Archive for November, 2009

DOSAGE AND ADMINISTRATION LEVITRA

Sunday, 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

Tuesday, 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

Thursday, 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

Thursday, 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.