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| |  Ipratropium Bromide Improves Sleep In COPD Patients RIDGEFIELD, CT -- May 14, 1999 -- A new publication in this month’s issue of the medical journal Chest provides evidence that ipratropium bromide solution may improve nocturnal arterial oxygen saturation (SaO2) and sleep quality in patients with moderate to severe chronic obstructive pulmonary disease (COPD). COPD is a smoking-related lung disease characterised by airflow obstruction and includes chronic bronchitis and emphysema. The National Center for Health Statistics reports there are an estimated 30 million Americans, or 15 percent of the U.S. adult population, who may be affected with COPD. Just over half, or 16 million, have been diagnosed with COPD, the fourth-leading cause of death in the U.S. Ipratropium bromide is a unique anticholinergic agent and an active ingredient in three FDA-approved bronchodilators: Boehringer Ingelheim Pharmaceuticals, Inc.’s Atrovent(R) (ipratropium bromide) Inhalation Solution, Atrovent(R) (ipratropium bromide) Inhalation Aerosol, recommended by the American Thoracic Society as first-line maintenance therapy in the treatment of COPD, and Combivent(R)(ipratropium bromide/albuterol sulfate) Inhalation Aerosol. Poor sleep quality related to symptoms is common in patients with COPD. In addition, several clinical studies have shown that patients with COPD are at risk of experiencing decreased SaO2 during sleep (nocturnal oxygen desaturation), mostly during the period of REM (rapid eye movement) sleep. Nocturnal oxygen desaturation can lead to pulmonary hypertension, a potentially fatal condition. The researchers theorise that increases in cholinergic tone during sleep-related hours may be a contributing factor in nocturnal oxygen desaturation and disturbed sleep in COPD patients. Therefore, the study results suggest that the anticholinergic agent ipratropium bromide may help improve these symptoms as well as provide effective bronchodilation in patients with COPD. The article describes a multi-centre, randomised, placebo-controlled and double-blinded study in 36 patients (ages 40 to 75 years old) with COPD. The study had two parallel four-week treatment arms; with 18 patients receiving ipratropium bromide solution 0.02% (IB) and the other half receiving placebo. Both treatments were administered four times daily via nebulizer. Evaluations were made using serial polysomnography, pulmonary function and assessment of perceived sleep quality using a visual analog scale (VAS) of zero to 10, with 10 being the highest score. Mean nocturnal SaO2 was significantly improved in the IB group compared to placebo after the first dose (92.7 percent +/- 0.4 versus 91.4 percent +/- 0.4) and after four weeks of treatment (92.8 percent +/- 0.5 versus 91.5 percent +/- 0.4). Interestingly, patients with the greatest oxygen desaturation at baseline experienced the greatest improvements in SaO2 levels. When asked "How did you sleep last night?", there was a significant improvement in perceived sleep quality with the group receiving ipratropium bromide compared to placebo (VAS: 7.2 +/- 0.5 versus 5.5 +/- 0.5). Sleep quality was most improved in those patients reporting poor sleep quality at baseline prior to therapy. A significant increase in REM sleep time was observed in the IB group compared to placebo (66.5 +/- 6.4 minutes versus 48.6 +/- 6.3 minutes). After four weeks of treatment, total sleep time increased and there was a trend toward fewer awakenings and arousals per hour in the IB group, but these measures did not reach statistical significance compared to placebo. At the end of the treatment period, evaluation of pulmonary function using spirometry showed a statistically significant improvement in the IB treatment group in increase in predose, pre-sleep FVC (3.40 +/- 0.10 versus 3.03 +/- 0.10) and flow rate at 50 percent of the vital capacity (0.66 +/- 0.04 versus 0.51 +/- 0.04) compared to placebo. There were no significant differences in morning-after, predose spirometry indexes. Most adverse events, such as headache, nervousness and dry mouth, were mild in nature and short in duration. "These findings demonstrate that ipratropium bromide can improve nocturnal arterial oxygen levels, REM sleep and perceived sleep quality in patients with COPD," said Richard Martin, MD, head of the pulmonary division, National Jewish Medical and Research Centre and professor of medicine at University of Colorado Health Sciences Centre, Denver, CO. "Ipratropium therapy should therefore be considered in treatment of these patients." Larger clinical studies are needed to further confirm these findings.
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