Health Watch

FDA APPROVES CICLESONIDE (ALVESCO)

The FDA has approved Ciclesonide (Alvesco) a novel inhaled corticosteroid for the treatment of bronchial asthma. Ciclesonide appears to have significant advantages over the inhaled steroids currently on the market. It is the first medication in this family that is inhaled in an inactive form. Ciclesonide is activated by an interaction with the lining cells of the bronchial tubes. This feature should reduce adverse effects involving the mouth, throat, esophagus, and stomach such as yeast infection. Ciclesonide is also rapidly metabolized reducing the possibility of total body steroid side effects. It is also administered once a day which should improve patient compliance. Ciclesonide will be available in two dosage strengths, 80 and 160ug.

WHAT IS COPD?

Chronic obstructive pulmonary disease (COPD) which includes emphysema and chronic bronchitis is a slowly progressive disease characterized by cough, sputum production, and shortness of breath. The most common cause of COPD is smoking. COPD is the fourth leading cause of death in this country and a major cause of disability. The National Heart, Lung, and Blood Institute (NHLBI) recommends that persons at risk for COPD (cigarette smokers or those exposed to secondhand smoke with the above symptoms) be tested for the disease with spirometry, a simple breathing test. Early diagnosis improves treatment outcome and prognosis.

ASTHMA AND OBESITY

A recent study has revealed that obese and overweight people are 50 percent more likely to get asthma than those of normal weight, suggesting that weight loss could help reduce the number of asthma cases. Asthma is an inflammatory disease of the airways which produces wheezing, coughing and shortness of breath. It affects about 7 percent of the U.S. adult population and accounts for more than 4000 fatalities each year in the U.S.. Obesity and being overweight affect about 65 percent of U.S. adults.  Obesity is known to produce other lung impairments, even among people who do not have asthma. These impairment result from the effect of increased abdominal girth and restriction of movement of the chest wall by fatty tissue resulting in a loss of lung capacity.

TO SCAN OR NOT TO SCAN?

Screening chest CAT scans for cigarette smokers who are at increased risk for lung cancer are now at the center of a controversy that stems from two conflicting studies. Several months ago a New England Journal of Medicine (NEJM) study concluded that screening chest CAT scans are the equivalent of mammography for the early detection of breast cancer and have the ability to prolong survival and increase the cure rate from lung cancer. A more recent article in the Journal of the American Medical Associaton (JAMA) concluded that early detection did in fact not prolong survival, arguing that whether a lung cancer was picked up early or late did not change the death rate. Two randomized studies are underway comparing chest CAT scans and plain x-rays in the detection and survival from lung cancer. Pending the results of these trials chest CAT scanning has the capability of detecting lesions that are as small as 1-2mm in diameter whereas for a lesion to be seen on a plain chest x-ray it must be 10 mm in size. By the time a lung cancer appears on a plain chest x-ray it has often already spread and is no longer curable. The JAMA article argues that there are lung cancers that are not lethal but does not consider the adverse effects of these slow growing tumors on the quality of life. It also argues that "false positive" CAT scans lead to unnecessary tests. Comment: It is clear that the behavior of all cancers differs but the principle of early detection as a rule provides a more favorable outcome and increases survival. Both of the current studies may suffer from statistical bias but future studies are likely to support the use of screening chest CAT scans for high risk individuals.

WHOOPING COUGH ON THE RISE

An increased number of cases of whooping cough which is caused by a bacterium known as Bordetella pertussis have been reported in adolescents and adults. These cases often do not present with the characteristic "whoop" due to the residual effect of childhood DTP (diptheria, tetanus, pertussis) vaccination. These patients often complain of a violent, persistent cough that often results in vomiting lasting for several weeks. Whooping cough is highly contagious so that outbreaks in schools and offices are common. An adult form of DPT vaccine (Adacel) became available in 2005 and is recommended for adolescents and adults aged 11 to 65.

CHANTIX FOR SMOKING CESSATION MEDICATION

Varenicline (Chantix) is approved by the FDA for smoking cessation. Chantix is the first of its kind, a selective nicotinic receptor agonist, which partially blocks the nicotine effects of smoking and eases withdrawal craving. By blocking the nicotine effects on the brain, this drug interferes with the gratification a smoker gets from lighting up which decreases the chance of relapse. In drug trials, 44% of subjects taking Chantix were smoke free at 12 weeks and 22% were still not smoking at the end of one year. Side effects of the drug include nausea which is transient and described as mild to moderate, insomnia, and vivid dreams. Since its release the FDA has add another a warning that Chantix may cause suicidal thoughts and mood changes. Comment: Chantix was superior to bupropion (Zyban) in clinical trials and is not an antidepressant. It is taken twice a day for 12 weeks with another 12 weeks for those who are successful in quitting smoking. As the one year data show, it is far from successful in all smokers but presents a better option in the struggle to reduce cigarette smoking. The additional warning regarding mood changes requires close monitoring by physicians of patients taking this medication.

INCREASED RISK OF PNEUMONIA IN ASTHMA

An article published in the New England Journal of Medicine reports that the authors found an increased incidence of a form of bacterial pneumonia in asthma sufferers, aged 2 to 49 years of age. The type of pneumonia studied is known as Pneumococcal which is caused by a streptococcus organism. It is the most common form of bacterial pneumonia in the general population. People with asthma had about twice the risk of developing Pneumococcal pneumonia as the general population. A vaccine against Pneumococcal pneumonia, known as Pneumovax, is widely available. Comment: This is the first study that indicates that asthma is a risk factor for the develop of Pneumococcal pneumonia and strongly suggests that all asthmatics be vaccinated against this organism.

POST-POLIO SYNDROME (PPS): NEW MANIFESTATION OF AN OLD DISEASE

It is estimated that between 25 and 40% of individuals who had polio as a child will develop a late manifestation of this disease known as Post-Polio Syndrome or PPS. PPS typically develops after a long period, usually 30 years following the infection but has been reported as early as 15 years and as late as 50 years post-polio. It is manifested as muscle weakness, fatigue and joint pain. It should be emphasized that PPS is not the same as polio and is not contagious. It is thought to represent a breakdown of new nerve connections that formed after the polio infection. It typically involves the muscles that were originally affected. PPS is treated with a combination of exercise and rest as well as physical therapy and the use of assistive devices such as canes and braces.

XOLAIR: WHO SHOULD RECEIVE IT?

Xolair, a new and unique treatment for allergic asthma, is approved by the FDA. Xolair is given by injection, once or twice a month and in clinical trials in patients with moderate to severe asthma reduced the severity and frequency of asthma attacks. Patients receiving Xolair also required fewer inhalations of corticosteroids and had fewer hospitalizations for asthma. Xolair works by neutralizing immunoglobulin E or IgE which is produced by allergic reactions, thereby aborting asthma attacks before they start. It is most effective in allergic asthmatics with elevated IgE levels. Xolair is expensive, costing between $5,000.00-$10,000.00 per year and is not approved for asthmatics under the age of 12. Early research data suggested that patients taking Xolair had an increased incidence of cancer but due to the small number of patients, it is unlikely that this is due to the drug. Comment: Xolair should be administered to the most severe, allergic asthmatics and is not indicated for mild to moderate patients. The FDA estimates that about 15% of asthmatics will be candidates for this drug. Current data indicates that it is greatly beneficial in this group.

LUNG REDUCTION SURGERY: WHO BENEFITS?

Based on the results of the National Emphysema Treatment Trial (NETT), a five year study comparing the effectiveness and safety of lung reduction surgery (LVRS) added to medical therapy versus medical therapy alone for advanced emphysema, Medicare will cover the high cost($30,000-$50,000) of the procedure for selected patients. A previous report in 2001 revealed that the procedure produced a high risk of death and little improvement in patients with the most severe degrees of emphysema which was widespread within their lungs. The NETT trial revealed that the effects of LVRS varied greatly among patients. Two characteristics, however, were found that helped predict the outcome from surgery--whether the disease was confined to the upper lobes of the lungs and the patient's exercise capacity. Those patients with emphysema mostly in their upper lobes with low exercise capacity after pulmonary rehabilitation but prior to surgery were most likely to live longer and function better after LVRS compared to a similar group who received medical therapy (including rehabilitation) alone. Comment: Lung reduction surgery in selected patients with emphysematous disease may result in improved pulmonary function, exercise capacity, and quality of life.

SPIRAL CT SCANS: TOO HIGH A PRICE?

A recent study from Johns Hopkins University School of Medicine, published in the The Journal of the American Medical Association analyzed the cost- effectiveness of spiral CT scans. These low dose x-rays scans have been shown to detect chest lesions that are not detectable by conventional x-rays. By detecting lung tumors when they are small, this technique has been found to improve survival from lung cancer. The scans may also produce "false-positive" results by revealing non-malignant lesions. The Johns Hopkins study estimated that there would be a 13% reduction in mortality from lung cancer if 100,000 current or heavy smokers were scanned once a year, starting at age 60. There would also be more than one thousand false-positive results, requiring unnecessary biopsies. The screening program would end up costing $116,300 per year of life saved for current smokers and $2.3 million per year for former smokers. The researchers concluded that the price was too high.

CIGARETTES FOR DEPRESSION?

A new study reports that cigarette smoking may have effects on the human brain similar to those of antidepressant drugs. This may explain the high rate of smoking among depressed people as well as their resistance to quitting. The study could not conclude if it was nicotine or other chemicals received during smoking directly affected the brains of those who were depressed. In this study, researchers found that the brains of long-term smokers had neurochemical abnormalities similar to the brains of animals treated with antidepressant drugs. Comment: Other investigators (see "The Breathing Disorders Sourcebook", page 192) have suspected that many individuals have unknowingly used nicotine through cigarette smoking as an antidepressant and this study provides scientific evidence. The results would also explain why antidepressant drugs can be helpful in smoking cessation.

ANTIOXIDANT VITAMINS LINKED TO HEALTHY LUNGS

Antioxidant vitamins include beta carotene, vitamin C, and vitamin E. When the body's cells burn oxygen, by-products called oxygen-free radicals are formed. These free radicals can damage tissue, and have been implicated in heart and lung disease as well as malignancy. Antioxidants work as scavengers, mopping up free radicals and converting them to harmless waste products. According to the results of a new study, having higher levels of vitamin E in the blood may protect the lungs, Reuters Health reported on May 7. In a study of 1,616 people aged 35 to 79, all of whom were free of respiratory illness, investigators found that people with high levels of vitamin E and beta-cryptoxanthin--a pigment found in oranges that is a member of the carotenoid family of nutrients--had healthier lungs than patients with lower levels, according to the report in the April issue of The American Journal of Respiratory and Critical Care Medicine. In addition to vitamin E and beta-cryptoxanthin, the researchers also found that low levels of vitamin C, vitamin A, lutein, beta-carotene and lycopene were associated with decreased lung function, according to the report.

OBESITY LINKED TO POOR LUNG FUNCTION

A new study reveals that increased abdominal body fat combined with decreased muscle mass during the aging process significantly reduces lung function in elderly men. The study looked at 97 Italian men, aged 67 to 78, and found that those who were obese had lower lung capacities. Men with greater amounts of muscle mass were found to have higher lung capacities. The researchers concluded that staying active and avoiding weight gain contributed to the maintenance of healthy lung function. Comment: Although this study targeted elderly men, the results should be applicable to the entire population. As belly fat increases, upward pressure on the diaphragm reduces lung capacity. An active lifestyle improves muscle mass which contributes to lung health. Plan to reduce excess weight and to walk for at least 20 minutes, three times a week.

INHALED STEROIDS SAFE AND EFFECTIVE FOR CHILDREN

A 5-year, 8-center study funded by the NIH and published in the New England Journal of Medicine, shows that inhaled corticosteroids are safe and effective for the long-term treatment of children with mild to moderate asthma. Asthma affects nearly 5 million children in the United States and childhood asthma is a leading cause of school absences. In the study noted, inhaled steroids provided superior control of asthma compared to a non-steroidal anti-inflammatory medication. The only adverse effect was a temporary one--a small reduction in the children's growth rate observed only in the first year of treatment. A second study published in the same journal found that the children attained normal adult height. Comment: Previous, smaller studies have suggested that inhaled corticosteroids might impair growth rates but this larger, long-term study confirms that these agents are safe and effective in children. Physicians and parents should feel comfortable using them.

ASTHMA MEDICATIONS DURING PREGNANCY

A joint position statement from the American College of Allergy, Asthma and Immunology (ACAAI) and the American College of Obstetricians and Gynecologists reports that pregnant women with asthma should continue to take their regular asthma medication, and should be carefully monitored throughout the pregnancy. The position statement covers newer asthma and allergy medications. The leukotriene inhibitors (Singulair, Accolate) are the only drugs for which there is too little data to make any recommendation except to suggest that they not be used during pregnancy unless absolutely necessary. The report also recommends that pregnant asthmatics avoid cigarette smoke, asthma triggers, and allergens. Comment: Uncontrolled asthma increases the risk of complications during pregnancy including miscarriage and premature birth. This report reaffirms the safety of the regular use of asthma medications during pregnancy.

RADON AND SMOKING

A recent report in Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC) states that smokers, who are at highest risk from radon exposure, are the least likely to test their homes for the presence of radon. Radon is a radiation-decay product that has been found sporadically in significant levels in residental dwellings. The report found that the combination of smoking and radon exposure raised the risk of lung cancer to very high levels. Eliminating excess radon exposures would prevent approximately 30% of radon-attributable lung cancer deaths, 86% of which occur among smokers, according to the report. Comment: This report clearly indicates that smokers should test their homes for radon exposure in addition to stopping smoking, to reduce the risk of lung cancer.

SMOKING CAUSES GENETIC DAMAGE

A recent report reveals that smokers, particularly those who started at a young age, have damage to their DNA that can lead to lung cancer. This genetic injury persists even after stopping smoking. Despite this, numerous studies have documented immediate and delayed health benefits after stopping, so that smokers should quit as soon as possible. In addition, the risk of lung cancer is less among former smokers than in active smokers.

ASTHMA CASES CONTINUE TO RISE

It is now estimated that 17.3 million Americans have asthma. Between 1980 and 1994 the prevalence of asthma in this country increased 75%. California has the largest estimated asthmatic population (2.27 million) followed by New York (1.24 million) and Texas (1.18 million). These statistics were published by the American Lung Association and the National Center for Environmental Health. A major survey on asthma reports that one in three children with asthma had to go to an emergency room because of an asthmatic attack in the past year. The survey also reported that 41 percent of all asthma patients, nearly six million Americans, were hospitalized, treated in emergency rooms or required other urgent care for asthma in the past year. The survey, which was funded by Glaxo Welcome Inc., concluded that the nation is falling far short of new government guidelines for asthma care and that for many people, a generally controllable disease is out of control.

PREVENTING STEROID-INDUCED OSTEOPOROSIS

The American College of Rheumatology has issued guidelines to help prevent osteoporosis in patient who receive long-term corticosteroids. More than 30 million Americans have disorders that may require treatment with corticosteroids. Patients with severe persistent bronchial asthma often require long-term use of corticosteroids for control. Steroids impair bone health when taken orally or by injection on a regular basis. They interfere with calcium absorption from foods and increase the amount of calcium lost through the kidneys. When calcium levels fall, calcium must be mobilized from the bone to return blood levels to normal, thereby reducing bone mass(osteoporosis). Corticosteroids also activate cells that break down bone called osteoclasts and inhibit bone forming cells called osteoblasts. The end result is bone breakdown and increased risk of fractures. Another important steroid effect on bone is through the reduction in production of sex hormones. Steroids suppress both estrogen and testosterone with the result of reducing bone density in both men and women. Steroid-induced osteoporosis is not associated with aging and may even affect children. The guidelines include recommendations that those receiving corticosteroids consume at least 1,500 milligrams of calcium and 800 international units of vitamin D a day, either through diet or supplements. In addition, patients should exercise regularly and avoid smoking and excessive alcohol use. Weightbearing exercises such as walking are preferred. Estrogen is recommended for women at or past menopause. Men receiving corticosteroids should have their testosterone level measured and may benefit from replacement therapy. Lastly, a bone density measurement is recommended for anyone starting a long course of corticosteroid.