PHILADELPHIA, Sept. 25 /PRNewswire/ — 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(1). 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.
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