Safety of @entity10453 in the maintenance treatment of XXXX .

@entity1 @entity565 @entity3045 @entity102 @entity551 @entity1540 @entity10453 @entity2263 @entity10 @entity204 @entity13521
BACKGROUND: @entity10453 is the first long-acting inhaled @entity2263 -agonist available in the US for the maintenance treatment of @entity565 . OBJECTIVE: To compare the safety of @entity10453 with that of the short-acting @entity2263 -agonist @entity3045 . METHODS: Two identically designed, prospective, randomized, double-blind, parallel studies were conducted comparing @entity10453 42 micrograms twice daily, @entity3045 180 micrograms four times daily, and placebo over 12 weeks in 556 @entity1 (12 to 73 years old) with mild-to-moderate @entity102 . @entity1 in each treatment group could use @entity3045 as needed to control acute symptoms. RESULTS: The incidence of potentially drug-related adverse events was similar among the treatment groups (range: 22% to 23%), with @entity10 being the most commonly reported (range: 9% to 10%). No @entity204 occurred during the studies. Concomitant use of > 4 puffs of supplemental @entity3045 per day in the @entity10453 group produced no increase in the incidence of adverse events either in general or of a cardiovascular nature. There were no statistically significant differences among treatment groups or clinically significant changes from pretreatment values in mean pulse rate, @entity551 , or clinical laboratory values after 12 weeks. There were no clinically significant differences among groups in heart rates nor were there differences in the frequency of supraventricular or @entity1540 during 24-hr Holter monitoring. The frequency of @entity565 exacerbations was lowest among @entity1 receiving @entity10453 (and highest among those who received placebo), and this rate did not increase over the 12 weeks. @entity565 exacerbations were treated successfully with nebulized @entity3045 (2.5 mg), with no evidence of any increased risk of cardiovascular events. CONCLUSIONS: @entity10453 42 micrograms twice daily is well-tolerated in @entity1 with @entity565 , having a similar safety profile as that of @entity3045 180 micrograms inhaled four times daily or placebo (plus as-needed @entity3045 ). Concomitant use of @entity3045 , either by @entity13521 or nebulization, did not affect the safety of @entity10453 . Extensive cardiovascular monitoring revealed no significant cardiovascular adverse effects or arrhythmogenic effects associated with @entity10453 over 12 weeks.
