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Multicenter, Randomized, Double-Blind, Placebo-Controlled Study on the Effect of Oral Tolvaptan on Left Ventricular Dilation and Function in Patients With Heart Failure and Systolic Dysfunction

James E. Udelson, MD^_*,_*, Frank A. McGrew, MD, Enrique Flores, MD, Hassan Ibrahim, MD, Stewart Katz, MD^¶, Gregory Koshkarian, MD^||, Terrence O'Brien, MD^_**, Marvin W. Kronenberg, MD, Christopher Zimmer, MD, Cesare Orlandi, MD and Marvin A. Konstam, MD^_*

^_* Division of Cardiology, Tufts-New England Medical Center/Tufts University School of Medicine, Boston, Massachusetts
The Stern Cardiovascular Center, Memphis, Tennessee
Georgia Heart Specialists, Covington, Georgia
North Ohio Research Ltd., Sandusky, Ohio
^¶ Yale University School of Medicine, New Haven, Connecticut
^|| Desert Cardiology of Tucson, Tucson, Arizona
^_** Ralph H. Johnson VA Medical Center, Charleston, South Carolina
Division of Cardiovascular Medicine, Vanderbilt University, Nashville, Tennessee
Otsuka America Pharmaceutical, Inc., Rockville, Maryland

View larger version (20K): [in this window] [in a new window] [Download PPT slide]   Figure 1 Effect of TLV on Time to Death or Heart Failure Hospitalization Time-to-event analysis evaluating patients randomized to tolvaptan (TLV) (red line) versus placebo (PLC) (blue line) with regard to death or hospitalization for worsening heart failure. There was a favorable effect of TLV on this combined end point.

View larger version (20K): [in this window] [in a new window] [Download PPT slide]   Figure 2 Effect of Tolvaptan and Placebo on VP Levels During the Course of the Trial Histogram of changes in vasopressin (VP) levels from baseline to week 54 (in pg/ml) for patients randomized to tolvaptan (open bars) or to placebo (cross-hatched bars). Group changes were significant (Table 7). The histogram of the changes in individual patients shows a shift to the right, which is consistent with the significant increase in the patients randomized to tolvaptan, as shown in Table 7.