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Efficacy and Safety of Fasudil in Patients With Stable Angina

A Double-Blind, Placebo-Controlled, Phase 2 Trial

Ralph M. Vicari, MD, FACC^_*,_*, Bernard Chaitman, MD, FACC, Deborah Keefe, MD, MPH, FACC, William B. Smith, MD, FACC, Steven G. Chrysant, MD, PhD, FACC^||, Melvin J. Tonkon, MD, FACC^¶, Neville Bittar, MD, FACC^#, Robert J. Weiss, MD, FACC^**, Hugo Morales-Ballejo, MD, FACC, Udho Thadani, MBBS, MRCP, FRCPC, FACC for the Fasudil Study Group

^_* MIMA Century Research Associates, Melbourne, Florida
St. Louis University, St. Louis, Missouri
Berlex, Inc., Montville, New Jersey
New Orleans Center for Clinical Research, New Orleans, Louisiana
^|| Oklahoma Cardiovascular and Hypertension Center, Oklahoma City, Oklahoma
^¶ Apex Research Institute, Santa Ana, California
^# Gemini Scientific, Madison, Wisconsin
^** Androscoggin Cardiology Associates, Auburn, Maine
VA Medical Center, University of Oklahoma Health Science Center, Oklahoma City, Oklahoma

View larger version (10K): [in a new window]   Figure 1 Schematic diagram of the study design. Exercise testing (X) was performed before dosing (trough), 1 h after dosing (peak), and 4 h after dosing of both fasudil and matching placebo tablets. tid = three times daily.

View larger version (27K): [in a new window]   Figure 2 Patient disposition during the study.

View larger version (22K): [in a new window]   Figure 3 Changes in exercise treadmill testing duration from baseline at peak for fasudil- (solid bars) and placebo-treated (open bars) patients (mean ± standard deviation). tid = three times daily.

View larger version (20K): [in a new window]   Figure 4 Changes in mean time to 1 mm ST-segment depression from baseline for fasudil- (solid bars) and placebo-treated (open bars) patients. *p = 0.001. tid = three times daily.

View larger version (18K): [in a new window]   Figure 5 Improvements in angina by 1 Canadian Cardiovascular Society angina class in patients treated with fasudil (solid bars) and placebo (open bars). tid = three times daily.

View larger version (18K): [in a new window]   Figure 6 Improvement in Seattle Angina Questionnaire score. (A) Physical limitation scale. (B) Treatment satisfaction scale. *p < 0.05. tid = three times daily. Open bars = placebo; solid bars = fasudil.