled corticosteroids,” he said.

Dr. Neil Schachter, a professor of pulmonary medicine at Mount Sinai Medical Center in New York City, noted that with only three types of drugs available to treat COPD, something new would be beneficial.

“It’s good to have new compounds introduced for the treatment of COPD … because some patients won’t respond to the three [types of] drugs now available,” Schachter said.

City Must Pay for Man’s Viagra

October 19th, 2009

A Swedish court has ordered local authorities to subsidize a 30-year-old man’s prescription for Viagra, according to UPI .

The man argued that having sex is essential to a reasonable quality of life, and the County Administrative Court in Majorna, Sweden, agreed.

A Swedish medical assistance program had denied the man’s original request because Viagra was not included on a list of subsidized medicines.

The court did not decide how often a person is entitled to receive the sexual potency pills, instead leaving that up to the local support unit of the program.

“This is clearly difficult to assess. How often should someone have Viagra? Is it once a week? Does that amount to a reasonable quality of life?” said Henrietta Nyberg, a spokesperson for the program.

Last year, British doctors treated a newborn boy with Viagra to open narrowed blood vessels around his lungs. The treatment was successful and the boy still takes Viagra six times a day in liquid form.

What is better Viagra or Levitra?

October 9th, 2009

Viagra and Levitra do not differ much from each other, since they work the same way in a body and cause same side effects. The difference consists in dosage of the drugs: the maximum doses of Levitra (20mg) equals to 100mg maximum dose of Viagra.

Levitra also may start to work quicker and be less sensitive to full stomach. But on the other hand, Levitra is a comparatively newer drug versus Viagra`s proven safety track record. Nonetheless people’s reaction to different drugs may vary; and if Levitra does not work for you, it makes sense to try Viagra, but not on the same day in order to avoid overdose.

Workplace Wellness Seems to Really Work

October 3rd, 2009

Workplace wellness programs are an effective way to reduce major risk factors for heart disease, such as smoking, obesity, high blood pressure and diabetes, says a new American Heart Association policy statement.

Each year, heart disease costs the United States about $304.6 billion, the association says. Companies spend 25 to 30 percent of their annual medical costs on employees with significant health risks, mainly because of their increased likelihood of experiencing heart disease and stroke, it says.

But the financial burden also falls on workers, it says, in the form of higher premiums, co-pays and deductibles, reduction or elimination of coverage and trade-offs between insurance benefits and wage or salary increases.

“Research shows that companies can save anywhere from $3 to $15 for every $1 spent on health and wellness within 12 to 18 months of implementing a [workplace wellness] program,” the statement’s lead author, Mercedes Carnethon, an assistant professor of preventive medicine at Northwestern University’s Feinberg School of Medicine, said in a news release from the heart association.

“Beyond cost savings and increased productivity, visionary employers are realizing the value of an employee’s total health,” she said. “An effective worksite wellness program can attract exceptional employees, enhance morale and reduce organizational conflict.”

More than 130 million Americans are employed, according to the association, which means that workplace wellness programs have the potential to reach a sizable population.

“We are making great strides in workplace wellness, but we also know that half of employees don’t have access to these programs, mainly because they work in small companies or for employers that have a small number of employees at multiple sites,” Carnethon said. “We are hoping this paper shows employers large and small the benefits these programs may provide to both their employees and their bottom line.”

Keys to a successful program, according to the policy statement, include:
Smoking/tobacco cessation and prevention
Regular physical activity
Stress management/reduction
Early detection/screening
Nutrition education and promotion
Weight management
Disease management
Cardiovascular disease education, including cardiopulmonary resuscitation (CPR) and automated external defibrillator (AED) training
Work environment changes that encourage healthy behaviors and promote occupational health and safety

The policy statement was published Sept 30 in Circulation.