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New Drug Looks Promising For Lung Disease
By Ed Edelson
HealthDay Reporter
FRIDAY, Aug. 12 (HealthDay News) -- Dutch doctors are reporting a successful trial of a new drug for chronic obstructive pulmonary disease (COPD), the collective name for lung problems that are the fourth-leading cause of death in the United States.
Most cases of COPD are caused by either chronic bronchitis, a destructive inflammation of the air-carrying passages of the lungs; or emphysema, in which the tiny air sacs in the lungs that allow oxygen to enter the blood are damaged. Smoking is a leading cause of both conditions.
The new drug, roflumilast, was developed in Europe and is being tested both there and in the United States in trials designed to lead to its approval for medical use. It reduces the inflammation that is a major feature of COPD.
The Dutch trial, the results of which are reported in the Aug. 13 issue of The Lancet, was led by lung experts at Leiden University Medical Center. They enrolled more than 1,100 COPD patients. Half were given standard treatment plus roflumilast, in two different doses, while the other half got a placebo, an inactive substance.
The trial lasted 24 weeks. Over that time, lung function, measured as the amount of air a person could expel from the lungs, improved significantly in patients who got a smaller dose of roflumilast. Those who got a larger dose reported even more improvement. There was no improvement in those who did not get the drug.
The number of severe attacks of breathing problems was 40 percent lower for people who got the larger dose of roflumilast and 28 percent lower for those getting the smaller dose, compared to those getting a placebo. And roflumilast also improved the quality of life of those who got it.
"Roflumilast is a promising candidate for anti-inflammatory COPD treatment," the researchers concluded. But, they added, "long-term studies are needed to fully assess the effect on health-related quality of life."
Such studies are taking place in the United States and Europe, said Dr. Neil Schachter, professor of pulmonary medicine and medical director of the respiratory care department at Mount Sinai Medical Center in New York City. He is involved in one of those studies.
Anti-inflammatory drugs already are used to treat COPD, but "this [roflumilast] is a new class of agent," Schachter said. "It is very specific for a certain enzyme that is involved in smooth muscle contraction, which is one of the features of bronchospasm."
Bronchospasm is the sudden narrowing of the air tubes that causes wheezing and other breathing problems.
Dr. Klaus Rabe is lead author of the new study and chairman of the department of pulmonology at Leiden University. He said, "The principle of interfering with this pathway is a very intriguing concept." But he has concerns about the drug's possible side effects, mainly those affecting the intestinal tract.
"We were able to provide this medication at concentrations that were comfortable to the participants," Rabe said of the study, which he noted is the largest yet done.
The U.S. trials "are for both COPD and asthma patients," Schachter said. "It's hoped that they will open a new class of drugs that have potential for both reducing symptoms of the diseases as well as hopefully some reversible components of the disease, so that it may slow down progression of the disease."
Schachter knows of at least two such studies, each of which is enrolling participants at a number of medical centers. The study in which he is involved has completed enrollment of patients, he said. Since such trials can run for six months or a year, results are not expected until some time next year at the earliest, he said.
Omega-3 diet benefits patients with lung problems
Highlight:
CHEST, the peer-reviewed journal of the American College of Chest Physicians, has published a study that determined a diet rich in omega-3 fatty acids benefits patients with chronic obstructive pulmonary disease (COPD) by improving their lung function and ability to exercise.
Original source:
www.medicalnewstoday.com/medicalnews.php?newsid=35578
Summary:
A diet rich in omega-3 fatty acids, such as those found in fish, canola oil, and walnuts, can have anti-inflammatory effects and improve the exercise capacity for patients with chronic obstructive pulmonary disease (COPD).
- For two years, Japanese researchers followed 32 patients with COPD on an omega-3 fatty acid-rich diet (treatment group) and 32 patients with COPD on a non-omega-3 fatty acid-rich diet (nontreatment group).
- Every three months, dyspnea scores, levels of inflammatory mediators, and exercise capacity were recorded.
- Overall, results showed that dyspnea scores and exercise capacity significantly improved and inflammatory mediators significantly decreased for patients in the treatment group, while there was no significant change in the nontreatment group.
- Researchers suggest that nutritional support with an omega-3 fatty acid-rich diet is a safe and practical method for treating COPD.
- The study appears in the December issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.
First and Only Oral Medication Approved for Pulmonary Arterial Hypertension in HIV Patients
MONTREAL, CANADA -- July 24, 2006 -- Tracleer® (bosentan) is now indicated by Health Canada for patients with pulmonary arterial hypertension (PAH) secondary to HIV in those who did not respond adequately to conventional therapy.
PAH is a life-threatening lung disease associated with elevated blood pressure inside the pulmonary artery. PAH patients typically present with unexplained symptoms such as fatigue, breathlessness, chest pain and fainting. People living with HIV are six to 12 times more likely to contract PAH than the uninfected population. Although there are a number of theories as to why this happens, the precise reasons remain unknown.[i]
This new indication for Tracleer® adds another separate and difficult patient population to those PAH patients who can benefit from the drug. Tracleer® had previously been approved in Canada for the treatment of patients with functional class III and IV (meaning a moderate to severe form of the disease) primary PAH and PAH secondary to scleroderma. It can offer significant clinical benefits including improvements in exercise capacity and a decrease in the rate of clinical worsening.
Tracleer® is the only approved oral treatment in Canada that blocks the body's endothelin receptors. Endothelin is a substance produced by the endothelial cells that form a layer lining the blood and lymph vessels. It has the effect of narrowing the blood vessels and can also harden tissues, causing scarring. Endothelin is known to be a key component in the development of PAH.
A study evaluating the impact of starting treatment with Tracleer® on the survival of primary PAH patients has shown that 96% of patients were alive after one year and 89% were alive after two years. This is compared to a predicted one and two year survival of 69% and 57% respectively based on National Institutes of Health (NIH) registry formula.
"It is a reassuring development that bosentan is now approved for patients who have PAH secondary to HIV, as this is a population for whom specific therapy for PAH was not available. Similar to other patients with PAH, people with HIV can become quite ill and die from their disease" said Dr. John Granton, Respirologist, Toronto General Hospital.
About Pulmonary Arterial Hypertension (PAH)
PAH is a rare and life-threatening disease characterized by abnormally high blood pressure in the pulmonary artery, the blood vessel that carries oxygen-poor blood from the right side of the heart to the lungs. In PAH, there is increased blood flow resistance in the pulmonary arteries, raising pressure and forcing the right side of the heart to work harder. The heart muscle starts to weaken, resulting in right-heart failure. There are a number of treatment options for PAH, although not yet a cure.
Important Safety Information
In clinical trials leading to the marketing approval of bosentan, approximately 11% of PAH patients receiving the drug experienced abnormal but reversible liver enzyme elevations. It is therefore important that patients undergo monthly liver monitoring. Due to the risk of birth defects, women who are pregnant, or of childbearing age who do not use a reliable method of contraception, must not take bosentan.
Tracleer is a registered trademark of Actelion Pharmaceuticals Ltd, CH-4123
Allschwil, Switzerland.
REFERENCE:
[i] http://aids-clinical-care.jwatch.org/cgi/content/full/2001/601/6, accessed January 24, 2006.
SOURCE: Actelion
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