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J Am Coll Cardiol, 2007; 50:600-606, doi:10.1016/j.jacc.2007.03.059 (Published online 29 July 2007).
© 2007 by the American College of Cardiology Foundation
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Effects of Multiple Oral Doses of an A1 Adenosine Antagonist, BG9928, in Patients With Heart Failure

Results of a Placebo-Controlled, Dose-Escalation Study

Barry Greenberg, MD*,1,*, Ignatius Thomas, MD{dagger},2, Dorothy Banish, MD{ddagger}, Steven Goldman, MD§, Edward Havranek, MD||,3, Barry M. Massie, MD,4, Ying Zhu, PhD#,5, Barry Ticho, MD, PhD#,5 and William T. Abraham, MD**,6

* University of California, Advanced Heart Failure Treatment Program, San Diego, California
{dagger} Medical Research Institute, Slidell, Louisiana
{ddagger} Tchefuncte Cardiovascular Associates, Covington, Louisiana
§ Tucson VA Medical Center, SAVAHCS, Sarver Heart Center, and University of Arizona, Tucson, Arizona
|| Denver Health Medical Center, Denver, Colorado
University of California and San Francisco VA Medical Center, San Francisco, California
# Biogen Idec Inc., Cambridge, Massachusetts
** The Ohio State University Heart Center, Division of Cardiology, Columbus, Ohio.


Figure 1
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  		Figure 1 Schematic Illustration of Study Design and Assessments

Timing and hourly intervals for assessments are described in the text. *Inpatient stays until 4 h after second and seventh dose and 32 h after tenth dose. {dagger}Also collected on day 16. {ddagger}Assessment hourly intervals at baseline: 0 to 4, 4 to 8, 8 to 12, and 12 to 24; on days 1, 6, 10, and 16: 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24. §Collection hourly intervals at baseline: 0 to 4, 4 to 8, 8 to 12, and 12 to 24; on days 1, 6, 10: 0 to 2, 2 to 4, 4 to 8, 8 to 12, and 12 to 24; on day 11: 28 h to 32 h after last dose. ||Collection hourly intervals at baseline: 0, 4, 8, 12, and 24; on days 1, 6, and 10: 2, 4, 8, and 12; on days 4 and 8: 0; on day 11: 4 and 8. NYHA = New York Heart Association; PGA = Physician’s Global Assessment; PO = per os (by mouth).

 

Figure 2
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  		Figure 2 Cumulative Urinary Sodium Excretion During Dosing

Cumulative urinary sodium excretion (mEq) over the interval of 0 to 8 h at baseline and after placebo or BG9928 administration on days 1, 6, and 10. *p < 0.05 versus placebo. {dagger}p = 0.055 versus placebo. n = 10/group except for 15- and 75-mg dose groups on day 10 (n = 9/group).

 

Figure 3
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  		Figure 3 Cumulative Urinary Potassium Excretion During Dosing

Cumulative urinary potassium excretion (mEq) over the interval of 0 to 8 h at baseline and after placebo or BG9928 administration on days 1, 6, and 10. *p < 0.05 versus placebo. n = 10/group except for 15- and 75-mg dose groups on day 10 (n = 9/group).

 

Figure 4
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  		Figure 4 Change in Renal Function During Dosing

Absolute change from baseline in adjusted creatinine clearance (CrCl) (ml/min/1.73 m2) for the interval of 2 to 24 h after placebo or BG9928 administration on days 1, 6, and 10. *p < 0.05 versus placebo. n = 7 to 10 per group.

 

Figure 5
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  		Figure 5 Change in Body Weight During Dosing

Average change in body weight (kg) from baseline to day 11 after placebo or BG9928 administration. n = 10/group.

 




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Copyright © 2007 by the American College of Cardiology Foundation.