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Comparison of the Efficacy of Dihydropyridine Calcium Channel Blockers in African American Patients With Hypertension
W. Dallas Hall, MD;
James W. Reed, MD;
John M. Flack, MD, MPH;
Carla Yunis, MD, MPH;
John Preisser, PhD;
and the ISHIB Investigators Group
Arch Intern Med. 1998;158:2029-2034.
Background Hypertension is a prevalent disease among African Americans, and successful treatment rates are low. Since calcium channel blockers are well-tolerated and efficacious in African Americans, we undertook this study to compare the efficacy, safety, and tolerability of 3 commonly prescribed calcium channel blockers: amlodipine besylate (Norvasc), nifedipine coat core (CC) (Adalat CC), and nifedipine gastrointestinal therapeutic system (GITS) (Procardia XL).
Methods One hundred ninety-two hypertensive patients across 10 study centers were randomly assigned to double-blind monotherapy with amlodipine besylate (5 mg/d), nifedipine CC (30 mg/d), or nifedipine GITS (30 mg/d) for 8 weeks. Patients not achieving therapeutic response after 4 weeks had their dose doubled for the next 4 weeks. The primary end point was a comparison of the average reduction (week 8 minus baseline) in 24-hour ambulatory diastolic blood pressure (DBP). Secondary end points included a comparison of average 24-hour ambulatory systolic blood pressure (SBP), office SBP or DBP reduction, responder rates, safety, and tolerability.
Results One hundred sixty-three patients were evaluable for efficacy after 8 weeks. There was no significant difference in the average 24-hour ambulatory DBP (-8.5, -9.0, and -6.1 mm Hg, respectively) or SBP (-14.3, -15.7, and -11.8 mm Hg, respectively) reduction. Average office SBP and DBP were reduced to a comparable degree (19-22 mm Hg [P=.50] and 12-14 mm Hg [P=.51], respectively). Responder rates (DBP <90 or reduced by  10 mm Hg) were similar (P=.38). Discontinuation rates and adverse event frequency were distributed similarly across the 3 treatment groups.
Conclusion The efficacy, safety, and tolerability of the 3 dihydropyridine calcium channel blockers are equivalent in African Americans with stages 1 and 2 hypertension.
From the Departments of Medicine, Emory University School of Medicine (Dr Hall) and Morehouse School of Medicine (Dr Reed), Atlanta, Ga, and Wayne State University School of Medicine, Detroit, Mich (Dr Flack); and the Departments of Medicine (Dr Flack) and Public Health Sciences (Drs Yunis and Preisser), Bowman Gray School of Medicine, Winston-Salem, NC. Participants in the ISHIB Investigators Group are listed in the acknowledgments at the end of this article. Drs Hall and Reed are members of the Bayer Cardiovascular Advisory Board.
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