Sep 27 2010
Today Astellas Pharma US, Inc. ("Astellas") announced results of a Phase IV study showing Lexiscan® (regadenoson) Injection was comparable to placebo in causing a >15% decrease in forced expiratory volume in one second (FEV1) in subjects with asthma or chronic obstructive pulmonary disease (COPD) who are likely candidates for myocardial perfusion imaging (MPI) studies. Results were presented during an oral presentation today at the 15th Annual Scientific Sessions of the American Society of Nuclear Cardiology (ASNC) in Philadelphia, Pennsylvania during a session highlighting late-breaker data.
Statistically, regadenoson was found to be not significantly different from placebo in causing a >15% decrease in FEV1 in patients with asthma (p = 0.1451) or COPD (p = 0.5790). Additionally, the change in FEV1 was not affected by baseline disease severity for either the asthma or the COPD subject groups.
Researchers evaluated 999 adult male and female patients (532 asthma and 467 COPD) 18 years of age and older in a multicenter, randomized, double-blind, placebo-controlled study to determine the safety and tolerability of regadenoson in subjects with asthma (FEV1 >60% predicted) or stable COPD (FEV1/FVC <0.70). The subjects had a diagnosis of CAD or risk factors for CAD as determined by a current medical diagnosis of at least two of the following conditions: Type 2 diabetes, hypertension, hypercholesterolemia, current or history of cigarette smoking (minimum 10 pack-years exposure) or obesity Body Mass Index (BMI > 30). A 2:1 randomization to receive a single 10-second IV injection of Lexiscan 0.4 mg (in 5 mL) or placebo was used.
Treatment-emergent adverse events were similar in frequency and severity to those observed in previous studies of regadenoson. Two regadenoson subjects in the COPD group received aminophylline for treatment of adverse events.
SOURCE Astellas Pharma US, Inc.
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