New asthma drugs, devices available
Several new drugs and devices have become available for the treatment of asthma in recent months, including:
· Zyflo (zileuton), a preventive drug from Abbott Park, IL-based Abbott Laboratories, is now available to patients older than 12. Zyflo is part of a new class of drugs that inhibit the formation of leukotrienes, molecules that contribute to the inflammation, swelling, bronchoconstriction, and mucus secretion seen in the airways of asthma patients.
Given in 600 mg tablets four times a day, Zyflo reduces asthma symptoms, decreases the need for inhaled steroids and beta-agonists, and improves lung function. It is not intended for treatment of acute asthma episodes. In clinical trials involving 5,500 patients, daytime symptoms improved by 36% and night-time symptoms by 31%. Sixty-two percent fewer patients required a steroid rescue.
The most significant side effect in clinical trials was upset stomach. Also, some patients experienced elevations in liver function tests. Patients on Zyflo should have their liver function tested prior to taking the drug and periodically thereafter. Those with active liver disease or elevated liver enzymes should not take Zyflo. Doses of theophylline, warfarin, and propranolol should be adjusted and patients monitored when taking Zyflo.
· Singulair (montelukast sodium), a leukotriene blocker from Merck & Co. of Whitehouse Station, NJ, was approved by the Rockville, MD-based U.S. Food and Drug Administration in February. The drug improves asthma control by significantly decreasing asthma attacks, preventing daytime and night-time symptoms, and reducing reliance on other asthma medicines such as quick-relieving bronchodilators. Some patients may be able to gradually reduce their use of inhaled steroids while taking Singulair, but they should not abruptly substitute it for oral or inhaled corticosteroids. They also should not use it to relieve an acute asthma episode.
Mild side effects
The drug is taken once a day in a 10 mg tablet for adults and a 5 mg cherry-flavored chewable tablet for children ages 6 to 14. In clinical trials of more than 3,000 patients, side effects were usually mild and included headache, influenza, and abdominal pain. There was no increase in side effects with extended treatment. In the trials, 81% of patients reported they felt better. They suffered 37% fewer asthma attacks and experienced 42% more days and nights with asthma under control.
· Pulmicort Turbohaler, from Astra USA Inc. of Westborough, MA, is the first corticosteroid dry powder inhaler available in the United States. The device's inhalation-driven system delivers the medication without the use of propellant gases such as chlorofluorocarbons.
It treats airway inflammation for patients who require oral corticosteroid therapy. When patients close their lips around the mouthpiece and breathe in, air drawn through the device delivers a fine dry powdered medication into the lungs. No coordination is required between activating the device and inhaling. Pulmicort Turbohaler contains 200 doses and a dose indicator that shows when the device is empty. Dosage is twice daily.
In clinical trials involving 1,300 patients, those using 200 mcg of Pulmicort Turbohaler twice daily for 12 weeks were able to reduce their use of bronchodilators for acute episodes by about 50%. Night-time symptoms also improved by 50%. Side effects include respiratory infection and headache.
Inhalation device corrects dosing
· The new SmartMist Respiratory Management System from Hayward, CA-based Aradigm Corp. acts as an inhalation device and a peak flow meter. Since many patients have difficulty getting the appropriate amount of medication to their lungs with standard metered dose inhalers, this device uses red and green lights to guide patients to inhale correctly. When the desired flow rate is established, the device automatically dispenses the drug. In clinical trials, patients achieved the correct dosing more than 90% of the time, compared with 45% of the time when using standard metered dose inhalers. The SmartMist device also monitors patient compliance by electronically recording dosing events and peak flow rates and storing them on a computer chip that can be downloaded for review by the physician.
[For more information, contact:
· Abbott Laboratories, Abbott Park, IL. (Zyflo.) Telephone: (847) 935-3456.
· Merck & Co., Whitehouse Station, NJ. (Singulair.) Telephone: (908) 423-1000.
· Astra USA Inc., Westborough, MA. (Pulmicort Turbohaler.) Telephone: (508) 836-8398.
· Aradigm Corp., Hayward, CA. (SmartMist Respiratory Management System.) Telephone: (510) 783-0100.]
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