|
 |
Volume 3 Issue 154 Published - 14:00 UTC 08:00 EST 7-Sep-2001 Next Update - 14:00 UTC 08:00 EST 8-Sep-2001
| Editor: Susan K. Boyer, RN © RAmEx Ars Medica, Inc. All rights reserved. |
|
|
 Novel Drug Demonstrates Ability To Reverse Stiffening Of Arteries That Occurs With Aging
A study published today in the American Journal of Respiratory Critical Care Medicine is the first to compare the safety and efficacy of new Advair(TM) Diskus(R) 100/50 (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) twice daily with Singulair(R)* 10mg (montelukast) once daily as initial maintenance therapy. The study demonstrated that Advair Diskus 100/50 was superior to Singulair 10 mg in improving lung function, reducing asthma symptoms, reducing rescue albuterol use, and reducing the number of asthma exacerbations in patients who were symptomatic on short-acting beta(2)-agonists (e.g., albuterol) alone. The study also found significantly greater improvements in morning PEF (peak expiratory flow), a standard measure of lung function, with Advair Diskus 100/50 compared with Singulair 10 mg in patients with milder asthma (FEV(1) > or equal to 70 percent predicted normal at study entry) as well as those with more moderate asthma (FEV(1) < 70 percent predicted normal at study entry). (FEV(1), forced expiratory volume in one second, is another standard measure of lung function.) Both inflammation and bronchoconstriction play crucial roles in causing asthma symptoms such as shortness of breath, wheezing, chest tightness, and cough. Optimal therapy for many asthma patients requires treatment of both of these components. "The study demonstrated that treating the two main components of asthma -- inflammation and bronchoconstriction -- with the lowest strength of Advair Diskus was a more effective initial maintenance treatment than Singulair, a single-agent therapy," said William J. Calhoun, MD, director of the asthma program at the University of Pittsburgh Medical School and lead author of the study. Advair Diskus treats the two main causes of asthma symptoms in one device. Advair Diskus does not replace fast-acting inhalers for the treatment of sudden symptoms. Study Details A 12-week, randomized, double-blind, double-dummy, multicenter study was conducted in 423 patients 15 years of age and older. Eligible patients had a baseline FEV(1) that was 50-80 percent of predicted normal and were uncontrolled on short-acting beta(2)-agonists alone (taking an average of 4-5 puffs of albuterol per day at baseline). The study showed that Advair Diskus 100/50 twice daily was significantly more effective than Singulair 10 mg once daily at: Improving lung function: Patients taking Advair Diskus 100/50 had twice as great an improvement in FEV(1) (0.54L, a 23 percent increase from a baseline of 2.46L) compared with those taking Singulair 10 mg (0.27L, an 11 percent increase from a baseline of 2.40L) at study endpoint. Reducing asthma symptoms: At baseline, patients in both treatment groups reported a low number of symptom-free days (3.9 percent and 5.8 percent of days for Advair Diskus 100/50 and Singulair 10 mg, respectively). At the end of the study, patients treated with Advair Diskus 100/50 had nearly twice as many symptom-free days (52.8 percent) as patients treated with Singulair 10 mg (27.5 percent). Reducing rescue albuterol use: At baseline, patients in both treatment groups reported a low number of rescue-free days (5.9 percent and 6.8 percent of days for Advair Diskus 100/50 and Singulair 10 mg, respectively). At the end of the study, patients treated with Advair Diskus 100/50 had nearly twice as many rescue-free days (58.9 percent) as patients treated with Singulair 10 mg (33.0 percent). Asthma exacerbations: No patients receiving Advair Diskus 100/50 experienced an exacerbation during the study period, compared with 11 patients (5 percent) receiving Singulair 10 mg. Likewise, in a replicate study, more than twice as many (13, or 6 percent) patients receiving Singulair 10 mg experienced exacerbations as did patients treated with Advair Diskus 100/50 (six, or 3 percent). Advair Diskus 100/50 provided significantly greater improvements in AM PEF within the first day of treatment compared with Singulair 10 mg (43.7 L/min vs. 10.0 L/min), and the improvements in AM PEF progressively increased over the 12-week study. It is also important to note that at the end of the study, a significantly greater percentage of patients receiving Advair Diskus 100/50 (81 percent) reported that they were either satisfied or very satisfied with their study medication compared with those receiving Singulair 10 mg (58 percent). The overall incidence of adverse events was similar between groups (61 percent with Advair Diskus 100/50 and 62 percent with Singulair 10 mg). Twenty-five (12 percent) patients treated with Advair Diskus 100/50 and 17 (8 percent) patients treated with Singulair 10 mg experienced at least one adverse event during the study that was considered by the investigator to be potentially related to treatment. The most commonly reported drug-related adverse events (> or equal to 1 percent in any group) were headache (2 percent in both treatment groups) and hoarseness (2 percent with Advair Diskus 100/50). Advair Diskus is indicated for the long-term, twice-daily, maintenance treatment of asthma in patients 12 years of age and older. It is not indicated for the relief of acute bronchospasm. Advair does not replace fast-acting inhalers for the treatment of sudden symptoms and should not be taken more than twice a day. People switching from an oral steroid like prednisone to Advair, which contains an inhaled steroid, need to be especially careful. While adjusting to the switch, a person is not as able to heal after surgery, infection, or serious injury. Advair should be used with caution in patients with cardiovascular disorders. Some patients may experience an increase in blood pressure or heart rate or a change in heart rhythm. Patients should see their doctor if their asthma does not improve. References: 1. Boulet LP, et al. Comparison of Diskus inhaler, a new multidose powder inhaler, with Diskhaler inhaler for the delivery of salmeterol to asthmatic patients. J Asthma 1995;32(6):429-436. 2. Calhoun W, et al. First-line maintenance therapy in asthma: fluticasone propionate/salmeterol combination vs montelukast. Am J Respir Crit Care Med 2001;164(5):759-763. |
||